By Megan Rauscher

NEW YORK (Reuters Health) – Women who accept their bodies,
flaws and all, are more likely to eat healthily or intuitively,
new research shows. This suggests that women’s typical reasons
for dieting — dissatisfaction with their bodies — may
backfire.

“There is a lot of negative body talk among women; women
think that they can best lose weight and feel better if they
are first dissatisfied with their bodies,” Dr. Tracy Tylka told
Reuters Health. “Rather, this research shows that adopting a
positive body image is more likely to be associated with
intuitive eating.”

Intuitive eaters don’t diet — they recognize and respond
to internal hunger and fullness cues to regulate what and how
much they eat, Tylka explained. Intuitive eating has three
components: “unconditional permission to eat when hungry and
whatever food is desired; eating for physical rather than
emotional reasons; and reliance on internal hunger/fullness
cues.”

Tylka, an assistant professor of psychology at Ohio State
University’s Marion campus has conducted several studies on the
concept of intuitive eating. In one study published in April
involving 199 college-aged women, Tylka found that women who
followed intuitive eating principles had a slightly lower body
weight than women who did not.

“Intuitive eating was negatively associated with body mass,
such that people who ate intuitively weighed less than people
who dieted,” she said.

In her latest studies presented this month at the American
Psychological Association meeting, Tylka and her colleagues
examined who was most likely to follow intuitive eating
principles.

They found, among nearly 600 college women, that those with
higher levels of appreciation and acceptance for their body
were more likely to be intuitive eaters.

Intuitive eaters spend less time thinking about how their
body appears to others and more time considering how their body
feels and functions, Tylka observed. They “perceive the body as
an agent of action rather than an object of
attraction…focusing on how the body functions rather than its
appearance,” Tylka told Reuters Health.

Intuitive eating, Tylka’s found, is “positively associated
with psychological well-being, such as self-esteem, positive
emotions, adaptive coping, self-acceptance, optimism, and
resilience in the face of stress.”

Intuitive eaters also reported receiving more positive
messages from parents and others regarding their bodies.

NEW YORK (Reuters) – A federal judge overturned a $50
million award handed down by jury against Merck & Co. earlier
this month in a case of a former FBI agent who had blamed the
withdrawn painkiller Vioxx for his heart attack, the Wall
Street Journal reported on its web site on Wednesday.

Merck did not immediately return phone calls seeking
comment.

A New Orleans jury in the federal trial had found that
Merck knowingly misrepresented or failed to disclose a material
fact regarding Vioxx safety to the plaintiff’s physician.

The jury on August 17 awarded 62-year-old Gerald Barnett
$50 million in compensatory damages and another $1 million in
punitive damages.

Merck, which pulled Vioxx from the market in September of
2004 after a study found the drug doubled the risk of heart
attack and stroke in long-term users, is facing more than
14,200 Vioxx product liability lawsuits.

INDIANAPOLIS, Aug. 29 /PRNewswire/ — UniCare Health Plan of Kansas, Inc. (UniCare) received a contract to provide health care benefits statewide to enrollees in the Kansas HealthWave programs — Title 19 (Medicaid) and Title 21 (State Children’s Health Insurance Program). UniCare is pleased with the opportunity to provide high-quality health benefits and community resources to a well qualified and an excellent department like the Kansas Health Policy Authority (KHPA) and Kansas Department of Administration, Division of Purchases.

The Kansas contract is the fourth Medicaid managed care award in the past two months to UniCare’s parent, WellPoint’s State Sponsored Business. The company was also selected for contracts in Indiana, Ohio, and Nevada.

UniCare is one of two vendors selected for this contract and is the only statewide vendor serving all three regions. There are approximately 160,000 HealthWave recipients, and UniCare expects to enroll approximately half of the recipients. Enrolled members will begin receiving health care benefits from UniCare and the other selected vendor on January 1, 2007.

“This latest award is recognition of our unique business model and our organization’s specialized ability to serve this vulnerable population,” said John Monahan, President, UniCare Health Plan of Kansas and State Sponsored Business for WellPoint, Inc. “Kansas HealthWave program administrators, providers, and recipients can trust in the strength and experience of UniCare to help improve health care quality and lower costs for Kansans.”

The HealthWave program provides access to hospital services, physicians, specialists, prescriptions, and vision benefits. UniCare members will receive additional benefits such as programs to aid in diabetes and obesity management and smoking cessation — benefits specifically designed to address high rates of these conditions in the Sunflower State.

UniCare will also open Community Resource Centers (CRCs) in Kansas. CRCs are a core component of our business model and are designed to provide local member outreach, health education, provider services, and other specialized programs. This innovative approach ensures that members and providers, in concert with UniCare, have a true managed care team with associates that live in the community, understand their needs and challenges, and share in the achievement of mutually beneficial outcomes. Additionally, UniCare is prepared to provide a smooth transition for new enrollees through its community-based model.

The contract is effective January 1, 2007 through June 30, 2011 with two 1-year renewal options.

WellPoint’s State Sponsored Business has more than a decade of expertise serving more than two million Medicaid managed care members and businesses in 11 states and the Commonwealth of Puerto Rico. Members have access to a wide network of health care providers as well as accredited, award winning health management programs.

The UniCare companies are wholly owned operating subsidiaries of WellPoint, Inc., the largest publicly traded commercial health benefits company in terms of membership in the United States. If the health plan is provided on a self-funded basis by the member’s employer, claims are administered by UniCare Life & Health Insurance Company, UniCare Health Plans of Texas, Inc. (HMO only in TX) or UniCare Health Plans of the Midwest, Inc. (HMO in IN and IL only). If the member’s health plan is insured or health maintenance organization coverage, the coverage is provided by one of the following companies: UniCare Life & Health Insurance Company, UniCare Health Insurance Company of the Midwest (IN and IL only), UniCare Health Plans of the Midwest, Inc. (HMO in IN and IL only), UniCare Health Plan of Virginia, Inc. (HMO only in Virginia), UniCare Health Insurance Company of Texas (TX only) or UniCare Health Plans of Texas, Inc. (HMO only in TX), each of which is a separately incorporated and capitalized subsidiary of WellPoint, Inc. UniCare can be found on the web at http://www.unicare.com/ . Not all UniCare products are available in all states where UniCare is marketed.

UniCare Health Plan of Kansas, Inc.

CONTACT: Tony Felts of UniCare, +1-317-287-6036,[email protected] ; or Leslie Porras of WellPoint, +1-805-557-6745,[email protected]

Web site: http://www.unicare.com/

By Emma Graham-Harrison

TONGXIN, China (Reuters) — Say “get rich” when you step
off a bus in the shabby northwestern Chinese town of Tongxin,
and a swarm of taxi drivers rush to offer their services.

None hopes to make a fortune, but for a few notes the
drivers are happy to guide visitors through a warren of muddy
backstreets to gated compounds where an illegal trade thrives.

But instead of dealing in guns or drugs, the criminals in
this corner of Ningxia province have caches of a tasteless
vegetable, prized only for the sound of its name.

Facai (pronounced fa-tsai) is a blue-green algae that grows
in the sandy semi-desert of western China, anchoring the fine
soil in place and retaining moisture to support other plants in
an area struggling to stop the desert expanding.

Its name sounds almost identical to characters meaning “get
rich,” making it popular — and extremely expensive — in
southern China, Hong Kong and cities with large ethnic Chinese
populations such as Singapore and New York.

Hunger for edible good luck is devastating China’s western
provinces, because it is harvested by raking up all the sparse
vegetation the facai grows among, leaving the sandy soil
exposed to the wind.

Dried and clumped together, its spindly black strands look
like a scouring pad or a head of very messy hair. Cooked, it
acquires the spongy texture of tree fungus, with a bland flavor
usually impossible to detect under heavy seasoning.

Groups of impoverished facai pickers, nicknamed “the
central fungus commission” in a bitter word play on the
all-powerful Central Military Commission in Beijing, then take
the bundles home to pick out the black strands and sell them on
to traders.

“The facai serves as a net that covers the sandy areas and
forms the base for other species to grow on,” said Lister
Cheung, chief executive of the Hong Kong Conservancy
Association which has been campaigning against eating facai for
several years.

“When it is collected they rake over sandy areas, and to
collect just one catty (21 ounces) they plow up the equivalent
of four to five football fields,” she added.

For that amount, a trader in Ningxia can earn almost as
much as the 300 yuan ($38) average monthly cash income for a
Chinese farmer.

Extra acres of exposed land contribute sand to the whirling
storms that each spring travel as far as the capital Beijing,
over 500 miles away, turning the air there as orange-yellow as
the Martian atmosphere in low-budget science-fiction films.

NO OPTIONS

This environmental devastation — and its visible impact on
the seat of China’s government — led to a ban on collection,
sale and export of the algae six years ago.

But the trade continues, centered on the predominantly
Muslim south of Ningxia because in one of the most
poverty-stricken regions of China residents have few other
options.

It is a land of dry river beds and scrappy exhausted hills.
One village, summing up a desperate thirst that has only
worsened with the mismanagement of recent years, is called
Hanjiaoshui, meaning “shout for water.”

Drug trading and use is rife, recurrent droughts make crops
fail regularly and even herding sheep and goats is strictly
controlled because their grazing speeds up desertification.

“It hasn’t rained for four years. How can I support my
family here?” said 22-year-old Ma Weijun, an unemployed father
squatting despondently beside his house outside the hamlet of
Xiamaguan.

Food handed out by the government to compensate for land
placed off limits by anti-desertification programs is of such
low quality only animals can eat it, other villagers say.

But the facai, which no one there will admit to picking,
sells for 400 yuan a kilogram (2.2 pounds) in nearby Tongxin.

It goes for five times that much in Hong Kong where it is
so prized that a double black market — for fake versions of
the illegal plant made from dyed seaweed or corn husks —
flourishes.

SELLERS FRET, DINERS ENJOY

The whole town knows where to buy the facai, but the ban
has pushed the trade underground and created a climate of fear.

A wholesale market, officially closed in 2000, is now
hidden down a maze of winding streets in the town’s
impoverished heart.

Sacks of facai in every stage of preparation from bundles
of grass to silky black bundles line the road. But there are no
Han Chinese or foreigners, and the Muslim traders block
photographs, grill outsiders and refuse to answer any
questions.

Even in the homes of wealthier middlemen, many of whom are
trying to shift into the wool trade, there is tension in the
air.

“I don’t do this any more, this is just the last of my
stock,” said one seller, glancing nervously at his courtyard
gate as he pulled bundles of the dried plant from a back room.

Only wealthy diners seem unconcerned and, ironically, the
ban and environmentalists’ campaigns have pushed up prices,
making it an even more prestigious treat for guests.

“We can’t eat it at home,” an official from one of the
city’s top state-owned firms explained at a dinner for foreign
visitors before popping a clump into her mouth.

“It’s expensive and it’s banned. But good for your health.”

($1 = 7.976 yuan)

By Ben Hirschler

LONDON (Reuters) – Childhood allergies are on the rise around the world, including in many developing countries where asthma, eczema and hay fever are emerging as important public health problems, scientists said on Friday.

Asthma, in particular, is responsible for millions of children missing school, ending up in hospital or even dying.

The underlying cause of the condition is inflammation of the airways but just what triggers the problem and why some people develop asthma and others do not is still poorly understood.

What is clear, however, is that more and more young children are suffering allergic disorders, with the prevalence of all allergies increasing notably in the past decade.

Researchers who carried out the International Study of Asthma and Allergies in Childhood in 1991 repeated the survey in 2002 and 2003 and found widespread increases in prevalence in 56 countries, especially among young children.

The study — details of which were published in the latest edition of the Lancet medical journal — surveyed parents of 193,000 children aged 6-7 years and 305,000 children aged 13-14 years in countries as diverse as South Africa, Brazil, Iran, Canada and Sweden.

The increases were greatest for eczema in the younger age group and for hay fever in both age groups. In the older age group, however, where prevalence of asthma had been high, there were some signs of decreases.

Nonetheless, in Britain — one of the developed countries with the worst allergy epidemics — asthma prevalence went up to 20.9 from 18.4 percent, hay fever increased to 10.1 from 9.8 percent and eczema to 16 from 13 percent between 1991 and 2003.

Professor Innes Asher of the University of Auckland, New Zealand, lead author of the study, said the rise in prevalence in many countries was “concerning,” especially as allergies often occurred in large population centres.

“Although changes in mean annual prevalence to the order of 0.5 percent might sound small, such changes could have substantial pubic health implications, especially since the increases took place most commonly in heavily populated countries,” he said.

Experts say a host of factors including air pollution, diet, lifestyle and exposure to bacteria in early life are likely to be linked to the rise in asthma and other allergies, but the reasons are likely to vary from place to place.

Given the diversity of the condition, the Lancet said in a editorial that asthma was in fact unlikely to be a single disease and the term should be abolished altogether.

A separate study published in the journal reinforced the benefits of combination medicines in tackling asthma.

Dr Klaus Rabe of Leiden University in the Netherlands said a 12-month study involving more than 3,000 people showed that giving asthma patients a top-up dose of AstraZeneca’s two-in-one drug Symbicort to relieve their symptoms was more effective than giving them a single drug top-up.

All patients in the study were already on a maintenance dose of Symbicort, which combines a corticosteroid with a long-acting beta agonist.

By Anne Harding

NEW YORK (Reuters Health) – A yellow jacket sting can be
more dangerous if a certain species of the insect is doing the
stinging, a new study shows.

Of the two most common yellow jacket species found in the
eastern US, Vespula maculifrons — which tends to live in large
underground nests — is much more likely to cause a systemic
reaction than is Vespula germanica, Dr. David B. K. Golden of
the Johns Hopkins Asthma and Allergy Center in Baltimore and
colleagues found.

This means that if a person with a history of severe
reactions to yellow jacket stings gets stung again without
reacting severely, the milder sting may simply have come from
the milder species — and doesn’t mean the person has outgrown
the allergy, Golden explained in an interview with Reuters
Health.

“What we hear from people is that ‘oh it was a fluke, it
will never happen again’,” he said. “That’s certainly not
something you can count on.”

A systemic reaction extends beyond the area where a person
was stung, and can range from mild responses such as
light-headedness to potentially fatal reactions such as
swelling that closes off the windpipe or a dramatic drop in
blood pressure.

Golden and his team initiated their study to determine why
some people react severely to yellow jacket stings and others
don’t. They tested reactions to yellow jacket venom in 111
healthy volunteers, who received a total of 175 sting
challenges over a three-year period, and report the results in
the Journal of Allergy and Clinical Immunology.

V. maculifrons was more likely to produce a systemic
reaction than V. germanica, the researchers found. And these
reactions were more common among people who had experienced
such a reaction previously. Among people with a history of
systemic reactions to yellow jacket stings, 41 percent had a
systemic reaction to V. maculifrons. But among those who had
not experienced systemic reactions in the past, just 3 percent
exhibited systemic reactions to V. germanica.

