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Cochrane Database of Systematic Reviews

Intervenciones farmacológicas para el dolor abdominal recurrente en niños

Information

DOI:
https://doi.org/10.1002/14651858.CD010973.pub2Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 06 March 2017see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane Developmental, Psychosocial and Learning Problems Group

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Alice E Martin

    Correspondence to: Paediatrics, Royal Devon and Exeter Hospital, Exeter, UK

    [email protected]

  • Tamsin V Newlove‐Delgado

    NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter Medical School, Exeter, UK

  • Rebecca A Abbott

    NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter Medical School, Exeter, UK

  • Alison Bethel

    NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter Medical School, Exeter, UK

  • Joanna Thompson‐Coon

    NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter Medical School, Exeter, UK

  • Rebecca Whear

    NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter Medical School, Exeter, UK

  • Stuart Logan

    NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter Medical School, Exeter, UK

Contributions of authors

  • Review design: AEM, SL

  • Review co‐ordination: AEM

  • Data collection:

    • Search strategy design: AEM, AB

    • Searches undertaken: AEM, AB

    • Search results screened: AEM, TVND, RAA, AB, JTC, RW

    • Retrieval of papers: AEM, AB

    • Paper screening and appraisal, and extraction of data: AEM, TVND, RAA, AB, JTC, RW

    • Writing to authors for additional information: AEM, AB, RAA, TVND

    • Entering the data into Review Manager 5: AEM, TVND, RAA, AB, JTC

  • Analysis of the data: AEM, TVND, RAA, AB, JTC, SL

  • Interpretation of the data:

    • Methodological perspective: AEM, TVND, RAA, AB, JTC

    • Clinical perspective: AEM, TVND, SL

Sources of support

Internal sources

  • National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care South West Peninsula (PenCLAHRC), UK.

    Funds the work of the evidence synthesis team.

External sources

  • None, Other.

Declarations of interest

The work of the evidence synthesis team is funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care South West Peninsula (PenCLAHRC). The Funder has had no role in the review itself.

Alice E Martin: none known.
Tamsin V Newlove‐Delgado: none known.
Rebecca A Abbott: none known.
Alison Bethel: none known.
Joanna Thompson‐Coon: none known.
Rebecca Whear: none known
Stuart Logan: none known.

The authors who practice clinical paediatrics are Alice E Martin and Stuart Logan. Alice is a Paediatric Trainee and works under the guidance of various consultant paediatricians. Stuart is a Consultant Paediatrician and treats children according to current best evidence, in light of their preference. There are therefore no conflicts of interest with this review.

Acknowledgements

We acknowledge the work of the original review authors: Angela Huertas‐Ceballos, Stuart Logan, Cathy Bennett, Sarah See, Colin Macarthur, and Morris Zwi. We would also like to acknowledge the work of the Cochrane Developmental, Psychosocial and Learning Problems Review Group, the editors, statistician, and peer reviewers who commented on early drafts of this review.

Version history

Published

Title

Stage

Authors

Version

2017 Mar 06

Pharmacological interventions for recurrent abdominal pain in childhood

Review

Alice E Martin, Tamsin V Newlove‐Delgado, Rebecca A Abbott, Alison Bethel, Joanna Thompson‐Coon, Rebecca Whear, Stuart Logan

https://doi.org/10.1002/14651858.CD010973.pub2

2014 Feb 14

Pharmacological interventions for recurrent abdominal pain in childhood

Protocol

Alice E Martin, Tamsin V Newlove‐Delgado, Rebecca A Abbott, Alison Bethel, Joanna Thompson‐Coon, Vasilis Nikolaou, Stuart Logan

https://doi.org/10.1002/14651858.CD010973

Differences between protocol and review

The differences between the protocol and the review are detailed in the Additional Methods Table in Appendix 2.

Rebecca Whear joined the team following the publication of the protocol.

Notes

This is a new review, which supersedes a previously published review (Huertas‐Ceballos 2008a).

Keywords

MeSH

Medical Subject Headings Check Words

Adolescent; Child; Child, Preschool; Humans;

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

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

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

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figures and Tables -
Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Summary of findings for the main comparison. Antispasmodics compared to placebo for recurrent abdominal pain

Antispasmodics compared to placebo for recurrent abdominal pain

Patient or population: school‐aged children (5 to 18 years of age) with recurrent abdominal pain

Settings: hospital paediatric outpatient clinics

Intervention: antispasmodic drugs

Comparison: placebo

Outcomes

Illustrative comparative risks* (SD)

Relative effect (95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Placebo

Intervention

Pain duration (mean pain duration, assessed at 4 weeks)

The mean duration of pain in the control group was 6.17 (± 11.61).

