Efficacy of a Complex Homeopathic Medication (Sinfrontal) in Patients with Acute Maxillary Sinusitis: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial
| Autor: | Kyra C. Kneis, Dmitriy I. Zabolotnyi, Andy Richardson, Marietta Kaszkin-Bettag, Reinhard Rettenberger, Marianne Heger, Peter Heger |
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| Rok vydání: | 2007 |
| Předmět: |
Adult
Male medicine.medical_specialty Placebo Severity of Illness Index Drug Administration Schedule law.invention Double-Blind Method Randomized controlled trial law Internal medicine Severity of illness medicine Humans Prospective Studies Prospective cohort study Sinusitis General Nursing Dose-Response Relationship Drug Plant Extracts business.industry Homeopathy Middle Aged Maxillary Sinusitis medicine.disease Anti-Bacterial Agents Surgery Clinical trial Treatment Outcome Complementary and alternative medicine Acute Disease Female Observational study Chiropractics Ukraine business Analysis Phytotherapy |
| Zdroj: | EXPLORE. 3:98-109 |
| ISSN: | 1550-8307 |
| Popis: | There is a demand for clinical trials that demonstrate homeopathic medications to be effective and safe in the treatment of acute maxillary sinusitis (AMS).The objective of this clinical trial was to demonstrate the efficacy of a complex homeopathic medication (Sinfrontal) compared with placebo in patients with AMS confirmed by sinus radiography.A prospective, randomized, double-blind, placebo-controlled, phase III clinical trial was conducted for a treatment period of 22 days, followed by an eight-week posttreatment observational phase.The clinical trial was conducted at six trial sites in the Ukraine.One hundred thirteen patients with radiography-confirmed AMS participated in the trial.Fifty-seven patients received Sinfrontal and 56 patients received placebo. Additionally, patients were allowed saline inhalations, paracetamol, and over-the-counter medications, but treatment with antibiotics or other treatment for sinusitis was not permitted.Primary outcome criterion was change of the sinusitis severity score (SSS) from day zero to day seven. Other efficacy assessments included radiographic and clinical cure, improvement in health state, ability to work or to follow usual activities, and treatment outcome.From day zero to day seven, Sinfrontal caused a significant reduction in the SSS total score compared with placebo (5.8 +/- 2.3 [6.0] points vs 2.3 +/- 1.8 [2.0] points; P.0001). On day 21, 39 (68.4%) patients on active medication had a complete remission of AMS symptoms compared with five (8.9%) placebo patients. All secondary outcome criteria displayed similar trends. Eight adverse events were reported that were assessed as being mild or moderate in intensity. No recurrence of AMS symptoms occurred by the end of the eight-week posttreatment observational phase.This complex homeopathic medication is safe and appears to be an effective treatment for acute maxillary sinusitis. |
| Databáze: | OpenAIRE |
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