Lack of benefit of dietary advice to men with angina: results of a controlled trial
Abstract
Objective To see whether mortality among men with angina can be reduced by dietary advice.Design A randomized controlled factorial trial.Setting Male patients of general practitioners in south Wales.Subjects A total of 3114 men under 70 y of age with angina.Interventions Subjects were randomly allocated to four groups: (1) advised to eat two portions of oily fish each week, or to take three fish oil capsules daily; (2) advised to eat more fruit, vegetables and oats; (3) given both the above types of advice; and (4) given no specific dietary advice. Mortality was ascertained after 3-9 y.Results Compliance was better with the fish advice than with the fruit advice. All-cause mortality was not reduced by either form of advice, and no other effects were attributable to fruit advice. Risk of cardiac death was higher among subjects advised to take oily fish than among those not so advised; the adjusted hazard ratio was 1.26 (95% confidence interval 1.00, 1.58; P=0.047), and even greater for sudden cardiac death (1.54; 95% CI 1.06, 2.23; P=0.025). The excess risk was largely located among the subgroup given fish oil capsules. There was no evidence that it was due to interactions with medication.Conclusions Advice to eat more fruit was poorly complied with and had no detectable effect on mortality. Men advised to eat oily fish, and particularly those supplied with fish oil capsules, had a higher risk of cardiac death. This result is unexplained; it may arise from risk compensation or some other effect on patients' or doctors' behaviour.
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There are conflicting data on whether PUFA affects sudden cardiac death.
“There are also some opposite data on the possible effect of polyunsaturated omega-3 fatty acids (PUFA) on sudden cardiac death (138,139).”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [138]
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InfluentialFruits, vegetables and coronary heart disease
Dauchet, L., Amouyel, P., & Dallongeville, J. (2009) · Nature Reviews Cardiology · doi:10.1038/nrcardio.2009.131 · Cited by 262 · see citing works
Omega 3 fatty acids for prevention and treatment of cardiovascular disease
Hooper, L., Harrison, R. A., Summerbell, C. D., Moore, H., Worthington, H. V., Ness, A., Capps, N., Davey Smith, G., Riemersma, R., & Ebrahim, S. (2004) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003177.pub2 · Cited by 264 · see citing works
Alexander, D. D., Miller, P. E., Elswyk, M. E. V., Kuratko, C. N., & Bylsma, L. C. (2017) · Mayo Clinic Proceedings · doi:10.1016/j.mayocp.2016.10.018 · Cited by 255 · see citing works
Omega-3 Fatty Acids for Cardioprotection
Lee, J. H., O’Keefe, J. H., Lavie, C. J., Marchioli, R., & Harris, W. S. (2008) · Mayo Clinic Proceedings · doi:10.4065/83.3.324 · Cited by 249 · see citing works
Omega-3 fatty acid supplementation and cardiovascular disease
Jump, D. Β., Depner, C. M., & Tripathy, S. (2012) · Journal of Lipid Research · doi:10.1194/jlr.r027904 · Cited by 243 · see citing works
Omega-3 fatty acids: cardiovascular benefits, sources and sustainability
Lee, J. H., O’Keefe, J. H., Lavie, C. J., & Harris, W. S. (2009) · Nature Reviews Cardiology · doi:10.1038/nrcardio.2009.188 · Cited by 227 · see citing works
Nutraceuticals and Atherosclerosis: Human Trials
Badimón, L., Vilahur, G., & Padró, T. (2010) · Cardiovascular Therapeutics · doi:10.1111/j.1755-5922.2010.00189.x · Cited by 223 · see citing works
“[34] based on a trial of 3114 men with angina, suggested that patients treated with fish oil capsules had a higher risk of sudden cardiac death than untreated control subjects [34].”
BackgroundFish oil and omega-3 fatty acids in cardiovascular disease: do they really work?
Kromhout, D., Yasuda, S., Geleijnse, J. M., & Shimokawa, H. (2011) · European Heart Journal · doi:10.1093/eurheartj/ehr362 · Cited by 222 · see citing works
“In a trial of patients with stable angina pectoris without previous MI, a detrimental effect of omega-3 fatty acids on sudden death was observed.(67) Thus, further studies are needed to determine which patient population may or may not benefit from omega-3 fatty acids supplementation.”
BackgroundHe, K. (2009) · Progress in Cardiovascular Diseases · doi:10.1016/j.pcad.2009.06.003 · Cited by 214 · see citing works
“In fact, the sudden death rate was significantly increased in the group given fish-specific advice.(124) Although DART II is the longest trial available so far, several major methodological limitations in this intervention study have been highlighted.”
