By Alfhaily, F Ewies, A A A
Key words: ACUPUNCTURE, HOT FLUSHES, VASOMOTOR SYMPTOMS ABSTRACT
There is an increased interest amongst women in seeking alternatives for hormone replacement therapy because of their fear of side-effects. It is claimed that acupuncture is effective for curing menopausal symptoms, and to be a safe treatment in the hands of well-trained and qualified practitioners. About one million acupuncture treatments are given in the National Health Service and two million privately each year in England for various indications. However, because its mechanism of action is not fully understood in physiological terms, acupuncture is considered by many clinicians to be of no value. This article reviews the currently available evidence as regards the effectiveness and safety of acupuncture in treating menopausal symptoms.
An increasing number of women are seeking alternatives for conventional hormone replacement therapy (HRT) because of their concerns over possible increased risks, particularly breast cancer1. Acupuncture, one of the oldest treatment modalities, is currently receiving wide publicity in the lay press and increased interest amongst postmenopausal women. Further, it is promoted by western organizations such as the British Medical Acupuncture Society2. It was estimated that one million acupuncture treatments are given in the National Health Service (NHS) and two million privately each year in England, and around 7% of the adult population received acupuncture for various indications3. Some studies have shown that acupuncture ameliorated vasomotor symptoms in postmenopausal women and was safe in those with previous breast cancer and taking tamoxifen. However, in spite of the increasing use, there is still a vast amount of prejudice with regards to acupuncture and techniques regarded as ‘complementary’ to traditional western medicine4.
The aim of this article is to review the currently available evidence as regards acupuncture in the treatment of menopausal symptoms, in order to provide more information for clinicians and the public about the effectiveness, safety and techniques. A search of the literature, using PubMed, was made by entering the key words: acupuncture, hot flushes, menopausal symptoms, and vasomotor symptoms. Also, for comparison, we used the Google search engine to look for key words that might help to identify additional articles. No limit was used on date of publication. A total of 17 relevant studies published in English language were identified and used, in the hope that this would explore unvisited areas for future research.
DEFINITION AND MECHANISM OF ACTION
Acupuncture originated in China 3500 years ago and works through stimulating certain points on the body by needle (acupuncture) or pressure (acupressure). Electrical stimulation of acupuncture needles at standardized points (electroacupuncture) is also used. The term ‘acupuncture’ derives from the Latin acus, a needle, and punctura, a puncture5. The Chinese method is holistic, based on the concept that no single part can be understood except in relation to the whole body6, and attention should be paid to maintain the body in harmonious balance within, and in relation to, the external environment. Acupuncture is alleged to balance the harmony within the body. The stimulation of certain points on the surface of the body affects the function of certain organs, and these points follow a predictable and stable pattern. The acupuncture points are positioned along meridians, where a meridian is defined as ‘the line that can be drawn linking the points associated with any particular organ’; meridians are channels for ‘Qi’ (pronounced chee, vital energy). Energy or Qi flows through the body from meridian to meridian. Disease and pain occur when there is a blockage in the flow of the Qi5-7. There are 365 acupuncture points, which lie along 20 meridians. Twelve of these meridians are primary, and correspond to specific organs, organ systems or functions; eight are secondary. To the Chinese, an organ comprises the organic structure and its entire functional system. It has been suggested that acupuncture might modulate the central nervous system and the release of neurotransmitters8. Furthermore, changes in brain functional magnetic resonance imaging (MRI) signals have been observed during acupuncture9.
VASOMOTOR SYMPTOMS IN THE WESTERN AND CHINESE MEDICINE
The Chinese explanation of hot flushes and other menopausal symptoms is vague in the context of Western medicine. In Chinese medicine, hot flushes result from deterioration in the yin of the liver, weakness in the blood of the heart and exhaustion of the water of the kidney. The deficiency of the water is countered by an excess fire, which disturbs the control of the yin and releases its yang. The associated menopausal symptoms could occur for one of the following reasons. First, the combined effects of deficiency in the water of the kidney, hyperactivity in the liver and flare-up of the fire of the heart could lead to palpitation, insomnia, and tiredness. Second, the imbalance between the liver and spleen might lead to depression, irritability, loss of temper and an oppressive feeling in the chest10.
