A prospective, multicenter, randomized, double-blind placebo-controlled trial on purified and specific Cytoplasmic pollen extract for hot flashes in breast cancer survivors.

Autor: Bounous VE; Gynecology and Obstetrics Unit, Umberto I Hospital of Turin, Department of Surgical Sciences, University of Turin, Turin, Italy., Cipullo I; Gynecology and Obstetrics Unit, Umberto I Hospital of Turin, Department of Surgical Sciences, University of Turin, Turin, Italy., D'Alonzo M; Gynecology and Obstetrics Unit, Umberto I Hospital of Turin, Department of Surgical Sciences, University of Turin, Turin, Italy., Martella S; Unit of Preventive Gynecology, IRCCS European Institute of Oncology, Milan, Italy., Franchi D; Unit of Preventive Gynecology, IRCCS European Institute of Oncology, Milan, Italy., Villa P; Department of Woman and Child Health and Public Health, Child Health Area, Sacred Heart Catholic University, Rome, Italy., Biglia N; Gynecology and Obstetrics Unit, Umberto I Hospital of Turin, Department of Surgical Sciences, University of Turin, Turin, Italy., Ferrero A; Gynecology and Obstetrics Unit, Umberto I Hospital of Turin, Department of Surgical Sciences, University of Turin, Turin, Italy.
Jazyk: angličtina
Zdroj: Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology [Gynecol Endocrinol] 2024 Dec; Vol. 40 (1), pp. 2334796. Date of Electronic Publication: 2024 May 17.
DOI: 10.1080/09513590.2024.2334796
Abstrakt: Objective: evaluate the efficacy and tolerability of PureCyTonin against hot flashes (HF) in breast cancer survivors (BCS).
Methods: a prospective, multicenter, randomized, double-blind placebo-controlled trial was conducted in Italy.
Interventions: administration of PureCyTonin or placebo, for 3 months. Effectiveness was investigated through the compilation of a daily diary for HF and of validated questionnaires (Menopause Rating Scale (MRS), Pittsburgh Sleep Quality Index (PSQI), Visual Analogical Scales (VAS) for HF, sweating, irritability, fatigue, sleep, quality of life), carried out before starting the treatment (T0), after 1 month (T1) and after 3 months (T2). Any side effects and HF diary were recorded at each visit.
Results: 19 women were randomized to receive PureCyTonin and 20 to placebo. At T2 compared to T0, in the PureCyTonin group, we found a reduction in the number of HF ( p  = 0.02) measured by daily diary. An improvement in the subjective perception of women regarding HF intensity ( p  = 0.04), sweat nuisance ( p  = 0.02), irritability ( p  = 0.03) and fatigue ( p  = 0.04) was observed through VAS scale measurement at T2 compared to T0.The total MRS score was significantly better in the PureCyTonin group at T1 ( p  = 0.03) compared to T0.
Conclusions: PureCyTonin significantly reduces HF number after 3 months of therapy in BCS and it is well-tolerated.
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje