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

Juliane Hellhammer; Katja Schmidt; Cristina Semaca; Rebecca Hufnagel

doi:10.1155/2022/2626645

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

Evid Based Complement Alternat Med. 2022 Feb 25:2022:2626645. doi: 10.1155/2022/2626645. eCollection 2022.

Authors

Juliane Hellhammer¹, Katja Schmidt¹, Cristina Semaca², Rebecca Hufnagel²

Affiliations

¹ Contract Research Institute, Daacro, Trier 54296, Germany.
² Clinical Research, Weleda AG, Schwäbisch Gmünd 73525, Germany.

Abstract

Introduction: Stress is associated with a multitude of physical and psychological health impairments. To tackle these health disorders, over-the-counter (OTC) products like Neurodoron® are popular since they are considered safe and tolerable. Experience reports and first studies indicate that Neurodoron® is efficient in the treatment of stress-associated health symptoms. To confirm this, a non-interventional study (NIS) with pharmacies was conducted.

Methods: The NIS was planned to enroll female and male patients who suffered from nervous exhaustion with symptoms caused by acute and/or chronic stress. The main outcome measures were characteristic stress symptoms, stress burden, and perceived stress. Further outcome measures included perceived efficacy and tolerability of the product as assessed by the patients and collection of adverse drug reactions (ADRs). A study duration of about 21 days with a recommended daily dose of 3-4 tablets was set.

Results: 279 patients were enrolled at 74 German pharmacies. The analyzed set (AS) included 272 patients (mean age 44.8 ± 14.4 years, 73.9% female). 175 patients of the AS completed the NIS. During the study, all stress symptoms declined significantly (total score 18.1 vs. 12.1 (of max. 39 points), p < 0.0001). Furthermore, a reduction of stress burden (relative difference in stress burden, VAS = -29.1%, p < 0.0001) was observed. For most patients, perceived stress was reduced at the study end (PSQ total score decreased in 70.9% of the patients). 75.9% of the study population rated the product efficacy as "good" or "very good" and 96.6% rated its tolerability as "good" or "very good." One uncritical ADR was reported. Discussion/Conclusion. This study adds information on the beneficial effects of Neurodoron® in self-medication. The results from this NIS showed a marked reduction in stress burden and perceived stress, along with an excellent safety profile of the medicinal product (MP) Neurodoron®. Further trials are required to confirm these results.