Administración de suplementos de folato en pacientes con anemia de células falciformes
Información
- DOI:
- https://doi.org/10.1002/14651858.CD011130.pub3Copiar DOI
- Base de datos:
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- Cochrane Database of Systematic Reviews
- Versión publicada:
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- 16 marzo 2018see what's new
- Tipo:
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- Intervention
- Etapa:
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- Review
- Grupo Editorial Cochrane:
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Grupo Cochrane de Fibrosis quística y enfermedades genéticas
- Copyright:
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- Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cifras del artículo
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Autores
Contributions of authors
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Conceiving the review: Cochrane Cystic Fibrosis & Genetic Disorders Review Group.
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Literature search for background: RD, SN, SSM, PS, LV.
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Writing the background, objectives and inclusion criteria sections: HH, RD, PS, LV.
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Writing data collection and analysis sections: RD, AL A, SN, LV, PS.
Sources of support
Internal sources
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No sources of support supplied
External sources
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The National Institute for Health Research (NIHR), UK
United Kingdom Cochrane Centre
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WHO/Cochrane/ Cornell University Summer Institute for Systematic Reviews in Nutrition for Global Policy Making, USA
The review was partially developed during the World Health Organization (WHO)/Cochrane/ Cornell University Summer Institute for Systematic Reviews in Nutrition for Global Policy Making hosted by the Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA, 27 July to 7 August, 2015. WHO partially supported this programme through Cornell University Conferences Services.
Declarations of interest
Ruchita Dixit: none known.
Sowmya Nettem: none known.
Simerjit S Madan: none known.
Htoo Htoo Kyaw Soe: none known
Adinegara BL Abas: none known
Leah Vance: has undertaken a research year that allowed for her participation in this review was supported by Grant 2014086 from the Doris Duke Charitable Foundation. She has no other conflicts to disclose.
Patrick Stover: none known.
Acknowledgements
We would like to thank: Tracey Remmington, Managing Editor, Cochrane Cystic Fibrosis & Genetic Disorders Review Group for managing the editorial process for the protocol and reviews; Natalie Hall, Information Specialist of the Cochrane Cystic Fibrosis & Genetic Disorders Review Group, for comments on the search strategy; and the editors of the Cochrane Cystic Fibrosis & Genetic Disorders Review Group for their comments on the protocol and full reviews. We are very grateful to Professor Datuk Dr Abdul Razzak Chief Executive of Melaka‐Manipal Medical College, Malaysia and Professor Dr Jaspal Singh, Dean, Faculty of Medicine, Melaka‐Manipal Medical College, Malaysia for their support, constructive comments and encouragement in writing the protocol and review.
The review was partially developed during the World Health Organization (WHO)/Cochrane/ Cornell University Summer Institute for Systematic Reviews in Nutrition for Global Policy Making hosted by the Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA, 27 July ‐ 7 August, 2015. WHO partially supported this programme through Cornell University Conferences Services.
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 also like to thank the referees for their peer review comments on the protocol and review.
