Feasibility in a homeopathy for seasonal allergic rhinitis RCT: importance of therapeutic relationship and organizational capacity

TL;DR

This study explored the feasibility of a homeopathy trial for seasonal allergies, focusing on patient-physician relationships and study organization.

Contribution

The study provides design-level recommendations for patient-centered RCTs in complex interventions.

Findings

Patients valued empathetic physician relationships and supportive study team interactions.

Documentation was seen as clear but time-consuming.

Recommendations include digital diaries and tracked medication shipping.

Abstract

Seasonal allergic rhinitis (SAR) patients often use homeopathy for symptom relief. The HOMEOSAR trial, a randomized, placebo-controlled, triple-blind multicenter study, included a qualitative sub-study to assess feasibility. This sub-study specifically examined the feasibility of the study, focusing in particular on two mechanism-rich domains—the therapeutic relationship and study organization—with special attention to study procedures, physician–patient relationships, organizational aspects, and interactions with the study team.

Semi-structured interviews with trial participants were conducted 6–8 weeks after baseline, corresponding to 2–4 weeks after study intervention ended. Data were coded, categorized, and analyzed using qualitative content analysis, both inductively from the material and deductively based on study aims. MAXQDA® software was used to support analysis.

Fifteen patients (mean age 43 years; range 20–67; 11 male) participated in the qualitative study (n = 8 standardized homeopathy, n = 2 individualized homeopathy, n = 5 placebo). They were recruited from nine study centers in Berlin. Results of the qualitative sub-study indicate the overall feasibility of the HOMEOSAR trial. Patients highlighted the empathetic and professional relationships with physicians and the supportive contact with the study team. While the documentation was seen as well-structured and clear, it was also described as time-consuming.

Findings of this qualitative study provide design-level recommendations (e.g., upfront communication of consultation length, digital diaries with free-text, tracked medication shipping, single contact point) for RCT studies. Beyond the specific homeopathy study context, these findings offer important methodological insights for designing patient-centered RCTs in complex intervention settings not only in the field of Complementary and Integrative Medicine.