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

Sci Rep. 2025 Feb 10;15(1):4899. doi: 10.1038/s41598-025-86651-2.

Abstract

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.

Keywords: Breast cancer; Breast conserving surgery; Breast oedema; Breast seroma; Early complications; Post-surgical pain; Surgical outcomes.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Breast Neoplasms* / drug therapy
  • Breast Neoplasms* / surgery
  • Bromelains* / administration & dosage
  • Bromelains* / therapeutic use
  • Double-Blind Method
  • Edema / etiology
  • Edema / prevention & control
  • Female
  • Humans
  • Middle Aged
  • Postoperative Complications* / prevention & control
  • Seroma / etiology
  • Seroma / prevention & control
  • Thioctic Acid* / administration & dosage
  • Thioctic Acid* / therapeutic use
  • Treatment Outcome

Substances

  • Bromelains
  • Thioctic Acid