Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial.

Importance: Acupuncture is used to induce ovulation in some women with polycystic ovary syndrome, without supporting clinical evidence. Objective: To assess whether active acupuncture, either alone or combined with clomiphene, increases the likelihood of live births among women with polycystic ovary syndrome. Design, Setting, and Participants: A double-blind (clomiphene vs placebo), single-blind (active vs control acupuncture) factorial trial was conducted at 21 sites (27 hospitals) in mainland China between July 6, 2012, and November 18, 2014, with 10 months of pregnancy follow-up until October 7, 2015. Chinese women with polycystic ovary syndrome were randomized in a 1:1:1:1 ratio to 4 groups. Interventions: Active or control acupuncture administered twice a week for 30 minutes per treatment and clomiphene or placebo administered for 5 days per cycle, for up to 4 cycles. The active acupuncture group received deep needle insertion with combined manual and low-frequency electrical stimulation; the control acupuncture group received superficial needle insertion, no manual stimulation, and mock electricity. Main Outcomes and Measures: The primary outcome was live birth. Secondary outcomes included adverse events. Results: Among the 1000 randomized women (mean [SD] age, 27.9 [3.3] years; mean [SD] body mass index, 24.2 [4.3]), 250 were randomized to each group; a total of 926 women (92.6%) completed the trial. Live births occurred in 69 of 235 women (29.4%) in the active acupuncture plus clomiphene group, 66 of 236 (28.0%) in the control acupuncture plus clomiphene group, 31 of 223 (13.9%) in the active acupuncture plus placebo group, and 39 of 232 (16.8%) in the control acupuncture plus placebo group. There was no significant interaction between active acupuncture and clomiphene (P = .39), so main effects were evaluated. The live birth rate was significantly higher in the women treated with clomiphene than with placebo (135 of 471 [28.7%] vs 70 of 455 [15.4%], respectively; difference, 13.3%; 95% CI, 8.0% to 18.5%) and not significantly different between women treated with active vs control acupuncture (100 of 458 [21.8%] vs 105 of 468 [22.4%], respectively; difference, -0.6%; 95% CI, -5.9% to 4.7%). Diarrhea and bruising were more common in patients receiving active acupuncture than control acupuncture (diarrhea: 25 of 500 [5.0%] vs 8 of 500 [1.6%], respectively; difference, 3.4%; 95% CI, 1.2% to 5.6%; bruising: 37 of 500 [7.4%] vs 9 of 500 [1.8%], respectively; difference, 5.6%; 95% CI, 3.0% to 8.2%). Conclusions and Relevance: Among Chinese women with polycystic ovary syndrome, the use of acupuncture with or without clomiphene, compared with control acupuncture and placebo, did not increase live births. This finding does not support acupuncture as an infertility treatment in such women. Trial Registration: clinicaltrials.gov Identifier: NCT01573858.

[Activity and role of tryptase after entrance of amniotic fluid into blood in rats].

OBJECTIVE: To investigate the activity and role of tryptase after entrance of amniotic fluid into blood in rats. METHODS: Thirty female Wistar rats (20 day pregnancy) were divided into the control group (10, injected with normal saline), amniotic group (10, injected with amniotic fluid), meconium group (10, injected with 1% meconium). After injection, pulmonary tissue was taken out. Tryptase activity was measured by special substrate. The histology of pulmonary tissue was determined by immunohistochemistry (HE). RESULTS: (1) Dropsy, hemorrhage, and infiltration of neutrophil (PMN), macrophage, leukomonocyte were observed in two experimental groups, but no such changes were found in control group. (2) After injection, tryptase activity in meconium group 176.4 +/- 8.6 and amniotic fluid group 165.4 +/- 7.4 was significantly higher than preexperimental groups 146.8 +/- 8.9 and 147.8 +/- 9.5, respectively (t = 7.58 and t = 4.64, P < 0.01); tryptase activity in control group was 145.3 +/- 10.6 before injection and 146.9 +/- 9.4 after injection, respectively, there was no difference (t = 0.37, P > 0.05). After injection, tryptase activity in meconium and amniotic fluid groups was significantly increased than that in control group (F = 30.66, P < 0.05). CONCLUSION: The activity of tryptase was significantly increased after entrance of amniotic fluid into blood in rats. Degranulation of mast cells to release tryptase may be the important cause of the pathophysiologic change after entrance of amniotic fluid into blood. These results suggest a role for mast cell activation in the mechanism of amniotic fluid embolism. This method is sensitive and effective for diagnosis of amniotic fluid embolism in clinic.