A randomized, double-blind, crossover trial comparing a silicone- versus water-based lubricant for sexual discomfort after breast cancer
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Discomfort during sexual activity is common after breast cancer. Vaginal estrogens are effective but commonly avoided due to systemic absorption. Despite the large commercial market for vaginal lubricants, no randomized studies have compared products. We aimed to compare efficacy and acceptability of two major types of lubricant for discomfort during sexual activity in postmenopausal breast cancer patients. In a single-center, randomized, double-blind, AB/BA crossover design, sexually active postmenopausal breast cancer patients used each lubricant for 4 weeks. The primary patient-reported efficacy outcome was total discomfort related to sexual activity (Fallowfield Sexual Activity Questionnaire Discomfort subscale SAQ-D). Acceptability was measured by patient preference and reported intention to continue using the products. Of 38 women analyzed, over 90 % experienced clinically significant sexually related distress at baseline. Water- and silicone-based lubricants did not differ statistically in efficacy based on total sexual discomfort (difference 0.7, 95 % confidence interval (CI) 0–1.4, p = 0.06). In a post hoc analysis, pain/discomfort during penetration improved more during silicone-based lubricant use than during water-based lubricant use (odds ratio 5.4, 95 % CI 1.3–22.1, p = 0.02). All aspects of sexual discomfort measured with diaries were reported more commonly with water- than silicone-based lubricant. Almost twice as many women preferred silicone-based to water-based lubricant than the converse (n = 20, 65 %, vs. n = 11, 35 %). 88 % continued to experience clinically significant sexually related distress despite use of either lubricant. Total sexual discomfort was lower after use of silicone-based lubricant than water-based, but many women continue to experience sexually related distress.
KeywordsDyspareunia Sexual activity Lubrication Quality of life Survivorship
Our thanks to the participants in the study, to study coordinator Soula Krejany, to study nurses Lee Ann Mahoney, Kathrine Allardice, and Lorraine Thomason, to research pharmacists Lisa Wolke and Christine Gilmartin and to the MSAC Clinic and RWH Pharmacy staff.
M Hickey and JL Marino designed the study. M Hickey recruited the participants and provided supervision and overview of findings. JL Marino constructed the database and contributed to the statistical analysis of the data. S Wong managed the randomization and lubricant allocation. S Braat contributed to the statistical analysis of the data. All authors contributed to the manuscript.
Compliance with ethical standards
Conflict of interest
The study was partially supported by an educational grant from pjur, Luxembourg, which included supply of both water- and silicone-based lubricants but not packaging for double blinding. The company had no input into the study design, data collection, analysis of findings, interpretation of results, or writing of this manuscript. The pjur group approved the submitted version of this manuscript.
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