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primary studies published RCT

A double-blind placebo-controlled trial of a pancreatic enzyme formulation (Panzytrat (R) 25 000) in the treatment of impaired lipid digestion in patients with cystic fibrosis.

  • Year: 1993
  • Date: 1993
  • Author: Chazalette JP
Source

DRUG INVEST. YR: 1993 VL: 5 DE: RCT NO: 5

Study design (if review, criteria of inclusion for studies)

randomised, controlled double-blind parallel group study

Participants

15 children (mean age 12 years) with proven cystic fibrosis and a lipid absorption coefficient (LAC) < 90%. 14 patients were evaluated

Interventions

Panzytrat (R) 25 000 (n = 7) or placebo (n = 7) orally during meals, in an age-adjusted dosage of 2 (< 18 months), 4 (18 months to puberty) or 6 (postpubertal) capsules daily for 8 days. Baseline values were established after treatment with a conventional powdered pancreatin preparation and an age-adjusted diet.

Outcome measures

efficacy

Main results

After treatment, the mean LAC was 80.5% in the Panzytrat (R) 25 000 group compared with 55.6% in the placebo group. In the Panzytrat (R) 25 000 group there was an improvement in LAC (+25%), stool weight (-46%), and in nondigested (-38%) and nonabsorbed (-47%) faecal fat. In contrast, in the placebo group there was a worsening of all 4 of these parameters with changes of -10% for LAC, +32% for stool weight, +36% for nondigested fat, and +46% for nonabsorbed fat. The difference between the Panzytrat (R) 25 000 and the placebo groups was statistically significant (p < 0.01) for all 4 parameters. Subjective assessment of efficacy by the clinician was rated as 'good' or 'excellent' for 86% of patients in the Panzytrat (R)) 25 000 group compared with 14% of those in the placebo group (p = 0.015).

Authors' conclusions

Tolerability was 'good' or 'excellent' in all patients except one placebo recipient who complained of digestive upset.

Keywords: Adolescent; Child; Infant; Oral; Pancreatic Enzyme Replacement Therapy; Panzytrat; placebo; Supplementation; Pancreas insufficiency; Pancreatic Diseases; Gastrointestinal Diseases; Malabsorption; Nutrition Disorders; Capsules; Powders; pharmacological_intervention; Gastrointestinal Agents;