Management of Varicose Veins with Sitcom Forte^® Tablet (Euphorbia Prostrata 100 mg and Calcium Dobesilate 500 mg) and Sitcom^®Cream (Euphorbia Prostrata Dry Extract 1% w/w): A Single-Arm Prospective Multi-Centric Efficacy and Safety Study

This was a single-arm multi-centric study conducted to evaluate the efficacy and safety of the Sitcom Forte^® tablet (Euphorbia prostrata 100 mg plus calcium dobesilate 500 mg) and Sitcom^® cream (Euphorbia prostrata dry extract cream) in patients (≥ 18 years of age) with varicose veins. A total of 104 patients, with a mean age of 47.0 years, were enrolled. They were advised to take a fixed-dose combination of Euphorbia prostrata plus calcium dobesilate tablets twice daily for 1 month and further once or twice daily (as per condition) for the next 2 months and local application of cream twice daily for 3 months. At the 3-month follow-up, the mean score of pain in the leg, swelling, tingling, numbness, and itching improved significantly from baseline (mean change: − 2.9 [69.2%], − 2.0 [57.8%], − 2.0 [68.0%], − 2.0 [67.1%], and − 2.2 [74.1%], respectively; P = 0.0001). At follow-up, ulcers completely healed in 58.3% of patients, and > 90% experienced good-to-excellent treatment improvement as assessed by physicians. The treatment was efficacious and well tolerated in patients with varicose veins, which may be attributed to the multimodal mechanism of action of Euphorbia prostrata and calcium dobesilate in the multifactorial pathophysiology of the disease.