How does acupuncture affect insulin sensitivity in women with polycystic ovary syndrome and insulin resistance? Study protocol of a prospective pilot study.
BACKGROUND
Hyperinsulinaemia and insulin resistance (IR) are key features of polycystic ovary syndrome (PCOS) and metabolic syndrome. The effect of 5 weeks of acupuncture treatment has been investigated in a completed prospective pilot trial (Clinicaltrials.gov: NCT01457209), and acupuncture with electrical stimulation applied to insulin-resistant rats with dihydrotestosterone-induced PCOS was shown to improve insulin sensitivity. Therefore, we now aim to conduct a prospective pilot study to evaluate whether using the same acupuncture treatment protocol given over a longer period of time (6 months) than in the previous pilot trial will improve insulin sensitivity in women with PCOS and IR. Our hypothesis is that acupuncture with combined manual and low-frequency electrical stimulation of the needles will improve insulin sensitivity in women with PCOS and IR.


METHODS
This is a prospective pilot trial. A total of 112 women with PCOS and IR will be recruited and categorised according to their body mass index (BMI) as normal weight (BMI=18.5-23 kg/m(2)) or as overweight/obese (BMI>23 kg/m(2)). Acupuncture will be applied three times per week for 6 months at 30 min per treatment. The primary outcome will be the change in insulin sensitivity before and after 6 months of acupuncture treatment, as measured by an oral glucose tolerance test.
Ethical approval of this study has been granted from the ethics committee of the First Affiliated Hospital of Guangzhou Medical University (No. 2013039). Written and informed consent will be obtained from each patient before any study procedure is performed, according to good clinical practice. The results of this trial will be disseminated in a peer-reviewed journal and presented at international congresses.


BACKGROUND
NCT02026323 and ChiCTR-OCH-13003921.
Research Institute of Integrated Traditional Chinese Medicine and Western Medicine, Guangzhou Medical University, Guangzhou, China Department of Traditional Chinese Medicine, The Fourth Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Yanhua
Y
Zheng
Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.
Elisabet
E
Stener-Victorin
Department of Obstetrics and Gynaecology, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, Hong Kong.
Ernest H Y
EH
Ng
Research Institute of Integrated Traditional Chinese Medicine and Western Medicine, Guangzhou Medical University, Guangzhou, China Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Juan
J
Li
Department of Gynecology, First Affiliated Hospital National Key Discipline, Specialty and Trial Base Heilongjiang University of Chinese Medicine, China.
Xiaoke
X
Wu
Research Institute of Integrated Traditional Chinese Medicine and Western Medicine, Guangzhou Medical University, Guangzhou, China Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Hongxia
H
Ma
D015670:Acupuncture Therapy / Q000379:methods; D000293:Adolescent; D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D005951:Glucose Tolerance Test; D006801:Humans; D007333:Insulin Resistance; D010865:Pilot Projects; D011085:Polycystic Ovary Syndrome / Q000150:complications / Q000378:metabolism / Q000628:therapy*; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
acupuncture; insulin resistance; polycystic ovary syndrome