Cost-effectiveness analysis for SilAtro-5-90 adjuvant treatment in the management of recurrent tonsillitis, compared with usual care only.

PURPOSE: Antibiotics are one possible treatment for patients with recurrent acute throat infections (ATI), but effectiveness can be modest. In view of worries over antibiotic resistance, treatment pathways that reduce recurrence of ATI are essential from a public health perspective. Integrative treatment strategies can be an option but there is still a high demand to provide evidence of their cost effectiveness. METHODS: We constructed a 4-state Markov model to compare the cost-effectiveness of SilAtro-5-90 as adjuvant homeopathic therapy to care as usual with care as usual alone in reducing the recurrence of ATI for children and adults with suspected moderate recurrent tonsillitis. The analysis was performed from a societal perspective in Germany over a 2-year period. Results are reported separately for children < 12 and for individuals aged 12 and over. The model draws on evidence from a multi-centre randomised clinical trial that found this strategy effective in reducing recurrence of ATI. Costs in 2019 € and outcomes after 1 year are discounted at a rate of 3% per annum. RESULTS: For adults and adolescents aged 12 years and over, incremental cost per ATI averted in the adjuvant therapy group was €156.64. If individuals enter the model on average with a history of 3.33 previous ATIs, adjuvant therapy has both lower costs and better outcomes than care as usual. For children (< 12 years) adjuvant therapy had both lower costs and ATI than care as usual. The economic case is stronger if adjuvant treatment reduces surgical referral. At a hypothetical cost per ATI averted threshold of €1000 probabilistic sensitivity analysis suggests Silatro-5-90 has a 65% (adults) and 71% (children) chance of being cost-effective. CONCLUSION: Our results indicate the importance of considering homeopathy as adjuvant therapy in the treatment of ATIs in individuals with recurrent tonsillitis from a socio-economic perspective. Further evaluation should assess how differences in uptake and sustained use of homeopathic adjuvant therapy, as well as changing patterns of antibiotic prescribing, impact on cost effectiveness.

[Actual considerations of post-tonsillectomy case management]. / Sovremennye aspekty vedeniia patsientov posle tonzilléktomii.

INTRODUCTION: Despite the large number of studies and clinical observations on timely analgesia in the postoperative period, there are no clearly formulated views on the nature of the pain syndrome, and there are no modern protocols for the treatment of pain after tonsillectomy. PURPOSE: The purpose of the study was to identify the effect of a homeopathic monocomponent herbal product Arnica Montana C9 (BUARON) on the condition of patients undergoing tonsillectomy. MATERIAL AND METHODS: The article presents a study that was conducted in patients with chronic decompensated tonsillitis who were admitted to the Department of Otorhinolaryngology, Pavlov First Saint Petersburg State Medical University for planned surgery. RESULTS: Entered the results of the study into the developed computer database on a personal computer using tables 'Microsoft Excel'. Carried out the analysis and statistical processing of the obtained data using the software package Statistica for Windows v.10.0, determined the parameters of descriptive statistics. DISCUSSION: In accordance with the results of statistical analysis, it was found that the use of a homeopathic monocomponent herbal product Arnica Montana C9 (BOIRON) in patients after tonsillectomy leads to a reduction in treatment time compared to traditional therapy. CONCLUSION: The use of Arnica Montana C9 (BOIRON) can reduce the severity of pain in patients after tonsillectomy.

Complementary and alternative medicine in the (symptomatic) treatment of acute tonsillitis in children: A systematic review.

BACKGROUND: Acute tonsillitis (including tonsillopharyngitis) in childhood is a common disease with a peak of illness in school-age. Most of these cases have a viral origin and antibiotic therapy is not indicated, therefore, effective symptomatic therapy is required. For this reason, complementary, alternative and integrative medicine therapies might be a solution. OBJECTIVE: The aim of this review is to demonstrate study status of such therapies. METHODS: The databases PubMed, Cochrane Library, OVID, CAMbase, CAM-QUEST® and Anthromedics were systematically screened for studies investigating complementary, alternative and integrative therapy approaches in paediatric cohorts. Studies were analyzed by therapy approach, study design, cohort and outcome, using the PRISMA 2020 checklist. RESULTS: The systematic literature search resulted in 321 articles. Five publications corresponded to the search criteria and were assigned to the following specific therapeutic categories: herbal medicine (3), homeopathy (1) and ayurvedic medicine (1). Clinical trials were found for the herbal compounds BNO 1030 (Impupret®) and EPs® 7630 (Umckaloabo), the homeopathic complex Tonzolyt® and the ayurvedic medicine Kanchnara-Guggulu and Pratisarana of Tankana­Madhu. Antimicrobial effects of essential oils and carvacrol as single agents as well as in combination with erythromycin were analysed in an in vitro study. CONCLUSION: Clinical studies indicate an improvement of symptoms and a good tolerability of all investigated remedies of complementary, alternative and integrative medicine in the treatment of tonsillitis in childhood. Nevertheless, quality and quantity of the studies were insufficient to make a reliable conclusion regarding effectiveness. Therefore, more clinical trials are urgently needed to achieve a meaningful result.

