Safety of Acupuncture in Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Abstract

Introduction:

Acupuncture has emerged as an effective adjunctive therapy for polycystic ovary syndrome (PCOS) with concern on the higher rate of adverse events (AE). In addition, timing of intervention, specific acupoints, and stimulation strength are concerning, as high-stimulation electroacupuncture (EA) may increase miscarriage risk. This review aims to systematically evaluate the safety profile of acupuncture in PCOS.

Materials and Methods:

PubMed, ScienceDirect, and Scopus were searched prior to September 8, 2024. This study included randomized controlled trials (RCTs) comparing acupuncture with “control” (sham/no acupuncture) or active drugs. Study quality was assessed using RoB 2.0. Meta-analyses were conducted with R Studio.

Results:

From 1,041 articles, 13 RCTs were included. There was no significant serious or life-threatening AE occurred in all trials. In acupuncture versus control groups, mild to moderate AEs were similar overall, except bruising, which was significantly more frequent at needle insertion sites with acupuncture (OR = 3.34; 95% CI: 1.76–6,37; p < 0.01). In acupuncture versus active drugs, there were no significantly higher mild to moderate AEs in the acupuncture group. Miscarriage rates were comparable with acupuncture versus controls or ovulation-induction drugs, particularly with low-frequency (2 Hz) EA applied prepregnancy. Collectively, the findings support acupuncture’s safety profile, including no significant increase in miscarriage risk when administered prior to pregnancy.

Conclusions:

Acupuncture has emerged as a safe option for complementary therapy in PCOS. Further research is needed to refine acupuncture protocols, which further position it as a preferred adjunctive treatment in PCOS.

CME available online at www.medicalacupuncture.org/cme Questions on page 290.

INTRODUCTION

Polycystic ovary syndrome (PCOS) is a common endocrine disorder that affects women during their reproductive years, characterized by a variety of symptoms, including irregular menstrual cycles, elevated androgen levels, and insulin resistance.¹ The implications of PCOS extend beyond reproductive health, significantly impacting metabolic and psychological well-being, prompting many women to explore alternative therapies in conjunction with standard treatments.^2,3 Acupuncture has gained recognition as a complementary method for alleviating the symptoms associated with PCOS.⁴ This practice involves the insertion of fine needles into acupoints on the body to promote energy flow and restore equilibrium. Numerous studies emphasize its effectiveness in regulating hormonal activity, potentially enhancing abnormal menstrual cycles and promoting follicle growth, thereby addressing infertility-related PCOS.^5–8 In addition, recent research suggests that acupuncture may play a beneficial role in enhancing ovulation rates and improving insulin sensitivity among women diagnosed with PCOS.⁹

While substantial evidence indicates that acupuncture can regulate hormonal imbalance, concerns have arisen regarding a higher incidence of adverse events (AE) such as abnormal vaginal bleeding, diarrhea, and vomiting in the acupuncture treatment group.¹⁰ A systematic review by Lim et al. also highlighted that the incidence of AE in the acupuncture group was significantly higher in comparison with a sham procedure.¹¹ Furthermore, there were major concerns regarding the timing of the intervention, the specific acupoints targeted, and the intensity of stimulation in women with PCOS who are seeking pregnancy. In particular, acupuncture applied during early, unrecognized pregnancy, especially with high stimulation at points such as Hegu (LI4) and Sanyinjiao (SP6), may potentially affect uterine activity and carry a risk of miscarriage.^12,13 Therefore, this review aims to systematically assess the safety of acupuncture as an adjunctive therapeutic option for PCOS.

MATERIALS AND METHODS

This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.¹⁴ This review was registered at PROSPERO with the identifier number CRD42024616709.

Study Eligibility

We included studies that met the following criteria: (1) A randomized controlled trial (RCT) that directly compared acupuncture with sham acupuncture, placebo, no acupuncture, or an active drug. (2) Enrolled patients were diagnosed with PCOS based on the Rotterdam criteria or clinical guidelines for diagnosis and treatment of PCOS by the Endocrinology Chinese Medical Association. (3) Studies included must report periprocedural or postprocedural AE. Reviews, books, letters, case reports, case series, and observational studies were excluded. Only studies that were available in full-text and published in English or Chinese were included in this study without time restriction.

