OBJECTIVES: To investigate the effectiveness of graduated elastic compression stockings (GECS) below the knee in improving symptoms in patients with varicose veins in the absence of high quality evidence. METHODS: This was a randomised double blind placebo controlled trial. Thirty patients with no experience of elastic stockings, presenting with primary varicose veins causing calf pain or aching were randomised to a GECS (18-21 mmHg at the ankle level, n=15) or a placebo stocking (0 mmHg, n=15). Pain or aching of the index leg after 1 week was the primary outcome measure. In patients with bilateral varicose veins the leg with the most severe pain/aching was considered. Other defined symptoms were secondary outcome measures. All symptoms were scored on a visual analogue scale (VAS). RESULTS: The two study groups were well balanced at baseline. At the completion of the study after 1 week, GECS were more effective than placebo stockings in reducing pain or aching (VAS score 1.7±3.0 vs. 4.5±2.8 for placebo, p=.02), while non-significant trends were observed for some of the remaining symptoms of the index leg, including feeling of swelling (VAS score 0.9±1.9 vs. 3.3±3.5 for placebo), paraesthesiae (VAS score 0.2±0.6 vs. 2.1±3.1 for placebo), and the number of symptoms other than pain or aching (1.3±1.1 vs. 2.8±1.7 for placebo). Number needed to treat (95% CI) for a 50% or complete improvement of pain or aching in the index leg was 2 (95% CI 1.2-5.5) and 2 (95% CI 1.2-5.3), respectively. Mean daily use of the placebo stockings and GECS was 8.0 hours and 10.2 hours, respectively (p=.13). CONCLUSIONS: Among patients with varicose veins, GECS seem effective in ameliorating symptoms, particularly pain or aching, compared with placebo stockings after 1 week of use. Long-term studies are justified.
RCT Entities:
OBJECTIVES: To investigate the effectiveness of graduated elastic compression stockings (GECS) below the knee in improving symptoms in patients with varicose veins in the absence of high quality evidence. METHODS: This was a randomised double blind placebo controlled trial. Thirty patients with no experience of elastic stockings, presenting with primary varicose veins causing calfpain or aching were randomised to a GECS (18-21 mmHg at the ankle level, n=15) or a placebo stocking (0 mmHg, n=15). Pain or aching of the index leg after 1 week was the primary outcome measure. In patients with bilateral varicose veins the leg with the most severe pain/aching was considered. Other defined symptoms were secondary outcome measures. All symptoms were scored on a visual analogue scale (VAS). RESULTS: The two study groups were well balanced at baseline. At the completion of the study after 1 week, GECS were more effective than placebo stockings in reducing pain or aching (VAS score 1.7±3.0 vs. 4.5±2.8 for placebo, p=.02), while non-significant trends were observed for some of the remaining symptoms of the index leg, including feeling of swelling (VAS score 0.9±1.9 vs. 3.3±3.5 for placebo), paraesthesiae (VAS score 0.2±0.6 vs. 2.1±3.1 for placebo), and the number of symptoms other than pain or aching (1.3±1.1 vs. 2.8±1.7 for placebo). Number needed to treat (95% CI) for a 50% or complete improvement of pain or aching in the index leg was 2 (95% CI 1.2-5.5) and 2 (95% CI 1.2-5.3), respectively. Mean daily use of the placebo stockings and GECS was 8.0 hours and 10.2 hours, respectively (p=.13). CONCLUSIONS: Among patients with varicose veins, GECS seem effective in ameliorating symptoms, particularly pain or aching, compared with placebo stockings after 1 week of use. Long-term studies are justified.