In western medicine, the exact pathophysiology of the hot flushes is still unknown but it could be related to an alteration in the set point temperature in the hypothalamus11. Both withdrawal and activation of endogenous opioids, e.g. beta-endorphin, have been suggested as underlying mechanisms; however, current evidence is insufficient because of lack of studies with appropriate design. Hot flushes were proposed to be hypothalamic thermoregulatory events originating from increased brain norepinephrine activity, due to decreased activity of hypothalamic opioids, which in turn is caused by estrogen withdrawal12,13. This was supported by the finding that hot flushes diminished with pharmacotherapy that increased opioid concentrations14. Nonetheless, opioid activation was also suspected because people receiving chlorpropamide flush after drinking alcohol15. Further, it was hypothesized that estrogen withdrawal could lead to reduction in the blood serotonin (5-HT) level and consequently to an up-regulation of 5-HT^sub 2A^ receptors. The activation of 5-HT^sub 2A^ receptors might disturb the hypothalamic set point temperature, which activates autonomic reactions to cool down the body, such as vasodilatation causing increased skin temperature and sweating16. It was shown that the 5-HT level was restored to normal after treatment with estrogen in women with spontaneous and surgical menopause17,18.
ACUPUNCTURE IN MANAGING MENOPAUSAL SYMPTOMS
Acupuncture was suggested to reduce the frequency of hot flushes by triggering the release of hypothalamic beta-endorphin, which is also partially responsible for a sense of well-being as well as having a pain-relieving effect19,20. It is unlikely that acupuncture has a placebo effect, since it was previously reported that the administration of placebo did not have an effect on the release of beta-endorphin21,22. Further, acupuncture was found to release 5- HT, which could relieve symptoms such as abdominal pain and cramps, mood swings and sleeplessness19, in addition to its speculated key role in the pathophysiology of hot flushes, as previously mentioned.
Treatment of hot flushes depends on stimulating several points. These can be divided into four groups: specific, homeostatic, sedative and others.
(1) BL.62 (Shenmai): 0.5 cm inferior to the tip of the lateral malleolus
(2) LR.14 (Qimen): vertically below the nipple in the 6th intercostal space
(3) KI.3 (Taixi): midway between the tip of the medial malleolus and the medial border of the tendo-achilles
(4) HT.7 (Shenmen): at the transverse wrist crease, on the radial side of the tendon of the flexor carpi ulnaris
(5) TE.6 (Zhigou): on the back of the forearm between ulna and radius, 3 cm proximal to the wrist crease.
These restore the balance in the internal environment of the body through modulation of the endocrine system, and sympathetic and parasympathetic activities23,24:
(1) SP.6 (Sanyinjiao): 3 cm above the tip of the medial malleolus on the medial border of the tibia
(2) LI.11 (Quchi): at the lateral end of the transverse elbow crease when the elbow is semi-flexed
(3) ST.36 (Zusanli): one fingerbreadth lateral to the inferior border of the tibial tuberosity, 3 cm below the knee joint.
They are used for the treatment of associated symptoms such as insomnia and anxiety:
(1) GV.20 (Baihui): on the vertex of the skull, 5 cm behind the anterior hairline, on the midline
(2) LI.4 (Hegu): at the highest point of the thenar eminence on the back of the hand when the forefinger and thumb are adducted.
Other points used
Other points that can be used are LR. 3, GB.20, GB.34, and CV.425.
Insertion of acupuncture needles causes minimal or no pain and less tissue injury than phlebotomy or parenteral injection, since it uses needles that are thinner than insulin needles. Acupuncture is safe when it is performed by experienced and well-trained practitioners, employing sterile and single-use needles. However, some adverse side-effects have been reported26. A recent study in Germany of 97 733 patients receiving acupuncture reported only six cases of potentially serious adverse events 6, including exacerbation of depression, asthma attack, hypertensive crisis, vasovagal reaction and pneumothorax. The most common minor adverse events included needle pain and local bleeding, both occurring in less than 5% of patients27. The needle size used varied between 0.2 and 0.3 mm, and there was no particular needle type or style that was linked to higher rates of adverse events28. One of the most common serious complications was the transmission of hepatitis viruses or other infectious agents via inadequately sterilized needles26; therefore, the use of disposable needles is essential. On the other hand, The Collaborative Group on Hormonal Factors in Breast Cancer, in their re-analysis of world-wide observational data, estimated that taking HRT from the age of 50 for more than 5 years would increase the risk of breast cancer by two extra cases per 1000 women29. Further, HRT was associated with a two-fold increase in venous thromboembolism, with the highest risk occurring in the first year of use30,31. EFFECTIVENESS
Acupuncture in healthy women with natural menopause