The findings show that even if a person has escaped a
severe reaction with a yellow jacket sting in the past, he or
she is not safe from having one in the future, the researchers
conclude.

Anybody who has suffered a severe reaction to a wasp, bee
or yellow jacket sting should be evaluated by an allergist,
Golden told Reuters Health, because immunization is available
for allergies to each type of venom that is 98 percent
protective against future severe reactions.

SOURCE: Journal of Allergy and Clinical Immunology,

WASHINGTON (Reuters) – U.S. health officials should halt sales of estrogen and testosterone combinations made by Solvay SA and Breckenridge Pharmaceutical to treat hot flashes, a women’s health group said on Tuesday.

The National Women’s Health Network, in a petition to the Food and Drug Administration, said sales of Solvay’s Estratest and Breckenridge’s Syntest should stop because they have never been proven safe and effective for relieving hot flashes associated with menopause.

Estratest has been available in the United States since 1964 but was never approved by the FDA, while Syntest has been sold since 1997, the group said.

In 2003, the FDA itself questioned the effectiveness of estrogen/testosterone combinations and said it was launching a formal inquiry into the products.

The women’s group said the FDA should tell the companies to stop selling the treatments until they provide evidence showing their safety and effectiveness.

“Despite a lack of efficacy for the labeled (use), Solvay and Breckenridge continue to circumvent the FDA regulatory process and market these products,” the petition said.

Use of either hormone alone is known to carry risks, the petition said. Estrogen may contribute to strokes, heart attacks, breast cancer and other problems. Testosterone’s risks include liver damage and fluid retention that can lead to high blood pressure or worsen heart failure.

Estratest sales totaled $119 million in North America in 2004, the women’s group said.

FDA spokeswoman Susan Cruzan said Solvay had asked for a hearing on Estratest and the agency was reviewing that request. A Solvay spokesman had no immediate comment.

Breckenridge President Larry Runsdorf said the company would study the petition and draft a response. “There have been studies that … seem to show the product is effective,” he said.

NEW YORK (Reuters Health) – Two cases of melioidosis, an
infectious disease caused by the bacterium Burkholderia
pseudomallei that is rare in the US, were reported to the
Florida Department of Health in 2005. Both patients had
recently visited or arrived from Honduras, where the disease is
endemic. One case resulted in paraplegia, and the other in
death.

In the CDC’s Morbidity and Mortality Report for August 18,
Dr. Aaron Kite-Powell, from the Broward County Health
Department in Florida, and his co-authors note that B.
pseudomallei infection usually manifests as pneumonia, but can
also cause septicemia and abscesses. Relapses are common, and
the infection can be reactivated years later.

B. pseudomallei is found in contaminated water and soil and
is spread to humans and animals through direct contact with the
contaminated source.

Risk factors for symptomatic disease include type 2
diabetes, renal or liver disease and chronic alcoholism.

The first Florida case, a 48-year-old man with a history of
diabetes and Guillain-Barre syndrome, presented at a hospital
in Broward County with back pain, fever, and weakness and
numbness in the legs. He had recently returned from a trip to
Honduras.

He began antibiotic therapy. B. pseudomallei was not
identified until the fifth day of his hospitalization, after
which he was discharged on antibiotic therapy.

Eleven days later, he returned with severe back and chest
pain, acute leg paralysis and loss of sensation. Imaging
studies revealed a spinal abscess, which was treated
surgically.

An 80-year old woman from Honduras was the second case. She
was hospitalized with pneumonia and fever, headache, weakness
and muscle pain. The next day she had a heart attack with
respiratory complications and died the following day. B.
pseudomallei was identified 4 days after her admission.

Follow-up showed that nine laboratory workers had been
exposed to B. pseudomallei under conditions considered to be
high risk, including handling the isolate outside of a
biosafety cabinet and sniffing an open culture plate.
Diagnostic serology showed that none of them were positive for
presence of the bacteria, and none reported symptoms.

SOURCE: Morbidity and Mortality Weekly Report, August 18,
2006.

By Nicolaides, A N; Fareed, J; Kakkar, A K; Breddin, H K; Et al

Disclaimer

Due to the evolving field of medicine, new research may, in due course, modify the recommendations presented in this document. At the time of publication, every attempt has been made to ensure that the information provided is up to date and accurate. It is the responsibility of the treating physician to determine best treatment for the patient. The authors, committee members, editors, and publishers cannot be held responsible for any legal issues that may arise from citation of this statement.

Evidence and grades of recommendation

We have used the following consistent method lor grades of recommendations in keeping with most other guidelines in this area,4 and first adopted by our group in 1999.

Grade A recommendations are based on Level 1 evidence from randomized controlled trials with consistent results (e.g., in systematic reviews), which are directly applicable to the target population. Single randomized controlled trials have not been accepted as Level 1 even when they were of a high quality and methodologically sound, and have been classified as Grade B.5-7

Grade B recommendations are based on Level 1 evidence from randomized controlled trials with less consistent results, limited power, or other methodological problems, which are directly applicable to the target population. Grade B recommendations are also based on Level I evidence from randomized controlled trials extrapolated from a different group of patients to the target population.

Grade C recommendations are based on Level 2 evidence from well- conducted observational studies with consistent results, directly applicable to the target population.

Recent proposals that a Grade C+ category be used instead of B for extrapolation from randomized trials and that A, B or C recommendations be prefaced by the Grade 1 or 2 according to the balance of benefits, risks and costs made by the “Seventh ACCP Conference of Anti-thrombotic and Thrombolytic Therapy: Evidence- Based Guidelines” 8 have not been used. Developers of national or local guidelines, which include all stakeholders and all relevant healthcare professionals, the public, patients, and healthcare funders, make such judgments more appropriately.

Only fully published, peer-reviewed papers of directly randomized comparisons for each prophylactic method have been used to determine risk reduction. Non-randomized comparisons of outcome in different trials such as those reported by Colditz et al.,9 Mohr el al.,10 and Imperiale et al.11 have not been included as they are potentially biased.

The relationship between the incidence of asymptomatic and the incidence of symptomatic venous thromboembolism (VTE) including pulmonary embolism (PE) has been known for some time.12-14 Reduction in the incidence of asymptomatic deep vein thrombosis (DVT) has recently been shown to be accompanied by a corresponding reduction for symptomatic DVT.15, 16 Demonstration that asymptomatic below knee DVT is associated with subsequent development of the post- thrombotic syndrome (PTS) 17 also validates adoption of surrogate endpoints for efficacy evaluation. Thus, evidence is presented for surrogate outcomes such as the incidence of asymptomatic DVT at screening as well as clinical outcomes (symptomatic DVT or PE) depending on availability of data.

This document presents the evidence in a concise format and attempts to indicate not only the magnitude of the effect of different prophylactic regimens but also the quality of the studies. Information on safety (clinically relevant bleeding and other adverse effects) is also provided. When randomized controlled studies are not available, the lack of data is stated and recommendations for the design of appropriate studies are made.

Regulatory bodies in Europe and North America now consider the various low molecular weight heparins (LMWHs) to be distinct drug products. They require clinical validation for specific indications for each drug and that each LMWH must be dosed according to the manufacturer’s label and recommendations. Therapeutic interchange among these products is not appropriate. The choice of LMWH should reflect the level of clinical evidence and the approval of the regulatory authorities for each indication. This is emphasized throughout the document.

Finally, evidence has been provided for and reference has been made to methods of prevention that are rarely or no longer used or the drug has been withdrawn (dextran, antiplatelet therapy, dihydroergotamine, melagatran/ximelagatran) in order to provide a complete picture to the clinicians and researchers who are new in the field. The reasons for no longer recommending these drugs have been stated.

The problem and the need for prevention

DVT and PE are major health problems with potential serious outcomes. Acutely, PE may be fatal. In the long term, pulmonary hypertension can develop from recurrent PE. Often overlooked is post- thrombotic chronic venous insufficiency (CVI) occurring as a result of DVT causing deep venous reflux or obstruction with skin changes and ulceration with adverse impact on quality of life and escalation of health care costs. In North America and Europe, the annual incidence is approximately 160 per 100 000 for DVT, 20 per 100 000 for symptomatic non-fatal PE and 50 per 100 000 for fatal autopsy- detected PE.18-23 The prevalence of venous ulceration is at least 300 per 100 000 and approximately 25% are due to DVT.24, 25 Estimates of the overall annual costs of CVI vary from 600-900 million euro (US$720 million-1 billion) in Western European countries,26, 27 representing 1-2% of the total health care budget, to 2.5 billion euro (US$3 billion) in the USA.28

Virchow’s triad of factors that predispose to VTE are venous stasis, alterations in blood constituents, and changes in the endothelium; these are as true today as when postulated in the 19th century. It is often necessary for at least 2 factors to coexist for VTE to occur. Principal clinical predisposing influences are immobilization, trauma, surgery, infection and the postpartum period.29 Other predisposing influences are age, obesity, malignancy, previous history of venous thrombosis, varicose veins, dehydration and hormone therapy.23, 30-39 In the background for all of these is predisposition due to thrombophilia.40 The type of risk factor, whether acute or persistent, determines the type and duration of therapy.

Patients admitted to hospital are particularly at risk for VTE and the problem continues after discharge.16, 41-44 Without prophylaxis, the incidence of DVT is high.

Although VTE is an appealing target for maximally effective prophylaxis, this goal has been difficult to achieve. Renewed efforts to educate should maximize utilization, coupled with a system of incentives, warnings, and, where feasible, computerized electronic alerts.44

General and vascular surgical patients

The risk

Patients who undergo non-orthopedic operative procedures are at risk of developing VTE 9, 45-49 (Tables I-IV).

The risk is increased by age, obesity, malignancy, prior history of venous thrombosis, varicose veins, and thrombophilic states. It is also affected by the nature and duration of the operation, type of anesthesia, immobility, dehydration and sepsis.30-34, 177, 178 Known clinical risk factors allow for classification of patients into high, medium or low risk of developing VTE (Tables VI and VII).

Studies in patients having abdominal or pelvic surgery 41, 180, 181 demonstrate that the risk continues after discharge from hospital. Further studies are needed before recommendations can be made on the optimal duration of prophylaxis.

Despite the use of intraoperative heparin or other perioperative antithrombotic agents, vascular surgical patients are at moderate risk. The incidence of postoperative asymptomatic DVT is of the order of 18% in patients having abdominal vascular surgery and 15% for those having peripheral vascular reconstruction (Table I). The reported incidence of proximal DVT (DVT in popliteal or more proximal veins) in patients having abdominal vascular reconstruction is 4-6%.139, 141 The incidence of symptomatic VTE within 90 days of major elective or urgent vascular procedures has been found to be 1.7% to 2.8% in one study.182 A large prospective European registry of vascular surgical procedures showed that the incidence of clinical DVT was 0.9% following aortic procedures and 0.7% following femoro-distal bypass operations.183

The risk of VTE in patients undergoing laparoscopic surgery appeal’s to he low. Three small prospective studies in which no prophylaxis was used showed an incidence of DVT detected by duplex ultrasound or venography in the range of 0-2%.184, 185 Other prospective studies in which some form of prophylaxis was used confirmed the low incidence 186-190 with the exception of one in which 11 of 20 patients developed DVT.191 Large series from surveys,192-194 registries,195-198 a literature review 199 and a population study 182 indicate that the risk for clinical postoperative VTE after laparoscopic procedures is less than 1%. The use of prophylaxis in these studies is not reported in detail, but there appears to be a wide variation from none to LMWH in 80% of patients in some hospitals.

Obesity is an independent risk factor for sudden postoperative fat\al PE.200,201 Bariatric surgery is associated with clinical VTE in 1.2% and with fatal PE in 0.3% of cases.202

Prophylactic methods and recommendations

GENERAL CONSIDERATIONS

In the 1970s, low dose unfractionated heparin (LDUH) (5 000 IU 8 or 12 hourly subcutaneousIy) was found to reduce both DVT (Level I evidence) and fatal PE.203-105 During the late 1980s, 2 published meta-analyses concerning prophylaxis with LDUH compared with no prophylaxis or placebo 46, 47 showed that the incidence of asymptomatic DVT was reduced from 22% to 9% (relative risk-RR-0.41; 95% confidence interval-CI-0.35 to 0.47) and fatal PE from 0.8% to 0.3% (RR 0.39; 95% CI 0.17 to 0.87), The price was a small increase in bleeding complications from 3.8% to 5.9% (RR 1.56 95% CI 1.21 to 1.99).

A multicenter study has found that LMWH not only reduces the incidence of fatal PE but also the overall surgical mortality as compared to controls without prophylaxis.206 Two small randomized placebo-controlled trials in patients having major oncological abdominal surgery207 and emergency abdominal surgery 208 demonstrated the effect of LMWH in reducing asymptomatic DVT.

Sixteen studies have compared LMWH with LDUH,209-224 and 6 studies compared different doses of LDUH or LMWH.214, 225-229

Nine meta-analyses and systematic reviews have compared LMWH with LDUH.230-238 There are some differences between the studies regarding selection of publications. Four of the meta-analyses reported that there was no difference in total mortality comparing LMWH with LDUH.231, 233-235 Two meta-analyses reported reduced incidence of symptomatic PE with LMWH from 0.7% to 0.31% (RR 0.43; 95% CI 0.33 to 0.54) 231, 233 and One showed a decrease of symptomatic VTE.235 The overall conclusion is that there is no large difference between LMWH and LDUH, but the latter has to be given 2- 3 times daily whereas LMWH is administered once daily.

LMWHs have a lower risk of heparin-induced thrombocytopenia (HIT) than LDUH.239, 240 High dose LMWH is more effective but is associated with a higher incidence of hemorrhagic complications than LDUH, whereas a low dose of LMWH has a similar efficacy but with less bleeding.233

Regulatory bodies in Europe and North America now consider the various LMWHs to be distinct drug products. They require clinical validation for specific indications for each drug. Therapeutic interchange among these products is not appropriate.

In a recent double-blind double-placebo randomized study in 2 927 (2 048 valuable) patients having high risk major abdominal surgery, fondaparinux 2.5 mg daily was at least as effective as perioperative LMWH (dalteparin 5 000 U daily) in preventing venographically detected DVT without any increase in bleeding.241

In the meta-analysis by Clagett et al.,46 dextran was also analysed and was found to reduce the incidence of fatal PE (RR 0.22; 95% CI 0.11 to 0.44) although the effect of dextran on DVT was relatively small (RR 0.76; 95% CT 0.64 to 0.91). The preventive effect of dextran on fatal PE has been updated and verified.242 It appears that fibrin formed in the presence of dextran is not cross- linked so that it is easily lysed by the body’s natural fibrinolytic activity.241, 244 However, dextran has inherent risks of fluid overload and anaphylactoid reactions 46 and its routine daily use has been abandoned. Currently, the administration of one perioperative infusion is considered effective in short-stay surgery and is used by some centers in patients where prophylaxis is considered indicated.

Graduated elastic compression (GEC) stockings reduce the incidence of asymptomatic DVT by approximately 50-60% as shown by several studies (Table VIII) and 3 systematic reviews,252-254 but the number of patients studied has been too small to assess the effects on PE.

