An Exploratory Study About The Effect Of Reinhartdt And Sea Cucumber Capsule On Chronic Primary Insomnia

Objective：1. To investigate the differences between insomnia group andnormal control group about the polysomnography parameters;2.To explore theeffect of Reinhartdt and Sea Cucumber capsule in treating chronic insomnia.Methods:1.40primary insomnia outpatients, matched for age, sex, recruited38healthy persons without insomnia problems.To monitor two groupspolysomnography differences;2.A randomized double-blind controlled trial wasdesigned to compare the Reinhartdt and Sea Cucumber capsule and placebo inchronic insomnia patients. Patients from the Shanghai Mental Health Center withinsomnia problems.The total number was40, including20women,20men, withaverage age of46.80years, mean disease duration of6years. The study includedfour stages, as screen stage, import stage, double-blind treatment stage and exportstage. Screen stage: sign the standard informed consent.Import stage:3-7days,assess the Pittsburgh Sleep Quality Index Scale(PSQI), Hamilton Depression RatingScale(HAMD), Hamilton Anxiety Scale(HAMA), Life Events Scale(LES), InsomniaSeverity Scale(ISI), Eysenck Personality Questionnaire(EPQ), and2nightspolysomnogram tests. Double-blind treatment stage:3capsules,three times perday for4weeks, wrote sleep diary;at the end, scales rated and PSG monitored.Export stage:2-7days after treatment, evaluate the adverse reactions.Results:1.Two groups have significant differences in sleep process: total sleeptime (TST), sleep latency (SL), number of awakenings (NAW), wake after sleep-onset(WASO); sleep architecture: S2time, deep sleep S3, S4stage time, S4percent.ButREM latency has no significance between two groups;2. There is no significantdifferences in chronic insomnia group who using Reinhartdt and Sea Cucumbercapsule.No matter the objective PSG or subjective scales,like PSQI, ISI.The treatmenteffect is similar to placebo.Conclusion:1. Insomnia group and normal group have significant differences insleep process and architecture. Polysomnography can help to diagnose and assesssleep problems;2.Based on the current experiment, Reinhartdt and Sea Cucumbercapsule don,t have effects in treating chronic primary insomnia patients.The effect of Reinhartdt and Sea Cucumber capsule is similar to placebo.