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Oral Spironolactone for Acne Vulgaris in Adult Females: A Hybrid Systematic Review.

ABSTRACT: BACKGROUND:The management of acne in adult females is problematic, with many having a history of treatment failure and some having a predisposition to androgen excess. Alternatives to oral antibiotics and combined oral contraceptives (COCs) are required. OBJECTIVE:Our aim was to conduct a hybrid systematic review of the evidence for benefits and potential harms of oral spironolactone in the management of acne in adult females. METHODS:The review was conducted according to a previously published protocol. Three reviewers independently selected relevant studies from the search results, extracted data, assessed the risk of bias, and rated the quality of the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS:Ten randomized controlled trials (RCTs) and 21 case series were retrieved. All trials were assessed as being at a 'high risk' of bias, and the quality of evidence was rated as low or very low for all outcomes. Apart from one crossover trial that demonstrated statistical superiority of a 200 mg daily dose versus inflamed lesions compared with placebo, data from the remaining trials were unhelpful in establishing the degree of efficacy of lower doses versus active comparators or placebo. Menstrual side effects were significantly more common with the 200 mg dose; frequency could be significantly reduced by concomitant use of a COC. Pooling of results for serum potassium supported the recent recommendation that routine monitoring is not required in this patient population. CONCLUSION:This systematic review of RCTs and case series identified evidence of limited quality to underpin the expert endorsement of spironolactone at the doses typically used (?100 mg/day) in everyday clinical practice.

SUBMITTER: Layton AM

PROVIDER: S-EPMC5360829 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Oral Spironolactone for Acne Vulgaris in Adult Females: A Hybrid Systematic Review.

Layton Alison M AM Eady E Anne EA Whitehouse Heather H Del Rosso James Q JQ Fedorowicz Zbys Z van Zuuren Esther J EJ

American journal of clinical dermatology 20170401 2

<h4>Background</h4>The management of acne in adult females is problematic, with many having a history of treatment failure and some having a predisposition to androgen excess. Alternatives to oral antibiotics and combined oral contraceptives (COCs) are required.<h4>Objective</h4>Our aim was to conduct a hybrid systematic review of the evidence for benefits and potential harms of oral spironolactone in the management of acne in adult females.<h4>Methods</h4>The review was conducted according to a ...[more]

PMID: 28155090

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Project description:IntroductionAcne is one of the most common inflammatory skin diseases worldwide and can have significant psychosocial impact and cause permanent scarring. Spironolactone, a potassium-sparing diuretic, has antiandrogenic properties, potentially reducing sebum production and hyperkeratinisation in acne-prone follicles. Dermatologists have prescribed spironolactone for acne in women for over 30 years, but robust clinical study data are lacking. This study seeks to evaluate whether spironolactone is clinically effective and cost-effective in treating acne in women.Methods and analysisWomen (≥18 years) with persistent facial acne requiring systemic therapy are randomised to receive one tablet per day of 50 mg spironolactone or a matched placebo until week 6, increasing to up to two tablets per day (total of 100 mg spironolactone or matched placebo) until week 24, along with usual topical therapy if desired. Study treatment stops at week 24; participants are informed of their treatment allocation and enter an unblinded observational follow-up period for up to 6 months (up to week 52 after baseline). Primary outcome is the Acne-specific Quality of Life (Acne-QoL) symptom subscale score at week 12. Secondary outcomes include Acne-QoL total and subscales; participant acne self-assessment recorded on a 6-point Likert scale at 6, 12, 24 weeks and up to 52 weeks; Investigator's Global Assessment at weeks 6 and 12; cost and cost effectiveness are assessed over 24 weeks. Aiming to detect a group difference of 2 points on the Acne-QoL symptom subscale (SD 5.8, effect size 0.35), allowing for 20% loss to follow-up, gives a sample size of 398 participants.Ethics and disseminationThis protocol was approved by Wales Research Ethics Committee (18/WA/0420). Follow-up to be completed in early 2022. Findings will be disseminated to participants, peer-reviewed journals, networks and patient groups, on social media, on the study website and the Southampton Clinical Trials Unit website to maximise impact.Trial registration numberISRCTN12892056;Pre-results.

