Pauline Anderson
February 24, 2017
“True” acupuncture reduces migraine frequency, number of days with migraine, and pain intensity compared with “sham” acupuncture and being wait-listed for acupuncture, a randomized trial shows.
These are some of the “several benefits” of acupuncture for patients with headache shown in this study, said author Fanrong Liang, MD, Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Sichuan, China.
The acupuncture treatment was not associated with any serious adverse events, and the effects persisted for 20 weeks after the treatment sessions, said Dr Liang.
The study, published online February 20 in JAMA Internal Medicine, included 249 patients who had migraine without aura whose headaches began before age 50 years. They had to have experienced migraines for at least a year and had acute migraine attacks 2 to 8 times a month for 3 months.
About two thirds of patients with migraine have migraine without aura. The study included only these patients because so many of them were available at clinical centers, said Dr Liang. About 77% of the study group were women.
Participants were randomly assigned to true acupuncture (TA) or sham acupuncture (SA) or were placed on a waiting list for acupuncture (WL). Those in both the TA and SA groups were blinded while the WL group was not.
The acupuncture procedures were carried out by trained experts with several years of experience.
Patients in the TA and SA groups received 20 acupuncture sessions (once per day for 5 consecutive days followed by a 2-day break), each lasting 30 minutes. Participants were not allowed to take prophylactic medications.
The TA group had treatment at four acupoints: two “obligatory” points on the head and two points on the limbs chosen “according to the syndrome differentiation of meridians in the headache region,” said Dr Liang. At each point, acupuncturists elicited the deqi sensation, a feeling of soreness or numbness that indicates effective needling.
Electrostimulation
The acupuncturist used electrostimulation, which, as Dr Liang explained, is similar to manual stimulation in that the same points are stimulated during treatment, but a small electric current is passed between pairs of acupuncture needles.
The acupuncture protocol used in the study is widely available, including in North America, said Dr Liang.
Members of the SA group were treated at four points thought not to be active acupuncture points, and acupuncturists made no attempt to induce the deqi sensation.
The number of needles, amount of electrostimulation, and duration of treatment, were identical in the TA and SA groups.
Study participants completed detailed headache diaries.
The primary outcome was change in frequency of migraine attacks from baseline to 16 weeks after randomization.
A total of 245 patients were included in the intention-to-treat population, who had received at least one treatment and one primary outcome measure. The authors noted that the 1.61% loss to follow-up is lower than that in other migraine prophylaxis studies.
At 16 weeks after randomization, the frequency of attacks had decreased by 3.2 in the TA group, 2.1 in the SA group, and 1.4 in the WL group. The difference between the TA and SA groups was 1.1 attacks (95% confidence interval [CI], 0.4 – 1.9; P = .002).
The difference between the TA and WL group was 1.8 attacks (95% CI, 1.1 – 2.5; P < .001). The SA group was not statistically different from the WL group.
The authors commented that the slight improvement in the WL group was probably due to the “Hawthorne effect,” wherein participants modify their behavior in response to knowing they’re being observed, or the effect of the regression to the mean. The effect in the SA group, they said, was possibly a result of the nonspecific physiologic effect experienced during needling or a placebo effect originating from frequent interactions with an acupuncturist.
As for secondary outcomes, researchers found the frequency of migraine attacks, migraine days, and visual analogue scale results were significantly lower in the TA group than in the other two groups from weeks 4 to 24.
Seven patients (five in the TA and two in the SA groups) reported adverse events, all mild or moderate. These patients fully recovered and didn’t withdraw from the trial.
Other studies — including a large trial in Germany published in JAMA in 2005 by Linde et al — did not show a difference between true and sham acupuncture in patients with migraine. The difference is due to several factors, said Dr Liang.
One was the use in the current study of the “semistandard therapy according to syndrome differentiation of meridians,” which is “a more practical approach.” The study also used electrostimulation and included only patients who had migraines without aura.
Although the current study didn’t compare the effect of acupuncture with pharmaceutical therapy in patients with migraine, Dr Liang pointed to a recent systematic review suggesting that acupuncture may be at least as effective as treatment with prophylactic drugs.
Unblinding Concern
In an accompanying editorial, Amy A. Gelfand, MD, Pediatric Headache Program, University of California, San Francisco, said a main concern of the study is the potential for unblinding of participants. It’s possible that the deqi sensation elicited in the TA group could have led to a higher degree of placebo response as there was no attempt to elicit this sensation in the SA group.
Dr Gelfand likened this to injections of onabotulinum toxin A for migraine prevention, wherein muscle weakness may lead to unblinding. Both acupuncture and onabotulinum toxin A injections involve multiple needle insertions and multiple rounds of treatment.
One study of onabotulinum toxin A for headache treatment showed that 85.1% of patients receiving the toxin vs 58.5% of those receiving placebo correctly guessed their treatment assignment. In another study, 86.1% of those receiving the toxin vs 57.8% of those receiving placebo correctly guessed their treatment assignment.
But because participants’ assessment of their treatment assignment was not reported in the current study, “it is not possible to determine how much of a potential issue unblinding may have been,” said Dr Gelfand.
She added that another study limitation was that acupuncturists were, by necessity, not blinded. “By training and interest, the acupuncturists likely believe that true acupuncture is effective and sham acupuncture is not” and may have unconsciously transmitted their impression of how likely or unlikely they thought a participant was to benefit from the treatment.
Although the study team tried to minimize the effect of this by blinding outcome assessors and statisticians, “this does not mitigate the potential influence that extensive contact with the acupuncturists could have had on participants’ expectation of benefit,” said Dr Gelfand.
She also raised the issue of logistic barriers to accessing regular acupuncture treatments from experts trained in electrical stimulation.
“To replicate the studied treatment regimen, a patient must live close enough to an acupuncture provider to be able to access near-daily treatment for a month. They also must have the lifestyle flexibility to allow them to miss partial days of work or school for a month, and the financial resources to pay for the treatment if their insurance does not cover it.”
Developing a self-administered home acupuncture device, if feasible, might get around some of these issues, she said.
In the meantime, it’s probably safe for patients with migraine to try acupuncture, but it’s not clear it’s effective, concluded Dr Gelfand. “The main risks are likely to their pocketbook and their time.”
The trial was supported by grants from 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. The study authors have disclosed no relevant financial relationships. Dr Gelfand consults for Eli Lilly and Zosano. She has received travel expenses from Teva and research funds from Allergan and eNeura. Her spouse consults for MedImmune and has received research support from Quest Diagnostics and personal compensation for medical-legal consulting.
JAMA Intern Med. Published online February 20, 2017. Abstract, Editorial