Economic evaluation of Sinfrontal in the treatment of acute maxillary sinusitis in adults.

Sinfrontal, a complex homeopathic medication, is popular in Germany for the treatment of ear, nose and throat and respiratory tract infections. Unlike many other homeopathic or herbal medications, the efficacy and safety of Sinfrontal has been demonstrated in a number of clinical studies of patients with sinusitis. To assess the cost effectiveness of Sinfrontal versus placebo in the treatment of adults with acute maxillary sinusitis (AMS) in Germany. A secondary objective was to assess the cost effectiveness of Sinfrontal versus standard treatment with antibacterials. Sinfrontal was compared with placebo in a cost-utility analysis based on data from a randomized controlled clinical trial over 3 weeks (Sinfrontal group: n = 57; placebo group: n = 56). Trial data were analysed from a societal perspective; resource use was valued with German unit costs for 2005. In a secondary analysis, the longer-term cost utility of Sinfrontal versus placebo was estimated over a total of 11 weeks based on an 8-week post-treatment observational phase. In addition, the cost effectiveness of Sinfrontal versus antibacterials was determined based on an indirect comparison of placebo-controlled trials. Sinfrontal led to incremental savings of euro 275 (95% CI 433, 103) per patient compared with placebo over 22 days, essentially due to the markedly reduced absenteeism from work (7.83 vs 12.9 workdays). Incremental utility amounted to 0.0087 QALYs (95% CI 0.0052, 0.0123), or 3.2 quality-adjusted life-days (QALDs). Bootstrapping showed that these findings were significant, with Sinfrontal being dominant in 99.9% of simulations. The results were robust to a number of sensitivity analyses. In the secondary analysis, Sinfrontal led to incremental cost savings of euro 511 and utility gains of 0.015 QALYs or 5.4 QALDs compared with placebo. Compared with antibacterials, Sinfrontal had a significantly higher cure rate (11% vs 59%; p < 0.001) at similar or lower costs. The results of this economic evaluation indicate that Sinfrontal may be a cost-effective treatment for AMS in adults.

Efficacy of a complex homeopathic medication (Sinfrontal) in patients with acute maxillary sinusitis: a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial.

BACKGROUND: There is a demand for clinical trials that demonstrate homeopathic medications to be effective and safe in the treatment of acute maxillary sinusitis (AMS). OBJECTIVE: 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. DESIGN: 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. SETTING: The clinical trial was conducted at six trial sites in the Ukraine. PARTICIPANTS: One hundred thirteen patients with radiography-confirmed AMS participated in the trial. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSION: This complex homeopathic medication is safe and appears to be an effective treatment for acute maxillary sinusitis.

Efficacy and safety of a special extract of Rheum rhaponticum (ERr 731) in perimenopausal women with climacteric complaints: a 12-week randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To investigate the efficacy and safety of the special extract ERr 731 from the roots of Rheum rhaponticum compared to placebo in perimenopausal women with climacteric complaints. DESIGN: A multicenter, prospective, randomized, double-blind, placebo-controlled, clinical trial in which 109 women with climacteric complaints received either one enteric-coated tablet of ERr 731 (n = 54) or placebo (n = 55) daily for 12 weeks. Primary outcome criterion for efficacy was the change in Menopause Rating Scale II (MRS II) total score after 12 weeks. Other efficacy assessments analyzed number and severity of hot flushes, menopause-specific quality of life, number of bleeding/spotting days, and treatment outcome. RESULTS: By 12 weeks, the MRS II total score and each MRS II symptom significantly decreased in the ERr 731 group compared to the placebo group (P < 0.0001). After 4 weeks, ERr 731 also significantly decreased the number and severity of hot flushes (P < 0.0001). After 12 weeks, the overall menopause-specific quality of life was significantly better in women treated with ERr 731 compared with placebo (P < 0.05). Treatment outcome assessed by investigators and participants was better in the ERr 731 group, and ERr 731 was better tolerated than placebo. There were no differences in gynecological findings including endometrial biopsies, bleeding, weight, blood pressure, pulse, and laboratory safety parameters between the treatment groups. No adverse events were classified as being related to the investigational medication. CONCLUSIONS: Compared to placebo, ERr 731 significantly reduces the occurrence and severity of climacteric complaints in perimenopause. It is also safe and well tolerated.