hyperforin and Depressive-Disorder--Major

Hypericum extracts have been regarded as antidepressant drugs without specific side effects by patients, medical professionals and researchers alike. Recently there has been discussion about potential interactions between St. John's wort and other drugs.. To investigate the tolerability of Hypericum extract by comparing adverse event rates observed during clinical trials with the herbal drug to those observed under placebo and synthetic antidepressants.. A data review was performed based on the original data of three double-blind, randomised multicenter trials, during which 594 out-patients suffering from mild to moderate depression according to DSM-IV criteria received 3 x 300 mg/day Hypericum extract (WS 5570, WS 5572, WS 5573) or placebo over a double-blind treatment period of 6 weeks. For the polled data from the three trials, the risk ratios and risk differences versus placebo for single and grouped adverse events were determined along with their 95% confidence intervals. The data were inspected for relevant differences between Hypericum extract and placebo and were compared to trials involving the administration of several synthetic antidepressants.. For the polled data of the three trials, the percentage of patients with any adverse events under Hypericum extract exposition was comparable to placebo. The drug was also found to be devoid of effects of sedation, anticholinergic reactions, gastrointestinal disturbances and sexual dysfunction often found in patients treated with tricyclic antidepressants or selective serotonin reuptake inhibitors.. The analysis did not reveal any specific effects of Hypericum extract.

Topics: Antidepressive Agents; Bridged Bicyclo Compounds; Depressive Disorder, Major; Dose-Response Relationship, Drug; Double-Blind Method; Humans; Hypericum; Multicenter Studies as Topic; Phloroglucinol; Phytotherapy; Plant Extracts; Randomized Controlled Trials as Topic; Risk; Terpenes

A previously reported clinical trial of Hypericum perforatum (St John's wort) in depression did not demonstrate efficacy. We assessed treatment adherence by measuring plasma hyperforin and evaluated the possible impact of adherence on study results.. Outpatients with major depression (N = 340) were randomized to an 8-week trial of H. perforatum (900-1500 mg/d), sertraline (50-100 mg/d) as active comparator, or placebo. Plasma was available from 292 patients (86% of randomized). Samples from the placebo and H. perforatum groups were assayed for hyperforin, and samples from the sertraline group for sertraline/N-desmethyl-sertraline.. Of the 104 patients randomized to placebo, 18 (17%) had detectable plasma hyperforin. Of the 97 patients randomized to H. perforatum, 17 (17%) had no detectable plasma hyperforin. All the assayed sertraline patients (N = 91) had plasma sertraline/N-desmethyl-sertraline. The clinical trial conclusions remained unchanged when only patients with plasma assay consistent with random assignment were included in the analyses.. One of every 6 patients assigned to placebo had plasma hyperforin, and 1 of every 6 patients assigned to H. perforatum had no detectable plasma hyperforin. The finding underscores the difficulty of enforcing treatment adherence in clinical trials of preparations that are readily available in the community.

Topics: Adult; Biomarkers; Bridged Bicyclo Compounds; Chi-Square Distribution; Depressive Disorder, Major; Double-Blind Method; Female; Humans; Hypericum; Male; Middle Aged; National Institutes of Health (U.S.); Patient Compliance; Phloroglucinol; Statistics, Nonparametric; Terpenes; United States