Max Haidvogl

Background: The aim of this study was to assess the effectiveness of homeopathy compared to conventional treatment in acute respiratory and ear complaints in a primary care setting. Methods: The study was designed as an international, multi-centre, comparative cohort study of non-randomised design. Patients, presenting themselves with at least one chief complaint: acute (≤ 7 days) runny nose, sore throat, ear pain, sinus pain or cough, were recruited at 57 primary care practices in Austria (8), Germany (8), the Netherlands (7), Russia (6), Spain (6), Ukraine (4), United Kingdom (10) and the USA (8) and given either homeopathic or conventional treatment. Therapy outcome was measured by using the response rate, defined as the proportion of patients experiencing 'complete recovery' or 'major improvement' in each treatment group. The primary outcome criterion was the response rate after 14 days of therapy. Results: Data of 1,577 patients were evaluated in the full analysis set of which 857 received homeopathic (H) and 720 conventional (C) treatment. The majority of patients in both groups reported their outcome after 14 days of treatment as complete recovery or major improvement (H: 86.9%; C: 86.0%; p = 0.0003 for non-inferiority testing). In the per-protocol set (H: 576 and C: 540 patients) similar results were obtained (H: 87.7%; C: 86.9%; p = 0.0019). Further subgroup analysis of the full analysis set showed no differences of response rates after 14 days in children (H: 88.5%; C: 84.5%) and adults (H: 85.6%; C: 86.6%). The unadjusted odds ratio (OR) of the primary outcome criterion was 1.40 (0.89–2.22) in children and 0.92 (0.63–1.34) in adults. Adjustments for demographic differences at baseline did not significantly alter the OR. The response rates after 7 and 28 days also showed no significant differences between both treatment groups. However, onset of improvement within the first 7 days after treatment was significantly faster upon homeopathic treatment both in children (p = 0.0488) and adults (p = 0.0001). Adverse drug reactions occurred more frequently in adults of the conventional group than in the homeopathic group (C: 7.6%; H: 3.1%, p = 0.0032), whereas in children the occurrence of adverse drug reactions was not significantly different (H: 2.0%; C: 2.4%, p = 0.7838). Conclusion: In primary care, homeopathic treatment for acute respiratory and ear complaints was not inferior to conventional treatment.

Objective: The primary objective is to evaluate the effectiveness of homeopathic treatment compared to conventional treatment for respiratory and ear complaints commonly seen in the primary care setting: runny nose, sore throat, ear pain, sinus pain, and cough. Method: This study is an international, multi-center, prospective, outcomes study on the effectiveness of homeopathic treatment compared to conventional treatment. The participating investigators will be divided into three groups: A total of 2400 patients will be recruited. Consecutive patients, age one month or older, presenting with one of the five chief complaints, and onset of symptoms less than seven days will be included into the study. Prior to enrolment into the trial each patient must provide written informed consent. Patient outcome will be measured using the Integrative Medicine Outcomes Scale (IMOS) at 7-, 14- and 28-d telephone follow-up. In addition, covariate data related to the following will be collected: patient demographics and medical history, patient preference for treatment and willingness to be randomized, health-related quality of life, primary treatment and adjunctive therapies prescribed, adverse events, type and length of consultation, follow-up recommendation, patient compliance, patient satisfaction with treatment, and patient willingness to choose therapy and health care provider again. The main outcome criterion will be the response rate according to the IMOS after 14 days of treatment. Results: Preliminary interim results will be presented. Conclusions: Lessons learned from the study will be discussed.