Search Strategy

In this study, we used three databases (PubMed, Scopus, and ScienceDirect) to collect eligible documents. The search was conducted using the following keywords: (“acupuncture” OR “acupuncture therapy”) AND (“PCOS” OR “Polycystic*” OR “polycystic ovarian disease” OR “Stein Leventhal syndrome”) for ScienceDirect and Scopus databases and (“acupuncture[MeSH]”) AND (“polycystic ovarian syndrome[MeSH]”) on PubMed prior to September 8, 2024. From this search, the documents were independently screened (title-abstract) by two reviewers (C.D.T. and K.M.). Any disagreements were resolved through arbitration with a third reviewer (I.N.). From the articles included, the following data were extracted: (1) first author and publication years, (2) mean age, (3) duration of acupuncture, (4) type of comparator, (5) total sample for each group, and (6) outcomes.

Quality Assessment

All of the studies included were assessed using the Risk of Bias (RoB) 2.0 tool for quality check. RoB 2.0 comprises five domains, each of which was determined to cover all significant mechanisms that potentially lead to bias incorporated into trial outcomes.¹⁵ Two reviewers (E.M.K. and N.E.S.) independently evaluated the risk of bias in eligible studies. Any disagreements or conflicts were solved with a third reviewer (I.N.).

Statistical Analysis

Meta-analysis was conducted on outcomes that met the eligible criteria using R Studio version 4.4.1 (Posit PBC, Boston, USA). The heterogeneity was evaluated using I² Higgins with values of 25%, 26–50%, and 50% indicating low, moderate, and high levels, respectively. A random-effect measure is employed when the heterogeneity test results are high, while a fixed-effect measure is employed when the heterogeneity level is low or moderate. The effect sizes were presented as an odds ratio (OR).

Outcomes

In this investigation, reported AEs were divided into three groups depending on their severity and the necessity for intervention. AEs that did not require additional treatment were categorized as mild to moderate. AEs that required further intervention or drugs as a follow-up treatment were classified as serious. AEs that were life-threatening and demanded immediate protocols to preserve the patient’s life were categorized as life-threatening. In addition, we also evaluated the miscarriage risk that may be present in the study that investigates acupuncture in PCOS women who are seeking pregnancy, with a focus on the timing, acupoints, and stimulation strength.

RESULTS

Main Information

The initial search yielded 1,041 documents. After removing 113 duplicates, a title-abstract screening was conducted, resulting in 63 documents proceeding to full-text review. Of 63 documents, 13 were irretrievable full-text. Out of the 50 RCTs, only 13 reported safety outcomes of acupuncture in PCOS.^10,16–27 A detailed screening process is presented in Figure 1. The baseline characteristics of each study are available in Table 1, with detailed quality assessment available in Supplementary Figure S1.

FIG. 1.

PRISMA flowchart.

Table 1.

