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The LFK index has been promoted as an improved method to detect bias in meta-analysis. Putatively, its performance does not depend on the number of studies in the meta-analysis. We conducted a simulation study, comparing the LFK index test to three standard tests for funnel plot asymmetry in settings with smaller or larger group sample sizes. In general, false positive rates of the LFK index test markedly depended on the number and size of studies as well as the between-study heterogeneity with values between 0% and almost 30%. Egger's test adhered well to the pre-specified significance level of 5% under homogeneity, but was too liberal (smaller groups) or conservative (larger groups) under heterogeneity. The rank test was too conservative for most simulation scenarios. The Thompson-Sharp test was too conservative under homogeneity, but adhered well to the significance level in case of heterogeneity. The true positive rate of the LFK index test was only larger compared with classic tests if the false positive rate was inflated. The power of classic tests was similar or larger than the LFK index test if the false positive rate of the LFK index test was used as significance level for the classic tests. Under ideal conditions, the false positive rate of the LFK index test markedly and unpredictably depends on the number and sample size of studies as well as the extent of between-study heterogeneity. The LFK index test in its current implementation should not be used to assess funnel plot asymmetry in meta-analysis.
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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.
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Hintergrund: Bis zu 40% aller Herzpatienten können den funktionellen Herz-Kreislauf-Beschwerden (FHKB) zugeordnet werden. Dieses Krankheitsbild ist häufig mit Schlafstörungen und Blutdruckauffälligkeiten vergesellschaftet. Somit war es von Interesse, diesen Zusammenhang im Rahmen einer nichtinterventionellen Studie mit Cardiodoron® - ein Arzneimittel, das Störungen der vegetativen Rhythmik entgegenwirkt - näher zu beleuchten. Patienten und Methoden: 92 Ärzte dokumentierten insgesamt 501 Patienten mit FHKB und/oder Schlafstörungen, die 3 bis 6 Monate Cardiodoron® (Dilution) erhielten. Die Subgruppe der 454 Patienten mit FHKB bzw. 269 Patienten mit vollständigen Werten wurde hinsichtlich kardiologisch relevanter Parameter genauer betrachtet und steht im Mittelpunkt dieser Publikation. Ergebnisse: Die ärztlicherseits bewertete Ausprägung der FHKB reduzierte sich um 68% von 1,9 auf 0,6 Punkte. Der Symptomsummenscore aus 30 Einzelsymptomen ging um 61% von 23,6 auf 9,1 Punkte zurück. Blutdruckauffälligkeiten waren mit 1,6 zu 0,7 Punkten rückläufig. Weiterhin beurteilten die Patienten ihr Befinden mittels der Beschwerden-Liste nach von Zerssen, deren Gesamtwert sich um 58% von 24,0 auf 10,2 Punkte verminderte. Schlussfolgerung: Cardiodoron® ist ein gut verträgliches Arzneimittel der anthroposophischen Therapierichtung mit positivem Effekt bei Patienten mit FHKB, insbesondere bei Blutdruckauffälligkeiten.