Oral Spironolactone for Acne Vulgaris in Adult Females: A Hybrid Systematic Review.

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hyperprolactinemia 1 endocrinologydiseases
norethindrone 1 endocrinologydiseasesdrugs
spironolactone 113 endocrinologydiseasesdrugs
bromocriptine 1 endocrinologydiseasesdrugs
cimetidine 7 endocrinologydiseasesdrugs
congenital adrenal hyperplasia 3 endocrinologydiseases
diabetes mellitus 1 endocrinologydiseases
hyperandrogenism 4 endocrinologydiseases
acromegaly 1 endocrinologydiseases
testosterone 2 endocrinologydiseasesdrugs

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Select Drug Character Offset Drug Term Instance
bromocriptine 36337 then continuously2–11 (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 patientsMessina et al. [[51]]NoEfficacy (not properly reported)
cimetidine 14926 lesion countsNo details providedWang et al. [[39]]16–33(a) ketoconazole 200 mg/day initially;(b) cimetidine 400 mg tid initially;(c) tetracycline 250 mg qid initiallyTopical treatment with unspecified active20 mg
cimetidine 26250 by Muhlemann et al. [[37]]Spironolactone versus CimetidineThree trials compared spironolactone with cimetidine using different daily doses of one or both drugs and different outcome measures [[33], [38], [39]].
cimetidine 26675 earliest trial [[33]] found no difference in acne severity score between spironolactone (100 mg/day) and cimetidine (1.6 g/day) [MD −4.20, 95% CI −17.48 to 9.08; p = 0.54] using the Michaëlsson scale [[78]].
cimetidine 26885 Similarly, the second study [[38]] found no difference between the same dose of spironolactone and cimetidine 1.4 g/day, using reduction in inflamed and non-inflamed lesions as the outcome measure. MDs were −3.3
cimetidine 27256 converted to a categorical improvement in 11/15 women receiving spironolactone and 6/14 women receiving cimetidine , showing at least a 50% reduction in lesions (RR 1.71, 95% CI 0.87–3.37; p = 0.12). In the final
cimetidine 27461 final trial [[39]], a lower dose of spironolactone (60 mg/day) was not significantly different to cimetidine for the number of participants with at least 50% reduction improvement (physician-assessed) at an initial
cimetidine 51947 efficacy.The trials that assessed comparative efficacy versus the anti-androgens flutamide, finasteride, cimetidine , ketoconazole and various COCs consistently found no difference between the spironolactone arm and the
norethindrone 38083 menstrual flare 23, history of ovarian cysts 4NR50–100 mg/day2–24 (mean 10)Oral antibiotics, COC ( norethindrone /EE), or both. 17 patients (20%) were treated with spironolactone alone; 46 (54%) were treated with a
spironolactone 704 was to conduct a hybrid systematic review of the evidence for benefits and potential harms of oral spironolactone in the management of acne in adult females.MethodsThe review was conducted according to a previously
spironolactone 2021 of RCTs and case series identified evidence of limited quality to underpin the expert endorsement of spironolactone at the doses typically used (≤100 mg/day) in everyday clinical practice.Electronic supplementary
spironolactone 2298 (doi:10.1007/s40257-016-0245-x) contains supplementary material, which is available to authorized users.Key PointsOral spironolactone is used off-label to treat persistent and late-onset acne in adult females.There is low-quality evidence
spironolactone 4704 sebocytes and inhibiting androgen-induced sebocyte proliferation [[16], [17]]. The systemic effects of spironolactone on adrenal synthesis of androgen precursors may also contribute to clinical efficacy, although at therapeutic
spironolactone 4887 clinical efficacy, although at therapeutic doses this may be unlikely [[18]]. The diuretic effect of spironolactone may benefit women who experience a premenstrual acne flare associated with fluid retention [[19]].Successful
spironolactone 5162 presents a considerable therapeutic challenge. As an anti-androgen and potential inhibitor of sebogenesis, spironolactone represents a possible alternative to oral isotretinoin and combined oral contraceptives (COCs), the
