Clinical Research On The Treatment Of Hypomenorrhea Of Kidney Deficiency With Self-prescribed Kidney-reinforcing And Essence-replenishing Decoction

ObjectiveThis study discusses the clinical efficacy and safety of the self-prescribed Kidney-reinforcing and Essence-replenishing Decoction in the treatment of hypomenorrhea of kidney deficiency and provides theoretical basis and objective proof for its clinical application and promotion.MethodsThe research objects are hypomenorrhea patients receiving treatment since January to November2011in the gynecological clinics of Traditional Chinese Medicine in Taiwan. Conduct TCM syndrome differentiation, and screen60cases in the type of kidney deficiency.The Treatment Group (30cases):Adopt self-prescribed Kidney-reinforcing and Essence-replenishing Decoction. Prescription:dodder15g, raspberry15g, prepared rhizome of rehmannia20g, fructus corni15g, angelica root10g, white peony root10g, Gold Theragran10g, solomonseal rhizome10g, placenta hominis15g, delegatined deerhorn15g, agallochum10g, caulis millettiae15g, incised notopterygium rhizome10g. Regimen:1dose per day decocted with warm water. Start after the menstruation stops until the next onset for3consecutive menstrual cycles. The Control Group:Catgut embedding therapy. Main acupoints:Qihai, Guanyuan, Zigong and Ciliao. Supplementing acupoints: adopt Shenshu for kidney deficiency, Geshu for blood deficiency, Guanyuanshu for blood coldness, Qihaishu for qi and blood stagnation, and Pishu for phlegmatic and dampness stagnation. Start treatment on the7th and20th day of the menstrual cycle. Treat twice each menstrual cycle for3consecutive menstrual cycles with6times of catgut embedding in total.Establish the criteria for total curative effect according to the Guiding Principles for Chinese Medicine New Drug Clinical Research issued by Ministry of Health, P. R. China. Cure:normal menstrual cycle and volume and disappearance of other symptoms. Excellence:basically normal menstrual cycle and volume and disappearance and relieve of other symptoms. Validity:changes in menstrual cycle and volume and relieve of other symptoms. Invalidity:no changes in menstrual cycle and volume.Statistics:After the clinical research, clinical material is timely summarized and input into the computer. Use EpiData3.01software to set up the database for data management.Use SPSS software for statistical analysis. The classified material is processed with x2inspection, the ranked sum data with two sample’s 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 test.ResuItsThe study participants are60qualified subjects,30cases in the Treatment Group and30in the Control Group. The total effective rate of the Treatment Group is higher than that of the Control Group. Comparing two groups’total curative effect, there’s significant difference and the curative effect of the Treatment Group is better than that of the Control Group. The clinical curative effect:the Treatment Group:the clinical cure rate is53.3%, the excellence rate is16.6%, the effective rate is20%, and the total effective rate is90%; The Control Group:the clinical cure rate is40%, the excellence rate is23.3%, the effective rate is16.6%, and the total effective rate is80%. Two groups’total effective rate comparison shows significant difference. After treatment, in terms of the improvement of clinical symptoms including menstruation volume (total), duration, menstruation color, menstruation quality, waist sore and knee weakness, burning sensation of five centers, dry stool and BBT abnormalities, the Treatment group is superior to the Control Group and the difference has statistical significance. No adverse reactions or toxic or side effects are observed during the trial in two groups. No abnormal change related to the medical treatment is found in blood and urine routines, the electrocardiogram examination and the liver and kidney function before and after treatment. This indicates the clinical application security of self-prescribed Kidney-reinforcing and Essence-replenishing Decoction. No adverse events are observed in two groups during the clinical trial.ConclusionIn the treatment of hypomenorrhea, the self-prescribed Kidney-reinforcing and Essence-replenishing Decoction has exact and confirmed curative effect. It’s safe without toxic or side effect. This provides theoretical basis and objective proof for its application and promotion.