BackgroundEffects of the Mediterranean Diet on Cardiovascular Outcomes—A Systematic Review and Meta-Analysis
Liyanage, T., Ninomiya, T., Wang, A., Neal, B., Jun, M., Wong, M. G., Jardine, M., Hillis, G. S., & Perkovic, V. (2016) · PLOS ONE · doi:10.1371/journal.pone.0159252 · Cited by 210 · see citing works
“Two studies were single-centre[13,20] and four were multi-centre[14,18,19,21].”
BackgroundMethodInfluentialOmega-3 fatty acids and cardiovascular disease
von Schacky, C. (2007) · Current Opinion in Clinical Nutrition & Metabolic Care · doi:10.1097/mco.0b013e3280127af0 · Cited by 207 · see citing works
The ORIGIN Trial Investigators (2007) · American Heart Journal · doi:10.1016/j.ahj.2007.09.009 · Cited by 205 · see citing works
“However, in a recent trial in 3114 men with angina, high-dose fish oil (3 g/d) consumption increased mortality.(37) This, and a new meta-analysis demonstrating uncertain benefits,(38) has highlighted the need for a double-blind trial.”
BackgroundOmega 3 Fatty Acids and Cardiovascular Outcomes: Systematic Review and Meta-Analysis
Kotwal, S., Jun, M., Sullivan, D., Perkovic, V., & Neal, B. (2012) · Circulation: Cardiovascular Quality and Outcomes · doi:10.1161/circoutcomes.112.966168 · Cited by 201 · see citing works
“Of these studies, 8 separately reported 1496 sudden deaths among 49 971 participants.(3,10,16,17,19,22,24,25) Treatment with ω-3 FA protected against vascular death (Figure 3; RR=0.”
BackgroundMediterranean Diet and Cardiovascular Disease Prevention: What Do We Know?
Salas‐Salvadó, J., Becerra‐Tomás, N., García-Gavilán, J. F., Bulló, M., & Barrubés, L. (2018) · Progress in Cardiovascular Diseases · doi:10.1016/j.pcad.2018.04.006 · Cited by 199 · see citing works
I Diretriz sobre o consumo de Gorduras e Saúde Cardiovascular
Santos, R., Gagliardi, A., Xavier, H. T., Magnoni, C., Cassani, R., Lottenberg, A., Filho, A. C., Araújo, D., Cesena, F., Alves, R., et al. (2013) · Arquivos Brasileiros de Cardiologia · doi:10.5935/abc.2013s003 · Cited by 199 · see citing works
A Quantitative Analysis of Fish Consumption and Coronary Heart Disease Mortality
König, A., Bouzan, C., Cohen, J. T., We, C., Kris‐Etherton, P. M., Gray, G. C., LAWRENCE, R., Savitz, D. A., & Teutsch, S. M. (2005) · American Journal of Preventive Medicine · doi:10.1016/j.amepre.2005.07.001 · Cited by 190 · see citing works
Omega-3 Fatty Acids and Cardiovascular Disease: Are There Benefits?
Bowen, K. J., Harris, W. S., & Kris‐Etherton, P. M. (2016) · Current Treatment Options in Cardiovascular Medicine · doi:10.1007/s11936-016-0487-1 · Cited by 197 · see citing works
Polyunsaturated fatty acids for the primary and secondary prevention of cardiovascular disease
Abdelhamid, A. S., Martin, N., Bridges, C., Brainard, J. S., Wang, X., Brown, T. J., Hanson, S., Jimoh, F. O., Ajabnoor, S. M., Deane, K. H., et al. (2018) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd012345.pub2 · Cited by 187 · see citing works
“Only erythrocyte fatty acid ratio reported, no TC or dietary intake data reported DART 2 - Burr 2003 Aimed to increase oily fish intake or update of fish oil capsules.”
