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Abstract
Background Carrageenan-containing gels researched for the prevention of sexually transmitted infections (STIs) have shown promising results for human papillomavirus prevention in women, but not in men. We conducted a narrative review to assess the safety of these gels for genital use.
Methods We searched PubMed using MeSH terms and keywords on 5 November 2023. Title/abstract of articles were screened to identify relevant ones. Full-text screening determined eligibility: empirical study evaluating safety of carrageenan-containing gel(s) for genital use.
Results Of the 125 identified records, 15 were eligible, comprising 14 (10 randomised controlled trials and 4 cohorts) unique study populations. Studies included women only (n=11), men only (n=1) or both (n=3); number of participants ranged from 4 to 6202. Safety was assessed for vaginal (n=13), penile (n=3) and anal use (n=2). Most studies assessed safety of Carraguard (53%), followed by Divine9 (14%), and one each of iota-carrageenan gel, lambda-carrageenan gel, Carvir, PC-6500 (griffithsin and carrageenan) and PC-1005 (MIV-150/zinc acetate/carrageenan). Safety assessment relied on self-report (80.0%), testing for STIs (53.3%), investigator-identified genital findings (93.3%) and/or testing for changes in genital flora (60.0%). Adverse events (AEs) were described by investigators as mostly mild, (mostly) comparable between groups, not observed and/or not significant for vaginal and penile use. Only one study, assessing anal use of carrageenan, reported a significantly higher proportion of AEs in the carrageenan compared with placebo group.
Conclusions Carrageenan-based gels are generally well tolerated for vaginal and penile, but not anal use. Studies on carrageenan gel’s safety for anal use are scarce.
- HPV
- Human Papillomavirus
- Anti-Infective Agents
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Footnotes
Handling editor Stefano Rusconi
Correction notice This article has been corrected since it was first published online. The author
Eduardo L Franco was incorrectly listed as Eduardo Franco.
Contributors CL, ME and ELF designed the review. CL performed the literature search, extracted the data and drafted the manuscript. All authors interpreted the data, critically reviewed the manuscript and approved the final version.
Funding This work was supported by the Canadian Institutes of Health Research (foundation grant FDN-143347 awarded to ELF) and by the Cancer Research Society (operating support, grant 70302, to the Division of Cancer Epidemiology).
Competing interests ELF reports grants and personal fees from Merck, grants, personal fees and non-financial support from Roche, and personal fees from GSK, outside the submitted work. ELF and ME hold a patent related to the discovery ‘DNA methylation markers for early detection of cervical cancer’, registered at the Office of Innovation and Partnerships, McGill University, Montreal, Quebec, Canada (October 2018). CL has no conflicts of interest to declare.
Provenance and peer review Not commissioned; externally peer reviewed.
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