January 9, 2014
Placebo Effect Enhances Effects Of Real Migraine Drug
redOrbit Staff & Wire Reports - Your Universe Online
A new study of migraine sufferers is the latest to demonstrate the remarkable power of the placebo effect, finding that what a doctor tells you when prescribing medicine can influence your body's response to it. The study, published Wednesday in the journal Science Translational Medicine, compared the effects of the common migraine drug Maxalt (rizatriptan) to an inactive placebo (sugar pill) in 66 sufferers of chronic migraine headaches, a condition whose symptoms include throbbing headaches, nausea, vomiting and sensitivity to light and sound.
The researchers from Harvard Medical School and Beth Israel Deaconess Medical Center (BIDMC) in Boston found that study participants reported relief from the placebos even when they knew they were taking them.
Interestingly, the researchers also found a 'reverse-placebo' effect, whereby patients who believed they were getting the placebo found that the real drug did not work as well as it should have.
The so-called 'placebo effect' is a powerful, effective medical treatment and has been found to help treat or reduce the symptoms of a wide variety of conditions such as irritable bowel syndrome (IBS), depression, anxiety, ADHD, restless leg syndrome and others.
However, the current study is the first to quantify how much pain relief is attributed to a drug's pharmacological effect, and how much to a placebo effect, and demonstrates that a positive message and a powerful medication are both important for effective clinical care.
The study uncovered three key findings: 1) the benefits of Maxalt increased when patients were told they were receiving an effective drug for the treatment of acute migraine; 2) when the identities of Maxalt tablets and placebo pills were switched, patients reported similar reductions in pain from placebo pills labeled as Maxalt as from Maxalt tablets labeled as placebo; and 3) study participants reported pain relief even when they knew the pill they were receiving was a placebo, compared with no treatment at all.
"One of the many implications of our findings is that when doctors set patients' expectations high, Maxalt [or, potentially, other migraine drugs] becomes more effective," said Rami Burstein, PhD, the study’s senior author and Director of Pain Research in the Department of Anesthesia, Critical Care and Pain Medicine at BIDMC.
"Increased effectiveness means shorter migraine attacks and shorter migraine attacks mean that less medication is needed," he said.
"This study untangled and reassembled the clinical effects of placebo and medication in a unique manner," said the study’s other senior author, Ted Kaptchuk, Director of the Program in Placebo Studies and Therapeutic Encounter (PiPS) at BIDMC and Harvard Medical School.
"Very few, if any, experiments have compared the effectiveness of medication under different degrees of information in a naturally recurring disease. Our discovery showing that subjects' reports of pain were nearly identical when they were told that an active drug was a placebo as when they were told that a placebo was an active drug demonstrates that the placebo effect is an unacknowledged partner for powerful medications,” Kaptchuk said.
The researchers studied over 450 attacks in the 66 participants. After an initial "no treatment" episode in which patients documented their headache pain and accompanying symptoms 30 minutes after headache onset, and again two hours later (2.5 hours after onset), the participants were provided with six envelopes containing pills to be taken for each of their next six migraine attacks.
Of the six treatments, two were made with positive expectations (envelopes labeled "Maxalt"), two were made with negative expectations (envelopes labeled "placebo"), and two were made with neutral expectations (envelopes labeled "Maxalt or placebo"). In each of the three situations – positive, negative or neutral – one of the two envelopes contained a Maxalt tablet while the other contained a placebo, no matter what the label actually indicated. The patients then documented their pain experiences in the same manner as they had initially in the no-treatment session.
The results consistently showed that giving the pills accompanied by positive information incrementally boosted the efficacy of both the active migraine medication and the inert placebo.
"When patients received Maxalt labeled as placebo, they were being treated by the medication – but without any positive expectation," Burstein said.
"This was an attempt to isolate the pharmaceutical effect of Maxalt from any placebo effect."
Conversely, the inert placebo labeled as Maxalt was an attempt to isolate the impact of the placebo effect from pharmaceutical effect.
"Even though Maxalt was superior to the placebo in terms of alleviating pain, we found that under each of the three messages, the placebo effect accounted for at least 50 percent of the subjects' overall pain relief. When, for example, Maxalt was labeled 'Maxalt,' the subjects' reports of pain relief more than doubled compared to when Maxalt was labeled 'placebo.' This tells us that the effectiveness of a good pharmaceutical may be doubled by enhancing the placebo effect,” said Kaptchuk.
The researchers were surprised to find that even when subjects were given a clearly labeled placebo, they reported pain relief when compared with no treatment.
"Contrary to conventional wisdom that patients respond to a placebo because they think they're getting an active drug, our findings reinforce the idea that open label placebo treatment may have a therapeutic benefit," wrote the study’s authors.
The researchers said the study’s findings suggest that placebos may someday provide a therapeutic boost to drug treatments, although further research is needed to explore how this is best applied in clinical care settings.