A meta-analysis of the placebo response in complementary and alternative medicine trials of irritable bowel syndrome.

Among patients with irritable bowel syndrome (IBS) enrolled in clinical trials of conventional medical therapy, the placebo response rate is high. IBS patients also frequently use complementary and alternative medicine (CAM), which may act through an 'enhanced placebo effect'. The purpose of this study was to estimate the magnitude of the placebo response rate in CAM trials for IBS and to identify factors that influence this response. We performed a systematic review and meta-analysis of randomized, placebo-controlled clinical trials of CAM therapies for IBS identified from MEDLINE/EMBASE/PsychLIT databases from 1970 to 2006. Placebo and active treatment response rates for global symptom improvement were assessed. Nineteen studies met the inclusion criteria. The pooled estimate of the placebo response rate was 42.6% (95% confidence interval, 38.0-46.5%). Significant heterogeneity existed across trials (range 15.0-72.2%, P < 0.00001). Higher placebo response rates correlated with a longer duration of treatment (r = 0.455, P = 0.05) and a greater number of office visits (r = 0.633, P = 0.03). Among IBS patients in CAM trials, the placebo response rate is high. That this rate is similar in magnitude to that seen in conventional medicine trials suggests that the placebo response is independent of the type of therapy used and that it is not particularly 'enhanced' in CAM trials.

The Frye hearing in Florida: an attempt to exclude scientific evidence.

State Supreme Courts require a minimum threshold of reliability and acceptance in the scientific community for all medical and similar evidence to be admitted at trial. In Florida and some other states, the courts adhere to what is known as the Frye standard, whereas in most states and in Federal Courts, it is the so-called Daubert standard. The jurisdiction of the present case is Hillsborough County (Tampa), Florida. Forensic pathologists seldom, if ever, are requested to participate in such hearings, unlike their toxicological and basic science colleagues who are more involved in research methodology and technical procedures. The burden is on the proponent of the evidence to prove the general acceptance of both the underlying scientific principle of the test and procedures used to apply that principle to the facts of the case at hand. The trial judge has the sole discretion to determine this question and general acceptance must be established by a preponderance of the evidence. The authors describe in detail a hearing in a case in which they were all involved. One author (WQS) had researched and documented the original scientific methodology in the literature. The situation involved a car and tractor trailer crash with the two occupants of the car dying of multiple trauma, whereas the truck driver was not injured. Autopsy of the auto driver revealed multiple injuries with exsanguination, and only vitreous humor and liver tissue, but not blood, were tested for ethyl alcohol. The estate of the driver of the automobile brought suit against the owner of the trucking company for wrongful death. The plaintiff requested a Frye hearing to question the reliability of testing other body specimens to translate to probable blood alcohol level. The testimony, submitted documents, and eventual decision by the judge are discussed.