Research - Sinusitis
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Efficacy of a complex homeopathic medication (Sinfrontal) in patients with acute maxillary sinusitis: a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial.
Zabolotnyi DI, Kneis KC, Richardson A, Rettenberger R, Heger M, Kaszkin-Bettag M, Heger PW.
Source - Research Institute for Ear, Nose, and Throat Diseases, Kiev, Ukraine.
AbstractBACKGROUND: 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.
Source : Explore NY
Link to Abstract
Homeopathy in acute rhinosinusitis: a double-blind, placebo controlled study shows the efficiency and tolerability of a homeopathic combination remedy].
[Article in German]
Friese KH, Zabalotnyi DI.
AbstractBACKGROUND: The efficacy and tolerability of a homeopathic combination remedy for the treatment of acute rhinosinusitis was investigated.
PATIENTS AND METHODS: A total of 144 patients with acute rhinosinusitis were treated in a randomized, double-blind study either with a homeopathic remedy (n=72) or placebo (n=72). At the control examinations after 7, 14 and 21 days, five sinusitis-typical symptoms were measured with scores from 0 (absent) to 4 (very strong). The change of sum score of the sinusitis-typical symptoms (max. 20 points) during the treatment served as the primary efficacy criterion.
RESULTS: In the homeopathic treatment group, the average sum score dropped from initially 12.1+/-1.6 to 5.9+/-2.0 points after 7 days. In the placebo group it decreased from 11.7+/-1.6 to 11.0+/-2.9 points (p<0.0001). The homeopathic treatment resulted in freedom from complaints in 90.3% of the patients and improvement in a further 8.3%, whereas in the placebo group, the complaints remained unchanged or became worse in 88.9% of the patients. Only one adverse event occurred in one patient from the placebo group.
CONCLUSION: The homeopathic product allows an effective and tolerable treatment of acute rhinosinusitis.
Source : HNO
Link to Abstract
Economic evaluation of Sinfrontal in the treatment of acute maxillary sinusitis in adults
.Kneis KC, Gandjour A.
Source University of Cologne, Cologne, Germany.
AbstractSinfrontal, 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.
Source : Appl Health Econ Health Policy.
Link to Abstract
Homeopathy in chronic sinusitis: a prospective multi-centric observational study.
Nayak C, Singh V, Singh VP, Oberai P, Roja V, Shitanshu SS, Sinha MN, Deewan D, Lakhera BC, Ramteke S, Kaushik S, Sarkar S, Mandal NR, Mohanan PG, Singh JR, Biswas S, Mathew G.
SourceCentral Council for Research in Homoeopathy, New Delhi, India.
Abstract
OBJECTIVE: The primary objective was to ascertain the therapeutic usefulness of homeopathic medicine in the management of chronic sinusitis (CS).
MATERIALS AND METHODS: Multicentre observational study at Institutes and Units of the Central Council for Research in Homoeopathy, India. Symptoms were assessed using the chronic sinusitis assessment score (CSAS). 17 pre-defined homeopathic medicines were shortlisted for prescription on the basis of repertorisation for the pathological symptoms of CS. Regimes and adjustment of regimes in the event of a change of symptoms were pre-defined. The follow-up period was for 6 months. Statistical analysis was done using SPSS version 16.
RESULTS: 628 patients suffering from CS confirmed on X-ray were enrolled from eight Institutes and Units of the Central Council for Research in Homoeopathy. All 550 patients with at least one follow-up assessment were analyzed. There was a statistically significant reduction in CSAS (P = 0.0001, Friedman test) after 3 and 6 months of treatment. Radiological appearances also improved. A total of 13 out of 17 pre-defined medicines were prescribed in 550 patients, Sil. (55.2% of 210), Calc. (62.5% of 98), Lyc. (69% of 55), Phos. (66.7% of 45) and Kali iod. (65% of 40) were found to be most useful having marked improvement. 4/17 medicines were never prescribed. No complications were observed during treatment.
CONCLUSION: Homeopathic treatment may be effective for CS patients. Controlled trials are required for further validation.
