23 < Relevant articles > Please go to PubMed here. Hara, T. A meta-analysis on the characteristics of placebo effects on urinary function in placebo-controlled clinical trials among Japanese patients. Int J Urol 30, 447-54 (2023). 10.1111/iju.15152 < Backgrounds > In the process of consultation and review on drugs and medical devices related to urination, the placebo effects in clinical trials with urinary function as the primary endpoint have been reported in Europe and the United States, but not in Japan. The natural history of placebo effects in Japanese clinical trials was considered to be the basic data required for the protocol planning and also useful in evaluating the study results for discussing the protocol, observation period, and effect size in consideration of the placebo effects that are different between Japan and overseas. < Outline> on the results review reports. The analysis revealed the placebo effects of urinary frequency, the effective continued period, etc. in Japanese patients and items, such as a urine volume which placebo effects. As seen in the figure, the placebo effects frequency were found to titrate up for approximately 12 weeks, indicating the between-trial differences are limited. Ethnic-group differences were similar to those reported previously in Western countries. < Impact on RS, expectations > Recognizing the natural history of urinary diseases, mean regression, and the placebo effects, and planning and evaluating clinical trials may lead to improved quality of consultation / review services. In addition, PMDA's own conduct of such research may also contribute to improved PMDA’s capabilities in reviews. With regard to the natural history of subjects in clinical trials, both placebo and nocebo effects are important viewpoints, and we believe that this research in Japanese patients will contribute to the promotion of RS. Office of Research Administration, Tomohiko Hara Meta-analysis was performed based in the published volume, the the measurement was less likely to be affected by the for urinary effect-A meta-analysis on the characteristics of placebo effects on urinary function in placebo-controlled clinical trials among Japanese patients
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