Influencing Factors Of The Placebo Response In Overactive Bladder

Since the birth of the first double-blind placebo-controlled clinical trial to evaluate the new drugs and treatments, placebo-controlled has become the golden standard to reflect the efficacy of the drugs. The researchers found significant and widespread placebo effect in placebo-controlled clinical trials. In the process of new drug R&D and clinical practice in modern times, the placebo effect has been a hot topic which caused widespread discussion. There are still a lot of debates about the influenceing factors of placebo effect so far. The influencing factors are different within different diseases. Too high of the placebo effect can affect the accuracy of the results of clinical trials, how to control the influencing factors to intervene in the placebo effect in order to decrease the placebo effect in clinical trials but increase the placebo effect in clinical practices which is good for the treatment of the disease has became the research hotspots in recent years.Overactive bladder (OAB) is one of the diseases which have strongest placebo effect. OAB is a common disease which is endangering the health of millions of people in the world. The diagnosing of OAB is mainly depending on the subjective feeling of patients. Because of the complexity of the clinical manifestations and other reasons, the diagnosis of the disease is easily missed. Patients paid little attention to the OAB, but this disease caused serious impact on the quality of life. Along with the increase of the tendency in aging in our country, the incidence of OAB is showed a trend of rising year by year, and with the gradual improvement of the living standards of the masses, people gradually increase their requirement of quality of life. People paid more and more attention to OAB. This study is analyzing the influencing factors of the placebo response in OAB. This will help to optimize the design of clinical trials in OAB and can also have some help on the reasonable treatment of OAB. Part I:Influencing factors of the placebo response in OAB Objective:To investigate the significant influencing factors of the placebo response in OAB. Materials and methods:Data for analysis came from the placebo group of a completed phased3, parallel group, randomized, double-blind, placebo-controlled multicenter clinical trial which aim at investigating the efficacy of OAB drug. Treatment response and treatment satisfaction were taken as the dependent variable respectively. Independent variables included demographic data, risk factors of OAB and OAB disease data. There are totally15independent variables. SAS9.2statistical software was used for statistical analysis. Kappa consistency test is used to assess the consistency of subjective and objective endpoints. Univariate logistic regression was used to find the suspicious influencing factors with statistical significance. Multivariate logistic regression was used to select the influencing factors.Results:When treatment response and treatment satisfaction were taken as the dependent variable respectively, the univariate logistic regression both showed that6variables had statistical significance. They were consumption of caffeine, duration of OAB, severity of urinary urgency, severity of OAB, prior OAB treatment and occurrence of adverse events. When the treatment response was taken as the dependent variable,the multivariate logistic regression further showed that patients with mild to moderate OAB disease was more likely to have stronger placebo response and patients who do not consume caffeine was more likely to have stronger placebo response than patients who do consume caffeine.When the treatment satisfaction was taken as the dependent variable, the analysis showed that subjects without prior OAB treatment experience had stronger placebo effect.Conclusion:Severity of OAB and consumption of caffeine are the independent influencing factors of the placebo response in OAB.Part II:Influencing factors of the nocebo response in OABObjective:To investigate the significant influencing factors of the nocebo response in OAB.Materials and methods:Data for analysis came from the placebo group of a completed phased3, parallel group, randomized, double-blind, placebo-controlled multicenter clinical trial which aim at investigating the efficacy of OAB drug. Adverse event was taken as the dependent variable. Independent variables included demographic data, risk factors of OAB and OAB disease data. There are totally12independent variables. SAS9.2statistical software was used for statistical analysis. Univariate logistic regression was used to find the suspicious influencing factors with statistical significance. Multivariate logistic regression was used to select the influencing factors.Results:The univariate logistic regression showed that4variables had statistical significance. They were consumption of caffeine, consumption of alcohol, duration of OAB, prior OAB drug treatment.The multivariate logistic regression further showed that compared to the patients with weaker nocebo effect, patients with stronger nocebo effect had three characteristics which were consumption of caffeine and alcohol and with prior OAB drug treatment.Conclusion:Consumption of caffeine and alcohol and prior OAB drug treatment are the independent influencing factors of the nocebo response in OAB.