Source : Homeopathy. 2012 Apr;101(2):84-91
Link to Abstract
Homeopathic treatment of patients with chronic sinusitis: A prospective observational study with 8 years follow-up
Claudia M Witt1*, Rainer Lüdtke2 and Stefan N Willich1
1 Institute for Social Medicine, Epidemiology and Health Economics, Charité University Medical Centre, D-10098 Berlin, Germany
2 Karl and Veronica Carstens-Foundation, Am Deimelsberg 36, D-45276 Essen, Germany
Abstract
Background An evaluation of homeopathic treatment and the outcomes in patients suffering from sinusitis for ≥12 weeks in a usual care situation.
Methods Subgroup analysis including all patients with chronic sinusitis (ICD-9: 473.9; ≥12 weeks duration) of a large prospective multicentre observational study population. Consecutive patients presenting for homeopathic treatment were followed-up for 2 years, and complaint severity, health-related quality of life (QoL), and medication use were regularly recorded. We also present here patient-reported health status 8 years post initial treatment.
Results The study included 134 adults (mean age 39.8 ± 10.4 years, 76.1% women), treated by 62 physicians. Patients had suffered from chronic sinusitis for 10.7 ± 9.8 years. Almost all patients (97.0%) had previously been treated with conventional medicine. For sinusitis, effect size (effect divided by standard deviation at baseline) of complaint severity was 1.58 (95% CI 1.77; 1.40), 2.15 (2.38; 1.92), and 2.43 (2.68; 2.18) at 3, 12, and 24 months respectively. QoL improved accordingly, with SF-36 changes in physical component score 0.27 (0.15; 0.39), 0.35 (0.19; 0.52), 0.44 (0.23; 0.65) and mental component score 0.66 (0.49; 0.84), 0.71 (0.50; 0.92), 0.65 (0.39; 0.92), 0.74 (0.49; 1.00) at these points. The effects were still present after 8 years with SF-36 physical component score 0.38 (0.10; 0.65) and mental component score 0.74 (0.49; 1.00).
Conclusion This observational study showed relevant improvements that persisted for 8 years in patients seeking homeopathic treatment because of sinusitis. The extent to which the observed effects are due to the life-style regulation and placebo or context effects associated with the treatment needs clarification in future explanatory studies.
Source : BMC
Link to Full Article
Efficacy of a complex homeopathic medication (Sinfrontal) in patients with acute maxillary sinusitis: a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial.
Zabolotnyi DI, Kneis KC, Richardson A, Rettenberger R, Heger M, Kaszkin-Bettag M, Heger PW.
Source - Research Institute for Ear, Nose, and Throat Diseases, Kiev, Ukraine.
AbstractBACKGROUND: 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.
Source : Explore NY
Link to Abstract
Homeopathy in acute rhinosinusitis: a double-blind, placebo controlled study shows the efficiency and tolerability of a homeopathic combination remedy].
[Article in German]
Friese KH, Zabalotnyi DI.
AbstractBACKGROUND: The efficacy and tolerability of a homeopathic combination remedy for the treatment of acute rhinosinusitis was investigated.
PATIENTS AND METHODS: A total of 144 patients with acute rhinosinusitis were treated in a randomized, double-blind study either with a homeopathic remedy (n=72) or placebo (n=72). At the control examinations after 7, 14 and 21 days, five sinusitis-typical symptoms were measured with scores from 0 (absent) to 4 (very strong). The change of sum score of the sinusitis-typical symptoms (max. 20 points) during the treatment served as the primary efficacy criterion.
RESULTS: In the homeopathic treatment group, the average sum score dropped from initially 12.1+/-1.6 to 5.9+/-2.0 points after 7 days. In the placebo group it decreased from 11.7+/-1.6 to 11.0+/-2.9 points (p<0.0001). The homeopathic treatment resulted in freedom from complaints in 90.3% of the patients and improvement in a further 8.3%, whereas in the placebo group, the complaints remained unchanged or became worse in 88.9% of the patients. Only one adverse event occurred in one patient from the placebo group.
CONCLUSION: The homeopathic product allows an effective and tolerable treatment of acute rhinosinusitis.
Source : HNO
Link to Abstract
Economic evaluation of Sinfrontal in the treatment of acute maxillary sinusitis in adults
.Kneis KC, Gandjour A.
Source University of Cologne, Cologne, Germany.
AbstractSinfrontal, 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.
