Upper GI bleed: peptic ulcer: no clear benefit from adding polidocanol to epinephrine for injection therapy

Clinical bottom line (level 1b-)

  1. Patients with bleeding peptic ulcers who had injection therapy using epinephrine and polidocanol compared with epinephrine alone were not clearly less likely to rebleed, require surgery or die.
Villanueva et al: Journal of Clinical Gastroenterology 1993; 17 (3): 195-200
Expires October 2002

The study

Unblinded ?concealed randomised trial with intention-to-treat
Setting: acute hospital, Spain

63 patients (aged mean 62, 68% male) admitted with melaena or haematemesis due to peptic ulcer disease (confirmed on endoscopy as actively bleeding or a visible vessel).

Excluded if
  • aged < 18


    • Note:
  • All patients had endoscopy within 4 hours of admission, followed by ranitidine.


Control Group: (n = 30, 30 analysed): injection therapy using epinephrine 1:10 000
Experimental Group: (n = 33, 33 analysed): injection therapy using epinephrine 1:10 000 and polidocanol 1%

100% followed for 12 days

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
recurrent bleeding 12 days 3
(10.0%)		 7
(21.2%)		 -110%
(-650% to 40%)		 -11.2%
(-28.8% to 6.39%)		 -9
(NNT = 16 to infinity;
NNH = 3 to infinity)
emergency surgery 12 days 4
(13.3%)		 5
(15.2%)		 -14%
(-280% to 66%)		 -1.82%
(-19.1% to 15.4%)		 -55
(NNT = 6 to infinity;
NNH = 5 to infinity)
death 12 days 2
(6.67%)		 1
(3.03%)		 55%
(-380% to 96%)		 3.64%
(-7.04% to 14.3%)		 28
(NNT = 10 to infinity;
NNH = 14 to infinity)

Comments

  1. The study is too small to show any difference between the two groups.

    Citation

    1. Villanueva C, Balanzo J, Equinos JC, et al: endoscopic injection therapy of bleeding ulcer: a prospective and randomized comparison of adrenaline alone or with polidocanol. Journal of Clinical Gastroenterology 1993; 17 (3): 195-200
    Contributor: Chris Ball, October 1999
    Reviewer:

    Clinical Question.
    Patient bleeding peptic ulcer
    Intervention or Exposure endoscopic injection therapy with epinephrine and polidocanol
    Comparison injection therapy with epinephrine
    Outcome death, rebleeding