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

P Dicillo, M Testini, L S Stucci, F P Prete, N Resta, M Piombino, M G Mastropasqua, M Maruccia, L Clemente, G Serio, F Puntillo, M Moschetta, A Pasculli, L I Sgaramella, G Rubini, Angela Gurrado, G Giudice

Journal: Scientific reports 2025;15(1):4899

PMID: 39929877

Free Full Text on Nature Publishing Group View on PubMed

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.

Address: Department of Precision and Regenerative Medicine and Ionian Area (DiMePreJ), Aldo Moro University, Bari, Italy.; Breast Care Unit, Policlinico of Bari, University of Medical School of Bari, P.zza G. Cesare 11, 70124, Bari, Italy.; Department of Interdisciplinary Medicine (DIM), University of Bari Aldo Moro, Bari, Italy.; Rehabilitation Service, IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy.; Department of Precision and Regenerative Medicine and Ionian Area (DiMePreJ), Aldo Moro University, Bari, Italy.; Breast Care Unit, Policlinico of Bari, University of Medical School of Bari, P.zza G. Cesare 11, 70124, Bari, Italy.; Breast Care Unit, Policlinico of Bari, University of Medical School of Bari, P.zza G. Cesare 11, 70124, Bari, Italy.; Radiation Oncology Department, AUOC, Policlinico of Bari, Bari, Italy.; Breast Care Unit, Policlinico of Bari, University of Medical School of Bari, P.zza G. Cesare 11, 70124, Bari, Italy.; Medical Oncology Unit, AUOC, Policlinico of Bari, Bari, Italy.; Department of Precision and Regenerative Medicine and Ionian Area (DiMePreJ), Aldo Moro University, Bari, Italy. [email protected].; Breast Care Unit, Policlinico of Bari, University of Medical School of Bari, P.zza G. Cesare 11, 70124, Bari, Italy. [email protected].

DOI: 10.1038/s41598-025-86651-2

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MeSH Terms: Humans, Bromelains, Thioctic Acid, Female, Middle Aged, Double-Blind Method, Adult, Breast Neoplasms, Edema, Seroma, Treatment Outcome, Postoperative Complications