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Author: Admin | 2025-04-28
Symptoms. The exaggeration would then go away once they are in the trial, resulting in an apparent treatment effect. This would affect both the treatment and placebo arms of the study, but would statistically obscure the treatment effect (which would be proportionally smaller).The way subjects are being treated in trials is also changing over time. They are getting more attention, perhaps more encouragement, and their overall experience in the trial is better. All of these things would magnify their placebo response to the experience.How to fix it?It is difficult to know how to fix the problem of growing placebo responses obscuring treatment effects without knowing the cause(s) (and even if it’s a problem). Reducing possible artifacts, however, is generally a good idea and might fix the problem (and provide evidence for the cause(s)).For example, subjects in a clinical trial could be given more balanced information about what to expect. They could be given, for example, statistically accurate information about the chance of getting the drug vs placebo, the probability that the drug works and the percentage of subjects for whom drugs typically work. This would shift subject expectations. It may also hamper recruitment, but recruitment number does not seem to be an issue.Steps could be taken also to make it more difficult for recruiters to fudge inclusion criteria. Perhaps they are not told what the criteria are, only what information to gather. Then a centralized unit will review the data and determine if the criteria are met. Careful attention can also be paid to inclusion criteria, to make them as objective as possible.Another approach already being used is to have a placebo lead-in period. In this study design all subjects are given a placebo prior to randomization, and those that have a placebo response are then statistically excluded from the primary outcome. Those who did not have a significant placebo response are randomized to treatment vs placebo. The effectiveness of this approach has yet to be determined, with results so far being mixed.Conclusion: Tuttle et al. raises more questions than it answersThe new study provokes more questions than it answers,
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