BackgroundFish and n−3 fatty acids for the prevention of fatal coronary heart disease and sudden cardiac death
Mozaffarian, D. (2008) · The American Journal of Clinical Nutrition · doi:10.1093/ajcn/87.6.1991s · Cited by 181 · see citing works
Colussi, G., Catena, C., Novello, M., Bertin, N., & Sechi, L. A. (2017) · Nutrition Metabolism and Cardiovascular Diseases · doi:10.1016/j.numecd.2016.07.011 · Cited by 182 · see citing works
Kabboul, N. N., TOMLINSON, G. A., Francis, T., Grace, S. L., Chaves, G., Rac, V. E., Daou-Kabboul, T., BIELECKI, J. M., Alter, D. A., & Krahn, M. D. (2018) · Journal of Clinical Medicine · doi:10.3390/jcm7120514 · Cited by 180 · see citing works
Omega-3 Fatty Acids and Cardiac Arrhythmias: Prior Studies and Recommendations for Future Research
London, B., Albert, C. M., Anderson, M. E., Giles, W. R., Wagoner, D. R. V., Balk, E. M., Billman, G. E., Chung, M. C., Lands, W. E. M., Leaf, A., et al. (2007) · Circulation · doi:10.1161/circulationaha.107.712984 · Cited by 174 · see citing works
Prevention of sudden cardiac death by n−3 polyunsaturated fatty acids
Leaf, A., Xiao, Y.-F., Kang, J. X., & Billman, G. E. (2003) · Pharmacology & Therapeutics · doi:10.1016/s0163-7258(03)00039-1 · Cited by 172 · see citing works
Saravanan, P., Bridgewater, B., West, A. L., O'Neill, S. C., Calder, P. C., & Davidson, N. C. (2009) · Circulation Arrhythmia and Electrophysiology · doi:10.1161/circep.109.899633 · Cited by 172 · see citing works
Bloomfield, H. E., Koeller, E., Greer, N., MacDonald, R., Kane, R., & Wilt, T. J. (2016) · Annals of Internal Medicine · doi:10.7326/m16-0361 · Cited by 159 · see citing works
“A study from Wales, a medium-risk-of-bias trial enrolling 3114 men, was interrupted by funding problems, leading to uncertainty regarding the integrity of outcomes reporting and analysis (90).”
BackgroundFats and fatty acid requirements for adults
Elmadfa, I., & Kornsteiner, M. (2009) · Annals of Nutrition and Metabolism · doi:10.1159/000228996 · Cited by 161 · see citing works
Usefulness of Omega-3 Fatty Acids and the Prevention of Coronary Heart Disease
Harper, C. R., & Jacobson, T. A. (2005) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2005.07.071 · Cited by 160 · see citing works
de Roos, B., Mavrommatis, Y., & Brouwer, I. A. (2009) · British Journal of Pharmacology · doi:10.1111/j.1476-5381.2009.00189.x · Cited by 151 · see citing works
“(Burr et al., 2003), in 3114 Welsh patients with stable angina without a myocardial infarction, showed no beneficial effect of n-3 PUFA intake during 9 year follow-up.”
InfluentialFish, human health and marine ecosystem health: policies in collision
Brunner, E. J., Jones, P. J. S., Friel, S., & Bartley, M. (2009) · International Journal of Epidemiology · doi:10.1093/ije/dyn157 · Cited by 147 · see citing works
Mohan, D., Mente, A., Dehghan, M., Rangarajan, S., O'Donnell, M. J., Hu, W., Dagenais, G. R., Wielgosz, A. T., Lear, S. A., Li, W., et al. (2021) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2021.0036 · Cited by 147 · see citing works
Polyunsaturated fatty acids for the primary and secondary prevention of cardiovascular disease
Abdelhamid, A. S., Martin, N., Bridges, C., Brainard, J. S., Wang, X., Brown, T. J., Hanson, S., Jimoh, F. O., Ajabnoor, S. M., Deane, K. H., et al. (2018) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd012345.pub3 · Cited by 147 · see citing works
Dietary fatty acids and cardiovascular disease
Salter, A. M. (2011) · animal · doi:10.1017/s1751731111002023 · Cited by 143 · see citing works
“…outcome of this analysis has sparked considerable debate, especially the concern regarding the inclusion of the Diet and Angina Randomized Trial (DART-2) by Burr et al. (2003), which reported adverse effects of increasing oily fish consumption/fish oil supplements in patients suffering from angina.”
BackgroundCarney, R. M., Freedland, K. E., Rubin, E. H., Rich, M. W., Steinmeyer, B. C., & Harris, W. S. (2009) · JAMA · doi:10.1001/jama.2009.1487 · Cited by 140 · see citing works
“Others have failed to find a benefit, and still others have reported that omega-3 supplements increase the risk of cardiac death.(40) These conflicting results have led to speculation about the clinical characteristics of cardiac patient subsets who may either benefit or be harmed by omega-3 supplements.”
BackgroundFatty acids and the immune system: from basic science to clinical applications
Yaqoob, P. (2004) · Proceedings of The Nutrition Society · doi:10.1079/pns2003328 · Cited by 139 · see citing works
“2002), although one study demonstrated a higher risk of cardiac death, which could not be explained (Burr et al. 2003).”
