An evaluation of emergency sclerotherapy of varices in randomized trials: looking the needle in the eye

Abstract

Background: The role of sclerotherapy for acute variceal bleeding is challenged by vasoactive drugs and by ligation.

Aim: A meta-analysis was performed to evaluate whether sclerotherapy remains a gold standard in acute variceal bleeding.

Methods: Sclerotherapy was evaluated across four randomized trial groups: (a) combined with vasoconstrictors vs. vasoconstrictors alone (five trials, with 400 patients); (b) vs. vasoconstrictors alone (15 trials, with 1296 patients); (c) vs. combination of vasoconstrictors and sclerotherapy (eight trials, with 1026 patients); (d) vs. ligation (12 trials, with 1309 patients). We used the risk difference (absolute risk reduction) as our main effect measure.

Results: The efficacy of acute sclerotherapy was highest vs. ligation at 95 %, with a small advantage for ligation (an overtube was used in eight trials) of 2.5 % (95 % CI 0.4 % to 4.6 %) ( P = 0.018), but no survival difference. Efficacy of sclerotherapy combined with vasoconstrictors vs. vasoconstrictors alone was 86 %, whereas it was 83 % for sclerotherapy vs. vasoconstrictors alone. In both these groups sclerotherapy was superior for control of bleeding at, respectively, 16.3 % (95 % CI 8.7 % to 23.9 % ( P = 0.0001) and 5.9 % (95 % CI, 1.5 % to 10.3 %) ( P = 0.008), with increased survival in the latter. In the combination group of sclerotherapy with vasoconstrictors, the efficacy of sclerotherapy alone was 69 %, with the combination superior in controlling bleeding, at 13.2 % (95 % CI, 8.4 % to 18.1 %) ( P < 0.0001) but with no survival difference.

Conclusion: This comparison of sclerotherapy across trials demonstrates a problem in defining its real efficacy. The conclusive evidence for substituting banding ligation or the combination of vasoconstrictors with sclerotherapy as better therapeutic approaches has not been provided in randomized trials. Sclerotherapy can remain a gold standard in variceal bleeding but there is scope for further studies of ligation and vasoactive drugs.