Valerian-hops combination and diphenhydramine for treating insomnia: a randomized placebo-controlled clinical trial

摘要: Context Insomnia is a prevalent health complaint associated with daytime impairments, reduced quality of life, and increased health-care costs. Although it often self-treated herbal dietary supplements or over-the-counter sleep aids, there still little evidence on the efficacy safety those products. Objective To evaluate valerian-hops combination diphenhydramine for treatment mild insomnia. Design setting Multicenter, randomized, placebo-controlled, parallel-group study conducted in 9 disorders centers throughout United States. Patients A total 184 adults (110 women, 74 men; mean age 44.3 years) Interventions (1) Two nightly tablets standardized extracts valerian (187-mg native extracts; 5-8:1, methanol 45% m/m) hops (41.9-mg 7-10:1, 28 days (n = 59), (2) placebo 65), (3) 2 (25 mg) 14 followed by 60). Outcome measures Sleep parameters measured daily diaries polysomnography, clinical outcome ratings from patients physicians, life measures. Results Modest improvements subjective were obtained both diphenhydramine, but few group comparisons reached statistical significance. Valerian produced slightly greater, though nonsignificant, reductions latency relative to at end greater than treatment. Diphenhydramine significantly increases efficiency trend time during first There was no significant difference any continuity variables polysomnography. In addition, alteration stages 3-4 rapid eye movement treatments. groups rated their insomnia severity lower Quality (Physical component) more improved days. residual effects serious adverse events either rebound following discontinuation. Conclusions The findings show modest hypnotic effect placebo. are life. Both treatments appear safe did not produce upon discontinuation this study. Overall, these indicate that might be useful adjuncts