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Meta-Analysis
. 2014 Jun 10;2014(6):CD001918.
doi: 10.1002/14651858.CD001918.pub3.

Dietary interventions (plant sterols, stanols, omega-3 fatty acids, soy protein and dietary fibers) for familial hypercholesterolaemia

Affiliations
Meta-Analysis

Dietary interventions (plant sterols, stanols, omega-3 fatty acids, soy protein and dietary fibers) for familial hypercholesterolaemia

Anita Malhotra et al. Cochrane Database Syst Rev. .

Abstract

Background: A cholesterol-lowering diet and several other dietary interventions have been suggested as a management approach either independently or as an adjuvant to drug therapy in children and adults with familial hypercholesterolaemia (FH). However, a consensus has yet to be reached on the most appropriate dietary treatment. Plant sterols are commonly used in FH although patients may know them by other names like phytosterols or stanols.

Objectives: To examine whether a cholesterol-lowering diet is more effective in reducing ischaemic heart disease and lowering cholesterol than no dietary intervention in children and adults with familial hypercholesterolaemia. Further, to compare the efficacy of supplementing a cholesterol-lowering diet with either omega-3 fatty acids, soya proteins, plant sterols or plant stanols.

Search methods: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Inborn Errors of Metabolism Trials Register, which is compiled from electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL) (updated with each new issue of The Cochrane Library), quarterly searches of MEDLINE and the prospective handsearching of one journal - Journal of Inherited Metabolic Disease. Most recent search of the Group's Inborn Errors of Metabolism Trials Register: 22 August 2013. We also searched PubMed to 05 February 2012.

Selection criteria: Randomised controlled trials, both published and unpublished, where a cholesterol-lowering diet in children and adults with familial hypercholesterolaemia has been compared to other forms of dietary treatment or to no dietary intervention were included.

Data collection and analysis: Two authors independently assessed the trial eligibility and risk of bias and one extracted the data, with independent verification of data extraction by a colleague.

Main results: In the 2014 update of the review, 15 trials have been included, with a total of 453 participants across seven comparison groups. The included trials had either a low or unclear risk of bias for most of the parameters used for risk assessment. Only short-term outcomes could be assessed due to the short duration of follow up in the included trials. None of the primary outcomes, (incidence of ischaemic heart disease, number of deaths and age at death) were evaluated in any of the included trials. No significant differences were noted for the majority of secondary outcomes for any of the planned comparisons. However, a significant difference was found for the following comparisons and outcomes: for the comparison between plant sterols and cholesterol-lowering diet (in favour of plant sterols), total cholesterol levels, mean difference 0.30 mmol/l (95% confidence interval 0.12 to 0.48); decreased serum LDL cholesterol, mean difference -0.60 mmol/l (95% CI -0.89 to -0.31). Fasting serum HDL cholesterol levels were elevated, mean difference -0.04 mmol/l (95% CI -0.11 to 0.03) and serum triglyceride concentration was reduced, mean difference -0.03 mmol/l (95% CI -0.15 to -0.09), although these changes were not statistically significant. Similarly, guar gum when given as an add on therapy to bezafibrate reduced total cholesterol and LDL levels as compared to bezafibrate alone.

Authors' conclusions: No conclusions can be made about the effectiveness of a cholesterol-lowering diet, or any of the other dietary interventions suggested for familial hypercholesterolaemia, for the primary outcomes: evidence and incidence of ischaemic heart disease, number of deaths and age at death,due to the lack of data on these. Large, parallel, randomised controlled trials are needed to investigate the effectiveness of a cholesterol-lowering diet and the addition of omega-3 fatty acids, plant sterols or stanols, soya protein, dietary fibers to a cholesterol-lowering diet.

PubMed Disclaimer

Conflict of interest statement

None declared.

