Louie 2005.
| Methods | Randomized Controlled Trial | |
| Participants | Numer randomised: 28, intervention group 10, control group 18. Setting: An academic, multi‐institutional, tertiary care health system. Teaching hospitals associated with UofA Hospital. Age: >17, mean age of intervention group: 65.3 (SD 18.3), mean age of control group 59 (SD 15.3). Sex: Intervention group; 6 males and 4 females, control group; 9 males and 9 females. Study period: July/15/1999‐Dec/15/2001. Diagnostic Criteria: For acute pancreatitis: Quote: "Eligible patients were required to have acute pancreatitis" Comment: Not stated. For Severity: 1‐Ranson's criteria at admission or diagnosis. 2‐CT grading system for pancreatitis of Balthazar and associates. Inclusion criteria: Patients were required to have acute pancreatitis. A Ransons score (calculated by counting 1 point for each of the criteria met over the 48‐ hour period) of 3 or greater, and inability to tolerate oral fluids after a maximum time from admission of 96 hours. Exclusion criteria: Patients were excluded if they did not meet these criteria (Above), If they were younger than 18 years, unable to accept enteral nutrition via the gastrointestinal tract, or already receiving nutritional support. Etiology: Intervention group: Cancer: 0, TG: 1, ERCP: 0, Biliary stones: 5, Alcohol: 2, Unknown: 2, APACHE II: 11.8 (SD 8.3), Ranson's Score: 4.7 (1.3), Balthazar CT Scan score: 3.4 (SD 1.3). Control group: Cancer: 0, ERCP: 1, TG: 1, Biliary stones: 7, Alcohol: 4, Unknown: 5 APACHE II: 12.7 (SD 5.5), Ranson's Score: 5 (SD 1.8), Balthazar CT Scan score: 4.2 (SD 0.8). |
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| Interventions | Intervention: Nasojejunal (NJ) feeding tubes were placed via gastroscopy and confirmed radiographically. Peptamen (Nestlé), a semielemental product with low fat content, was infused at 25 mL/h and increased by 10 mL/h every 6 hours, until the target rate was achieved. Control: In the PN group, long‐term vascular catheters were placed percutaneously and confirmed radiographically. PN was initially infused with a 10% dextrose solution and Intralipid (Baxter) at half of the calculated energy requirements; then increased over 2 days to achieve 100% of the target energy rate. |
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| Outcomes | Attenuation of the inflammatory Response. The effectiveness of nutrition. The natural history and morbidity of pancreatitis. The morbidity from each nutritional modality. An economic evaluation of the nutrition technology |
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| Notes | Funding source: Not stated. Conflicts of interest: Non declared. Ethical approval: Yes. Sample size calculation: Yes, they conservatively assumed a clinically important difference to be a mean of 2 days, with a standard deviation of 3 days, to achieve a 50% reduction in C‐reactive protein levels. To observe a difference between the groups, the total sample size was estimated at 58 participants to achieve an α= 0.05 and a β = 0.2. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | Quote: "patients were blindly randomised to receive either PN or EN and stratified by hospital, by means of computer‐ generated assignment placed in sealed, opaque envelopes" Comment: Probably done. |
| Allocation concealment? | Low risk | Quote: "patients were blindly randomised to receive either PN or EN and stratified by hospital, by means of computer‐ generated assignment placed in sealed, opaque envelopes" Comment: Probably done. |
| Blinding? All outcomes | Unclear risk | Comment:The study did not address this. |
| Incomplete outcome data addressed? All outcomes | Low risk | Quote: "In all, 28 patients consented to participate and completed the study" Comment: No missing data. |
| Free of selective reporting? | Low risk | Comment: Probably yes, because all primary and secondary outcomes stated in the introduction were clearly presented in the result section. |
| Free of other bias? | Low risk | |