Study of effectiveness of Alpha-Tons in cases of Tonsillopharyngitis
The present study was an open, multicentre, randomized, controlled clinical study conducted between Nov. 2006 to Nov. 2008. The aim of the study was to assess the effectiveness and tolerability of Alpha-Tons in patients with 3 different types of chronic tonsillitis. 143 patients were included into the study. Patients were divided into 3 subgroups depending on the type of chronic tonsillitis which was identified by an ENT specialist. Children of both sexes, aged 6 – 18 years diagnosis of chronic compensated tonsillitis, chronic decompensated tonsillitis characterized by recurrent tonsillitis, and chronic decompensated tonsillitis characterized by tonsillitis-related cardiac, symptoms who have rejected surgical treatment and Presence of typical symptoms of chronic tonsillitis were included for the study. Typical symptoms of chronic tonsillitis (TSCT) rated on the basis of 5 symptoms Caseous detritus or liquid pus in the cryps, 2) Ridged thickening and chronic hyperemia of the edges of the palatine arches 3) Friability or superficial sclerosis of the tonsillar surface 4) Scarring of the paratonsillar tissue, adhesions with the palatine arches 5) Regional lymphadenitis. The maximum score was 20.
|Points||Severity of symptoms (1 – 5)|
The patient exclusion criteria were patients with forms of decompensated chronic tonsillitis other than tonsillitis-related cardiac symptoms were excluded, and patients with an indication for an antibiotic therapy or patients with a concomitant pharmacotherapy that could influence the study results. Severe organ failure and a confirmed or suspected hypersensitivity to Alpha-Tons (or better to one of the ingredients of Alpha-Tons) were further exclusion criteria. All patients of the study received symptomatic treatment measures like palatine tonsillar crypt irrigation with Furacilin and ultrasound treatment of the tonsils. The patients who were randomized into the Alpha-Tons group received – besides the symptomatic treatment – an add-on-therapy with Alpha-Tons (1 tablet 3 times a day for 3 courses each of 60 consecutive days). 7 control examinations within the course of treatment had been done and the observational period lasted for 18 months. Primary outcome criterion was the change in total TSCT sum score between the patient´s inclusion into the study (day 0) and the end of the study (day 540 ± 5). Secondary outcome criteria were assessment of chronic tonsillitis typical single symptoms at the end of the study, changes in ECG parameters, changes in the prevalence of fatigue, satisfaction with treatment (rated on the „Integrative Medicine Patient Satisfaction Scale“), tolerability and safety of Alpha-Toms. Out of 143 patients included into the study, approximately half of them were male (around 53 %) and the other half (around 47 %) was female. Patients were uniformly distributed between the 3 diagnostic subgroups.
The mean TSCT sum score was significantly lower in the Alpha-Tons group during the course of treatment. After 240 days, children treated with Alpha-Tons showed a 2-fold decrease of total sum score (p < 0.01) compared to baseline ratings.
Similar changes seen in the patients with chronic decompensated tonsillitis. The TSCT sum score decreased significantly until end of treatment by a factor of 3.6 in the Alpha-Tons group compared to a 1.6-fold decrease in the control group.
Whereas children of the control group showed no significant improvement of total TSCT score within the course of treatment, a significant reduction of the total TSCT sum score – by a factor of 2 – was demonstrated in the Alpha-Tons group (p < 0.01). At the end of study it has been seen that the chronic tonsillitis typical single symptoms reduced 10 times less frequent in the Alpha- Tons group in patients with CCT and CDT (p < 0.01), swelling of tonsils, friability and/or sclerosis of their surfaces were 2 times less frequent in the Alpha-Tons group in patients with CCT and CDT (p < 0.01) and children in the Alpha-Tons group showed more than 3-fold reductions (p < 0.01) in the total score compared to control group in all 3 diagnostic subgroups. The results of the study identified a significant improvement in cardiac symptoms in the group of children treated with Alpha-Tons.
Changes in ECG parameters:
Very interestingly at inclusion into the study around 63 % of all patients were suffering from fatigue, this changed dramatically at the end of the study but at the end of the study, fatigue was present in only 7.2 % of patients treated with Alpha-Tons (that is an almost 56 % decrease compared to baseline measures), whereas was still present in 1/3 of patients in the control group. Successful treatment of chronic tonsillitis includes not only sanitisation of the lymphoid apparatus of the throat, but is also a method of healing and strengthening the body as a whole. It is concluded from the study, patients were satisfied with their treatment as assessed on the Integrative Medicine Patient Satisfaction Scale, and tolerability of Alpha-Tons was rated “good” in all patients
Reference: Kryuchko, TA et al. [Results of clinical studies on the use of Tonsilotren in children with chronic tonsillitis.]. (2010)