MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

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. One tablet of this anthroposophic remedy contains the following active ingredients:

  • 83.3 mg Aurum metallicum praeparatum trituration (trit.) D10,
  • 83.3 mg Kalium phosphoricicum trit. D6,
  • 8.3 mg Ferrum-Quarz trit. D2.

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.

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.

In total, 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),  < 0.0001). Furthermore, a reduction of stress burden (relative difference in stress burden, VAS = −29.1%,  < 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.

The authors concluded that 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.

I beg to differ!

The study had no control group and therefore one cannot possibly attribute any of the observed changes to the anthroposophic remedy. They are more likely to be due to:

  • the natural history of the condition,
  • regression towards the mean,
  • a placebo effects,
  • other treatments administered during the trial period.

Sadly, the authors discuss none of these possibilities in their paper.

In view of this, I am tempted to rephrase their conclusions as follows:

This study adds no valuable information on the effects of Neurodoron® in self-medication. The results from this NIS showed what utter nonsense the Weleda marketing team is capable of producing in an attempt to boost sales.

PS

These declarations of the 4 study authors and the sponsorship are revealing, I thought:

RH and CS are employees of Weleda AG, Germany. JH and KS work for daacro GmbH & Co. KG, a clinical research organization, Germany. The authors declare that there are no conflicts of interest.

This study was financed by the pharmaceutical company Weleda AG, Arlesheim, the employer of RH and CS. Weleda commissioned the CRO daacro for their contribution to the manuscript.

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