Kim Yun Hwan, Park Sanghui, Lee Maria, Hahn Seokyung, Jeon Myung Jae
Departments of Obstetrics and Gynecology and Pathology, Ewha Womans University School of Medicine, and the Department of Obstetrics and Gynecology, College of Medicine, and the Medical Research Collaborating Center, Seoul National University Hospital, Seoul, Republic of Korea.
Obstet Gynecol. 2017 May;129(5):870-876. doi: 10.1097/AOG.0000000000001988.
To assess whether a pH-balanced vaginal gel containing lactic acid is more effective than a placebo (lactate-free gel) in improving dyspareunia and sexual function among breast cancer survivors who were premenopausal at diagnosis and had dyspareunia after adjuvant chemotherapy.
In a single-center, double-blind, randomized trial, a pH-balanced gel or placebo was administered three times per week at bedtime as well as during sexual intercourse for 8 weeks. The primary outcome was the improvement of dyspareunia measured by pain score of the Female Sexual Function Index after the treatment. Secondary outcomes included the total and individual domains of Female Sexual Function Index score, sexual dysfunction (a total Female Sexual Function Index score less than 25.0), vaginal pH, vaginal maturation index, and adverse events related to the intervention. A sample size of 47 per group was planned to achieve 80% power to detect a 19% difference in the primary outcome.
From October 2009 and March 2013, 167 women were screened and 136 were randomized: 69 to a pH-balanced gel and 67 to placebo. Baseline characteristics were similar in both groups. Although there was no difference between the two groups, both experienced a significant improvement of dyspareunia. The increase in median pain score from baseline was 1.2 in both groups (median [interquartile range] from 2.8 [2.0-4.0] to 4.0 [2.8-4.8] in the pH-balanced group and from 3.2 [2.0-4.0] to 4.4 [3.2-4.8] in the placebo group; all P<.01). Overall Female Sexual Function Index score and the frequency of sexual dysfunction also did not differ between the two groups although there was a significant improvement. On the other hand, vaginal pH and vaginal maturation index were slightly but significantly improved only in the pH-balanced group. There were no severe adverse events in either group.
The pH-balanced vaginal gel is not superior to the placebo in improving dyspareunia and overall sexual function.
ClinicalTrials.gov, https://www.clinicaltrials.gov, NCT00981305.
评估含乳酸的pH平衡阴道凝胶在改善诊断时处于绝经前且辅助化疗后出现性交困难的乳腺癌幸存者的性交困难和性功能方面是否比安慰剂（无乳酸凝胶）更有效。
在一项单中心、双盲、随机试验中，pH平衡凝胶或安慰剂在睡前以及性交期间每周给药三次，共8周。主要结局是通过治疗后女性性功能指数的疼痛评分来衡量性交困难的改善情况。次要结局包括女性性功能指数评分的总和各个领域、性功能障碍（女性性功能指数总分低于25.0）、阴道pH值、阴道成熟指数以及与干预相关的不良事件。计划每组样本量为47例，以获得80%的检验效能来检测主要结局中19%的差异。
从2009年10月至2013年3月，167名女性接受筛查，136名被随机分组：69名使用pH平衡凝胶，67名使用安慰剂。两组的基线特征相似。虽然两组之间没有差异，但两组的性交困难均有显著改善。两组从基线开始的中位疼痛评分增加均为1.2（pH平衡组从2.8[2.0 - 4.0]至4.0[2.8 - 4.8]，安慰剂组从3.2[2.0 - 4.0]至4.4[3.2 - 4.8]；所有P <.01）。尽管有显著改善，但两组的女性性功能指数总分和性功能障碍频率也没有差异。另一方面，仅pH平衡组的阴道pH值和阴道成熟指数有轻微但显著的改善。两组均无严重不良事件。
pH平衡阴道凝胶在改善性交困难和总体性功能方面并不优于安慰剂。
ClinicalTrials.gov，https://www.clinicaltrials.gov，NCT00981305 。
