| Study | Intervention/comparison | Population | Outcomes | Comments |
|---|---|---|---|---|
| Beker 1994 (USA) Cross-over RCT | High-dose: 1500u lipase per kg/body for meals & 750u lipase per kg/body for snacks. Low-dose: 500u lipase per kg/body for meals & 250u lipase per kg/body for snacks. Additional information:
| N=21 children and young people with CF Age (SD, range): 11.5; 5 to 28 years | Reduction of steatorrhoea and faecal fat
| |
| Brady 1991 (USA) Cross-over RCT | High-dose: median 12 (8 to 18) capsules per meal Low-dose: median 3 (2 to 5) capsules per meal. Additional information: Constituent enzymes per capsule: 7.020u of lipase. Daily fat intake (g) 94±6 in both groups. | N=9 children with CF Age (median, range): 9; 6 to 10 years | Reduction of steatorrhoea and faecal fat
| |
| Durie 1980 (Canada) Cross-over RCT | Pancrelipase alone: 26 Pancrease capsules (Cotazym) per day, 6 per meal and 3 per snack Pancrelipase + Cimetidine (200 & 300 mg. tablets) | N=21 children and young people with CF Age: 10 to 17 years | Reduction of steatorrhoea and faecal fat
| |
| Francisco 2002 (USA) Cross-over RCT | Pancrease (MT10 or MT16) + adjunct low-dose or high-dose Ranitidine. Children weighting ≤40 kg were given ranitidine 5 mg/kg or 10 mg/kg daily, divided into 2 equal doses 30 minutes before breakfast and dinner. Children weighting >40 kg and adults received 150 mg or 300 mg twice daily. Pancrease (MT10 or MT16) + adjunct Omeprazole (adults only) 20 mg daily, 30 minutes before breakfast Pancrease (MT10 or MT16) + placebo Additional information: diet fat was kept constant | N=22 people with CF 12 children and young people, age: 6 to 17 years; 10 adults, age: 18 to 36 years | Reduction of steatorrhoea and faecal fat
| |
| Heijerman 1991 (Netherlands) Cross-over RCT | High-dose 4 capsules × 3 times per day Low-dose 2 capsules × 3 times per day. Additional information: Constituent enzymes per capsule 5000u lipase, 2900u lipase, 330u protease. Fat intake was not standardized | N=9 adults with CF Age (median, range): 29; 23 to 42 years | Resolution of symptoms of malabsorption
| Both high-dose and low-dose are low-dose and very low-dose in current practice: indirect evidence |
| Heijerman 1993 (Netherlands) Cross-over RCT | Pancrease 2 caps, 3 per day and Omeprazole placebo Pancrease 2 caps, 3 per day + Omeprazole 20 mg once in the morning Additional information: Constituent enzymes per capsule of Pancrease: 5000 units lipase, 2900 units amylase, 330 units protease per capsule | N=11 adults with cystic fibrosis Age: 20 to 42 | Resolution of symptoms of malabsorption
| This dose is a very-low dose in current practice: indirect evidence |
| Mitchell 1982 (New Zealand) Cross-over RCT | High-dose 22 capsules/day Low-dose 11 capsules/day Pancrease®. Additional information: Constituent enzymes per capsule 4,000 USNF lipase units; 25,000 USNF protease units; 20,000 amylase units. Fat intake was not standardized | N=12 children and young people with CF Age: (mean, SD): 9.6±2.1 years | Resolution of symptoms of malabsorption
|
CF: cystic fibrosis; CFA: coefficient of fat absorption; FFE: faecal fat excretion; RCT: randomised controlled trial; SD: standard deviation
From: 10, Other monitoring, assessment and management
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