Upper GI bleed: cirrhosis: varices: sclerotherapy and octreotide prevented more bleeds than sclerotherapy alone.

Clinical bottom line (level 1b)

  1. Patients with bleeding oesophageal varices who received sclerotherapy and octreotide, compared with sclerotherapy alone, were less likely to rebleed (NNT = 67 at 15 days) .
  2. Patients on octreotide and sclerotherapy required, on average, one unit fewer of blood.
  3. There was no clear effect on mortality or adverse effects.
Besson et al: New England Journal of Medicine 1995; 333: 555-560
Expires July 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: fifteen acute hospitals, France

199 patients (aged range 28 to 79 years; mean 59, 76% male) active variceal bleeding at endoscopy (spurting or oozing from oesophageal or cardiac varices; or non-bleeding varices, but blood and no other cause (and haematemesis or melaena within last 24 hours (91% had alcoholic cirrhosis)

Excluded if
  • bleeding within 15 days
  • previous sclerotherapy
  • balloon tamponade or vasoactive drugs used within 8 days
  • hepatorenal syndrome or end-stage cirrhosis
  • hepatocellular carcinoma or non-cirrhotic portal hypertension
  • aged >80

Control Group: (n = 101, 101 analysed): emergency sclerotherapy, followed by placebo infusions
Experimental Group: (n = 98, 98 analysed): emergency sclerotherapy, followed by octreotide infusion at 25 µ g/hours, made up as 500 µ g in 500 ml 0.9% saline for 5 days
All patients had conventional therapy with fluids, vitamins, lactulose, and further sclerotherapy after 5 days if needed.
100% followed for 5 days
Outcome notes:
  • rebleed : fall in blood pressure >20 mmHg, Hb fall <9 g/dl, Hct <0.30; requiring > 2 units of blood within 2 hours

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
rebleed 5 days 25
(24.8%)		 11
(11.2%)		 55%
(13% to 76%)		 13.5%
(3.04% to 24.0%)		 7
(4 to 33)
death 5 days 10
(9.90%)		 7
(7.14%)		 28%
(-82% to 71%)		 2.76%
(-4.98% to 10.5%)		 36
(NNT = 10 to infinity;
NNH = 20 to infinity)
hyperglycaemia 5 days 13
(12.9%)		 23
(23.5%)		 -82%
(-239% to 2%)		 -10.6%
(-21.2% to 0.04%)		 -9
(NNT = 2850 to infinity;
NNH = 5 to infinity)
oesophageal ulcers 5 days 62
(61.4%)		 61
(62.2%)		 -1%
(-26% to 18%)		 -0.86%
(-14.4% to 12.6%)		 -120
(NNT = 8 to infinity;
NNH = 7 to infinity)
rebleed 15 days 29
(28.7%)		 14
(14.3%)		 50%
(12% to 72%)		 14.4%
(3.21% to 25.7%)		 7
(4 to 31)
death 15 days 12
(11.9%)		 12
(12.2%)		 -3%
(-118% to 51%)		 -0.36%
(-9.42% to 8.69%)		 -280
(NNT = 12 to infinity;
NNH = 11 to infinity)

  • Patients given octreotide required fewer transfusions (~0.8 units).
  • Deaths were from rebleeding, encephalopathy and acidosis.

    • Comments

    1. Patients were randomised in blocks of four.
    2. The effect on rebleeding was independent of the Child-Pugh class (Mantel-Haenszel test).
    3. The study is too small to show any clear effect on mortality.

    Citation

    1. Besson I, et al: Sclerotherapy with or without octreotide for acute variceal bleeding. New England Journal of Medicine 1995; 333: 555-560
    Contributor: Alan Townsend, Sharon Straus and Chris Ball, July 2000
    Reviewer:

    Clinical Question.
    Patient bleeding oesophageal varices
    Intervention or Exposure sclerotherapy and octreotide
    Comparison sclerotherapy alone
    Outcome rebleeding, mortality