The mean duration of pain in the intervention group was51.6 (± 23.74).

MD ‐25.4 (‐35.5 to ‐15.3)

120 (1)

⊕⊝⊝⊝
Very low1

Asgarshirazi 2015

No evidence of efficacy

Pain improvement (clinician judged, assessed at 2 weeks)

9 of 21 children in the control group had an improvement in pain.

15 of 21 children in the intervention group had an improvement in pain.

OR 3.33 (0.93 to 12.01)

42 (1)

⊕⊝⊝⊝
Very low2

Kline 2001

No evidence of efficacy

Pain frequency (episodes of pain in 4 weeks, assessed after 4 weeks)

The mean number of episodes of pain in the control group was 21.6 (32.4).

The mean number of episodes of pain in the intervention group was10.3 (14).

MD 11.3 (2.4 to 20.1)

132 (1)

⊕⊝⊝⊝
Very low3

Narang 2015

No evidence of efficacy

Pain improvement (self reported response to treatment, assessed at 4 weeks)

The response to treatment in the control group was 30.3%.

The response to treatment in the intervention group was 40.6%.

OR 1.6 (0.7 to 3.4)

115 (1)

⊕⊕⊝⊝
Low4

Pourmoghaddas 2014

No evidence of efficacy

*The basis for the assumed risk (e.g., the median control group risk across studies) is provided in footnotes. The corresponding risk is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; MD: mean difference; OR: odds ratio; SD: standard deviation

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Downgraded for low methodological quality due to single, small study; risk of bias from incomplete outcome data and differential loss of participants between groups. The placebo differed in preparation and dose timing compared to the intervention drug.
2Downgraded for low methodological quality due to single, small study; risk of bias from selective outcome reporting and short follow‐up.
3Downgraded for low methodological quality due to single, small study; risk of bias from selective outcome reporting and the method of altering the drug doses.
4Downgraded for single, small study. Not duplicated.

Figures and Tables -
Summary of findings for the main comparison. Antispasmodics compared to placebo for recurrent abdominal pain
Table 1. Assessment of risk of bias in included studies

Domain

'Risk of bias' judgement

Low

High

Unclear

Selection bias 

Random sequence generation

If the study details any of the following methods: (1) simple randomisation (such as coin‐tossing, throwing dice, or dealing previously shuffled cards, a list of random numbers, or computer‐generated random numbers); or (2) restricted randomisation such as blocked, ideally with varying block sizes or stratified groups, provided that within‐group randomisation is not affected

If the study details no randomisation or an inadequate method such as alternation, assignment based on date of birth, case record number, and date of presentation. These latter methods may be referred to as ‘quasi‐random’.

If there is insufficient detail to judge the risk of bias

 

Allocation concealment

If the study details concealed allocation sequence in sufficient detail to determine that allocations could not have been foreseen in advance of, or during, enrolment

If the study details a method where the allocation is known prior to assignment

If there is insufficient detail to judge the risk of bias

Performance bias 

Blinding of participants and personnel

If the study details a method of blinding participants and personnel. Detail would need to be sufficient to show that participants and personnel were unable to identify the therapeutic intervention from the control intervention. 

If the methods detail that the participants or study personnel were not blinded to the study medication or placebo

If there is insufficient detail to judge the risk of bias

Detection bias 

Blinding of outcome assessment

If the study details a blinded outcome assessment. This may only be possible for outcomes that are externally assessed.

If the outcome assessment is not blinded. We expect this may be unavoidable for self rated outcomes of unblinded interventions.

If there is insufficient detail to judge the risk of bias

 

Attrition bias

Incomplete outcome data

If the study reports attrition and exclusions, including the numbers in each intervention group (compared with total randomised participants), reasons for attrition or exclusions, and any re‐inclusions; the impact of missing data is not believed to have altered the conclusions; and reasons for the missing data are acceptable

We may judge the risk of attrition bias to be high due to the amount, nature, or handling (such as per‐protocol analysis) of incomplete outcome data.

If there is insufficient detail to judge the risk of bias, e.g. if the number of children randomised to each treatment is not reported

Reporting bias

Selective reporting

If there is complete reporting of all outcome data. This will be determined based on comparison of the protocol and published study, if available.

If the reporting is selective so that some outcome data are not reported

If there is insufficient detail to judge the risk of bias, e.g. protocols are unavailable

Other sources of bias

Other bias

If the study is judged to be at low of risk of other potential sources of bias, such as no differential loss to follow‐up or an adequate washout period in cross‐over trials

If there are other sources of bias, such as differential loss to follow‐up or an inadequate washout period in cross‐over trials

If there is insufficient detail to judge the risk of bias

Figures and Tables -
Table 1. Assessment of risk of bias in included studies