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A randomised controlled trial of micronised purified flavonoid fraction vs placebo in patients with chronic venous disease.
Eur J Vasc Endovasc Surg. 2002 Jan; 23(1):73-6.EJ

Abstract

OBJECTIVE

to evaluate the efficacy of a micronised purified flavonoid fraction (MPFF) in the treatment of chronic venous disease (CVD).

DESIGN

prospective double blind, randomised, control study.

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 ultrasonographic parameters. On the other hand, in patients with edema (20 in the MPFF group, 23 in the 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 did not change the symptoms of CVD, except night 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.

Authors+Show Affiliations

Section of Vascular Surgery, Department of Surgery, Lund University Hospital, Sweden.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11748952

Citation

Danielsson, G, et al. "A Randomised Controlled Trial of Micronised Purified Flavonoid Fraction Vs Placebo in Patients With Chronic Venous Disease." European Journal of Vascular and Endovascular Surgery : the Official Journal of the European Society for Vascular Surgery, vol. 23, no. 1, 2002, pp. 73-6.
Danielsson G, Jungbeck C, Peterson K, et al. A randomised controlled trial of micronised purified flavonoid fraction vs placebo in patients with chronic venous disease. Eur J Vasc Endovasc Surg. 2002;23(1):73-6.
Danielsson, G., Jungbeck, C., Peterson, K., & Norgren, L. (2002). A randomised controlled trial of micronised purified flavonoid fraction vs placebo in patients with chronic venous disease. European Journal of Vascular and Endovascular Surgery : the Official Journal of the European Society for Vascular Surgery, 23(1), 73-6.
Danielsson G, et al. A Randomised Controlled Trial of Micronised Purified Flavonoid Fraction Vs Placebo in Patients With Chronic Venous Disease. Eur J Vasc Endovasc Surg. 2002;23(1):73-6. PubMed PMID: 11748952.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomised controlled trial of micronised purified flavonoid fraction vs placebo in patients with chronic venous disease. AU - Danielsson,G, AU - Jungbeck,C, AU - Peterson,K, AU - Norgren,L, PY - 2001/12/26/pubmed PY - 2002/3/8/medline PY - 2001/12/26/entrez SP - 73 EP - 6 JF - European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery JO - Eur J Vasc Endovasc Surg VL - 23 IS - 1 N2 - OBJECTIVE: to evaluate the efficacy of a micronised purified flavonoid fraction (MPFF) in the treatment of chronic venous disease (CVD). DESIGN: prospective double blind, randomised, control study. 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 ultrasonographic parameters. On the other hand, in patients with edema (20 in the MPFF group, 23 in the 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 did not change the symptoms of CVD, except night 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. SN - 1078-5884 UR - https://www.unboundmedicine.com/medline/citation/11748952/A_randomised_controlled_trial_of_micronised_purified_flavonoid_fraction_vs_placebo_in_patients_with_chronic_venous_disease_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S107858840191531X DB - PRIME DP - Unbound Medicine ER -