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An evaluation of homeopathic treatment and the outcomes in patients suffering from sinusitis for ?12 weeks in a usual care situation.
This observational study showed relevant improvements that persisted for 8 years in patients seeking homeopathic treatment because of sinusitis. BackgroundChronic sinusitis is generally accepted to be a common illness incurring considerable costs, despite limited epidemiological data[1]. In this prospective multi-centre observational study, patients were included consecutively upon their first consultation with a participating physician, and subsequently followed up, using standardised questionnaires. Before treatment (at baseline) and independent of their physicians, patients recorded the complaints that instigated homeopathic treatment, and rated their severity on a numeric rating scale (NRS, 0 = no complaints, 10 = maximum severity) [21].
As outcome measures, we defined: mean sinusitis severity, mean severity of all baseline diagnoses (pooled physician assessment), mean severity of all complaints (pooled patient assessment), and QoL scores. Usually, patients seek treatment when their health is below average (such as severe pain, low QoL, etc.). The consultations consisted of an extensive initial consultation (table 3), followed by the analysis of the case. The strongest improvements in the severity of complaints were seen in the first 3 months, they generally continued during the first 24 months and persisted for another 6 years (Table 4). 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. 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.
The health-related quality of life (QoL) was recorded with the MOS SF-36 [22] questionnaire. A natural alleviation of their diseases (regression to the mean) can be mistaken for an effect at the beginning of treatment [25].
These patients were treated by 62 physicians (including 1 Ear, nose and throat (ENT) specialist).
Almost all patients received the first homeopathic medication on the day of their first consultation, three patients had to wait for ?1 week, ?1 month, and longer, respectively.
Half of all prescriptions were covered by 10 homeopathic remedies (figure 1), but in total, 145 remedies were applied.
Percent of prescriptions during study period, remedies identified with traditional abbreviations (in decreasing order of frequency: Sepia, Pulsatilla, Lycopodium, Phosphorus, Carcinosinum, Nux vomica, Sulphur, Natrium muriaticum, Staphisagria, Silicea).

The physicians' assessments of the severity change tended to be more positive than patients' own assessments (data not shown). Polyps, which may or may not be present are increasingly recognized as part of the sinusitis pathology [1, 2].
Written informed consent and approval by the ethics review board of the Charite University Medical Centre were obtained.
The first questionnaires were personally given to the patients by the study physicians and were completed before treatment. In order to separate regression to the mean and treatment effects, the mean of the target population must be known or plausibly assumed.
Almost all accompanying diagnoses assessed at baseline were chronic diseases that had previously been under treatment-mostly with conventional medicine (Tables 1, 2). The subsequent consultations, about half of them telephone calls, were much shorter than the initial history taking (Table 3).
The improvements in health-related QoL were of smaller effect size (Table 4) but statistically significant. 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). Patients sent them in sealed envelopes directly to the study office, from where they received follow-up questionnaires after 3, 12, and 24 months, and 8 years, with every complaint being transferred to the follow-up questionnaires to ensure continuous assessment. For the QoL, we applied Mee and Chua's test [26] under the assumption that the patients had the same QoL as the general German population [22]. All diagnoses seen in more than 5% of the patients were present for at least five years (Table 2).
While the role of fungi and hormonal changes during pregnancy are unclear, it may also be an early symptom of systemic disease [1, 3, 4].Standard treatment recommendations are to suppress the inflammatory process with corticosteroids [1, 5, 6], antibiotics may be also necessary to combat opportunistic infections [1, 7], and possible underlying diseases may require their own specific medication. At baseline, 3, 12 and 24 months, the participating physicians recorded up to 4 diagnoses per patient and assessed their severity on identical NRS. Each was given 20 distinct, but plausible values, based on correlations with non-missing values and reflecting the overall variability of data. After 24 months, sinusitis and other baseline diagnoses were considerably relieved (Table 5), while large reductions in the use of conventional medicines and health care services were observed (Table 6).
On a continuous basis, they recorded the homeopathic treatment, use of any conventional therapies, and all referrals.

Surgical intervention was found to be as effective as medical treatment, but should be reserved for refractory cases [1, 3, 5]. These were analysed separately (see below), and the results pooled to calculate treatment effects and p-values. Some complementary and alternative medical (CAM) treatments might be helpful as adjuvants [8].
For each imputed data set, treatment effects were estimated on the basis of a generalised multiple linear regression model, following the recommendations by Diggle et al [24]. It appears that homeopaths are consulted more frequently by patients with acute and chronic sinusitis (13% of the homeopathy group vs. We assumed the treatment course to be mixed with a piecewise linear part (0–3 months, 3–24 months, and 24 to 72 months). 7% of the conventional group in an observational comparison study) [9], but to date no research has looked into the effects of homeopathy for chronic sinusitis.Homeopathy is practised in many regions of the world [10], especially in high-income countries, where it is the most popular treatment form among the traditional, complementary, or alternative medical therapies [10–12]. 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'). Standardised effects (d) were calculated by dividing treatment effects as estimated above by baseline standard deviations. 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 [13, 14] might be a consequence of trial selection [15]. 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 [16–19]) with respect to diagnosis. This paper presents the 134 adults consulting a homeopathic physician because of chronic sinusitis.

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