Effects of Acupuncture on Body Mass Index in Overweight and Obese Women With Polycystic Ovary Syndrome (PCOS )

NCT ID: NCT04193371

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-06
• Study Completion Date: 2024-12-31

Brief Summary

This is a cross-sectional case-control study combined with a randomised controlled trial (RCT) study. This study aims to compare the effect of acupuncture, with usual care (lifestyle management) for weight control, with BMI (Body Mass index) as main outcome along with improvement of reproductive and metabolic dysfunction in overweight and obese women with PCOS, and further exploring the alteration of lipidomics, bile acid omics, proteomics and branched-chain amino acids between PCOS and the normal controls, and before and after the acupuncture treatment in different gourps.

Detailed Description

Polycystic ovary syndrome (PCOS) affects 6 to 18% of all women and is the most common female endocrine and metabolic disorder during the reproductive years. PCOS is characterized by anovulation, hyperandrogenism and metabolic dysfunction.Obesity is ~40% higher in women with PCOS than in healthy women. Overweight results in irregular cycles, insulin resistance and infertility. Acupuncture is assumed to reduce weight The overall hypothesis is that if the Body mass index (BMI) decreased, ovulation can be induced, hyperandrogenism decreased, and insulin sensitivity improved in these women. Although several treatment strategies have shown efficacy, importantly, there is a need for Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Therefore, the investigators aim to compare the effect of acupuncture, with usual care (lifestyle management) for weight loss, and improvement and prevention of reproductive and metabolic dysfunction in overweight and obese women with PCOS. We further compare the differences of PCOS and the controls with the methods of lipidomics, bile acid omics, proteomics and branched-chain amino acids, exploring the mechanisms of acupuncture on PCOS with this kind of methods.

Conditions

PCOS; Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

active acupuncture + lifestyle management

Participants in this group are treated by active acupuncture and lifestyle management for 4 months and follow up 4 months after the last treatment.

Group Type: EXPERIMENTAL

Active acupuncture

Intervention Type: OTHER

The rationale of the active acupuncture protocol is based on Western Medical Acupuncture theories and follows CONSORT and STRICTA protocols. All patients received acupuncture treatment for 30 minutes three times a week, with a maximum of 48 acupuncture treatments.

Lifestyle management

Intervention Type: OTHER

All women will receive lifestyle management before randomization after baseline measurements. The lifestyle management assisted by a PCOS lifestyle management system (Invention patent, ZL 2015 1 0500978.9).

All participants will get a step-counter for daily use and physical exercise diary for daily reporting of exercise: number of steps, type of activity, intensity and time (minutes). Once a week each participant receive a SMS in which they report the activity during the week.

control acupuncture + lifestyle management

Participants in this group are treated by control acupuncture and lifestyle management for four months and follow up 4 months after the last treatment.

Group Type: SHAM_COMPARATOR

Sham acupuncture

Intervention Type: OTHER

In the sham acupuncture protocol, 2 needles were inserted superficially to a depth of less than 5 mm, 1 in each shoulder and 1 in each upper arm at nonacupuncture and non-meridian points, and then, 4 needles were attached to electrodes and the stimulator was turned on to mimic the active acupuncture but with zero intensity, no electrical stimulation. They also received the treatment for 30 minutes three times a week and a maximum of 48 treatments.

Lifestyle management

Intervention Type: OTHER

All women will receive lifestyle management before randomization after baseline measurements. The lifestyle management assisted by a PCOS lifestyle management system (Invention patent, ZL 2015 1 0500978.9).

All participants will get a step-counter for daily use and physical exercise diary for daily reporting of exercise: number of steps, type of activity, intensity and time (minutes). Once a week each participant receive a SMS in which they report the activity during the week.

Interventions

Active acupuncture

The rationale of the active acupuncture protocol is based on Western Medical Acupuncture theories and follows CONSORT and STRICTA protocols. All patients received acupuncture treatment for 30 minutes three times a week, with a maximum of 48 acupuncture treatments.

Intervention Type: OTHER

Sham acupuncture

In the sham acupuncture protocol, 2 needles were inserted superficially to a depth of less than 5 mm, 1 in each shoulder and 1 in each upper arm at nonacupuncture and non-meridian points, and then, 4 needles were attached to electrodes and the stimulator was turned on to mimic the active acupuncture but with zero intensity, no electrical stimulation. They also received the treatment for 30 minutes three times a week and a maximum of 48 treatments.

Intervention Type: OTHER

Lifestyle management

All women will receive lifestyle management before randomization after baseline measurements. The lifestyle management assisted by a PCOS lifestyle management system (Invention patent, ZL 2015 1 0500978.9).

All participants will get a step-counter for daily use and physical exercise diary for daily reporting of exercise: number of steps, type of activity, intensity and time (minutes). Once a week each participant receive a SMS in which they report the activity during the week.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 20 to 40 years
• BMI≥ 24 to <40
• PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL.

Controls should have BMI>25to<40, regular cycles with 28 days±2 days and no signs of hyperandrogenism and PCO morphology on ultrasound

Exclusion Criteria

• Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L) thyroid dysfunction and hyperprolactinemia.
• Type I diabetes or not well controlled type II diabetes
• Pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months.
• Pregnancy or breastfeeding the last 6 months
• Acupuncture last 3 months
• Daily smoking and alcoholic intake

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

haolin zhang

Role: STUDY_DIRECTOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

PekingUTH TCM

Identifier Type: -

Identifier Source: org_study_id