Random, Single Blindness Clinical Study Of Acupoint Catgut Embedding On Simple Obesity Patients

Purpose:Although there are many theses about using the acu-point catgut embedding to treat obesity, the rigorous clinical researches that exclude the placebo effect of acu-point catgut embedding for obese patients are still absent. This clinical trial was designed to eliminate the efficacy of acu-point catgut embedding for obesity if resulted from the placebo effect. The study expected to use the design of randomization and single-blind study to meet the modern requirement of evidence-based research approach in academic and practical field.Methods:This study utilized the purposive sampling. The investigation subjects were simple obese patients that came from Taipei County Hospital Chinese Medicine Clinics. The eligible outpatients consistent with this clinical trial and voluntary could enroll the project after signed the Taipei County Hospital Medical Ethics and Institutional Review Board - Informed Consent Form. The research site selected at Taipei County Hospital Banciao branch in Taiwan.The age of female subjects is from 18 to 65 years old, and their BMI must be more than 24 km/m2. The subjects were voluntary and could coordinate the study processing wholly. In addition, the test had to exclude the subjects that had the followed physiological conditions for their safety:endocrine diseases (thyroid, gonad, or pituitary dysfunction), heart diseases (cardiac arrhythmias, myocardial infarction, and heart failure, with pacemaker), immune and allergic diseases (Systemic Lupus Erythematosus, asthma, etc.), pregnancy, lactating, and six months postpartum female, without controlling weight with drugs (Chinese and Western medicine) within three months.All of the subjects were divided into experimental group (acu-point catgut embedding group) and control group (without acu-point catgut embedding) by randomization and single-blind. The experimental group was processed the treatment for two months and the control group was used placebo. The data of experimental group and control group during the two months was input to computer, and utilized the Excel, and SPSS software to compare the difference before and after of BMI and fat ratio between two groups.Results:The t-test for before and after treatment date of the experiment group showed that the BMI (t=2.901, P＜.05), and fat ratio (t=2.432, P<.05) were significant difference. To compared with the experiment group, the before and after treatment date of control group about BMI (t=.394, P>.05), and fat ratio (t=.362, P>.05) were not significant difference. The results indicated that the acu-point catgut embedding treatment had the significant efficacy of weight loss to weight and fat ratio for the obesity of BMI greater than 24. Conclusions:This clinical study could exclude the placebo effect of acu-point catgut embedding treatment and showed that the acu-point catgut embedding treatment could reduce weight significantly for the simple obesity. Furthermore, to compare the BMI and fat ratio of subjects between before and after treatment, both of them were significant difference.