Evidence map›Paper›PMID 38081673›Full record

Trial reportBMJ open2023

Cost-effectiveness of Spironolactone for Adult Female Acne (SAFA): economic evaluation alongside a randomised controlled trial.

Sarah Pyne, Tracey H Sach, Megan Lawrence, Susanne Renz, Zina Eminton, Beth Stuart, Kim S Thomas, Nick Francis, Irene Soulsby, Karen Thomas and 8 more

Open access · goldAbstract readRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
1.1field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 7 institutions in 1 country.

Sarah PyneHealth Economics Group, Norwich Medical School, University of East Anglia, Norwich, Norfolk, UK.ORCID 0000-0003-0093-9125
Tracey H SachHealth Economics Group, Norwich Medical School, University of East Anglia, Norwich, Norfolk, UK t.sach@soton.ac.uk.ORCID 0000-0002-8098-9220
Megan LawrenceSouthampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Susanne RenzSouthampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Zina EmintonSouthampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Beth StuartPrimary Care Research Centre, School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.ORCID 0000-0001-5432-7437
Kim S ThomasCentre for Evidence Based Dermatology, University of Nottingham, Nottingham, UK.ORCID 0000-0001-7785-7465
Nick FrancisPrimary Care Research Centre, School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.ORCID 0000-0001-8939-7312
Irene SoulsbyPublic Contributor, Primary Care Research Centre, University of Southampton, Southampton, Hampshire, UK.
Karen ThomasPublic Contributor, Primary Care Research Centre, University of Southampton, Southampton, Hampshire, UK.
Natalia V PermyakovaSouthampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Matthew J RiddPopulation Health Sciences, University of Bristol, Bristol, Bristol, UK.ORCID 0000-0002-7954-8823
Paul LittlePrimary Care Research Centre, School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.ORCID 0000-0003-3664-1873
Ingrid MullerPrimary Care Research Centre, School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.ORCID 0000-0001-9341-6133
Jacqui NuttallSouthampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Gareth GriffithsSouthampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Alison M LaytonSkin Research Centre, Hull York Medical School, University of York, York, North Yorkshire, UK.
Miriam SanterPrimary Care Research Centre, School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.ORCID 0000-0001-7264-5260
University Hospital Southampton NHS Foundation Trust · GBUniversity of Southampton · GBUniversity of East Anglia · GBUniversity of Nottingham · GBQueen Mary University of London · GBUniversity of Bristol · GBUniversity of York · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 NUMBER: ISRCTN registry (ISRCTN12892056).

Indexed as

Acne VulgarisSpironolactoneAdultCost-Benefit AnalysisCost-Effectiveness AnalysisFemaleHumansQuality-Adjusted Life YearsQuality of LifeState MedicineSpironolactoneAcneAdult dermatologyClinical TrialDermatologyHealth economicsHEALTH ECONOMICS

Identifiers

PMID38081673
PMCPMC10729081
OpenAlexW4389542050

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.