Key messages
-
Acupuncture compared with sham acupuncture may have little or no effect on rates of live birth, multiple pregnancy (twins, triplets, etc.), ovulation, clinical pregnancy (confirmed by an ultrasound scan), or miscarriage in women with polycystic ovary syndrome. Minor side effects are probably more common with acupuncture compared to sham acupuncture.
-
Current studies do not provide strong evidence that acupuncture improves fertility outcomes in women with polycystic ovary syndrome, and more high-quality studies are needed.
-
Side effects of acupuncture include dizziness, nausea, bruising, insomnia, abdominal pain, and skin rashes, which should be considered when weighing potential benefits and risks.
What is polycystic ovary syndrome?
Women with polycystic ovary syndrome develop multiple cysts (fluid-filled sacs) on their ovaries (the organs responsible for producing eggs). These women often have infrequent or very light menstruation (periods), difficulty conceiving (becoming pregnant), and excessive hair growth, although some women may experience no noticeable symptoms. Standard treatments for polycystic ovary syndrome include prescription medicines, lifestyle changes, and sometimes surgery.
How might acupuncture help with polycystic ovary syndrome?
There is some evidence suggesting that acupuncture may influence ovulation (release of the egg) by affecting hormone levels. Acupuncture is a Chinese medicine therapy that involves inserting fine needles into specific points on the skin. However, the exact mechanism of how acupuncture works for polycystic ovary syndrome remains unclear.
What did we want to find out?
We wanted to know whether acupuncture was better than sham acupuncture, no treatment, lifestyle changes, or prescription medicines for improving:
-
live birth rates;
-
multiple pregnancy rates (more than one baby per pregnancy);
-
ovulation rates;
-
clinical pregnancy rates (pregnancy confirmed by ultrasound);
-
restoration of regular menstrual periods;
-
miscarriage rates; and
-
side effects.
Our two main populations of interest were women who wanted to become pregnant and those who wanted to have regular ovulation and manage symptoms.
What did we do?
We searched medical databases for clinical studies that randomly assigned women with polycystic ovary syndrome to one of two or more treatment groups (acupuncture and one or more comparators).
What did we find?
This review included nine studies with 1606 women. The studies compared acupuncture with sham acupuncture, relaxation sessions, clomiphene (a medicine used to induce ovulation), or Diane-35 (a combined oral contraceptive pill containing ethinylestradiol and cyproterone acetate). One study compared low-frequency electroacupuncture (where small electrical currents are passed through the acupuncture needles) with physical exercise or no treatment.
Main results
Only the study comparing acupuncture with sham acupuncture evaluated live birth and multiple pregnancy rates. Acupuncture compared with sham acupuncture may have little or no effect on rates of live birth, multiple pregnancy, ovulation, clinical pregnancy, or miscarriage. Acupuncture may reduce the number of days between menstrual periods after 12 weeks compared with sham acupuncture, but the evidence is very uncertain. Side effects are probably more common with acupuncture.
We are unsure about the effect of low-frequency electroacupuncture versus exercise or no intervention on restored regular menstrual periods or side effects, because the evidence is very uncertain.
We are unsure about the effect of acupuncture compared with relaxation on ovulation rates, because the evidence is very uncertain.
We are unsure about the effect of acupuncture compared with clomiphene on restored regular menstrual periods or side effects, because the evidence is very uncertain.
We are unsure about the effect of acupuncture compared with Diane-35 on ovulation rates, clinical pregnancy rates, and restored regular menstrual periods, because the evidence is very uncertain.
Side effects recorded in the acupuncture groups included dizziness, nausea (feeling sick), bruising, insomnia, abdominal pain, and skin rashes. These side effects were generally mild.
What are the limitations of the evidence?
We have little confidence in the evidence because most studies did not report our main outcomes of interest, and because there were few studies in each comparison.
How up-to-date is this evidence?
This review updates our previous review. The evidence is current to December 2024.
Read the full abstract
Polycystic ovarian syndrome (PCOS) is characterised by the clinical signs of oligo-amenorrhoea, infertility and hirsutism. Conventional treatment of PCOS includes a range of oral pharmacological agents, lifestyle changes and surgical modalities. Beta-endorphin is present in the follicular fluid of both normal and polycystic ovaries. It was demonstrated that the beta-endorphin levels in ovarian follicular fluid of otherwise healthy women who were undergoing ovulation were much higher than the levels measured in plasma. Given that acupuncture impacts on beta-endorphin production, which may affect gonadotropin-releasing hormone (GnRH) secretion, it is postulated that acupuncture may have a role in ovulation induction via increased beta-endorphin production effecting GnRH secretion. This is an update of our previous review published in 2016.