BackgroundLong-chain omega-3 fatty acids: time to establish a dietary reference intake
Flock, M. R., Harris, W. S., & Kris‐Etherton, P. M. (2013) · Nutrition Reviews · doi:10.1111/nure.12071 · Cited by 136 · see citing works
Svensson, M., Schmidt, E. B., Jørgensen, K. A., & Christensen, J. H. (2006) · Clinical Journal of the American Society of Nephrology · doi:10.2215/cjn.00630206 · Cited by 145 · see citing works
Dietary Fatty Acids and Colorectal Cancer: A Case-Control Study
Τheodoratou, E., McNeill, G., Cetnarskyj, R., Farrington, S. M., Tenesa, A., Barnetson, R. A., Porteous, M. E., Dunlop, M. G., & Campbell, H. (2007) · American Journal of Epidemiology · doi:10.1093/aje/kwm063 · Cited by 130 · see citing works
“The two largest studies (26, 27) were originally designed to examine the effect of x3 PUFAs on cardiovascular mortality and did not have cancer as a primary study outcome.”
BackgroundFilion, K. B., Khoury, F. E., Bielinski, M., Schiller, I., Dendukuri, N., & Brophy, J. M. (2010) · BMC Cardiovascular Disorders · doi:10.1186/1471-2261-10-24 · Cited by 124 · see citing works
Domei, T., Yokoi, H., Kuramitsu, S., Soga, Y., Arita, T., Andò, K., Shirai, S., Kondo, K., Sakai, K., Goya, M., et al. (2011) · Circulation Journal · doi:10.1253/circj.cj-11-0941 · Cited by 123 · see citing works
Brouwer, I. A., Raitt, M. H., Dullemeijer, C., Kraemer, D. F., Zock, P. L., Morris, C., Katan, M. B., Connor, W. E., Camm, J. A., Schouten, E. G., et al. (2008) · European Heart Journal · doi:10.1093/eurheartj/ehp003 · Cited by 120 · see citing works
“In the DART 2 trial patients with stable angina, intake of fish oil did not show protective effects.(19) The present pooled analysis on 423 patients with a previous MI also did not show a significant protective effect, although the observed difference and its CI cannot definitely exclude the benefit of fish oil in thi…”
ResultFish Intake, Marine Omega-3 Fatty Acids, and Mortality in a Cohort of Postmenopausal Women
Folsom, A. R. (2004) · American Journal of Epidemiology · doi:10.1093/aje/kwh307 · Cited by 121 · see citing works
“A recent secondary prevention trial of omega-3 fatty acids also showed no benefit in patients with angina (21), in contrast with earlier secondary prevention trials showing benefit in patients with a prior myocardial infarction (22, 23).”
ResultHartweg, J., Farmer, A. A., Perera, R., Holman, R. R., & Neil, H. A. W. (2007) · Diabetologia · doi:10.1007/s00125-007-0695-z · Cited by 120 · see citing works
Weichselbaum, E., Coe, S., Buttriss, J. L., & Stanner, S. A. (2013) · Nutrition Bulletin · doi:10.1111/nbu.12021 · Cited by 118 · see citing works
- Authors
- Burr, M. L., Ashfield-Watt, P. A. L., Dunstan, F. D. J., Fehily, A. M., Breay, P., Ashton, T., Zotos, P. C., Haboubi, N. A. A., & Elwood, P. C.
- Affiliations
- Cardiff University (GB)
- Corresponding author
- Burr, M L
- Venue
- European Journal of Clinical Nutrition
- Published
- 2003-02-01
- Volume
- 57
- Issue
- 2
- Pages
- 193-200
- ISSN
- 0954-3007 (ISSN-L)
- 1476-5640
- OpenAlex
- W2095073323
- Cited by
- 409
- References
- 30
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 2 · 2023: 1 · 2022: 7 · 2021: 3 · 2020: 8 · 2019: 10 · 2018: 19 · 2017: 11 · 2016: 18 · 2015: 17 · 2014: 14 · 2013: 22 · 2012: 27
- FWCI
- 30.10
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- European Journal of Clinical Nutrition (publishedVersion)
- PubMed (publishedVersion)
- ORCA Online Research @Cardiff (Cardiff University) (submittedVersion)
- Funders
- British Heart Foundation
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutritional Studies and Diet
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Health and Mental Health
- Keywords
- angina pectoris, dietary recommendations, oily fish, fish oil capsules, fruit and vegetable intake, oat, all-cause mortality, cardiovascular mortality, sudden cardiac death, dietary adherence, risk compensation, men
- MeSH terms
- Angina Pectoris, Diet, Fatty Acids, Unsaturated, Fish Oils, Fruit, Humans, Male, Middle Aged, Time Factors, Vegetables, Wales, Eicosapentaenoic Acid, Survival Analysis, Avena, beta Carotene, Nutritional Sciences
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