改良酸枣仁汤治疗原发性失眠随机安慰剂对照试验

摘要

Objective:To evaluate the efficacy and safety of modified suanzaorentang,on primary insomnia over a period of 4 weeks on both subjective and objective sleep quality.Methods:A prospective,randomized,double-blind,placebo-controlled trial (RCT) involving 162 primary insomniac subjects (mean age 47 years,range 21 to 64 years;female:68.5％) was conducted at 2 university hospital sleep centers in Hong Kong.Among 162 subjects,86％ (n =139) completed the whole trial.Participants received either 4 weeks Chinese herbal formula (modified suanzaorentang group) or placebo by block randomization.Main outcome measures were subjective measures of sleep quality,and objective outcome measures including sleep onset latency,wake after sleep onset,sleep efficiency and sleep stages derived from polysomnography,and sleep variability from actigraphy.Results:After 4-week of treatment,the treatment group showed more improvement in subjective sleep quality as measured 100 mm visual analogue scales [deepness of sleep,95％ CI =-16.0(-22.1--9.9) vs.-7.1 (-13.3--1.0),P ＜ 0.05;refreshing sleep,95％ CI =-12.0(-18.2--5.8) vs.-2.2(-8.9-4.5),P ＜ 0.05] than placebo group.However,the two groups did not have any differences over the objective measures and the Insomnia Severity Index total score.No difference in overall adverse events was found between the two groups.Conclusion:The study shows that a short term (4 weeks) treatment of modified suanzaorentang could improve perceived sleep quality but not subjective sleep difficulty or objective sleep parameters.In particular,modified suanzaorentang has good safety profile and tolerability.%目的:酸枣仁汤作为传统古方已广泛用于失眠症,但对其疗效进行设计严格的研究却不多.本研究的目的是用主观和客观睡眠质量评价方法,对改良酸枣仁汤治疗原发性失眠的安全性和疗效进行为期4周的临床研究.方法:随机、双盲、安慰剂对照临床试验(临床研究注册号CUHK-CCT0087).162位原发性失眠患者(年龄21～64岁,平均47岁;女性占68.5％),在香港中文大学两所附属医院的睡眠中心接受治疗和评估,其中139人(86％)按计划完成全部治疗和评估.受试者随机分为两组,分别接受改良酸枣仁汤(每日2包,每包5g)或安慰剂治疗.采用主观睡眠质量(subjective measures)及客观睡眠(objective measures)评价各睡眠阶段指标的变化.结果:4周后,治疗组VAS (visual analogue scales)测试比安慰剂组明显改善[睡眠深度,95％ CI=-16.0(-22.1～-9.9)vs.-7.1(-13.3～-1.0),P＜0.05;恢复性睡眠,95％CI=-12.0(-18.2～-5.8)vs.-2.2(-8.9 ～4.5),P＜0.05].两组客观指标、失眠严重程度评分及不良反应发生率差异均无统计学意义(均P＞0.05).结论:短期服用改良酸枣仁汤可改善主观睡眠质量,但客观睡眠指标改善不明显.研究显示改良酸枣仁汤具有良好的安全性和耐受性.