spironolactone 5716 review focusing primarily on hirsutism included only one randomized controlled trial (RCT) of oral spironolactone for acne in its analyses and concluded there was insufficient evidence for effectiveness in treating
spironolactone 5973 review, based largely on clinical experience, highlighted the potential therapeutic usefulness of oral spironolactone in the management of acne in adult females, and detailed recommendations about appropriate use and monitoring
spironolactone 6328 conducted a hybrid systematic review of all studies that had assessed the clinical efficacy of oral spironolactone for acne in women. The primary aim was to determine whether oral spironolactone monotherapy produces
spironolactone 6408 clinical efficacy of oral spironolactone for acne in women. The primary aim was to determine whether oral spironolactone monotherapy produces a degree of improvement in acne that is clinically important and comparable to
spironolactone 7237 (electronic supplementary material). The following trials registers were searched using the search terms spironolactone AND acne or ‘polycystic ovarian syndrome’.metaRegister of Controlled Trials (www.controlled-trials.com);US
spironolactone 11443 [54], [55], [57], [59], [60]], and three [[53], [56], [58]] articles reporting on the side effects of spironolactone in female patients with acne, but which contained no data on clinical outcomes. Eleven studies [[61]–[71]]
spironolactone 12357 did not mention any sources of funding [[31], [33], [36]–[39]], one was funded by a manufacturer of spironolactone [[30]], two were funded by non-industrial sponsors [[34], [35]] and one received no support from a pharmaceutical
spironolactone 12504 non-industrial sponsors [[34], [35]] and one received no support from a pharmaceutical company [[32]]. A spironolactone manufacturer supplied the active and placebo treatment in two trials [[31], [37]]. Declarations stating
spironolactone 12830 Table 1.Table 1Characteristics of included RCTsStudy IDAge range, yearsComparatorConcomitant medicationsDose of spironolactone Duration of therapy, monthsPrimary diagnosisDiagnoses excludedMain clinical outcome measure (acne)BlindingCusan
spironolactone 17226 [[31]–[33], [35], [36], [38], [39]].Effect of the InterventionsThe ten RCTs included 16 comparisons of spironolactone versus placebo or active treatment. The quality of the evidence was assessed for all comparisons and
spironolactone 17927 a crossover trial that examined 29 women [[37]]. For the inflamed lesion count, the MD in favor of spironolactone was 26.1 lesions fewer, despite baseline imbalance in favor of the placebo (p < 0.00001; PP population
spironolactone 18240 carryover effects, were not reported. Combined data from both phases showed that 18/21 women taking spironolactone , compared with 5/21 taking placebo, reported improvement (RR 3.6, 95% CI 1.64–7.89; p = 0.001),
spironolactone 18534 3.75, 95% CI 1.51–9.34; p = 0.005). In a mixed gender RCT [[36]], 24/30 participants receiving spironolactone (50 mg/day, including 27 women) improved, compared with 2/25 receiving placebo (PP population); separate
spironolactone 19120 improvement quantified. For details and quality of evidence, see Table 2.Table 2Summary of findings for spironolactone versus placeboSpironolactone (50, 100, 150, 200 mg/day and 25 mg bid) compared with placebo for adult
spironolactone 19841 CI)No. of participants (no. of studies)Quality of the evidence (GRADE)CommentsRisk with placeboRisk with spironolactone (50, 100, 150, 200 mg/day and 25 mg bid)Physician-assessed change in total lesion count (inflamed
spironolactone 20409 were only obtained from the study by Muhlemann et al. [[37]] for a dose of 200 mg/day. Treatment with spironolactone was more effective than placebo for inflamed lesions (p < 0.00001). Mansurul and Islam [[36]] failed
spironolactone 20709 acne severityFollow-up: mean 12 weeksIn the study by Goodfellow et al. [[31]], 6/9 females receiving spironolactone (≥100 mg/day) had improved (extent not reported). No data were available for females receiving placebo.
