Spironolactone for Acne
Verdict: Published with Warning
Across 5 PubMed studies, the evidence for Spironolactone in Acne grades Tier A — moderate evidence. Effective, but with safety or population caveats.
A 🔵 A Moderate Evidence Published with Warning
Why this grade7-layer evidence engine
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Scoring transparency
All scores computed by a 7-layer evidence engine — fully auditableRaw score 0.74
D
C
B
A
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← counter-evidence / ineffectiveeffective / strong evidence →
Final grade
A · Published with Warning
Confidence
86%
Highly consistent evidence
Evidence level
E2
Multiple high-quality MAs (≥2 independent, consistent)
▸View the full decision path (audit trail)
- compute_raw_score — 加權公式: L2×0.30 + L3×0.25 + L5×0.25 + L11×0.10 + L1×0.10 = 0.745
- tier_from_score — 依分數區間映射至 tier letter
- apply_hec_rules — 高品質 SR/MA 顯示 positive (3 篇 > 0 negative)
- tier_strict_requirement_check — Tier 條件達標，未降階
- detect_disputes — 偵測到 0 個 hard + 0 個 soft dispute
- decide_status — 依 tier + dispute 結果決定 status
PubMed studies (5)L2 · primary research & systematic reviews
Efficacy and Safety of Oral Spironolactone for Women With Acne Vulgaris: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials With Trial Sequential Analysis
Finding: Objective acne improvement was sixfold higher with oral spironolactone than placebo (OR 6.59, 95% CI 3.50-12.43, p<0.00001, I2=0%), while menstrual irregularity (OR 1.09, p=0.88) and breast enlargement (OR 1.37, p=0.26) were not significantly increased.
View on PubMed Effectiveness of spironolactone for women with acne vulgaris (SAFA) in England and Wales: pragmatic, multicentre, phase 3, double blind, randomised controlled trial
Finding: Adjusted Acne-QoL symptom subscale favoured spironolactone by 1.27 points at week 12 (95% CI 0.07-2.46) and 3.45 points at week 24 (95% CI 2.16-4.75), with investigator-assessed treatment success of 19% vs 6% at week 12 (OR 5.18, 95% CI 2.18-12.28).
View on PubMed Spironolactone for the Treatment of Moderate to Severe Acne in Adult Women: A Systematic Review and Meta-Analysis of Randomised Controlled Trials
Finding: Spironolactone significantly increased the odds of treatment success (pooled OR 2.51 vs placebo or doxycycline), but the public abstract does not report the number of included trials, the total sample size, the 95% CI, or a p-value.
View on PubMed Efficacy and safety of Spironolactone in treating patients with acne vulgaris: a systematic review and meta-analysis of 1,086 patients
Finding: Topical 5% spironolactone reduced total lesion count (MD -6.85, 95% CI -10.94 to -2.76, p<0.01) and ASI (MD -6.33, 95% CI -8.89 to -3.76, p<0.01); safety profile described as excellent, but the authors caution that few eligible trials were available.
View on PubMed Oral and topical spironolactone in acne treatment: A meta-analysis of effectiveness and safety
Finding: Spironolactone significantly reduced ASI (MD -6.53, 95% CI -10.83 to -2.22, p=0.003) but showed NO statistically significant difference in total lesion, comedone, or papule counts at the 4-, 8-, and 12-week intervals; adverse events including menstrual abnormalities were similar across groups.
View on PubMed Regulatory & authoritative positionsL4/L5 · FDA / EMA / NIH ODS / Cochrane / Mayo …
L4a US FDA
Supportive
Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats. Spironolactone should be used only in those conditions described under INDICATIONS AND USAGE. Unnecessary use of this drug should be avoided. ALDACTONE is indicated for: Treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hosp… source↗
L4b EU EFSA
Supportive
Qaialdo received marketing authorization on 26 May 2023. It is authorized to manage refractory oedema associated with congestive heart failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, and for diagnosis and treatment of primary aldosteronism and essential hypertension. The medicine can only be obtained with a prescription, and children should only be tre… source↗
L4c UK NHS
Supportive
It's used to treat: swelling, in the ankles, feet and other parts of the body, caused by fluid build-up (oedema), heart failure, high blood pressure (hypertension) if other medicines have not worked. It's only available with a prescription. Spironolactone is not usually recommended during pregnancy. This is because it can potentially affect a baby's development. [Serious side effects include] h… source↗
L4d TW TFDA / 衛福部
Supportive
安達通錠25 毫克 Aldactone Tablets 25 mg 衛署藥輸字第022610號 本藥須由醫師處方使用。適應症：利尿、高血壓、原發性醛類脂醇過多症。孕婦用藥分級：D 級。高血鉀症徵象(有高達26%病人發生，即使與Thiazide 利尿劑合用亦如此)。 source↗
L4e WHO
Supportive
Spironolactone is an aldosterone receptor antagonist used to treat edema, hypertension, heart failure, and aldosteronism. More specifically, its antimineralocorticoid activity is responsible for its therapeutic efficacy in the treatment of edema, high blood pressure, heart failure, hyperaldosteronism, and ascites due to cirrhosis. Additionally, spironolactone reduces the rate of testosterone pr… source↗
L5a NIH Office of Dietary Supplements
Supportive
Spironolactone tablets are indicated for: (1) the treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure, and (2) use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Additionally, spironolactone is indicated for the management of edema in adult pa… source↗
L5b Mayo Clinic
Supportive
Approximately two-thirds of patients (66.1%) had a complete response [to spironolactone at a median dose of 100 mg daily]; 85.1% had a complete response or a partial response greater than 50%. Median times to initial response and maximum response were 3 and 5 months. Efficacy was observed across all severity subtypes of acne, including those with papulopustular and nodulocystic acne. Patients r… source↗
L5c Cleveland Clinic
Supportive
The American Academy of Dermatology (AAD) states that spironolactone has been shown to reduce acne by 50% to 100%. Spironolactone is usually prescribed as an oral medication (pill form) in doses ranging from 25 milligrams (mg) to 200 mg per day. Research shows that a low dose of 50 mg per day may be sufficient to treat hormonal acne. If you are pregnant, planning a pregnancy or breastfeeding, y… source↗
L5d Harvard Health
Supportive
For women with hormonally driven acne that flares with the menstrual cycle, a medication called spironolactone, which keeps testosterone in check, can be prescribed. source↗
L5e Specialty Society (condition-mapped)
Supportive
Hormonal therapies such as combined oral contraceptives or spironolactone to address hormonal causes of acne. source↗