Acupuncture in the Regulation of Dai Meridian for Polycystic Ovarian Syndrome Patients With Abdominal Obesity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- rate of recovered ovulation
研究概览
简要总结
The purpose of this study is to determine whether the use of electroacupuncture to dredge and regulate Dai Meridian combined with lifestyle modification are more effective than lifestyle modification only in the treatment of anovulation and hyperandrogenism due to polycystic ovary syndrome (PCOS) with abdominal obesity.Two thirds of participants will receive electroacupuncture and lifestyle modification in combination, while the other one third will receive lifestyle modification only.
详细描述
Obesity, especially abdominal obesity, is one of most common clinical features of polycystic ovary syndrome, a widely and seriously influenced complex disorder related to reproduction and metabolism. Excessive accumulation of adipose tissue in the abdominal organs often leads to insulin resistance, which will increase the harm of hyperandrogenism and exacerbate ovulation disorders and metabolic abnormalities.
Weight loss, likely beneficial for both reproductive and metabolic dysfunction in this setting , has been generally recommended as a first-line therapy for obese women with PCOS and can be accomplished via lifestyle modification and electroacupuncture. What's more, stimulating acupoints of Dai Meridian can regulate menstrual cycles and treat infertility according to the theory of traditional Chinese medicine. However, how much benefits patients will additionally get from the Combined therapy is not clear now.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Polycystic Ovarian Syndrome.
- •Clinical diagnosis of abdominal obesity.
- •Agree to participate in clinical trials.
排除标准
- •Endocrine or neoplastic causes of amenorrhoea, anovulation and hyperandrogenemia, including central nervous system abnormalities, premature ovarian failure, thyroid disease, Cushing's syndrome,androgen secreting tumors, congenital adrenal hyperplasia, and hyperprolactinaemia.
- •Patients suffering from other serious diseases(cardiocerebrovascular diseases, damage to the function of liver and kidney, and mental illness).
- •Patients taking hormonal and metabolic drugs within 12 weeks of study entry affecting the judgment of results.
- •Pregnant or breast feeding.
研究组 & 干预措施
acupuncture & lifestyle modification
Electro-acupuncture is given three times a week with diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks.
干预措施: electroacupuncture (Device)
acupuncture & lifestyle modification
Electro-acupuncture is given three times a week with diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks.
干预措施: lifestyle modification (Behavioral)
lifestyle modification
diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks
干预措施: lifestyle modification (Behavioral)
结局指标
主要结局
rate of recovered ovulation
时间窗: 12 weeks
the proportion of patients who have ovulation after treatment
次要结局
- LH(12 weeks)
- quantity of menstruation(12 weeks)
- Serum total testosterone (T)(12 weeks)
- evidence of clinically definite hyperandrogenism confirmed by mF-G score(12 weeks)
- evidence of clinically definite hyperandrogenism confirmed by the Global Acne Grading System(12 weeks)
- frequency of menstruation(12 weeks)
- FSH(12 weeks)
- ovarian volume measured by ultrasound(12 weeks)
- follicle number pre ovary measured by ultrasound(12 weeks)
- ovarian stromal blood flow measured by ultrasound(12 weeks)
- body weight in kilograms(4, 8 and 12 weeks)
- waist circumference in centimeter(4, 8 and 12 weeks)
- BMI in kg/m^2(4, 8 and 12 weeks)
- waist-to-height ratio(4, 8 and 12 weeks)
- Fasting serum PAI-1 level(12 weeks)
- International physical activity scale (IPAQ) short version(4, 8 and 12 weeks)
研究者
Hui Hu
Director,clinical research
Dongfang Hospital Beijing University of Chinese Medicine