Table.
| Author, date and country | Patient group | Study type (level of evidence) | Outcomes | Key results | Study weaknesses | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Imperiale et al,1 1997 USA | 1829 patients from 14 randomised clinical trials comparing SST or octreotide with H2 blockers or placebo in patients with clinical or endoscopic evidence of acute nonvariceal upper GI haemorrhage. 7 trials placebo controlled, 7 used cimetidine, 5 used ranidine. 8 trials blinded | Meta‐analysis of 14 trials;database search of English language articles between 1966 and 1996 and the bibliographies of all related articles and textbook chapters. Medline Jan 66–Oct 96, Embase 1980–1996 | Continued bleed or rebleed (all trials) | RR 0.53 (95% CI 0.43 to 0.63) NNT5 | Very heterogeneous studies re protocols and doses of drugs, outcome measures, interventions and study groups (some high risk only, some excluded high risk. proportion of patients with active bleeding ranged from 13–100%)). ?Publication bias; though calculations show would need 18 trials showing no difference for p>0.05, are h2 blockers equivalent to placebo? What is the ideal treatment duration? | |||||
| Surgery (all trials) | RR 0.71 (CI 0.61 to 0.81) NNT8 | |||||||||
| Continued bleed or rebleed (SST only) | RR 0.50 (CI 0.39 to 0.60) NNT5 | |||||||||
| Continued bleed or rebleed (octreotide only) | RR 0.72 (CI 0.35 to 1.08) NS | |||||||||
| Continued bleeding (SST only) | RR 0.41 (CI 0.29 to 0.53) NNT4 | |||||||||
| Surgery (SST only) | RR 0.70 (CI 0.58 to 0.82) NNT7 | |||||||||
| Investigator blinded trials: | ||||||||||
| Continued bleeding or rebleed | RR 0.73 (CI 0.64 to 0.81) NNT11 | |||||||||
| Surgery | RR 0.94 (CI 0.87 to 1.001) | |||||||||
| For PU bleeding alone, continued/rebleed | RR 0.48 (CI 0.39 to 0.59) NNT 4 | |||||||||
| Non peptic ulcer bleeding, continued/rebleed | RR 0.62 (CI 0.39 to 1.002) | |||||||||
| Archimandritis et al,2 2000 Greece | 84 patients over a 12 month period, scoped within the first 24 hours. Randomised to ranitidine and octreotide (50 mg IV three times daily and 100 µg S/C tds)(40) or ranitidine (50 mg IV tds) alone (44). | Prospective RCT; not blinded | No. of units tx – ranitidine | 1.07± 0.24 | Not blind. Small numbers. S/C octreotide and ?wrong dose | |||||
| Ranitidine/octreotide | 1.7±0.37 p = 0.16 (NS) | |||||||||
| Days in hospital: ranitidine | 8.39±0.47 | |||||||||
| Ranitidine/octreotide | 9.20±0.53 p = 0.25 (NS) | |||||||||
| Txd patients: ranitidine | 23/44 | |||||||||
| Ranitidine/octreotide | 21/40 p = 1.0 (NS) | |||||||||
| Emergency op: ranitidine | 3 | |||||||||
| Ranitidine/octreotide | 3 p = 1.0 (NS) | |||||||||
| Saruc et al,3l 2003 Turkey | 21 patients with bleeding peptic ulcer‐endoscoped within 6 hours. Given SST 250 µg/hr for 72 hrs after bolus 250.Each patient had SMA‐V, SMA‐PI, PV‐F and RA‐RI measured by doppler on day 1 of infusion infusion and 6 hours post‐infusion | Observational lab trial ‐not blind | PV‐F‐during infusion | 33.7±12.7 cm3/s | Laboratory trial. Not blind. Small numbers. High no of exclusions including NSAID use. ?Correlation between large vessel flow and clinical picture. ?Influence of mucosal bleeding | |||||
| PV‐F‐post infusion | 56.3±16.0 p = 0.001 | |||||||||
| SMA‐V during infusion | 39.7±13.1 | |||||||||
| SMA‐V post infusion | 64.4±15.1p = 0.01 | |||||||||
| SMA‐PI during infusion | 2.0±0.8 | |||||||||
| SMA‐PI post infusion | 2.8±0.8 p = 0.02 | |||||||||
| Correlation between PV‐F and risk of rebleed | r = 0.55, p = 0.03 (r = 0.2 is correlation) | |||||||||
| Correlation between SMA‐V and risk of rebleed | r = 0.22, p‐0.22 | |||||||||
| No change in RA‐RI | ||||||||||
| Avgerinos et al,3 2005 Greece | 43 patients with malaena/haematemesis with endoscopic signs of stages 2c and 3 Forrest classification. Randomised to SST (15), pantoprazole (14) or placebo (14) and then had gastric pH monitoring for 24 hrs | Prospective RCT (placebo controlled)‐double blind | Mean gastric pH ‐SST | 1.94±0.18 to 6.13±0.37 p<0.0001 | pH study only with no correlation to actual risk of rebleed or need for surgical intervention according to power calculations, study sample not large enough; however, study stopped as SST appeared superior to placebo high no of patients excluded from trial (143). | |||||
| PAN | 1.93±0.16 to 5.65±0.37 p<0.0001 | |||||||||
| Placebo | 1.86±0.12 to 2.10±0.15 p = 0.0917 |
IV, intravenous, S/C, subcutaneous; tds, three times daily, NS, non‐significant; GI, gastrointestinal, PU, peptic ulcer; SST, somatostatin; SMA‐V superior mesenteric artery velocity; SMA‐PI, SMA pulsatility index; PV‐F, portal venous volume flow; RA‐RI, renal artery resistance index.