Acupuncture may be helpful for migraine prevention, according to a randomized controlled trial from China.
The trial included both real and sham acupuncture, as well as a wait-list control group. Over 16 weeks, real acupuncture treatment was associated with a greater reduction in migraine attacks without aura than sham acupuncture and the wait-list control (3.2 attacks versus 2.1 attacks and 1.4 attacks), according to Fanrong Liang, MD, of Chengdu University of Traditional Chinese Medicine in Sichuan in China, and colleagues.
“Acupuncture should be considered as one option for migraine prophylaxis in light of our findings,” they wrote online in JAMA Internal Medicine.
But in an accompanying editorial, Amy Gelfand, MD, of the University of California San Francisco, warned that the study was seriously limited by its lack of blinding, both among participants — who may have been able to tell whether they were in the real or sham acupuncture group based on pain intensity — and acupuncture practitioners.
“By training and interest, the acupuncturists likely believe that true acupuncture is effective and sham acupuncture is not,” Gelfand wrote. “They may have unconsciously transmitted to the participants their impression of how likely, or unlikely (ie., a potential ‘nocebo’ effect for the sham group), they thought the participant was to benefit from the treatment being given.”
Migraine prevention currently consists of pharmacologic options like divalproex sodium, topiramate, metoprolol, and propranolol, but these are often associated with adverse events such as weight gain, fatigue, sleep disturbance, and gastrointestinal intolerance. They also carry a risk of medication overuse headache and a possible uptick in headache frequency.
Some migraine patients have turned to acupuncture, but clinical study results of its efficacy for prevention have been inconsistent, so Liang’s group conducted their three-arm study at three clinical sites in China.
They enrolled 249 adult patients who had migraine, without aura, who had an attack frequency of two to eight per month. Most of these patients (77%) were female. They were randomized to one of the three groups after an initial 4-week baseline period.
Those in the real acupuncture arm received treatment for 30 minutes a day, 5 days a week, for 4 consecutive weeks. Needles were inserted at four specific points, and therapists elicited the “Deqi” sensation each time; this is a feeling of soreness, numbness, distention, or radiating that indicates effective needling.
Those in the sham acupuncture group had needles inserted at points considered to be inactive, with no attempts at drawing out Deqi.
The primary outcome was the change in frequency of migraine attacks at 16 weeks; a total of 245 of the patients were included in the final intention-to-treat analysis.
Overall, Liang’s group found that attack frequency fell significantly more in the true acupuncture group than in the sham group (3.2 attacks versus 2.1 attacks, P<0.002), and true acupuncture also beat out the wait-list group (3.2 versus 1.4, P<0.001). The sham group wasn’t statistically different from the wait-list group.
They also found that mean migraine days were significantly lower in the true acupuncture group than in the sham group (2 versus 3.1 days, P=0.005), and the same went for the headache intensity score as measured by the Visual Analog Scale (VAS) (3.4 versus 4.2, P=0.008).
The authors noted that there were no serious adverse events, which could be a major advantage for acupuncture over pharmacotherapeutic migraine prevention.
Study limitations included using fewer acupoints than are typical, and not being able to blind the wait-list group.
Gelfand pointed out the additional limitations of not blinding the real and sham acupuncture participants, or the practitioners.
She said the study “doesn’t convincingly demonstrate acupuncture’s efficacy for migraine prevention” because participants experiencing Deqi could have led to a higher degree of placebo response.
But Gelfand acknowledged that the treatment effect size seen in the study was “on par with what is seen” in other migraine prevention studies, and that it does suggest some benefit for acupuncture over medications, including a lack of serious adverse events and a persisting benefit.
“It is probably safe to try — it is not clear it is effective,” she wrote. “The main risks are likely to [a patient’s] pocketbook and their time.”
The study was supported by the State Key Program for Basic Research of China, the National Natural Science Foundation of China, and the Project of Youth Fund of Sichuan Province.
Liang and co-authors disclosed no relevant relationships with industry.
Gelfand disclosed relevant relationships with Eli Lilly, Zosano, Teva, Allergan, eNeura, MedImmune, and Quest.
- Reviewed by Henry A. Solomon, MD, FACP, FACC Clinical Associate Professor, Weill Cornell Medical College and Dorothy Caputo, MA, BSN, RN, Nurse Planner