Estudio aleatorizado, doble ciego, sobre la eficacia del tratamiento homeopático en niños con amigdalitis recurrente / Randomized, double-blind study on the efficacy of homeopathic treatment in children with recurrent tonsillitis

La eficacia y seguridad del tratamiento homeopático fueron investigadas en niños con amigdalitis recurrente para la que se indicaba cirugía. Métodos: Estudio clínico prospectivo, aleatorizado, doble ciego, que incluyó 40 niños de entre 3 y 7 años de edad; 20 niños fueron tratados con medicación homeopática y otros 20 niños, con placebo. El seguimiento fue de 4 meses por niño. La evaluación de los resultados fue clínica mediante un cuestionario estándar y examen clínico el primer y último día de tratamiento. La amigdalitis recurrente se definió como ocurrencia de 5 a 7 episodios de amigdalitis bacteriana aguda al año. Resultados: Del grupo de 18 niños que completó el tratamiento homeopático, 14 no presentó episodio alguno de amigdalitis bacteriana aguda; del grupo de 15 niños que recibió placebo, 5 pacientes no presentaron amigdalitis. Esta diferencia fue estadísticamente significativa (p = 0,015). Ninguno de los pacientes presentó efectos secundarios. Conclusiones: El tratamiento homeopático fue efectivo en niños con amigdalitis recurrente, en comparación con el placebo; a 14 niños (78%) ya no se les indicó cirugía. El tratamiento homeopático no se asoció con eventos adversos.

The efficacy and safety of homeopathic treatment was investigated on children with recurrent tonsillitis justifying surgery. Methods: Prospective, randomized,double-blind clinical trial that included 40 children between ages of 3 to 7 years old;20 children were treated with homeopathic medication and 20 children with placebo. Follow up was 4 months per child. Assessment of results was clinical by means of a standard questionnaire and clinical examination on the first and last day of treatment.Recurrent tonsillitis was defined as 5 to 7 episodes of bacterial acute tonsillitis per year. Results: From the group of 18 children who completed homeopathic treatment, 14 did not present any episode of acute bacterial tonsillitis; from the group of 15 children whoreceived placebo 5 patients did not present tonsillitis; this difference was statistically significant (p= 0,015). None of the patient exhibited side effects. Conclusions: Homeopathic treatment was effective in children with recurrent tonsillitis compared to placebo, 14 children (78%) were no longer indicated surgery. Homeopathic treatment was not associated with adverse events.

Effectiveness of an add-on treatment with the homeopathic medication SilAtro-5-90 in recurrent tonsillitis: An international, pragmatic, randomized, controlled clinical trial.

OBJECTIVE: To investigate the effectiveness and safety of the homeopathic product SilAtro-5-90 in recurrent tonsillitis. METHODS: In this international, pragmatic, controlled clinical trial, 256 patients (6-60 years) with moderate recurrent tonsillitis were randomized to receive either SilAtro-5-90 in addition to standard symptomatic treatment, or to receive standard treatment only. The primary outcome was the mean time period between consecutive acute throat infections (ATI) within 1 year (analyzed via repeated events analysis). RESULTS: During the evaluation year, the risk of getting an ATI was significantly lower (hazard ratio: 0.45, proportional means model, p = 0.0002, ITT) with SilAtro-5-90 compared to control. Tonsillitis-specific symptoms were significantly reduced (p < 0.0001, ITT) and the need of antibiotics to treat acute throat infections (p = 0.0008; ITT) decreased. 3 non-serious adverse drug reactions were reported for SilAtro-5-90. CONCLUSIONS: An integrative treatment approach where SilAtro-5-90 is given alongside mainstream symptomatic treatment may bring therapeutic benefit to patients suffering from recurrent tonsillitis. TRIAL REGISTRATION: ISRCTN registry: Registration number ISRCTN19016626, registered 23 January 2013.

Randomized, double-blind trial on the efficacy of homeopathic treatment in children with recurrent tonsillitis

OBJECTIVE: The efficacy and safety of homeopathic treatment was investigated onchildren with recurrent tonsillitis justifying surgery. METHODS: Prospective, randomized, double-blind clinical trial that included 40 children between ages of 3 to 7 years old;20 children were treated with homeopathic medication and 20 children with placebo. Follow up was 4 months per child. Assessment of results was clinical by means of astandard questionnaire and clinical examination on the first and last day of treatment. Recurrent tonsillitis was defined as 5 to 7 episodes of bacterial acute tonsillitis per year. RESULTS: From the group of 18 children who completed homeopathic treatment, 14 did not present any episode of acute bacterial tonsillitis; from the group of 15 children who received placebo 5 patients did not present tonsillitis; this difference was statistically significant (p= 0,015). None of the patient exhibited side effects. CONCLUSIONS: Homeopathic treatment was effective in children with recurrent tonsillitis compared toplacebo, 14 children (78%) were no longer indicated surgery. Homeopathic treatment was not associated with adverse events.

