PMID- 27404053
OWN - NLM
STAT- MEDLINE
DCOM- 20170928
LR  - 20181202
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 32
IP  - 11
DP  - 2016 Nov
TI  - Clinical acceptability study of micronized purified flavonoid fraction 1000 mg 
      tablets versus 500 mg tablets in patients suffering acute hemorrhoidal disease.
PG  - 1821-1826
AB  - 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.
FAU - Shelygin, Yuri
AU  - Shelygin Y
AD  - a State Scientific Center of Coloproctology, Ministry of Health of Russian 
      Federation , Moscow , Russia.
FAU - Krivokapic, Zoran
AU  - Krivokapic Z
AD  - b Institute for Digestive Diseases, Clinical Center of Serbia , Belgrade , 
      Serbia.
FAU - Frolov, S A
AU  - Frolov SA
AD  - a State Scientific Center of Coloproctology, Ministry of Health of Russian 
      Federation , Moscow , Russia.
FAU - Kostarev, I V
AU  - Kostarev IV
AD  - a State Scientific Center of Coloproctology, Ministry of Health of Russian 
      Federation , Moscow , Russia.
FAU - Astashov, V L
AU  - Astashov VL
AD  - c Burdenko General Military Clinical Hospital, Consultative Diagnostic Centre , 
      Moscow , Russia.
FAU - Vasiliev, S V
AU  - Vasiliev SV
AD  - d City Clinical Hospital No. 9, Saint-Petersburg Scientific Practical Centre of 
      Coloproctology , Saint-Petersburg , Russia.
FAU - Lakhin, A V
AU  - Lakhin AV
AD  - e Lipetsk Regional Clinical Hospital , Department of Coloproctology 6A , Lipetsk 
      , Russia.
FAU - Rodoman, G V
AU  - Rodoman GV
AD  - f City Clinical Hospital No. 24, Moscow City Centre of Coloproctology , Moscow , 
      Russia.
FAU - Soloviev, A O
AU  - Soloviev AO
AD  - g ZAO Medical Scientific Productive Establishment Dvizhenie , Volgograd.
FAU - Stoyko, Y M
AU  - Stoyko YM
AD  - h National Pirogov Medical Surgical Centre, Phlebology Service , Moscow , Russia.
FAU - Khitaryan, A G
AU  - Khitaryan AG
AD  - i Railway Clinical Hospital on Rostov-Glavniy Railway Station , 1st Surgery 
      Department , Rostov-on-Don , Russia.
FAU - Nechay, I A
AU  - Nechay IA
AD  - f City Clinical Hospital No. 24, Moscow City Centre of Coloproctology , Moscow , 
      Russia.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160825
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Flavonoids)
RN  - 0 (Tablets)
SB  - IM
MH  - Acute Disease
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Double-Blind Method
MH  - Female
MH  - Flavonoids/administration & dosage/*therapeutic use
MH  - Hemorrhage/drug therapy
MH  - Hemorrhoids/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Tablets
OTO - NOTNLM
OT  - Acceptability
OT  - Anal pain
OT  - Bleeding
OT  - Hemorrhoidal disease
OT  - MPFF
EDAT- 2016/10/19 06:00
MHDA- 2017/09/29 06:00
CRDT- 2016/07/13 06:00
PHST- 2016/10/19 06:00 [pubmed]
PHST- 2017/09/29 06:00 [medline]
PHST- 2016/07/13 06:00 [entrez]
AID - 10.1080/03007995.2016.1211520 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2016 Nov;32(11):1821-1826. doi: 10.1080/03007995.2016.1211520. 
      Epub 2016 Aug 25.