Upper GI bleed: in patients with varices adding somatostatin to sclerotherapy reduces treatment failure and quantity of transfusions required.

Clinical bottom line (level 1b)

  1. Patients with cirrhosis and upper GI bleeding who received somatostatin and sclerotherapy compared with sclerotherapy alone were less likely to fail treatment (NNT = 5 at 5 days) .
  2. Endoscopists found sclerotherapy easier when somatostatin was used.
Avgerinos et al: Lancet 1997; 350: 1495-1499
Expires December 2002

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 9 acute hospitals, Greece, Netherlands and Belgium

205 patients (aged mean 58, 71% male) with cirrhosis and suspected of having an upper GI bleed

Excluded if
  • aged < 18
  • sclerotherapy not indicated on endoscopy
  • previously included or undergone sclerotherapy within previous 30 days
  • received other therapy for bleeding episode
  • decision made before bleeding to avoid specific medical therapy
  • pregnant or lactating
  • known allergy to mannitol
  • GI bleed not requiring volume replacement
  • initial bleed longer than 12 hours before admission


Note:
  • All patients had endoscopy at 1 and 8 hours after admission, and sclerotherapy was performed (using ethanolamine or aethoxysclerol) if there was active variceal bleeding, blood clots on varices or varices without any other visible cause of bleeding.
  • All patients had a nasogastric tube inserted, and had regular aspiration for 12 hours.


Control Group: (n = 104, 104 analysed): placebo
Experimental Group: (n = 101, 101 analysed): somatostatin 6 mg in 500 ml saline iv over 24 hours for 5 days. Two boluses of 250 micrograms were given - on initiation of infusion, and 1 minute before endoscopy. Up to eight more boluses could be given if there was clinical signs of bleeding.

100% followed for 5 days
Outcome notes:
  • treatment failure : at least one of: transfusion of an excess of blood products (more than 1 unit required per gram of Hb to bring Hb to 110 g/l); haematemesis, haemodynamic instability, use of rescue therapy (repeat sclerotherapy, balloon tamponade, banding or TIPS), or death

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
treatment failure 5 days 57
(54.81%)		 35
(34.65%)		 37%
(13% to 54%)		 20.15%
(6.83% to 33.48%)		 5
(3 to 15)

Outcome Control Group
(SD)		 Experimental Group
(SD)		 Mean Difference
(95% CI)
ease of sclerotherapy (visual analogue score: mm) 4.70
(0.4) 		2.80
(0.3) 		1.9
(1.8 to 2.0)

Comments

  1. The study is too small to show any difference between the two groups for death, or further intervention.
  2. Patients were randomised in blocks of four.
  3. As the severity of the liver disease is accepted to be the main predictor of long-term survival, patients with more hepatic reserve capacity may benefit from the addition of somatostatin by avoiding treatment failure during bleeding episodes.

Citation

  1. Avgerinos A, Nevens F, Raptis S, et al: Early administration of somatostatin and efficacy of sclerotherapy in acute oesophageal variceal bleeds: the European Acute Bleeding Oesophageal Variceal Episodes (ABOVE) randomised trial. Lancet 1997; 350: 1495-1499
Search Terms: reference in Cochrane review
Contributor: Chris Ball and Musab Hayatli, December 1999
Reviewer: Zoltan Bodnar

Clinical Question.
Patient cirrhosis and varices with suspected upper GI bleed
Intervention or Exposure somatostatin and sclerotherapy
Comparison sclerotherapy
Outcome treatment failure, ease of sclerotherapy