Efficacy of Kun'anle Decoction Combined with Femoston in the Treatment of Perimenopausal Women with Sleep Disorder:A Randomized Controlled Trial
Objective To evaluate the efficacy of Kun'anle Decoction(KD)combined with Femoston for perimenopausal patients with sleep disorder.Methods A total of 267 perimenopausal outpatients with sleep disorder at Climacteric Clinic,Second Affiliated Hospital of Zhejiang Chinese Medical University and Hangzhou Women's Hospital were enrolled in the study.And 150 patients met the inclusion criteria and were assigned to 3 groups(Chinese medicine group,Western medicine group,integrative medicine group)using random number table,50 cases in each group.Patients in Chinese medicine group took KD.Those in Western medicine group took Femoston.Those in integrative medicine group took both KD and Femoston simultaneously.After 3 months of treatment,Pittsburgh Sleep Quality Index(PSQI),modified Kupperman index,blood glucose,liver function[alanine aminotransferase(ALT)and aspartate aminotransferase(AST)],renal function(creatinine,Cr),blood lipids[triglyceride(TG),total cholesterol(TC),high density lipoprotein-cholesterol(HDL-C),low density lipoprotein-cholesterol(LDL-C)],and sex hormone levels[follicle stimulating hormone(FSH),luteinizing hormone(LH),estradiol(E2)]were compared among 3 groups.Results Totally 142 patients completed follow-ups,including 46 in Chinese medicine group,48 in Western medicine group,and 48 in integrative medicine group.After 3 months of treatment the PSQI decreased in the 3 groups.Compared with the other 2 groups,patients in integrative medicine group slept faster,awoke later,had less nighttime awakenings and longer total sleep time(P<0.05).Each symptom score and total scores in modified Kupperman index were lower than those before treatment.The scores of hectic fever,insomnia,irritability,and fatigue decreased more in integrative medicine group(P<0.05).Blood glucose and TC decreased in the 3 groups(P<0.05).But HDL-C level increased significantly in Chinese medicine group and integrative medicine group with statistical difference(P<0.05).Levels of FSH and LH decreased and E2 level increased(P<0.05),but with no significant differences among the 3 groups(P>0.05).Conclusion The treatment of KD combined with Femoston effectively relieved discomfortable perimenopausal sleep disorders.
perimenopausal periodsleep disorderKun'anle DecoctionFemostonChinese herbal compoundintegrative medicine