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

Introduction: 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. Methods: 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. Results: Fifteen patients (mean age 43 years; range 20-67; 11 male) participated in the qualitative study ( Conclusion: 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.