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• W208546318 abstract "Editor—Fan et al’s paper is the second in the BMJ recently to investigate prophylaxis against adverse effects of snake antivenom.1 Earlier, Premawardhena et al in Sri Lanka concluded that giving low dose subcutaneous adrenaline before antivenom could prevent acute adverse reactions.2 The Brazilian study (by Fan et al) showed no benefit in using promethazine as pretreatment.1 Perhaps more interesting than the conclusions, however, is that both these clinical trials were stopped early because of interim analyses; they provide examples of the use and pitfalls of such analyses.The Sri Lankan group stopped recruitment halfway through its study since the analysis showed a significant reduction in all acute adverse effects when adrenaline was used as pretreatment rather than placebo (P=0.0002). Unfortunately, in subanalysis of the severity of adverse reactions in the two groups the differences in incidence of mild, moderate, and severe reactions barely reached significance due to the low power of the analysis (about 50%) and the small numbers. This is important since it is mainly the moderate and severe reactions that we wish to prevent. As it was, the trial was stopped because of a supposed benefit, but we cannot advise the use of subcutaneous adrenaline because of unconvincing evidence. In the Brazilian study the interim analysis was in the form of sequential analysis. The use of this method, and to some degree the negative outcome of the study, prevents arguments of the nature used above.Interim analyses are often required on ethical grounds, but final data analysis and clinical importance should be borne in mind when they are planned. Too often, emphasis is put on the ethics of continuing a trial in which some patients receive an apparently inferior treatment. Stopping the trial may, however, result in the evidence for the supposedly better treatment being insufficient for policy changes to be recommended—this too is unethical.Using and stating defined methodologies, as in Fan et al’s study, can help, but we must always bear in mind that statistics are an aid to reason, not a replacement for it. The dangers of stopping a trial too early have been addressed recently by Pocock and White3 and need to be fully appreciated by clinical researchers." @default.
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• W208546318 modified "2023-09-26" @default.
• W208546318 title "Prophylaxis against early anaphylactic reactions to snake antivenom" @default.
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• W208546318 doi "https://doi.org/10.1136/bmj.319.7214.920a" @default.
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