spironolactone 20899 for females receiving placebo. In the study by Mansurul and Islam [[36]], 24/30 patients receiving spironolactone (27 women, 3 men) versus 2/25 receiving placebo (including up to six men) had less acne (extent unclear)In
spironolactone 21189 combined, expressed as the number with at least 50% reduction in lesion count, showed 15/20 patients in the spironolactone group versus 4/20 in the placebo group, with a RR of 3.75 (95% CI 1.51–9.34; p = 0.005). This outcome
spironolactone 21934 acne severityFollow-up: mean 12 weeksIn the study by Goodfellow et al. [[31]], 6/9 women receiving spironolactone ≥ 100 mg reported improvement (extent not specified)In the study by Muhlemann et al. [[37]], data
spironolactone 22216 scale (improved = better or much better), showed 18/21 considered themselves improved while receiving spironolactone versus 5/21 in the placebo group, with an RR of 3.6 (95% CI 1.64–7.89; p = 0.001)34 (2 RCTs)⊕◯◯◯Very
spironolactone 23138 were reported for the placebo group in either trial. In the study by Muhlemann et al. [[37]], 11/15 spironolactone -treated patients not using an oral contraceptive reported menstrual irregularity, 3/21 reported nausea,
spironolactone 23535 females in the study by Mansurul and Islam [[36]](3 RCTs)⊕◯◯◯Very lowd,fThe reported effects of spironolactone on the menstrual cycle are well known. No unexpected side effects were reported. RRs could not be calculated
spironolactone 25303 the difference in lesion count reduction, which was already large, if there had been carryover of the spironolactone effect after the washout period had endedcAlthough only inflamed lesions were counted, and therefore
spironolactone 26230 imbalance in the study by Muhlemann et al. [[37]]Spironolactone versus CimetidineThree trials compared spironolactone with cimetidine using different daily doses of one or both drugs and different outcome measures [[33],
spironolactone 26642 between the two drugs. The earliest trial [[33]] found no difference in acne severity score between spironolactone (100 mg/day) and cimetidine (1.6 g/day) [MD −4.20, 95% CI −17.48 to 9.08; p = 0.54] using the
spironolactone 26866 Michaëlsson scale [[78]]. Similarly, the second study [[38]] found no difference between the same dose of spironolactone and cimetidine 1.4 g/day, using reduction in inflamed and non-inflamed lesions as the outcome measure.
spironolactone 27216 p = 0.12). Lesion counts were also converted to a categorical improvement in 11/15 women receiving spironolactone and 6/14 women receiving cimetidine, showing at least a 50% reduction in lesions (RR 1.71, 95% CI 0.87–3.37;
spironolactone 27398 reduction in lesions (RR 1.71, 95% CI 0.87–3.37; p = 0.12). In the final trial [[39]], a lower dose of spironolactone (60 mg/day) was not significantly different to cimetidine for the number of participants with at least
spironolactone 27899 Different COC Alone or Combined with an Anti-AndrogenAmong the remaining comparisons, four compared spironolactone in combination with a COC versus a COC alone [[35]] or combined with an anti-androgen: flutamide [[30]],
spironolactone 28110 [[30]], finasteride [[34]] or additional cyproterone acetate [[32]]. One trial compared 25 mg/day spironolactone plus desogestrel/ethinyl estradiol (EE) versus cyproterone acetate/EE [[35]]. Assessed using the global
spironolactone 28507 For details and quality of evidence, see Electronic Supplementary Table 5.A second trial compared spironolactone (100 mg/day) plus norgestimate/EE with (1) norgestimate/EE alone and (2) cyproterone acetate/EE plus
spironolactone 29690 found no difference in the rate of improvement or magnitude of the reduction in severity score for spironolactone plus cyproterone acetate/EE compared with finasteride plus the same COC (p > 0.05 for all time points,
spironolactone 30026 almost unchanged during the 6-month post-treatment follow-up period. The other trial [[30]] compared spironolactone plus levonorgestrel/EE versus flutamide plus the same COC using the Cremoncini score [[77]], which included
spironolactone 30503 significance not reported by the investigators. At month 9 (end of the treatment phase), 5/10 or 7/10 in the spironolactone arm (investigators’ text unclear) versus 11/12 in the flutamide arm had a lower severity score [[30]].
spironolactone 31279 arm were not equal, the study may not have been sufficiently powered to detect a difference between spironolactone (n = 63) and tetracycline (n = 14). For details and quality of evidence, see Electronic Supplementary
spironolactone 31877 [[74]] (in Portuguese) and two possible case series (in Czech) including acne patients treated with spironolactone [[72], [75]] were unobtainable and had either no abstract or an uninformative abstract. Two further
spironolactone 32540 make a clear statement about concomitant medications, making attribution of any clinical effect to spironolactone uncertain [[41], [43]–[45], [49], [51], [55]]. Further details are reported in Table 3. Insufficient
spironolactone 32748 Insufficient data were provided to conduct any subgroup analyses on the effect of dose or duration of spironolactone therapy on efficacy or side effects. Within the case series, between 216 and 259 of 728 women (29.7–35.6%)
spironolactone 33132 IDProspective?What was reportedAge range, yearsPrimary diagnosisSecondary diagnosesDiagnoses excludedDose of spironolactone Duration of therapy, monthsConcomitant medicationsAzizlerli et al. [[40]]Yes (clarified by email)Efficacy
spironolactone 35781 tretinoinOr Adapalene™ at bedtime. Most had been receiving the topical retinoid prior to starting spironolactone Lubbos et al. [[49]]UnclearEfficacy and safety14–38Idiopathic acneOligomenorrhea 13NR50 mg bid on
spironolactone 38147 4NR50–100 mg/day2–24 (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%)
spironolactone 38213 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 38272 (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 contraceptivesShaw
spironolactone 38331 systemic antibiotics; 10 (12%) received spironolactone plus oral contraceptives; 12 (14%) received spironolactone plus antibiotics and oral contraceptivesShaw and White [[58]]NoSafety18–52Adult acneNRNR50–100 mg/day0.5–122
spironolactone 38780 200 mg/dayMean 19.5Trimethoprim 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
spironolactone 39916 pooled data shows that acne improved (to any extent) in 427/550 women (77.6%, ITT population) receiving spironolactone at any dose. Using the PP population, the proportion who improved was 427/454 (94.1%). These improvement
spironolactone 40627 in acne severity at month 3, and an average 52% reduction at month 6, in eight women receiving a spironolactone dose of 200 mg/day (no measures of dispersion or p values were reported). Turowski and James [[59]]
spironolactone 40970 measure of dispersion) on a scale of 1–10 (lower is worse). Most of the women in this study, which used spironolactone doses of 50–100 mg/day, were receiving concomitant medications and were treated for an average of
spironolactone 41304 by month 3, from 32.86 (standard deviation [SD] 16.15) to 6.92 (SD 4.99), a reduction of 78.9% with spironolactone monotherapy at 100 mg/day (p < 0.001, investigators’ calculation). Furthermore, in the study by
spironolactone 41626 count fell from 15.0 to 8.5 (no measures of dispersion and no p-values) in 14 women treated with a spironolactone dose of 75–150 mg/day for an average of 17 months. Two studies [[46], [51]] did not report any quantifiable
spironolactone 42627 difference in the proportion of participants who dropped out due to side effects: 14/303 (4.6%) receiving spironolactone at any dose versus 10/343 (2.9%) receiving the comparators (RR 1.58, 95% CI 0.71–3.52; p = 0.26).
spironolactone 42910 trials [[31], [36]]. In the case series, 49/729 (6.7%) women dropped out due to the side effects of spironolactone (ITT population). This was not significantly different to the rate in the RCTs (RR 0.69, 95% CI 0.39–1.23;
spironolactone 43969 p < 0.00001).Within the RCTs, it was possible to compare the incidence of menstrual disturbances in women receiving spironolactone with and without concomitant use of a COC. The incidence appeared significantly lower when spironolactone
spironolactone 44075 spironolactone with and without concomitant use of a COC. The incidence appeared significantly lower when spironolactone was combined with a COC: 32/146 without a COC versus 6/112 with a COC (RR 0.24, 95% CI 0.11–0.56;
spironolactone 44456 The number of women with menstrual irregularities was 12/23 receiving a COC versus 21/24 receiving spironolactone monotherapy (RR 0.60, 95% CI 0.39–0.91; p = 0.02). In a minority of women with abnormal menses,
spironolactone 44571 monotherapy (RR 0.60, 95% CI 0.39–0.91; p = 0.02). In a minority of women with abnormal menses, spironolactone therapy was reported to normalize the menstrual cycle [[41], [52], [57]].Other commonly reported side
spironolactone 45448 medications, especially COCs, in many of the studies, side effects could not be unambiguously attributed to spironolactone . Among the 10 case series of spironolactone monotherapy in 370 women in which concomitant therapies
spironolactone 45492 studies, side effects could not be unambiguously attributed to spironolactone. Among the 10 case series of spironolactone monotherapy in 370 women in which concomitant therapies were not mentioned [[41], [43]–[45], [49],
spironolactone 45847 polyuria (4) and breast tenderness (4).Table 4Summary of common and very common adverse side effects of spironolactone (≥1% of the ITT population for RCTs and/or case series)Side effectRCTs (eligible ITT population = 326
spironolactone 46839 [57], [60]] involving 312 women (PP population) as a means of detecting possible adverse effects of spironolactone on fluid balance and kidney function. Serum electrolyte data reporting was inadequate in almost all
spironolactone 47462 serum potassium was measured in otherwise healthy women with acne treated with 50–150 mg/day of spironolactone [[56]]. Mild hyperkalemia was detected in 6/60 (10%) women. It is impossible to determine whether the
spironolactone 47866 retrospective analysis of serum potassium levels in 974 women aged 18–45 years taking 50–200 mg/day of spironolactone for acne, seen in two US hospitals between December 2000 and March 2014. Among 1802 measurements, 13
spironolactone 48515 experience of successful use of the drug to treat large numbers of women with persistent or late-onset acne, spironolactone is pivotal to their clinical practice. Such experience suggests that the important role of spironolactone
spironolactone 48621 spironolactone is pivotal to their clinical practice. Such experience suggests that the important role of spironolactone in this hard-to-manage patient population has been largely underrecognized and provided the rationale
spironolactone 48866 What the review has highlighted is a paucity of high-quality evidence for the effectiveness of oral spironolactone in the management of acne in adult females. The results should not be misinterpreted to mean that the
spironolactone 49759 data from similar comparisons was not possible.The trials fell into two categories: (1) comparisons of spironolactone monotherapy versus placebo; and (2) comparisons of mono or combination therapy versus active treatment.
spironolactone 50282 therapies such as antibiotics or isotretinoin, nor was there any direct head-to-head comparison of spironolactone monotherapy with a COC of proven anti-acne efficacy, such as cyproterone acetate plus ethinyl estradiol.Despite
spironolactone 50531 evidence available, some tentative conclusions can still be drawn. First, at a daily dose of 200 mg, spironolactone was found to be significantly superior to placebo versus inflamed lesions in a crossover trial in which
spironolactone 50753 of 29 women completed 3 months of treatment. Baseline imbalance and a possible carryover effect of spironolactone into the second phase would have reduced the magnitude of the difference in efficacy between spironolactone
spironolactone 50861 spironolactone into the second phase would have reduced the magnitude of the difference in efficacy between spironolactone and placebo, which was already large. This statistically significant result was not reported by the
spironolactone 51054 was not reported by the authors of a frequently cited Cochrane review, which evaluated the effects of spironolactone for hirsutism and acne [[23]]. Equally, the Cochrane review may have also inadvertently misled authors
spironolactone 51257 misled authors of subsequent reports by stating that “there was no evidence for effectiveness [of spironolactone ] for the treatment of acne vulgaris”. In contrast to the crossover trial, no conclusions can be drawn
spironolactone 51481 the two parallel group comparisons versus placebo regarding the absolute efficacy of lower doses of spironolactone . Spironolactone appeared to be more effective than placebo, but by how much was not quantified and indeed
spironolactone 52034 finasteride, cimetidine, ketoconazole and various COCs consistently found no difference between the spironolactone arm and the anti-androgen arm. With the exception of the COCs for which anti-acne efficacy has been
spironolactone 52334 comparators is scarce and/or contradictory [[84]–[92]]. What these anti-androgens have in common with spironolactone and COCs is the expectation that they will reduce sebum secretion at the doses used via their effects
spironolactone 52631 difference in efficacy versus these agents is unhelpful in terms of quantifying the effect size for spironolactone , especially as some of the trials most likely had too few participants to detect a significant difference,
spironolactone 52840 difference, if in fact such a difference existed.Table 5Summary of the modes of action in acne of spironolactone and anti-androgens used as comparators or concomitant medications within the RCTsDrugProposed mode of
spironolactone 56168 including skin, reduces serum levels of androgens and androgen precursorsFour of the RCTs evaluated spironolactone in combination with a COC. Hirsutism or PCOS was the primary diagnosis and acne was the secondary diagnosis.