Version history
| Published | Title | Stage | Authors | Version |
| 2018 Mar 16 | Folate supplementation in people with sickle cell disease | Review | Ruchita Dixit, Sowmya Nettem, Simerjit S Madan, Htoo Htoo Kyaw Soe, Adinegara BL Abas, Leah D Vance, Patrick J Stover | |
| 2016 Feb 16 | Folate supplementation in people with sickle cell disease | Review | Ruchita Dixit, Sowmya Nettem, Simerjit S Madan, Htoo Htoo Kyaw Soe, Adinegara BL Abas, Leah D Vance, Patrick J Stover | |
| 2014 May 25 | Folate supplementation in patients with sickle cell disease | Protocol | Ruchita Dixit, Sowmya Nettem, Simerjit S Madan, Htoo Htoo Kyaw Soe, Adinegara BL Abas | |
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
Medical Subject Headings Check Words
Child, Preschool; Humans; Infant;
PICO
Study flow diagram
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Comparison 1: Folic acid supplementation versus placebo, Outcome 1: Acute splenic sequestration
Comparison 1: Folic acid supplementation versus placebo, Outcome 2: Painful episodes
Comparison 1: Folic acid supplementation versus placebo, Outcome 3: Minor Infections
Comparison 1: Folic acid supplementation versus placebo, Outcome 4: Major Infection
Comparison 1: Folic acid supplementation versus placebo, Outcome 5: Dactylitis
| Folic acid compared with calcium lactate for sickle cell (SS) disease | ||||||
| Patient or population: 117 children with homozygous sickle cell (SS) disease Settings: hospital Intervention: folic acid 5 mg Comparison: calcium lactate (placebo) | ||||||
| Outcomes1 | Illustrative comparative risks* (95% CI) | Relative effect | No of Participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| calcium lactate (placebo) | folic acid 5 mg | |||||
| Folate concentration Serum folate levels, measured between 6 and 12 months after entry to the study | 1. values in excess of 18 pg/L occurring in 6/39 (15%) children in the placebo group. 2. levels below 5 pg/L occurring in 15/39 (39%) | 1. values in excess of 18 pg/L occurring in 33/41 (81 %) in 2. levels below 5 pg/L None in the folic acid group. | NA | 80/115 (70%) (1 study) | ⊕⊕⊝⊝ low2 | There were marked differences between trial groups in the distribution of serum folate levels. |
| Haemoglobin concentration Haematological analyses were performed in the 100/115 (87%) children in whom baseline (within 2 months of entry to study) and 1 year (between 10 and 14 months after entry) | See comment | See comment | NA | 100/115 (87%) (1 study) | ⊕⊕⊝⊝ low2 | There were no significant differences in total haemoglobin (Hb) either at baseline or after 1 year. |
| Adverse events ‐ acute splenic sequestration Clinical events experienced by children during the 1 year period commencing at entry to the trial | 8/56 Total episodes 15 | 9/59 Total episodes 12 | RR 1.07 (95% CI 0.44 to 2.57) | 115 (1 study) | ⊕⊕⊝⊝ low2 | There were no significant differences in these measures of growth between the folic acid and placebo groups. |
| Adverse events ‐ painful episodes Clinical events experienced by children during the 1 year period commencing at entry to the trial | 18/56 Total episodes 27 | 22/59 Total episodes 39 | RR 1.16 (95% CI 0.70 to 1.92) | 115 (1 study) | ⊕⊕⊝⊝ low2 | There were no significant differences in painful episodes |
| Adverse events ‐ minor Infections Clinical events experienced by children during the 1 year period commencing at entry to the trial | 48 out of 56 children Total episodes/child: 2.3 | 50 out of 59 children Total episodes/child: 2.7 | RR 0.99 (95% CI 0.85 to 1.15) | 115 (1 study) | ⊕⊕⊝⊝ low2 | There were no differences in minor infections |
| Adverse events ‐ major infections Clinical events experienced by children during the 1 year period commencing at entry to the trial | 15 out of 56 children Total episodes/child: 19 | 14 out of 59 children Total episodes/child: 18 | RR 0.89 (95% CI 0.47 to 1.66) | 115 (1 study) | ⊕⊕⊝⊝ low2 | There were no differences in major infections |
| Adverse events ‐ dactylitis Clinical events experienced by children during the 1 year period commencing at entry to the trial | 17 out of 56 children Total episodes: 32 | 12 out of 59 children Total episodes:15 | RR 0.67 (95% CI 0.37 to 1.27) | 115 (1 study) | ⊕⊕⊝⊝ low2 | There were no differences in dactylitis events |
| *The basis for the assumed risk is the risk in the control group. The corresponding risk (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). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1. Pre‐specified adverse events of 'Increased incidence of priapism' and 'The risk of masking cobalamin deficiency with consequent neuropsychiatric manifestations (nanogram per litre (ng/L))' were not assessed in the included trial (Rabb 1983). In the included trial, there was no difference between the folic acid and placebo groups for growth, determined by height‐for‐age and weight‐for‐age as well as height and growth velocity. 2. Reason for downgrading evidence to low ‐ very serious risk of bias (two domains of high risk of bias). | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Acute splenic sequestration Show forest plot | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 1.2 Painful episodes Show forest plot | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 1.3 Minor Infections Show forest plot | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 1.4 Major Infection Show forest plot | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 1.5 Dactylitis Show forest plot | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