Baseline Characteristics

First author	Published year	Location	Acupuncture modality	Comparator	Acupuncture point	Acupuncture duration	AEs reported on the study
Cao et al.16	2019	China	Manual acupuncture	EPA/EE	Fuke, Huanchao, Tianhuang/Yin Lingquan (SP6), Renhuang/Sanyinjiao (SP6), Guanyan (CV4) and Zigong (EX-CA1)	Twice every week for 12 weeks	Mild to moderate AEs (transient bruising and post-treatment soreness)
Dong et al.23	2022	China	Electroacupuncture (2 Hz)	Sham acupuncture	Set 1: Yaoyangguan (GV3), Qihai (CV6), Baihui (GV20), Guilai (ST29), Sanyinjiao (SP6), Yinlingquan (SP9), Hegu (LI4)	Twice a week for 32 sessions	Mild to moderate AEs (itching, swelling); serious AEs (adipoma and mammary gland hyperplasia)
					Set 2: Zhongji (CV3), Qihai (CV6), Baihui (GV20), Tianshu (ST25), Guilai (ST29), Sanyinjiao (SP6)
Altutunji et al.19	2019	China	Manual acupuncture	Sham acupuncture	Tai chong (LIV3), Sanynjiao (SP6), Diji (SP8), Zusanli (ST36), Xuehai (SP10), Guilai (ST29), Hegu (LI14), and Guan Yuan (Ren4)	Daily from the third day of the menstrual cycle to the day of HCG injection	Miscarriage rate
Wen et al.21	2022	China	Electroacupuncture (2 Hz)	Sham acupuncture and metformin	N/A	Three times a week for 48 sessions	Mild to moderate AEs (nausea, vomiting, bruising, stomach discomfort, abnormal vaginal bleeding, diarrhea); serious AE (tuberculosis)
Muharam et al.25	2022	Indonesia	Electroacupuncture (2 Hz)	Sham acupuncture	Zhongji (CV3), Guanyuan (CV4), Qihai (CV6), Tianshu (ST25), Shuidao (ST28), Zusanli (ST36), Chengsan (BL57), Sanyinjiao (SP6)	Three times a week for 12 sessions	Mild to moderate AE (hematoma)
Pastore et al.26	2011	United States	Manual acupuncture	Sham acupuncture	Shenshu (UB23), Pangguangshu (UB28), Sanyinjiao (SP6), Yinlingquan (SP9)	Twice a week for 4 weeks, then once a week for 4 weeks	Serious AE (back-spasm)
Lin et al.17	2022	China	Electroacupuncture (2 Hz)	Letrozole combined with HCG	Menstrual period: Zigong (EX-CA1), Guilai (ST29), San Yinjiao (SP6), Taichong (LR3), Hegu (LI4)	Once every 2 days for 12 weeks, starting from the third day of the menstrual cycle to the day of HCG injection	Miscarriage rate
					Folicular period: Qihai (CV6), Dahe (KI12), Luanchao, Zusanli (ST36), Taixi (KI3)
					Ovulatory period: Luanchao, Wushu (GB27), (CV6), Zhongji (CV3), Xuehai (SP10), Sanyinjiao (SP6), Hegu (LI4), Taichong (LR3)
					Luteal period: Zigong (EX-CA1), Xuehai (SP10), Zusanli (ST36), Sanyinjiao (SP6), Taixi (KI3)
Pan et al.27	2022	China	Manual acupuncture	Sham acupuncture	Guanyuan (RN4), Zigong (EX-CA1), Guilai (ST29), Zusanli (ST36), San Yinjiao (SP6)	Twice a week for 12 weeks	Mild to moderate AE (abdominal pain)
Jia-man et al.18	2022	China	Manual acupuncture	No acupuncture	Guanyuan (RN4), Qihai (CV6), Zhongji (CV3), Zigong (EX-CA1), Mingmen (GV4), Yaoyangguan (GV3), Shenshu (BL23), Ciliao (BL32)	Daily from the ovarian hyperstimulation process until ovulation	Miscarriage rate
Rashidi et al.22	2013	Iran	Electroacupuncture (2 Hz)	No acupuncture	First three sessions: Hegu (LI4), Sanyinjiao (SP6), Taichong (LR3), Zhongji (CV4), Baihui (GV20), Zusanli (ST36), Ovary auricular point, Uterus auricular point	Only five sessions: 21st day of the previous cycle, the first day of stimulation, 2 days before ovum pick-up, immediately before embryo-transfer, immediately after embryo-transfer	Miscarriage rate
					Last two sessions: Taichong (LR3), Xuehai (SP10), Neiguan (PC6), Guilai (ST29), Shenmen auricular point
Jedel et al.24	2011	Sweden	Electroacupuncture (2 Hz)	No acupuncture	Zhongwan (RN12), Tianshu (ST25), Daheng (SP15), Daimai (GB26)	Twice a week until the day of oocyte collection	Mild to moderate AEs (hematoma and dizziness)
Wu et al.10	2017	China	Manual Acupuncture	Sham acupuncture and clomiphine	Zhongji (CV3), Qihai (CV6), Guilai (ST29), Sanyinjiao (SP6), Yinlingquan (SP9)	14 sessions for over 16 weeks	Mild to moderate AEs (bruising, abnormal vaginal bleeding, diarrhea; serious AE (mammary gland hyperplasia); miscarriage rate
Zheng et al.20	2013	China	Manual acupuncture	Metformin	Guanyan (CV4), Qihai (CV6), Xiawan (CV10), Zhongwan (CV12) Zusanli (ST21), Tianshu (ST25), Shushen (ST28)	Twice a week for 6 months	Mild to moderate AEs (nausea, vomiting, dizziness, and weakness)

All of the acupuncture sessions were conducted by certified medical acupuncturists. Across 13 studies, there was no life-threatening AE observed.

