A Double-Blind, Placebo-Controlled Trial of Sinecch (Arnica) for Post-Operative Pain in Breast Augmentation Patients – ABSTRACT

Home » Doctor Article » A Double-Blind, Placebo-Controlled Trial of Sinecch (Arnica) for Post-Operative Pain in Breast Augmentation Patients – ABSTRACT

Arnica is the most frequently used homeopathic agent in cosmetic surgery today. Recent studies have demonstrated that active treatment significantly reduces post-operative swelling and echymosis in liposuction and facelift patients. Significant post-operative pain reduction has also been attributed anecdotally to Sinecch (Arnica). We present our results from a double-blind, placebo-controlled trial designed to determine if active treatment with Arnica reduces post-operative pain in dual-plane, subpectoral breast augmentation patients. Methods: 81 patients enrolled and 70 completed the protocol, 34 in the placebo group and 36 in the active therapy. All 70 patients provided complete outcome data. The ages ranged from 19 to 50. 13 were nulliparous while 57 had at least one full term pregnancy. All patients underwent a dual-plane, subpectoral breast augmentation by the same plastic surgeon under a general anesthetic with an average blood loss of 1-2 cc per breast. The smooth, round saline filled implants ranged in size from 200cc to 350cc with the average being 250cc. All patients were given 40 Tylenol #3 tablets. Other medications included Keflex, Colace and a pre-op Scopolamine patch. Post-operative pain was documented by two methods. The first was with a visual analog pain scale. This was recorded on the day of surgery and post-op days 1,2,3,4 and 5, both in the morning and at bedtime. The patients also recorded their pain pill consumption on the day of surgery, and on post-op days 1,2,3,4, and 5. The surgeon, the surgeon’s staff and the patients re all blinded to the active and placebo treatments. Pain level and pill counts were compared by t tests and rank-sum tests. Results: Pain level, as measured by the visual analog scale, was not significantly different between the placebo and active treatments, with a difference in overall mean pain level of less than 0.4 points on a scale of 0 to 10 (p).325), and no significant differences on any post-op day. Total pill counts differed by less than 2 pills and did not differ significantly (p=O.36). Also, no significant difference was noted in pill counts for any specific day. Conclusion: We found no significant differences in outcomes of pain level and the number of pain pills taken either by primary or secondary analysis of the data. This study concludes that active treatment with Arnica makes no difference to post-operative pain in dual-plane, subpectoral breast augmentation patients in which careful hemostasis is employed.