Neurodoron® for Stress Impairments: A Prospective, Multicenter Non-Interventional Trial

Area of Science:

• Pharmacovigilance
• Complementary Medicine
• Stress Management

Background:

• Stress significantly impacts physical and psychological health.
• Over-the-counter (OTC) products are sought for safe and tolerable stress management.
• Neurodoron® shows promise in treating stress-related symptoms.

Purpose of the Study:

• To evaluate the efficacy and tolerability of Neurodoron® in patients with stress-induced nervous exhaustion.
• To assess the impact of Neurodoron® on characteristic stress symptoms, stress burden, and perceived stress.
• To gather data on adverse drug reactions (ADRs) in a real-world setting.

Main Methods:

• A non-interventional study (NIS) involving 272 patients across 74 German pharmacies.
• Patients with symptoms of acute and/or chronic stress were enrolled.
• Outcomes included stress symptom scores, stress burden (VAS), perceived stress (PSQ), efficacy, and tolerability ratings over approximately 21 days.

Main Results:

• Significant reduction in total stress symptom scores (18.1 to 12.1, p < 0.0001).
• Marked decrease in stress burden (VAS -29.1%, p < 0.0001) and perceived stress (PSQ decreased in 70.9% of patients).
• High ratings for efficacy (75.9% "good" or "very good") and tolerability (96.6% "good" or "very good"); one uncritical ADR reported.

Conclusions:

• This NIS provides evidence for the beneficial effects of Neurodoron® in self-managed stress.
• The study demonstrated a significant reduction in stress burden and perceived stress with an excellent safety profile.
• Further clinical trials are recommended to substantiate these findings.