Effects of Neurodoron® in patients with nervous exhaustion – Results from a randomized controlled clinical trial

Bergtholdt, Bettina; Hellhammer, Juliane; Semaca, Cristina; Schnelle, Martin

doi:10.1016/j.eujim.2016.08.105

Cited by 1 publication

(3 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Patients of the physician-based NIS showed a significant reduction of all 39 recorded symptoms such as irritability, headaches, and sleep disorder. e double-blind RCT that followed in 2011/2012 [41] to demonstrate the efficacy in patients with nervous fatigue following diagnostic criteria defined in ICD-10 [42] showed similar results. While there was no statistically significant difference to the placebo in the symptom sum score, 10 of the 12 symptoms tested in a post hoc analysis showed favourable trends in the Neurodoron ® group compared to the control group.…”

Section: Discussionmentioning

confidence: 89%

“…For Neurodoron ® , two clinical studies were performed between 2008 and 2012, indicating that the anthroposophic drug can be an efficient treatment for stress-related health problems [40,41]. A first multicenter NIS conducted by practicing physicians in Germany from 2008 to 2009 [40] investigated the effect of the MP in participants reporting stress-related nervous fatigue.…”

Section: Introductionmentioning

confidence: 99%

“…Neurodoron ® [41] followed to demonstrate the efficacy in participants with nervous fatigue following diagnostic criteria defined in ICD-10 [42]. Significant improvements were observed for the symptoms of nervousness and irritability.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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

Hellhammer

Schmidt

Semaca

2022

Evidence-Based Complementary and Alternative Medicine

Self Cite

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionmentioning

confidence: 89%

Section: Introductionmentioning

confidence: 99%