- Prof. Ernst harshly criticizes research paper, saying it was ‘badly designed’
A study on miniscalpel acupuncture conducted by an Oriental medical college with the financial support from the Ministry of Health and Welfare has received harsh criticism from a British expert of alternative medicine.
The research paper in question was “Efficacy and Safety of Miniscalpel Acupuncture on Knee Osteoarthritis: A randomized controlled pilot trial,” published in the Journal of Pharmacopuncture, a publication of the Korean Pharmacopuncture Institute.
|This is the capture of the blog of Professor Edzard Ernst of the University of Exeter in the United Kingdom.|
Professor Edzard Ernst, who set up the Department of Alternative Medicine at the University of Exeter, made cutting remarks on the study in a writing posted on his blog on Oct. 25, pointing out that this study was badly designed to affirm the efficacy and safety of miniscalpel acupuncture (MA) and was full of errors and defects.
“This is an awful study with the mistitle of ‘pilot’ used by its authors to publish it in a sham academic journal,” Professor Ernst said.
Miniscalpel acupuncture is a relatively new type of non-invasive acupuncture or microsurgery using a small needle-scalpel invested by Professor Zhu Hanzhang in 1976.
Prof. Ernst used to point out that most of the documents that said MA has effects on easing pains of knee osteoarthritis (KOA) were based on clinical trials carried out in China, which have methodological flaws while maintaining a better clinical study is needed to verify the efficacy of MA.
The British professor then took note of a new study, the one carried by a Korean oriental medicine college. Ernst introduced in detail the contents and results of the research.
The researchers recruited 24 participants and divided them into two groups – MA (experimental) and acupuncture group (control). The MA group received treatment once a week for three weeks while the acupuncture group received treatments two times per week for three weeks, and compared them by visual analog scale (VAS).
The authors concluded that “although both MA and acupuncture groups provided similar effects concerning pain control in patients with KOA, MA may be more effective in providing pain relief because the same relief was obtained with fewer treatments. A large-scale clinical study is warranted to clarify these findings further.”
Professor Ernst said, “I can recommend this article to anyone who wants a quick introduction into the critical analysis of clinical trials. It is a veritable treasure trove of mistakes, flaws, errors, and fallacies, etc.
He noted that the number of participants was far from enough, and the comparison of the control group was also wrong.
“The authors’ aim of investigating the safety of MA is unobtainable. It would require not 24 but probably 24,000 patients,” Ernst said. “The authors’ aim of investigating the efficacy of MA is equally unobtainable. It would require a much larger sample than 24, a sham control arm, identical treatment schedules, patient-blinding, etc.”
The British expert went on to say, “The authors’ statement that both MA and acupuncture provided similar effects with regard to pain control in patients with KOA is misleading. It implies that both interventions had specific effects. Without a sham control arm, this is pure speculation.”
The way this study was designed, it should have been clear from the start that it would not produce any meaningful findings. Seen from this perspective, running the trial could even be seen as a breach of research ethics, Ernst blasted.
He called for the Korean Ministry of Health and Welfare, which provided financial support for this study, to reexamine strategy to pay research cost immediately.
“The following footnote is worth mentioning: ‘This study is supported by a grant from the Ministry of Health and Welfare of Korea,’” Professor Ernst said. “It suggests to me that this ministry should urgently reexamine its strategy to pay research cost. It needs to recruit evaluators who have the ability to make a critical analysis.”
The Institute for Science-based Medicine translated Professor Ernst’s writing and posted it on its blog. An official at the Korea Medical Association’s special committee to deal with oriental medicine said, “The ministry has ended up disgracing itself while wasting taxpayers’ money.”