BackgroundBerotralstat (BCX7353) is a recently approved, oral, once-daily kallikrein inhibitor for hereditary angioedema (HAE) prophylaxis. In the APeX-2 trial, berotralstat reduced HAE attack rates over 24 weeks, with favorable safety and tolerability profile.ObjectiveEvaluate safety, tolerability, effectiveness 48 weeks.MethodsAPeX-2 phase 3, parallel-group, multicenter trial (NCT03485911) in...

TA-65 is a small molecule telomerase activator extracted from Astragalus species. A previous observational study suggested that decreased the number of immunosenescent cells in healthy subjects. Here we examined impact much larger randomized, double-blind, and placebo-controlled study. This aims to evaluate effects on senescent CD8+CD28- T was placebo-controlled, multi-arm parallel trial 500 Su...

A pooled analysis of randomized placebo controlled antidepressant trials shows that the rate of antidepressant and placebo responders are 50% and 30% respectively. The traditional calculation of drug-placebo difference (50-30=20%) in these drug-trials is based on the assumption that all placebo responders should be antidepressant responders. However, it seems to be not the case, since about one...

Considerable intellectual and practical effort has been expended on designing and evaluating placebo controls in acupuncture studies. Somewhat less attention has been paid to the question: Why use a placebo in a randomized trial of acupuncture? This is partly because placebo controls have generally been seen as an inherent part of randomized trial methodology. As a result, most acupuncture tria...

A IM : to evaluate efficacy and safety of ustekinumab in Russian patients with ulcerative colitis UNIFI study. PATIENTS AND METHODS: the program (CNTO1275UCO3001) consisted two randomized placebo-controlled trials: an 8-week induction study a 44-week maintenance long-term period. This analysis included from 14 centers. RESULTS enrolled 74 Russia, 89.2% (n = 66) were bionaive. The paper presents...

UNLABELLED The typical placebo response (ie, the nonspecific effects in the placebo group including benign natural course, regression to the mean, expectation/conditioning effects, and others) in randomized trials in complex regional pain syndrome (CRPS) is unknown. We recently observed a surprising near-absence of placebo response in a randomized controlled trial we conducted on patients with ...

This systematic review was performed to investigate the ethical justification, methodological quality, validity and safety of placebo controls in randomized placebo-controlled surgical trials.Central, MEDLINE, and EMBASE were systematically searched to identify randomized controlled trials comparing a surgical procedure to a placebo. "Surgical procedure" was defined as a medical procedure invol...

Background Dietary treatment containing fiber-rich foods may contribute to lowering weight in obese women. Objective To investigate the effect of a hypoenergetic diet combined with pumpkin seed flour (PSF) consumption on quality, anthropometric indices, and glucose lipid metabolism Methods We conducted randomized, double-blind, placebo-controlled, 90-day clinical trial women, distributed into f...

We evaluated the efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents (6-17 years) with autism spectrum disorder (ASD) in a randomized, double-blind, placebo-controlled 8-week study in Japan. Patients received flexibly dosed aripiprazole (1-15 mg/day) or placebo. Ninety-two patients were randomized to placebo (n = 45) or aripiprazole (n = 47). Aripipr...

Abstract Background Patients with major depressive disorder (MDD) often do not respond to antidepressant (ADT) monotherapy alone and may require adjunctive treatment provide adequate symptom relief. Cariprazine (CAR) is a dopamine D 3 -preferring /D 2 serotonin 5-HT 1A receptor partial agonist approved treat adults schizophrenia manic, mixed, or episodes of bipolar I disorder. Post hoc analysis...