Project description:OBJECTIVE:We evaluated current evidence from randomised controlled trials (RCTs) regarding the effectiveness of chemical peeling for treating acne vulgaris. METHODS:Standard Cochrane methodological procedures were used. We searched MEDLINE, Cochrane Central Register of Controlled Trials and EMBASE via OvidSP through April 2017. Reviewers independently assessed eligibility, risk of bias and extracted data. RESULTS:Twelve RCTs (387 participants) were included. Effectiveness was not significantly different: trichloroacetic acid versus salicylic acid (SA) (percentage of total improvement: risk ratio (RR) 0.89; 95% CI 0.73 to 1.10), glycolic acid (GA) versus amino fruit acid (the reduction of inflammatory lesions: mean difference (MD), 0.20; 95%?CI -3.03 to 3.43), SA versus pyruvic acid (excellent or good improvement: RR 1.11; 95%?CI 0.73 to 1.69), GA versus SA (good or fair improvement: RR 1.00; 95%?CI 0.85 to 1.18), GA versus Jessner's solution (JS) (self-reported improvements: RR 1.00; 95%?CI 0.44 to 2.26), and lipohydroxy acid versus SA (reduction of non-inflammatory lesions: 55.6%vs48.5%, p=0.878). Combined SA and mandelic acid peeling was superior to GA peeling (percentage of improvement in total acne score: 85.3%vs68.5%, p<0.001). GA peeling was superior to placebo (excellent or good improvement: RR 2.30; 95%?CI 1.40 to 3.77). SA peeling may be superior to JS peeling for comedones (reduction of comedones: 53.4%vs26.3%, p=0.001) but less effective than phototherapy for pustules (number of pustules: MD -7.00; 95%?CI -10.84 to -3.16). LIMITATIONS:The methodological quality of the included RCTs was very low to moderate. Meta-analysis was not possible due to the significant clinical heterogeneity across studies. CONCLUSION:Commonly used chemical peels appear to be similarly effective for mild-to-moderate acne vulgaris and well tolerated. However, based on current limited evidence, a robust conclusion cannot be drawn regarding any definitive superiority or equality among the currently used chemical peels. Well-designed RCTs are needed to identify optimal regimens.

Project description:BackgroundMultiple factors have been attributed to acne vulgaris predisposition and individual variations in the severity of skin symptoms, and genetics stood out as one of the major factors.MethodsWe performed a systematic review on the genes and their variants that have been investigated for association with acne presentation and severity. A random-effect meta-analysis using the allele model (minor allele vs. major allele) was also conducted to provide an overall estimation of risk effects of frequently reported gene variants. This included a subset data of 982 acne cases and 846 controls extracted from our existing GWAS database on various allergic and skin diseases among Singapore Chinese.ResultsSystematic review of 51 articles covering Asians and Caucasians found 60 genes/loci and their 100 variants implicated in acne; majority of them were in the intron, coding region/missense, and promoter regions. The commonly studied candidate genes/gene families include tumor necrosis factor (TNF), and the interleukin (IL) and cytochrome P450 (CYP) gene families. Our meta-analysis showed that most of the analyzed gene variants exhibited insignificant pooled odds ratio (pOR) and significant heterogeneity between studies. Nevertheless, we found that TNF rs1800629 A allele carriers and CYP17A1 rs743572 T allele carriers had significantly reduced mild acne risk [pOR: 0.60; 95% Confidence Interval (CI): 0.33-0.86] and severe acne risk (pOR: 0.59; 95% CI: 0.40-0.79), respectively, across populations. Overall, FST (follistatin) rs629725 A allele poses a significantly modest increased risk for acne presentation (pOR: 1.19, 95% CI: 1.14, 1.23), but neither TIMP2 (TIMP metallopeptidase inhibitor 2) rs8179090 nor CYP1A1 rs4646903 (pOR: 0.96, 95% CI: 0.80-1.12; pOR: 0.95, 95% CI: 0.83, 1.08), respectively. We discovered 15 novel SNPs in the 3' UTR region of the Toll-like Receptor 4 gene (TLR4) associated with acne presentation.ConclusionsThis systematic review and meta-analysis suggest that genes influencing inflammatory responses, specifically TNF, and genes influencing the function and activity of sebaceous glands, specifically CYP17A1 and FST, have potential risk variants for acne presentation and severity across populations. Understanding the genetic susceptibility factors and biological pathways involved in the pathogenesis of acne will help us to gain insights into developing effective acne treatments.

