A new study published in JAMA investigated the long-term effects of acupuncture compared with sham acupuncture and being placed in a waiting-list control group for migraine prophylaxis. The trial was a 24-week randomized clinical trial (4 weeks of treatment followed by 20 weeks of follow-up). Participants were randomly assigned to 1) true acupuncture, 2) sham acupuncture, or 3) a waiting-list control group. The trial was conducted from October 2012 to September 2014 in outpatient settings at three clinical sites in China. Participants 18 to 65 years old were enrolled with migraine without aura based on the criteria of the International Headache Society, with migraine occurring 2 to 8 times per month.
Participants in the true acupuncture and sham acupuncture groups received treatment 5 days per week for 4 weeks for a total of 20 sessions. Participants in the waiting-list group did not receive acupuncture but were informed that 20 sessions of acupuncture would be provided free of charge at the end of the trial. Participants used diaries to record migraine attacks. The primary outcome was the change in the frequency of migraine attacks from baseline to week 16. Secondary outcome measures included the migraine days, average headache severity, and medication intake every 4 weeks within 24 weeks.
A total of 249 participants 18 to 65 years old were enrolled, and 245 were included in the intention-to-treat analyses. Baseline characteristics were comparable across the 3 groups. The mean (SD) change in frequency of migraine attacks differed significantly among the 3 groups at 16 weeks after randomization; the mean (SD) frequency of attacks decreased in the true acupuncture group by 3.2 (2.1), in the sham acupuncture group by 2.1 (2.5), and the waiting-list group by 1.4 (2.5); a greater reduction was observed in the true acupuncture than in the sham acupuncture group (difference of 1.1 attacks; 95% CI, 0.4-1.9; P = .002) and in the true acupuncture vs waiting-list group (difference of 1.8 attacks; 95% CI, 1.1-2.5; P < .001). Sham acupuncture was not statistically different from the waiting-list group (difference of 0.7 attacks; 95% CI, −0.1 to 1.4; P = .07).
The authors concluded that among patients with migraine without aura, true acupuncture may be associated with long-term reduction in migraine recurrence compared with sham acupuncture or assigned to a waiting list.
Note the cautious phraseology: “… acupuncture may be associated with long-term reduction …”
The authors were, of course, well advised to be so atypically cautious:
- Comparisons to the waiting list group are meaningless for informing us about the specific effects of acupuncture, as they fail to control for placebo-effects.
- Comparisons between real and sham acupuncture must be taken with a sizable pinch of salt, as the study was not therapist-blind and the acupuncturists may easily have influenced their patients in various ways to report the desired result (the success of patient-blinding was not reported but would have gone some way to solving this problem).
- The effect size of the benefit is tiny and of doubtful clinical relevance.
My biggest concern, however, is the fact that the study originates from China, a country where virtually 100% of all acupuncture studies produce positive (or should that be ‘false-positive’?) findings and data fabrication has been reported to be rife. These facts do not inspire trustworthiness, in my view.
So, does acupuncture work for migraine? The current Cochrane review included 22 studies and its authors concluded that the available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long-term studies, more than one year in duration, are lacking.
So, maybe acupuncture is effective. Personally, I am not convinced and certainly do not think that the new JAMA study significantly strengthened the evidence.
The 2016 Cochrane review, mades changes to an earlier Cochrane review of acupuncture for migraine (2009). The scope of the recent review was narrowed to episodic migraine.
In addition, 5 of the original 22 trials in the earlier review were replaced by new trials. The reason given was that the 5 replaced trials included people who had had migraine for less than 12 months.
That was not considered a problem for the earlier review, why then for the recent review?
Whatever the reason, the new review applies to people who have suffered from episodic migraine for 12 months or more. Not to migraine sufferers in general.
It’s worth noting that two of the trial replacements were of Chinese origin. Edzard criticised one of these trials (Ying Li, 2012) for a common failing in acupuncture trials: stimulating true acupuncture patients to induce deqi sensation, but not sham receiving patients, thereby compromising effective blinding.
I have reservations about drawing a firm conclusion about the efficacy of acupuncture for migraine on the basis of the new Cochrane review.
I should have mentioned that the 2009 Cochrane review found no difference between acupuncture and sham. Swapping 5 trials from the first review, for 5 new trials, reversed the result.
Given the contradictory results of the two Cochrane reviews I would say that the available evidence is: Contradictory!
When talking about acupuncture, it seems necessary to remind the reader of certain basic facts.
Some of them are obvious, and I shall speak about them later. Another fact is not obvious, but nevertheless important. Without doubt, acupuncture theory plays a decisive role in the one book (more correctly, the two books) which till today are considered as the very foundation of TCM theory: the “Huangdi Neijing”. However, as I showed in a recent essay (“Acupuncture in ancient China: How important was it really?”, Journal of Integrative Medicine (Shanghai), January 2013, Vol.11, No.1, p. 45-53): There is no proof that clinical acupuncture was really broadly used in China even at the time when the “Huangdi Neijing” was compiled. There are some stories about acupuncture applied on two or three of about 400 emperors in China’s history, but those stories may be legends. And different from today, we have reasons to suppose that acupuncture was hardly ever applied as a single therapy (without adding herbs).
