Sexual dysfunction following retinoid treatment: a systematic review
Heidi Oi-Yee Li; Elena Pastukhova; Olivier Brandts-Longtin; Adrian Joseph-Michel Bailey; Marcus G. Tan; Mark G. Kirchhof
British Journal of Dermatology2024
In plain terms
Researchers searched two large medical databases for studies of sexual problems linked to retinoid medicines taken by mouth, such as isotretinoin for acne. Of 880 records, 11 studies fit: six reports on single patients and five larger studies. The findings disagreed: a database of side-effect reports linked isotretinoin with slightly more reports of erection problems than expected, while a large health-records study found no difference between men with acne who took it and men who did not. The authors concluded the evidence is conflicting and of low quality, and cannot show whether retinoids cause these problems.
What it doesn’t show: It can't settle whether sexual problems last after a retinoid is stopped: most of the studies it found described problems during treatment, it did not look at lasting problems separately, and the studies were too different to combine.
Summary (paraphrased)
A short systematic review in a major dermatology journal surveys the evidence on sexual dysfunction after systemic retinoid therapy, in the context of existing product-label warnings for post-retinoid sexual dysfunction and recent regulatory safety decisions. It concludes that the available evidence is conflicting and of low quality, and that causation between retinoids and sexual dysfunction cannot currently be established. The letter uses PRSD for sexual side effects of retinoids in general: most included studies described effects during treatment, and persistence after stopping was not assessed separately. The authors advise dermatologists and patients to be aware of the contradictory data. They also suggest that routine screening for sexual side effects during treatment may be reasonable, since patients are unlikely to volunteer these concerns.
Evidence
Extracted from the full text; page numbers refer to the paper. The library’s own notes are labelled as such.
- Design
- Systematic reviewSystematic review (research letter), registered on PROSPERO (CRD42023495820), MEDLINE and Embase searched from inception to 26 January 2024 following PRISMA, JBI risk-of-bias appraisal, narrative synthesis without meta-analysis
- Setting
- Human studies published 1988–2024, from the USA, Denmark, Ireland, the UK, Italy and Turkey, plus one global online case series
- Population
- People treated with systemic retinoids (isotretinoin, etretinate or acitretin) for acne, psoriasis or ichthyosis, in studies of 1 to 13,600 participants.
- Size
- 11 · 11 studies from 880 records (6 case reports, 2 case series, 2 cross-sectional, 1 cohort); participants per study 1 to 13,600
- Exposure
- Systemic retinoids; isotretinoin in 7 studies, etretinate in 2, acitretin in 2
- Compared with
- Only the cohort study had an untreated comparison group (men with acne on no systemic medication); the FAERS study compared against reports for other drugs
- Outcome
- Any reported sexual dysfunction or genital side effect (e.g. erectile dysfunction, loss of libido, ejaculation failure, genital anaesthesia, vulvovaginal dryness, painful sex, vaginal bleeding); no included study used a validated scale.
- Follow-up
- Not applicable; follow-up in the included studies was mostly unclear
Key results
- 11 of 880 records included: 6 case reports, 2 case series, 2 cross-sectional studies and 1 cohort study; designs too varied for meta-analysis · p. 175
- Women: in one cross-sectional study 20 of 50 women (40%) on isotretinoin had vulvovaginal symptoms after more than 3 months of treatment, including vulval dryness in 16 of 50 (32%) and painful sex in 10 of 50 (20%); in a study of acitretin, vaginal dryness in 11 of 160 women (6.9%) · p. 175, Table 1 (p. 176)
- Men on isotretinoin, conflicting results: a FAERS analysis of 181 men found a weak signal for erectile dysfunction (PRR 1.24, 95% CI 1.03–1.45), while a matched TriNetX cohort of 13,600 found no difference in erectile dysfunction (aRR 1.0, 95% CI 0.55–1.4), sexual dysfunction (0.74, 0.39–1.38), decreased libido (1.0, 0.42–2.4) or PDE5 inhibitor use (1.1, 0.62–1.9) · p. 175, Table 1 (p. 176)
- RxISK case series of 54 isotretinoin cases (49 men, 5 women): erectile dysfunction in 46 of 49 men (94%), loss of libido in 35 of 49 (71%), genital anaesthesia in 18 of 49 (37%); loss of libido in 5 of 5 women and genital anaesthesia in 3 of 5 · Table 1 (p. 176)
- The text reports more than 300 PRSD cases across the studies (p. 175); the affected people listed in Table 1 sum to about 278 (6 single cases, 54, 181, 20 women in one study and 17 genital or sexual events in another; the cohort gives no case count). The cited RxISK paper's title refers to 300 cases across three drug classes, of which 54 were isotretinoin · pp. 175–177, Table 1
- Conclusion: the evidence is conflicting and of low quality, and causation between retinoids and PRSD cannot be established; the authors suggest routine screening for sexual side effects during treatment may be reasonable · p. 175
Limitations the authors note
- Most included papers were case studies, with small samples, no control groups, and confounding, selection and reporting biases
- The few larger studies relied on administrative or reporting databases; TriNetX is limited by generalisability and under-reporting, and FAERS may over-report because anyone can file
- Confounders such as mental illness, self-esteem, other illnesses and other medicines were not adjusted for
- No included study used validated objective scales to classify PRSD
- Study designs were too varied for a meta-analysis
Also worth weighing (library’s note)
- The letter uses PRSD for any sexual side effect of retinoids; most included reports describe effects during treatment, and persistence after stopping is not assessed separately (pp. 175–176)
- A short research letter; only two databases were searched, and the number of reviewers, a flow diagram and reasons for exclusion are not reported
- Canada is listed among the study countries (p. 175), but no included study in Table 1 is from Canada
- For erectile dysfunction in the cohort study, the interval 0.55–1.4 is not centred on the stated aRR of 1.0 on the ratio scale (its midpoint is about 0.88), unlike the other three estimates; the figure may need checking against the original paper
- The letter calls a dose finding from a cross-sectional study a "causal relationship" (p. 175), which that design cannot establish
Funding: No specific grant from any funding agency Interests: None declared
What it can support (library’s note): That, as of January 2024, published evidence on sexual dysfunction with systemic retinoids was sparse, conflicting and mostly low quality, and could not establish causation. It does not show that retinoids do not cause lasting sexual problems, and it did not assess persistence after stopping separately.
Why it’s in the corpus
The most prominent peer-reviewed synthesis to date that directly names PRSD; its "conflicting, low-quality evidence" verdict is the key counterweight the corpus needs alongside patient-reported and pharmacovigilance data.
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