Arnica Montana and Bellis Perennis for Prevention of Seroma Following Mastectomy and Immediate Breast Reconstruction: Prospective, Randomized, Double-Blind, Placebo- Controlled Trial

Background Seroma is a common surgical complication created by the inflammatory process that follows mastectomy and reconstruction. It is, thus, common practice to insert surgical drains, which often often remain in place for long periods and delay recovery. In light of the many advantages of holistic treatment, there has been a global trend of integrating them with conventional medicine. In this study, the investigators examined the effect of Arnica montana and Bellis perennis on seroma prevention after mastectomy and breast reconstruction.

Study design The investigators conducted a prospective, double-blind, randomized, controlled study to asses the effect of homeopathic remedies on seroma in 55 patients (78 breasts), who had undergone mastectomy for cancer or risk reduction, followed by immediate implant and Acellular Dermal Matrix (ADM)-based breast reconstruction in the Department of Plastic & Reconstructive Surgery at Shaare Zedek Medical Center in Jerusalem, Israel, between January 2016 and August 2017 (Figure 1). The study protocol was approved by the Institutional Review Board and it was registered on the ClinicalTrials.gov register.

Subjects All subjects were female, aged over 18 years, who underwent mastectomy, either for breast cancer or for risk reduction, followed by immediate breast reconstruction. In some patients, this was performed in a single procedure - direct to implant (DTI) (n=42); in others, it was in two stages tissue expander (TE) (n=36), depending on presurgical evaluation, risk factors and clinical assessment of perfusion of the mastectomy skin flaps. All subjects signed informed consent forms after receiving a detailed explanation of the study from one of its investigators.

The investigators excluded patients with: (a) conditions which could affect wound-healing; (b) coagulation problems (autoimmune and hematological diseases, etc.); (c) taking medication which affects the immunological or hematological system (steroids, anticoagulants, chemotherapeutic agents, etc.); and (d) with unbalanced background diseases. Active smokers were instructed to stop smoking at least three weeks prior to surgery and a month postoperatively.

Study medication and randomization and surgical techniques Experimental medications and placebos were prepared and delivered in accordance with the Homeopathic Pharmacopoeia of the United States (HPUS). Stem tinctures of Arnica montana, Bellis perennis and 40% alcohol as placebo were diluted 1:100 with 40% alcohol, and vigorously shaken. This process was repeated 30 times for a theoretical final concentration of 10-60 of the stem solutions. Spherical saccharose globules, approximately 1 mm in diameter, were wetted with the diluted tinctures and dried, resulting in three groups of the experimental medication: Arnica montana C30 (10-60), Bellis perennis C30 (10-60) and alcohol dilutions as placebo. The medications were packed in bottles, each containing 5 grams of the preparation, and consecutively numbered. The prefix 'A' indicated Arnica montana, and 'B' Bellis perennis .