Efficacy of Acupunture on Menstrual Frequency in Women With Polycystic Ovary Syndrome: Protocol for a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 172
- 主要终点
- The proportion of participants who have at least a 50% increase from baseline in monthly menstrual frequency
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is a dysfunction of endocrine system of women of reproductive age. Approximately 5%-10% women in China have this syndrome. Irregular menstruation (oligomenorrhea or amenorrhea), hirsutism and obesity are the common clinical manifestations of PCOS. The aim of this study is to evaluate the efficacy of acupuncture in improving the menstrual frequency of PCOS patients who do not have fertility requirements.
详细描述
Methods: A total of 172 participants diagnosed with polycystic ovary syndrome would be randomly assigned to either the acupuncture group or sham-acupuncture group, at a ratio of 1:1. Participants in both groups will receive treatment for 12 weeks, three times a week. The primary outcome will be the proportion of participants with at least a 50% increase from baseline in the monthly menstrual frequency from baseline after 12 weeks intervention, while secondary outcomes will be the difference in anthropometrics, serum hormone level, ovarian morphology, anxiety and depression, and quality of life from baseline to after 12 weeks intervention and to 12 weeks post-intervention follow-up between groups.
Discussion The aim of this study is to evaluate the efficacy and safety of acupuncture for improving menstrual frequency and other symptoms of patients with PCOS. The limitation of this trial is that it would be difficult to blind the acupuncturists. Additionally, these findings may not be suitable for women with PCOS who are seeking pregnancy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants fulfilling any one of the following criteria will be excluded. Participants who fulfill the following criteria will be included.
- •Participants meet the Rotterdam diagnostic criteria with oligomenorrhea or amenorrhea. (Oligomenorrhoea is defined as an intermenstrual interval of >35 days or <8 menstrual bleedings in the past year. Amenorrhoea is defined as absent menstrual bleeding or no menstrual bleeding in the previous 90 days.)
- •Participants who have at least two of the following features that meet the Rotterdam diagnostic criteria:
- •Clinical or biochemical hyperandrogenism: Biochemical hyperandrogenaemia is defined as a total serum testosterone concentration above normal threshold, and/or clinical hyperandrogenism is defined as a Ferriman-Gallwey (FG) score of ≥5 or acne defined by the Global Acne Grading System (GAGS) as "mild"/ "moderate"/ "severe"/ "very severe".
- •Polycystic ovary morphology is defined as the presence of ≥12 follicles in each ovary measuring 2-9 mm in diameter and/or an ovarian volume >10 mL on transvaginal ultrasound.
- •Participants who are between 18 to 40 years old.
- •Participants who joined the research and provided a signed informed consent voluntarily.
排除标准
- •Participants with fertility requirements.
- •Participants with oligomenorrhea or amenorrhea caused by hyperandrogenemia, premature ovarian failure, or hypothalamus or pituitary disorders.
- •Participants with hyperandrogenism caused by congenital adrenal hyperplasia, Cushing's syndrome and androgen-secreting tumors.
- •Participants with endocrine disorders such as thyroid dysfunction, adrenal disorders, hyperprolactinemia and diabetes mellitus.
- •Participants with severe heart disease, hepatic disease, renal system and hematopoietic system disease, or malnutrition of the whole body.
- •Participants who use hormones or other medications that would affect reproductive function, or received the same protocol of this study in the past three months.
结局指标
主要结局
The proportion of participants who have at least a 50% increase from baseline in monthly menstrual frequency
时间窗: Months 3
Baseline monthly menstrual frequency was calculated through the number of menstrual bleeds in three months before intervention divided by three. Monthly menstrual frequency from baseline to three months was calculated through the number of menstrual bleeds during the three month-intervention divided by three.
次要结局
- Change in menstrual frequency(Months 6)
- Change in hirsutism(Months 3 and 6)
- The change in progesterone (Prog) from baseline(Months 3 and 6)
- The change in the number of follicles <9 mm from baseline(Months 3 and 6)
- Change in acne(Months 3 and 6)
- The change in measurements for body mass index (BMI) from baseline(Months 3 and 6)
- The change in measurements for waist-hip ratio (WHR) from baseline(Months 3 and 6)
- The change in serum luteinizing hormone (LH) from baseline(Months 3 and 6)
- The change in follicle stimulating hormone (FSH) from baseline(Months 3 and 6)
- The change in LH/FSH ratio from baseline(Months 3 and 6)
- The change in prolactin (PRL) from baseline(Months 3 and 6)
- The change in dehydroepiandrosterone (DHEA) from baseline(Months 3 and 6)
- The change in androstenedione (AND) from baseline(Months 3 and 6)
- The change in mean difference in ovary volume from baseline(Months 3 and 6)
- The change in testosterone (T) from baseline(Months 3 and 6)
- The change in estrogen (E) from baseline(Months 3 and 6)
- The change in sex-hormone binding globulin (SHBG) from baseline(Months 3 and 6)
- The change in thickness of the endometrium from baseline(Months 3 and 6)
- Change in quality of life(Months 3 and 6)
- Change in anxiety and depression(Months 3 and 6)
研究者
Zhou Jing
Department of Acupuncture, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences