title: Management of urogenital atrophy in breast cancer patients: a systematic review of available evidence from randomized trials.
abstract: Symptoms of urogenital atrophy are common in breast cancer survivors. Its optimal management is currently unknown. A systematic review of randomized controlled trials (RCTs) evaluating treatments for urogenital atrophy in breast cancer patients was performed. EMBASE, Ovid Medline and the Cochrane Library were searched from 1946 to November 2014. Outcomes included improvements in both vaginal symptoms (e.g., dryness, pain, dyspareunia and itching) and vaginal hormone response measured by validated scales [e.g., Vaginal Health Index (VHI) and Vaginal Maturation Index (VMI)]. Of 430 unique citations identified, 4 studies (n = 196) met inclusion criteria. Interventions included pH-balanced gel, Replens(®), lidocaine, Estring(®) and Vagifem(®). Sample sizes ranged from 7 to 98 patients. Given the heterogeneity of the studies, a narrative synthesis of results was performed. One study of 98 patients suggested that vaginal pH-balanced gel (mean VHI 5.00 ± 0.816, mean VMI 51.18 ± 3.753) was more efficient than placebo (VHI 16.98 ± 3.875, p < 0.001, VMI 47.87 ± 2.728, p < 0.001) at 12 weeks in providing vaginal symptom relief. In patients who used lidocaine, 90 % had reduced dyspareunia compared to saline in a study of 46 patients. Although increased serum estradiol occurred, both Estring(®) and Vagifem(®) were shown to improve quality of life and VMI in a study of seven patients. Treatment of urogenital atrophy remains a challenging issue and there is a paucity of RCT evidence addressing this knowledge gap. It is evident that more prospective trials are needed.
authors.affiliation: Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.
authors.forename: Sasha
authors.initials: S
authors.lastname: Mazzarello
authors.affiliation: Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
authors.forename: Brian
authors.initials: B
authors.lastname: Hutton
authors.affiliation: Division of Medical Oncology and Department of Medicine, The Ottawa Hospital Cancer Centre, University of Ottawa, 501 Smyth Road, Box 912, Ottawa, ON, K1H 8L6, Canada.
authors.forename: Mohammed F K
authors.initials: MFK
authors.lastname: Ibrahim
authors.affiliation: Division of Medical Oncology and Department of Medicine, The Ottawa Hospital Cancer Centre, University of Ottawa, 501 Smyth Road, Box 912, Ottawa, ON, K1H 8L6, Canada.
authors.forename: Carmel
authors.initials: C
authors.lastname: Jacobs
authors.affiliation: The Ottawa Hospital, Ottawa, Canada.
authors.forename: Risa
authors.initials: R
authors.lastname: Shorr
authors.affiliation: Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Smith
authors.affiliation: Division of Medical Oncology and Department of Medicine, The Ottawa Hospital Cancer Centre, University of Ottawa, 501 Smyth Road, Box 912, Ottawa, ON, K1H 8L6, Canada.
authors.forename: Terry
authors.initials: T
authors.lastname: Ng
authors.affiliation: Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada. mclemons@toh.on.ca.|Division of Medical Oncology and Department of Medicine, The Ottawa Hospital Cancer Centre, University of Ottawa, 501 Smyth Road, Box 912, Ottawa, ON, K1H 8L6, Canada. mclemons@toh.on.ca.
authors.forename: Mark
authors.initials: M
authors.lastname: Clemons
mesh_terms: D001284:Atrophy; D001943:Breast Neoplasms / Q000150:complications*; D019468:Disease Management; D005260:Female; D052776:Female Urogenital Diseases / Q000209:etiology / Q000473:pathology* / Q000628:therapy*; D006801:Humans; D016032:Randomized Controlled Trials as Topic