Intermittent pneumatic compression (IPC) (Table IX) reduces the incidence of asymptomatic DVT by approximately 69% (95% CI 58% to 77%) but the number of patients studied has been too small to assess the effects on PE.

Aspirin reduces DVT by 30% (Table X) and PE by 50% (Table XI).

Combined modalities: evidence from randomized controlled studies shows that combinations of prophylactic methods are more effective than using each method singly. These include LDUH with GEC (Tables XII and XIII), LDUH and antiplatelet agents,170 LDUH and IPC,246 263 dextran and GEC,264 GEC and IPC,270, 271 and LDUH and dihydroergotamine which is no longer manufactured or used because of the risk of vasospasm.272-279

However, the number of studies is relatively small for some combinations and more are needed, particularly in high-risk patients. A randomized study involving 2 551 patients undergoing cardiac surgery has demonstrated a reduction in the incidence of PE from 4% in the LDUH group to 1.5% in the group receiving LDUH combined with IPC (RR 0.37 95% CI 0.22 to 0.63).280

In the majority of studies, the duration of prophylaxis has been for 5-7 days. However, several studies suggest that the risk continues after discharge from hospital.41, 180, 281, 282 Extended prophylaxis to 1 month reduces asymptomatic DVT further by approximately 50-70%.229, 283, 284 However, further studies are needed to determine the optimum duration of prophylaxis beyond 1 week in different groups of patients.

In a review of members of the American Society for Bariatric Surgery, 95% of the surgeons routinely used some form of thromboprophylaxis.285 In one study, a higher dose of LMWH in combination with GEC and IPC was associated with fewer thrombotic events compared to a lower dose group alone (0.6% vs 5.7%). Bleeding was rare occurring in 2/481 patients.286

RECOMMENDATIONS

Low-risk patients are those without risk factors undergoing minor surgery. The data are insufficient to make any recommendations. On the basis of risk/benefit ratio and extrapolation from studies in moderate-risk patients, it is the practice in some countries to use GEC stockings in addition to early ambulation and adequate hydration (Grade C).

Moderate-risk patients are those over the age of 40 years undergoing major surgery for benign disease. The use of LDUH 5 000 IU commenced preoperatively and continued twice or 3 times daily, or LMWH initiated and dosed according to manufacturers recommendations for moderaterisk patients are recommended (Grade A). An alternative method, especially in patients at risk for or with active bleeding, is IPC with GEC compression used continuously until the patient is ambulant (Grade A).

High-risk patients are those aged over 60 years with additional risk factors. LDUH (5 000 IU commenced 2 h before operation and continued postoperatively 3 times a day) (Grade A) or LMWH initiated and dosed according to the manufacturers recommendations are recommended (Grade A). Both may be combined with mechanical methods (GEC or IPC) (Grade B). Fondaparinux (one study) is a Grade B recommendation.

These recommendations are extrapolated to patients undergoing vascular or bariatric surgical procedures in the absence of evidence from prospective clinical trials (Grade C).

Laparoscopic surgery for major prolonged procedures will reduce venous flow in the legs and activate blood coagulation.186 199 Prophylactic subcutaneous LDUH, LMWH, or IPC with GEC are recommended only in patients with additional risk factors (Grade C).

Urologic surgery

The risk

In the 1970s, the incidence of DVT in the absence of prophylaxis was found to be 32% in patients having retropubic prostatectomy and 9% in patients having transurethral resection (Table I). The incidence of symptomatic VTE is currently in the range of 1-5% and PE is the most common cause of postoperative death.182,287,288

Prophylactic methods and recommendations

GENERAL CONSIDERATIONS

One small randomized study demonstrated that IPC was effective in preventing silent DVT when compared with UFH or no prophylaxis 107 (RR 0.27 95% CI 0.14 to 0.52). LDUH was effective in reducing asymptomatic DVT in 3 randomiz.ed studies in which the control groups did not have prophylaxis (RR 0.22 95% CI 0.11 to 0.47).108, 112, 289 A large study of 579 patients having radical prostatectomy did not find any difference in the number of pelvic lymphoceles or blood loss between those receiving LDUH and those not having prophylaxis.290 LMWH has not been studied by randomized controlled studies and there are no studies for patients having transurethral resection.

RECOMMENDATIONS

IPC with GEC is recommended based on one randomized study and by extrapolation from trials in patients having general surgery (Grade B). LDUH (Grade A) giving 5 000 U commenced 2 h before operation and continued 3 times a day in the postoperative period is recommended. An alternative is LMWH initiated and dosed according to the manufacturer’s recommendations by extrapolation from general surgery (Grade C).

Gynecology

The risk

Thromboembolic complications after gynecological surgery occur with approximately the same frequency as for general surgeiy. Patients undergoing major gynecological surgery (e.g. over 30 min duration) aged 40 years or over have a significant risk of postoperative VTE (Table I). This risk will increase with additional risk factors such as obesity, previous VTE, malignancy or immobility. However, the incidence appears to be much lower for benign gynecological surgery and vaginal procedures (Table I). PE is a leading cause of death following gynecological cancer surgew 291 and accounts for approximately 20% of perioperative hysterectomy deaths.292 Risk factors for DVT include those listed for general surgery.293, 294

An additional risk for VTE is the use of estrogen containing combined oral contraceptives (COC),295 which are used by 18% of women in a UK studv.296 COC increase the risk of VTE.295 However, the absolute risk is small and represents an increase from 5 to 15- 30 per 100000 women years.297 The latter is lower than the risk of pregnancy, which is estimated at 100 cases per 100 00\0 maternities. The risk of postoperative VTE showed an increase from 0.5% to 1% for pill users versus non-users in early studies.298 The absolute excess risk in COC users has to be balanced against the risk of stopping the pill 4 to 6 weeks before surgery which includes unwanted pregnancy, the effects of surgery and anesthesia on a pregnancy, and the risks of subsequent termination. Each case should be assessed in relation to additional risk factors. Before major surgery, COC should be discontinued for at least 4 weeks and alternative contraception advised. If it is elected not to discontinue COC then the patient should receive prophylaxis as if for at least a moderate- risk patient. Other estrogen-containing preparations should be considered to carry the same risk as COC at least until studies become available. In emergency surgery or when COC have not been discontinued, VTE prophylaxis should be given at least as moderate- risk category. COC do not need to be discontinued before minor surgery without immobilization. Progestogen-only oral contraceptives need not be discontinued even when immobilization is expected.299

Hormone replacement therapy (HRT) should be included as a risk factor for VTE when assessing patients for elective or emergency surgery.300 HRT does not need to be stopped routinely prior to surgery provided that appropriate thromboprophylaxis is used such as LDUH or LMWH.301 Transdermal HRT has less effect on blood coagulation and appears to have a lower VTE risk than oral HRT.302

Prophylactic methods and recommendations

GENERAL CONSIDERATIONS

Low-risk patients: a Level I study 25 demonstrated a lower DVT rate with the use of GEC (0% vs 4%; P

Moderate-risk patients: subcutaneous LDUH (5 000 IU, 12 hourly),130, 150, 152, 303 or LMWH (initiated and dosed according to the manufacturer’s recommendations) 304, 305 are effective for preventing DVT.

IPC has been shown to be as effective as LDUH or LMWH for preventing DVT when used continuously for 5 days,129, 257, 306 with no bleeding complications.306 Thus, in patients with a high risk of bleeding, IPC can be used as an alternative to heparin prophylaxis until the patient is ambulatory.

Laparoscopic surgery for major prolonged procedures will reduce venous flow in the legs and activate blood coagulation.186, 199 Prophylactic subcutaneous LDUH, LMWH, or IPC combined with GEC are recommended only in patients with additional risk factors (Grade C).

High-risk patients: LMWH 130, 210 305, 306 initiated and dosed according to the manufacturers recommendations), or IPC (throughout hospital stay) 129 are equally effective. Randomized controlled studies in patients having gynecologic oncology surgery have shown no difference in efficacy between LMWH and LDUH given 3 times a day for thromboprophylaxis against DVT or PE and no difference in the risk of bleeding.210, 307-309 The risk of wound hematomas appears to be reduced by avoiding subcutaneous injection near the wound. LMWH has the advantage of once daily injection and is less likely to cause HIT.

RECOMMENDATIONS

Low-risk patients: they should receive GEC (Grade B) in addition to early ambulation and adequate hydration.

Moderate-risk patients: LDUH (5 000 IU, 12 hourly), LMWH (initiated and dosed according to the manufacturer’s recommendations) or IPC are Grade A recommendations. LMWH is the preferred method because it has the advantage of once daily injection and is less likely to cause HIT. IPC is the method of choice in patients with a high risk of bleeding.

High-risk patients: LMWH (initiated and dosed according to the manulacturer’s recommendations) (Grade A), LDUH (5 000 IU 8 hourly) (Grade A) or IPC (throughout hospital stay) (Grade B) are recommended. LMWH or LDUH combined with IPC or GEC stockings provides optimal prophylaxis (Grade B).

Obstetrics

The risk

Pregnancy is a risk factor for VTE with a 10-fold increase compared with the risk for non-pregnant women. The time of greatest risk is the puerperium. PE remains the leading direct cause of maternal deaths in the UK.310 Additional risk factors tor VTE in pregnancy and the puerperium include obesity, age over 35 years, thrombophilic states, Cesarean section and surgical procedures during pregnancy and the puerperium.311 Risk assessment for VTE is recommended for all women in early pregnancy.310

Prophylactic methods and recommendations

GENERAL CONSIDERATIONS

The Cochrane Review of VTE prophylaxis in pregnancy and the puerperium examined 8 trials involving 649 women. It was not possible to assess the effects of interventions because of the limited number of trials and the small sample sizes.312 Large scale randomized trials of currently used interventions are required.

Table XIV summarizes management strategies for various clinical situations.

Women at high risk of VTE including those with previous confirmed VTE should be offered prepregnancy counseling to agree to a management plan. The thrombotic risk exists from the beginning of pregnancy.

Women with previous VTE or a strong family history of VTE, particularly where VTE occurs at a young age (

Systematic reviews and retrospective studies have concluded that LMWH is now the treatment of choice in pregnancy compared to UH in view of efficacy and safety 313-317 (Grade B). The risks of HIT and osteoporosis during pregnancy are reduced with LMWH as compared with LDUH.318, 319

The overall risk of recurrence of DVT during pregnancy has been reported as 2-3% 320 and is higher in those with an underlying thrombophilia or idiopathic thrombosis (6%). A further study repotted a recurrence rate per 100 patient-years 10.9% during and 3.7% outside pregnancy.321 Thus, women in whom a previous VTE occurred in association with a temporary risk factor that is no longer present and no known thrombophilia or additional risk factors should be offered postpartum thromboprophylaxis with LMWH (Grade C). GEC stockings during pregnancy should be considered in addition to postpartum prophylaxis (Grade C). Women in whom a previous VTE was estrogen-related (pregnancy or the combined contraceptive pill), or additional risk factors are present such as obesity should be started with throiriboprophylaxis with LMWH as early as possible in pregnancy (Grade C).

Women with thrombophilias have an increased risk of VTE in pregnancy and the risk varies with the specific thrombophilia. Women with previous VTE and thrombophilia should be offered thromboprophylaxis with LMWH antenatally and throughout the 6 weeks postpartum (Grade B).

Women who are on long-term anticoagulant thromboprophylaxis for VTE and women with anti-thrombiri deficiency are at very high risk (30%) during pregnancy. Those on vitamin K antagonists (VKA) should be advised to switch to LMWH as soon as pregnancy is confirmed because of the risk of embryopathy from warfarin between the 6th and 12th week of pregnancy. In both situations, LMWH dosage should be similar to that used for the treatment of VTE (Grade B).

Table XV shows the most recent Royal College of Obstetricians and Gynecologists (RCOG) guidelines301 for recommended LMWH dosage in pregnancy. Further reports since this guideline was published suggest that a once-daily dosage of tinzaparin provides adequate 24- h cover 322, 323 but more studies are needed concerning its safety and especially the risk of osteoporosis.

Women with a previous VTE and a lhrombophilia such as protein C deficiency, Factor V Leiden, Prothrombin 20210A or protein S deficiency who are at moderately increased risk of VTE should receive LMWH (e.g. enoxaparin 40 mg daily, dalteparin 5000 U daily or tinzaparin 4500 U daily in women of normal body weight) from early pregnancy (Grade C).

Women with no personal history of venous thrombosis but who have a thrombophilic defect identified may require thromboprophylaxis. This will depend on the type of thrombophilia, the family history, and the presence of additional risk factors (e.g. obesity, immobilization and hyperemesis). All should be offered anticoagulant prophylaxis following delivery. The risk of thrombosis should be discussed with the patient antenatally and GEC stockings should be considered (Grade C).

Women with antiphospholipid antibody syndrome (lupus anticoagulant or anticardiolipin antibodies) and recurrent miscarriages should receive thromboprophylaxis with unfractionated heparin (UFH) and low dose aspirin (75 mg/day) 324, 325 from the time of diagnosis of pregnancy (Grade A). Although such therapy is aimed at preventing pregnancy loss that is related to placental thrombosis, these women are also at risk for VTE and prophylaxis with LMWH should continue for at least 2 to 5 days alter delivery.301 In women with antiphospholipid syndrome and previous VTH, postpartum prophylaxis should he continued for 6 weeks (Grade C).

Delivery and the pueperium.-Management of delivery: patients on LMWH antenatally and who wish epidural anesthesia should have heparin prophylaxis discontinued with the onset of labor. An epidural or spinal block is not advised for at least 12 h after prophylactic LMWH administration and 24 h after therapeutic doses have been discontinued.126 LMWH should not be given for at least 4 h after the epidural catheter has been inserted or removed and the catheter should not be removed within 10 to 12 h of the most recent injection.327 For delivery by elective Caesarea\n section, the woman should receive a thromboprophylactic dose of LMWH on the day before delivery. On the day of delivery the thromboprophylactic dose of LMWH should be given 3 h postoperatively or 4 h after removal of the epidural catheter (Grade C).

Management of the puerperium: in addition to previous VTE and thrombophilias, other risk factors should be considered for postpartum prophylaxis: age over 35 years, obesity, Caesarean section (particularly an emergency procedure during labor), gross varicose veins, pre-eclampsia and immobilization (Grade C).

Postpartum thromboprophylaxis is recommended in women with previous VTE, known thrombophilias and other thrombotic risk factors. The first postpartum daily dose of subcutaneous LMWH (enoxaparin 40 mg, dalteparin 5 000 U daily or tinzaparin 50 U/kg) should be given 3 to 4 h after delivery. Postpartum anticoagulation should be continued for a minimum of 6 weeks in patients with previous VTE or thrombophilia. In other patients, prophylaxis should continue until discharge from hospital, and the need for prophylaxis should be reviewed if the hospital stay continues beyond 5 days (Grade B).

