A Randomized, Double-Blind Multicentre Clinical Trial Comparing the Efficacy of Calcium Dobesilate with Placebo in the Treatment of Chronic Venous Disease
Abstract:Treatment with calcium dobesilate was not found to be superior to placebo on the QoL of CVD patients. The sustained effect of calcium dobesilate observed after treatment should be confirmed in future studies.
“…Perseverance of the drug is unlikely because elimination of calcium dobesilate after oral administration is 50% at 24 h (Tejerina and Ruiz 1998). Interestingly, in a study of chronic venous disease in humans it was noted that there was a persistent positive effect of dobesilate on quality of life compared to placebo (Martinez-Zapata et al 2008), suggesting a sustained therapeutic action.…”
Background and purposeThe presence of bone marrow edema in patients with osteoarthritis is associated with pain and disease progression. Management of bone edema with the synthetic prostacyclin iloprost may be complicated by side effects. Calcium dobesilate, a treatment for chronic venous disease, shares some pharmacological actions with iloprost but appears to be better tolerated. Anecdotal reports have suggested that calcium dobesilate may be useful for medical management of osteoarthritis, possibly by reducing bone marrow edema, and this study was performed to investigate possible benefits of treatment.MethodsThe effects of a 6-week period of oral calcium dobesilate administration on tibial intramedullary pressure dynamics and physical joint characteristics were evaluated in 20 rabbits with unilaterally induced knee osteoarthritis that were randomly allocated to either a treatment group or a placebo control group. Treatment or placebo started 8 weeks after induction of osteoarthritis, and was followed by a 4-week washout period.ResultsCalcium dobesilate did not affect joint thickness or range of motion, nor individual pressure measurements, compared to placebo. Pressure ranges in the operated limb were greater than in the intact limb after 8 weeks, and approached those of the intact limb after 6 weeks of treatment with calcium dobesilate but not with placebo. Inter-limb differences were lower (p = 0.02) in the dobesilate group following the washout period.InterpretationCalcium dobesilate had a detectable effect on pressure dynamics in the subchondral bone of osteoarthritic joints in this model. The significance of these effects for pain and function should be established.
“…Perseverance of the drug is unlikely because elimination of calcium dobesilate after oral administration is 50% at 24 h (Tejerina and Ruiz 1998). Interestingly, in a study of chronic venous disease in humans it was noted that there was a persistent positive effect of dobesilate on quality of life compared to placebo (Martinez-Zapata et al 2008), suggesting a sustained therapeutic action.…”
Background and purposeThe presence of bone marrow edema in patients with osteoarthritis is associated with pain and disease progression. Management of bone edema with the synthetic prostacyclin iloprost may be complicated by side effects. Calcium dobesilate, a treatment for chronic venous disease, shares some pharmacological actions with iloprost but appears to be better tolerated. Anecdotal reports have suggested that calcium dobesilate may be useful for medical management of osteoarthritis, possibly by reducing bone marrow edema, and this study was performed to investigate possible benefits of treatment.MethodsThe effects of a 6-week period of oral calcium dobesilate administration on tibial intramedullary pressure dynamics and physical joint characteristics were evaluated in 20 rabbits with unilaterally induced knee osteoarthritis that were randomly allocated to either a treatment group or a placebo control group. Treatment or placebo started 8 weeks after induction of osteoarthritis, and was followed by a 4-week washout period.ResultsCalcium dobesilate did not affect joint thickness or range of motion, nor individual pressure measurements, compared to placebo. Pressure ranges in the operated limb were greater than in the intact limb after 8 weeks, and approached those of the intact limb after 6 weeks of treatment with calcium dobesilate but not with placebo. Inter-limb differences were lower (p = 0.02) in the dobesilate group following the washout period.InterpretationCalcium dobesilate had a detectable effect on pressure dynamics in the subchondral bone of osteoarthritic joints in this model. The significance of these effects for pain and function should be established.
“…This difference was significant at 12 months but not at three months (primary outcome), statistically. 31 This may indicate that single therapy with calcium dobesilate should be supported with others to achieve more improvement.…”
Results demonstrate that a combination of calcium dobesilate and oxerutin shows a better improvement of complaints. These observations have to be confirmed in larger series with objective tests. Changes of quality of life after a combination therapy might also be of interest.
“…However, a meta-analysis in 2008 involving 509 patients failed to show any edema, symptoms, and quality-of-life in patients consuming calcium dobesilate in comparison with placebo[33] (evidence Level A). A trial demonstrated the increased efficacy of dobesilate with a combination with oxerutins[34] (evidence Level C).…”
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