A Randomized Controlled Trial of Acupuncture for Insulin Resistance in Patients With Polycystic Ovary Syndrome

Department of Traditional Chinese Medicine (TCM), Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing 100191, China.

To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture plus lifestyle management (treatment group), 2) placebo plus lifestyle management (control group) in the treatment of insulin resistance in PCOS patients.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome (PCOS)
• Intervention / Treatment: Device: acupuncture; Device: Sham acupuncture; Other: lifestyle intervention

Detailed Description

A prospective, randomized controlled trial design was used to select women with polycystic ovary syndrome as the research subjects. 144 subjects who met the inclusion and exclusion criteria were randomly divided into an acupuncture plus lifestyle intervention group (treatment group) and a placebo plus lifestyle intervention group (control group). The differences in glucose metabolism and reproductive endocrinology were compared between the two groups.

1. To verify the efficacy and safety of acupuncture intervention on insulin resistance in PCOS;
2. To explore the effects of acupuncture on androgen and lipid levels, ovarian function, reproductive dysfunction, mood and quality of life in women with PCOS.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• For the PCOS group, 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

Exclusion Criteria:

1. 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.
2. Type I diabetes or not well controlled type II diabetes
3. Stage 2 hypertension (resting blood pressure ≥160/100mmHg)
4. Psychiatric diagnoses or using psychiatric medications including antidepressants
5. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: control group; sham acupuncture	Device: Sham acupuncture; Sham acupuncture; Other: lifestyle intervention; lifestyle intervention
Experimental: Experimental group; acupuncture	Device: acupuncture; acupuncture; Other: lifestyle intervention; lifestyle intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HOMA-IR	calculation of HOMA-IR: [fasting insulin (μU/mL) × fasting glucose (mmol/L)] / 22.5) [Time Frame: Baseline]	baseline and after 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hirsutism(FG score >4）, acne and early alopecia	general condition	baseline and after 4 months
AUC insulin	during oral glucose tolerance test (OGTT), AUCarea under the glucose tolerance curve	baseline and after 4 months
Follicle stimulating hormone (FSH)	Examined with the blood sample	baseline and after 4 months
luteinizing hormone (LH)	Examined with the blood sample	baseline and after 4 months
Progestin (P)	Examined with the blood sample	baseline and after 4 months
Estrogen (E2)	Examined with the blood sample	baseline and after 4 months
Prolactin (PRL)	Examined with the blood sample	baseline and after 4 months
Androgen(T)	Examined with the blood sample	baseline and after 4 months
Anti-mullerian hormone (AMH)	Examined with the blood sample	baseline and after 4 months
Sex hormone-binding globulin (SHBG)	Examined with the blood sample	baseline and after 4 months
Free testosterone index (FAI)	testosterone (nmol/ml) ×100 / SHBG (nmol/ml).	baseline and after treatment
total cholesterol	Examined with the blood sample	baseline and after 4 months
triglycerides	Examined with the blood sample	baseline and after 4 months
high density lipoprotein (HDL)	Examined with the blood sample	baseline and after 4 months
low density lipoprotein (LDL)	Examined with the blood sample	baseline and after 4 months
Bile acidomics	Quantitative detection of bile acids in blood and feces by targeted metabolomics (ultra-performance liquid chromatography-time-of-flight mass spectrometry).	baseline and after 4 months
Metagenomics and 16S rDNA sequencing analysis	gDNA was extracted by fecal genomic DNA kit and sequenced by Illumina Hiseq 4000.	baseline and after 4 months
short form-36 (SF36)	determine the health quality of life by the questionnaire of SF36 (0-100 score), the higher, the better	baseline and after 4 months
Self-Rating Anxiety Scale (SAS)	determine the anxiety level with the questionnaire of SAS (20-100 score), the higher, the worse.	baseline and after 4 months
Self-Rating Depress Scale (SDS)	determine the depress level with the questionnaire of SDS (20-100 score), the higher, the worse	baseline and after 4 months
polycystic ovary syndrome questionnaire, PCOSQ	Mood, weight, body hair, acne, infertility, menstrual symptoms, and menstrual predictability in women with PCOS	baseline and after 4 months
BMI	calculation:BMI=weight(kg)/height(m)^2	baseline and after 4 months
Fat%	examined by body composition analyzer	baseline and after 4 months
waist to hip ratio(WHR)	calculation of WHR: waist circumference(cm)/ hip circumference(cm)	baseline and after 4 months
glycosylated hemoglobin level	Examined with the blood sample	baseline and after 4 months
ovarian size	baseline and after 4 months, explained by 3 diameters: length(cm) * width(cm) * height(cm)	baseline and after 4 months
number of follicles	observed by B-ultrasound	baseline and after 4 months
uterine size	observed by B-ultrasound	baseline and after 4 months
endometrial thickness	observed by B-ultrasound	baseline and after 4 months

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Director: haolin zhang, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: insulin resistance
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Pathologic Processes; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Disease; Genital Diseases, Female; Glucose Metabolism Disorders; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Hyperinsulinism; Ovarian Cysts; Cysts; Syndrome; Polycystic Ovary Syndrome; Insulin Resistance
• Other Study ID Numbers: PKUTH TCM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We haven't decided whether to share the data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No