If a patient does not wish to continue on selfinjections of LMWH, VKA can be commenced on the 1st or 2nd postpartum day. LMWH can be discontinued when the INR has been within the target range of 2-3 for 2 consecutive days. GEC stockings can be added to LMWH in high- risk patients and should be used where LMWH is contraindicated. Where anticoagulants are contraindicated, GEC stockings should be worn for at least 6 weeks following delivery and can be combined with 75 mg of Aspirin daily (Grade C).

Patients who develop VTE during pregnancy or the puerperium should be referred for hematological screening to determine if they have underlying thrombophilia and counseled about the increased risk of COC pills. Progestogen-only contraception is suitable for these women. They should also be counseled about the need for prophylactic treatment in any future pregnancy.

Breast feeding is not contraindicated with either LMWH, UFH or warfarin (Grade C).328, 329

Orthopedic surgery and trauma

Elective hip replacement

The risk

In the absence of prophylaxis, patients undergoing elective major joint replacement and those with hip fracture have a DVT risk of approximately 50% (Table I).330-332 The frequencies of proximal DVT (Table II) and PE (Tables III and IV) are also high. Symptomatic events range from 2-5%.333 Studies on clinical DVT and PE indicate a postoperative risk period of approximately 3 months 331,333.334 (Table V). Recent mortality studies have confirmed a reduced survival for 2-3 months following elective total hip replacement (THR) surgery with the highest death rate initially early after operation.335,336

There is a high incidence of proximal DVT (18-36%) in patients having THR 64, 67, 68, 70, 73, 337-340 in contrast to patients having total knee replacement (TKR) in whom the preponderance of thrombosis is distal.83-85, 341, 342

Modern THR surgery is performed with a continuing reduction in hospital stay (3-6 days) so that patients are discharged while still at risk. Thus, the majority of clinical events appear after hospital discharge, giving a false impression of a decreasing problem.182, 334

Prophylactic methods and recommendations

GENERAL CONSIDERATIONS

The majority of studies in elective orthopedic surgery have been carried out on elective THR patients. Prophylactic methods that have been investigated include aspirin, clextran, fixed LDUH, adjusted dose UFH, fixed LDUH with dihydroergotamine (no longer manufactured), LMWH, heparinoid, recombinant hirudin, the direct thrombin inhibitor melagatran (withdrawn due to hepatotoxicity) fixed mini-dose and adjusted doses of VKA, GEC stockings, IPC and foot impulse technology (FIT). To determine the risk reduction lor each prophylactic method, only randomized studies with systematic screening tests for DVT are used for this analysis (Tables X, XI, XVI-XVIII).

LDUH (5 000 IU 8 or 12 hourly) was found to be effective for reducing DVT from 46.8% to 23.3% (RR 0.5 95% CI 0.43 to 0.58) (meta- analysis of 20 randomized controlled studies(Level I evidence)47 in patients having elective THR and was the method of choice in the 1980s.

It has since been demonstrated that LMWH is superior to UFH for elective THR surgery reducing DVT from 21.2% to 13.8% (RR 0.66 95% CI 0.52 to 0.84) and PE from 4.1% to 1.7% (RR 0.4; 95% CI 0.19 to 0.84) 231, 232, 234, 236, 340, 359-363 (Level I evidence). Thus, LDUH is no longer recommended.

As indicated in the section on “General and vascular surgical patients”, regulatory bodies in Europe and North America now consider the various LMWHs to be distinct drug products. They require clinical validation for specific indications for each drug. Therapeutic interchange among these products is not appropriate.

Randomized controlled studies have shown that recombinant hirudin is more effective than LDUH 364-366 or LMWH.365 Of 2 079 patients studied, 1 587 were included in the primary efficacy analysis. Overall, DVT was reduced with hirudin 15 mg twice daily compared with 40 mg enoxaparin from 25.5% to 18.45% (P=0.001; RRR 28%). The safety profile was the same in both groups.365

Several randomized controlled trials have compared VKA with LMWH. LMWH was found to be more effective 355, 356, 367, 368 or at least as effective 358 in the prevention of asymptomatic DVT. However, this was at the expense of a slight increase in hemorrhagic complications. When LMWH was started before or immediately after surgery, there was a marked reduction of proximal DVT from 3% to 0.8% (RR 0.28; 95% CI 0.1 to 0.74).369 Symptomatic DVT was also reduced from 4.4% in the warfarin group to 1.5% in the LMWH group (RR 0.32; 95% CI 0.12 to 0.88). A recent meta-analysis of VKA in orthopedic surgery 37 showed a RR of 0.56 (95% CI 0.37 to 0.84) for DVT and 0.23 for PE (95% CI 0.09 to 0.59) compared with placebo. VKA were less effective than LMWH in preventing total DVT (RR 1.51, CI 1.27 to 1.79) and proximal DVT (RR 1.51 95% CT 1.04 to 2.17) although the risk of wound hematoma was increased from 3.3% in the VKA recipients to 5.3% in LMWH recipients (RR 2.29; CI 1.09 to 7.75).

In a recent clinical trial on THR patients,371 1 279 patients were randomized on the 3rd postoperative day to LMWH or to warfarin for the subsequent 6 weeks. The primary endpoint was the overall clinical failure rate, i.e. symptomatic VTE (radiologically confirmed), major hemorrhage or deaths. The failure rate was 3.7% in the LMWH group and 8.3% in the warfarin group (P=0.01). Major bleeding occurred in 1.4% in the LMWH group and in 5.5% in the warfarin group. It appears that reduced bleeding seen initially after surgery due to the slow onset of action for warfarin is off- set by long-term increased bleeding. Furthermore, national drug registries have shown warfarin to be a major cause of readmission and fatal bleeding.372, 373 With these data, and because of the need for monitoring, the small therapeutic window and the risk of drug interactions, some surgeons find it difficult to see an advantage for VKA over LMWH.

In contrast to LMWH, the pentasaccharide fondaparinux, is a pure synthetic chemical compound. It is a potent indirect inhibitor of factor Xa and acts by a catalytic effect facilitating antithrombin binding to activated factor X and represents one of many attributes of heparins. The drug is administered by subcutaneous injection once daily. It has been registered internationally for major orthopedic surgery. Two large randomized controlled trials compared fondaparinux to enoxaparin.374, 375 Reduction of asymptomatic DVT was 26% (RR 0.74 95% CI 0.47 to 0.89) and symptomatic PE was 56% (RR 0.44 95% CI 0.27 to 0.66) with fondaparinux. For the 2 studies combined, the incidence of major bleeding was 3% in the fondaparinux and 2.1% in the enoxaparin patients (P>0.05). Fondaparinux may accumulate and increase bleeding in patients with impaired renal function.

A meta-analysis in the early 1990s 170 demonstrated that antiplatelet therapy in elective hip surgery is only moderately effective for protection against DVT (RR 0.7; 95% CI 0.61 to 0.82) (Table X) but the observed reduction in the risk of PE was substantial (RR 0.49; 95% CI 0.26 to 0.92) (Table XI). However, the recent PEP study 262,376 showed that aspirin is not as valuable as the metaanalysis suggested. Over 13 000 hip fracture patients were randomized to have either aspirin or placebo. The overall death rate was identical in each group. Risk reduction for symptomatic VTE was from 2.5% to 1.6% and this was only 1/2 of that expected from LMWH and 1/3 from pentasaccharide. The reduced risk of VTE was matched by an increased risk of blood transfusion, gastrointestinal bleeding and wound bleeding. In a supplementary group of 4 000 elective hip and knee replacement patients, there was an insignificant difference in symptomatic VTE.376 The relative weak thrombophylactic effect of aspirin therefore carries an alternative complication rate and its use might deprive patients of safer or more effective prophylaxis.

The Cochrane database 254 and an earlier metaanalysis 252 shows that GEC is effective in reducing DVT in hospitalized patients, but there are few robust studies specific to orthopedic surgery.69, 377 In addition, there are disadvantages to graduated elastic compression in trauma cases in which the limb has to be regularly inspected. Because other methods of prevention are more effective, GEC stockings on their own are not recommended.

IPC is effective in patients having THR 64, 68, 344 (Table XVI, hip replacement) reducing DVT from 43.6% in the control groups to 21% in the compression groups (RR 0.48; 95% CI 0.36 to 0.64) (Level I evidence). It offers an alternative for surgeons with concerns or patients with contraindications to chemical prophylaxis. It can also be used as an additi\onal method for those at particularly high risk. In a recent randomized study 378 in 131 patients having THR and TKR, the combination of LMWH plus IPC was more effective than LMWH plus GEC stockings (DVT incidence 0% versus 28%).

Recent data demonstrate that FIT combined with GEC is effective in reducing the incidence of proximal DVT in patients having hip or knee replacement (Table XVII) with reduced bleeding and swelling. Direct comparisons with chemical prophylaxis are sparse; there is probably superiority to UFH 348 and equivalence with LMWH for THR 350, 379 but not for TKR.351

Mechanical methods are intuitively attractive to orthopedic surgeons because of the lack of risk for bleeding. The small number of randomized studies available sets mechanical methods at a disadvantage compared with the considerable number of large studies of chemical prophylaxis. Mechanical methods are generally cumbersome and need supervision from health personnel. Nevertheless, they offer an alternative during the early postoperative period for surgeons with concerns about bleeding or for patients with contraindications to chemical prophylaxis. They may also be used as an additional method for those at particularly high risk 378 although this aspect requires confirmation with further studies.

Modern technology has made IPC devices light, silent, more portable and more effective in preventing stasis by sensing venous volume so that the compression period follows immediately alter venous refilling. In addition, different sleeve designs and materials have been used to improve patient compliance.380

Melagatran is a direct thrombin inhibitor that had been developed for subcutaneous administration and as the prodrug ximelagatran for oral administration. It had been approved for short-term use in orthopedic surgery in some countries. Four randomi/.ed controlled studies have compared melagatran/ximelagatran with enoxaparin.381- 384 when melagatran was administered immediately before surgery and on the evening of surgery and then orally twice a day, the incidence of DVT was lower than with enoxaparin that was started the evening before surgery and continued each evening thereafter. Jn the EXPRESS trial,381 total VTE was reduced from 26.6% to 20.3% (P=0.0003). Fatal bleeding, critical site bleeding and bleeding requiring re- operation did not differ between the 2 groups. “Excessive” bleeding, i.e. bleeding as subjectively judged by the local investigator was 1.2% with enoxaparin vs 3.1% with melagatran. For clarification bleeding events in the EXPRESS trial 381 were evaluated and classified (i.e. “adjudicated”) by a group of physicians external to the sponsor, not subjectively by the local investigator. However, one category of bleeding called excessive bleeding, was not adjudicated but instead was a subjective assessment by the local investigators of bleeding observed which they thought was in excess of what they usually observed. When the melagatran/ximelagatran regimen was started after operation, the incidence of DVT was lower in the enoxaparin group (METHRO III) 384 and bleeding rates were the same in both groups. In a North American study where both oral ximelagatran 24 mg bid and enoxaparin 30 mg bid were commenced the day after THR surgery and continued for 7-12 days, venographic DVT plus symptomatic VTE was detected in 4.6% of the enoxaparin group and 7.9% of the ximelagatran recipients (P=0.03). Major bleeding was less than 1% in both groups.

The melagatran/ximelagatran regimen had been approved by 18 countries across Europe, South America and Asia for short-term prophylaxis in major hip and knee surgery. Because of concerns about an increase in myocardial infarctions, elevation of liver enzymes and a case of fatal liver failure in the long-term studies, the FDA had not given approval. Because of a second case of severe liver damage a week after short-term therapy, melagatran/ximelagatran has been withdrawn from the market and its development terminated (http:/ / www.astrazeneca.com/pressrelease/ 5217.aspx).

Meta-analysis shows that spinal and epidural anesthesia reduce both thromboembolism and perhaps mortality in hip fractures,385, 386 and TKR.387-389 This method does not reduce risk sufficiently on its own, but should be regarded as a useful adjunct. Initial European experience suggested that neuraxial anesthesia could be safely used in the presence of LMWH.390 However, more recently there have been concerns that a spinal hematoma may develop on very rare occasions.391, 392 Guidelines have been suggested.327,393 LMWH (or pentasaccharide) can be given safely 4 h after removal of the epidural catheter (see pregnancy). However, LMWH or pentasaccharide should be avoided whilst a continuous postoperative neuraxial block is in place. The catheter should not be inserted until serum levels of the chemical agent used are at their lowest. This means that postoperative administration of the agent is, generally, safer and more predictable than pre-operative administration when epidural analgesia is needed.

Timing of prophylaxis.-VTE prophylaxis involves a balance of risks and benefits. Chemical prophylaxis poses a dilemma: for a given dose the closer it is administrated to surgery, the better the thromboprophylaxis but the greater is the risk of bleeding complications.355 In Europe, LMWH is given at a lower dose prior to operation, providing an anticoagulant effect to counteract the intraoperative activation of coagulation factors and venous stasis. However, if a given dose of the drug is administered too long before surgery then, intraoperative blood levels would be inadequate for effective prophylaxis, whereas if given too close to surgery then surgical bleeding is a threat. In North America, LMWH is given after surgery at a higher dose and more frequently. This should reduce the risk of surgical bleeding, yet intraoperative thrombogenesis is not prevented and thrombi may have already begun forming. The drug is now expected to be therapeutic as well as prophylactic. Therefore, prophylaxis needs to be given close but not too close to surgery.369,394

IPC and FIT sleeves are available in sterile packages that allow their intraoperative use, reducing the risk of bleeding and the time the patient is not under prophylaxis.346,395,396

Duration of proplivlaxis in elective orthopedic surgery.-Studies in patients having THR 174, 181, 331,334,355,397-401 demonstrate that there is prolonged risk with 45-80% of all symptomatic events occurring after discharge from hospital.203,331,402,403

Randomized controlled studies in patients having THR indicate that prolonged thromboprophylaxis with LMWH for up to 35 days is safe and effective irrespective of whether in-hospital prophylaxis was with LMWH or warfarin. It decreases the frequency of venographically detected total DVT, proximal DVT and symptomatic VTE after the 7th day by more than 50%.359,401,404-407 Further studies are needed before recommendations can be made for prophylaxis beyond 35 days. The optimal duration of prophylaxis is unknown. Epidemiological data on postoperative death rates indicate a much longer duration of risk in subgroups such as emergency patients (e.g. hip fracture) and patients with co-morbidity (e.g. rheumatoid arthritis) in which vascular deaths dominate.336,408

One randomized controlled trial compared warfarin prophylaxis (INR 2-3) for 9 days with warfarin extended for 1 month after hospital discharge. VTE occurred in 5.1% of in-hospital prophylaxis patients and 0.5% in those having extended prophylaxis (RR 9.4; 95% CI 1.2 to 73.5).409 This study was prematurely terminated because of the superiority of prolonged prophylaxis. As indicated above, it has been subsequently demonstrated that extended prophylaxis with warfarin is associated with more hemorrhagic complications than with LMWH.371

RECOMMENDATIONS

LMWH initiated and dosed according to the manufacturer’s recommendations, fondaparinux, oral anticoagulant therapy, IPC or FIT combined with GEC are Grade A recommendations. The preferred methods are LMWH or fondaparinux for in-hospital prevention. IPC or FIT combined with GEC stockings are an equivalent alternative to LMWH for those surgeons or anesthetists concerned about bleeding either in all or in certain patients. These devices can be used as long as tolerated and then replaced with chemical prophylaxis for the rest of the 5-week period of risk. Recombinant hirudin (Revasc) is approved for short-term prophylaxis in approximately 20 European countries and can be used in patients with HIT (Grade A).

