Active acupuncture does not improve live birth rate in Chinese women with PCOS
Active acupuncture, with or without clomiphene, does not increase live births in Chinese women with polycystic ovary symptom (PCOS), a new randomized, multicentre clinical trial reveals.
“[A]ctive acupuncture provided no additional benefit over control acupuncture,” said researchers. On the other hand, “[t]his trial found that clomiphene was superior to placebo for achieving live births among infertile women with PCOS.”
Of the 1,000 women (mean age 27.9±3.3 years) eligible for enrolment, 235 were randomized to receive active acupuncture with clomiphene, 236 to control acupuncture with clomiphene, 223 to active acupuncture with placebo and 232 to control acupuncture with placebo. The rest withdrew from the study.
Live births were reported in 29.4 percent (n=69) of the patients in the active acupuncture with clomiphene group, 28.0 percent (n=66) in the control acupuncture with clomiphene group, 13.9 percent (n=31) in the active acupuncture with placebo group and 16.8 percent (n=39) in the control acupuncture with placebo group. [JAMA 2017;317:2502-2514]
The rate of live birth was significantly greater in participants who received clomiphene (28.7 percent) than those who received placebo (14.5 percent; difference, 13.3 percent; 95 percent CI, 8.0 to 18.5 percent).
On the other hand, active acupuncture did not produce significant improvements in the rate of live birth compared with control acupuncture (21.8 vs 22.4 percent; difference, -0.6 percent; -5.9 to 4.7 percent).
While there have been previous studies that have demonstrated the efficacy of active acupuncture for inducing ovulation, the difficulty of establishing controls and placebos for acupuncture may have interfered with the quality of the findings of these studies, according to the investigators.
“A Cochrane review found insufficient evidence for active acupuncture compared with control acupuncture to treat anovulation and infertility in women with PCOS,” they said. [Cochrane Database Syst Rev 2016;5:CD007689]
The rate of ovulation per cycle was significantly greater in participants who received clomiphene (66.0 percent) than placebo (33.8 percent; difference, 32.1 percent; 28.9 to 35.4 percent). Similarly, ovulation rate per woman was also higher with clomiphene (93.2 percent) than with placebo (69.9 percent; difference, 23.3 percent; 18.5 to 28.1 percent).
Clomiphene also yielded higher conception (45.4 percent) and pregnancy (30.6 percent) rates than placebo (23.3 and 16.3 percent, respectively). Respective differences were significant (22.1 percent; 16.2 to 28.1 percent; and 14.3 percent; 8.9 to 19.7 percent).
“Secondary outcomes of ovulation and pregnancy were more likely to occur after treatment with clomiphene than with placebo, but not with active acupuncture vs control acupuncture,” according to the researchers.
Only 72 cases of serious adverse events were reported. Patients receiving clomiphene had less vaginal bleeding than placebo (2.0 vs 9.4 percent; difference, -7.4 percent; -10.2 to -4.6 percent) but had higher rates of dysmenorrhoea (2.6 vs 0.6 percent; difference, 2.0 percent; 0.4 to 3.6 percent).
On the other hand, active acupuncture yielded more bruising (7.4 vs 1.8 percent; difference, 5.6 percent; 3.0 to 8.2 percent) and diarrhoea (5.0 vs 1.6 percent; difference, 3.4 percent; 1.2 to 5.6 percent) than control acupuncture.
All participants had confirmed PCOS according to the Rotterdam criteria. All participating couples were asked to have regular intercourse with intent to conceive during the study period.
Acupuncture procedures were 30 minutes long and administered twice a week for a maximum of 32 treatments. Active acupuncture included deep insertion and manual and low-frequency electrical stimulation.
“These findings do not support acupuncture alone or combined with clomiphene as an infertility treatment in patients with PCOS,” researchers said.