| ObjectiveThe study intends to explore the clinical efficacy and safety of Pill of Anemarrhena, Phellodendron and Rehmannia in the treatment of preceeded menorrhea and provide scientific basis for its clinical application.MethodsThe research objects are90patients of preceeded menorrhea receiving treatment from Taiwan Kangcheng TCM Clinic from January2010to December2011. They are classified as kidney deficiency and blood heat in TCM syndrome differentiation and irregular menstruation (polymenorrhea) in Western Medicine.90cases are randomly divided into two groups:Group of Modified Pill of Anemarrhena, Phellodendron and Rehmannia (45cases) and Liangdi Decoction Control Group (45cases). The treatment courses are both3menstruation cycles for two groups. Evaluate the clinical curative effect from patients'menstruation cycles, menstruation volume, color, quality and other major symptoms and body signs. Evaluate its safety from the analysis of blood, urine, stool, liver and kidney function and cardiogram, etc.Administration method:Patients in the Treatment Group orally take Pill of Anemarrhena, Phellodendron and Rehmannia (Taiwan scientific TCM products) twice a day with20g each time. Take it after mixing with water. Stop administration during menstruation.3menstruation cycles make1treatment course. Accompanying symptoms and signs may occur during preceeded menorrhea, therefore asthenic fever and sthenic fever, yin deficiency and yang predominance often coexist. Medicine may be modified at different periods of menstruation cycles. The Control Group:Take Liangdi Decoction (Taiwan scientific medicine products, powder). Basic prescription for the medicine: rehmannia dried rhizome, figwort root, ophiopogonis tuber, white peony root, lycium bark, medicinal glue. Take twice a day with20g each time. Take after mixing with water. Its modification is the same as the Treatment Group. Stop administration during menstruation.3menstruation cycles make1treatment course. No other drugs for preceeded menorrhea treatment are allowed to use in both groups during treatment.Conduct efficacy and safety evaluation after1treatment course for two groups. Scoring is adopted for evaluation. At the same time record the value of each parameter.Statistical method:Use Epi Data3.01software to process the clinical material. The ranked data is processed with Wilcoxon rank sum test (correction), the classified material with%test, two samples'average with t test or Wilcoxon rank sum test, AP comparison with t test or Wilcoxon pairing rank sum test. The analysis is conducted with SPSS17.0software. The statistical graph is made by Graphd Prism4.03software.ResultsThe study has90qualified subjects,45cases in the Treatment Group (Modified Pill of Anemarrhena, Phellodendron and Rehmannia Group) and45in the Control Group (Liangdi Decoction Group). The treatment courses of two groups both consist of three menstrual cycles. For the Treatment Group, the recent clinical cure rate is46.58%, the excellence rate is24.38%, the effective rate is20.0%and the total effective rate is91.20%; for the Control Group, the recent clinical cure rate is35.47%, the excellence rate is33.33%, the effective rate is17.7%and the total effective rate is86.7%. The comparison of two groups'total curative effect shows significant difference (P<0.05)Safety test indicates that the analysis of blood, urine, stool, kidney and liver function, electrocardiogram shows no abnormal changes before and after treatment which indicates the safety for clinical application and no obvious toxic side effects.Administering drugs for3menstruation cycles, the author finds BBT double-phase tendency appears in both the2groups. However, the improvement in the Treatment Group is significantly greater than that of the Control Group and there's statistically significant difference (P<0.05). After treatment, two groups'clinical syndromes are improved at certain degrees. The score records decrease in both groups and the difference is statistically significant (P<0.05).Conelus ionUsing the modified Pill of Anemarrhena, Phellodendron and Rehmannia to treat the preceeded menorrhea in the type of kidney deficiency and blood heat has exact curative effect. It's safe and atoxic. This provides theoretical basis for its clinical application and promotion. However, its functioning mechanism still needs to be furthur investigated. |