Effectiveness of an add-on treatment with the homeopathic medication SilAtro-5-90 in recurrent tonsillitis: An international, pragmatic, randomized, controlled clinical trial

Abstract

Objective: To investigate the effectiveness and safety of the homeopathic product SilAtro-5-90 in recurrent tonsillitis. Methods: In this international, pragmatic, controlled clinical trial, 256 patients (6e60 years) with moderate recurrent tonsillitis were randomized to receive either SilAtro-5-90 in addition to standard symptomatic treatment, or to receive standard treatment only. The primary outcome was the mean time period between consecutive acute throat infections (ATI) within 1 year (analyzed via repeated events analysis). Results: During the evaluation year, the risk of getting an ATI was significantly lower (hazard ratio: 0.45, proportional means model, p 1⁄4 0.0002, ITT) with SilAtro-5-90 compared to control. Tonsillitis-specific symptoms were significantly reduced (p < 0.0001, ITT) and the need of antibiotics to treat acute throat infections (p 1⁄4 0.0008; ITT) decreased. 3 non-serious adverse drug reactions were reported for SilAtro-5-90. Conclusions: An integrative treatment approach where SilAtro-5-90 is given alongside mainstream symptomatic treatment may bring therapeutic benefit to patients suffering from recurrent tonsillitis. Trial registration: ISRCTN registry: Registration number ISRCTN19016626, registered 23 January 2013. © 2017 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).