Upper GI bleed: varices: octreotide and band ligation prevented rebleeding better than band ligation alone.

Clinical bottom line (level 1b)

  1. Patients with bleeding oesophageal varices who had octreotide and endoscopic band ligation compared with band ligation alone were less likely to rebleed (NNT = 3 at 30 days) or require a balloon tamponade (NNT = 5 at 30 days) .
  2. There was no clear difference in ability to control initial bleeding or subsequent mortality.
Sung et al: Lancet 1995; 346: 1666-1669
Expires October 2002

The study

Unblinded ?concealed randomised trial without intention-to-treat
Setting: university hospital, Hong Kong

100 patients (aged 17 to 78; mean 57, 71% male) with endoscopically-confirmed oesophageal varices and active or recent haemorrhage (cherry-red spot or fibrin clot)

Excluded if
  • aged <16
  • previous endoscopic treatment of oesophageal varices or shunt surgery
  • possible alternative source for bleeding
  • history of hepatocellular carcinoma

Control Group: (n = 50, 47 analysed): endoscopic variceal ligation
Experimental Group: (n = 50, 47 analysed): endoscopic variceal ligation and octreotide 50 µ g iv bolus followed by 50 µ g/hr iv for 5 days
All patients had band ligation until varices were obliterated.
94% followed for 30 days
Outcome notes:
  • rebleeding : haematemesis or fall in systolic blood pressure to < 90mmH and a persistent tachycardia
  • balloon tamponade required : haematemesis > 500 ml, systolic blood pressure < 90mmHg and pulse >100 beats/min for 2 hours, and requiring more than 6 units in 24 hours to maintain blood pressure.

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
initial haemostasis 30 days 44
(93.6%)		 45
(95.7%)		 2%
(-7% to 13%)		 2.13%
(-6.94% to 11.2%)		 47
(NNT = 9 to infinity;
NNH = 14 to infinity)
rebleeding 30 days 18
(38.3%)		 4
(8.51%)		 78%
(39% to 92%)		 29.8%
(13.8% to 45.8%)		 3
(2 to 7)
balloon tamponade required 30 days 10
(21.3%)		 1
(2.13%)		 90%
(25% to 99%)		 19.2%
(6.74% to 31.6%)		 5
(3 to 15)
death in hospital unknown 9
(19.2%)		 4
(8.51%)		 56%
(-34% to 85%)		 10.6%
(-3.15% to 24.4%)		 9
(NNT = 4 to infinity;
NNH = 32 to infinity)
death 30 days 11
(23.4%)		 5
(10.6%)		 55%
(-21% to 83%)		 12.8%
(-2.21% to 27.7%)		 8
(NNT = 4 to infinity;
NNH = 45 to infinity)

Comments

  1. The study is too small to show any effect on mortality.

Citation

  1. Sung JJ, Chung SC, Yung MY, et al: . Lancet 1995; 346: 1666-1669
Contributor: Alan Townsend and Chris Ball, October 1999
Reviewer: .

Clinical Question.
Patient bleeding oesophageal varices
Intervention or Exposure octreotide and endoscopic band ligation
Comparison endoscopic band ligation
Outcome mortality, rebleeding