This was a small randomised controlled trial of a medication for an active inflammatory condition. The trial was unnecessary, as several large trials and a recent non-systematic review had shown that the medication was beneficial for flare-ups of the condition. In this case, all patients were taken off non-steroidal anti-inflammatory drugs (NSAIDs) and then they were randomly allocated to receive the medication or an inert placebo. The randomisation was inadequate (“patients were consecutively enrolled in two groups”). The paper gave no details of ethical approval or informed consent. As patients had to stop taking NSAIDs, which were controlling their pain and other symptoms, is it ethical that half received an inert placebo?
_ Ethics committee approval should be requested, but how far could this be challenged if the authors had it, in which case the local ethics committee in question should be queried. _ It was correct to trial an established treatment against a new treatment, and not just a placebo. But it would be wrong to test a drug against other drugs that had been found to be ineffective. _ The editor should go back to the authors and ask whether they had informed consent, to reply to the concerns about poor practice demonstrated, and show evidence of ethics committee approval. _ If no reply is received then the editor should go directly to the head of the institution. Which point was the most serious? Firstly, that the trial shouldn’t have been done at all; secondly, that the patients had been taken off the effective treatment; or thirdly, that there had been insufficient randomisation? _ COPE has no agenda to say whether a trial should or shouldn’t have been done and that insufficient randomisation would probably not constitute the need to report to the author’s institution either.
The editor wrote to the author and received a satisfactory reply. The authors had obtained patient consent. Few if any patients had to be taken off painkillers for the study, because they had inactive or burnt-out disease.