A DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL COMPARING SODIUM TETRADECYL SULFATE AND ETHANOLAMINE OLEATE IN THE SCLEROTHERAPY OF BLEEDING ESOPHAGEAL-VARICES

The efficacy and side effects of 3 % sodium tetradecyl sulphate (STD) and 5 % ethanolamine oleate (ETH) were compared in 95 patients admitte d with variceal bleeding. The patients were allocated in a randomised fashion to one of the treatment groups when varices were identified wh ich 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. Intravaric eal 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 in tervals until all oesophageal varices were obliterated. Bleeding was s uccessfully 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-inj ection 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 perforat ion of the oesophagus. It is concluded that STD and ETH are both effec tive in controlling variceal haemorrhage, but STD obliterates the vari ces in significantly fewer sessions.