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Study flow diagram (Moher 2009)
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Figure 1

Study flow diagram (Moher 2009)

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Comparison 1 Cisapride versus placebo, Outcome 1 Total gastrointestinal symptoms.
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Analysis 1.1

Comparison 1 Cisapride versus placebo, Outcome 1 Total gastrointestinal symptoms.

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Comparison 1 Cisapride versus placebo, Outcome 2 Abdominal pain.
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Analysis 1.2

Comparison 1 Cisapride versus placebo, Outcome 2 Abdominal pain.

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Comparison 1 Cisapride versus placebo, Outcome 3 Abdominal distension.
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Analysis 1.3

Comparison 1 Cisapride versus placebo, Outcome 3 Abdominal distension.

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Summary of findings for the main comparison. Cisapride compared to placebo for preventing distal intestinal obstruction syndrome (DIOS) in cystic fibrosis

Cisapride compared to placebo for preventing distal intestinal obstruction syndrome (DIOS) in cystic fibrosis

Patient or population: preventing DIOS in cystic fibrosis
Setting: tertiary Centre
Intervention: cisapride
Comparison: placebo

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with placebo

Risk with cisapride

Radiological diagnosis of DIOS (physician‐measured radiological scores)

Follow‐up: baseline to 6 months

Trial investigators stated that there was no significant difference between cisapride and placebo.

NA

17
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1 2 3

Radiologist scored for radiographic signs of DIOS, no numerical data available.

Adverse effects (participant interviews)

Follow‐up: 3 to 12 months

No adverse effects were noted in either group.

NA

17
(1 RCT)

⊕⊝⊝⊝
VERY LOW 2 3 4

No numerical data available.

Total gastrointestinal symptom scores (participant‐reported symptom scores from 20 to 100)

Follow‐up: 3 to 12 months

The mean difference was 7.6 lower in the cisapride arm
(14.73 lower to 0.47 lower) than when the same participants took a placebo.

NA

17
(1 RCT)

⊕⊝⊝⊝
VERY LOW 2 3 4

Score made up of 10 different gastrointestinal symptoms: heartburn, flatulence, regurgitation, fullness, abdominal distension, abdominal pain, diarrhoea, nausea, vomiting, anorexia.

Hospitalisation for any cause

Outcome not reported.

NA

NA

Hospitalisation for DIOS

Outcome not reported.

NA

NA

Quality of life

Outcome not reported.

NA

NA

Tolerability

Outcome not reported.

NA

NA

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; DIOS: distal intestinal obstruction syndrome; NA: not applicable; RCT: randomised controlled trial.

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low certainty: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect.
Very low certainty: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

1. Selective reporting may have occurred with this outcome; allocation concealment and sequence generation was unclear.

2. Cisapride is a prokinetic, not a typical laxative agent (different to protocol). The study was conducted in 1990 when cisapride was still prescribed. It has now been taken off the UK market and other international markets due to its rare but serious cardiac effects.

3. Very small number of participants in the trial does not give sufficient information to give a precise effect estimate.

4. Allocation concealment and sequence generation ranked as unclear risk of bias.
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Summary of findings for the main comparison. Cisapride compared to placebo for preventing distal intestinal obstruction syndrome (DIOS) in cystic fibrosis
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Table 1. Alterations in global symptoms

Intervention

Total number of participants

Felt better

Felt the same

Felt worse

Cisapride

17

12

2

3

Placebo

17

3

2

12
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Table 1. Alterations in global symptoms
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Comparison 1. Cisapride versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Total gastrointestinal symptoms Show forest plot

1

Mean Difference (Fixed, 95% CI)

Totals not selected

1.1 At 6 months

1

Mean Difference (Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Abdominal pain Show forest plot

1

Mean Difference (Fixed, 95% CI)

Totals not selected

2.1 At 6 months

1

Mean Difference (Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Abdominal distension Show forest plot

1

Mean Difference (Fixed, 95% CI)

Totals not selected

3.1 At 6 months

1

Mean Difference (Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 1. Cisapride versus placebo
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