Two years ago, I reported about an acupuncture review that was, in my view, a fairly clear case of scientific misconduct. To remind you, here is my from 22/11/22 about it:
Acupuncture is emerging as a potential therapy for relieving pain, but the effectiveness of acupuncture for relieving low back and/or pelvic pain (LBPP) during pregnancy remains controversial. This meta-analysis aimed to investigate the effects of acupuncture on pain, functional status, and quality of life for women with LBPP pain during pregnancy.
The authors included all RCTs evaluating the effects of acupuncture on LBPP during pregnancy. Data extraction and study quality assessments were independently performed by three reviewers. The mean differences (MDs) with 95% CIs for pooled data were calculated. The primary outcomes were pain, functional status, and quality of life. The secondary outcomes were overall effects (a questionnaire at a post-treatment visit within a week after the last treatment to determine the number of people who received good or excellent help), analgesic consumption, Apgar scores >7 at 5 min, adverse events, gestational age at birth, induction of labor and mode of birth.
Ten studies, reporting on a total of 1040 women, were included. Overall, acupuncture
- relieved pain during pregnancy (MD=1.70, 95% CI: (0.95 to 2.45), p<0.00001, I2=90%),
- improved functional status (MD=12.44, 95% CI: (3.32 to 21.55), p=0.007, I2=94%),
- improved quality of life (MD=−8.89, 95% CI: (−11.90 to –5.88), p<0.00001, I2 = 57%).
There was a significant difference in overall effects (OR=0.13, 95% CI: (0.07 to 0.23), p<0.00001, I2 = 7%). However, there was no significant difference in analgesic consumption during the study period (OR=2.49, 95% CI: (0.08 to 80.25), p=0.61, I2=61%) and Apgar scores of newborns (OR=1.02, 95% CI: (0.37 to 2.83), p=0.97, I2 = 0%). Preterm birth from acupuncture during the study period was reported in two studies. Although preterm contractions were reported in two studies, all infants were in good health at birth. In terms of gestational age at birth, induction of labor, and mode of birth, only one study reported the gestational age at birth (mean gestation 40 weeks).
The authors concluded that acupuncture significantly improved pain, functional status and quality of life in women with LBPP during the pregnancy. Additionally, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are still needed to further confirm these results.
What should we make of this paper?
In case you are in a hurry: NOT A LOT!
In case you need more, here are a few points:
- many trials were of poor quality;
- there was evidence of publication bias;
- there was considerable heterogeneity within the studies.
The most important issue is one studiously avoided in the paper: the treatment of the control groups. One has to dig deep into this paper to find that the control groups could be treated with “other treatments, no intervention, and placebo acupuncture”. Trials comparing acupuncture combined plus other treatments with other treatments were also considered to be eligible. In other words, the analyses included studies that compared acupuncture to no treatment at all as well as studies that followed the infamous ‘A+Bversus B’ design. Seven studies used no intervention or standard of care in the control group thus not controlling for placebo effects.
Nobody can thus be in the slightest surprised that the overall result of the meta-analysis was positive – false positive, that is! And the worst is that this glaring limitation was not discussed as a feature that prevents firm conclusions.
Dishonest researchers?
Biased reviewers?
Incompetent editors?
Truly unbelievable!!!
In consideration of these points, let me rephrase the conclusions:
The well-documented placebo (and other non-specific) effects of acupuncture improved pain, functional status and quality of life in women with LBPP during the pregnancy. Unsurprisingly, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are not needed to further confirm these results.
PS
I find it exasperating to see that more and more (formerly) reputable journals are misleading us with such rubbish!!!
_________________________
Now – 2 years later! – the journal (BMJ-Open) has retracted the article and posted the following notice about the decision:
BMJ Open has retracted this article.1 After publication, multiple issues were raised with the journal concerning the design and reporting of the study. The editors and integrity team investigated the issues with the authors. There were fundamental flaws with the research, including the control group selection and data extraction, not amenable to correction.
I am delighted that this misleading paper is now officially discredited. Yet, I do have some concerns:
WHY DOES IT TAKE 2 YEARS TO IDENTIFY SOMETHING AS FRAUDULENT RUBBISH, WHEN IT TOOK ME ALL OF ~30 MINUTES?
