title: Subjective and polysomnographic evaluation of a herbal preparation in insomnia.
abstract: In the present study a polyherbal preparatian was evaluated for clinical efficacy and safety in insomnia by subjective and Polysomnographic method. Thirtynine patients were included. After placebo run-in period, 2 tablets of the test formulation were given daily at bed time for 21 days. Sleep parameters - onset, duration, number of awakenings, quality and daytime hangover were recorded on a diary card. Before and after treatment with the test drug, computerised polysomnography was performed to record sleep parameters - total sleep time, sleep latency, efficiency and wake period. During the course of treatment with active drug, incidence of side effect was noted. The present herbal preparation produced significant improvement in sleep parameters. In most of the patients total sleep was significantly increased. Mean total sleep time was increased from 344 ±11.4 min to 403 ±11.2 min (p<0.001). There [was significant reduction in mean sleep latency from 40 ± 4.3 min to 29 ± 3.2 min (p<0.001) and similarly, mean number of nocturnal awakening decreased from 1.6 ± 0.12 to 1.03 ± 0.08 (p<0.001). The subjective improvement was correlated with Polysomnographie parameters. Total sleep time increased from 204 ± 31 min to 262 ± 38.6 min. Wake period during sleep reduced from 275 ± 23 min to 191 ± 38 min and the persistence sleep latency from 85 ± 23 to 24 ± 5.7 min. The sleep efficiency improved from 42 ± 5.7%, to 57 ± 6.6% with herbal formulation. The sleep period from stage I-IV increased from 43 ±2.8% to 54 ±4.1%. There was improvement in sleep quality score from 1.5 ± 0.04 to 1.8 ± 0.04. Test drug did not produce any feeling of hangover or day time sleeplessness, 11 patients complained mild epigastric distress after test drug. It can be concluded that the herbal formulation has good hypnotic activity and can be used in insominia.
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Hyderabad, India.
authors.forename: P
authors.initials: P
authors.lastname: Usha Rani
authors.forename: M U
authors.initials: MU
authors.lastname: Naidu