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. 2017 Feb 2;18(2):169–191. doi: 10.1007/s40257-016-0245-x

Table 3.

Characteristics of the included case series

Study ID Prospective? What was reported Age range, years Primary diagnosis Secondary diagnoses Diagnoses excluded Dose of spironolactone Duration of therapy, months Concomitant medications
Azizlerli et al. [40] Yes (clarified by email) Efficacy and safety 18–33 Acne Hirsutism 9, menstrual irregularities 7 NR Starting at 200 mg and reducing to 100 or 50 mg/day over 5 months 1–18 (mean 9) Levonorgestrel/EE 12
Beksac et al. [41] Unclear Efficacy and safety 18–27 Idiopathic hirsutism Therapy resistant acne 7, menstrual irregularities 6 Obesity, major abnormalities in serum androgens 50 mg bid (n = 16); 50 mg/day (n = 6) from days 5 to 26 of the menstrual cycle 9 NR
Bravo Garcia et al. [42] Unclear Efficacy and safety 12–37 Acne Polycystic ovaries 35, idiopathic hyperandrogenemia 18, hirsutism and/or irregular menses 23 Hyperthyroidism, hyperprolactinemia,
congenital adrenal hyperplasia, Cushing’s syndrome, ovarian and adrenal tumors
50 mg bid from days 5 to 21 of the menstrual cycle 6 None permitted
Burke and Cunliffe [43] Unclear (probably retrospective) Efficacy NR Acne 8, hirsutism 12, alopecia 7 Primary diagnoses were mutually exclusive NR 200 mg/day 6 NR
Cortez de Castro et al. [44] Unclear Efficacy and safety 18–44 Persistent recalcitrant acne None reported Patients were otherwise healthy No evidence of endocrinopathies, no menstrual irregularities 2 × 25 mg bid (12 h apart) from start of menstruation for 15 days 1–11 NR
Hana et al. [45] Unclear Efficacy and safety 24–34 Hirsutism Seborrhea 6,
Abnormal menses 5, PCOS 4, adrenal carcinoma 1, acromegaly 1
NR 75 mg/day 24–34 NR
Hughes and Cunliffe [46] No Efficacy (not properly reported) and safety 21–51 Hirsutism 24, acne 21, acne and hirsutism 8, seborrhea 1 NR NR 200 mg/day initially, reduced in 8 patients as not tolerated 1–45 Unspecified oral contraceptive in 23 patients
Krunic et al. [47] Yes Efficacy and safety (latter not properly reported) 18–43 Severe papulo-pustular or nodulo-cystic acne that had failed to respond to at least one standard treatment None reported Pre-existing hyperkalemia, liver or kidney disease, diabetes mellitus 100 mg od in the morning Up to 6 Drospirenone/EE. Previously prescribed topical acne treatments continued
Lessner et al. [48] No Efficacy and safety 19–57 Cyclical late-onset acne vulgaris (i.e. acne worsening premenstrually, with lesions predominantly
on the lower face and neck)
NR Receiving oral or topical antibiotics or treated with PDT Initial dose 50 mg/day, escalated to 200 mg/day as and when necessary in 25 mg increments every 3 months. 11 patients were increased to 75 mg, and 4 were increased from 75 to 100 mg 2–102 Majority also treated with topical tretinoin
Or Adapalene™ at bedtime. Most had been receiving the topical retinoid prior to starting spironolactone
Lubbos et al. [49] Unclear Efficacy and safety 14–38 Idiopathic acne Oligomenorrhea 13 NR 50 mg bid on days 5–21 of the menstrual cycle 2–49
Therapy continued unless
‘significant’ adverse effects occurred
NR
Masahashi et al. [50] Unclear Efficacy and safety 21–36 Hyperandrogenism Oligomenorrhea 8, amenorrhea 9, acne and oily skin 5, oily skin 1, hirsutism 1, hirsutism 9, oily skin 1 NR 100–150 mg/day from day 5 of the menstrual cycle, then continuously 2–11 (mean 4.4) None 7, clomiphene (100 mg/day for 5 days from week 4) 10, plus bromocriptine (1.5–2.5 mg/day from week 8) in 3 patients
Messina et al. [51] No Efficacy (not properly reported) and safety 19–33 Hirsutism without any other sign of virilization Acne (unknown number), seborrhea (unknown number),
PCOS 1
All but the PCOS case had regular menses
Hirsutism associated with congenital adrenal hyperplasia or androgen-secreting tumor Group A (n = 10): 400 mg/day for first 10 days then 200–300 mg. Group B (n = 8): 200 mg/day continuously
Therapy started on the fifth day of the menstrual cycle in both groups
Up to 8.3 NR
Pugeat et al. [52] Unclear Efficacy and safety 16–42 Hirsutism Amenorrhea 8 ‘Associated pathologies’ 75 mg/day from the start of menstruation Demegestone 0.5 mg on days 14–24 of the cycle added from month 7 12 None permitted
Plovanich et al. [53] No Safety (serum electrolyte data only) 18–45 Acne Endocrine disorders including PCOS, hirsutism, alopecia, and hyperandrogenism 298 Heart failure, renal failure, renal disease 50–200 mg/day (personal communication) NR NR
Saint-Jean et al. [54] Unclear Efficacy and safety >20 Recalcitrant acne One patient had PCOS, 5 had irregular menses, 4 reported a premenstrual flare NR 75–150 mg/day Mean 17 months A topical acne treatment (not specified)
Sato et al. [55] Yes Efficacy and safety 15–46, both genders Acne NR NR 200 mg/day for first 8 weeks, then reduced by 50 mg every 4 weeks 5 months NR
Shaw [56] No Safety (serum electrolyte data only) NR Acne NR NR 50–150 mg/day NR NR
Shaw [57] No Efficacy and safety 18 –52 Inflammatory papular or nodular acne in 51/85 cases of adult onset; recalcitrant in 76 cases Hormonal influence 68, hirsutism 16, menstrual flare 23, history of ovarian cysts 4 NR 50–100 mg/day 2–24 (mean 10) Oral antibiotics, COC (norethindrone/EE), or both. 17 patients (20%) were treated with spironolactone alone; 46 (54%) were treated with a combination of spironolactone and systemic antibiotics; 10 (12%) received spironolactone plus oral contraceptives; 12 (14%) received spironolactone plus antibiotics and oral contraceptives
Shaw and White [58] No Safety 18–52 Adult acne NR NR 50–100 mg/day 0.5–122 (mean 28.5) Topical therapies, systemic antibiotics or oral contraceptives
Turowksi and James [59] No Efficacy and safety 18–59 Recalcitrant acne NR NR 50–100 mg, decreasing according to response. One patient receiving 200 mg/day Mean 19.5 Trimethoprim 2, cotrimoxazole 3 or amoxicillin 2 initiated at the same time as spironolactone. Concomitant topical medications (started earlier) included topical retinoid 22, azelaic acid 4 and benzoyl peroxide 11. 14 or 15 women were already taking a COC, 2 were using a depot hormonal contraceptive, and 4 were started on a COC
Yemisci et al. [60] Yes Efficacy and safety 18–31 Acne in adult females NR Pregnant women, women using oral contraceptives or other drugs with possible effects on hormone levels, and women with irregular menstruation or hirsutism were excluded 50 mg bid on days 5–21 of the cycle 3 Not permitted

od once daily, bid twice daily, COC combined oral contraceptive, EE ethinyl estradiol, PCOS polycystic ovarian syndrome, PDT photodynamic therapy, NR not reported