Two recent prospective, parallel, randomized Swedish studies, involving 102 postmenopausal women, assessed the effect of transdermal placebo versus estrogen treatment (study I), and oral estrogen versus acupuncture or applied relaxation (study II), using the Kupperman index. It was found that the number of hot flushes per 24 h decreased significantly after 4 and 12 weeks in all groups except the placebo group32. However, this trial did not include a placebo acupuncture control group. In a recent, randomized, controlled pilot study, active or placebo acupuncture (placebo needles that do not penetrate the skin at sham acupuncture points) was administered to investigate the effectiveness of acupuncture on postmenopausal nocturnal hot flushes and sleep in 29 postmenopausal women, experiencing at least seven moderate to severe hot flushes daily. Acupuncture significantly reduced the severity of nocturnal hot flushes compared with placebo. The frequency of the flushes was reduced in both groups, with no influence on sleep33. Another controlled study34 randomized 45 postmenopausal women with vasomotor symptoms into three treatment groups: electro-acupuncture (n = 15), superficial needle insertion (n = 13) and unopposed 2 mg 17beta- estradiol orally (n = 15) for 12 weeks with 6 months’ follow-up. The mean number of hot flushes per 24 h, the Kupperman index and the general climacteric symptoms score decreased (p
Grille and colleagues35 randomly selected 45 menopausal women from two hospital clinics and divided them into three groups: HRT (n = 15), acupuncture (n = 15) and no treatment (n = 5). Groups one and two had comparable increases in serum estradiol levels. Nonetheless, the effect of both acupuncture and HRT wore off after stopping the treatment, and it was necessary to continue the treatment to maintain benefit. In a fourth randomized, controlled study36, 24 women were randomized to either an electro-acupuncture treatment group or to a control group (shallow acupuncture needle insertion at the same points) for 8 weeks. The number of hot flushes and night sweating decreased significantly by >50% in both groups, but symptoms recurred within 3 months in the control group, in contrast to the treated women who remained asymptomatic. Further, the investigators found no spontaneous decrease in the frequency of hot flushes in 12 untreated women (from the waiting-list group) during the 8 weeks of treatment. Moreover, the excretion of the potent vasodilating neuropeptide, calcitonin gene-related peptide-like immunoreactivity, decreased significantly during treatment in the electro-acupuncture group. This is a very potent vasodilator that could be involved in the pathogenesis of hot flushes. Nevertheless, the use of shallow needle insertion at correct acupuncture points as a control method was suboptimal because it was expected to have some effect. The ideal control would have been to use sham acupuncture, which involves points on the body not recognized as acupuncture points. Using the same control, Sandberg and colleagues37 found, in a single-blind, randomized, controlled study, no difference between electro-acupuncture and extremely superficial needle insertion as regards general psychological well-being and experience of climacteric symptoms in 30 women aged 48-60 years, whose natural menopause status was confirmed by elevated levels of follicle stimulating hormone. Both parameters were significantly ameliorated in the treatment and control groups, and improvement continued for 6 months after treatment. The sole difference was improvement of mood in the electro-acupuncture group by the 12th week of treatment (p
Cohen and colleagues38 conducted a small study stimulating specific acupuncture points related to menopausal symptoms (n = 8), while the control group (n = 9) had treatment designated as a general tonic to benefit the flow of Ch’i. Both groups received 9 weeks of treatment, followed by three no-treatment weeks. The treatment group showed a significant reduction in the number of hot flushes and episodes of sleeplessness when compared with controls; however, mood swings were significantly improved in both groups. Di Conchetto39 reported 2 years of acupuncture treatment of 100 women with menopausal hot flushes, with another 2 years of follow-up. They were divided into three groups, treated with combined acupuncture and moxibustion, electro-acupuncture, or acupuncture alone. Twenty women had complete remission, and 65 had a reduction in their symptoms. However, it was an uncontrolled study, there were no formal outcome measures, and it was not clear whether the reduction of symptoms was assessed by the patient or the doctor. In another uncontrolled study, 25 women with menopausal symptoms were treated for 1 year with combined acupuncture and moxibustion. Ten women improved completely, and the remaining 15 had partial improvement and reduction in their intake of sedatives or antidepressants40. Again, there were no formal outcome measures. Another small study41 to evaluate the effects of acupuncture on the quality of life of 11 women with menopausal symptoms showed that it significantly improved vasomotor and other symptoms during 5 weeks of treatment, and this continued for 3 months after the treatment. Nevertheless, there was no change in psychosocial or sexual symptoms. Further, in a case notes review of 238 women complaining of joint pain associated with menopause and treated with acupuncture for 8 months, 51% reported complete relief, 26% reported noticeable reduction in their symptoms, 13% reported accepted reduction in their symptoms but with tendency for recurrence, and 10% reported some improvement42.