Prophylaxis with LMWH should be initialed either before or after operation depending on the adopted regimen (Grade A). Fondaparinux should be started at least 6 to 8 h after surgeiy Prophylaxis should be continued for 4-6 weeks with LMWH (Grade A) or fondaparinux (Grade C, extrapolation from hip fracture trial).

Elective knee joint replacement

The risk

Data from THR should not be extrapolated to TKR. The incidence of asymptomatic DVT detected by venography is higher in patients having TKR than THR. However, the incidence of above knee DVT is lower than in patients having THR (see section on THR above).

Prophylactic methods and recommendations

GENERAL CONSIDERATIONS

IPC is effective in patients having knee replacement (RR 0.27; 95% CI 0.14 to 0.49) (Table XVI, knee replacement). One small study demonstrated that IPC reduced the incidence of asymptomatic DVT from 65% to 6%.80 A subsequent study found IPC to be more effective than aspirin.345 IPC was found to be less effective than coumadin for preventing venographically detected DVT (32% vs 19%).410 FIT was also effective in 2 studies 86, 342 but showed inferiority when compared to LMWH in 2 other studies 351, 352 (Table XVII).411

A randomized controlled study demonstrated that LMWH was more effective than placebo. It reduced venographically detected DVT from 65% in the placebo group to \19% in the LMWH group (RR 0.3; 95% CI0.16 to 0.58).41-1 Subsequent studies demonstrated that LMWH was more effective than LDUH (RR 0.75; 95% CI 0.58 to 0.92) 413, 414 or warfarin (RR 0.68; 95% CI 0.62 to 0.76) (Table XVIII).

Fondaparinux (2.5 mgs.c. once daily stalling 6 h alter surgery) was more effective than enoxaparin (30 mg s.c. bid starting 12-24 h after surgery) in one study.415 VTE (defined as venographically detected DVT, symptomatic DVT or symptomatic. PE) was reduced from 27.8% in the enoxaparin group to 12.5% in the fondaparinux group (RR 0.45; 95% CI 0.32 to 0.62). However, major bleeding was more common with fondaparinux (2.1% vs 0.2%, P=0.006). This increased rate of bleeding when fondaparinux was given within 6 h of surgery was confirmed in a meta-analysis 416 including this study and 3 other randomi/.ed controlled trials comparing fondaparinux with enoxaparin in patients having orthopedic surgery other than TKR.

Subcutaneous melagatran followed by oral ximelagatran had the same efficacy and safety as LMWH.382, 417 Three randomized control studies compared oral ximelagatran 24 mg bid or 36 mg bid starting the morning after surgeiy with adjusted dose warfarin (INR range 1.8 to 3) starting on the evening after surgeiy418-420 The incidence of DVT was the same in both groups for the 24 mg bid dose but the overall VTE or death rate was reduced with the 36 mg bid dose. There was no difference in hemorrhagic complications between either dose of ximelagatran and warfarin.

The melagatran/ximelagatran regimen had been approved by 18 countries across Europe, South America and Asia for short-term prophylaxis in major hip and knee surgery. Because of concerns about an increase in mvocardial infarctions, elevation of liver enzymes and a case of fatal liver failure in the long-term studies, the FDA had not given approval. Because of a second case of severe liver damage a week after short-term therapy melagatran/ximelagatran has been withdrawn from the market and its development terminated (http:/ /www.astrazeneca.com/pressrelease/5217. aspx).

DURATION PROPHYLAXIS

The effect of extending prophylaxis using LMWH to 30-42 days beyond hospitali/.ation on svmptomatic DVT in patients having TKR is less (OR 0.74; 95% CI 0.26 to 2.15; P>0.05) than in patients having THR (OR 0.33; 95% CI 0.19 to 0.56; P

RECOMMENDATIONS

LMWH (initiated and dosed according to the manulacturer’s recommendations) or warfarin (although less effective) are Grade A recommendations. Fondaparinux is a Grade B recommendation (one study). IPC or FIT plus GEC stockings are alternative options but more studies are needed (Grade B).

Hip fracture surgery

The risk

Patients having hip fracture surgery have the highest rates of DVT (46-60%) (Tables I, III, IV) 98, 421, 422 and fatal PE (2.5- 7.5%).338, 422, 433 Jhe VTE risk period lasts for 2-3 months after hip fracture surgery in spite of common short-term prophylaxis 333,334 and the 90-day risk of overall death is 13%.424 After hip fracture, the risk is greater than the standardized mortality, the majority dying of vascular events despite the fact that most patients receive some form of short-term prophylaxis.355, 336

Prophylactic methods and recommendations

GENERAL CONSIDERATIONS

Because the risks of DVT and PE, including fatal PE, are high in patients with hip fracture (Tables I, III, IV), prophylaxis should start as soon as possible after diagnosis and should be the same as that recommended for elective hip surgeiy

Reduction in asymptomatic DVT has been demonstrated by IPC (RR 0.2; 95% CI 0.07 to 0.55) 344 (Table XVI) and FIT in combination with GEC 353 (RR 0.32; 95% CI 0.32 to 0.67) (Table XVII). In the most recent study 343 the combined endpoint of PE and proximal DVT using duplex ultrasound was reduced from 12% in the group without prophylaxis to 4% in the IPC group. More studies are needed.

A meta-analvsis 170 demonstrated that antiplatelet therapy in traumatic orthopedic surgery is only slightly effective for protection against DVT (RR 6.86; 95% CI 0.73 to 1) (Table X) but the observed reduction in the risk of PE is substantial (RR 0.4; 95% CI 0.22 to 0.71) (Table XI). In the randomized, placebo-controlled trial of patients undergoing surgery for hip fracture (13 356 patients) or for elective hip or knee arthroplasty (4 088 patients), aspirin in a dose of 160 mg daily started preoperativelv was used as the primary prophylactic agent for 35 days. In the patients with hip fracture, aspirin reduced the incidence of symptomatic DVT by 29% (95%. CI 3% to 48%; P=0.03) and PE by 43% (95% CI 18% to 60%; P=0.002). PE or DVT was confirmed in 105 (1.6%) of 6 679 patients assigned aspirin compared with 165 (2.5%) of 6 677 patients assigned placebo, which represents an absolute reduction of 9 per 1 000 and a proportional reduction of 36% (95% CI 19% to 50%; P=0.0003). However, the complication rate (transfusion requirements and bleeding) offset much of the reduction in symptomatic VTE. The death rate was equivalent in the placebo and aspirin groups.262 Since other methods are more effective, aspirin on its own is not recommended for routine thrombophylaxis.

In the 1970s, LDUH had been found to be effective in reducing asymptomatic DVT (RR 0.51 ; 95% CI 0.42 to 0.62) (Table XVII) and although an overview of trials had not demonstrated a significant reduction in total PE, there was a significant reduction in fatal PE.47

LMWH has been assessed against placebo,70, 229 LDUH,425 danaparoicl,426 high dose (40 mgenoxaparin) LMWH 427 and fondaparinux.428 LMWH has been found to be equally effective as LDUH without increase in hemoirhagic complications.429

Three randomized controlled trials have demonstrated that VKA are effective in preventing asymptomatic DVT with a 61% RR reduction for DVT and 66% for proximal DVT, compared with no prophylaxis.98, 430, 431 The increase in hemoirhagic complications reported varied from 0% to 47% without any increased bleeding in the most recent trial.98

Foridaparinux given for 11 days was more effective compared with LMWH in reducing VTE from 19.1% to 8.3% (RR 0.46; 95% CI 0.32 to 0.59) and proximal DVT from 4.3% to 0.9% (RR 0.22 95% CI 0.09 to ().53).428 There was no difference in major bleeding but minor bleeding was increased from 2.1% in theenoxaparin group to 4.1% in the fondaparinux group (P=0.02). In a second study, patients who received fondaparinux for 7 days were randoinized to continual ion with fondaparinux or placebo for a further 3 weeks.432 The incidence ol venographic DVT was 1.4% in the extended prophylaxis group and 35% in the placebo group (RR 0.04; 95% CI 0.01 to 0.13). Symptomatic VTE was 0.3% and 2.7%, respectively (RR 0.11; 95% CI 0.01 to 0.88). There was no difference in hemorrhagic complications.

Delayed admission to hospital or delayed surgery following hip fractures is associated with a high incidence of DVT developing prior to surgeiy433-436 The incidence of preoperative DVT as shown by venography can be as high as 62% for all DVT and 14% for proximal DVT when the delay is 48 h or more.436 Thus, it is strongly recommended that if surgical delay is anticipated, prophylaxis with LDUH or LMWH is commenced as close to the fracture as possible. Prophylaxis should be restarted once postoperative hemostasis has been achieved.

RECOMMENDATIONS

LMWH (initiated and dosed according to the manufacturer’s recommendations), fondaparinux, adjusted dose VKA (INR: range 2-3), or LDUH are Grade A recommendations. IPC or FIT combined with GEC should be used when there are contraindications for pharmacological prophylaxis (Grade B). If surgery is likely to be delayed, prophylaxis should be initiated with LMWH or IPC or FIT plus GEC as close to the fracture as possible (Grade C).

Knee arthroscopy

The risk

Knee arthroscopy is a very common procedure varying from a simple diagnostic technique to an extensive repair of injured soft tissues. A tourniquet is usually used.

The incidence of DVT in patients undergoing arthroscopic procedures in the absence of prophylaxis as demonstrated by routine venography or duplex ultrasound is approximately 7% for all thrombi and 1.4% for proximal DVT (Table I).84, 163-168, 437 The risk is minimal for diagnostic arthroscopy,165, 334 but the risk is increased if the tourniquet is applied for more than 1 h or if therapeutic arthroscopy is performed.163, 165

Symptomatic VTE occurs after arthroscopy without prophylaxis but it is very rare. In a 10-year prospective study, clinical and radiologically confirmed symptomatic DVT occuired in 0.6%.165, 334 One prospective study lound symptomatic PE within 5 weeks after surgery in 1/101 patients who had received LMWH for about 2 days.438

Prophylactic methods and recommendations

GENERAL CONSIDERATIONS

LMWH was effective compared with no prophylaxis in reducing the incidence of ultrasound detected DVT in 2 blind randomized studies of patients scheduled for arthroscopy, with 239 patients in one 167 and 130 patients in the other.168 The incidence of DVT was reduced from 8% in the control groups to 1% in the LMWH groups (RR 0.12 95% CI 0.03 to 0.53). Bleeding complications were not increased.

Thus, although clinical VTE is uncommon and fatalities are rare, the huge number of patients undergoing knee arthroscopy surgery makes VTE complications potentially relatively frequent. There is a clear correlation between age and degree of trauma with VTE.84 This justifies prophylaxis in patients with additional risk factors along with prolonged tourniquet application or when extensive surgery beyond a simple diagnostic procedure is performed.

RECOMMENDATIONS

Recommendation for simple diagnostic arthroscopy: routine prophylaxis is not recommended unless other risk factors are present (Grade C).

Recommendation for arthroscopic surgery (e.g. ligament reconstmctions): LMWH starting before or alter surgery (Grade B) or IPC in the presence of contr\aindications to LMWH are recommended (Grade C) until full ambulation.

Isolated below knee injuries

The risk

Patients with below knee injuries and immobilization have a DVT incidence in the range of 10-35% depending on the type and severity of injury (Table I) 144-149 and carry a risk of clinical PE in the range of 0.4-2.1%.424 The frequency of symptomatic events is unknown.

Prophvlactic methods and recommendations

GENERAL CONSIDERATIONS

This group is so heterogeneous that studies and recommendations are difficult to devise.

In one study of 253 patients with plaster casts of which the majority had soft tissue injuries, the ultrasonic incidence of DVT at cast removal was reduced from 17% in the control group to 5% in a LMWH group.146 It was reduced from 4% in the control group to 0% in the LMWH group 146 in another study of 339 patients.147 Considering both studies the RR was 0.21 (95% CI 0.09 to 0.49).

In patients with lower leg fractures, the 5-week incidence of venographic DVT was reduced from 18% in the control group to 10% in the LMWH group in one study (n=293) 148 and from 13% to 11% in another (n=150).149 Considering both studies, the effect of LMWH on DVT was not significant (P>0.05) (RR 0.64 95% CI 0.39 to 1.05). More studies are needed in well-defined groups of patients.

RECOMMENDATIONS

Currently available data based on small studies of a mixture of different types of injury do not allow routine prophylaxis to be recommended for isolated limb trauma. However, a thorough risk assessment and an approach using LMWH standardized by an institution yet individualized for each patient is recommended.

Multiple trauma

The risk

The incidence of DVT in patients who have sustained major trauma is in excess of 50% 77, 78, 439-442 (Table I) and PE is the 3rd leading cause of death in those who survive beyond the 1st dav.77, 443-445 The risk is particularly high in patients with spinal cord injury, pelvic fracture and those needing surgery.77, 78, 446-448

Prophylactic methods and recommendations

GENERAL CONSIDERATIONS

Patients with polytrauma have a particularly high risk for VTE. The tissue factor released by multiple injuries is potentiated by the likely surgical interventions and the subsequent prolonged immobility 446 produces marked venous stasis. Routine venography has shown a DVT frequency of 58% in these patients.77

Well-designed studies in this area are few and thromboprophylaxis has to be assessed according to the risk for bleeding. However, in the absence of intracranial bleeding and when bleeding is under control, LMWH (enoxaparin 30 mg bid) started within 36 h of injury has been shown to be more effective than LDUH (5 000 IU bid).439 It reduced the incidence of venographic DVT from 44% in the LDUH to 31% in the LMWH group (RR 0.7; 95% CI 0.51 to 0.97). The superiority of LMWH to LDUH has been confirmed by a subsequent study and a meta- analvsis.441, 449 A study comparing nadroparin fixed daily dose versus a weight-adjusted dose did not demonstrate any significant difference (0% vs 3% DVT).450

Three randomized controlled trials have tested the efficacy of IPC. The first was in patients with pelvic fractures but the study was small and underpowered so that the DVT reduction from 11% in the control group to 6% in the IPC group was not significant (P>0.05).343 IPC or FIT was compared with enoxaparin 30 mg bid in the second with an incidence of DVT of 2% and 1%, respectively.451 In the third, IPC was compared with FIT with an incidence of DVT of 6% and 21%, respectively (P

Mechanical methods are attractive if chemical prophylaxis is contraindicated. However, more studies are needed to confirm the efficacy of IPC as this would be the method of choice in patients in whom LMWH is contraindicated because of increased or continuing risk of bleeding.

