背景:安慰剂对此类客观指标的影响,精子质量和不育,以前没有研究过,但是一些研究报告说,安慰剂甚至可能扭曲客观的结果。本研究的目的是评估安慰剂对精子异常和/或不育患者生育能力的影响。
方法:我们搜索了两个数据库(Scopus和MEDLINE),并确定了安慰剂对照临床试验,重点是精子异常和/或男性不育治疗。主要结果包括精液参数的变化(体积,总计数,精液中的精子浓度,渐进运动,形态(正常细胞)。次要结果包括DNA片段化和妊娠率的变化。
结果:包括1983年至2022年发表的77篇文章。观察到以下值具有统计学意义的变化:精子总数,平均变化0.16(95%CI0.05,0.26);P=0.004,I2=75.1%;和渐进运动,平均变化0.13(95%CI0.02,0.24);P=0.026,I2=84.9%。相比之下,安慰剂不影响精子浓度,精子体积,精子形态或DNA碎片指数。用Egger测试和漏斗图测量的所有值的发表偏倚都很低。
结论:目前的荟萃分析表明安慰剂组精子总数和进行性运动性有统计学意义的增加。相比之下,安慰剂不影响精子浓度,精子体积,精子形态和DNA碎片指数。在计划或分析安慰剂对照临床试验时,应考虑这些发现。
BACKGROUND: Placebo influence on such objective indicators, as sperm quality and infertility, has not been studied previously, but some studies report that placebo may distort even objective outcomes. The aim of current study is to assess the placebo effect on fertility in patients suffering from sperm abnormalities and/or infertility.
METHODS: We conducted a search of two databases (Scopus and MEDLINE) and identified placebo-controlled clinical trials which focused on sperm abnormalities and/or male infertility treatment. Primary outcomes included changes in semen parameters (volume, total count, sperm concentration in semen, progressive motility, morphology (normal cells)). Secondary outcomes included DNA fragmentation and change in pregnancy rate.
RESULTS: Seventy-seven articles published from 1983 to 2022 were included. Statistically significant changes were observed for the following values: total sperm count, mean change 0.16 (95% CI 0.05, 0.26); P=0.004, I2=75.1%; and progressive motility, mean change 0.13 (95% CI 0.02, 0.24); P=0.026, I2=84.9%. In contrast, placebo did not affect sperm concentration, sperm volume, sperm morphology or DNA fragmentation index. The publication bias for all the values measured with Egger\'s test and funnel plots was low.
CONCLUSIONS: The current meta-analysis indicated a statistically significant increase of total sperm count and progressive motility in the placebo group. In contrast, placebo did not affect sperm concentration, sperm volume, sperm morphology and DNA fragmentation index. These findings should be considered while planning or analyzing placebo-controlled clinical trials.