International integrative primary care outcomes study (IIPCOS-2): an international research project of homeopathy in primary care

Abstract

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:

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  Homeopathic treatment;

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  Homeopathic or conventional treatment according to the patient’s preference, either randomized or non-randomized;

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  Conventional treatment.

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.