Figures

1
1
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
1.1
1.1. Analysis
Comparison 1 Cholesterol‐lowering diet compared to no dietary intervention or nutritional advice, Outcome 1 Fasting serum total cholesterol concentration (mmol/l).
1.2
1.2. Analysis
Comparison 1 Cholesterol‐lowering diet compared to no dietary intervention or nutritional advice, Outcome 2 Fasting serum LDL cholesterol concentration (mmol/l).
1.3
1.3. Analysis
Comparison 1 Cholesterol‐lowering diet compared to no dietary intervention or nutritional advice, Outcome 3 Fasting serum HDL cholesterol concentration (mmol/l).
1.4
1.4. Analysis
Comparison 1 Cholesterol‐lowering diet compared to no dietary intervention or nutritional advice, Outcome 4 Fasting serum triglyceride concentration (mmol/l).
1.5
1.5. Analysis
Comparison 1 Cholesterol‐lowering diet compared to no dietary intervention or nutritional advice, Outcome 5 Fasting serum apolipoprotein A1 concentration (g/l).
1.6
1.6. Analysis
Comparison 1 Cholesterol‐lowering diet compared to no dietary intervention or nutritional advice, Outcome 6 Fasting serum apolipoprotein B‐100 concentration (g/l).
2.1
2.1. Analysis
Comparison 2 ω‐fatty acids added to background cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 1 Fasting serum total cholesterol concentration (mmol/l).
2.2
2.2. Analysis
Comparison 2 ω‐fatty acids added to background cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 2 Fasting serum LDL cholesterol concentration (mmol/l).
2.3
2.3. Analysis
Comparison 2 ω‐fatty acids added to background cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 3 Fasting serum HDL cholesterol concentration (mmol/l).
2.4
2.4. Analysis
Comparison 2 ω‐fatty acids added to background cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 4 Fasting serum triglyceride concentration (mmol/l).
2.5
2.5. Analysis
Comparison 2 ω‐fatty acids added to background cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 5 Fasting serum apolipoprotein A1 concentration (g/l).
2.6
2.6. Analysis
Comparison 2 ω‐fatty acids added to background cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 6 Fasting serum apolipoprotein B‐100 concentration (g/l).
3.1
3.1. Analysis
Comparison 3 Plant stanols added to cholesterol‐lowering diet compared to cholesterol‐lowering diet alone, Outcome 1 Fasting serum total cholesterol concentration (mmol/l).
3.2
3.2. Analysis
Comparison 3 Plant stanols added to cholesterol‐lowering diet compared to cholesterol‐lowering diet alone, Outcome 2 Fasting serum LDL cholesterol concentration (mmol/l).
3.3
3.3. Analysis
Comparison 3 Plant stanols added to cholesterol‐lowering diet compared to cholesterol‐lowering diet alone, Outcome 3 Fasting serum HDL cholesterol concentration (mmol/l).
3.4
3.4. Analysis
Comparison 3 Plant stanols added to cholesterol‐lowering diet compared to cholesterol‐lowering diet alone, Outcome 4 Fasting serum triglyceride concentration (mmol/l).
4.1
4.1. Analysis
Comparison 4 Plant sterols added to cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 1 Fasting serum total cholesterol concentration(mmol/l).
4.2
4.2. Analysis
Comparison 4 Plant sterols added to cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 2 Fasting serum LDL cholesterol concentration (mmol/l).
4.3
4.3. Analysis
Comparison 4 Plant sterols added to cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 3 Fasting serum HDL cholesterol concentration (mmol/l).
4.4
4.4. Analysis
Comparison 4 Plant sterols added to cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 4 Fasting serum triglyceride concentration (mmol/l).
4.5
4.5. Analysis
Comparison 4 Plant sterols added to cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 5 Fasting serum apolipoprotein A1concentration (g/l).
4.6
4.6. Analysis
Comparison 4 Plant sterols added to cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 6 Fasting serum apolipoprotein B‐100 concentratiom (g/l).
5.1
5.1. Analysis
Comparison 5 Soy protein in addition to cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 1 Fasting serum total cholesterol concentration (mmol/l).
5.2
5.2. Analysis
Comparison 5 Soy protein in addition to cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 2 Fasting serum LDL cholesterol concentration (mmol/l).
5.3
5.3. Analysis
Comparison 5 Soy protein in addition to cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 3 Fasting serum HDL cholesterol concentration (mmol/l).
5.4
5.4. Analysis
Comparison 5 Soy protein in addition to cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 4 Fasting serum triglyceride concentration (mmol/l).
5.5
5.5. Analysis
Comparison 5 Soy protein in addition to cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 5 Fasting serum apolipoprotein A1 concentration (g/l).
5.6
5.6. Analysis
Comparison 5 Soy protein in addition to cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 6 Fasting serum apolipoprotein B‐100 concentration (g/l).
5.7
5.7. Analysis
Comparison 5 Soy protein in addition to cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 7 Weight (kg).
5.8
5.8. Analysis
Comparison 5 Soy protein in addition to cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 8 Height (cm).
5.9
5.9. Analysis
Comparison 5 Soy protein in addition to cholesterol‐lowering diet compared to cholesterol‐lowering diet, Outcome 9 Body mass index.
6.1
6.1. Analysis
Comparison 6 Dietary fibers as a form of dietary intervention compared to another form of dietary intervention or drug or no treatment, Outcome 1 Fasting serum total cholesterol concentration (mmol/l).
6.2
6.2. Analysis
Comparison 6 Dietary fibers as a form of dietary intervention compared to another form of dietary intervention or drug or no treatment, Outcome 2 Fasting serum LDL cholesterol concentration (mmol/l).
6.3
6.3. Analysis
Comparison 6 Dietary fibers as a form of dietary intervention compared to another form of dietary intervention or drug or no treatment, Outcome 3 Fasting serum HDL cholesterol concentration (mmol/l).
6.4
6.4. Analysis
Comparison 6 Dietary fibers as a form of dietary intervention compared to another form of dietary intervention or drug or no treatment, Outcome 4 Fasting serum triglyceride concentration (mmol/l).
6.5
6.5. Analysis
Comparison 6 Dietary fibers as a form of dietary intervention compared to another form of dietary intervention or drug or no treatment, Outcome 5 Fasting serum apolipoprotein A1 concentration (g/l).
6.6
6.6. Analysis
Comparison 6 Dietary fibers as a form of dietary intervention compared to another form of dietary intervention or drug or no treatment, Outcome 6 Fasting serum apolipoprotein B‐100 concentration (g/l).
6.7
6.7. Analysis
Comparison 6 Dietary fibers as a form of dietary intervention compared to another form of dietary intervention or drug or no treatment, Outcome 7 Weight.