Randomized, double-blind trial on the efficacy of homeopathic treatment inchildren with recurrent tonsillitis

Objective: The efficacy and safety of homeopathic treatment was investigated onchildren with recurrent tonsillitis justifying surgery. Methods: Prospective, randomized,double-blind clinical trial that included 40 children between ages of 3 to 7 years old;20 children were treated with homeopathic medication and 20 children with placebo.Follow up was 4 months per child. Assessment of results was clinical by means of astandard questionnaire and clinical examination on the first and last day of treatment.Recurrent tonsillitis was defined as 5 to 7 episodes of bacterial acute tonsillitis per year.Results: From the group of 18 children who completed homeopathic treatment, 14 didnot present any episode of acute bacterial tonsillitis; from the group of 15 children whoreceived placebo 5 patients did not present tonsillitis; this difference was statisticallysignificant (p= 0,015). None of the patient exhibited side effects. Conclusions:Homeopathic treatment was effective in children with recurrent tonsillitis compared toplacebo, 14 children (78%) were no longer indicated surgery. Homeopathic treatmentwas not associated with adverse events. (AU)

Estudo clínico, duplo-cego, randomizado, em crianças com amigdalites recorrentes submetidas a tratamento homeopático / Randomized, double-blind trial on the efficacy of homeopathic treatment in children with recurrent tonsillitis

Objetivo: Avaliar a eficácia e a segurança do tratamento homeopático em crianças com amigdalite recorrente, com indicação cirúrgica. Métodos: Estudo prospectivo, duplo-cego, randomizado, em que foram incluídas 40 crianças com idade variando de 3 a 7 anos; 20 crianças foram tratadas com medicação homeopática individualizada e 20 crianças receberam placebo. A duração do estudo de cada paciente foi de 4 meses. A avaliação dos resultados foi clínica, por meio de questionário padrão, de exame otorrinolaringológico, no primeiro e no último dia do tratamento. Utilizou-se como critério de amigdalites de repetição a ocorrência de 5 a 7 episódios de amigdalites agudas ao ano. Resultados: Das 18 crianças que completaram o tratamento homeopático, 14 não apresentaram nenhum episódio de amigdalite aguda bacteriana; das 15 crianças que receberam placebo por 4 meses, 5 pacientes não apresentaram amigdalite, com diferenças estatisticamente significantes (p= 0,015). Nenhum dos pacientes apresentou efeitos colaterais aos medicamentos prescritos. Conclusões: O tratamento homeopático foi eficaz nas crianças com amigdalites recorrentes, quandocomparado ao placebo, excluindo 14 crianças (78%) da indicação cirúrgica. O medicamento homeopático não provocou eventos adversos nas crianças. (AU)

Estudo clínico, duplo-cego, randomizado, em crianças com amigdalites recorrentes submetidas a tratamento homeopático / A double-blind, randomized clinical study in children with recurrent tonsillitis undergoing homeopathic treatment

Objetivo: Avaliar a eficácia e a segurança do tratamento homeopático em crianças com amigdalite recorrente, com indicação cirúrgica. Métodos: Estudo prospectivo, duplo-cego, randomizado, em que foram incluídas 40 crianças com idade variando de 3 a 7 anos; 20 crianças foram tratadas com medicação homeopática individualizada e 20 crianças receberam placebo. A duração do estudo de cada paciente foi de 4 meses. A avaliação dos resultados foi clínica, por meio de questionário padrão, de exame otorrinolaringológico, no primeiro e no último dia do tratamento. Utilizou-se como critério de amigdalites de repetição a ocorrência de 5 a 7 episódios de amigdalites agudas ao ano. Resultados: Das 18 crianças que completaram o tratamento homeopático, 14 não apresentaram nenhum episódio de amigdalite aguda bacteriana; das 15 crianças que receberam placebo por 4 meses, 5 pacientes não apresentaram amigdalite, com diferenças estatisticamente significantes (p= 0,015). Nenhum dos pacientes apresentou efeitos colaterais aos medicamentos prescritos. Conclusões: O tratamento homeopático foi eficaz nas crianças com amigdalites recorrentes, quandocomparado ao placebo, excluindo 14 crianças (78%) da indicação cirúrgica. O medicamento homeopático não provocou eventos adversos nas crianças. (AU)

Objective: The efficacy and security of homeopathic treatment was investigated on children with recurrent tonsillitis justifying surgery. Methods: Prospective, randomized, double-blind clinical trial that included 40 children between ages of 3 to 7 years old, 20 children were treated with homeopathic medication and 20 children with placebo. The duration of the study of each child was 4 months. The evaluation of the results was clinical, by means of a standard questionnaire and clinical examination on the first and last day of treatment. Recurrent tonsillitis was defined as 5 to 7 episodes of bacterial acute tonsillitis per year. Results: From the group of 18 children who completed homeopathic treatment, 14 did not present any episode of acute bacterial tonsillitis; from the group of 15 children who received placebo 5 patients did not present tonsillitis; this difference was statistically significant (p= 0,015). None of the patient exhibited side effects. Conclusions: homeopathic treatment was effective in the children with recurrent tonsillitis compared to placebo, 14 children (78%) were no longer indicated surgery. Homeopathic treatment was not associated with adverse events. (AU)