RESUMO
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 (6-60 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 = 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 = 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.