Project description:ObjectiveThis study aims to estimate the cost-effectiveness of oral spironolactone plus routine topical treatment compared with routine topical treatment alone for persistent acne in adult women from a British NHS perspective over 24 weeks.DesignEconomic evaluation undertaken alongside a pragmatic, parallel, double-blind, randomised trial.SettingPrimary and secondary healthcare, community and social media advertising.ParticipantsWomen ≥18 years with persistent facial acne judged to warrant oral antibiotic treatment.InterventionsParticipants were randomised 1:1 to 50 mg/day spironolactone (increasing to 100 mg/day after 6 weeks) or matched placebo until week 24. Participants in both groups could continue topical treatment.Main outcome measuresCost-utility analysis assessed incremental cost per quality-adjusted life year (QALY) using the EQ-5D-5L. Cost-effectiveness analysis estimated incremental cost per unit change on the Acne-QoL symptom subscale. Adjusted analysis included randomisation stratification variables (centre, baseline severity (investigator's global assessment, IGA <3 vs ≥3)) and baseline variables (Acne-QoL symptom subscale score, resource use costs, EQ-5D score and use of topical treatments).ResultsSpironolactone did not appear cost-effective in the complete case analysis (n=126 spironolactone, n=109 control), compared with no active systemic treatment (adjusted incremental cost per QALY £67 191; unadjusted £34 770). Incremental cost per QALY was £27 879 (adjusted), just below the upper National Institute for Health and Care Excellence's threshold value of £30 000, where multiple imputation took account of missing data. Incremental cost per QALY for other sensitivity analyses varied around the base-case, highlighting the degree of uncertainty. The adjusted incremental cost per point change on the Acne-QoL symptom subscale for spironolactone compared with no active systemic treatment was £38.21 (complete case analysis).ConclusionsThe results demonstrate a high level of uncertainty, particularly with respect to estimates of incremental QALYs. Compared with no active systemic treatment, spironolactone was estimated to be marginally cost-effective where multiple imputation was performed but was not cost-effective in complete case analysis.Trial registration numberISRCTN registry (ISRCTN12892056).

Project description:BackgroundAcne vulgaris is a common skin condition that may cause psychosocial distress. There is evidence that topical treatment combinations, chemical peels and photochemical therapy (combined blue/red light) are effective for mild-to-moderate acne, while topical treatment combinations, oral antibiotics combined with topical treatments, oral isotretinoin and photodynamic therapy are most effective for moderate-to-severe acne. Effective treatments have varying costs. The National Institute for Health and Care Excellence (NICE) in England considers cost-effectiveness when producing national clinical, public health and social care guidance.AimTo assess the cost-effectiveness of treatments for mild-to-moderate and moderate-to-severe acne to inform relevant NICE guidance.MethodsA decision-analytical model compared costs and quality-adjusted life-years (QALYs) of effective topical pharmacological, oral pharmacological, physical and combined treatments for mild-to-moderate and moderate-to-severe acne, from the perspective of the National Health Service in England. Effectiveness data were derived from a network meta-analysis. Other model input parameters were based on published sources, supplemented by expert opinion.ResultsAll of the assessed treatments were more cost-effective than treatment with placebo (general practitioner visits without active treatment). For mild-to-moderate acne, topical treatment combinations and photochemical therapy (combined blue/red light) were most cost-effective. For moderate-to-severe acne, topical treatment combinations, oral antibiotics combined with topical treatments, and oral isotretinoin were the most cost-effective. Results showed uncertainty, as reflected in the wide confidence intervals around mean treatment rankings.ConclusionA range of treatments are cost-effective for the management of acne. Well-conducted studies are needed to examine the long-term clinical efficacy and cost-effectiveness of the full range of acne treatments.

Dataset Information

Oral Spironolactone for Acne Vulgaris in Adult Females: A Hybrid Systematic Review.

Publications

Oral Spironolactone for Acne Vulgaris in Adult Females: A Hybrid Systematic Review.

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