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Cochrane Database of Systematic Reviews

Intervenciones para la prevención del síndrome de obstrucción intestinal distal (SOID) en la fibrosis quística

Esta versión no es la más reciente

Información

DOI:
https://doi.org/10.1002/14651858.CD012619.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 12 junio 2018see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Fibrosis quística y enfermedades genéticas

Copyright:
  1. Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Cifras del artículo

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Contraer

Autores

  • Jessica Green

    Academic Department of Child Health, Royal Stoke University Hospital, Stoke‐on‐Trent, UK

  • Francis J Gilchrist

    Academic Department of Child Health, Royal Stoke University Hospital, Stoke‐on‐Trent, UK

  • Will Carroll

    Correspondencia a: Department of Paediatric Respiratory Medicine, University Hospitals of the North Midlands, Stoke‐on‐Trent, UK

    [email protected]

Contributions of authors

Roles and responsibilities

TASK

WHO UNDERTOOK THE TASK

Protocol stage: draft the protocol

WC

Review stage: select which trials to include (2 + 1 arbiter)

JG + WC + FG as arbiter

Review stage: extract data from trials (2 people)

JG + WC

Review stage: enter data into RevMan

JG

Review stage: carry out the analysis

JG + WC

Review stage: interpret the analysis

JG + WC

Review stage: draft the final review

JG + WC

Update stage: update the review

WC

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • National Institute for Health Research, UK.

    This systematic review was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to the Cochrane Cystic Fibrosis and Genetic Disorders Group.

Declarations of interest

Jessica Green declares no known potential conflict of interest.

Dr Will Carroll declares no known potential conflict of interest.

Dr Francis J Gilchrist declares no known potential conflict of interest.

Acknowledgements

This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to the Cochrane Cystic Fibrosis and Genetic Disorders Group. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.

We would like to thank Nikki Jahnke (Managing Editor at the Cochrane Cystic Fibrosis and Genetic Disorders Group) for her support and guidance throughout this review.

Version history

Published

Title

Stage

Authors

Version

2021 Dec 22

Interventions for preventing distal intestinal obstruction syndrome (DIOS) in cystic fibrosis

Review

Will Carroll, Jessica Green, Francis J Gilchrist

https://doi.org/10.1002/14651858.CD012619.pub3

2018 Jun 12

Interventions for preventing distal intestinal obstruction syndrome (DIOS) in cystic fibrosis

Review

Jessica Green, Francis J Gilchrist, Will Carroll

https://doi.org/10.1002/14651858.CD012619.pub2

2017 Apr 11

Interventions for preventing distal intestinal obstruction syndrome (DIOS) in cystic fibrosis

Protocol

Jessica Green, Will Carroll, Francis J Gilchrist

https://doi.org/10.1002/14651858.CD012619

Differences between protocol and review

In the protocol, we did not list prokinetic agents as a possible treatment for distal intestinal obstruction syndrome (DIOS). However, we have now included them in the review because there is evidence in the literature for their role in treating constipation and generally increasing colonic transit and motility (Boyle 2009; Colombo 2011). As the treatment of constipation is especially important in the prevention of DIOS, we decided to include them as a possible intervention in this review.

Keywords

MeSH

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Study flow diagram (Moher 2009)
Figuras y tablas -
Figure 1

Study flow diagram (Moher 2009)

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

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

Comparison 1 Cisapride versus placebo, Outcome 1 Total gastrointestinal symptoms.
Figuras y tablas -
Analysis 1.1

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

Comparison 1 Cisapride versus placebo, Outcome 2 Abdominal pain.
Figuras y tablas -
Analysis 1.2

Comparison 1 Cisapride versus placebo, Outcome 2 Abdominal pain.

Comparison 1 Cisapride versus placebo, Outcome 3 Abdominal distension.
Figuras y tablas -
Analysis 1.3

Comparison 1 Cisapride versus placebo, Outcome 3 Abdominal distension.

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.

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

Figuras y tablas -
Table 1. Alterations in global symptoms
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