In an open-label, prospective non-randomized cohort study, we compared the effectiveness and tolerability profiles of the homeopathic remedy Nervoheel N with those of the benzodiazepine, lorazepam, in 248 patients with insomnia, distress, anxieties, restlessness or burnout and similar nervous conditions ('mild nervous disorders'). Patients were treated with Nervoheel N or lorazepam at the recommended doses for a maximum of 4 weeks. Dose variations were allowed if in the patient's best interest. Treatment effects were evaluated by the practitioner in a dialogue with the patient at the start of treatment, after 2 weeks and after maximally 4 weeks of treatment. Tolerability data were recorded as adverse events. At baseline, lorazepam patients were on average slightly older and there was a somewhat greater percentage of men in this group than in the Nervoheel group. Both treatment groups reported significant symptomatic improvements of similar magnitude during the course of the study. The sum of symptom scores improved by 4.4 points with Nervoheel N and by 4.2 points with lorazepam. The differences between the treatment groups were not significant. All differences between treatments were within 10% of the maximum score ranges, demonstrating non-inferiority of Nervoheel N. Both treatments were well tolerated, with few adverse events and very good self-assessed tolerability ratings by the patients. Thus, in patients who opt for a homeopathic treatment regimen for the short-term relief of mild nervous disorders, the effects of Nervoheel N are non-inferior to those of lorazepam.
Keywords: benzodiazepine; clinical practice; homeopathy; tolerability.