Source : Appl Health Econ Health Policy.
Link to Abstract
Homeopathy in chronic sinusitis: a prospective multi-centric observational study.
Nayak C, Singh V, Singh VP, Oberai P, Roja V, Shitanshu SS, Sinha MN, Deewan D, Lakhera BC, Ramteke S, Kaushik S, Sarkar S, Mandal NR, Mohanan PG, Singh JR, Biswas S, Mathew G.
SourceCentral Council for Research in Homoeopathy, New Delhi, India.
Abstract
OBJECTIVE: The primary objective was to ascertain the therapeutic usefulness of homeopathic medicine in the management of chronic sinusitis (CS).
MATERIALS AND METHODS: Multicentre observational study at Institutes and Units of the Central Council for Research in Homoeopathy, India. Symptoms were assessed using the chronic sinusitis assessment score (CSAS). 17 pre-defined homeopathic medicines were shortlisted for prescription on the basis of repertorisation for the pathological symptoms of CS. Regimes and adjustment of regimes in the event of a change of symptoms were pre-defined. The follow-up period was for 6 months. Statistical analysis was done using SPSS version 16.
RESULTS: 628 patients suffering from CS confirmed on X-ray were enrolled from eight Institutes and Units of the Central Council for Research in Homoeopathy. All 550 patients with at least one follow-up assessment were analyzed. There was a statistically significant reduction in CSAS (P = 0.0001, Friedman test) after 3 and 6 months of treatment. Radiological appearances also improved. A total of 13 out of 17 pre-defined medicines were prescribed in 550 patients, Sil. (55.2% of 210), Calc. (62.5% of 98), Lyc. (69% of 55), Phos. (66.7% of 45) and Kali iod. (65% of 40) were found to be most useful having marked improvement. 4/17 medicines were never prescribed. No complications were observed during treatment.
CONCLUSION: Homeopathic treatment may be effective for CS patients. Controlled trials are required for further validation.
Source : Homeopathy. 2012 Apr;101(2):84-91
Link to Abstract
Homeopathic treatment of patients with chronic sinusitis: A prospective observational study with 8 years follow-up
Claudia M Witt1*, Rainer Lüdtke2 and Stefan N Willich1
1 Institute for Social Medicine, Epidemiology and Health Economics, Charité University Medical Centre, D-10098 Berlin, Germany
2 Karl and Veronica Carstens-Foundation, Am Deimelsberg 36, D-45276 Essen, Germany
Abstract
Background An evaluation of homeopathic treatment and the outcomes in patients suffering from sinusitis for ≥12 weeks in a usual care situation.
Methods Subgroup analysis including all patients with chronic sinusitis (ICD-9: 473.9; ≥12 weeks duration) of a large prospective multicentre observational study population. Consecutive patients presenting for homeopathic treatment were followed-up for 2 years, and complaint severity, health-related quality of life (QoL), and medication use were regularly recorded. We also present here patient-reported health status 8 years post initial treatment.
Results The study included 134 adults (mean age 39.8 ± 10.4 years, 76.1% women), treated by 62 physicians. Patients had suffered from chronic sinusitis for 10.7 ± 9.8 years. Almost all patients (97.0%) had previously been treated with conventional medicine. For sinusitis, effect size (effect divided by standard deviation at baseline) of complaint severity was 1.58 (95% CI 1.77; 1.40), 2.15 (2.38; 1.92), and 2.43 (2.68; 2.18) at 3, 12, and 24 months respectively. QoL improved accordingly, with SF-36 changes in physical component score 0.27 (0.15; 0.39), 0.35 (0.19; 0.52), 0.44 (0.23; 0.65) and mental component score 0.66 (0.49; 0.84), 0.71 (0.50; 0.92), 0.65 (0.39; 0.92), 0.74 (0.49; 1.00) at these points. The effects were still present after 8 years with SF-36 physical component score 0.38 (0.10; 0.65) and mental component score 0.74 (0.49; 1.00).
Conclusion This observational study showed relevant improvements that persisted for 8 years in patients seeking homeopathic treatment because of sinusitis. The extent to which the observed effects are due to the life-style regulation and placebo or context effects associated with the treatment needs clarification in future explanatory studies.
Source : BMC
Link to Full Article