Clinical Effectiveness of Hawthorn, Lemon Balm and Magnesium on Patients with Distress Disorders: Preliminary Data by a Survey of Italian Gastroenterologists

Abstract

Aims: distress disorders (DD) include psychological symptoms such as sleep disorders, fatigue and psychophysical exhaustion that are common to many mental diseases. DD is often associated with somatic symptoms such as abdominal pain or bowel dysfunction. The aim of this study was to evaluate in patients with DD the effectiveness of a nutraceutical containing Hawthorn, Lemon Balm, and Magnesium (Vagostabil®) on psychological and abdominal symptoms. For this purpose, a clinical survey was conducted by 7 Italian gastroenterologists. Methodology: 85 patients with DD (60 F, mean age 51,6 yrs), identified by a score > 18 based on the Hamilton Anxiety Rating Scale (HAM-A), were included in the study. All patients assumed Vagostabil®, three tablets a day for two months. The same HAM-A score and a VAS score for abdominal pain were used to measure clinical results. Results: the mean score of the HAM-A scale decreased from 28.61 to 18.22 after 1 month and to 11.46 after 2 months of treatment respectively (P = .001 for all comparisons). An overall reduction of HAM-A score by 59.94 % was observed at the end of the treatment (P = .001). Similarly, VAS score for abdominal pain decreased from 7.59 to 4.86 after 1 month, and to 2.41 at the end of the treatment (P = .001 for both comparisons). A global reduction of 68.25% in the VAS score was observed at the end of the survey (P = .001). Conclusion: this clinical survey showed that Vagostabil® can ameliorate psychological symptoms and associated abdominal pain in patients with DD. These preliminary data suggest that Vagostabil® could be utilized by gastroenterologists in functional gastrointestinal disorders. However, further studies are needed to confirm these data.