Homeopathic treatment of patients with chronic sinusitis: A prospective observational study with 8 years follow-up
Claudia M Witt, Rainer Lüdtke, and Stefan N Willich
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.
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.
Background
Chronic sinusitis is generally accepted to be a common illness incurring considerable costs, despite limited epidemiological data. It is defined as an inflammation of the nasal mucosa and paranasal sinuses for at least 12 weeks which may cause nasal blockage or congestion, mucous discharge, facial pain or pressure, and/or impaired smell. Polyps, which may or may not be present are increasingly recognized as part of the sinusitis pathology. Several factors have been found to contribute to the disease, namely, insufficient ciliary motility, allergy and asthma, bacterial infection, and more rarely, morphological anomalies, immune deficiencies and Samter's triad (salicylate sensitivity, asthma, nasal polyps). While the role of fungi and hormonal changes during pregnancy are unclear, it may also be an early symptom of systemic disease.
Standard treatment recommendations are to suppress the inflammatory process with corticosteroids, antibiotics may be also necessary to combat opportunistic infections, and possible underlying diseases may require their own specific medication. Saline douching can provide some symptomatic relief. Surgical intervention was found to be as effective as medical treatment, but should be reserved for refractory cases. Some complementary and alternative medical (CAM) treatments might be helpful as adjuvants. It appears that homeopaths are consulted more frequently by patients with acute and chronic sinusitis (13% of the homeopathy group vs. 7% of the conventional group in an observational comparison study), but to date no research has looked into the effects of homeopathy for chronic sinusitis.
Homeopathy is practised in many regions of the world, especially in high-income countries, where it is the most popular treatment form among the traditional, complementary, or alternative medical therapies. Homeopathic prescribing accounts for concomitant symptoms in addition to the predominant pathology, therefore the same main diagnosis may be treated with different remedies in different patients ('individualisation'). The prescribed drugs ('remedies') are under constant debate. They are produced by alternating steps of diluting and agitating a starting substance ('potentiating'). After several repetitions, dilutions beyond Avogadro's number are reached, and the probability approaches zero that even a single molecule of the starting substance
remains present in the drug. Such 'high potencies' are often used, however their effects are the subject of scientific controversy.
Apparently, the inconsistent results seen in meta-analyses of placebo-controlled trials pooling a great variety of diseases and ailments might be a consequence of trial selection. We analyzed the data from our prospective observational study, which globally evaluated details and effects under homeopathic treatment in a usual care situation (3981 patients over 8 years) with respect to diagnosis. This paper presents the 134 adults consulting a homeopathic physician because of chronic sinusitis.
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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.
Background
Chronic sinusitis is generally accepted to be a common illness incurring considerable costs, despite limited epidemiological data. It is defined as an inflammation of the nasal mucosa and paranasal sinuses for at least 12 weeks which may cause nasal blockage or congestion, mucous discharge, facial pain or pressure, and/or impaired smell. Polyps, which may or may not be present are increasingly recognized as part of the sinusitis pathology. Several factors have been found to contribute to the disease, namely, insufficient ciliary motility, allergy and asthma, bacterial infection, and more rarely, morphological anomalies, immune deficiencies and Samter's triad (salicylate sensitivity, asthma, nasal polyps). While the role of fungi and hormonal changes during pregnancy are unclear, it may also be an early symptom of systemic disease.
Standard treatment recommendations are to suppress the inflammatory process with corticosteroids, antibiotics may be also necessary to combat opportunistic infections, and possible underlying diseases may require their own specific medication. Saline douching can provide some symptomatic relief. Surgical intervention was found to be as effective as medical treatment, but should be reserved for refractory cases. Some complementary and alternative medical (CAM) treatments might be helpful as adjuvants. It appears that homeopaths are consulted more frequently by patients with acute and chronic sinusitis (13% of the homeopathy group vs. 7% of the conventional group in an observational comparison study), but to date no research has looked into the effects of homeopathy for chronic sinusitis.
Homeopathy is practised in many regions of the world, especially in high-income countries, where it is the most popular treatment form among the traditional, complementary, or alternative medical therapies. Homeopathic prescribing accounts for concomitant symptoms in addition to the predominant pathology, therefore the same main diagnosis may be treated with different remedies in different patients ('individualisation'). The prescribed drugs ('remedies') are under constant debate. They are produced by alternating steps of diluting and agitating a starting substance ('potentiating'). After several repetitions, dilutions beyond Avogadro's number are reached, and the probability approaches zero that even a single molecule of the starting substance
remains present in the drug. Such 'high potencies' are often used, however their effects are the subject of scientific controversy.
Apparently, the inconsistent results seen in meta-analyses of placebo-controlled trials pooling a great variety of diseases and ailments might be a consequence of trial selection. We analyzed the data from our prospective observational study, which globally evaluated details and effects under homeopathic treatment in a usual care situation (3981 patients over 8 years) with respect to diagnosis. This paper presents the 134 adults consulting a homeopathic physician because of chronic sinusitis.
DOWNLOAD COMPLETE PDF HERE
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