Yuri Shelygin1, Zoran Krivokapic2, S A Frolov1, I V Kostarev1, V L Astashov3, S V Vasiliev4, A V Lakhin5, G V Rodoman6, A O Soloviev7, Y M Stoyko8, A G Khitaryan9, I A Nechay6. 1. a State Scientific Center of Coloproctology, Ministry of Health of Russian Federation , Moscow , Russia. 2. b Institute for Digestive Diseases, Clinical Center of Serbia , Belgrade , Serbia. 3. c Burdenko General Military Clinical Hospital, Consultative Diagnostic Centre , Moscow , Russia. 4. d City Clinical Hospital No. 9, Saint-Petersburg Scientific Practical Centre of Coloproctology , Saint-Petersburg , Russia. 5. e Lipetsk Regional Clinical Hospital , Department of Coloproctology 6A , Lipetsk , Russia. 6. f City Clinical Hospital No. 24, Moscow City Centre of Coloproctology , Moscow , Russia. 7. g ZAO Medical Scientific Productive Establishment Dvizhenie , Volgograd. 8. h National Pirogov Medical Surgical Centre, Phlebology Service , Moscow , Russia. 9. i Railway Clinical Hospital on Rostov-Glavniy Railway Station , 1st Surgery Department , Rostov-on-Don , Russia.
Abstract
OBJECTIVE: To compare the clinical acceptability of micronized purified flavonoid fraction (MPFF) 1000 mg with MPFF 500 mg tablets, administered at the same daily dose in patients suffering non-complicated acute hemorrhoids. BACKGROUND:MPFF is an established treatment for hemorrhoidal disease. METHODS: This was a double-blind, multi-center, randomized study. Patients took either MPFF 1000 mg or 500 mg tablets for 7 days (daily dose; 3 g over 4 days followed by 2 g over 3 days). Adverse events were recorded in a patient diary. On day 7, anal pain and bleeding were assessed (visual analog scale [VAS] and Dimitroulopoulos scale, respectively). RESULTS: Patients (162) were randomized to MPFF 1000 mg (79) and MPFF 500 mg (83). No serious adverse events (AEs) occurred; 10 emergent AEs were considered treatment-related (6 for MPFF 1000 mg and 4 for 500 mg). Both regimens were associated with significant reduction in anal pain (VAS); -2.37 cm MPFF 1000 mg (P < 0.001) and -2.17 cm 500 mg (P < 0.001), with a slight trend in favor of MPFF 1000 mg (mean global reduction -2.27 cm, P < 0.001). Bleeding improved significantly in both groups of patients, 56% of patients on MPFF 1000 mg versus 61% on MPFF 500 mg. Bleeding ceased after treatment in 47% patients on MPFF 1000 mg versus 54% on 500 mg. CONCLUSION: After 7 days of treatment with MPFF at the same daily dose, both regimens reduced anal pain and bleeding. MPFF 1000 mg had a comparable safety profile to MPFF 500 mg, with the advantage of fewer tablets. Key limitations: Safety study.
RCT Entities:
OBJECTIVE: To compare the clinical acceptability of micronized purified flavonoid fraction (MPFF) 1000 mg with MPFF 500 mg tablets, administered at the same daily dose in patients suffering non-complicated acute hemorrhoids. BACKGROUND:MPFF is an established treatment for hemorrhoidal disease. METHODS: This was a double-blind, multi-center, randomized study. Patients took either MPFF 1000 mg or 500 mg tablets for 7 days (daily dose; 3 g over 4 days followed by 2 g over 3 days). Adverse events were recorded in a patient diary. On day 7, anal pain and bleeding were assessed (visual analog scale [VAS] and Dimitroulopoulos scale, respectively). RESULTS:Patients (162) were randomized to MPFF 1000 mg (79) and MPFF 500 mg (83). No serious adverse events (AEs) occurred; 10 emergent AEs were considered treatment-related (6 for MPFF 1000 mg and 4 for 500 mg). Both regimens were associated with significant reduction in anal pain (VAS); -2.37 cm MPFF 1000 mg (P < 0.001) and -2.17 cm 500 mg (P < 0.001), with a slight trend in favor of MPFF 1000 mg (mean global reduction -2.27 cm, P < 0.001). Bleeding improved significantly in both groups of patients, 56% of patients on MPFF 1000 mg versus 61% on MPFF 500 mg. Bleeding ceased after treatment in 47% patients on MPFF 1000 mg versus 54% on 500 mg. CONCLUSION: After 7 days of treatment with MPFF at the same daily dose, both regimens reduced anal pain and bleeding. MPFF 1000 mg had a comparable safety profile to MPFF 500 mg, with the advantage of fewer tablets. Key limitations: Safety study.
Authors: Samar H Gerges; Sara A Wahdan; Doaa A Elsherbiny; Ebtehal El-Demerdash Journal: Eur J Drug Metab Pharmacokinet Date: 2021-10-23 Impact factor: 2.441