HCG, human chorionic gonadotropin; EPA/EE, cyroproterone acetate/ethinylestradiol; N/A, not available.

From 13 RCTs, there were 6 trials that used sham acupuncture as a comparator,^{19,21,23,25–27} 2 used no acupuncture as a comparator,^22,24 1 used cyproterone acetate/ethinylestradiol (EPA/EE) as a comparator,¹⁶ 2 used metformin as a comparator,^20,21 1 used letrozole combined with human chorionic gonadotropin (HCG) as a comparator,¹⁷ and 1 used clomiphene as a comparator.¹⁰ To optimize the analysis, the sham acupuncture and no acupuncture as comparators were grouped together as the “control” group, while the trials using EPA/EE, metformin, letrozole combined with HCG, and clomiphene were categorized as “active drugs.” Among the 13 RCTs, acupuncture was delivered using either manual acupuncture or low-frequency (2 Hz) electroacupuncture (EA). In all trials involving women seeking pregnancy, conception occurred either naturally (manual intercourse) or through in vitro fertilization (IVF).

Acupuncture versus Control Group

Out of eight trials comparing acupuncture versus the control group, five observed mild to moderate AEs.^{10,21,23–25} Bruising at the needle insertion site was higher in two studies, with Wu et al. (2017) reporting higher bruising in the acupuncture group (23/250 vs. 8/250) and Wen et al. (2022) finding it statistically significant (17/114 vs. 5/114; p = 0.007).^10,21 Hematoma was observed in two studies, with two cases reported by Muharam et al. (2022) and three by Jedel et al. (2011) in the acupuncture group.^24,25 Two studies reported abnormal vaginal bleeding. Wu et al. (2017) found more cases in the control group (22/250 vs. 25/250; p = 1.00), while Wen et al. (2022) observed it in the acupuncture group (1/114 vs. 0/114; p = 1.00), with neither showing statistical significance.^10,21 Dizziness was reported in two studies, with Wen et al. (2022) observing equal occurrences in both groups (3/114 vs. 3/114) and Jedel et al. (2011) reporting only one case in the acupuncture group.^21,24 Diarrhea incidence was comparable between groups, as reported by Wu et al. (2017) (2/250 vs. 1/250) and Wen et al. (2022) (4/114 vs. 6/114).^10,21 Other mild to moderate AEs, including itching, swelling, and gastrointestinal AEs (nausea, vomiting, and stomach discomfort), were reported by individual studies, with none showing statistically significant differences.^{10,21,23–25}

Further analyses using meta-analysis evaluated the pooled OR between the two approaches, with the details of the results presented in Figure 2. Overall, there was no significant difference in hematoma, abnormal vaginal bleeding, dizziness, and diarrhea across five studies. However, acupuncture showed a significantly higher risk of bruising at needle insertion sites (OR = 3.34; 95% CI: 1.76–6.37; p < 0.01).

FIG. 2.

Meta-analysis of AEs. (A) Bruising; (B) hematoma; (C) abnormal vaginal bleeding; (D) dizziness; (E) diarrhea. All meta-analyses were conducted with fixed-effect model with Mantel-Haenszel weighting approach.

Across four trials that reported serious AEs, there was no significantly higher incidence in the acupuncture group.^10,21,23,26 Reported events included cases of lipoma, tuberculosis, and back spasm; however, none of the serious AEs were causally related to acupuncture as judged by study authors.^21,23,26 In addition, Wu et al. (2017) and Dong et al. (2022) each observed one case of mammary gland hyperplasia in the control group, with no such cases in the acupuncture group.^10,23 Notably, across all trials, no life-threatening AEs were reported during either the periprocedural or postprocedural acupuncture sessions.

Acupuncture versus Active Drugs Group

From five trials with active drugs as comparators, there were only mild to moderate AEs and one case of serious AE observed, with no life-threatening AEs occurring.^{10,16,17,20,21} In the studies using metformin as a comparator, Wen et al. (2022) found a lower incidence of diarrhea, loss of appetite, and vomiting reported at the 4-month follow-up (p < 0.05). Similarly, Zheng et al. (2013) observed a higher rate of mild to moderate AE, including nausea, vomiting, dizziness, and weakness in the metformin group, while there was none in the acupuncture group.²⁰ In the study using clomiphene as comparator, Wu et al. (2017) reported a generally higher incidence of mild to moderate AEs in the acupuncture group. Specifically, the acupuncture group showed higher rates of abnormal vaginal bleeding (22/250 vs. 8/250), diarrhea (16/250 vs. 3/250), and bruising (23/250 vs. 1/250), although no p-values were provided.¹⁰ In the study using EPA/EE as a comparator, Cao et al. (2019) reported comparable mild to moderate AEs, such as transient bruising and post-treatment soreness.¹⁶

