Neurodoron(R) in patients with neurasthenia -- A randomized, double-blind, placebo-controlled clinical trial

1IntroductionThe term neurasthenia has been introduced in the late 19th century. Stress was indicated as one of the main triggers. Many treatment options are available to reduce the associated symptoms. Complementary and alternative medicine (CAM) is widely used due to its long tradition and positive safety profile. This Phase IV placebo-controlled clinical trial was designed to demonstrate efficacy and safety of the CAM-product Neurodoron(R) in patients with neurasthenia. MethodsThis monocentre, randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted in a dedicated outpatient German trial site. Women and men aged 18 and above were randomized to receive either Neurodoron(R) or matching placebo if they reported typical symptoms of neurasthenia and a severe psychiatric disorder could be excluded. The primary objectives were a reduction in characteristic symptoms of nervous exhaustion and perceived stress as well as improvement in general health status after 6 weeks of treatment. Results204 patients underwent screening, 78 were randomized in each treatment group, and 77 patients each received treatment (intention-to-treat (ITT) population = 154 patients). For none of the primary efficacy variables, an advantage in favor of Neurodoron(R) could be demonstrated in the pre-specified analysis (p-values between 0.505 to 0.773, Students t-test). In a post-hoc analysis of intra-individual differences after 6 weeks treatment, a significant advantage of Neurodoron(R) vs. placebo was shown for characteristic symptoms of nervous exhaustion (irritability (p = 0.020); nervousness (p = 0.045), Students t-test). Adverse Event (AE) rates were similar between treatment groups, in both groups 6 AEs were assessed as causally related to treatment (severity mild or moderate). No AE resulted in discontinuation of treatment. ConclusionA significant improvement of neurasthenia was seen for the total study population at the end of the treatment period. Superiority of Neurodoron(R) vs. placebo could not be demonstrated with the pre-specified analysis. However, the post-hoc analysis suggests Neurodoron(R) as a beneficial option over placebo for the treatment of neurasthenia, especially given its confirmed markedly good safety.