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Cochrane Database of Systematic Reviews

Intervenciones para la hemocromatosis hereditaria

Información

DOI:
https://doi.org/10.1002/14651858.CD011647.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 08 marzo 2017see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:

  1. Grupo Cochrane de Hepatobiliar

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

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Autores

  • Elena Buzzetti

    Sheila Sherlock Liver Centre, Royal Free Hospital and the UCL Institute of Liver and Digestive Health, London, UK

  • Maria Kalafateli

    Sheila Sherlock Liver Centre, Royal Free Hospital and the UCL Institute of Liver and Digestive Health, London, UK

  • Douglas Thorburn

    Sheila Sherlock Liver Centre, Royal Free Hospital and the UCL Institute of Liver and Digestive Health, London, UK

  • Brian R Davidson

    Department of Surgery, Royal Free Campus, UCL Medical School, London, UK

  • Emmanuel Tsochatzis

    Sheila Sherlock Liver Centre, Royal Free Hospital and the UCL Institute of Liver and Digestive Health, London, UK

  • Kurinchi Selvan Gurusamy

    Correspondencia a: Department of Surgery, Royal Free Campus, UCL Medical School, London, UK

    [email protected]

Contributions of authors

EB and MK extracted data and provided them in a format that could be analysed.
KG wrote the review.
ET, DT, and BD critically commented on the review.
All review authors approved this version before publication.

Sources of support

Internal sources

  • University College London, UK.

External sources

  • National Institute for Health Research, UK.

    This project was supported by the National Institute for Health Research (NIHR), via Cochrane Infrastructure, Cochrane Programme Grant, or Cochrane Incentive funding to the Cochrane Hepato‐Biliary and Upper Gastrointestinal and Pancreatic Diseases Groups. The views and opinions expressed therein are those of the review authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, the National Health Service, or the Department of Health. The funding covered salary, equipment, and other resources to complete this review.

  • Elena Buzzetti, Italy.

    Dr Elena Buzzetti was supported by an educational grant from AIGO (Associazione Italiana Gastroenterologi Ospedalieri) and M.I.M.I (Montecatini Interactive Medicine International).

Declarations of interest

This report is independent research funded by the National Institute for Health Research (NIHR Cochrane Programme Grants, 13/89/03 ‐ Evidence‐based diagnosis and management of upper digestive, hepato‐biliary, and pancreatic disorders). The views expressed in this publication are those of the review authors and not necessarily those of the National Health Service (NHS), the NIHR, or the Department of Health.

EB: has no financial disclosures.
MK: has no financial disclosures.
DT: funded by Astellas for his attendance at the International Liver Transplantation Society meeting in 2014; received GBP 25,000 from Boston Scientific to fund a clinical research fellow in 2013.
BD: has no financial disclosures.
ET: has no financial disclosures.
KG: has no financial disclosures.

Acknowledgements

We thank the Cochrane Comparing of Multiple Interventions Methods Group and the Cochrane Hepato‐Biliary Group for their support and advice. We also thank the copy editors who improved the clarity of the review.

Peer reviewers of the review: Barbara de Graaff, Australia; Dario Conte, Italy; Ronald Koretz, USA; Theis Lange, Denmark.

Contact editor: Janus Christian Jakobsen, Denmark.
Sign‐off editor: Christian Gluud, Denmark.

Cochrane Review Group funding acknowledgement: the Danish State is the largest single funder of The Cochrane Hepato‐Biliary Group through its investment in The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Denmark.

Disclaimer: the views and opinions expressed in this review are those of the review authors and do not necessarily reflect those of the Danish State or The Copenhagen Trial Unit.

Version history

Published

Title

Stage

Authors

Version

2017 Mar 08

Interventions for hereditary haemochromatosis

Review

Elena Buzzetti, Maria Kalafateli, Douglas Thorburn, Brian R Davidson, Emmanuel Tsochatzis, Kurinchi Selvan Gurusamy

https://doi.org/10.1002/14651858.CD011647.pub2

2015 Apr 14

Treatments for hereditary haemochromatosis: a network meta‐analysis

Protocol

Kurinchi Selvan Gurusamy, Emmanuel Tsochatzis, Douglas Thorburn, Brian R Davidson

https://doi.org/10.1002/14651858.CD011647

Differences between protocol and review

  • There was only one comparison. So we did not perform the network meta‐analysis, and assessed the comparative benefits and harms of different interventions using standard Cochrane methodology. The methodology that we plan to use if we conduct a network meta‐analysis in future is available in Appendix 1.