RECOMMENDATIONS

LMWH starting as soon as bleeding risk is acceptable (Grade A) or IPC in the presence of contraindications to LMWH (Grade B) and continued until lull ambulation.

Elective spine surgery

The risk

The incidence of DVT detected by routine venography in the absence of prophylaxis has been found to be 18% (Table I), 154, 453 A review of studies on complications in patients having spinal fusion reported a 3.7% incidence for symptomatic DVT and 2.2% for PE.454

Prophylactic methods and recommendations

GENERAL CONSIDERATIONS

Two small randomized controlled studies comparing no prophylaxis with LDUH 455 and with enoxaparin 768 demonstrated that prophylaxis reduces the incidence of asymptomatic DVT from 20% and 10% respectively to 0%. In a prospective non-randomized study of 306 patients769 venographically detected DVT was found in 6% of those having IPC and in 21% of those without prophylaxis.

RECOMMENDATIONS

Mechanical method: IPC (Grade B); drug: LMWH (Grade B); initiation: before operation for IPC or after operation for LMWH; duration: during hospilalization (Grade C).

Spinal cord injury

The risk

In the absence of prophylaxis the incidence of silent DVT is of the order of 35% (Table I). In this group of patients, PE is the 3rd leading cause of death.456, 457 In a series of 1 649 patients undergoing rehabilitation, symptomatic DVT occurred in 10% and PE in 3%.458

Prophylactic methods and recommendations

GENERAL CONSIDERATIONS

LDUH and a combination of LDUH with GEC were compared with no prophylaxis in a randomized controlled study.108 The incidence of venographic DVT was 47% and 50% in the control and LDUH groups and 7% in the group that received combined prophylaxis. Subsequently, 2 small randomi/ed controlled

Merck & Co., Inc. announced today that Luciano Rossetti, M.D., has been named senior vice president and franchise head, Diabetes and Obesity, Merck Research Laboratories (MRL). Dr. Rossetti assumes his new role on Sept. 1 and will report to Peter S. Kim, Ph.D., president, MRL.

“Luciano Rossetti is a truly outstanding physician scientist whose work has had a major impact on our understanding of diabetes and obesity. We are delighted to bring a scientist of his stature to the MRL team,” Dr. Kim said. “Luciano is a proven leader with a deep commitment to improving the lives of patients, and his appointment will enhance our efforts to develop innovative new medicines for these two rapidly growing global public health problems.”

Dr. Rossetti, 49, comes to MRL after 15 years at the Albert Einstein College of Medicine of Yeshiva University in the Bronx, N.Y., where he served as Professor of Medicine and Professor of Molecular Pharmacology, while holding the Judy R. and Alfred A. Rosenberg Endowed Chair in Diabetes Research. Since 2002, he has also served as the Director of the Einstein Diabetes Research Center.

In this newly-created position, Dr. Rossetti will have overall responsibility for scientific direction across the drug discovery and development process for Merck’s key therapeutic areas of diabetes and obesity. He will be based at Merck’s research facility in Rahway, N.J.

“I join Peter Kim in expressing how delighted we are that a scientist of Dr. Rossetti’s world-class caliber is joining the MRL team in this key leadership role,” said Richard T. Clark, chief executive officer and president, Merck. “I am confident that Dr. Rossetti will make outstanding contributions to Merck research and help us continue our longstanding tradition of developing innovative new medicines to improve the health and well-being of patients around the world.”

Dr. Rossetti received his medical training at Trieste University Medical School, and completed his intern/residence in Internal Medicine at Rome University Medical School in Italy. He also carried out postdoctoral research in the Department of Internal Medicine, Section of Endocrinology, at Yale University Medical School in New Haven, Conn. An internationally recognized diabetes investigator, Dr. Rossetti has made major contributions to the understanding of the biochemical and molecular mechanism mediating the sensing of nutrients and the role of leptin in the regulation of glucose and fat metabolism. He is an expert in the application of molecular genetics and pharmacological approaches to studies on appetite and metabolic control by the hypothalamus.

Dr. Rossetti recently delivered the opening keynote address at the 5th International Metabolic Diseases Drug Discovery and Development World Summit, considered to be the premier conference for diabetes and obesity researchers. In 2000, he was honored with the prestigious Outstanding Scientific Achievement Award of the American Diabetes Association in recognition of groundbreaking research in diabetes that demonstrates independence of thought and originality.

Dr. Rossetti is an elected member of the American Society for Clinical Investigation and the Association of American Physicians.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck’s business, particularly those mentioned in the cautionary statements in Item 1 of Merck’s Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

BEIJING (Reuters) – A disease control office in Beijing has
opened the city’s first officially sanctioned online gay
chatroom, but most of the posts come from the Web site’s
managers, a newspaper reported on Monday.

A link marked “comrade forum” — “comrades” being Chinese
slang for gay men — on the Chaoyang District Disease
Prevention and Control Center’s Web site (www.cystd.com)
provides open threads for people to discuss their feelings and
seek counseling, the Beijing Times said.

Few people apart from the site’s managers have left posts
since the forum opened two months ago, in part due to people’s
concerns about restrictions, the paper quoted Fu Qingyuan, an
employee from the disease control center, as saying.

“Actually, such concerns are really unnecessary,” Fu said,
adding that apart from “people selling sex, obscene images and
other unsavory content,” posts would be largely untouched.

Fu, however, said health and disease prevention would be
the main focus of the forum, an “obvious distinction” to other
professional “comrade” Web sites set up by gay men.

“The purpose of the site is to let all gay people express
their true needs, to allow health workers to better communicate
with them and to prevent and control the possibility of AIDS
risks developing,” Fu said.

In China, homosexuality, while no longer officially
considered a mental disorder, is still an off limits subject
for many.

In a Beijing survey, only 15 percent of 482 men who had sex
with men understood that they were at risk of contracting HIV,
according to a 2005 report by the United Nations’ UNAIDS.

China estimates it has five to 10 million gay men and about
80 percent have admitted knowing nothing about the spread of
HIV/AIDS, state media have reported.

China reported 75,000 new HIV infections last year and
estimates it has 650,000 HIV/AIDS cases, but some experts say
the number may be higher.

By Ben Blanchard and Tan Ee Lyn

BEIJING/HONG KONG — Lexy Zhang laughs nervously as he talks about his first experiences picking up men for sex in a country where condoms are widely available for family planning but not always promoted to prevent AIDS.

“I was just having unsafe sex all the time,” said the 26-year-old, sitting in a fashionable Beijing bar frequented by gay men.

“Lots of gay Chinese think it’s great that you don’t have to worry about pregnancy but have no idea about sexually transmitted diseases,” said Zhang, adding he now would never consider having unsafe sex.

“There are just not enough organizations paying attention to this community. The government thinks it doesn’t exist.”

How to prevent the spread of AIDS in places like China will be a major focus of researchers and policymakers at the 16th International AIDS Conference, which opens on Sunday in Toronto.

In China, homosexuality, while no longer officially considered a mental disorder, is still an off limits subject for many. That taboo often extends to discussions about AIDS and condom use for men who have sex with men.

Condoms are widely available thanks to China’s long-standing one-child policy, but conservative attitudes and an unwillingness to talk about sex mean the connection with AIDS prevention is not always made.

“Sex is taboo, and condoms have mainly been used as part of family planning rather than for safe sex,” said Lee Folland, a graduate student doing research at Cambridge University on the social marketing of condoms in China.

In a Beijing survey, only 15 percent of 482 men who had sex with men understood that they were at risk of contracting HIV, according to a 2005 report by the United Nations’ UNAIDS. Some 49 percent reported having had unprotected anal intercourse with men in the prior six months.

A survey in late 2004 by the Chinese Center for Disease Control and Prevention in the northeastern city of Harbin found that almost 20 percent of men who had sex with other men also slept with women. More than 10 percent were married.

“There is strong social pressure to get married — or what would the neighbors say? It’s not only about how your parents would react, but how others will react to your parents,” Folland said, referring to fear of social ostracism for parents whose sons were thought to be gay.

Condoms and safe sex information are often not available in Chinese gay bars or saunas. Although they are starting to appear thanks to volunteer groups and outreach programs and a government belatedly waking up to the problem.

But even that information can sometimes be too tame to include pictures of how a condom is used.

“Otherwise in China it would probably be considered pornography,” said Chinese AIDS activist River Wei.

BORDER COMPLICATIONS

In Hong Kong, Ricky Fan, 40, goes cruising once a week at one of the city’s many gay saunas, venues that have become increasingly popular in recent years among men looking for anonymous sex with other men.

These places are invariably pitch black. But once acclimatized to the darkness, visitors are likely to be greeted by eyecatching flyers and postcards on safe sex, HIV testing and free condoms from the locker rooms to the many tiny cubicles.

The message is certainly not lost on the more frisky members of Hong Kong’s gay population.

“I always use condoms, 100 percent of the time. Because it’s safer,” said Fan, who has visited saunas in the last five years in Hong Kong, mainland China, Thailand, Taiwan and Japan.

“I will push away anyone who doesn’t use them.”

But this attitude is far from the norm. New HIV infections among men who have sex with men have shot up in almost every big city in Asia in recent years.

Insiders attribute it to unsafe sex, made worse by a population that is relatively cash-rich and highly mobile.

“In Hong Kong, those who are unattractive and can’t find anyone go to Shenzhen (across the border in southern China) to buy ‘money boys,”‘ said sauna owner Ray Chong, referring to gigolos who service male clients in big Chinese cities.

“They pay more to get the boys not to use any condoms.”

MOBILE POPULATION

Activist groups, which have done much to keep new HIV infections down in Hong Kong, say their work is complicated by the rise in the commercial sex trade on the mainland, which shares an increasingly porous border with Hong Kong.

“Infection rates have gone up among men who have sex with men in Asia because the population is so mobile, so our work cannot remain so localized. We have to go where they go,” said Lau Chi-chung of AIDS Concern, a Hong Kong-based group which has promoted awareness of the disease since the mid-1990s.

“What we can do is limited. We have to collaborate with the government, other NGOs (nongovernmental organizations) in mainland China to spread the message.”

Another problem in China is that many men who have sex with men do not identify themselves as gay or bisexual. Indeed, thanks to a lack of education and cultural taboos they are not even be aware the concept exists, activists say.

“If you’re 40, have been married all your life, have kids and live in the countryside then one day you discover your true self and have sex with a man, you aren’t going to be thinking about using a condom,” said Wei.

“But that one time could be enough to get you infected.”

NEW YORK (Reuters Health) – To reduce the risk of illness
and death, twins should be delivered before 40 weeks of
gestation, but there is no added benefit in delivering them by
38 weeks of gestation, new research suggests. In fact, delivery
at 37 weeks appears to raise the risk of needing assisted
ventilation.

The findings run counter to some reports that have
suggested improved outcomes with delivery by 38 weeks
gestation. Still, other studies, like the current one, have
failed to identify a benefit with earlier delivery.

The latest findings, which appear in the American Journal
of Obstetrics and Gynecology, are based on a look at 60,443
twin pairs that were delivered in the US between 1995 and 1997.
The study only included pregnancies that had reached at least
37 weeks of gestation.

Compared with twins delivered at 37 weeks gestation, those
delivered at or beyond 40 weeks were over 2.5-times more likely
to die.

By contrast, delivery at 38 and 39 weeks gestation did not
significantly increase or decrease mortality relative to
delivery at 37 weeks.

Similarly, delivery at or beyond 40 weeks gestation
increased the risk of low Apgar scores by at least 74 percent,
lead author Dr. Jennifer E. Soucie, from the University of
Ottawa in Ontario, Canada, and colleagues note. Apgar scoring
is a method of quickly checking newborns, based on their heart
rate, breathing, muscle tone, response to stimulus and color.

Delivery at 39 weeks cut the likelihood of ventilation use
by 17 percent relative to delivery at 37 weeks, the report
indicates.

“This study suggests that the optimal date of delivery for
twins should be

SOURCE: American Journal of Obstetrics and Gynecology July
2006.

SOMERSET, N.J., Aug. 10 /PRNewswire-FirstCall/ — The Therapeutics Institute (“TTI”), an inVentiv Health company , today announced that it has launched unique service to meet high volume training needs required for complex pharmaceutical products, medical devices and delivery systems. At the same time, TTI has also announced that BD, a global medical technology company, and two additional top pharmaceutical and medical device clients have signed up for this new service offering.

TTI’s new service will use a nationally based team of licensed and certified “on call” clinical specialists to assist in the conversion and installation of in-service training so that pharmaceutical and medical device clients can quickly and efficiently meet demand with tailored programs that are flexible and scalable. TTI’s “on call” specialist service will develop training programs that meet industry requirements and promote standardization, ensure safety and accuracy of product use in hospital setting.

Commenting on the TTI offering, Joy Morrell, Vice President and Managing Director, The Therapeutics Institute said, “We have found that working with pharmaceutical and medical device companies, education makes a difference in product delivery uptake. Since the “on call” specialist training service we are offering is both volume-driven and time-sensitive, we are able to quickly and efficiently carry these programs out.”

Kathy Sullivan, Senior Director / Marketing of BD Medical, a segment of BD, said, “Through the relationship with TTI, BD is looking forward to expanding upon our reputation as a high-touch provider of clinical and product support to the healthcare community.”

Terry Herring, President and CEO of inVentiv Commercial Services commented, “This innovative and flexible service should have a favorable impact on overall headcount and SG&A on the client side, two important factors in this current environment.”

About The Therapeutics Institute

The Therapeutics Institute helps pharmaceutical companies, healthcare providers, practices and associations raise awareness and educate patients to reach and maintain optimum health outcomes. The Therapeutics Institute offers Clinical Nurse Educator (CNE), On-Call Specialists (including Nurse Specialists), Medical Science Liaison (MSL) or other medical education teams who are uniquely equipped to reach target physicians and influential groups to affect outcomes.

About inVentiv Health

inVentiv Health is the leading provider of commercialization and complementary services to the global pharmaceutical, life sciences and biotechnology industries. inVentiv delivers its customized clinical, sales, marketing and communications solutions through its three core business segments: inVentiv Clinical, inVentiv Communications and inVentiv Commercial. inVentiv Health currently works with over 200 unique pharmaceutical, biotech and life sciences clients, including all top 20 global pharmaceutical companies. For more information, visit http://www.inventivhealth.com/.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks that may cause inVentiv Health’s performance to differ materially. Such risks include, without limitation: changes in trends in the pharmaceutical industry or in pharmaceutical outsourcing; our ability to compete successfully with other services in the market; our ability to maintain large client contracts or to enter into new contracts; uncertainties related to future incentive payments; and, our ability to operate successfully in new lines of business. Readers of this press release are referred to documents filed from time to time by inVentiv Health Inc. with the Securities and Exchange Commission for further discussion of these and other factors.

inVentiv Health, Inc.