Objectives
To assess the benefits and harms of acupuncture in managing fertility and symptoms in oligo/anovulatory women with polycystic ovary syndrome.
Search strategy
We searched the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, AMED, and three Chinese databases (CNKI, CBM, and VIP). We also reviewed trial registries and reference lists for related papers. The searches in CENTRAL, MEDLINE, Embase, PsycINFO, and CNKI are current to December 2024. The VIP search is current to November 2024. The CBM database search is current to November 2015. We also performed reference checking and citation searching and contacted study authors to identify additional studies.
Selection criteria
We included randomised controlled trials (RCTs) that studied the efficacy of acupuncture treatment for oligo/anovulatory women with PCOS. We excluded quasi- or pseudo-RCTs.
Data collection and analysis
Two review authors independently selected the studies, extracted data and assessed risk of bias. We calculated risk ratios (RR), mean difference (MD), standardised mean difference (SMD) and 95% confidence intervals (CIs). Primary outcomes were live birth rate, multiple pregnancy rate and ovulation rate, and secondary outcomes were clinical pregnancy rate, restored regular menstruation period, miscarriage rate and adverse events. We assessed the quality of the evidence using GRADE methods.
Main results
We included eight RCTs with 1546 women. Five RCTs were included in our previous review and three new RCTs were added in this update of the review. They compared true acupuncture versus sham acupuncture (three RCTs), true acupuncture versus relaxation (one RCT), true acupuncture versus clomiphene (one RCT), low-frequency electroacupuncture versus physical exercise or no intervention (one RCT) and true acupuncture versus Diane-35 (two RCTs). Studies that compared true acupuncture versus Diane-35 did not measure fertility outcomes as they were focused on symptom control.
Seven of the studies were at high risk of bias in at least one domain.
For true acupuncture versus sham acupuncture, we could not exclude clinically relevant differences in live birth (RR 0.97, 95% CI 0.76 to 1.24; 1 RCT, 926 women; low-quality evidence); multiple pregnancy rate (RR 0.89, 95% CI 0.33 to 2.45; 1 RCT, 926 women; low-quality evidence); ovulation rate (SMD 0.02, 95% CI –0.15 to 0.19, I2 = 0%; 2 RCTs, 1010 women; low-quality evidence); clinical pregnancy rate (RR 1.03, 95% CI 0.82 to 1.29; I2 = 0%; 3 RCTs, 1117 women; low-quality evidence) and miscarriage rate (RR 1.10, 95% CI 0.77 to 1.56; 1 RCT, 926 women; low-quality evidence).
Number of intermenstrual days may have improved in participants receiving true acupuncture compared to sham acupuncture (MD –312.09 days, 95% CI –344.59 to –279.59; 1 RCT, 141 women; low-quality evidence).
True acupuncture probably worsens adverse events compared to sham acupuncture (RR 1.16, 95% CI 1.02 to 1.31; I2 = 0%; 3 RCTs, 1230 women; moderate-quality evidence).
No studies reported data on live birth rate and multiple pregnancy rate for the other comparisons: physical exercise or no intervention, relaxation and clomiphene. Studies including Diane-35 did not measure fertility outcomes.
We were uncertain whether acupuncture improved ovulation rate (measured by ultrasound three months post treatment) compared to relaxation (MD 0.35, 95% CI 0.14 to 0.56; 1 RCT, 28 women; very low-quality evidence) or Diane-35 (RR 1.45, 95% CI 0.87 to 2.42; 1 RCT, 58 women; very low-quality evidence).
Overall evidence ranged from very low quality to moderate quality. The main limitations were failure to report important clinical outcomes and very serious imprecision.
Authors' conclusions
We found no clear evidence of a difference between acupuncture and sham acupuncture in rates of live birth, multiple pregnancy, ovulation, clinical pregnancy, miscarriage, or restoration of regular menstrual periods. Acupuncture is probably associated with a greater risk of adverse events. It is unclear whether acupuncture improves ovulation rate compared with relaxation or Diane-35.
In studies that compared acupuncture with exercise, no intervention, clomiphene, and Diane-35, adverse events reported in the acupuncture group included vaginal bleeding, weight gain, fatigue, dizziness, nausea, and subcutaneous haematoma.
The limited number of RCTs and variability in outcome reporting mean that the effectiveness of acupuncture for PCOS remains uncertain.
Funding
The review authors declare no funding support or financial conflicts of interest.
Registration
Protocol (2009) DOI 10.1002/14651858.CD007689
Original review (2011) DOI 10.1002/14651858.CD007689.pub2
Review update (2016) DOI 10.1002/14651858.CD007689.pub3
Review update (2019) DOI 10.1002/14651858.CD007689.pub4
