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Therapeutic Effectiveness of a Complex Homeopathic Medication in Patients from 6 to 60 Years with Recurrent Tonsillitis
05 February 2018 (online)
Background and Aims: The current recommendations of watchful waiting for patients affected by a moderate recurrent tonsillitis (RT) shed an interesting light on homeopathy as a treatment option. The current trial was set up to investigate the clinical effectiveness and safety of the complex homeopathic medication Tonsilotren in patients with moderate RT.
Methods: We conducted a pragmatic, randomized, controlled clinical trial in Germany, Spain and Ukraine in patients aged 6 to 60 years with moderate RT. The combined treatment of Tonsilotren and symptomatic medication (test group) was compared with symptomatic medication alone (control group). Thereby, Tonsilotren (Atropinum sulfuricum D5, Hepar sulfuris D3, Kalium bichromicum D4, Silicea D2, Mercurius bijodatus D8) was given during three treatment periods (TPs) of 8 weeks each. Endpoints were the rate of recurrent acute throat infections (ATIs) within 1 year (analyzed via repeated events analysis), the number of RT symptoms, the antibiotics consumption as well as the incidence of adverse events (AEs).
Results: The 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). From the end of the first TP until the end of the trial, patients in the test group had significantly less RT symptoms compared with patients in the control group (p < 0.0001, MWU-test). Also, the number of ATIs treated with antibiotics was significantly lower in the test compared with the control group (37% vs. 58.2%; 95% CI: 9.13–33.36; p = 0.0008; χ 2-test). From the 225 AEs in the test group, 3 AEs (gastroenteritis, nausea and foul taste) were rated as related to Tonsilotren.
Conclusion: Trial results indicate that Tonsilotren may be a gentle therapeutic option in moderate RT treatment.
Keywords: Recurrent tonsillitis, acute throat infection, complex homeopathic medication, randomized controlled clinical trial