A multicentre open clinical trial to assess the tolerability and efficacy of Boldocynara®, a traditional herbal preparation for functional digestive disorders

Functional digestive disorders lead the list of visits to gastroenterologists and affect up to 40% of the population, with only a minority seeking medical care for it. Boldocynara®, a proprietary combination product consisting of artichoke leaves, milk thistle fruits, dandelion herb and root, and boldo leaves, has been traditionally used to treat indigestion. In this study including 75 patients aged 18 to 71 years and suffering from functional digestive disorders at least twice weekly since at least 2 months, Boldocynara® applied in a newly developed solid form at a dosage of 2 × 1 tablet daily proved to be well tolerated and efficacious in reducing these complaints as evaluated via the SF-LDQ measuring frequency and severity of dyspepsia, heartburn, regurgitation and nausea and a Global questionnaire on fat intolerance, upper abdominal pain, epigastric discomfort, abdominal bloating, postprandial fullness, flatulence, abdominal cramps, constipation, diarrhoea and stool irregularities. All symptoms decreased significantly over the 6 weeks treatment period (p < 0.0001), reflected simultaneously by a significant improvement of all items assessed via the QoL-SF-12. The SF-LDQ total score decreased under therapy from 6.3 ± 2.9 to 1.4 ± 2.0 regarding frequency of dyspeptic symptoms and from 3.6 ± 3.8 to 0.7 ± 1.7 regarding their interference with normal activities, whilst the digestive symptoms evaluated with the global questionnaire total score decreased from 17.9 ± 6.4 to 4.9 ± 5.9 for their frequency and from 9.6 ± 9.7 to 1.2 ± 2.9 for their interference with normal activities. Tolerability was rated as very good or good by 89% of physicians and 91% of patients. The evaluation of the related laboratory parameters showed a high degree of safety. Boldocynara®, the tested traditional herbal blend, demonstrated in this study clearly good clinical value in terms of efficacy, safety and tolerability in the treatment of functional digestive disorders.