Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Institute of Integration of Traditional Chinese Medicine and Western Medicine, Guangzhou Medical University, Guangzhou, Guangdong, China.
Hum Reprod. 2022 Mar 1;37(3):542-552. doi: 10.1093/humrep/deab272.
Does acupuncture improve insulin sensitivity more effectively than metformin or sham acupuncture in women with polycystic ovary syndrome (PCOS) and insulin resistance (IR)?
Among women with PCOS and IR, acupuncture was not more effective than metformin or sham acupuncture in improving insulin sensitivity.
Uncontrolled trials have shown that acupuncture improved insulin sensitivity with fewer side effects compared with metformin in women with PCOS and IR. However, data from randomized trials between acupuncture and metformin or sham acupuncture are lacking.
STUDY DESIGN, SIZE, DURATION: This was a three-armed randomized controlled trial enrolling a total of 342 women with PCOS and IR from three hospitals between November 2015 and February 2018, with a 3-month follow-up until October 2018.
PARTICIPANTS/MATERIALS, SETTING, METHODS: Women aged from 18 to 40 years with PCOS and homeostasis model assessment of insulin resistance (HOMA-IR) ≥2.14 were randomly assigned (n = 114 per group) to receive true acupuncture plus placebo (true acupuncture), metformin plus sham acupuncture (metformin, 0.5 g three times daily) or sham acupuncture plus placebo (sham acupuncture) for 4 months, with an additional 3-month follow-up. True or sham acupuncture was given three times per week, and 0.5 g metformin or placebo was given three times daily. The primary outcome was change in HOMA-IR from baseline to 4 months after baseline visit. Secondary outcomes included changes in the glucose AUC during an oral glucose tolerance test, BMI and side effects at 4 months after baseline visit.
After 4 months of treatment, the changes of HOMA-IR were -0.5 (decreased 14.7%) in the true acupuncture group, -1.0 (decreased 25.0%) in the metformin group and -0.3 (decreased 8.6%) in the sham acupuncture group, when compared with baseline. True acupuncture is not as effective as metformin in improving HOMA-IR at 4 months after baseline visit (difference, 0.6; 95% CI, 0.1-1.1). No significant difference was found in change in HOMA-IR between true and sham acupuncture groups at 4 months after baseline visit (difference, -0.2; 95% CI, -0.7 to 0.3). During the 4 months of treatment, gastrointestinal side effects were more frequent in the metformin group, including diarrhea, nausea, loss of appetite, fatigue, vomiting and stomach discomfort (31.6%, 13.2%, 11.4%, 8.8%, 14.0% and 8.8%, respectively). Bruising was more common in the true acupuncture group (14.9%).
LIMITATIONS, REASONS FOR CAUTION: This study might have underestimated the sample size in the true acupuncture group with 4 months of treatment to enable detection of statistically significant changes in HOMA-IR with fixed acupuncture (i.e. a non-personalized protocol). Participants who withdrew because of pregnancy did not have further blood tests and this can introduce bias.
True acupuncture did not improve insulin sensitivity as effectively as metformin in women with PCOS and IR, but it is better than metformin in improving glucose metabolism (which might reduce the risk of type 2 diabetes) and has less side effects. Metformin had a higher incidence of gastrointestinal adverse effects than acupuncture groups, and thus acupuncture might be a non-pharmacological treatment with low risk for women with PCOS. Further studies are needed to evaluate the effect of acupuncture combined with metformin on insulin sensitivity in these women.
STUDY FUNDING/COMPETING INTEREST(S): This work was supported by grants 2017A020213004 and 2014A020221060 from the Science and Technology Planning Project of Guangdong Province. The authors have no conflicts of interest.
Clinicaltrials.gov number: NCT02491333.
8 July 2015.
DATE OF FIRST PATIENT’S ENROLLMENT: 11 November 2015.
在患有多囊卵巢综合征（PCOS）和胰岛素抵抗（IR）的女性中，与二甲双胍或假针刺相比，针刺是否更能有效改善胰岛素敏感性？
在患有 PCOS 和 IR 的女性中，与二甲双胍或假针刺相比，针刺在改善胰岛素敏感性方面没有更有效。
未经对照的试验表明，与二甲双胍相比，针刺在改善胰岛素敏感性方面具有更少的副作用。然而，缺乏针刺与二甲双胍或假针刺之间的随机试验数据。
研究设计、规模、持续时间：这是一项为期 3 个月的三臂随机对照试验，共纳入了 2015 年 11 月至 2018 年 2 月期间来自三家医院的 342 名患有 PCOS 和 IR 的女性，随访至 2018 年 10 月。
参与者/材料、设置、方法：年龄在 18 至 40 岁之间，具有多囊卵巢综合征和稳态模型评估的胰岛素抵抗（HOMA-IR）≥2.14 的女性被随机分配（每组 114 名）接受真针刺加安慰剂（真针刺）、二甲双胍加假针刺（二甲双胍，每天 0.5 克三次）或假针刺加安慰剂（假针刺）治疗 4 个月，随后进行 3 个月的随访。真或假针刺每周进行三次，0.5 克二甲双胍或安慰剂每天进行三次。主要结果是从基线到基线后 4 个月 HOMA-IR 的变化。次要结果包括口服葡萄糖耐量试验期间的血糖 AUC 变化、BMI 和基线后 4 个月的副作用。
治疗 4 个月后，真针刺组 HOMA-IR 的变化为-0.5（减少 14.7%），二甲双胍组为-1.0（减少 25.0%），假针刺组为-0.3（减少 8.6%）。与基线相比，真针刺在改善 HOMA-IR 方面不如二甲双胍有效（差异为 0.6；95%CI，0.1-1.1）。在基线后 4 个月时，真和假针刺组之间 HOMA-IR 的变化没有显著差异（差异为-0.2；95%CI，-0.7 至 0.3）。在 4 个月的治疗期间，二甲双胍组胃肠道副作用更常见，包括腹泻、恶心、食欲不振、疲劳、呕吐和胃部不适（分别为 31.6%、13.2%、11.4%、8.8%、14.0%和 8.8%）。真针刺组更常见瘀伤（14.9%）。
局限性、谨慎的原因：这项研究可能低估了在 4 个月的治疗期间真针刺组的样本量，以便能够检测到固定针刺时 HOMA-IR 的统计学显著变化（即非个性化方案）。由于怀孕而退出的参与者没有进一步进行血液检查，这可能会引入偏差。
与二甲双胍相比，真针刺并未有效改善 PCOS 和 IR 女性的胰岛素敏感性，但在改善葡萄糖代谢方面优于二甲双胍（这可能降低 2 型糖尿病的风险），且副作用较少。与针刺组相比，二甲双胍组胃肠道不良反应发生率更高，因此针刺可能是一种风险较低的非药物治疗方法，适用于患有 PCOS 的女性。需要进一步研究评估这些女性中针刺联合二甲双胍对胰岛素敏感性的影响。
研究资金/利益冲突：这项工作得到了广东省科技计划项目 2017A020213004 和 2014A020221060 的支持。作者没有利益冲突。
Clinicaltrials.gov 编号：NCT02491333。
2015 年 7 月 8 日。
2015 年 11 月 11 日。
