Results of an international, randomized clinical trial with a homeopathic medication in patients with recurrent tonsillitis

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Kishchuk V V, Palm J, Keller T, Weber S, De Jaegere S and Klement P

Vinnytsia Regional Clinical Hospital, Ukraine

: J Otol Rhinol

Abstract

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Background & Aims: In the light of discussions regarding possible therapies of patients affected by a moderate Recurrent Tonsillitis (RT), for whom recent clinical guidelines recommend a watchful waiting period, the current clinical trial was performed. It assessed the effectiveness and safety of the homeopathic medicinal product SilAtro-5-90 in patients with moderate RT. Methods: The open-label randomized clinical trial was conducted in Germany, Spain and Ukraine in patients aged 6-60 years with moderate RT. The combined treatment of SilAtro-5-90 (Atropinum sulfuricum D5, Hepar sulfuris D3, Kalium bichromicum D4, Silicea D2, Mercurius bijodatus D8) and symptomatic medication (test group) was compared to symptomatic medication alone (control group). SilAtro-5-90 was given during 3 treatment periods of 8 weeks each. Endpoints were the mean period of time between consecutive Acute Throat Infections (ATI) within 1 year (analyzed via repeated events analysis), the number of days the patients were suffering from RT symptoms as well as the incidence of Adverse Events (AEs). Results: ITT population comprised 254 patients (86 patients <12 years, 51 patients from 12 to <18 years, 117 patients ≥18 years) with a moderate RT. The hazard of getting an ATI was significantly lower in the test group than in the control group (hazard ratio=0.45; 95%-CI: 0.34-0.60; p<0.0001; intensity model). Already during the first treatment period, patients in the test group were free of RT symptoms during significantly more days (MWU-test; p<0.0001). From the 225 AEs in the test group, 3 AEs (gastroenteritis, nausea and foul taste) were rated as related to SilAtro-5-90. Conclusion: Trial results indicate that SilAtro-5-90 may be a well-tolerated and effective therapeutic option in the treatment of moderate RT.

Biography

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Kishchuk V V is the Professor of the Department of Otorhinolaryngology at Vinnitsa National Medical University. He is also the author and co-author of scientific publications, including textbooks for otolaryngology for students and interns, has 19 innovative proposals and 9 inventions.

E-mail: kvv4488@ukr.net