Instead of just insisting on a triumphant ‘I TOLD YOU SO’, let me provide some constructive advice to reviewers and journal editors.
- Many journal editors are to lazy to find reviewers themselves and ask the submitting author to name a few. Having myself published in the BMJ Open (the journal that published the paper in question) I fear that this might have been the case in the present instance. This habit invites poor reviews, e.g. reviews from colleagues who owe a favour to the submitting authors. It does not promote objective reviews and should be abandonned.
- Papers on acupuncture originating from China (as the one in question) are very likely to be biased (or worse), as we have so often discussed on this blog. Editors should be extra careful with such submissions.
- Reviewers who have in the past overlooked obvious flaws in a paper should be banned from further reviewing in future.
- Editors should understand the reviewers’ comments only as guidelines and still have an obligation to check the actual submissions themselves. the responsibility for publishing an article lies with them alone.
- Editors who repeatedly make such mistakes should be dismissed.
I think that adhering to these suggestions might improve the quality of published research … and, by Jove, this would be badly needed in the realm of so-called alternative medicine!!!
And why hasn’t the British Journal of Clinical Pharmacology retracted your 2002 article? If there are indications of fraud as when you say you were a “trained homeopath” or your excessive self-citation of your papers in the journal Perfusion that also have indications of data manipulation. Yes, Ernst, I have those papers and there are cases where you don’t even mention ORs. You also have accusations of altering data in adverse harm studies, copying and recycling paragraphs and accusations of manipulating statistical data.
1) “indications of fraud as when you say you were a “trained homeopath”” – I am a ‘trained homeopath’ because I received training in homeopathy and the title ‘homeopath’ is not protected.
2) “your excessive self-citation of your papers in the journal Perfusion” – depending on the subject, this can be justified and/or necessary.
3) “Yes, Ernst, I have those papers and there are cases where you don’t even mention ORs. You also have accusations of altering data in adverse harm studies, copying and recycling paragraphs and accusations of manipulating statistical data.” This is BS and part of what is known as ‘Ernst’s Law’ (https://edzardernst.com/2013/11/ernsts-law/).
In your self bio you say that you were only given 6 months of training in various forms of therapies. I have searched and there is no document that endorses you as a “trained homeopath”. So, according to your logic, if they give me training for six months in a medical subject I can already call myself a doctor, right?
2. I have the articles you published in Perfusion, and it is very strange. It was not one attempt, but with your letter in the Journal of Clinical Epidemiology, several desperate attempts to refute the conclusions of Linde et al. In one of your meta-analyses you do not even mention ORs, who reviewed that article? In the others you made fanciful correlations to try to square that all trials met that the higher the quality, the lower the effect. It is very curious, and I think Robert Hanh is right.
1) too dim to spell the name of Hahn correctly?
2) too dim to understand science? https://edzardernst.com/2018/06/an-analysis-of-hahns-critique-of-my-homeopathy-papers-yes-ideology-does-seem-to-play-a-part/
1. It is a typo, and this does not affect that there is no proof that you were a homeopath. So, that is a good point for them to make corrections to your article or retract it.
2. I know your criticism of Hahn. In it you just make an ad hominem to Hahn’s beliefs and digress from the topic. While it is true that Hahn is not mentioning your articles in Perfusion, I am. You still don’t answer why one of these doesn’t mention Odds Ratios. You still fail to explain how it is that in the Morrison et al article there is evidence of data dredging and manipulation in order to contradict the correlation of Linde et al. Furthermore, your blatant attempt in the Journal of Clinical Epidemiology is another good indication of potential fraud.
Hahn RG. Homeopathy: meta-analyses of pooled clinical data. Forsch Komplementmed; Research in Complementary Medicine. 2013 Oct;20(5):376–81. doi:10.1159/000355916. Epub 2013‑10‑17. PMID: 24200828.
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Here is another retraction notice after slanderous comments were made against the scientific value of a chiropractic rehabilitation device, Denneroll. https://retractionwatch.com/2024/08/05/journal-republishes-chiropractic-paper-it-had-retracted-after-legal-threats/