Acupuncture in women with breast cancer and menopausal symptoms
A randomized study evaluated the effect of electro-acupuncture (n = 17) and applied relaxation (n = 14) for 12 weeks on vasomotor symptoms in postmenopausal women being treated for breast cancer. It was found that the number of hot flushes per 24 h was significantly decreased and the mean Kupperman index score was significantly reduced in both groups and remained unchanged 6 months after the end of treatment43. However, this study did not involve a non-treated control group and the effect might, to some degree, be related to the care of the therapists. In a small uncontrolled study, Towlerton and Filshie reported that acupuncture treatment reduced the severity and duration of hot flushes in eight out of 12 postmenopausal women receiving tamoxifen for breast cancer25. A retrospective audit20 of the electronic records of 182 women with breast cancer, who had 6 weeks of acupuncture treatment and were then taught to perform self- acupuncture weekly for up to 6 years, showed that 114 (62.6%) gained >/= 50% reduction in hot flushes and 30 (16.5%) gained
Most studies of acupuncture treatment were flawed by methodological problems, including poor design, lack of follow-up data and substandard treatment. However, the major problem, which many investigators consider to be still unresolved, is the definition of an appropriate placebo control. The use of inappropriate placebo controls has bedevilled acupuncture research and led to serious misinterpretation of the results of the clinical trials46. It is fundamental to find a control condition with small or non-existent physiological effects as well as to ensure that the psychological impacts of the true treatment and control are equivalent, i.e. they have equivalent placebo power. It may not matter too much whether the placebo has, as in a drug trial, the same form as the real treatment, but it is of great concern in skilled physical treatments on conscious patients where changes to the treatment may be noticed by the patients. Since acupuncture is becoming widely used, patients will be more aware of the sensations of the correct treatment and more able to detect variations introduced in control procedures46.
Table 1 Summary of the studies that investigated the effectiveness of acupuncture in managing menopausal symptoms
Table 1 Summary of the studies that investigated the effectiveness of acupuncture in managing menopausal symptoms
Sham acupuncture (stimulating non-classical points using the same depth of insertion and stimulation as real acupuncture) was initially assumed by most investigators to be ineffective, and therefore ideal as a placebo. Nonetheless, this was challenged by Lewith and colleagues47 who found that sham acupuncture had an analgesic effect in 40-50% of patients in comparison with 60% for real acupuncture. Controlled trials also showed significant analgesic effect from both classical and non-classical locations48,49. The issue became complicated further by finding that treatment of non-painful conditions, such as the use of P6 to treat nausea, is different; there is evidence to suggest that point location is important and acupuncture away from P6 has a little effect on nausea and is primarily a placebo50. Minimal acupuncture was implemented in many studies using variable methods; commonly, needles were placed away from classical points, inserted only 1-2 mm and stimulated extremely lightly. Although it was argued that this almost exactly matched the real treatment and maintained its psychological impact, it might still have some therapeutic effect that could make it harder to demonstrate a difference between treatment and control51. It could be assumed that a different clinician, a different group of patients, and a different setting may all influence the perception of the respective treatments or control procedures; therefore, a credible control method in one study does not necessarily mean that it will be suitable in all46.
The majority of women treated with acupuncture have a reduction of more than 50% in their hot flushes and this effect continued as long as 6 months after treatment, in some studies, without any adverse events (Table 1). Despite these encouraging results, definitive conclusions cannot be reached. The majority of these studies are of poor quality, of small size, or used an inadequate control method; therefore, doubt remains about their reliability and the reported results could be entirely due to a placebo effect. It is recommended that therapies purported to alleviate vasomotor symptoms should be compared with a placebo and an established therapy, since placebo treatment caused more than 50% reduction in hot flushes in the clinical trials that evaluated the effect of oral HRT52’53. Therefore, there is a need for large, double-blind, randomized, controlled trials comparing acupuncture with HRT and credible placebo acupuncture in order to provide reliable evidence. Further, rigorous economic evaluation of acupuncture is important before offering it in the NHS for treating menopausal symptoms.
Conflict of interest Nil.
Source of funding Nil.
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F. Alfhaiy and A. A. A. Ewies
Department of Obstetrics and Gynaecology, Ipswich Hospital NHS Trust, UK
Correspondence: Dr A. A. A. Ewies, Department of Obstetrics & Gynaecology, The Ipswich Hospital NHS Trust, Maternity Block, Heath Road, Ipswich IP4 5PD, Suffolk, UK
Copyright Taylor & Francis Ltd. Oct 2007
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