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Meta-analysis of clinical trials of Cyclo 3 Fort in the treatment of chronic venous insufficiency.
Int Angiol. 2003 Sep; 22(3):250-62.IA

Abstract

AIM

Chronic venous insufficiency (CVI) of the lower limbs is a major cause of morbidity and varicose veins affect 20% to 60% of adults in the western world. The treatment of patients with CVI attempts to reduce both clinical symptoms and the development of chronic venous disease. A meta-analysis using data from all clinical trials and studies of Cyclo 3 Fort, a combination of root extract of the Ruscus aculeatus plant (150 mg per capsule), hesperidin methyl chalcone (150 mg) and ascorbic acid (100 mg), was carried out to estimate the overall effect on the symptoms and severity of chronic venous insufficiency.

METHODS

The meta-analysis included 20 placebo controlled, randomised, double blind studies and 5 randomised studies against a comparator drug. There were 6 single arm studies of Cyclo 3 Fort alone with no placebo arm. In all studies the response to Cyclo 3 Fort was compared to baseline values. In total there was information from 10,246 subjects.

RESULTS

On a 4 point symptom severity scale, where 0 corresponds to no symptoms and 3 to severe symptoms, Cyclo 3 Fort significantly reduces the severity of pain by 0.44 (0.12) points; cramps 0.26 (0.08), heaviness 0.53 (0.11), and paraesthesia 0.29 (0.10) compared to placebo. There is also a significant reduction in venous capacity of 0.70 (0.19) ml/100 ml with Cyclo 3 Fort compared to placebo. We also found reductions in the severity of oedema 0.43 (0.20) points, and decreases in calf and ankle circumference, 0.73 (0.37) cms and 1.17 (0.83) cm, respectively, among patients treated with Cyclo 3 Fort compared to placebo which were not statistically significant.

CONCLUSION

Despite questions surrounding the variability of data quality and sample size of some of the studies, we conclude that in patients with CVI Cyclo 3 Fort significantly reduces the severity of the symptoms compared to placebo. This study is a strong and objective demonstration of the clinical efficacy of Cyclo 3 Fort in treating patients with CVI.

Authors+Show Affiliations

Boyle P
Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy. peter.boyle@ieo.it
Diehm C
No affiliation info available
Robertson C
No affiliation info available

MeSH

AdultCardiovascular AgentsChronic DiseaseHumansPlant ExtractsTreatment OutcomeVenous Insufficiency

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14612852

Citation

Boyle, P, et al. "Meta-analysis of Clinical Trials of Cyclo 3 Fort in the Treatment of Chronic Venous Insufficiency." International Angiology : a Journal of the International Union of Angiology, vol. 22, no. 3, 2003, pp. 250-62.
Boyle P, Diehm C, Robertson C. Meta-analysis of clinical trials of Cyclo 3 Fort in the treatment of chronic venous insufficiency. Int Angiol. 2003;22(3):250-62.
Boyle, P., Diehm, C., & Robertson, C. (2003). Meta-analysis of clinical trials of Cyclo 3 Fort in the treatment of chronic venous insufficiency. International Angiology : a Journal of the International Union of Angiology, 22(3), 250-62.
Boyle P, Diehm C, Robertson C. Meta-analysis of Clinical Trials of Cyclo 3 Fort in the Treatment of Chronic Venous Insufficiency. Int Angiol. 2003;22(3):250-62. PubMed PMID: 14612852.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Meta-analysis of clinical trials of Cyclo 3 Fort in the treatment of chronic venous insufficiency. AU - Boyle,P, AU - Diehm,C, AU - Robertson,C, PY - 2003/11/13/pubmed PY - 2004/4/14/medline PY - 2003/11/13/entrez SP - 250 EP - 62 JF - International angiology : a journal of the International Union of Angiology JO - Int Angiol VL - 22 IS - 3 N2 - AIM: Chronic venous insufficiency (CVI) of the lower limbs is a major cause of morbidity and varicose veins affect 20% to 60% of adults in the western world. The treatment of patients with CVI attempts to reduce both clinical symptoms and the development of chronic venous disease. A meta-analysis using data from all clinical trials and studies of Cyclo 3 Fort, a combination of root extract of the Ruscus aculeatus plant (150 mg per capsule), hesperidin methyl chalcone (150 mg) and ascorbic acid (100 mg), was carried out to estimate the overall effect on the symptoms and severity of chronic venous insufficiency. METHODS: The meta-analysis included 20 placebo controlled, randomised, double blind studies and 5 randomised studies against a comparator drug. There were 6 single arm studies of Cyclo 3 Fort alone with no placebo arm. In all studies the response to Cyclo 3 Fort was compared to baseline values. In total there was information from 10,246 subjects. RESULTS: On a 4 point symptom severity scale, where 0 corresponds to no symptoms and 3 to severe symptoms, Cyclo 3 Fort significantly reduces the severity of pain by 0.44 (0.12) points; cramps 0.26 (0.08), heaviness 0.53 (0.11), and paraesthesia 0.29 (0.10) compared to placebo. There is also a significant reduction in venous capacity of 0.70 (0.19) ml/100 ml with Cyclo 3 Fort compared to placebo. We also found reductions in the severity of oedema 0.43 (0.20) points, and decreases in calf and ankle circumference, 0.73 (0.37) cms and 1.17 (0.83) cm, respectively, among patients treated with Cyclo 3 Fort compared to placebo which were not statistically significant. CONCLUSION: Despite questions surrounding the variability of data quality and sample size of some of the studies, we conclude that in patients with CVI Cyclo 3 Fort significantly reduces the severity of the symptoms compared to placebo. This study is a strong and objective demonstration of the clinical efficacy of Cyclo 3 Fort in treating patients with CVI. SN - 0392-9590 UR - https://www.unboundmedicine.com/medline/citation/14612852/Meta_analysis_of_clinical_trials_of_Cyclo_3_Fort_in_the_treatment_of_chronic_venous_insufficiency_ DB - PRIME DP - Unbound Medicine ER -