A Double-Blind Randomized Controlled Trial Comparing Sodium Tetradecyl Sulphate and Ethanolamine Oleate in the Sclerotherapy of Bleeding Oesophageal Varices

Abstract

The efficacy and side effects of 3 % sodium tetradecyl sulphate (STD) and 5 % ethanolamine oleate (ETH) were compared in 95 patients admitted with variceal bleeding. The patients were allocated in a randomised fashion to one of the treatment groups when varices were identified which were either actively bleeding or had signs of recent haemorrhage. Endoscopic examination was performed within 24 hours of admission. The endoscopist had no knowledge of which sclerosant was used. Intravariceal injections of 2 ml aliquots up to a maximum of 20 ml were made in a double-blinded manner. Repeat injections were performed at weekly intervals until all oesophageal varices were obliterated. Bleeding was successfully controlled in 42/48 (87.5 %) patients in the STD group and 41/47 (87.2 %) patients in the ETH group after one session of therapy. Variceal obliteration was achieved after 3.3 ± 1.3 sessions of STD and 4.5 ± 1.9 sessions of ETH (p < 0.05 Student's t-test). Post-injection pyrexia was significantly more common in the STD group (42 % vs 30 % p < 0.05, chi-square test). There was no difference in the rates of subsequent oesophageal ulceration, stricture formation or perforation of the oesophagus. It is concluded that STD and ETH are both effective in controlling variceal haemorrhage, but STD obliterates the varices in significantly fewer sessions.