Randomised double blind trial of somatostatin in the treatment of massive upper gastrointestinal haemorrhage.

Abstract

SUMMARY In order to evaluate the effect of somatostatin in the treatment of massive upper gastrointestinal bleeding a randomised double blind trial of 95 patients has been undertaken during a 28 months period. Patients with oesophageal varices have been excluded as well as patients with diabetes. All patients were endoscoped within eight hours of admission to the hospital, whereupon the source of bleeding and types of stigmata were assessed. Forty six patients, chosen at random, were given a 72 hour infusion of somatostatin, while the remaining 49 patients received infusion of placebo. The two groups were well matched for sex, age, and source of bleeding. On the day after admission, an additional endoscopy was performed at which eight patients in the somatostatin group and 16 in the placebo group were found to have a persistent bleeding. A total of five patients in the somatostatin group and 14 in the placebo group underwent surgery (Fisher's exact test, 2-tail, p=004). Rebleeding occurred in six patients in the somatostatin group, of whom five experienced rebleeding after completion of the somatostatin treatment. In the placebo group, rebleeding occurred in five patients, of whom four rebled on the day after admission. The need for blood transfusions and the mortality rate did not differ significantly between the two groups. No toxic side effects were found as a result of the infusion of somatostatin. In this study, somatostatin reduced the number of patients needing surgery with massive upper gastrointestinal bleeding.The mortality rate in massive upper gastrointestinal haemorrhage is still high especially in elderly patients. Neither the use of medication (cimetidine, 12 tranexamic acid2 3) nor endoscopic treatment (Nd-YAG4 5 or Argon laser,6 7 electrocoagulation8) has proved sufficiently beneficial to be used routinely.Somatostatin has been shown to be a potent inhibitor of gastric secretion of acid, pepsin, and intrinsic factor.Y"1 The peptide inhibits both basal and hormone induced secretion when administered by intravenous route, and the basal gastric secretion when administered intragastrically.'2 It also has a stimulative effect on gastric mucous production.'3 Splanchnic blood flow decreases after intravenous infusion of somatostatin.14 lS In addition, somato-

Drug Therapy for Non-Variceal Upper Gastrointestinal Bleeding

“…In three trials [83,86,87] in which the time to control bleeding was assessed, the time to achieve haemostasis was significantly reduced in somatostatin-treated patients compared to the controls. In the trial by Magnusson et al [84], all patients were in shock on admission to hospital, and a large proportion were actively bleeding and had stigmata indicative of early recurrent bleeding. Somatostatin significantly reduced the need for surgical intervention compared to placebo in these patients (p = 0.04).…”

Somatostatin in the Treatment of Non-Variceal Upper Gastrointestinal Bleeding

“…In three trials [82,85,86] in which the time to control bleeding was assessed, the time to achieve haemostasis was significantly reduced in somatostatin-treated patients compared to the controls. In the trial by Magnusson et al [83], all patients were in shock on admission to hospital, and a large proportion were actively bleeding and had stigmata indicative of early recurrent bleeding. Somatostatin significantly reduced the need for surgical intervention compared to placebo in these patients (p = 0.04).…”

Treatment of Acute Nonvariceal Upper Gastrointestinal Hemorrhage

“…Active treatment was efficacious for peptic ulcer bleeding with a trend toward efficacy for nonpeptic ulcer bleeding. Although the overall results suggested a decreased need for surgery in the somatostatin group, a subgroup analysis of investigator-blinded trials revealed 50 Digestion 1999;60(suppl 2): [47][48][49][50][51][52] Meier/Wettstein…”

“…The efficacy of somatostatin in the control of nonvariceal upper gastrointestinal hemorrhage is uncertain. Eight trials [49][50][51][52][53][54][55][56] showed positive effects whilst 4 trials [57][58][59][60] showed no favorable effect as com-…”