RESUMO
Objective: To analyze the effect of acupuncture versus hormone replacement therapy (HRT) for premature ovarian insufficiency (POI). Methods: China National Knowledge Infrastructure (CNKI), Wanfang Academic Journal Full-text Database (Wanfang), Chongqing VIP Database (CQVIP), China Biology Medicine Disc (CBM), Web of Science, Cochrane Library, PubMed, and Excerpta Medica Database (EMBASE) were searched up to January 31st, 2019 to identify randomized controlled trials (RCTs) evaluating the effect of acupuncture for POI. The primary outcome was the level of basal serum follicle- stimulating hormone (FSH). Secondary outcomes included serum levels of luteinizing hormone (LH), estradiol (E2) and anti-Müllerian hormone (AMH). Two authors extracted data independently and assessed the risk of bias and the methodological quality using the Cochrane's tool. Meta-analysis was conducted by RevMan version 5.3. Results: Eight eligible RCTs with a total of 496 POI patients were included in the meta-analysis. The pooled results showed that there was a significant reduction in the basal serum FSH level (MD=-5.82, 95%CI:-9.76 to -1.87, I2=82%, P=0.004) and a remarkable elevation in the basal E2 level (SMD=0.93, 95%CI: 0.34 to 1.52, I2=88%, P=0.002) in the acupuncture group when compared with the control. Subgroup analysis showed that compared with HRT, a significant decrease in the FSH level was observed in both acupuncture alone (MD=-4.53, 95%CI:-8.96 to -0.10, I2=73%, P=0.04) and acupuncture plus HRT (MD=-9.60, 95%CI:-17.60 to -1.61, I2=50%, P=0.02), while a remarkable elevation of E2 was only found in acupuncture plus HRT (SMD=1.43, 95%CI: 1.03 to 1.82, I2=0%, P<0.00001). There was no significant difference in the LH level between acupuncture and HRT (MD=-3.16, 95%CI:-9.41 to 3.10, I2=0%, P=0.32), only one trial reported AMH, and no significant difference was found between acupuncture and HRT. Conclusion: The present study indicated that acupuncture had an advantage over HRT in reducing serum FSH level and increasing serum E2 level in women with POI. However, evidence supporting the finding is limited due to the small sample size, potential methodological flaws and significant heterogeneity. Hence, this conclusion still needs to be verified by high-quality RCTs.
RESUMO
To explore the basic principles and methods of quality control of clinical registry research in the field of acupuncture. This study drawed on the data quality control methods of clinical trials in the United States and combined clinical practice experience, based on the "International Patient Registry Platform of Acupuncture and Moxibustion", and the registry study of acupuncture treatment for early-onset ovarian insufficiency as a model. The principles of accuracy, authenticity, consistency and completeness were followed. A remote and on-site quality control method with remote quality control as the main and on-site quality control as the supplement is formed, with a view to providing ideas and reference for the quality control of registry research.