This pilot study tested the feasibility of using US Food and Drug Administration (FDA)–recommended endpoints to evaluate the efficacy of acupuncture in the treatment of IBS. It was designed as a multicenter randomized clinical trial, conducted in 4 tertiary hospitals in China from July 1, 2020, to March 31, 2021, and 14-week data collection was completed in March 2021. Individuals with a diagnosis of IBS with diarrhea (IBS-D) were randomized to 1 of 3 groups:
- acupuncture groups 1 (using specific acupoints [SA])
- acupuncture group 2 (using nonspecific acupoints [NSA])
- sham acupuncture group (non-acupoints [NA])
Patients in all groups received twelve 30-minute sessions over 4 consecutive weeks at 3 sessions per week, ideally every other day.
The primary outcome was the response rate at week 4, which was defined as the proportion of patients whose worst abdominal pain score (score range, 0-10, with 0 indicating no pain and 10 indicating unbearable severe pain) decreased by at least 30% and the number of type 6 or 7 stool days decreased by 50% or greater.
Ninety patients (54 male [60.0%]; mean [SD] age, 34.5 [11.3] years) were enrolled, with 30 patients in each group. There were substantial improvements in the primary outcomes for all groups
- response rates in the SA group = 46.7% [95% CI, 28.8%-65.4%]
- response rate in the NSA group = 46.7% [95% CI, 28.8%-65.4%]
- response rate in the NA group = 26.7% [95% CI, 13.0%-46.2%]
The difference between the groups was not statistically significant (P = .18). The response rates of adequate relief at week 4 were 64.3% (95% CI, 44.1%-80.7%) in the SA group, 62.1% (95% CI, 42.4%-78.7%) in the NSA group, and 55.2% (95% CI, 36.0%-73.0%) in the NA group (P = .76). Adverse events were reported in 2 patients (6.7%) in the SA group and 3 patients (10%) in NSA or NA group.
The authors concluded that acupuncture in both the SA and NSA groups showed clinically meaningful improvement in IBS-D symptoms, although there were no significant differences among the 3 groups. These findings suggest that acupuncture is feasible and safe; a larger, sufficiently powered trial is needed to accurately assess efficacy.
WHAT A LOAD OF TOSH!
Here are some of the most obvious issues I have with this new study:
- A pilot study is not about reporting effectiveness/efficacy but about testing the feasibility of a study.
- That acupuncture is feasible has been known for ~2000 years.
- The conclusion that acupuncture is safe is not warranted on the basis of the data; for that we would need a much larger investigation.
- The authors seem to have used our sham needle without acknowledging it.
- The authors are affiliated with the International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, yet they state that they have no conflicts of interest.
- The results are clearly negative, yet the authors seem to attempt to draw a positive conclusion.
The main question that occurs to me is this: how low has the JAMA sunk to publish such junk?
5 Responses to JAMA just published another truly awful acupuncture study
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Who owns JAMA? Who are JAMA’s investors?
Follow the money!
Edzard, please send these concerns as a letter-to-the-editor to be published in JAMA so that it becomes known to the readers of the journal! Especially points three and six should have been obvious to any peer reviewer in JAMA.
Then we will see if and how the authors respond.
I hope the following doesn’t mean what I think it means (the above study was published in JAMA Network Open):
Aha, it was a pre-review manuscript. This means that JAMA hasn’t looked at it yet.
Many thanks, Dan.