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A randomised controlled trial of micronised purified flavonoid fraction vs placebo in patients with chronic venous disease

Danielsson, Gudmundur LU ; Jungbeck, C; Peterson, Klas LU and Norgren, Lars LU (2002) In European Journal of Vascular and Endovascular Surgery 23(1). p.73-76
Abstract
Objective: to evaluate the efficacy of a micromised purified flavonoid fraction (MPFF) in the treatment of chronic venous disease (CVD). Design: prospective doable blind, randomised, control shady. Patients and methods: one hundred and one patients with symptomatic CVD were randomly allocated to treatment for 60 days with either MPFF (51 patients) or placebo (50 patients) 500 mg twice daily. There were 28 men and 73 women, aged 22-65 years (mean age 48 years). No difference regarding age, gender, clinical class or duration of symptoms was recorded between the treatment and placebo groups. A global score for evaluation of symptoms was used. Patients were investigated with plethysmography (foot-volumetry) and duplex-ultrasonography before... (More)
Objective: to evaluate the efficacy of a micromised purified flavonoid fraction (MPFF) in the treatment of chronic venous disease (CVD). Design: prospective doable blind, randomised, control shady. Patients and methods: one hundred and one patients with symptomatic CVD were randomly allocated to treatment for 60 days with either MPFF (51 patients) or placebo (50 patients) 500 mg twice daily. There were 28 men and 73 women, aged 22-65 years (mean age 48 years). No difference regarding age, gender, clinical class or duration of symptoms was recorded between the treatment and placebo groups. A global score for evaluation of symptoms was used. Patients were investigated with plethysmography (foot-volumetry) and duplex-ultrasonography before and after the treatment period. For statistical comparison Cochran-Mantel-Haenszel test, two-sided Student t-test and covariance analysis were used and p<0.05 was regarded significant. Results: improvement of the global score of symptoms was reported by 21 patients in the MPFF group and by 16 in the placebo group (N.S.). For the whole groups, no significant differences were recorded before and after treatment regarding foot-volumetric or ultrasonography parameters. On the other hand, in patients with edema (20 in the MPFF group, 23 in tire placebo group) ultrasonographic reflux time was significantly reduced for those in the treatment group (p=0.03). This finding did not correlate to clinical symptoms. Conclusion: in this study, MPFF dirt trot change the symptoms of CVD, except might cramps. A secondary finding was reduced reflux times in patients with oedema, although no ultrasonographic or foot-volumetric parameters changed significantly for the whole group. The role of MPFF in treatment of patients with CVD needs to be further analysed in a large population. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
flavonoid function, micronised purified, chronic venous disease, pharmacological treatment
in
European Journal of Vascular and Endovascular Surgery
volume
23
issue
1
pages
73 - 76
publisher
Elsevier
external identifiers
  • pmid:11748952
  • wos:000173794100013
  • scopus:0036133970
ISSN
1532-2165
DOI
10.1053/ejvs.2001.1531
language
English
LU publication?
yes
id
984d6061-e7cb-461b-9ed4-ef38a475068c (old id 343497)
date added to LUP
2007-08-02 14:56:48
date last changed
2017-03-05 04:13:47
@article{984d6061-e7cb-461b-9ed4-ef38a475068c,
  abstract     = {Objective: to evaluate the efficacy of a micromised purified flavonoid fraction (MPFF) in the treatment of chronic venous disease (CVD). Design: prospective doable blind, randomised, control shady. Patients and methods: one hundred and one patients with symptomatic CVD were randomly allocated to treatment for 60 days with either MPFF (51 patients) or placebo (50 patients) 500 mg twice daily. There were 28 men and 73 women, aged 22-65 years (mean age 48 years). No difference regarding age, gender, clinical class or duration of symptoms was recorded between the treatment and placebo groups. A global score for evaluation of symptoms was used. Patients were investigated with plethysmography (foot-volumetry) and duplex-ultrasonography before and after the treatment period. For statistical comparison Cochran-Mantel-Haenszel test, two-sided Student t-test and covariance analysis were used and p&lt;0.05 was regarded significant. Results: improvement of the global score of symptoms was reported by 21 patients in the MPFF group and by 16 in the placebo group (N.S.). For the whole groups, no significant differences were recorded before and after treatment regarding foot-volumetric or ultrasonography parameters. On the other hand, in patients with edema (20 in the MPFF group, 23 in tire placebo group) ultrasonographic reflux time was significantly reduced for those in the treatment group (p=0.03). This finding did not correlate to clinical symptoms. Conclusion: in this study, MPFF dirt trot change the symptoms of CVD, except might cramps. A secondary finding was reduced reflux times in patients with oedema, although no ultrasonographic or foot-volumetric parameters changed significantly for the whole group. The role of MPFF in treatment of patients with CVD needs to be further analysed in a large population.},
  author       = {Danielsson, Gudmundur and Jungbeck, C and Peterson, Klas and Norgren, Lars},
  issn         = {1532-2165},
  keyword      = {flavonoid function,micronised purified,chronic venous disease,pharmacological treatment},
  language     = {eng},
  number       = {1},
  pages        = {73--76},
  publisher    = {Elsevier},
  series       = {European Journal of Vascular and Endovascular Surgery},
  title        = {A randomised controlled trial of micronised purified flavonoid fraction vs placebo in patients with chronic venous disease},
  url          = {http://dx.doi.org/10.1053/ejvs.2001.1531},
  volume       = {23},
  year         = {2002},
}