A new trial concludes that “acupuncture can be used as an optional preventive therapy for chronic migraine” – but I beg to differ.

To date, two open-label clinical trials have indicated that acupuncture may be more effective than standard medication for chronic migraine. However, drawing definitive conclusions from these trials is challenging. Studies employing a double-dummy design can eliminate the placebo effect and offer more unbiased estimates of efficacy.

This double-dummy, single-blind, randomized controlled trial compared the efficacy and safety of acupuncture and topiramate for chronic migraine. Participants, aged 18–65 years and diagnosed with chronic migraine, were randomly assigned (1:1) to receive:

• acupuncture (three sessions/week) plus topiramate placebo (acupuncture group),
• or topiramate (50–100 mg/day) plus sham acupuncture (topiramate group) over 12 weeks.

The primary outcome was the mean change in monthly migraine days during weeks 1–12.

Of 123 screened patients, 60 (mean age 45.8, 81.7% female) were randomly assigned to the acupuncture or topiramate groups. Acupuncture demonstrated significantly greater reductions in monthly migraine days than topiramate. No severe adverse events were reported.
The authors concluded that acupuncture may be safe and effective for treating chronic migraine. The efficacy of 12 weeks of acupuncture was sustained for 24 weeks and superior to that of topiramate. Acupuncture can be used as an optional preventive therapy for chronic migraine.

I beg to differ!

The authors claim that the participants, outcome assessors, and statistical analysts were blinded (masked) to the group allocations. However, the success of patient blinding was not tested. Why?

The authors state that, in the acupuncture group, “twirling, lifting, and thrusting were performed to produce deqi (a sensation of soreness, numbness, distention, or heaviness that indicates effective needling)… In the topiramate group, sham acupuncture was administered on non-effective acupoints, without manual deqi manipulations.” In other words, patients could very easily tell to which group they had been randomised.

This, in turn, means that a placebo effect – possibly enhanced by verbal or non-verbal communication from the (non-blinded) actupuncturists – has most likely caused the observed outcomes. I therefore feel the need to re-phrase the authors’ conclusions:

This study confirms that acupuncture produces a large placebo effect. Whether it has any effects beyond placebo cannot be determined by this study. Until this point has been clarified, acupuncture should not be used as a preventive therapy for chronic migraine.