MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

Earlier this year, I started the ‘WORST PAPER OF 2022 COMPETITION’. You will ask what is there to win in this competition? I agree: a competition without a prize is no fun. Therefore, I suggest offering the winner (that is the author of the winning paper) one of my books that best fits his/her subject. I am sure this will over-joy him or her. And how do we identify the winner? I suggest that I continue blogging about nominated papers (I hope to identify about 10 in total), and towards the end of the year, I let my readers decide democratically.

In this spirit of democratic voting, let me suggest to you ENTRY No 6:

This study was to ascertain the efficacy of dry cupping therapy (DCT) and optimal cup application time duration for cervical spondylosis (CS). It was designed as a randomized clinical trial involving 45 participants with clinically diagnosed CS. The eligible subjects were randomly allocated into three groups, each having 15 participants. Each of the three groups, i.e., A, B, and C, received DCT daily for 15 days for 8 min, 10 min, and 12 min, respectively. All the participants were evaluated at the baseline, 7th, and 15th day of the trial using the neck disability index (NDI) as well as the visual analog scale (VAS).

The baseline means ± SD of NDI and VAS scores were significantly reduced in all three groups at the end of the trial. Although all three groups were statistically equal in terms of NDI, group C demonstrated greater efficacy in terms of VAS.

The authors concluded that the per-protocol analysis showed that dry cupping effectively alleviated neck pain across all treatment groups. Although this effect on neck disability index was statistically equal in all three groups, the 12-min protocol was more successful in reducing pain.

Who would design such a study and why?

  • The authors claim they wanted to ascertain the efficacy of DCT. A trial is for testing, not ascertaining. And this study does certainly not test for efficacy.
  • The groups were too small to generate a meaningful result of what, in fact, was an equivalence study.
  • Intra-group changes in symptoms between baseline and time points during treatment are irrelevant in a controlled trial.
  • The slightly better results of group C are most likely due to chance or non-specific effects (a longer application of a placebo would generate better outcomes that a shorter one).
  • The study participants had cervical spondylosis, yet the conclusion is about neck pain. The two are not identical.
  • The title of the paper promises that we learn something about the safety of DCT. Sadly, a trial with just 45 patients has no chance in hell to pick up adverse effects in a reliable way.
  • As there is no control group, the study cannot tell us anything about possible specific effects of DCT.

The authors of the study have impressive affiliations:

  • Department of Ilaj bil Tadbir, Luqman Unani Medical College Hospital and Research Center, Bijapur, India.
  • Department of Ilaj bil Tadbir, National Institute of Unani Medicine, Bengaluru, India.
  • Department of Moalajat, Luqman Unani Medical College Hospital and Research Center, Bijapur, India.

I would have hoped that researchers from national institutions and medical colleges should be able to design a trial that has at least a small chance to produce a meaningful finding. As it turns out, my hope was badly disappointed.

3 Responses to The ‘WORST PAPER OF 2022 COMPETITION’ entry No 6: “The efficacy and safety of dry cupping in cervical spondylosis with optimization of cup application time – A randomized clinical trial”

  • Bit curious this – was told by your department in Exeter when you were there that a sample for a trial could be quite small – 10 or so was mentioned.

    • the sample size depends amongst others on the outcome measure and its variability.
      you were told by my dept? we had no spokesperson!
      in any case, the low sample size is not the main flaw in this study.

  • Prof. Ernst,

    I doubt we can expect a better quality study from institutes that teach unani medicine, classified as quackery by Indian Medical Association: https://en.wikipedia.org/wiki/Unani_medicine

    Especially, when it comes to educational institutions in India, I don’t think having “National Institute” and “Medical College” means they are good institutions. There is a network of such institutes funded and run by AYUSH ministry to promote traditional medicine and most of them produce poor quality studies. One of the two institutes (National Institute of Unani Medicine) that this study was conducted at is run by AYUSH ministry.

    At present, there are 41 recognized colleges of Unani medicine – including the National Institute of Unani Medicine (NIUM), Bangalore – in the country, which provide education and training facilities in the system. These colleges have a total admission capacity of 1750 students per year for undergraduate courses.

    The Ministry of AYUSH, runs a premier institute, the National Institute of Unani Medicine (NIUM), Bangalore. This institute established in the year 1984, imparts quality education, training and research in the Unani system of medicine.

    https://pratibha.digitalindiacorporation.in/ayuweb/en/a-career-in-unani-medicine/

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