Compared with active drugs, acupuncture is a relatively safe treatment option. The noticeable gastrointestinal AEs observed in this group were primarily associated with metformin rather than acupuncture. Although there was higher abnormal vaginal bleeding in the acupuncture group, there was reservation regarding the use of clomiphene in Wu et al. (2017), as it is clinically effective in regulating abnormal vaginal bleeding in PCOS and should not be interpreted as acupuncture significantly increasing the risk of abnormal vaginal bleeding.¹⁰

Acupuncture and Miscarriage Risk in PCOS

Miscarriage is clinically defined as the loss of fetus prior to 20 weeks of gestation, also referred to as spontaneous abortion.²⁸ A review of 13 studies examining the relationship between acupuncture and miscarriage risk reveals several important findings. Among these studies, five specifically analyzed miscarriage rates between the acupuncture and control or active drugs group.^{10,17–19,22} As summarized in Table 2, these studies differed in both conception methods and the timing of intervention relative to early pregnancy. Among the five studies, four studies administered acupuncture in the period before early pregnancy had potentially occurred.^10,17–19

Table 2.

The Detailed Protocol Timing of the Acupuncture Procedure for Those Seeking Pregnancy

Author (year)	Conception type	Acupuncture period	Did acupuncture overlap with early pregnancy?	Pregnancy monitoring
Altutunji et al. (2019)19	IVF	Day 3 to HCG day	No (stopped before ET)	HCG after ET
Lin et al. (2022)17	IVF	Day 3 to HCG day	No (stopped before ovulation)	HCG and/or ultrasound
Jia-man et al. (2022)18	IVF	Until ovulation	No (stopped before ET)	HCG and/or ultrasound
Rashidi et al. (2013)22	IVF	Five sessions, including sessions immediately before and after ET	Yes (during peri-implantation)	Ultrasound after ET
Wu et al. (2017)10	Natural (manual intercourse)	Regular sessions until pregnancy	No (stopped upon pregnancy detection)	Regular HCG test and pregnancy sign follow-up

IVF, in vitro fertilization; HCG, human chorionic gonadotropin; ET, embryo transfer.

Altutunji et al. (2019) reported no miscarriage in the acupuncture group among women with PCOS undergoing IVF.¹⁹ Similarly, Jia man et al. (2022) observed comparable miscarriage rates in control groups using IVF compared with those receiving acupuncture at specific points, including Guanyuan (CV4), Qihai (CV6), Zhongji (CV3), and bilateral Zigong (EX-CA1).¹⁸ In addition, Wu et al. (2017) noted nonsignificant differences in the miscarriage rate in the control group during the first trimester (13/250 vs. 17/250) among pregnancy-seeking women with PCOS who engaged in manual intercourse.¹⁰ Rashidi et al. (2013) reported a higher incidence of miscarriage in the acupuncture group, although this finding was not statistically significant (p = 0.573).²² Furthermore, two studies that utilized ovulation induction drugs as a control indicated a lower incidence of miscarriage in the acupuncture group. Lin et al. found significantly lower early miscarriage rate in the acupuncture group (2/19 vs. 5/10; p < 0.05), while Wu et al. (2017) reported lower early miscarriage rate as well (13/250 vs. 25/250; p < 0.05).^10,17

Consistently, all studies adopted protocols using low-frequency EA (2 Hz), which is considered optimal for safety and efficacy. Overall, the evidence suggests that when acupuncture is limited to the prepregnancy period, whether in natural conception or IVF settings, it does not increase the risk of miscarriage. This supports the role of acupuncture as a safe complementary treatment for women seeking to conceive, as long as treatment is discontinued before or immediately upon pregnancy detection.

