Effectiveness of a Homeopathic Product in Recurrent Tonsillitis

We conducted a pragmatic, randomized, controlled clinical trial in Germany, Spain and Ukraine in patients aged 6-60 years with moderate recurrent tonsillitis [1]. The combined treatment of the homeopathic remedy 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) over a period of 14 months. Thereby, SilAtro-5-90 was given during 3 treatment periods of 8 weeks each.


Introduction
Recent clinical practice guidelines recommend watchful waiting for patients moderately affected by recurrent acute throat infections (ATI). Alternative therapies with a beneficial safety profile such as homeopathic remedies may be an interesting option for patients suffering from a moderate recurrent tonsillitis during this waiting time.
The results showed that 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; ITT). Furthermore, already during the first treatment period, patients in the test group were free of recurrent tonsillitis symptoms during significantly more days (MWU-test; p<0.0001; ITT) compared to those of the control group. Also the number of acute throat infections treated with antibiotics was significantly lower in the test group compared to the control group (37% vs. 58.2%; 95%-CI: 9.13-33.36; p=0.0008; Chi 2 test; ITT).
SilAtro-5-90 was well tolerated: from the 225 adverse events (AEs) in the test group, only 3 AEs (gastroenteritis, nausea and foul taste) were assessed as being related to SilAtro-5-90. The percentage of patients/investigators having rated the tolerability of SilAtro-5-90 as "very good" or "good" ranged from 98.4% at the end of the first treatment period to 100% at the end of the third treatment period.
These results expand previous research with SilAtro-5-90. The efficacy of SilAtro-5-90 had previously been demonstrated in acute tonsillitis based on several studies, whereof 2 randomized placebocontrolled double-blinded trials [2,3]. In these trials, children suffering from acute tonsillitis, who were treated with SilAtro-5-90 experienced a significant reduction of tonsillitis-associated symptoms by day 4 of the treatment compared to children in the placebo group.
Research of SilAtro-5-90 in recurrent tonsillitis is scarcer: an observational study, in which 605 patients with recurrent tonsillitis took SilAtro-5-90 during consecutive 8 weeks, showed that 78.8% of the patients did not have recurrent tonsillitis complaints anymore at the end of this 8 weeks treatment period. Also, the tolerability of SilAtro-5-90 was rated predominantly as "very good" or "good" by the investigators and the patients. Our above mentioned clinical trial now confirmed the effectiveness and tolerability results of this observational study in scientifically more rigorous controlled conditions. It additionally made the interesting and important observation that patients in the SilAtro-5-90 group used overall less antibiotics for the treatment of recurrent tonsillitis.
The mechanisms by which SilAtro-5-90 may reduce ATIs and recurrent tonsillitis-specific symptoms were not investigated in the current study. Our results, however, support the idea that SilAtro-5-90 may stimulate the body's own adaptive healing process, which is one of the general homeopathic principles [4]. Moreover, they contribute to the clinical evidence for the use of SilAtro-5-90 in patients with recurrent tonsillitis. Finally, our results suggest that patients in the SilAtro-5-90 group were less susceptible to bacterial throat infections than patients in the control group, which is in turn an indication for an increased self-healing power in patients having been treated homeopathically.

Conclusion
Whereas double-blind clinical trials had already previously demonstrated the effectiveness of SilAtro-5-90 in the treatment of acute tonsillitis, the results of our recent research described above, substantiate prior findings on the use of SilAtro-5-90 in recurrent tonsillitis. They support the notion that an integrative treatment approach where SilAtro-5-90 is given alongside mainstream symptomatic treatment may bring therapeutic benefit to patients suffering from recurrent tonsillitis.