Ye Ren, Yuan Zhengzhong, Dai Chunxiu, Li Wei, Song Xiuhua, Cheng Zhiqing, Hu Wanhua, Lin Yan, Wang Xiaoyun, Sun Shuchen, He Jincai
The First Affiliated Hosptial of Wenzhou Medical College, Wenzhou 325000, China.
Zhongguo Zhong Yao Za Zhi. 2011 Aug;36(16):2285-9.
To appraise the clinical efficacy, safety and compliance of the intervention of spleen-restoring decoction combined with dormancy hygiene education and the intervention of spleen-restoring decoction alone on sub-healthy insomnia of deficiency of both the heart and spleen pattern.
Study design took multi-centers, blind and randomized control trial, 107 participants with sub-healthy insomnia of deficiency of both the heart and spleen pattern were assigned to A group (52 cases) which was treated with the intervention of spleen-restoring decoction combined with dormancy hygiene education and B group (55 cases) which was treated with the intervention of spleen-restoring decoction single, compared by efficacy, PSQI score, CGI score, WHOQOL-BREF score and security.
The efficacy of two group was 79.58%. There was no significant different between them. The PSQI scores before treatment was (11.80 +/- 2.08) and which afer treatment was (6.78 +/- 2.84) of A group. The PSQI scores before treatment was (11.61 +/- 2.00) and which afer treatment was (6.73 +/- 2.27) of B group. There was significant difference in PSQI scores both A group and B group after treatment (P < 0.01); the results of CGI score and WHOQOL-BREF score before and after measurement showed the same as PSQI. There were no significant difference between two groups in all scores after treatment and there was no interaction between time pots and treatment factors . Withdrawal reaction analysis: comparing CGI after withdraw 2 weeks and at the end of treatment course, there was no significant difference between two groups. The same result was in comparison among groups.
Both the intervention of spleen-restoring decoction integrating with dormancy hygiene education and spleen-restoring decoction had obvious clinical efficacy on treating subhealthy insomnia of deficiency of both the heart and spleen pattern, and had high compliance and safety. The intervention of spleen-restoring decoction integrating with dormancy hygiene education showed no better clinical efficacy than spleen-restoring decoction did.
评价归脾汤联合睡眠卫生教育干预与单纯归脾汤干预对心脾两虚型亚健康失眠的临床疗效、安全性及依从性。
采用多中心、盲法、随机对照试验，将107例心脾两虚型亚健康失眠患者分为A组（52例），采用归脾汤联合睡眠卫生教育干预；B组（55例），采用单纯归脾汤干预，比较两组疗效、PSQI评分、CGI评分、WHOQOL-BREF评分及安全性。
两组总有效率均为79.58%，组间比较差异无统计学意义。A组治疗前PSQI评分为（11.80±2.08）分，治疗后为（6.78±2.84）分；B组治疗前PSQI评分为（11.61±2.00）分，治疗后为（6.73±2.27）分。两组治疗后PSQI评分比较差异有统计学意义（P<0.01）；CGI评分和WHOQOL-BREF评分治疗前后变化与PSQI评分相似。两组治疗后各评分组间比较差异无统计学意义，且时间因素与治疗因素无交互作用。撤药反应分析：停药2周后与疗程结束时CGI评分组间比较差异无统计学意义，组内比较结果相同。
归脾汤联合睡眠卫生教育干预与单纯归脾汤干预治疗心脾两虚型亚健康失眠均有明显临床疗效，且依从性及安全性高。归脾汤联合睡眠卫生教育干预临床疗效并不优于单纯归脾汤干预。
