Abstract

Relevance: Sore throat is the main complaint in patients with acute tonsillitis (AT) and one of the most frequent motivations for prescribing antibiotics. Since no convincing evidence has been found that antibiotics relieve pain, current recommendations suggest that the main goal of treatment should be to relieve sore throat pain with nonsteroidal anti-inflammatory drugs. However, a major drawback is their slow onset of action and high level of adverse effects. Improving topical therapy methods seems a promising direction.

The purpose of the study was to evaluate the therapeutic efficacy, safety, tolerability, and benefits of AT treatment with the additional use of biclotymol spray compared to systemic NSAIDs (ibuprofen).

Materials and methods: 122 patients with AT aged 18-60 years were randomised in a multicentre, randomised, open-label, comparative, prospective parallel-group study, and completed the study. In addition to standard AT therapy with benzydamine hydrochloride, the treatment group received biclotymol spray (Hexaspray®), and the control group received ibuprofen tablets.

Assessment criteria: reduction in the severity of AT symptoms, assessed by the doctor in points according to the MSS scale at each visit compared to Visit 1, dynamics of self-assessment of symptoms according to VAS, changes in the total symptom score, taking NSAIDs, frequency of adverse events and antibiotic prescriptions.

Results: Additional use of biclotymol spray demonstrates comparable efficacy to systemic NSAIDs (ibuprofen) in the regression dynamics of AT symptoms assessed by the physician and symptoms assessed by the patients themselves. The results indicate the absence of significant difference in treatment outcomes and frequency of antibiotic therapy prescriptions between patients in the treatment and control groups. There is a significant difference in the intake of systemic NSAIDs between the treatment and control groups and a significantly higher – 5.4 times – number of adverse side effects.

Conclusion: Combined anti-inflammatory and analgesic therapy with the additional use of biclotymol exerts a pronounced clinical effect of AT treatment, which is comparable to the additional administration of systemic ibuprofen.

Analgesic therapy using ibuprofen is accompanied by a significantly higher, 5.4 times, number of adverse side effects compared to topical biclotymol (p<0.05), therefore the topical drug has a significant advantage in terms of systemic side effects.

The proven analgesic effect is an important argument for reducing the desire of patients and doctors to prescribe antibiotics and reducing their use.

Keywords: tonsillitis, sore throat, treatment, biclotymol.