Randomized controlled trials on treatment by homeopaths and self-treatment with homeopathic medicines: design and protocol

Abstract

Background and objective: This study investigates (1) whether treatment by homeopaths is more efficacious than self-selected conventional health care and (2) whether self-treatment with self-selected homeopathic medicines is more efficacious than placebo in preventing childhood upper respiratory tract infections (URTIs).

Design: A four-arm randomized controlled trial involving two independent investigations, one open and pragmatic (evaluating the effect of treatment by homeopaths including homeopathic medicines) and one double-blinded (evaluating the effect of self-treatment with homeopathic medicine).

Patients: The planned sample size is 420 children below the age of 10, recruited by a postal invitation to all children diagnosed with URTIs when attending a casualty department in Trondheim, Norway.

Interventions: The children are randomly assigned to receive either (1) self-selected homeopathic medicine or placebo (270 patients), (2) treatment by one of four different homeopaths who could prescribe any homeopathic medicine (75 patients), or (3) waiting list control using self-selected conventional health care (75 patients).

Main outcome measure: Total URTI symptom scores from patients' diary over 12 weeks. PLAN: The results of these two studies (available at the end of 2004) have the potential to provide information about the efficacy of treatment by homeopaths independently from the efficacy of homeopathic medicines in children with URTIs.