<p>Aim of study is to analyze Bromelain’ effects on the most common early complications after BCS (oedema and seroma). From January 2021 to December 2023 a double-blind randomized placebo-controlled trial was performed on 114 candidates for BCS at our Academic Unit. Group A received a supplement of Casperome™—Boswellia Phytosome<sup>®</sup> + Bromelain (CBB) in combination with alpha-lipoic acid + superoxide dismutase + B and D vitamins + centella asiatica. Group B received a supplement of CBB + placebo. Group C received placebo. The therapies were administrated for 30&#xa0;days. On GEE logistic regression, drugs combination in A seems to be associated with statistical fewer oedema compared with C (P = 0.018 at 1&#xa0;day and P = 0.002 after 1&#xa0;month). Comparing B to C, B gained a significative value after 1&#xa0;month (P = 0.007). On GEE logistic regression, the drugs combination in A has been associated with statistical fewer seroma compared with C (P = 0.009 at 15thpostoperative day and P &lt; 0.001 after 1&#xa0;month). B vs C reaches significant values 15&#xa0;day and 1&#xa0;month after surgery (P = 0.002 and P &lt; 0.001, respectively). The current study is the first analyzing the employment of CBB association with/without neurotrophic agent on prevention of early complications after BCS.</p>

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Randomized controlled trial of bromelain and alpha-lipoic acid in breast conservative surgery

  • L. I. Sgaramella,
  • A. Pasculli,
  • M. Moschetta,
  • F. Puntillo,
  • P. Dicillo,
  • L. Clemente,
  • M. Maruccia,
  • M. G. Mastropasqua,
  • M. Piombino,
  • N. Resta,
  • G. Rubini,
  • F. P. Prete,
  • G. Serio,
  • L. S. Stucci,
  • G. Giudice,
  • M. Testini,
  • Angela Gurrado,
  • C. Altini,
  • M. Amendolagine,
  • C. Angelini,
  • C. Caporusso,
  • A. Carrieri,
  • C. Deleo,
  • G. M. De Luca,
  • V. Deruvo,
  • G. L. Digiulio,
  • R. Elia,
  • M. Favetta,
  • F. Iuele,
  • S. Gentile,
  • M. Giglio,
  • A. M. Giorgio,
  • T. Grassi,
  • E. Lacalendola,
  • M. Lambo,
  • L. Lapadula,
  • W. Lavermicocca,
  • V. Lorusso,
  • L. Macchia,
  • A. Magno,
  • S. Mastrorillo,
  • A. Nitti,
  • F. Palma,
  • A. R. Pisani,
  • E. Poli,
  • V. Ronghi,
  • F. Solfrizzo,
  • P. Tedeschi,
  • M. Telegrafo

摘要

Aim of study is to analyze Bromelain’ effects on the most common early complications after BCS (oedema and seroma). From January 2021 to December 2023 a double-blind randomized placebo-controlled trial was performed on 114 candidates for BCS at our Academic Unit. Group A received a supplement of Casperome™—Boswellia Phytosome® + Bromelain (CBB) in combination with alpha-lipoic acid + superoxide dismutase + B and D vitamins + centella asiatica. Group B received a supplement of CBB + placebo. Group C received placebo. The therapies were administrated for 30 days. On GEE logistic regression, drugs combination in A seems to be associated with statistical fewer oedema compared with C (P = 0.018 at 1 day and P = 0.002 after 1 month). Comparing B to C, B gained a significative value after 1 month (P = 0.007). On GEE logistic regression, the drugs combination in A has been associated with statistical fewer seroma compared with C (P = 0.009 at 15thpostoperative day and P < 0.001 after 1 month). B vs C reaches significant values 15 day and 1 month after surgery (P = 0.002 and P < 0.001, respectively). The current study is the first analyzing the employment of CBB association with/without neurotrophic agent on prevention of early complications after BCS.