Fernandes 2014.
Methods | A 4‐arm parallel RCT | |
Participants | 80 postmenopausal women with symptoms of vaginal atrophy Age (mean, SD): Group A: 57.0 (5.4); Group B: 56.2 (5.3); Group C: 56.4 (4.8); Group D: 57.7 (4.7) Inclusion criteria: women aged 40–70 years with physiological menopause and a history of amenorrhoea for > 3 years with a follicle‐stimulating hormone level of > 30 mIU/mL. They had not taken hormonal treatment for menopausal symptoms in the past 6 months, had shown normal Pap smears and mammograms for the past 12 months, and had complaints compatible with the symptoms of vaginal atrophy (vaginal dryness, vulvovaginal irritation/itching, and pain at sexual activity 6 months ago) Exclusion criteria: women who were expected to undergo an oophorectomy or hysterectomy and those with a body mass index < 18.5 kg/m2 or > 30 kg/m2. "We excluded those women with a contraindication for the use of estrogen or testosterone, namely those with a history of myocardial infarction, severe hypertension, diabetes mellitus, thromboembolic disease, liver failure, ulcerative colitis, Crohn’s disease, breast or endometrial cancer, fibrocystic breast disease with atypical hyperplasia, genital bleeding of unknown origin, a family history of breast cancer, endometrial hyperplasia, or positive serology for human immunodeficiency virus, hepatitis B, or C". Finally, women were excluded if they had a vaginal infection at the time of their gynecological examination. |
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Interventions |
Group A: acid polyacrylic (n = 20) Vaginal cream with polyacrylic acid (Vagidrat®, Myralis Pharma Ltd, Aguai, Sao Paulo, Brazil) one vaginal applicator with 3 g cream per application. Group B: testosterone (n = 20) Vaginal cream with testosterone propionate: 1 vaginal applicator with 1 g of cream per application containing 300 μg testosterone propionate prepared using testosterone micronised powder in an emollient cream with silicone to keep the cream iso‐osmolar Group C: estrogen vaginal cream (n = 20) Vaginal cream with conjugated estrogens (Premarin®, Wyeth Pharmaceuticals, Itapevi, São Paulo, Brazil): one vaginal applicator with 1 g of cream per application containing 0.625 mg conjugated estrogens Group D: lubricant (placebo; n = 20) Lubricant with glycerin gel (K‐Y jelly Johnson & Johnson, São José dos Campos, São José dos Campos, Brazil) 3 g in one applicator per application adjusted to maintain similarity with the polyacrylic acid application. This group was used as a control for the 3 other treatment groups Duration: 12 weeks |
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Outcomes | Adverse event (allergic vaginitis) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | It was stated that, "All participants were given a number (1–80) according to their order of inclusion in the study." |
Allocation concealment (selection bias) | Unclear risk | Insufficient information on method used in allocation concealment |
Blinding (performance bias) | Low risk | It was reported that, "Dispensation of the topical agent was done by a gynecologist who was not part of the selection/interview team" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information was reported on the blinding of outcome assessor |
Incomplete outcome data (attrition bias) All outcomes | Low risk | It was reported that, "Data were analyzed according to intention to treat, including all participants in each group" |
Selective reporting (reporting bias) | Low risk | All the outcomes specified in the methods section were reported |
Other bias | Unclear risk | It was reported that, "There were no significant differences between groups in terms of age, time after menopause, skin color, smoking habits, numbers of pregnancies, or socioeconomic status" |