Clinical Research On The Treatment Of Leukorrhagia Of Spleen Deficiency With Wandai Decoction

ObjectiveThis clinical control study discusses the clinical efficacy and safety of Wandai Decoction in the treatment of leukorrhagia of spleen deficiency.; Through the comparison with Baofukang Suppository (vaginal administration), the author observes the clinical curative effect of Wandai Decoction in the treatment of leukorrhagia of spleen deficiency. It is summarized from the comparison that TCM therapy is a better way for leukorrhagia treatment.MethodsThe subjects are leukorrhagia (spleen deficiency) patients treated in SUN Xiufeng’s TCM Clinic in Taiwan from February to November2011. The TCM diagnosis refers to the diagnosis standards for TCM Internal Medicine, Surgery, Gynecology and Pediatrics issued by State Administration of Traditional Chinese Medicine. The research objects are leukorrhagia patients of spleen deficiency who meet the inclusion criteria. Western Medicine inspection of vaginal excretion finds no pathogenic bacteria or inflammatory cells in these patients. Also, it is excluded the possibility that the reproductive system structural disease and vaginal foreign body stimulus cause the increase of leucorrhea. The TCM differentiation diagnosis and treatment refer to the Guiding Principles for TCM New Drug Clinical Research by ZHENG Xiaoyu, Theory and Practice of TCM by XIA Guicheng and Diagrams for TCM Gynecology by ZHANG Aifang. All of the patients’clinical manifestations meet the criteria of leukorrhagia of spleen deficiency of TCM:major symptoms:a large quantity or huge quantity of leucorrhea in white or light yellow with loose quality and without foul smell or with loose and sticky and continuous quality; white or yellow complexion, eat less, have loose stool, fatigue, tasteless, no sense of thirsty, not warm enough in four limbs, distension in face or four limbs, light tongue texture, fat tongue body or with teeth imprints, thin and white tongue moss and extenuate pulse. Tongue and pulse:light tongue texture, fat tongue body or with teeth imprints, thin and white tongue moss and extenuate pulse. Evaluate according to the symptom scoring method listed in Guiding Principles for TCM New Drug Clinical Research.The Treatment Group:Adopt modified Wandai Decoction. Prescription:radix codonopsitis30g, atractylodes macrocephala15g, white peony root15g, Chinese yam20g, atractylodes15g, orange peel10g, radix bupleuri10g, black f ineleaf schizonepeta herb15g, isapgol15g, licorice10g. Decoct one dose with water daily and take half in the morning and half in the afternoon. Start taking it after the menstruation stops.7days make1treatment course and take for3consecutive courses. The Control Group:Take Baofukang Suppository1piece (1.74g) for vaginal administration manufactured by Hainan Bikai Pharmaceutical Co., LTD. Take once daily after the menstruation stops.7days make1treatment course and take for3consecutive courses. At the end of the study, the clinical material is timely summarized and input into the computer. Set up a database with EpiData3.01software and use SPSS software for statistical analysis. Conduct statistical analysis and comparison of two groups’total clinical curative effect and curative effect of clinical symptoms and body signs and finally make an objective evaluation of clinical curative effect and its safety. Statistical methods:classified material is tested with x2inspection, ranked data comparison with Wilcoxon rank sum test (correction), two samples’mean differences with t test or Wilcoxon rank sum test and the self AP comparison with matching t test or Wilcoxon matching rank sum test. Statistical analysis is conducted with SPSS17.0statistical software.ResultsThe study has collected60qualified cases with30cases in the Treatment Group and30in the Control Group. For the total effective rate, the Treatment Group is superior to the Control Group.Two groups’total curative effect comparison shows significant difference and the Treatment Group has better curative effect than the Control Group.After treatment, the two groups’syndrome scores decrease and the Wandai Decoction Group has significant decrease and the difference has statistical significance (P<0.05). Among the30cases in the Wandai Decoction Group,21 are of full recovery,6of excellence,3of validity,0of invalidity, the total effective rate100%, the full recovery rate70.0%, the full recovery and the excellence rate90.0%. Among the30cases in the Control Group,2are of full recovery,5of excellence,9of validity,14of invalidity, the total effective rate53.3%, the full recovery rate6.7%, the full recovery and the excellence rate23.3%. There’s statistical significance (P<0.01) in the comparison of two groups’curative effect and total curative effect. This indicates that in aspects of the improvement of TCM syndromes, Wandai Decoction has more obvious curative effect than Baofukang Suppository (vaginal administration). Wandai Decoction Group also has better curative effect than the Control Group in improving the color, quality and quantity of patients’luekorrhea.In the course of the study, conduct safety testing before and after treatment of patients’blood and urine and stool routines, kidney and liver function, and electrocardiogram routine and no abnormality is found. This shows that the therapy has clinical application security and has its clinical promotion and research value.To summarize the observation results mentioned above, in terms of clinical symptom improvement and TCM syndrome curative effect, the comparison of Wandai Decoction Group and the Control Group shows significant difference (.P<0.05) This indicates that Wandai Decoction Group has confirmed clinical curative effect without toxic or side effects. This may be furthur researched and promoted in clinical service.ConclusionIn terms of clinical symptom improvement and TCM syndrome curative effect, the comparison of Wandai Decoction Group and the Control Group shows significant difference. This indicates that Wandai Decoction Group has confirmed clinical curative effect.Wandai Decoction can tonify the spleen, tooth the liver, remove the dampness, stop leucorrhea, inhibit bacteria and increase immunity, thus in terms of curing the Traditional Chinese Medicine syndromes, it has quite good curative effect.No obvious damage to liver and kidney function and blood system is found in the research. Wandai Decoction has clinical application security. It may be furthur promoted in clinical service.