MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Two recent reviews have evaluated the evidence for acupuncture as a means of preventing migraine attacks.

The first review assessed the efficacy and safety of acupuncture for the prophylaxis of episodic or chronic migraine in adult patients compared to pharmacological treatment.

The authors included randomized controlled trials published in western languages that compared any treatment involving needle insertion (with or without manual or electrical stimulation) at acupuncture points, pain points or trigger points, with any pharmacological prophylaxis in adult (≥18 years) with chronic or episodic migraine with or without aura according to the criteria of the International Headache Society.

Nine randomized trials were included encompassing 1,484 patients. At the end of the intervention, a small reduction was found in favor of acupuncture for the number of days with migraine per month: (SMD: -0.37; 95% CI -1.64 to -0.11), and for response rate (RR: 1.46; 95% CI 1.16-1.84). A moderate effect emerged in the reduction of pain intensity in favor of acupuncture (SMD: -0.36; 95% CI -0.60 to -0.13), and a large reduction in favor of acupuncture in both the dropout rate due to any reason (RR 0.39; 95% CI 0.18 to 0.84) and the dropout rate due to adverse event (RR 0.26; 95% CI 0.09 to 0.74). The quality of the evidence was moderate for all these primary outcomes. Results at longest follow-up confirmed these effects.

The authors concluded that, based on moderate certainty of evidence, we conclude that acupuncture is mildly more effective and much safer than medication for the prophylaxis of migraine.

 

The second review aimed to perform a network meta-analysis to compare the effectiveness and acceptability between topiramate, acupuncture, and Botulinum neurotoxin A (BoNT-A).

The authors searched OVID Medline, Embase, the Cochrane register of controlled trials (CENTRAL), the Chinese Clinical Trial Register, and clinicaltrials.gov for randomized controlled trials (RCTs) that compared topiramate, acupuncture, and BoNT-A with any of them or placebo in the preventive treatment of chronic migraine. A network meta-analysis was performed by using a frequentist approach and a random-effects model. The primary outcomes were the reduction in monthly headache days and monthly migraine days at week 12. Acceptability was defined as the number of dropouts owing to adverse events.

A total of 15 RCTs (n = 2545) could be included. Eleven RCTs were at low risk of bias. The network meta-analyses (n = 2061) showed that acupuncture (2061 participants; standardized mean difference [SMD] -1.61, 95% CI: -2.35 to -0.87) and topiramate (582 participants; SMD -0.4, 95% CI: -0.75 to -0.04) ranked the most effective in the reduction of monthly headache days and migraine days, respectively; but they were not significantly superior over BoNT-A. Topiramate caused the most treatment-related adverse events and the highest rate of dropouts owing to adverse events.

The authors concluded that Topiramate and acupuncture were not superior over BoNT-A; BoNT-A was still the primary preventive treatment of chronic migraine. Large-scale RCTs with direct comparison of these three treatments are warranted to verify the findings.

Unquestionably, these are interesting findings. How reliable are they? Acupuncture trials are in several ways notoriously tricky, and many of the primary studies were of poor quality. This means the results are not as reliable as one would hope. Yet, it seems to me that migraine prevention is one of the indications where the evidence for acupuncture is strongest.

A second question might be practicability. How realistic is it for a patient to receive regular acupuncture sessions for migraine prevention? And finally, we might ask how cost-effective acupuncture is for that purpose and how its cost-effectiveness compares to other options.

2 Responses to Acupuncture for chronic migraine prevention? Two new systematic reviews yield encouraging evidence

  • it remains underwhelming nonetheless.

    and can we say that any result is specific to the actual “acupuncture” and not to some other non-specific effect?

    when we have so many studies that demonstrate little or no difference between “real” and sham acupuncture, that toothpicks work just as well as penetrating needles, that it seems to matter not a jot where one actually places the needles, that effects have been demonstrated using a dummy plastic arm instead of the patient’s own arm, and so on it remains difficult to take it seriously as a treatment.

    And of course it doesn’t remove the possibility of a strong theatrical placebo effect. These people are making a large personal investment in the therapy – by making multiple attendances to receive a treatment which is time consuming and in which they have presumably already expressed some belief or hope – and many may even be desperate! Or am I missing something?

    There remains the mystery of how this therapy is supposed to work when so many sham variations work just as well.
    Especially when the much vaunted meridians and Qi have yet to be discovered or measured.
    And if acupuncture actually does work for preventing migraines how come it is so absolutely bloody useless at doing anything else claimed for it?

    Plus if we give it any credibility for migraine it will give it unwarranted credibility by association for absolutely every other ludicrous indication that is claimed for it from ingrowing toe-nails to curing cancer! You just know that any whiff of legitimacy will be used by every LaC or whatever from here to Timbuctoo to fill their waiting rooms with the hapless and the hopeless.

    There is a further major issue with migraine prophylaxis though: current prophylactic drug regimes suck! Trials of these drugs clearly demonstrate a high placebo response also and this is often shown to persist for months – this has been replicated in paediatric studies too. But even the best drug response trials show very modest migraine reductions – so the bar is set very low! All of these drugs are re-purposed from some other indication anyway – anti-epileptics, anti-hypertensives etc – none are specifically designed for purpose (whatever that might be in this case.)

    There are hundreds of papers and how-to’s on migraine prophylaxis: over the only real additions were the SSRIs which have very modest benefits, and then Topiramate which was a modest advance and more recently Botox. Otherwise they are more or less re-iterations of the same thing.

    Topiramate is the most effective of a bad lot – followed by amitriptyline – and both are most often discontinued owing to side-effects. The remainder are a pretty indifferent lot and as anyone who has ever tried treating someone with frequent episodic migraine would know is a pretty soulless task because people understandably don’t like taking medication with unpleasant side-effects for what turns out to be a very small statistical (and hence usually to them not very appreciable) reduction in frequency. And working your way through the list at several months each takes years.

    Botox is the gold standard. If you’re going to use needles why not use one with a proven track record, with real stuff in them, and we know how it works?

  • The first review says that sham acupuncture is demonstrated not to be a placebo because a light touch of the skin alleviates the affective component of pain. Therefore the review did not include comparisons between acupuncture and sham.

    There can be no decisive way of determining whether acupuncture produces anything other than a placebo response (in this case an affective effect) if all there is to acupuncture is the light touching of the skin, but there is more to it than that. De qi cannot be induced by a light touch on the surface of the skin. The question is whether any perceived benefit arising from the digging, poking and twisting resulting in the “de qi” sensation, is due to anything other than a strong placebo response.

    Regarding the authors’ criteria for “acupuncture intensity”:

    Number of sessions, (≥8 vs. <8)
    Number of acupoints, (≥10 vs. <10)
    Achievement of de-qi (yes vs. no/not reported).

    On the basis of these criteria only the presence or absence of de qi can clearly distinguish true from sham acupuncture.

    I have read that skilled acupuncturists can recognise when de qi has been induced – or not induced. A skilled acupuncturist knows whether or not a trial patient has had the ideal acupuncture treatment or not. If that is correct it is a serious limitation in blinding in sham acupuncture trials.

    The first review excluded from its meta-analysis the only trial to include botulinum toxin A, considering its protocol dosage to be insufficient to be therapeutically effective. I think that was a poor decision. Flawed the protocol may have been, but it was the only trial with that treatment and should have been included.

    The clear superiority of botulinum toxin A in the second review also brings into question the decision not to include the trial with that treatment in the first review’s meta-analysis.

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