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

Oncologia
Imagem de arquivo, ilustrativa — não é do estudo. Células de câncer de mama ao microscópio óptico. Cecil Fox/National Cancer Institute · domínio público · Wikimedia Commons

Ensaio clínico randomizadoNível 2 · Nova evidênciaGynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology17 mai 20245 citações

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Resumo original em inglês

O que aconteceu

evaluate the efficacy and tolerability of PureCyTonin against hot flashes (HF) in breast cancer survivors (BCS).

a prospective, multicenter, randomized, double-blind placebo-controlled trial was conducted in Italy.

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.

O que encontraram

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.

Por que isso importa

PureCyTonin significantly reduces HF number after 3 months of therapy in BCS and it is well-tolerated.

Resumo publicado sob licença CC BY. A tradução para o português ainda não chegou a este estudo.

O estudo original

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

Valentina Elisabetta Bounous, Isabella Cipullo, Marta D'Alonzo, Silvia Martella, Dorella Franchi, Paola Villa, Nicoletta Biglia, Annamaria Ferrero

Descritores MeSH

  • Cancer Survivors
  • Breast Neoplasms
  • Hot Flashes
  • Treatment Outcome
  • Double-Blind Method
  • Female
  • Humans
  • Middle Aged
  • Plant Extracts
  • Pollen

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