Quick Evidence Synopsis

Date completed: July 21, 2015

Elsevier EBM Center contributors: Megan Sands-Lincoln PhD, MPH and David R. Goldmann, MD

What is the clinical question? What are the benefits and harms of oral contraceptives for acne vulgaris in women?

Intervention	Quality of Evidence ^a	Balance Between Benefits and Harms ^b
Oral contraceptives vs placebo	Low	Likely to be beneficial

a Quality of evidence scale (GRADE [Grading of Recommendations Assessment, Development, and Evaluation]): high, moderate, low, and very low. For more information on the GRADE rating system, see http://www.gradeworkinggroup.org/index.htm .

b The Guideline Elements Model: http://gem.med.yale.edu/default.htm .

What are the parameters of our evidence search?

Population: menstruating women with acne

Sociodemographic status, including age, ethnicity, and geographic location; diet; weight; physical activity level; menstrual history; use of helmets and sports gear; cosmetic use; medication use (eg, lithium, isoniazid, phenytoin, steroids, anabolic steroids); presence or absence of hyperandrogenism; acne lesion count and grade (various systems); comorbidities.

Setting: outpatient
Intervention: oral contraceptives containing an estrogen and a progestin

Dose, frequency, duration.

Comparator: placebo
Outcomes: change in lesion count, participant self-assessment of improvement, adverse events (outcomes assessed at 24 weeks or 6 cycles)

What is the basis for our conclusions?

Population: menstruating women with acne
Settings: outpatient
Intervention: combined oral contraceptives(various types and doses), combinations among and with topical and nondrug treatments
Comparator: placebo

See data in Table 1

Table 1

Intervention for OCP containing dienogest

Outcomes	Assumed Risk ^a	Corresponding Risk ^a	Relative Effect (95% CI)	Number of Participants (Studies)	Confidence in the Effect Estimates (GRADE)	Comments
Outcomes	Placebo	COC	Relative Effect (95% CI)	Number of Participants (Studies)	Confidence in the Effect Estimates (GRADE)	Comments
Intervention: Oral Contraceptives Containing Levonorgestrel 100 μg/EE 20 μg
Change in (mean decreased) lesion count ≤168 d	−9.8 N = 291	−19.95 N = 281	−9.98 (−16.51, −3.93)	572 (2 RCTs)	Moderate	Favors treatment
Lesion improvement (based on participant self-assessment) ≤168 d	193 out of 291	228 out of 281	2.13 (1.47, 3.09)	572 (2 RCTs)	Low	Favors treatment
Adverse event (discontinuation) ≤168 d	6 out of 176	9 out of 174	1.54 (0.55, 4.31)	350 (1 RCT)	Low	No difference
Intervention: Oral Contraceptives Containing Norethindrone Acetate 1 mg/EE 20/30/35 μg
Adverse event (discontinuation) 168 d	7 out of 296	20 out of 297	2.73 (1.26, 5.90)	593 (1 RCT)	Low	Favors control
Intervention: Oral Contraceptives Containing Norgestimate 180/215/250 μg/EE 35 μg
Change in total lesion count (mean) 168 d	−16.7 N = 194	−26.5 N = 193	−9.32 (−14.19, −4.45)	387 (2 RCTs)	Low	Favors treatment
Lesion improvement (based on participant self-assessment) 168 d	38 out of 80	68 out of 83	4.50 (2.37–8.56)	163 (1 RCT)	Low	Favors treatment
Adverse event (discontinuation) 168 d	9 out of 242	18 out of 246	1.98 (0.91–4.30)	488 (2 RCTs)	Low	No difference
Intervention: Oral Contraceptives Containing Dienogest 2 mg/EE 30 μg
Total lesion count; mean reduction (%)	−39.4% (SD=33.6) N = 259	−54.7% (SD=26.3) N = 515	−15.30 (−19.98, −10.62)	774 (1 RCT)	Low	Favors treatment
Adverse event (discontinuation) 168 d	3 out of 264	8 out of 525	1.33 (0.38–4.67)	789 (1 RCT)	Low	No difference
Intervention: Oral Contraceptives Containing Drospirenone 3 mg/EE 20 μg
Change in total lesion count; mean(%) 168 d	37.7 (118.7) N = 86	66.8 (31.5) N = 87	29.08 (3.13, 55.03)	173 (1 RCT)	Low	Favors treatment
Lesion improvement (based on participant self-assessment) 168 d	62 out of 73	75 out of 79	3.06 (1.06, 8.85)	152 (1 RCT)	Low	Favors treatment
Adverse event (discontinuation) 168 d	24 out of 626	37 out of 625	1.57 (0.94, 2.62)	1251 (3 RCTs)	Moderate	No difference