spironolactone 56540 COC alone. Despite this, only one trial included a COC monotherapy arm and found no benefit of adding spironolactone to norgestimate/EE [[32]], although, at trend, the combination was more effective. In this three-arm
spironolactone 56811 times as many women in the combination arm as those receiving COC monotherapy. Any added benefit of spironolactone might have been revealed had treatment arms been of equal size.One potentially more useful trial put
spironolactone 56927 might have been revealed had treatment arms been of equal size.One potentially more useful trial put spironolactone head-to-head against oral tetracycline and found no difference in efficacy over 8 weeks of treatment
spironolactone 57169 is necessary in interpreting the results as this trial was also unbalanced, with 63 women receiving spironolactone but only 14 receiving tetracycline. Interestingly, the duration of therapy was consistently short (2–3 months)
spironolactone 57507 which hirsutism was the primary diagnosis. After only 3 months of treatment, the response of acne to spironolactone may not be optimal. The case series show that clinicians often use longer courses to manage acne in
spironolactone 58238 improvement continued until month 12, when the reduction was 89% [[34]]. Both used 100 mg/day of spironolactone in combination with a COC—the former in combination with triphasic levonorgestrel/EE and the latter
spironolactone 58493 acetate/EE. In the follow-up phase, acne returned to baseline levels over 6 months in those treated with spironolactone plus levonorgestrel/EE, but there was no relapse in those treated with cyproterone acetate/EE. The data
spironolactone 58620 levonorgestrel/EE, but there was no relapse in those treated with cyproterone acetate/EE. The data for the spironolactone plus levonorgestrel/EE combination may be somewhat misleading as a non-validated scoring method which
spironolactone 58833 which combined acne with seborrhea and alopecia was used [[77]]. Neither study included a COC-only or spironolactone -only treatment arm, making it impossible to determine the contribution of spironolactone to the efficacy
spironolactone 58922 COC-only or spironolactone-only treatment arm, making it impossible to determine the contribution of spironolactone to the efficacy of the combination.Two studies made apparently contradictory observations in respect
spironolactone 59057 the combination.Two studies made apparently contradictory observations in respect of the efficacy of spironolactone against comedonal (non-inflamed) lesions. One case series found that residual acne was more likely to
spironolactone 59534 comparisons to be made. As only these two studies evaluated comedones, it is not possible to know whether spironolactone monotherapy is effective versus non-inflamed lesions. Expert reviews [[24], [56]], commentaries [[111]],
spironolactone 59697 lesions. Expert reviews [[24], [56]], commentaries [[111]], and acne treatment guidelines that include spironolactone , such as the recent US guidelines [[112]], are silent on this important point. ‘Hormonal acne’ is
spironolactone 60045 acne and, in most instances, comedones will be present [[113]].Dropout rates due to side effects in spironolactone -treated participants were low in the RCTs and case series, suggesting that most women who begin the
spironolactone 60971 study in 974 women [[53]] concluded that routine monitoring of serum potassium in healthy women taking spironolactone for acne is not necessary. The findings from this systematic review support that conclusion. Occasional
spironolactone 61369 series, hyperkalemia was invariably mild and clinically insignificant. Some of the side effects of spironolactone , notably nausea, fatigue, and especially muscle weakness, can be indicative of hyperkalemia and, if
spironolactone 61657 justified. Crucially, the non-requirement for routine testing would reduce the overall direct costs of spironolactone treatment.While endorsing key aspects of expert opinion with hard data and providing some new insights,
spironolactone 61886 systematic review has highlighted existing important gaps in the evidence about how best to utilize oral spironolactone in managing acne in women, including clarifying the optimum dose and dosing regimen to maximize benefits
spironolactone 62216 therapies and what these should be, which types of acne are likely to be responsive, and how effective spironolactone is compared with standard therapies. It is interesting to note that several current acne guidelines
spironolactone 62369 It is interesting to note that several current acne guidelines and treatment recommendations include spironolactone on the basis of consensus and/or expert opinion [[112], [116], [117]]. Others either do not mention
spironolactone 62484 on the basis of consensus and/or expert opinion [[112], [116], [117]]. Others either do not mention spironolactone [[118]–[121]], or specifically say it is regarded as ineffective, not recommended [[122], [123]] or