Update of

References

References to studies included in this review

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Carmen‐Ramon 1998 {published data only}
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Carroll 1975 {published data only}
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Carroll 1978 {published data only}
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Childs 1981 {published data only}
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Colquhoun 1992 {published data only}
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Dattilo 1992 {published data only}
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Davidson 1991 {published data only}
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de Groot 1963 {published data only}
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Demke 1991 {published data only}
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Durrington 1977 {published data only}
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Dyerberg 1978 {published data only}
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Ehnholm 1982 {published data only}
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Ehnholm 1984 {published data only}
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Erickson 1964 {published data only}
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Falko 1980 {published data only}
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Farquhar 1956 {published data only}
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Fernandes 1977 {published data only}
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Fernandes 1981 {published data only}
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Ferro‐Luzzi 1984 {published data only}
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Fisher 1983 {published data only}
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Flaim 1981 {published data only}
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Flynn 1981 {published data only}
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Forsythe 1986 {published data only}
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Frank 1978 {published data only}
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Glueck 1978 {published data only}
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Glueck 1979 {published data only}
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Glueck 1983 {published data only}
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Goldberg 1982 {published data only}
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Gustafsson 1982 {published data only}
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Gustafsson 1983 {published data only}
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Hoeg 1984 {published data only}
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Kudchodkar 1976 {published data only}
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Kuo 1979 {published data only}
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Kuo 1981 {published data only}
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Lovati 1987 {published data only}
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LRCP 1984a {published data only}
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Miettinen 1989b {published data only}
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Saynor 1984b {published data only}
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Schaefer 1981 {published data only}
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Shorey 1981 {published data only}
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Simons 1985a {published data only}
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Simons 1985b {published data only}
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Singer 1983 {published data only}
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Singer 1984 {published data only}
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Singer 1986 {published data only}
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Sirtori 1977 {published data only}
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Sirtori 1979 {published data only}
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Sirtori 1981 {published data only}
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Sirtori 1986 {published data only}
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Sirtori 1992 {published data only}
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Sperling 1987 {published data only}
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Stein 1975 {published data only}
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Stein 1982 {published data only}
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Stephens 1996 {published data only}
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Szczeklik 1985 {published data only}
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Thorngren 1981 {published data only}
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Thorngren 1984 {published data only}
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Thorngren 1986 {published data only}
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Tonstad 1997b {published data only}
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Uusitupa 1991 {published data only}
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Vessby 1980a {published data only}
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Vessby 1980b {published data only}
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Vessby 1982 {published data only}
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References to studies awaiting assessment

Fuentes 2008 {published data only}
    1. Fuentes F, Lopez‐Miranda J, Garcia A, Perez‐Martinez P, Moreno J, Cofan M, et al. Basal plasma concentrations of plant sterols can predict LDL‐C response to sitosterol in patients with familial hypercholesterolemia. European Journal of Clinical Nutrition 2008;62(4):495‐501. - PubMed
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References to ongoing studies

Párraga ongoing {published data only}
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