Randomised Controlled Trials May Underestimate Drug Effects: Balanced Placebo Trial Design
نویسندگان
چکیده
منابع مشابه
Randomised Controlled Trials May Underestimate Drug Effects: Balanced Placebo Trial Design
BACKGROUND It is an inherent assumption in randomised controlled trials that the drug effect can be estimated by subtracting the response during placebo from the response during active drug treatment. OBJECTIVE To test the assumption of additivity. The primary hypothesis was that the total treatment effect is smaller than the sum of the drug effect and the placebo effect. The secondary hypoth...
متن کاملDrug*placebo interaction effect may bias clinical trials interpretation: hybrid balanced placebo and randomized placebo-controlled design
BACKGROUND Conventional randomized placebo-controlled study design assumes the absence of drug*placebo interaction. We hypothesized the presence of such an interaction and that conventionally estimated drug effect might be biased. The objectives of the study were to determine the drug*placebo interaction effect (main) and compare conventionally estimated and interaction model-estimated drug eff...
متن کاملInteraction between drug and placebo effects: a cross-over balanced placebo design trial
BACKGROUND The total effect of a medication is the sum of its drug effect, placebo effect (meaning response), and their possible interaction. Current interpretation of clinical trials' results assumes no interaction. Demonstrating such an interaction has been difficult due to lack of an appropriate study design. METHODS 180 adults were randomized to caffeine (300 mg) or placebo groups. Each g...
متن کاملA quasi-placebo may have a role in some randomised controlled trials
Dear Editor, Migraine-prevention trials in children and young people have been disappointing. As chief investigator for P3MC, the placebo-controlled migraine-prevention trial of pizotifen and propranolol in the UK [1] that was abandoned because of poor recruitment, I have had a great deal to reflect on. And while having a placebo was not the main factor in the trial’s failure, I think that it c...
متن کاملRandomised placebo-controlled trials of surgery: ethical analysis and guidelines
Use of a placebo control in surgical trials is a divisive issue. We argue that, in principle, placebo controls for surgery are necessary in the same way as for medicine. However, there are important differences between these types of trial, which both increase justification and limit application of surgical studies. We propose that surgical randomised placebo-controlled trials are ethical if ce...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: PLoS ONE
سال: 2014
ISSN: 1932-6203
DOI: 10.1371/journal.pone.0084104