CONTACT: Investors, Corporate – John Emery, CFO, inVentiv Health, Inc.,+1-732-537-4804, [email protected]; Media – Felicia Vonella,inVentiv Health, Inc., +1-212-308-7155, [email protected]

Web site: http://www.inventivhealth.com/

By Victoria Averill

NIMIKOR CHIEFDOM, Sierra Leone (Reuters) – Chief Aiah
Lebbie weighs a small but heavy pile of metallic flakes
glistening in the palm of his hand.

It is gold, found by small-scale or artisanal diamond
miners in the tailings of a diamond gravel pit in Nimikor,
Lebbie’s chiefdom, in Sierra Leone’s eastern province.

Unaware of soaring gold prices on international markets and
more concerned with looking for diamonds, miners sell these
flakes to the chief for a just a few dollars.

“People are so obsessed with diamonds in Sierra Leone, they
overlook the value and abundance of this gold,” Lebbie said.

“They think in the short term, the quick fix of finding a
single diamond, but really with gold the long-term potential is
enormous.”

Sierra Leone is notorious for its “blood diamonds” which
helped fuel a brutal 1991-2002 civil war, made famous by images
of drugged child soldiers and mutilated civilians.

Diamonds are now at the heart of a burgeoning mining sector
as the country tries to recover from the war and combat
poverty, but geologists say Sierra Leone’s untapped gold
potential may even exceed that of diamonds.

Gold has been uncovered in the north, east and south of the
country, but the size of the deposits is not yet known.

No gold mining licenses have been issued and there are no
official exporters — even though the Ministry of Mines and
Mineral Resources reported 2005 exports of some $250,000.

The government says it does not know how much gold is being
produced. But it suspects production and exports are far
greater than the amount being declared.

“Perhaps the rest is being smuggled,” said Mohamed
Mansaray, director of the Geological Surveys Department.

REGIONAL CURRENCY

In the absence of a regional single currency, gold allows
trade between the poor nations of West Africa, offering
security from the vagaries of local exchange rate fluctuations.

With no manufacturing industry of its own, Sierra Leone
buys light manufactured goods from neighboring Guinea, and
experts say much of its gold heads north over the border in
return.

That means the treasury misses out on any export levies,
which could help fund government efforts to rebuild the country
after years of civil war.

One mineral sector observer said the government may be
reluctant to interfere in such informal transactions for fear
of upsetting cross-border trade, which is essential to meet
local demand and which provides a livelihood for thousands of
traders.

“But it’s also possible that some people are getting a cut
from trade between the two countries, or that gold is being
exported illegally from Sierra Leone which would explain the
low export figures,” said the observer, who declined to be
named.

Official connivance in systematic abuse of mineral wealth
should set alarm bells ringing in the former British colony.

Widespread government corruption is generally believed to
have been a major factor in triggering the war, in which rebels
backed by neighboring Liberia’s leading warlord Charles Taylor
seized the eastern diamond fields.

Gold never made many headlines during the conflict but some
believe it played as significant a role as diamonds in
bankrolling the fighting.

Since Sierra Leone began regulating its diamond industry
and joined the anti-blood diamond Kimberley Process in 2003,
illegal mining and smuggling have been reduced and official
exports have risen from $1.2 million in 1999 to over $140
million in 2005.

That has helped the post-war economy grow by more than 7
percent per annum in the past three years.

But official gold production has failed to keep pace, and
the lack of regulations is a hurdle.

“People are also getting away with (smuggling gold) as no
questions are being asked,” said Lawrence Ndola-Myers,
government diamond valuer at the Gold and Diamond Department.

By Amy Norton

NEW YORK (Reuters Health) – Music that depicts women as sex objects and men as insatiable studs may encourage some teenagers to become sexually active, according to a study of U.S. teens.

While popular music, from rap to country, is full of sexual content, that depiction of sex varies widely. And in the new study, researchers found that the distinction between “degrading” and “non-degrading” sexual lyrics may make a difference in teenagers’ behavior.

Of the 1,461 adolescents aged 12 to 17 they followed, those who regularly listened to music with degrading lyrics at the start of the study were more likely to start having sex over the next two years. In contrast, there was no evidence that sexual yet non-degrading music swayed teenagers’ behavior.

“We think this is an important distinction,” lead study author Dr. Steven C. Martino told Reuters Health.

It’s not just a matter of music being sexually explicit, said Martino, a researcher at RAND Corp. in Pittsburgh. Songs can be sexual, even explicitly so, but portray sex in the context of a relationship, for example.

Degrading lyrics, on the other hand, depict women as submissive sex objects or men as players on the prowl. And this seems to be the problem, according to the study findings, which were published this week in the journal Pediatrics.

“If I’m a 13-year-old boy, and I keep hearing that women are sex objects and men are players, then I might start to think that’s a reasonable way for me to be,” Martino said.

Similarly, he noted, young girls, rather than being offended by the portrayal of women in these tunes, might get the message that it’s normal for them to be treated disrespectfully.

It’s impossible to show that the music teens listen to directly causes them to have sex, Martino pointed out. But he and his colleagues did weigh a range of other factors that could have explained the relationship between degrading lyrics and teen sex — like race, parents’ education and teenagers’ reported levels of parental supervision and religious conviction.

“This study provides a very strong basis to believe that the kinds of music kids listen to influences their sexual behavior,” Martino said.

Since it’s probably impossible for parents to shield their kids from sexually degrading music, he recommended that they talk with their children about the subject — which may help them to “think critically” about the lyrics they hear, rather than just accepting them.

“That way, they’ll have their parents’ views as filters,” Martino said.

SOURCE: Pediatrics, August 2006.

By Jessica Wohl

CHICAGO (Reuters) – Mouthwash makers were once satisfied
with telling customers that their products stop bad breath. Now
they’re getting more aggressive, touting emerging science that
a healthy mouth may lead to a healthy body.

There are still no studies proving a connection between
oral health and overall health, but a new campaign from
Listerine sets out to explain the relationship.

A print advertisement which debuted in Wednesday’s edition
of USA Today depicts a Listerine bottle donning a stethoscope.

“If you think it’s just for your mouth, think bigger,” the
ad states.

“There’s an association between the health of the mouth and
the health of the body,” said Dr. Madeline Monaco, director of
oral care professional relations, and a member of Listerine’s
research & development team.

Still, while there is a “pretty strong association,” she
said, no cause and effect studies have been conducted to show
if gingivitis or advanced gum disease can cause health problems
such as heart disease or diabetes.

The new educational push comes as Listerine, the No. 1
mouthwash from Pfizer Inc., feels some pressure from Procter &
Gamble Co.’s Crest Pro-Health, which came to the U.S. market in
early 2005.

“The reality is that there’s more competition out there and
so the perennial category standard bearer, Listerine, is
feeling it,” said Robert Passikoff is founder and president of
consultancy Brand Keys Inc.

The advertisement only says that “emerging science
suggests” a link, wording safe enough for the American Dental
Association to give its seal of acceptance. Listerine is also
sponsoring an ADA brochure entitled “Health Mouth Health Body:
Making the Connection.”

The latest campaign comes after Listerine had to change its
advertising in January 2005 after a judge ruled that comparing
the mouthwash to dental floss was false and misleading.

“We really did our homework to make sure that what we were
saying reflected the state of the science,” Monaco said,
including discussions with the ADA, the American Heart
Association and the American Medical Association.

Listerine commanded 45 percent of the overall
mouthwash/dental rinse market in the United States in the year
ended July 16, but its sales slipped 4.9 percent, according to
Information Resources Inc., whose data excludes Wal-Mart. Crest
Pro-Health had a 9.3 percent share of the market in that time.

“Our share is down a little bit, as you’d expect from a
major new competitor coming into the marketplace,” said Jeremy
Puttock, a Listerine marketing director.

He called the new push “a significant initiative for
Listerine” but declined to disclose financial details.

Listerine also updated its web site
(http://www.listerine.com) this week to tout the ideas. At the
same time, Crest Pro-Health is coming out with a new toothpaste
and discusses the healthy mouth-healthy body connection on its
own site (http://www.crest.com/prohealth/home.jsp).

Johnson & Johnson is set to buy Pfizer’s consumer products
business later this year. Pfizer said that it did not discuss
the new Listerine campaign with J&J.

NEW YORK (Reuters Health) – Girls whose families criticize
their weight or eating habits may develop lasting problems with
body image and self-esteem, a new study suggests.

Researchers found that of 455 college women with poor body
image, more than 80 percent said their parents or siblings had
made negative comments about their bodies during childhood.

Many believed the comments reflected a general lack of love
and support or were even part of a pattern of emotional abuse
— with some saying family members also called them “ugly,”
“stupid” or “lazy.”

But in more cases than not, the women said their parents or
siblings had only occasionally made comments about their weight
and body shape.

“The data suggest that even a few comments may have a
negative impact,” the study authors report in the journal
Pediatrics.

“In fact, in otherwise or generally supportive families, a
few negative comments may have a particularly detrimental
impact, because they stand out against patterns of little or no
criticism,” write the researchers, led by Dr. C. Barr Taylor of
Stanford Medical Center in California.

Parents, they say, need to be aware that their words can
have lasting effects on how their daughters feel about
themselves.

All of the women in the study were part of a larger project
looking at eating disorder prevention; they were considered to
be at high risk based on their excessive worries about their
weight, shape and eating habits. At the start of the study,
they all completed a battery of surveys, including ones that
asked about hurtful comments during childhood and current
levels of self-esteem.

Most of the women said that family members had made some
negative remarks about their bodies. Based on their reports,
more than half of mothers had made such comments, as had
roughly 40 percent of fathers and 40 percent of brothers and
sisters.

Women whose parents had said these things showed relatively
lower self-esteem and felt a lack of support from their
families.

According to Taylor and colleagues, parents who are worried
about their daughter’s weight and health need to find ways to
give “constructive advice” about healthy eating and exercise
without being critical.

It’s also important for parents to lead by example,
following a balanced diet, getting regular exercise and
refraining from criticizing their own bodies, according to the
researchers. Stanford University has a pamphlet with advice for
parents that can be downloaded from
http://bml.stanford.edu/mcknight.

SOURCE: Pediatrics, August 2006.

NEW YORK (Reuters Health) – Deep heat treatment can help
relieve shoulder pain due to inflammation or tearing of rotator
cuff tendon, a new study confirms.

There is currently no agreed-upon treatment for patients
with inflammation or tears in the tendons that make up the
rotator cuff of the shoulder, Dr. Nicola Maffulli of Keele
University School of Medicine in Stoke on Trent, England and
colleagues write.

Hyperthermia, in which the surface of the skin is kept cool
while tissues deep in the affected area are heated with
microwaves to about 110 degrees F, has recently been introduced
as a physical therapy and rehabilitation technique, Maffulli
and her team note in the August issue of the American Journal
of Sports Medicine.

After having success with hyperthermia for treatment of
tendon and muscle injuries in athletes, the researchers tested
the approach in a pilot study of patients with a type of
rotator cuff injury known as supraspinatus tendinopathy. The
supraspinatus muscle is located on the top of the shoulder
blade and is joined to the humerus bone at the top of the arm
by a tendon.

They divided 37 athletes, all of whom had been experiencing
shoulder pain for three to six months, into three groups. One
received hyperthermia treatment three times a week for four
weeks; the second group was given ultrasound therapy on the
same schedule; and the third group performed five minutes of
exercise twice daily for four weeks.

The researchers assessed the study participants’ pain
before treatment, immediately after treatment was completed,
and six weeks after the end of treatment. Only patients in the
hyperthermia group reported a significant reduction in pain
after treatment and during follow-up. Four patients reported
feeling some discomfort due to the high temperature, but
treatment was not halted for this reason and the discomfort was
temporary.

Maffulli and her colleagues conclude that hyperthermia is
effective in the short-term for treating supraspinatus
tendinopathy and should be tested in larger and more diverse
groups of patients, including non-athletes. The technique
should also be investigated for treating other types of rotator
cuff injury.

SOURCE: The American Journal of Sports Medicine, August
2006.

By Alaa Shahine

TYRE, Lebanon (Reuters) – Hussein Ali Ayoub was washing his
face one morning in his border village of Maroun al-Ras in
southern Lebanon when the ceiling suddenly collapsed.

He had refused to follow his parents to a nearby shelter
before Israeli bombardment of the village. His last memories
are hearing two loud explosions before waking up at a hospital
in the city of Tyre, suffering wounds in his foot, knees and
back. His parents are missing, and so are his wife and four
children.

“I can’t stop thinking of them,” he said, sitting on a
mattress at a U.N.-run school in the Palestinian refugee camp
of al-Buss in Tyre that is sheltering hundreds of Lebanese
families who fled the war between Israel and Hizbollah.

“If I don’t hear from them for another week, I will go mad.
I will explode,” the 43-year-old construction worker said.

Ayoub’s wife, Najibeh, had taken her daughter and three
sons to a village near Tyre before the bombing of Maroun
al-Ras, a scene of fierce fighting between advancing Israeli
troops and Hizbollah guerrillas. When he went to check on them,
they were gone, leaving no trace behind.

The 25-day-old war, ignited after Hizbollah’s capture of
two Israeli soldiers in a cross-border raid, has taken a heavy
toll on civilians in Lebanon.

The Beirut government says at least 900 people have been
killed and one million, a quarter of the population, have been
displaced. A Reuters tally puts the death toll at 734 in
Lebanon and 75 Israelis.

FADING HOPE

As anxious as he may be, Ayoub still hopes to find his wife
and children. For some other refugees, the most they can hope
for is that the bodies of loved ones will be recovered.

“My parents are under the rubble of my house and they are
probably dead,” said Abduallh Hussein, 57, lighting a
cigarette. His father, Mohammed Ali, 85, and his 80-year-old
mother were stuck in the village of Tair Harfa, one of many in
Tyre’s hinterland that has come under heavy Israeli attacks.

“I hope I can go there, pull them out and bury them,” said
Hussein, whose hands are rough from chopping wood for living.

Hussein has lost relatives in past wars — his brother
Abbas was killed shortly after the 1982 Israeli invasion of
Lebanon and two nephews, Nidal and Mouein, were Hizbollah
fighters who were killed fighting to Israel in south Lebanon in
the 1980s.

Another refugee, Mohammed Rasatmi, has not seen his cousin
Mahmoud since the Israeli bombing of al-Qasmieyh village near
Tyre about a week ago.

“We are no different than other people who are losing their
family members in this war,” said the 45-year-old gardener, now
a refugee in the city of Sidon.

At Sidon’s town hall, aid workers have set up a detailed
computer database for the refugees who have flocked to the
city, the largest in the south, helping them locate missing
relatives.

“We were able to reunite many people,” said Mohammed
Nahouli, sitting at a partitioned corner in the main hall where
volunteer aid workers, mostly young college graduates, sit
behind computer screens to sort out the refugees’ data.

A group of refugees gathered around one worker to hand in
information about missing relatives. One of them, 70-year-old
Mohammed Shammout, was asking about his son, Moustafa.

