Dataset Information

Oxybutynin vs Placebo for Hot Flashes in Women With or Without Breast Cancer: A Randomized, Double-Blind Clinical Trial (ACCRU SC-1603).

ABSTRACT: Background:Hot flashes (HFs) negatively affect quality of life among perimenopausal and postmenopausal women. This study investigated the efficacy of oxybutynin vs placebo in decreasing HFs. Methods:In this randomized, multicenter, double-blind study, women with and without breast cancer with 28 or more HFs per week, lasting longer than 30?days, who were not candidates for estrogen-based therapy, were assigned to oral oxybutynin (2.5?mg twice a day or 5?mg twice a day) or placebo for 6?weeks. The primary endpoint was the intrapatient change from baseline in weekly HF score between each oxybutynin dose and placebo using a repeated-measures mixed model. Secondary endpoints included changes in weekly HF frequency, HF-related daily interference scale questionnaires, and self-reported symptoms. Results:We enrolled 150 women. Baseline characteristics were well balanced. Mean (SD) age was 57 (8.2) years. Two-thirds (65%) were taking tamoxifen or an aromatase inhibitor. Patients on both oxybutynin doses reported greater reductions in the weekly HF score (5?mg twice a day: -16.9 [SD 15.6], 2.5?mg twice a day: -10.6 [SD 7.7]), placebo -5.7 (SD 10.2); P?

SUBMITTER: Leon-Ferre RA

PROVIDER: S-EPMC7050158 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Oxybutynin vs Placebo for Hot Flashes in Women With or Without Breast Cancer: A Randomized, Double-Blind Clinical Trial (ACCRU SC-1603).

Leon-Ferre Roberto A RA Novotny Paul J PJ Wolfe Eric G EG Faubion Stephanie S SS Ruddy Kathryn J KJ Flora Daniel D Dakhil Christopher S R CSR Rowland Kendrith M KM Graham Mark L ML Le-Lindqwister Nguyet N Smith Thomas J TJ Loprinzi Charles L CL

JNCI cancer spectrum 20191021 1

<h4>Background</h4>Hot flashes (HFs) negatively affect quality of life among perimenopausal and postmenopausal women. This study investigated the efficacy of oxybutynin vs placebo in decreasing HFs.<h4>Methods</h4>In this randomized, multicenter, double-blind study, women with and without breast cancer with 28 or more HFs per week, lasting longer than 30 days, who were not candidates for estrogen-based therapy, were assigned to oral oxybutynin (2.5 mg twice a day or 5 mg twice a day) or placebo ...[more]

PMID: 32337497

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Project description:BackgroundHomeopathic medicines have a place among the non-hormonal therapies for the treatment of hot flashes during the menopause.ObjectiveThe objective of this study was to evaluate the efficacy of the non-hormonal treatment BRN-01 in reducing hot flashes in menopausal women.Study designThis was a multicenter, randomized, double-blind, placebo-controlled study carried out between June 2010 and July 2011.SettingThe study was conducted in 35 active centers in France (gynecologists in private practice).PatientsOne hundred and eight menopausal women, ≥ 50 years of age, were enrolled in the study. The eligibility criteria included menopause for <24 months and ≥ 5 hot flashes per day with a significant negative effect on the women's professional and/or personal life.InterventionTreatment was either BRN-01 tablets, a registered homeopathic medicine containing Actaea racemosa (4 centesimal dilutions [4CH]), Arnica montana (4CH), Glonoinum (4CH), Lachesis mutus (5CH), and Sanguinaria canadensis (4CH), or identical placebo tablets, prepared by Laboratoires Boiron according to European Pharmacopoeia standards. Oral treatment (2 to 4 tablets per day) was started on day 3 after study enrollment and was continued for 12 weeks.Main outcome measureThe main outcome measure was the hot flash score (HFS) compared before, during, and after treatment. Secondary outcome criteria were the quality of life (QoL) [measured using the Hot Flash Related Daily Interference Scale (HFRDIS)], severity of symptoms (measured using the Menopause Rating Scale), evolution of the mean dosage, and compliance. All adverse events (AEs) were recorded.ResultsOne hundred and one women were included in the final analysis (intent-to-treat population: BRN-01, n = 50; placebo, n = 51). The global HFS over the 12 weeks, assessed as the area under the curve (AUC) adjusted for baseline values, was significantly lower in the BRN-01 group than in the placebo group (mean ± SD 88.2 ± 6.5 versus 107.2 ± 6.4; p = 0.0411). BRN-01 was well tolerated; the frequency of AEs was similar in the two treatment groups, and no serious AEs were attributable to BRN-01.ConclusionBRN-01 seemed to have a significant effect on the HFS, compared with placebo. According to the results of this clinical trial, BRN-01 may be considered a new therapeutic option with a safe profile for hot flashes in menopausal women who do not want or are not able to take hormone replacement therapy or other recognized treatments for this indication. Trial registration number (EudraCT): 2009-016959-21.

Project description:ObjectiveTo quantify the impact of objectively recorded hot flashes on objective sleep in perimenopausal women.DesignCross-sectional study. Participants underwent 1-5 laboratory-based polysomnographic recordings for a total of 63 nights, including sternal skin-conductance measures, from which 222 hot flashes were identified according to established criteria. Data were analyzed with hierarchical mixed-effect models and Spearman's rank correlations.SettingSleep laboratory.Patient(s)Thirty-four perimenopausal women (age ± SD: 50.4 ± 2.7 years).Intervention(s)None.Main outcome measure(s)Perceived and polysomnographic sleep measures (sleep quality, amount of time spent awake after sleep onset, and number of awakenings). Subjective (frequency and level of bother) and objective (frequency and amount of hot flash-associated awake time) hot-flash measures.Result(s)Women had an average of 3.5 (95% confidence interval: 2.8-4.2, range = 1-9) objective hot flashes per night. A total of 69.4% of hot flashes were associated with an awakening. Hot flash-associated time awake per night was, on average, 16.6 minutes (95% confidence interval: 10.8-22.4 minutes), which accounted for 27.2% (SD 27.1) of total awake time per night. Hot flash-associated time awake, but not hot flash frequency, was negatively associated with sleep efficiency and positively associated with waking after sleep onset. In addition, self-reported wakefulness correlated with hot flash-associated waking, suggesting that women's estimates of wakefulness are influenced by the amount of time spent awake in association with hot flashes during the night. Having more perceived and bothersome hot flashes was correlated with more perceived wakefulness and awakenings and more objective hot flash-associated time awake and hot-flash frequency.Conclusion(s)The presence of physiological hot flashes accounts for a significant proportion of total objective time awake during the night in perimenopausal women.

Dataset Information

Oxybutynin vs Placebo for Hot Flashes in Women With or Without Breast Cancer: A Randomized, Double-Blind Clinical Trial (ACCRU SC-1603).

Publications

Oxybutynin vs Placebo for Hot Flashes in Women With or Without Breast Cancer: A Randomized, Double-Blind Clinical Trial (ACCRU SC-1603).

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