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.

Production and partial purification of tannase from Aspergillus ficuum Gim 3.6.

A novel fungal strain, Aspergillus ficuum Gim 3.6, was evaluated for its tannase-producing capability in a wheat bran-based solid-state fermentation. Thin-layer chromatography (TLC) analysis revealed that the strain was able to degrade tannic acid to gallic acid and pyrogallol during the fermentation process. Quantitation of enzyme activity demonstrated that this strain was capable of producing a relatively high yield of extracellular tannase. Single-factor optimization of process parameters resulted in high yield of tannase after 60 hr of incubation at a pH of 5.0 at 30°C, 1 mL of inoculum size, and 1:1 solid-liquid ratio in the presence of 2.0% (w/v) tannic acid as inducer. The potential of aqueous two-phase extraction (ATPE) for the purification of tannase was investigated. Influence of various parameters such as phase-forming salt, molecular weight of polyethylene glycol (PEG), pH, and stability ratio on tannase partition and purification was studied. In all the systems, the target enzyme was observed to preferentially partition to the PEG-rich top phase, and the best result of purification (2.74-fold) with an enzyme activity recovery of 77.17% was obtained in the system containing 17% (w/w) sodium citrate and 18.18% (w/w) PEG1000, at pH 7.0.

[Expression of novel apoptosis-related protein PDCD5 in granulosa cells of polysystic ovary syndrome].

OBJECTIVE: To detect the novel apoptosis-related protein PDCD5 expression in granulosa cells of polysystic ovary syndrome (PCOS) and normal ovary, and explore the pathogenesis of PCOS. METHODS: The granulosa cells were collected from 30 cases of PCOS and normal ovary in IVF-ET. Expression of PDCD5 was detected by flow cytometry; immunofluorescence and immunohistochemistry. Cell apoptosis was detected by Propidium Iodide (PI) staining. RESULTS: The number of hypodiploidy cells associated with apoptosis in granulosa cells of PCOS was greater than that of the normal control. PDCD5 protein expression in PCOS granulosa cells was significantly higher than that in normal ovary (P<0.05). PDCD5-positive cells were mainly observed in cytoplasm. There was no significant difference between the two groups in terms of age, basal serum FSH concentration, number of ampules of FSH administered. CONCLUSION: Our data suggest that PDCD5 is an important apoptosis regulating factor in granulosa cells of PCOS and normal ovary, which might be involved in the pathogenesis of PCOS.

[The differential expression profile of polycystic ovary syndrome associated genes].

OBJECTIVE: To explore the gene differential expression pattern of polycystic ovary syndrome. METHODS: We carried out microarray analysis to define the gene networks by the PCOS granulosa cells in order to identify differentially expressed genes in PCOS patients. These granulosa cells of five PCOS cases and five control cases which were derived during oocyte retrieval from women undergoing IVF. RESULTS: As compared with control human ovarian granulosa cells, 46 genes were screened out, 25 genes were up-regulated, and 21 genes were down-regulated in PCOS. These differentially expressed genes were involved in various biologic functions, such as regulation of fatty acid metabolism, cell-cell signal transduction, immune and inflammatory response, reflecting the complexity of clinical manifestations of PCOS. CONCLUSION: Microarray analysis technology is an effective method to identify novel PCOS associated candidate genes.