Spironolactone for Fphl
Verdict: Published with Warning
Across 6 PubMed studies, the evidence for Spironolactone in Fphl 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 0.71
D
C
B
A
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← counter-evidence / ineffectiveeffective / strong evidence →
Final grade
A · Published with Warning
Confidence
90%
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 = 0.715
- tier_from_score — 依分數區間映射至 tier letter
- apply_hec_rules — 高品質 SR/MA 顯示 positive (2 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 (6)L2 · primary research & systematic reviews
The Efficacy and Safety of Oral Spironolactone in the Treatment of Female Pattern Hair Loss: A Systematic Review and Meta-Analysis
Finding: Across 5 studies (413 patients) the overall improvement rate was 56.60%, higher with combination therapy (65.80%, e.g. + minoxidil) than monotherapy (43.21%), while 37.80% had no/modest improvement.
View on PubMed The efficacy of the combination of topical minoxidil and oral spironolactone compared with the combination of topical minoxidil and oral finasteride in women with androgenic alopecia, female and male hair loss patterns: A blinded randomized clinical trial
Finding: An 'excellent' response occurred in 56.7% of the minoxidil+spironolactone group vs 0% with minoxidil+finasteride (p=0.01); ineffective in 6.7% vs 16.7% respectively, with no placebo arm.
View on PubMed The Efficacy and Safety of Oral and Topical Spironolactone in Androgenetic Alopecia Treatment: A Systematic Review
Finding: Both oral and topical spironolactone showed efficacy for hair recovery in AGA, but no pooled effect size was reported; topical use had significantly fewer side effects than oral and was deemed suitable for any gender.
View on PubMed Treatment of female pattern hair loss with oral antiandrogens
Finding: Among the 80 women on oral antiandrogens, 44% had hair regrowth, 44% no clear change and 12% continued losing hair, so 88% had no progression or improvement; high midscalp grade was the only predictor and authors stressed a placebo-controlled trial is needed.
View on PubMed Efficacy and safety profile of oral spironolactone use for androgenic alopecia: A systematic review
Finding: This JAAD research-letter systematic review concluded oral spironolactone is an effective and reasonably tolerated off-label option for AGA, but PubMed carries no structured abstract so no pooled effect size or p-value could be verified.
View on PubMed Safety of Antiandrogens for the Treatment of Female Androgenetic Alopecia with Respect to Gynecologic Malignancies
Finding: This safety review concluded spironolactone 'seems to be safe for the systemic treatment of FAGA, even in high-risk populations,' with no quantified increase in gynecologic/breast cancer risk, though uncertainty remains for other antiandrogens.
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
Spironolactone (Aldactone), which is taken in a pill, seems to work best in women who haven't yet reached menopause. It is not approved by the U.S. Food and Drug Administration for hair loss, but it's helpful for hair loss. Spironolactone shouldn't be taken if you're pregnant or intending to become pregnant. Sometimes, it can cause headaches, breast tenderness or irregular menstrual periods, bu… source↗
L5c Cleveland Clinic
Supportive
Of the antiandrogen drugs used off-label, it is the one most commonly used. It has been used to treat female pattern hair loss for over two decades and has a good safety profile. An open-label trial showed that spironolactone 200 mg daily improved hair regrowth in 44% of patients at 12 months, which was comparable to cyproterone acetate. source↗
L5d Harvard Health
Supportive
Some women who don't respond to minoxidil may benefit from the addition of the diuretic drug spironolactone (Aldactone) for treatment of androgenic alopecia because this drug has anti-androgen properties. This medication is especially helpful for women with polycystic ovary syndrome (PCOS) because they tend to make excess androgens. Doctors will usually prescribe spironolactone together with an… source↗
L5e Specialty Society (condition-mapped)
Supportive
Oral spironolactone is a prescription medication that women can take to prevent further hair loss and increase hair thickness. Studies show that it is effective in about 40% of women who have female pattern hair loss. source↗