So we have to state: Acupuncture in China became widely used only after 1954 (not 1949!), and in the West partly after 1935 (based upon teachings of the impostor Soulié de Morant, who pretended having studied and practised acupuncture in China), and partly after Nixon’s visit to China in 1972.
So, what is really evident about acupuncture? Not very much, I’m afraid. Certainly not the existence of those strange conduits called “meridians”. Even less the ridiculous assumption of a “flow of qi” within them (for which the swindler Soulié de Morant invented the concept and the terms of “energy” flowing in the “meridians” – whilst all Chinese sources speak of “qi and blood” flowing in the “jingluo”, which makes the alleged existence of a separate circulation system outside arteries and veins even more improbable).
Equally improbable, if not ridiculous, is the alleged existence of things like the “twelve divergent meridians” or the “fifteen collaterals”. Without any clinical evidence is the alleged existence (or the clinical value) of functional point categories like “Yuan Points”, “Luo Points”, “Back-Shu-Points” or “Front-Mu-Points” (though teaching them is a basic source of income for the acupuncture societies).
Without sufficient evidence is even the most important aspect of clinical acupuncture (including my own): Choosing points according to the assumption that certain points have specific qualities and abilities which other points do not have (like needling St36-Zusanli for stomach problems as well as for psychic aspects, or LI04-Hegu for any pain in the upper part of the body).
Which leaves us with just two undeniable facts. First, that acupuncture causes micro-injuries – which is, in fact, not much, but nevertheless enough to believe that any result of those small injuries might not be explained merely as placebo.
The other fact is the setting. With a dozen or more needles in different places of the body, the patient is obliged either to doze off for about half an hour, or to meditate. He HAS to calm down, which often is what he needs most. Moreover, he knows and feels that those needles represent the hand of the therapist (and do not forget that the German term for medical treatment is “BeHANDlung”). Considering that there is a branch of medical science called psychoneuroimmunology, it seems probable that those cases of migraine which have a clear psychosomatic component will show positive reactions after acupuncture treatment.
One might object: If so, why not make the patient meditate without the needles? Well, you may try. But will he listen to you? And will his relaxation be as deep as the one enforced upon him by the needles?
Enough reasons for me to consider acupuncture as a small but useful kind of therapy which surely offers something more than pure placebo.
With my best regards to Skeptic Edzard Ernst
and the kind readers of this blog, from
Dr. med. Hanjo Lehmann
Deutsches Institut für TCM
Cranachstr. 1, D-12157 Berlin
Tel. +49 – 175 – 644 9006
Mail: [email protected]
It’s wise to be skeptical of many claims, including those of pharmaceutical companies(one of the pillars of “modern medicine”). It seems their funded researchers’ conclusions are often bought and paid for relative to positive outcomes of their drug studies.
According to C. P. Vega, M.D. and Marcia Frellick, there are implications for medical clinicians who routinely imbibe as veridical whatever drivel they hear from their drug reps; note I have added my own comments parenthetically.
“A previous systematic review by Lundh and colleagues found that research sponsored by industry was more likely than nonsponsored research to have favorable outcomes for benefits, harms, and overall conclusions. Sponsored research was more likely to draw conclusions unsupported by study data. (Imagine that!)
The current study by Ahn and colleagues suggests that studies in which the first author receives some form of compensation from the drug maker are more likely to include positive results. (Say it ain’t so!)
A torrent of clinical data is available on a daily basis; therefore, keeping track of all of these data and practicing some healthy skepticism toward the results are daunting tasks. (and not routinely performed by GP’s) The healthcare team may help by using solid medical evidence to construct algorithms that promote evidence-based care at the local level. (For many practicing physicians, EbM = follow the prescribing advice of the drug reps who buy their staff and them free lunches weekly)”
Micro-injuries may indeed add to the multifarious components of the placebo effect. Potentially fatal injuries resulting from incompetence or freak accident would not.
If the real problem is psychological in nature then that fact should be addressed explicitly. If acupuncture is to be used as meditation with needles, patients should be told that is what they are receiving – and why.
If a patient accepts being needled as an aid to meditation, all well and good, but why limit their possible choices? There’s CBT or straight forward psychotherapy. And in terms of hands-on treatment massage is much safer than acupuncture.
But does Dr. Lehmann explain all that to his patients? Does any acupuncturist?
If not, why not?
If meditation is what is needed – that is what a patient should have. They should not be kidded that needles have any effect.
That would be dishonest.
I routinely offer these kinds of explanation to patients who express an interest in discussing it. I also discuss the idea of ‘energy flow’/meridians, with skepticism, and talk about how the Neijing seemed to talk much more about blood flow than anything else. And I frequently recommend meditation! People come with various preconceptions, various experiences with conventional healthcare, and I try to give treat them as intelligent adults who can make up their own minds about what I offer – many of them conclude that’s it’s valuable to them.