Vasoprotectives: efficacy and safety of capillary stabilising agents for venous insufficiency or haemorrhoids

Fischer S, Zechmeister-Koss I
Record ID 32015000389
Authors' objectives: Chronic venous insufficiency (CVI) and haemorrhoidal diseases (HD) are very common, affecting about 20 to 40% of the Austrian population. Even if CVI and HD are not directly associated with mortality, both diseases severely affect the quality of life. One frequently chosen approach to reduce symptoms is oral treatment with capillary stabilising agents. However, while roughly € 20 million are spent annually on these drugs, their benefit has never been thoroughly evaluated so far. The aim of this systematic review was to assess the efficacy and safety of a treatment of CVI and HD with capillary stabilising agents that are listed in the Austrian Code of Reimbursement (EKO).
Authors' recommendations: Since the strength of the evidence of nearly all identified studies is low, we cannot draw a final conclusion on the efficacy of capillary stabilising agents for the treatment of CVI and HD. Major limitations of the studies are, firstly, the lack of transparency concerning the study design (e.g., unclear allocation concealment) and, secondly, study designs that introduce a high risk of bias. Examples for the latter are the small number of patients with short durations of treatment or flexibly allowing people to have additional interventions (e.g., wearing compression stockings for CVI treatment), which raises the question of whether any effect measured was due to the drug treatment or to the additional intervention. Moreover, some of the used outcome indicators (leg volume, symptoms measured on scales from 1-3) are obsolete according to today's standards and, therefore, are a very weak outcome to draw a conclusion for efficacy as a whole. From the numerous patient-relevant signs and symptoms of CVI and HD presented in the studies, some single parameters showed better improvement in the groups that received capillary stabilising agents than in the control groups. In addition, some of the differences between the groups were statistically significant. However, the clinical relevance of any improvement presented was marginal and, in most cases, even negligible. For Doxium® 500 mg capsules (for CVI only), Venoruton® (for CVI only), Daflon® 500 mg tablets (for CVI and HD) and Venosin retard® 50 mg capsules (for CVI only) the evidence shows a weak tendency for a benefit, yet the results are very uncertain. For Reparil® 20 mg dragées we could not identify any efficacy-assessing evidence and, therefore, it is unclear whether the drug is more effective than other alternatives. Future reimbursement of the drugs should be made conditional upon the generation of robust evidence concerning patients' benefits. This needs to be provided by the manufacturers. Cooperation with public payers in terms of study design (particularly concerning the selection of outcome parameters) is recommended.
Project Status: Completed
Year Published: 2014
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: Austria
MeSH Terms
  • Chronic Disease
  • Hemorrhoids
  • Anticoagulants
  • Flavonoids
  • Calcium Dobesilate
  • Hydroxyethylrutoside
  • Escin
Organisation Name: Ludwig Boltzmann Institute for Health Technology Assessment
Contact Address: Ludwig Boltzmann Institute for fuer Health Technology Assessment (LBI-HTA), Garnisongasse 7/rechte Stiege Mezzanin (Top 20), 1090 Vienna, Austria. Tel: +43 1 236 8119 - 0 Fax: +43 1 236 8119 - 99
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Copyright: Ludwig Boltzmann Institut fuer Health Technology Assessment (LBI-HTA)
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