DISCUSSION

Acupuncture is an effective complementary care for women with PCOS. However, safety concerns remain, as several studies have reported a higher incidence of AE in patients receiving acupuncture.^11,12,29,30 In this study, we found that there were no life-threatening or significant serious AE in the acupuncture group. The only notable significant mild to moderate AE in acupuncture was only bruises at the needle site. Acupuncture is intended to stimulate local circulation and neural pathways to promote the body’s natural regulatory mechanisms; bruising is an unintended side effect rather than a desired therapeutic effect.³¹ While the occurrence of mild bruising is generally considered acceptable within clinical practice, this AE should be minimized with such a gentle, precise insertion and by avoiding high-vascular areas, such as face and abdomen.³² Some points of acupuncture for PCOS also need to be mentioned due to their proximity to high vascular units. Sanyinjiao (SP6), commonly used as a hormonal regulation point, is located close to the posterior tibial artery and saphenous vein.³³ Tianshu (ST25) is another example that commonly generates a subcutaneous hematoma, due to its proximity to the superficial blood vessels in the abdominal area.^34,35

In this review, we also highlight the important aspect of miscarriage risk, as several studies suggest cautious acupuncture timing, considering the high uterotonic effect.^13,36 This concern is relevant, since PCOS patients usually proceed within 12 sessions to 48 sessions while trying to conceive, increasing the possibility that treatment may overlap with early, unrecognized pregnancy.^16,23,26 Notably, among the five studies examined, only one continued acupuncture after embryo transfer, potentially overlapping with the early gestational period.²² However, even in such scenarios, the observed miscarriage rate in the acupuncture group was not significantly different from controls. Hence, we suggest that acupuncture is safe for PCOS women with PCOS who are seeking pregnancy, irrespective of the method of conception (manual intercourse or IVF). To further minimize risk, we recommend that future protocols incorporate early pregnancy detection tools, such as regular measurement of basal body temperature or serial β-HCG testing, to promptly identify conception and ensure timely discontinuation of acupuncture.^37,38

The specific concern includes determining the stimulation strength and target acupoint. EA as the newer acupuncture modality offers a lower risk of bruising and hematoma compared with manual acupuncture, as it uses electricity to trigger the point, rather than manual method that is associated with a greater risk of vascular injury.³² However, the selection of stimulation strength plays a significant role in the outcomes. In this review, all of the studies used manual acupuncture or low-frequency EA with 2 Hz, as low-frequency EA is believed to optimally regulate the hypothalamic-pituitary-ovarian (HPO) axis without overstimulating it, which potentially exacerbates hormonal imbalance.^39,40 Low-frequency EA also assists in minimizing the risk of miscarriage, as excessive and aggressive stimulation is contraindicated in pregnancy.³⁷ In addition, the low-frequency EA promotes β-endorphins, which provide additional pain relief and stress reduction, enhancing its therapeutic benefits for PCOS.^39,41

Acupoint selection also plays a significant role in managing PCOS. In this review, while there is no clear evidence of an absolute contraindication of acupoint for PCOS, it is important to note that certain points, such as Sanyinjiao (SP6) and Hegu (LI4), are traditionally considered contraindicated in pregnancy due to their potential to stimulate uterine contractions. However, they remain to be essential points for PCOS management in nonpregnant individuals.^12,13 Frequently used points, such as Sanyinjiao (SP6), Guilai (ST29), Guanyuan (CV4), and Zusanli (ST36), are employed consistently across protocols due to their established benefits in regulating the HPO axis.⁴² Optimal acupoints also should align with the patient’s symptoms and treatment phase. For instance, Sanyinjiao (SP6) and Guilai (ST29) are effective during the menstrual phase for regulating blood flow, while Zusanli (ST36) and Qihai (CV6) are effective in the follicular phase to support follicle development.^17,39,42 These findings highlight the need for personalized acupuncture approaches and suggest the establishment of protocols for maximizing benefits.

Acupuncture is generally safe in PCOS. However, it is also essential to pinpoint the practitioner’s skills and consideration of individuals’ specific health conditions. Inexperienced practitioners tend to have an inaccurate selection of acupuncture points, potentially leading to AEs. In addition, inexperienced practitioners may have improper needle insertion that causes tissue damage, nerve injury, or life-threatening conditions.⁴³ Proper technique, proper timing, sterile procedure, and understanding the risk-benefit of acupuncture in PCOS are crucial aspects for the safe application of acupuncture.