  • We performed Trial Sequential Analysis in addition to conventional method of assessing the risk of random errors using P‐value.

Notes

There was considerable overlap between the 'Methods' of this review and those of several other reviews written by the same group of authors.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Adult; Humans; Middle Aged;

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.
Figuras y tablas -
Figure 1

Study flow diagram.

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

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

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

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

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Trial Sequential Analysis of adverse events (proportion) performed using an alpha error of 2.5%, power of 90% (beta error of 10%), relative risk reduction of 20%, control group proportion (Pc) observed in trials (21.6% for proportion of people with adverse events), and observed diversity (0%) shows that the accrued sample size was only a small fraction of the diversity‐adjusted required information size (DARIS) that the boundaries could not be drawn. The Z‐curve (blue line) does not cross the conventional boundaries (dotted green line). There was a high risk of random errors.
Figuras y tablas -
Figure 4

Trial Sequential Analysis of adverse events (proportion) performed using an alpha error of 2.5%, power of 90% (beta error of 10%), relative risk reduction of 20%, control group proportion (Pc) observed in trials (21.6% for proportion of people with adverse events), and observed diversity (0%) shows that the accrued sample size was only a small fraction of the diversity‐adjusted required information size (DARIS) that the boundaries could not be drawn. The Z‐curve (blue line) does not cross the conventional boundaries (dotted green line). There was a high risk of random errors.

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Comparison 1 Therapeutic erythrocytapheresis versus phlebotomy, Outcome 1 Adverse events (proportion).
Figuras y tablas -
Analysis 1.1

Comparison 1 Therapeutic erythrocytapheresis versus phlebotomy, Outcome 1 Adverse events (proportion).

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Comparison 1 Therapeutic erythrocytapheresis versus phlebotomy, Outcome 2 Adverse events (number).
Figuras y tablas -
Analysis 1.2

Comparison 1 Therapeutic erythrocytapheresis versus phlebotomy, Outcome 2 Adverse events (number).

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Comparison 1 Therapeutic erythrocytapheresis versus phlebotomy, Outcome 3 Health‐related quality of life (EQ‐VAS).
Figuras y tablas -
Analysis 1.3

Comparison 1 Therapeutic erythrocytapheresis versus phlebotomy, Outcome 3 Health‐related quality of life (EQ‐VAS).

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Summary of findings for the main comparison. Erythrocytapheresis versus phlebotomy for hereditary haemochromatosis

Erythrocytapheresis versus phlebotomy for hereditary haemochromatosis

Patient or population: people with hereditary haemochromatosis
Settings: secondary or tertiary
Intervention: erythrocytapheresis
Comparison: phlebotomy

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Assumed risk

Corresponding risk

Phlebotomy

Therapeutic erythrocytapheresis

Long‐term mortality

None of the included trials reported mortality beyond 1 year.

Mortality

Follow‐up period: 8 months

There was no mortality in either group in the short‐term in the 1 trial that reported this information.

38
(1 study)

⊕⊝⊝⊝
Very low1,2

Serious adverse events

Follow‐up period: 8 months

There were no serious adverse events in either group in the 1 trial that reported this information.

38
(1 study)

⊕⊝⊝⊝
Very low1,2

Health‐related quality of life
EQ‐VAS. Scale from: 0 to 100.

Follow‐up period: 8 months

The mean health‐related quality of life in the control groups was
68

The mean health‐related quality of life in the intervention groups was
1 higher
(10.8 lower to 12.8 higher)

‐

38
(1 study)

⊕⊝⊝⊝
Very low1,2

Health‐related quality of life beyond one year

None of the included trials reported health‐related quality of life beyond one year

*The basis for the assumed risk is the mean control group proportion or control event rate. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval.

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.

1 Downgraded one level for risk of bias.
2 Downgraded two levels for imprecision (one level for small sample size and one level for wide confidence intervals).

Figuras y tablas -
Summary of findings for the main comparison. Erythrocytapheresis versus phlebotomy for hereditary haemochromatosis
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Comparison 1. Therapeutic erythrocytapheresis versus phlebotomy

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Adverse events (proportion) Show forest plot

2

100

Odds Ratio (M‐H, Fixed, 95% CI)

0.93 [0.36, 2.43]

2 Adverse events (number) Show forest plot

1

Rate Ratio (Fixed, 95% CI)

Totals not selected

3 Health‐related quality of life (EQ‐VAS) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 1. Therapeutic erythrocytapheresis versus phlebotomy
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