Clinical Research On The Treatment Of Menopausal Sleep Disorder Of Liver Stagnation With Modified Bupleurum, Keel And Ostreae Decoction

ObjectiveThis clinical study discusses the clinical curative effect and safety of Bupleurum, Keel and Ostreae Decoction to treat menopause sleep disorders of liver stagnation, explores the effective and safe method for menopause sleep disorder treatment with Chinese herbal medicine and expects furthur standardizing the clinical curative effect and achieving good social benefits.MethodsThe research objects:60menopause syndrome patients treated from January to December2011in Taiwan Chinese Medicine gynecology clinics with TCM syndrome differentiation of liver stagnation and Western Medicine diagnosis of sleep disorder of menopause syndrome. The participants are randomly classified into the Treatment Group (30cases, Modified Bupleurum, Keel and Ostreae Decoction Group) and the Control Group (30cases, Stagnation Soothing and Nerve Calming Decoction Group).10days make1treatment course and make statistical analysis of the curative effect after3treatment courses. Evaluate the clinical efficacy from the sleeping time score and the symptom improvement degree. Evaluate its safety from aspects of blood and urine routines, liver and kidney function and cardiogram examination.Therapy:the Treatment Group:Adopt the modified Bupleurum, Keel and Ostreae Decoction:bupleuri9g, prepared rhizome pinelliae with juice of rhizima zingiberis recens9g, raw keel30g, raw oysters30g, scutellaria10g, radix codonopsitis10g, hoelen10g, prepared radix et rhizome rhei with wine10g, raw licorice root6g, raw ginger3pieces, and red jujube5pieces. The Control Group:Adopt Stagnation Soothing and Nerve Calming Decoction:albiziae cortex30g, caulis polygoni multiflori30g, lily20g, jujube seed20g, bupleuri radix10g, turmeric root-tuber10g, gardenia10g, biotae semen10g, rehmannia dride rhizome10g, gastrodia elata10g, corydalis tuber10g, angelica10g, corium stomachium12g, stir-baking fructus hordei germinatus et crataegi et massa fermentata medicinal is12g, rhynchophylla12g, toosendan fructus9g.10days make a period of treatment. Stop administration temporarily during menstruation. After3courses, conduct statistical analysis of the curative effect.Observatory indexes:Adopt PSQI and Menopausal Symptom Evaluation Scale. After the clinical research, the clinical material is timely summarized and input into the computer. Use EpiData3.01software to set up a database for data management.Statistical methods:Classified material is processed with x2inspection, the ranked data with Wilcoxon rank sum inspection (correction), two samples’ mean differences with t test or Wilcoxon rank sum inspection, and the self AP comparison with matching t test or Wilcoxon matching rank sum inspection. Statistical analysis is made with SPSS17.0statistical software.ResultsThe study participants are60qualified cases, with30in the Treatment Group, and30in the Control Group. In the analysis of the baseline characteristics comparability comparison, the difference has no statistical significance (P>0.05) in the comparison of the Treatment Group’s and the Control Group’s age, gender, course of illness and PSQI total score, indicating the comparability of two groups’baseline characteristics.The total curative effective rate of the Treatment Group is96.67%and that of the Control Group is86.67%and the difference has statistical significance (P<0.05).PSQI includes7parts:hour of sleep, hour of falling asleep, daytime function, sleeping quality, sleeping efficiency and sleeping disorders. By intragroup comparison, two groups’difference with self AP comparison shows statistical significance (P<0.05), indicating that two groups can both effectively improve patients’sleeping. By the intergroup comparison, the Treatment Group is superior to the Control Group in evaluation of hour of sleep, daytime function, sleeping quality and sleeping disorders and the difference shows statistical significance (P<0.05). Two groups have close curative effect in other aspects and the difference has no statistical significance (P>0.05). No abnormality is found in blood and urine routines, liver and kidney function and cardiogram examinations of two groups before and after treatment.ConclusionIn the treatment of menopause sleep disorder of liver stagnation, the Bupleuri, Keel and Ostreae Decoction can improve patients’sleeping quality, shorten the time of falling asleep, prolong the sleeping time, improve the sleeping efficiency and relive the sleeping disorders and enhance the daytime function. The Treatment Group is superior to the Control Group (Stagnation Soothing and Nerve Calming Decoction) in improving the sleeping hour, relieving sleeping disorders and enhancing sleeping quality and daytime function. It’s safe and reliable with no toxic or side effect. Therefore it’s worthy of clinical application.Expectation:Due to the limit of time, personnel and facilities, the conclusion of this research still needs the confirmation of large-sample and multi-center investigation. The author hopes to conduct the multi-angle, multi-discipline and multi-level in-depth study on sleeping disorders of menopause syndrome patients and explore an effective therapy to furthur improve the curative effect and relieve pain for patients.