This randomized clinical trial (RCT) tested whether acupuncture is effective for the prevention of chronic tension-type headaches (CTTH). The researchers recruited 218 participants who were diagnosed with CTTH.
- The participants in the intervention group received 20 sessions of true acupuncture (TA group) over 8 weeks. The acupuncture treatments were standardized across participants, and each acupuncture site was needled to achieve deqi sensation. Each treatment session lasted 30 minutes.
- The participants in the control group received the same sessions and treatment frequency of superficial acupuncture (SA group)—defined as a type of sham control by avoiding deqi sensation at each acupuncture site.
The main outcome measure was the responder rate at 16 weeks after randomization. Followed-up was 32 weeks. A responder was defined as a participant who reported at least a 50% reduction in the monthly number of headache days (MHDs).
The responder rate was 68.2% in the TA group (n=110) versus 48.1% in the SA group (n=108) at week 16 (odds ratio, 2.65; 95%CI, 1.5 to 4.77; p<0.001); and 68.2% in the TA group versus 50% in the SA group at week 32 (odds ratio, 2.4; 95%CI, 1.36 to 4.3; p<0.001). The reduction in MHDs was 13.1±9.8 days in the TA group versus 8.8±9.6 days in the SA group at week 16 (mean difference, 4.3 days; 95%CI, 2.0 to 6.5; p<0.001), and the reduction was 14±10.5 days in the TA group versus 9.5±9.3 days in the SA group at week 32 (mean difference, 4.5 days; 95%CI, 2.1 to 6.8; p<0.001). Four mild adverse events were reported; three in the TA group versus one in the SA group.
The authors concluded that the 8-week TA treatment was effective for the prophylaxis of CTTH. Further studies might focus on the cost-effectiveness of the treatment.
“Our study showed that deqi sensation could enhance the effect of acupuncture in the treatment of chronic TTH, and the effect of acupuncture lasted at least 6 months when the treatment was stopped,” said co-investigator Ying Li, MD, PhD, The Third Hospital/Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Why am I not convinced?
Assuming that all the findings are correctly reported, the study does not at all show that the treatment was effective. It merely demonstrates that those patients who knew that were receiving TA told the researcher that they improved more than those who knew they has sham acupuncture. The difference in outcomes is not in the least surprising: patients’ knowledge of having had the verum leads to a placebo effect and to social desirability (patients giving the researchers positive responses simply because they were thankful for being looked after). Patients’ knowledge of having had the sham treatment leads to disappointment and thus worse outcomes.
But this is not the only reason why I am skeptical about this study. The authors claim they achieved deqi at every treatment. That is 20 treatments in 110 patients or 2 200 deqis! I think someone might be telling porkies here. Deqi cannot reliably be elicited on every single occasion. I, therefore, feel that perhaps the authors of this trial were a bit more than generous when writing up their study, and I am reminded of the recent report claiming that more than 80% of clinical trial data from China are fabricated.
7 Responses to Acupuncture for the prevention of headache? How to fool (almost) everyone with an RCT
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I don’t believe there is robust evidence that deqi even exists. Over 20 years ago I was given acupuncture by my GP, who said that I should feel a sensation. I felt nothing. Several treatments, from different practitioners – still nothing. My personal anecdote for what it’s worth, but the published studies don’t look any more convincing.
Exactly. And this is just one of several essential elements of ‘energy medicine’ for which no scientific evidence exists AT ALL, but which are simply taken for granted nevertheless.
The frustrating thing is that alternative practitioners and proponents not only posit the existence of these things without a shred of good evidence, but succeed in convincing lawmakers that these things are real, in order to further their alternative agenda (licensing, gain more or less equal rights as real medicine etc.). Chi (‘life energy’) and meridians are just some of the most prominent unproven phenomena(*).
This also extends to other forms of quackery, such as erroneous claims that homeopathic products contain ‘small amounts’ of active substances (most products don’t contain any active substance at all), and claims that there are lots of homeopathic preparations out there with proven effects (there is not one homeopathic preparation that shows an effect in any repeatable way).
Pedlars of herbal products routinely lie when they replace the correct phrasing “… is traditionally used for …” with “… is effective for …“, suggesting proven efficacy instead of unproven traditional beliefs. And so on …
*: See e.g. this bit of legalese in Arizona, granting acupuncturists far more rights and credit than they deserve: https://www.azleg.gov/ars/32/03901.htm
“3. “Adjunctive therapies” means the manual, mechanical, magnetic, thermal, electrical or electromagnetic stimulation of acupuncture points and energy pathways, auricular and detoxification therapy, the use of ion cord devices, electroacupuncture, nutritional counseling, therapeutic exercise, the use of nonionizing lasers and acupressure.”
The bold terms are unproven forms of quackery that have no place in legislature – I count no less than 9 of them in this one sentence. Yet these things are simply enumerated as if they were real and proven.
That Medscape Neurology reports this with the headline “Deep Acupuncture Points to Greater Headache Relief “ without questioning the study and quotes, Jennifer Bickel, MD, a senior member of neurology at Moffit Cancer Center and professor of oncologic sciences at University of South Florida in Tampa, as saying that “ the study provides a deeper understanding of acupuncture’s efficacy for chronic TTH, which could aid clinicians who are unfamiliar with the therapy or when and how to refer treatment.” is even more alarming.
I agree
“Dr. Bickel has been nationally recognized for her work in headache advocacy, research and education. She is also a medical acupuncturist with a focus on headache and pain relief.” [my emphasis]
https://moffitt.org/providers/jennifer-bickel-young/
Obviously not double blinded. Can you imagine then scenario? Did you feel deqi? No? are you sure? Let my try again………………etc etc
Over 80% of clinical trial data out of China are fabricated, but also to my knowledge there has never been a negative acupuncture study come out of China, and China is responsible for more retractions than the rest of the world combined.
Apparently the Chinese government is supposed to be cracking down on this type of study, but their support for acupuncture and indeed for all kinds of BS supplements makes such a crackdown very hard to believe.