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Mainly randomized controlled and quasi randomized trials have been considered that provide a high quality level of evidence.
The meta-analysis and data synthesis were done separately for the studies that included both region- and age-specific prevalence data, since these studies were mainly randomized community sampling.
However, these studies were mainly randomized clinical trials (RCTs) in which the efficacy of a treatment in optimal controlled experimental conditions was evaluated, and few studies have compared therapeutic effectiveness using a clinical databases, under the conditions of clinical practice.
The level of evidence was pooled into two categories: the high level category that included the 1a to 2c categories (mainly randomized clinical trials or cohort studies) and the low level that included the 3 to 5 categories (mainly case-control studies, series of cases, cases and expert opinions).
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In the Phase II trial subjects were randomized mainly in Eastern European countries.
Drop-out rates were relatively high mainly because patients that were randomized to receive insulin treatment would then decide to leave the study probably because they initially believed they would enter the oral medication arm although they were thoroughly instructed that this was a randomized trial.
Randomized controlled trials focused mainly on improvement of communication and symptom distress.
In total 12 randomized trials also including mainly patients younger than 70 years could be identified by the investigators.
In the trial 588 newly admitted patients, mainly with a rehabilitation purpose, were randomized to either the control group that received usual care only or to the intervention group that received usual care and an Australian Medical Sheepskin.
A total of 12,537 high CV disease risk patients, including 1,456 individuals with prediabetes (impaired fasting glucose [IFG] or impaired glucose tolerance [IGT]) were randomized to standard care (mainly oral hypoglycemic agents) or to insulin glargine.
In a group of rather small controlled trials reviewed by the FDA, 13 incident cancer cases (mainly skin cancers) were found among patients randomized to hypnotics, but none were found among the sometimes-smaller randomized placebo groups.
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