OBJECTIVE To describe the pain decrease considered as clinically relevant when designing a trial and reporting its results. METHODS A systematic review of the literature in MEDLINE was conducted to select randomized controlled trials (RCTs) with pain as a primary outcome. Data extracted included the definition (terms and values) of a clinically relevant difference in pain, the type of pain st...

Randomized controlled trials (RCTs) are a useful tool to check the effectiveness of drugs but have come to shape the culture of medicine in a manner that increasingly compromises medical care. Dependence on RCT evidence is compromised by the well-known problems stemming non-publication of trials, lack of access to trial data, ghostwriting of those trials that are published and a variety of codi...

The United States, along with other resource-rich countries, leads global health care by advancing medical care through randomized controlled trials (RCTs). While most medical research is conducted in these resource-rich areas, RCTs, including replications of previous trials, are additionally carried out in low- and middle-income countries. On the basis of positive findings from several RCTs co...

In the era of molecular oncology, patients still define a useful therapy as one that allows them to live longer and helps them to live better. Although patient outcomes have clearly improved as a result of randomized controlled trials (RCT), it is critical that contemporary trials retain the perspective of these fundamental patient-centered outcomes. Trends in study design, results, and interpr...

In evidence-based medicine, randomized controlled trials (RCTs) are the preferred method for evaluating the efficacy of interventions. In regard to acupuncture RCTs, the most difficult issues are the design of the control group and implementation of the principle of "double-blinding." We compared the advantages and limitations associated with different control group designs in acupuncture RCTs,...

INTRODUCTION Although classical randomized clinical trials (RCTs) are the gold standard for proof of drug efficacy, randomized discontinuation trials (RDTs), sometimes called "enriched" trials, are used increasingly, especially in psychiatric maintenance studies. METHODS A narrative review of two decades of experience with RDTs. RESULTS RDTs in psychiatric maintenance trials tend to use a d...

Recent randomized controlled trials (RCTs) suggest that psychodynamic therapy (PDT) may be useful in the treatment of anxiety disorders. This paper presents the most comprehensive meta-analysis to date examining the controlled effects of PDT for anxiety disorders. 14 RCTs totaling 1073 patients were included. PDT was found to be significantly more effective than control conditions (g=0.64). PDT...

Randomized controlled trials (RCTs) are considered the gold standard study design to investigate the effect of health interventions, including treatment. However, in some situations, it may be unnecessary, inappropriate, impossible, or inadequate to perform an RCT. In these special situations, well-designed observational studies, including cohort and case-control studies, may provide an alterna...

Network meta-analysis is increasingly used to allow comparison of multiple treatment alternatives simultaneously, some of which may not have been compared directly in primary research studies. The majority of network meta-analyses published to date have incorporated data from randomized controlled trials (RCTs) only; however, inclusion of non-randomized studies may sometimes be considered. Non-...

OBJECTIVE Although prophylactic antibiotics have been shown by randomized clinical trials (RCTs) to help prevent deep infection after craniotomies, recent reports have suggested that antibiotics are not effective in preventing postcraniotomy meningitis. METHODS Data on meningitis as an end point from RCTs on prophylactic antibiotics for craniotomies were pooled in a random-effects meta-analys...