Acne and PCOS with hyperandrogenism
Moderate-to-severe acne in women with hyperandrogenism signs (seborrhea, hirsutism, irregular menses) and polycystic ovary syndrome. Per AEDV 2023 and Spanish SEEN 2022 hormonal therapy (COCs with antiandrogenic progestin: drospirenone, dienogest, cyproterone) is second-line after topical retinoids and systemic antibiotics. Cyproterone 2 mg + ethinylestradiol 35 µg (Diane 35) is approved only for acne with hirsutism resistant to other therapy, not as first-line.
Also known as: Androgen-dependent acne, PCOS-related hirsutism
Drugs used for this condition
- BCyproterone acetate + EthinylestradiolSecond line · Antiandrogenic COCSevere acne with hirsutism unresponsive to topical retinoids and systemic antibiotics. Per AEDV 2023 and EMA 2013, Diane 35 is second-line after systemic retinoids (isotretinoin) in women who also need contraception. Use no longer than 3–6 months after symptom resolution. Switch to drospirenone- or dienogest-containing COCs if contraception is still needed.
- BEthinylestradiolSecond line · Estrogens. Natural and semisynthetic estrogens, plainSelected COCs with ethinylestradiol (combined with drospirenone, norgestimate, cyproterone) are FDA-approved for moderate acne in women of reproductive age who also need contraception. The effect develops over 3–6 months. Prescribed only when contraindications to combined hormonal contraception are absent and after discussion of risk-benefit balance with the patient (thromboembolism risk versus added benefit over standard anti-acne therapy).
- BEthinylestradiol + NorgestimateSecond line · COC with norgestimateModerate acne in women who also need contraception. Per AEDV 2023, COCs with antiandrogenic progestins (norgestimate, dienogest, drospirenone) are second-line after topical retinoids and systemic antibiotics. Effect by 3–6 months. For acne without contraceptive need, systemic retinoids or antibiotics, not COCs.
Marketing claims without evidence base
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
- DBifidobacterium longumNot recommended · Probiotic, Bifidobacterium genus bacteria. Supplement in Russia and Spain; marketing segment of «psychobiotics» promising gut-brain axis effects. AEMPS does not register it as a medicineBifidobacterium longum is a probiotic strain added to supplements and marketed for acne and as support in polycystic ovary syndrome with hyperandrogenism. There is no convincing evidence that taking this strain improves acne or lowers androgen levels in PCOS. For acne, topical retinoids, benzoyl peroxide, azelaic acid, and systemic options where indicated have proven benefit; for PCOS with hyperandrogenism, doctor-selected hormonal therapy, metformin, and weight management help. The strain is harmless, but do not use it in place of treatment with proven benefit – that risks delaying the care you actually need.
- DDiindolylmethane (DIM)Not recommended · Indole-3-carbinol metabolite from cruciferous vegetables, supplement. AEMPS does not register as medicineDiindolylmethane (DIM) is a compound formed from indole-3-carbinol in cruciferous vegetables; it's marketed as a supplement that balances androgen metabolism and so helps with acne and the hyperandrogenism of PCOS. DIM hasn't shown convincing benefit for this use – there's no solid evidence base for acne or PCOS. For acne and hyperandrogenism in PCOS, other approaches have proven results: topical retinoids and azelaic acid, combined oral contraceptives and spironolactone prescribed by a doctor, and weight loss when there's insulin resistance.
How to read tiers A–F
Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.
- AStrong evidence – first or second line in international guidelines
- BRecommended in selected cases
- CStudy data contradict each other
- DBenefit not proven, no documented harm
- FDocumented harm, or risk without benefit