Effect of SAMITAL® in the treatment of chemotherapy-induced mucositis in adult oncohematological patients.

AIM: We sought to evaluate the efficacy and safety of SAMITAL(®) (Indena SpA, Milan, Italy), a highly standardized botanical formulation, in reducing mucositis in patients undergoing treatment for hematological malignancies. PATIENTS & METHODS: In this observational, uncontrolled study, a total of 25 consecutively enrolled patients (19 males, aged 18-74 years) with chemotherapy-induced mucositis were compassionately treated orally with SAMITAL (three to four times per day) for 4-22 days per cycle. RESULTS: Patients demonstrated clinically relevant reductions in WHO mucositis grade with a reduction in pain, mucosal erosions, bleeding, dysphagia/feeding impairment and improvements in quality of life. SAMITAL was well tolerated and no local or systemic pharmacological, allergic, toxic or synergistic/antagonistic side effects were reported. Of note, SAMITAL also showed efficacy when administered prophylactically. CONCLUSION: These results add weight to previous experiences with SAMITAL. However, randomized, placebo-controlled clinical trials will need to confirm the suitability of SAMITAL for use in the treatment of mucositis.

Management of gastrointestinal mucositis due to cancer therapies in pediatric patients: results of a case series with SAMITAL(®).

BACKGROUND: Gastrointestinal mucositis is a common debilitating complication of chemotherapy and one for which there is currently no effective long-term treatment. OBJECTIVES: To report our experience with the use of SAMITAL(®), a new oral suspension formulation based on the combination of three standardized extracts from Vaccinium myrtillus, Macleaya cordata fruits and Echinacea angustifolia roots in the prevention and treatment of chemotherapy-induced gastrointestinal mucositis in pediatric patients. METHODS: 20 pediatric patients undergoing chemotherapy for a range of oncological conditions were followed. Patients initially received oral SAMITAL(®) to treat gastrointestinal mucositis and were then given SAMITAL(®) prophylactically to prevent recurrences with successive cycles of chemotherapy. RESULTS: SAMITAL(®) significantly decreased gastrointestinal mucositis grade after the first episode with a reduction of mean scores from 3.2 ± 0.7 at baseline to 0.4 ± 0.6 at the end of treatment (p < 0.001). SAMITAL(®) reduced pain, mucosal erosions, bleeding and dysphagia/feeding impairment. SAMITAL(®) improved patients' overall condition and quality of life after the first administration and lowered the need for parenteral nutrition. Importantly, it allowed chemotherapy cycles to be continued without complications. CONCLUSION: Results from this case series suggest that SAMITAL(®) may play an important role in the prevention and treatment of chemotherapy-induced gastrointestinal mucositis in children and adolescents and as such warrants investigation in controlled studies.