Singh 2008.
Study characteristics | ||
Methods | RCT. Parallel design with 2 arms. Duration: 3 months. Location: India. |
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Participants |
Inclusion criteria: adults with chronic pancreatitis and undernourished, BMI < 18.5 kg/m² or > 10% weight loss in previous 6 months. Exclusion criteria: clinically apparent steatorrhoea, pancreatic cancer, biliary obstruction, undergoing endoscopic or surgical therapy, uncontrolled diabetes, acute exacerbation of pancreatitis, large pseudocysts, currently consuming alcohol, opioid addicts, comorbid condititions eg. chronic liver disease. Number randomised: 60 participants (intervention group, n = 31; intervention group 2, n = 29). Attrition: 6 dropouts (intervention group, n = 4; intervention group 2, n = 2). Gender split: 50 males, 10 females. Age: mean (SD), intervention group 1, 28 (10) years; intervention group 2, 32 (10) years. Nutritional status: mean (SD) BMI: intervention group 1, 16.7 (1.6) kg/m2, intervention group 2, 17.2 (1.7) kg/m2. |
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Interventions |
Intervention (intervention group 1): particpants received ONS in the form of a nutritional supplement enriched with medium chain triglycerides to meet predicted energy requirements. Intervention (intervention group 2): participants received dietary advice in the form of dietary advice from a dietitian to meet predicted energy requirements. |
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Outcomes | BMI*, weight* TSF*, MAMC*, energy and protein intake, nitrogen balance, faecal fat, pain score. | |
Publication details |
Language: English. Funding: Indian Council for Medical Research. Publication status: peer‐reviewed journal. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random number list. |
Allocation concealment (selection bias) | Low risk | Carried out by individual not otherwise involved in the study. |
Blinding (performance bias and detection bias) Clinical outcomes | Low risk | Outcome assessment blinded to treatment. |
Blinding (performance bias and detection bias) Functional outcomes | Low risk | Outcome assessment blinded to treatment. |
Blinding (performance bias and detection bias) Nutritional outcomes | Low risk | Outcome assessment blinded to treatment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded and likely that researchers and participants were aware of group allocation as this was a nutritional intervention. It is possible that assessment of some outcomes was influenced by lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All outcome assessment was assessed blinded to group allocation. Quote: "the person assessing outcome was blinded to the treatment the patient was receiving". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Fully reported and similar between groups: 4/31 (13%) intervention group at 1.5 months, 2/29 (7%) control group at 1.5 months. But all included in the final analysis. |
Selective reporting (reporting bias) | Unclear risk | No protocol identified. All outcomes reported but not in a format usable for meta analysis. Data on change in weight, TSF, MAC and energy intake were reported as mean (SD) at baseline and mean (SD) at end of intervention, therefore mean change (SD) obtained from authors. |
Other bias | Low risk | Baseline variables given, groups similar at baseline. |