“Tell your colleagues to say his name on the radio,” he
told a visiting reporter. “Tell him ‘Your father is looking for
you’.”

LONDON (Reuters) – Hundreds of Britons are being urged to
attend what is being branded as Europe’s first
“Masturbate-a-thon,” a leading British reproductive healthcare
charity said on Friday.

Marie Stopes International, which is hosting the event with
HIV/AIDS charity the Terrence Higgins Trust, said it expected
up to 200 people to attend the sponsored masturbation session
in Clerkenwell, central London, on Saturday.

“It is a bit of a publicity stunt but we hope it will raise
awareness,” a Marie Stopes spokeswoman told Reuters.

“We want to get people talking about safer sex,
masturbation and to lift taboos.”

Participants, who have to be over 18, can bring any aids
they need and can take part in four different rooms — a
comfort area, a mixed area, along with men and women only
areas.

However, the rules on the event’s Web site states there can
be no touching of other participants nor are people allowed to
fake orgasms.

“The amount you raise will be determined by how many
minutes you masturbate and/or how many orgasms you achieve,”
the Web site said.

The Marie Stopes spokeswoman said local religious groups
had been initially outraged, but after people had heard what
the event was about, most had approved it.

Police had also given it their approval.

Similar events have been staged in San Francisco for the
last six years raising $25,000 for women’s health initiatives
and HIV prevention. If successful, Marie Stopes said it could
take place elsewhere in mainland Europe next year.

By Mohammed Abbas

KHARTOUM — At the crowded Beauty Queen parlor in Sudan’s capital Khartoum, beautician Selma Awa says she just cannot understand why so many of her clients want to get their skin lightened.

“One hundred percent of women who come here have it done,” she said. “People think it’s prettier to look white. In my opinion, dark is prettier. I don’t know who they want to look like.”

In many countries in Africa, the Middle East and Asia lighter-colored skin is considered prettier and paler women are believed to be wealthier, more educated and more desirable.

This attitude has led to a boom in the use of skin-lightening products in Sudan, a vast country torn by war where skin color also has political connotations.

Rasha Moussa, a maid, pulls some skin-whitening cream from her handbag.

“I use it on my face to make my face shine. The Sudanese see the light color as better than dark. I think it’s a complex that we have,” she said.

“People judge you here by your color … If they see me and someone else with lighter skin wearing the same clothes, they would say she is living a comfortable life and I’m a poor woman,” she added.

Millions of women throughout Africa use creams and soaps containing chemicals, like hydroquinone, to lighten the color of their skin. But the creams can cause long-term damage.

Dermatologists say prolonged use of hydroquinone and mercury-based products, also found in some creams, destroys the skin’s protective outer layer. Eventually the skin starts to burn, itch or blister, becomes extremely sensitive to sunlight and then turns even blacker than before.

Prolonged use can damage the nerves or even lead to kidney failure or skin cancer and so prove fatal.

“It’s a very bad problem here. It sometimes kills the patient … It’s bad, bad news,” said a doctor at a Khartoum hospital. He said the number of women coming to the dermatology department with problems caused by skin-whitening treatments had grown to at least one in four of all dermatology patients.

MODERN STYLE?

In Khartoum, skin-whitening creams are displayed prominently in stores and on roadside adverts. Products advertised on Arab television channels promise the creams will also make a woman more confident and glamorous.

In one advert, a previously unremarkable female television presenter delivers a stunning report after using whitening cream. Her handsome male colleague, who has previously ignored her, says: “You were great. What are you doing at four?”

In another, a singer leaves the stage with stage fright but returns after lightening her skin and performs wonderfully.

At the Modern Style bridal store, an array of skin-whitening creams adorn the front desk. Next door, a photography studio displays wedding portraits of women with very pale skin.

Modern Style’s Egyptian owner Samira Magar tied the growing preference for white wedding dresses, which are not traditional in Sudan, to the desire for pale skin.

“More Sudanese are getting white wedding dresses, so they want to look like Egyptians and Europeans,” she said.

“I think it’s an inferiority complex. They think that if they’re white in color, they are more beautiful,” she added.

Magar said some women had resorted to mercury and harsh prescription creams not meant for cosmetic use, leaving their faces disfigured on their wedding day.

SINISTER TONE

Natural methods of skin whitening have been used for centuries, Magar said, but in Sudan the use of chemicals began in the 1980s and has thrived since.

The doctor at the Khartoum hospital, who declined to be named, said the creams now used can cause irritation and infection, blotching, eczema, and that most contain steroids.

The doctor said that rather than ask why women use the creams, men should be asked why they prefer pale skin.

“Here, all men want to sit with or marry a woman with light skin. If any man wants to marry, he says the first choice is for a woman with light skin … Why is this?”

While a tan can be seen as something of a status symbol in the West, darker skin marks out women in Africa, the Middle East and Asia as poorer people who have no choice but to toil under the hot sun.

In Sudan, Africa’s biggest country, over two decades of civil war between lighter-skinned northerners and darker southerners has given skin tone more sinister connotations, and the meaning of the various shades is nuanced.

Northerners, who are mainly Muslims and claim Arab lineage, have traditionally held power. A north-south coalition government now shares power after a peace deal last year.

During civil strife, skin tone often meant the difference between life and death. Southerners, traditionally Christian or animist, complain of prejudice against them in everyday life, and some northerners privately claim superiority over their darker and non-Arab countrymen.

Following is Niagara Sunday’s weekly listing of upcoming public events held around Niagara County.

If you would like your event included, send the information two weeks in advance to: Niagara Community Calendar, c/o The Buffalo News, 8353 Niagara Falls Blvd., Niagara Falls, NY 14304, fax to: 283- 1691 or e-mail to: [email protected].

>Today

DINNER: All-you-can-eat pasta dinner, noon to 5 p.m., Masonic Temple, One Cottage St., Lockport. Served by Niagara-Orleans District, Order of the Eastern Star. Cost $5.

OLD OLCOTT DAYS: Historical displays of 1900s Olcott, souvenirs, postcards, photos, narrated trolley tours, Coney Island hot dogs, music, free admission and parking, noon to 5 p.m., Ontario Street.

CEMETERY TOUR: Orleans County historian Bill Lattin offers tour of the Marble Orchard, 2 p.m., Village Cemetery, 505 Cayuga St., Lewiston. Adults, $10; children younger than 12, $5.

PERFORMANCE:Lockport Federation of Musicians Concert Band, 2 to 4 p.m., Lockport Town Hall, 6560 Dysinger Road.

—–

>Monday

BUY A SUNFLOWER: Niagara Hospice and the other four Hospices of Western New York have partnered with Wilson Farms, Sugar Creek and Wilson Farms Express stores for Sunflower Days. For a minimum $1, donors can purchase a paper sunflower. Proceeds benefit Hospices.

PERFORMANCE:Bittersweet Rose, as part of Blue Mondays, 7 to 9 p.m., Hennepin Park Gazebo, Fourth and Center streets, Lewiston. Free.

ARTS AND CRAFTS: For children ages 3 to 12, 2 p.m., LaSalle Branch Library, 8728 Buffalo Ave., Niagara Falls. Call 283-8309 to register. COMPUTER TUTORING: One-onone computer classes with Technical Services Librarian Sarah J. Watson, 3 to 3:45 p.m. and 4 to 4:45 p.m., Lewiston Public Library, 305 S. Eighth St. Call 754- 4720 to register.

ART SHOW: Garden Reflections, an art and sculpture show, noon to 5 p.m., Kenan Center House Gallery, 433 Locust St., Lockport. Continues noon to 5 p.m. through Friday and 2 to 5 p.m. Sunday.

ADULT FITNESS: Low-impact aerobics, 10 a.m. to 1 p.m. Mondays and Wednesdays, Niagara Falls Recreation Department, LaSalle Facility, 9501 Colvin Blvd. Free.

EXERCISE: PACE (People With Arthritis Can Exercise), a program of gentle exercise that combines recreation and socialization, 1 to 2:30 p.m. Mondays, DeGraff Community Center of Kaleida Health, 139 Division St., North Tonawanda. Cost is $25 for a 10-week course. Call 690-2271 to register.

FREE CLINIC: Sexually Transmitted Disease Clinic, noon to 3:30 p.m., Trott Access Center, 1001 11th St., Niagara Falls. Confidential and anonymous. No appointment needed. Use the Elmwood Street entrance. Continues Thursday.

SUPPORT GROUP: Recovery Inc., a self-help community mental health resource, 7 to 9 p.m., St. Teresa’s School basement, McKoon and College avenues, Niagara Falls.

TODDLER STORY HOUR: Miss Sandra Toddler Story Hour, 10:30 a.m., Lewiston Public Library, 305 S. Eighth St. Call 754-4720 to register. gister.

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>Tuesday

CELTIC FESTIVAL: Gaelic Storm and Enter the Haggis will perform at Artpark’s annual Celtic Festival, as part of First Niagara Tuesday in the Park, 6:30 p.m., Artpark, Lewiston. Free.

FREE CLINIC: An immunization clinic for children, 9 to 11:30 a.m. on the third Tuesday of every month, Trinity Lutheran Church, 67 Saxton St., Lockport. Appointments only by calling 278-1903. Clinics also held in North Tonawanda and in Niagara Falls.

CAR SHOW: Niagara Falls Cruisers Car Club show, 5 to 9 p.m., next to the parking lot for Sal Maglie Stadium, Hyde Park Boulevard, Niagara Falls.

OPEN ENROLLMENT: Enrollment for Medicaid, Child Health Plus and Family Health Plus, 9 a.m. to 3 p.m., Hamilton B. Mizer Primary Care Center, 501 10th St., Niagara Falls. Bring identification showing date of birth, a current utility bill or other address verification, and wage information. For more information, call 285-1563.

NAR-ANON:Helping families cope with substance abuse by someone, 7 to 8:30 p.m., Clearview Outpatient Center, 66 Mead St., North Tonawanda.

AUDITIONS, ANYONE?: Niagara Fine Arts Program will hold auditions for “Seussical – the Musical!” 6 p.m., music suite of Niagara Falls High School, 4455 Porter Road. Participants must bring vocal selections. Continues Wednesday. Call 284-5456 or visit www.niagarafinearts.org for more information.

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>Wednesday

GOURMET COOKING CLASS: “Dietary Supplements: What’s the Big Deal?” featuring flax pizza bread, garlic dipping sauce and green tea marinated cucumbers, 10 a.m., Mary C. Dyster Community Education Room, Niagara Falls Memorial Medical Center, 621 10th St. Free through most insurance programs. To register, call 278-4523.

MAKE A BOOKMARK: Children in grades 4 to 9 can make beaded bookmarks and an origami treasure cup, 10:30 to 11:30 a.m., North Tonawanda Public Library, 505 Meadow Drive.

GREAT NIAGARA STEAKOUT: Put on the by Niagara Police Athletic League; golf begins, 11 a.m.; appetizers, 5 p.m.; dinner, 6 p.m., Hyde Park Golf Course and Oasis, 4343 Porter Road, Niagara Falls. Golf packages, $60 and $75 per person. Dinner only, $35. Call 286- 7038 for more information.

AUDITIONS, ANYONE?: Niagara Fine Arts Program will hold auditions for “Seussical – the Musical!” 6 p.m., music suite of Niagara Falls High School, 4455 Porter Road, Niagara Falls. Participants must bring vocal selections. Call 284-5456 or visit www.niagarafinearts.org for more information.

FREE DANCE CLASS: Dance instructor Joan Harris teaches line dances, including the electric slide, Jersey strut, Louisiana strut, steppin’, my way and the Jackie Gleason, 5 to 7 p.m., Doris Jones Family Resource Building, 3001 Ninth St., Niagara Falls. Call 285- 5374 to register.

OVEREATERS ANONYMOUS: 12:30 p.m., Clearview Treatment Center, 66 Mead St., North Tonawanda.

MEETING:Panic Anxiety Depression Support Group, 6:30 p.m., Mental Health Association, 36 Pine St., Lockport.

SUPPORT GROUP: Breast cancer support, 7 p.m. DeGraff Community Center, 139 Division St., North Tonawanda.

SUPPORT GROUP: Onward, healing and compassion for divorced or separated people, 7 p.m., St. John the Baptist School, 160 Chestnut St., Lockport. Free.

FREE LEGAL ADVICE: Legal Advocacy Service, sponsored by Mental Health Association in Niagara County, offers free legal advice to qualified clients, 9 a.m. to 4:30 p.m., 36 Pine St., Lockport. For information and appointments, call Betty 433-3780.

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>Thursday

REHAB PICNIC: Lockport Memorial Hospital’s cardiac rehabilitation picnic for patients and their spouses, 3 p.m., with dinner at 5:30, Widewaters Marina Shelter, Market Street, Lockport. Bring table service, a picnic food item to share and lawn chairs. Meat and beverages will be provided. Call 514-5505 by Monday to reserve a place.

A.M. LOCKPORT TOASTMASTERS: 7 to 8:30 a.m., Friendly’s Restaurant, 2 W. Main St., Lockport. Guests and visitors welcome.

PERFORMANCE:Lewiston Jazz Project features Ron Corsaro and the UpState Express, 7 to 9 p.m., Academy Park, Center Street, Lewiston.

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>Friday

CAR CRUISE: Weekly car cruise with free admission, 5 p.m. to dusk, Page’s Whistle Pig Restaurant, Packard and Military roads, Town of Niagara. Hosted by Freewheelers Car Club.

RECREATION PROGRAM:For developmentally disabled children 3 to 10 years old, 2 to 6 p.m., Niagara United Cerebral Palsy, 9812 Lockport Road, Town of Niagara.

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>Saturday

FAMILY WEEKENDS: “Return of the Robots,” where children can use recycled household items to create an Earth-friendly robot, noon to 4 p.m., Artpark, Lewiston. Call 754-4375 for more information or go online to www.artpark.net. Continues Sunday.

ITALIAN FESTIVAL: With bocce, ethnic foods, children’s pageant, music, contests, citizens’ awards, 5K run and more, noon to 10 p.m., Columbus Park and Pine Avenue from Portage Road to 15th Street, Niagara Falls. Continues Sunday.

—–

>Next Sunday

SUPPORT GROUP: Recovery Inc., a self-help community mental health resource, 2 to 4 p.m., First United Methodist Church, 8210 Buffalo Ave., Niagara Falls. Use the back entrance.

MUSEUM HOURS: 2 to 4 p.m., Das Haus, museum of the Historical Society of North German Settlements in Western New York, 2549 Niagara Road, Bergholz.

ITALIAN FESTIVAL: With bocce, ethnic foods, children’s pageant, music, contests, citizens’ awards, 5K run and more, noon to 10 p.m., Columbus Park and Pine Avenue from Portage Road to 15th Street, Niagara Falls.

PERFORMANCE:Pocket Change, 2 to 4 p.m., Olcott Lions Club Band Shelter, Krull Park, Olcott.

(c) 2006 Buffalo News. Provided by ProQuest Information and Learning. All rights Reserved.