spironolactone 63023 certainly duplicate publications of included case series), we are confident that all the RCTs evaluating spironolactone for acne in women have been retrieved and no clinical trial evidence has been overlooked. Until such
spironolactone 64260 powered RCT versus placebo, preferably of monotherapy, so that it is possible to establish whether spironolactone is effective against inflamed and non-inflamed lesions without concomitant use of a topical agent that
spironolactone 64720 sufficiently long enough for any anti-acne effect to be maximalized. If such a study confirms the utility of spironolactone , then head-to-head comparisons versus widely used oral therapies (antibiotics, COCs, isotretinoin) could
spironolactone 66030 identified 10 RCTs and 21 case series that provided some evidence of the benefit and potential harms of oral spironolactone for acne in adult females. The most frequently reported outcome measure was physician-reported improvement
spironolactone 66396 and none of the case seriesResults from one RCT of crossover design at high risk of bias showed that spironolactone at a daily dose of 200 mg was significantly more effective than placebo against inflamed lesions (low-quality
spironolactone 68301 for the duration of the studyIntervention (I)Type, frequency, dose, duration, prognostic factorOral spironolactone at an initial dose of 25 or 50 mg/day, escalating as and if necessary to 100 mg/day after 6–8 weeks
spironolactone 70415 systematic review has revealed a lack of high-quality evidence on the benefits and potential harms of oral spironolactone for managing acne in women. However, it has shown that (1) there is low-quality, but statistically highly
testosterone 4548 been used off-label for acne since the 1980s. A reduction in sebum may be achieved by blocking dihydro testosterone binding to the androgen receptor within sebocytes and inhibiting androgen-induced sebocyte proliferation
testosterone 53623 ≥1 g/day [[82], [84], [93]]AR antagonistInhibits 2-hydroxylation of estradiol, thereby reducing testosterone productionNACyproterone acetate/EE (Diane-35™)Suppression of sebum excretion [[94]–[99]]AR antagonist/partial
Select Disease Character Offset Disease Term Instance
acromegaly 34565 [[45]]UnclearEfficacy and safety24–34HirsutismSeborrhea 6,Abnormal menses 5, PCOS 4, adrenal carcinoma 1, acromegaly 1NR75 mg/day24–34NRHughes and Cunliffe [[46]]NoEfficacy (not properly reported) and safety21–51Hirsutism
congenital adrenal hyperplasia 33868 idiopathic hyperandrogenemia 18, hirsutism and/or irregular menses 23Hyperthyroidism, hyperprolactinemia, congenital adrenal hyperplasia , Cushing’s syndrome, ovarian and adrenal tumors50 mg bid from days 5 to 21 of the menstrual cycle6None
congenital adrenal hyperplasia 36640 seborrhea (unknown number),PCOS 1All but the PCOS case had regular mensesHirsutism associated with congenital adrenal hyperplasia or androgen-secreting tumorGroup A (n = 10): 400 mg/day for first 10 days then 200–300 mg. Group
congenital adrenal hyperplasia 68032 intending to become pregnant Androgen-secreting adrenal or ovarian tumor Cushing’s syndrome, late-onset congenital adrenal hyperplasia Unwilling to stop oral and topical anti-acne medications prior to the baseline visit Unwilling to
diabetes mellitus 35099 to at least one standard treatmentNone reportedPre-existing hyperkalemia, liver or kidney disease, diabetes mellitus 100 mg od in the morningUp to 6Drospirenone/EE. Previously prescribed topical acne treatments continuedLessner
hyperandrogenism 3342 polycystic ovarian syndrome (PCOS) [[2], [3], [6]–[9]]. However, many patients have no signs of peripheral hyperandrogenism other than acne. Serum profiles of androgens and gonadotrophins are often normal [[10], [11]].In both
hyperandrogenism 37254 (serum electrolyte data only)18–45AcneEndocrine disorders including PCOS, hirsutism, alopecia, and hyperandrogenism 298Heart failure, renal failure, renal disease50–200 mg/day (personal communication)NRNRSaint-Jean
hyperandrogenism 65809 emotional distress and sometimes accompanied by hyperandrogenemia and/or other signs of peripheral hyperandrogenism , such as hirsutism and alopeciaEvidence (E)What is the current evidence?This systematic review identified
hyperandrogenism 67790 on the faceWomen with PCOS can be included. In addition, women with additional signs of peripheral hyperandrogenism can also be included as long as the endocrinopathies listed below have been excludedExclusion criteria: Pregnant
hyperprolactinemia 33849 safety12–37AcnePolycystic ovaries 35, idiopathic hyperandrogenemia 18, hirsutism and/or irregular menses 23Hyperthyroidism, hyperprolactinemia ,congenital adrenal hyperplasia, Cushing’s syndrome, ovarian and adrenal tumors50 mg bid from days

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