Medical food and food supplements: Not always as safe as generally assumed

Annals of Internal Medicine

Volumn 156, Issue 12, 2012, Pages 894-895

  Reichenbach, Stephan ^a   Jüni, Peter ^a  

^a UNIVERSITY OF BERN   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

BIOFLAVONOID; CHONDROITIN; FLAVOCOXID; GLUCOSAMINE; HERBACEOUS AGENT; NAPROXEN; UNCLASSIFIED DRUG;

ACUTE LIVER FAILURE; DIET SUPPLEMENTATION; EDITORIAL; FOOD; FOOD SAFETY; HUMAN; LIVER INJURY; MEDICAL FOOD; OSTEOARTHRITIS; PATIENT SAFETY; PRIORITY JOURNAL;

EID: 84862750321     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/0003-4819-156-12-201206190-00012     Document Type: Editorial

References (22)

1. Jinks C, Jordan K, Croft P. Measuring the population impact of knee pain and disability with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Pain. 2002;100:55-64. [PMID: 12435459]
2. McAlindon TE, Snow S, Cooper C, Dieppe PA. Radiographic patterns of osteoarthritis of the knee joint in the community: the importance of the patellofemoral joint. Ann Rheum Dis. 1992;51:844-9. [PMID: 1632657]
3. Felson DT. Developments in the clinical understanding of osteoarthritis. Arthritis Res Ther. 2009;11:203. [PMID: 19232065]
4. Lawrence JS, Bremner JM, Bier F. Osteo-arthrosis. Prevalence in the population and relationship between symptoms and x-ray changes. Ann Rheum Dis. 1966;25:1-24. [PMID: 5905334]
5. Nguyen US, Zhang Y, Zhu Y, Niu J, Zhang B, Felson DT. Increasing prevalence of knee pain and symptomatic knee osteoarthritis: survey and cohort data. Ann Intern Med. 2011;155:725-32. [PMID: 22147711]
6. Hochberg MC, Altman RD, Toupin April K, Benkhalti M, Guyatt G, McGowan J, et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012;64:465-74.
7. Lane NE, Schnitzer TJ, Birbara CA, Mokhtarani M, Shelton DL, Smith MD, et al. Tanezumab for the treatment of pain from osteoarthritis of the knee. N Engl J Med. 2010;363:1521-31. [PMID: 20942668]
8. Wandel S, Jüni P, Tendal B, Nüesch E, Villiger PM, Welton NJ, et al. Effects of glucosamine, chondroitin, or placebo in patients with osteoarthritis of hip or knee: network meta-analysis. BMJ. 2010;341:c4675. [PMID: 20847017]
9. Radimer K, Bindewald B, Hughes J, Ervin B, Swanson C, Picciano MF. Dietary supplement use by US adults: data from the National Health and Nutrition Examination Survey, 1999-2000. Am J Epidemiol. 2004;160:339-49. [PMID: 15286019]
10. Landström E, Hursti UK, Becker W, Magnusson M. Use of functional foods among Swedish consumers is related to health-consciousness and perceived effect. Br J Nutr. 2007;98:1058-69. [PMID: 17640416]
11. Chalasani N, Vuppalanchi R, Navarro V, Fontana R, Bonkovsky H, Barnhart H, et al; Drug-Induced Liver Injury Network Acute liver injury due to flavocoxid (Limbrel), a medical food for osteoarthritis. A case series. Ann Intern Med. 2012;156:857-60.
12. Pillai L, Burnett BP, Levy RM; GOAL Study Cooperative Group. GOAL: multicenter, open-label, post-marketing study of flavocoxid, a novel dual pathway inhibitor anti-inflammatory agent of botanical origin. Curr Med Res Opin. 2010;26:1055-63. [PMID: 20225990]
13. Altavilla D, Squadrito F, Bitto A, Polito F, Burnett BP, Di Stefano V, et al. Flavocoxid, a dual inhibitor of cyclooxygenase and 5-lipoxygenase, blunts proinflammatory phenotype activation in endotoxin-stimulated macrophages. Br J Pharmacol. 2009;157:1410-8. [PMID: 19681869]
14. Levy RM, Saikovsky R, Shmidt E, Khokhlov A, Burnett BP. Flavocoxid is as effective as naproxen for managing the signs and symptoms of osteoarthritis of the knee in humans: a short-term randomized, double-blind pilot study. Nutr Res. 2009;29:298-304. [PMID: 19555810]
15. Levy RM, Khokhlov A, Kopenkin S, Bart B, Ermolova T, Kantemirova R, et al. Efficacy and safety of flavocoxid, a novel therapeutic, compared with naproxen: a randomized multicenter controlled trial in subjects with osteoarthritis of the knee. Adv Ther. 2010;27:731-42. [PMID: 20845002]
16. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152:726-32. [PMID: 20335313]
17. Jüni P, Altman DG, Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials. BMJ. 2001;323:42-6. [PMID: 11440947]
18. Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ. 2008; 336:601-5. [PMID: 18316340]
19. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA. 2006;295:1152-60. [PMID:16522836]
20. Stickel F, Kessebohm K, Weimann R, Seitz HK. Review of liver injury associated with dietary supplements. Liver Int. 2011;31:595-605. [PMID:21457433]
21. U.S. Food and Drug Administration. Guidance, Compliance & Regulatory Information. Silver Spring, MD: U.S. Food and Drug Administration;2011. Accessed at www.fda.gov/food/dietarysupplements/GuidanceCompliance RegulatoryInformation on 16 April 2012.
22. Vandenbroucke JP, Psaty BM. Benefits and risks of drug treatments: how to combine the best evidence on benefits with the best data about adverse effects. JAMA. 2008;300:2417-9. [PMID: 19033592]