Abstract
Introduction Insomnia is one of the most common disorders which affects quality of life and work performance resulting in considerable economic consequences when inadequately treated. Patients frequently request homeopathic treatment in routine clinical practice based on positive experiences. This highlights the need for systematic data collection on treatment options for insomnia in primary care settings. Methods This open-label, two-arm, prospective, multicenter, non-interventional cohort study compared patients treated over 12 weeks with individualized, classical homeopathy by general practitioners with additional qualifications in homeopathy (HOM) to patients receiving treatment with chemically synthesized drugs by general practitioners working in conventional medicine (KON). Routine clinical data were collected and the questionnaires Pittsburgh Sleep Quality Index (PSQI), Measure Yourself Medical Outcome Profile (MYMOP), and Integrative Medicine Patient Satisfaction Scale (IMPSS) were applied to measure outcomes. Results 84 patients (54 HOM from 14 sites; 30 KON from 7 sites) were included in the analyses. Demographic characteristics were not statistically different between the two groups except for school education and highest educational qualification, which both were higher in the HOM group. At baseline, PSQI total score (TS) (HOM: 11.5, CI: 10.7 to 12.4; KON: 12.9, CI: 11.6 to 14.1) and MYMOP Profile Score (PS) (HOM: 3.7, CI: 3.6 to 3.9; KON: 3.7, CI: 3.4 to 4.1) indicated no significant intergroup differences in terms of severity. After 12 weeks, PSQI TS (HOM: -4.73, CI: -5.97 to -3.48; KON: -3.90, CI: -5.46 to -2.33) and MYMOP PS (HOM: -1.58, CI: -1.96 to -1.21; KON: -1.43, CI: -1.89 to -0.97) significantly improved in both groups (p < 0.001, two-sided p-values of ANCOVA models). Intergroup comparison found no significant differences (HOM vs KON: PSQI TS: -0.83; CI: -2.90 to 1.24, MYMOP PS: -0.16; CI: -0.77 to 0.46). Both groups were satisfied with their treatment, with higher treatment satisfaction ratings for the HOM group (p < 0.010, two-sided p-value of the Cochran-Armitage-Trend test). Adverse drug reactions (ADRs) occurred less frequently in the HOM group (3/54 (5.6%) patients) than in the KON group (9/34 (26.5%) patients). There were no serious ADRs in both groups. Conclusion These real-world data show that the conventional and homeopathic medical approaches in primary care both led to an amelioration of insomnia symptoms of initially comparable severity after 12 weeks, with no differences between the treatments. Both treatment options were well tolerated. However, patients in the HOM group had fewer ADRs and were more satisfied with their treatment.