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The two camps of gastric prophylaxis join forces to settle their differences
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Sucralfate and Histamine blockers are effective as a prophylaxis against GI
bleeding. Sucralfate may be superior in terms of reduced pneumonia and
mortality but the level of evidence is not high. There is a need for a well
conducted trial comparing sucralfate with H2 blockers and their effects on
bleeding, pneumonia and mortality.
Level of evidence 1++ |
Citation/s:
Stress Ulcer Prophylaxis in Critically Ill Patients. (1996) JAMA. 275;4: 308-314
Cook DJ, Reeve BK, Guyatt GH, Heyland DK, Griffiths LE, Buckingham L, Tryba M
Lead author's name and fax: Dr DJ Cook, Department of Medicine, Font-bonne Building, St Josephs Building, 50 Charlton Ave E, Ontario, Canada L8N 4A6 Three-part Clinical Question: In intensive care patients does the use of gastric prophylaxis have a significant impact on; the
occurrence of GI bleeding, pneumonia or mortality. Is there a difference between Histamine blockers, sucralfate and antacids.
Search Terms: The Review:
Data Sources: : Medline, Embase, Citation Index, pharmaceutical companies, hand search, mail shot, own files, non-English sources, Unpublished work
National research files
Study Selection: Inclusion criteria for selection for overview: (1) Design (randomized clinical trials comparing groups of patients taking one or more prophylactic drugs with each other or with an untreated control group. (2) Target population (critically ill adult patients). (3) Outcome measure (GI bleed or pneumonia). Authors of abstract publications were contacted to request full manuscripts and data sets.
Definitions used
Overt bleeding: haematemesis, bloody gastric aspirate, malena or PR bleeding
Clinically significant bleeding: overt bleeding accompanied by;
(a) a decrease in blood pressure of 20mmHg within 24hrs of bleeding.
(b) a decrease in blood pressure of 10mmHg and an increase in heart rate of 20bpm on orthostatic change.
(c) a decrease in haemoglobin of 20g/L and a transfusion of 2U blood within 24 Hrs or as gastric bleeding requiring surgery.
Data Extraction: Critically ill adult patients, given gastric prophylaxis (antacids, H2-receptor antagonists or sucralfate) and the presence of GI haemorrhage or pneumonia. Mortality.
The studies were multiple independent reviews of individual reports. They were tested for heterogeneity. The Evidence:
| Outcome | Time to Outcome | Typical CER | Typical OR | RRR | NNT |
| Clinically important Gastro-intestinal bleeding. Sucralfate vs H2 Blocker |
ICU discharge | .03 |
1.28 |
-27% | -124 |
| 95% Confidence Intervals: |
0.27 to 6.11 | |
46 to -8 |
| Pneumonia. Sucralfate vs H2 Blocker |
ICU discharge | .18 |
0.78 |
19% | 30 |
| 95% Confidence Intervals: |
0.6 to 1.01 | |
16 to -679 |
| Mortality. Sucralfate vs H2 Blocker |
ICU discharge | .22 |
0.83 |
14% | 33 |
| 95% Confidence Intervals: |
.62 to 1.09 | |
14 to -66 |
Comments:
The conclusions of this study were:
(1) A
trend towards a lower incidence of pneumonia associated with sucralfate as compared with antacids and a trend towards a decreased incidence of pneumonia when sucralfate is compared to histamine blockers.
(2) Sucralfate is associated with a lower mortality rate compared with antacids and a trend toward lower mortality when compared with H2
blockers.
(3) No evidence suggesting differential effectiveness of sucralfate vs either antacids or H2 blockers in treating overt bleeding or clinically significant bleeding.
(4) A
further well conducted RCT was merited to improve the precision of the effect on bleeding and determine whether the reductions in the rates of pneumonia and mortality are real when comparing sucralfate and H2 blockers.
These results differ from the conclusions of the previous
independent analysis by the two authors. The possible reasons given for this were:
(1) Different questions were posed. (Tryba looked at all agents, Cook only considered antacids, sucralfate and H2
blockers)
(2) Inclusion of different studies
(3) Different definitions of bleeding
(4) No specific weighting schemes were used
(5) Analytical strategies were different.
Further reading: As a result of this Meta-analysis the two senior
authors combined forces to carry out the definitive Sucralfate vs Ranitidine
RCT. (A comparison of sucralfate and ranitidine for the prevention of upper gastrointestinal bleeding in patients requiring mechanical ventilation. NEJM 1998; 338:791-7
Deborah Cook et al for the Canadian Critical Care Trials Group) Appraised by: Dr Chris Cairns, Intensive Care Unit, Edinburgh Royal Infirmary; Wednesday, April 10, 2002
Email: Chris.Cairns@btinternet.com
Kill or Update By: March 2005
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