Somatostatin in bleeding oesophageal varicesBMJ 1996; 312 doi: https://doi.org/10.1136/bmj.312.7028.442 (Published 17 February 1996) Cite this as: BMJ 1996;312:442
Important information about trial was omitted
- S A Jenkins,
- I N Baxter
- Non-clinical scientist Reader in surgery University Department of Surgery, Glasgow Royal Infirmary, Glasgow G31 2ER
EDITOR,—We find it hard to understand why, in Peter C Gotzsche and colleagues' double blind placebo controlled trial of somatostatin in acute variceal haemorrhage, patients were not randomised for long periods after the onset of haemorrhage.1 Patients with cirrhosis do not tolerate prolonged periods of bleeding.
The authors elected not to use bolus administration of somatostatin as soon as the continuous infusion was established despite good evidence for this method of administration.2 In 19 randomised controlled trials of somatostatin the poorest rates of control have been obtained in those studies in which no or inadequate bolus doses were given.3
The authors do not state when sclerotherapy was performed in relation to the end of treatment with placebo and somatostatin; if it was delayed then it is not surprising that there was no difference between the groups with respect to outcome.
Neither the severity of haemorrhage before entry into the trial nor the amount of rebleeding are defined. A small amount of rebleeding sufficient to colour the gastric aspirate may have occurred in both groups. From the data given it is impossible to determine the extent of rebleeding in both groups.
The 13 patients subsequently shown not to have varices and the 13 patients with bleeding from oesophageal ulcers should have been excluded from the trial. The authors justify the inclusion of these patients on the basis of an “intent to treat.” Early confirmation of variceal haemorrhage is, however, mandatory in high risk patients, and those bleeding from other sources should have been excluded. This would have reduced the number of patients evaluated to 60 and increased the type II error even further. Furthermore, the inclusion of only 86 patients (of whom only 60 were bleeding from varices) in a five year study suggests that patients may have been selected.
One group has suggested that somatostatin should be the first line treatment for variceal bleeding, with injection sclerotherapy being delayed until haemorrhage is controlled, when the procedure is technically easier and safer.4 Furthermore, somatostatin has been shown to be as effective as injection sclerotherapy in controlling acute variceal haemorrhage and preventing rebleeding over five days.5
In summary, Gotzche and colleagues' trial has numerous flaws in design, and important data essential for a proper evaluation of the results are omitted. Such poorly designed and presented trials serve to confuse the role of somatostatin in the control of acute variceal bleeding.