Although several insights are brought by this review, there were several limitations of the literature that have to be acknowledged. In this study, we can only review a limited dataset of studies, as many RCTs do not report AEs that occurred during the procedure. We also cannot differentiate the PCOS severity or PCOS phenotypes, as different PCOS phenotypes may correspond differently to acupuncture intervention and may result in different AEs. We also cannot identify adjunctive therapy alongside with acupuncture such as moxibustion or herbal treatment. This omission introduces a potential source of confounding, as AEs observed in these studies cannot be conclusively attributed to acupuncture alone.

CONCLUSIONS

Acupuncture has emerged as a safe option for complementary therapy in PCOS. While mild and moderate AEs, such as bruising, are significant, they are manageable with proper techniques, with no clear evidence of absolute contraindication regarding acupoints selection. Practitioners should prioritize low-frequency EA to optimize therapeutic benefits while reducing risk, particularly the risk of miscarriage in pregnancy-seeking women with cautious treatment protocol. The selection of acupoints must align with the patient’s symptoms and the treatment phase, emphasizing personalized acupuncture approaches to maximize benefits. Further research is needed to refine acupuncture protocols in PCOS to enhance the safety profile and further position it as a preferred adjunctive treatment in PCOS.

AUTHORS’ CONTRIBUTIONS

I.N. contributed to the conceptualization of the study. C.D.T. and K.M. were responsible for data curation and investigation. C.D.T., K.M., I.H., N.E.S., and E.M.K. drafted the original article, while M.F.I. and I.N. reviewed and edited the article. All authors have read and approved the final version of the article.

AUTHOR DISCLOSURE STATEMENT

No competing financial interests exist.

FUNDING INFORMATION

No funding was received for this article.

To receive CME credit, you must complete the quiz online at: www.medicalacupuncture.org/cme

CME Quiz Questions

Article learning objectives: After studying this article, participants should be able to identify and describe the acupuncture points used in PCOS; review the possible adverse effects associated with Acupuncture treatment; and describe the advantages and precautions with the use of electroacupuncture in PCOS.

Publication date: August 14, 2025

Expiration date: August 31, 2028

Disclosure Information:

Pending disclosure submissions. None of the authors, editors, or reviewers of this educational activity have relevant financial relationship(s) with ineligible companies to disclose.

Questions:

• 1.In this meta-analysis, Acupuncture's usefulness in PCOS include which of the following:
  • A.Decreasing vaginal discharge and body weight
  • B.Hormonal balance and promotion of follicle growth
  • C.Decreasing anxiety, promoting sleep, and decreasing acne
  • D.Regulating hair growth and body weight

  Correct answer: B

• 2.Which statement is included in the article authors’ assessment and classification of adverse events (AE)?
  • A.AE that require further intervention or medication are classified as moderate AE.
  • B.AE that did not require treatment are classified as mild to moderate AE.
  • C.Swelling and GI symptoms including nausea, vomiting were considered serious AE.
  • D.AE that are life threatening are classified as serious AE.

  Correct answer: B

• 3.With regards to the use of electroacupuncture in PCOS, the study shows which of the following statements?
  • A.Low frequency electroacupuncture is associated with higher risk of bruising and hematoma formation.
  • B.Low frequency electroacupuncture increases pain and stress in patients with PCOS.
  • C.Low frequency electroacupuncture is believed to regulate the hypothalmic-pituitary-ovarian (HPO) axis without overstimulating it.
  • D.Low frequency electroacupuncture is associated with excessive and aggressive stimulation leading to vascular injury.

  Correct answer: C

• 4.Among the 8 studies comparing acupuncture versus control groups in this meta-analysis, statistically significant adverse effects reported included
  • A.Miscarriage in 1 study, nausea and vomting in 3 studies, abdominal discomfort in 1 study
  • B.Diarrhea in 2 studies, constipation in 1 study, headache in 2 studies
  • C.Miscarriage in 2 studies, sweating in 1 study, excess sedation in 2 studies
  • D.Bruising in 2 studies, hematoma in 2 studiees, abnormal vaginal bleeding in 2 studies, dizziness in 2 studies

  Correct answer: D

• 5.Among the 13 trials analyzed that included a compartor group, which are the different comparator methods utilized?
  • A.Sham acupuncture, metformin, letrozole + HCG, and no acupuncture
  • B.Sham acupuncture, oral contraceptives, wait list
  • C.No acupuncture, clomiphene, metformin
  • D.Letrozole, metformin, counseling

  Correct answer: A

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