메뉴 건너뛰기




Volumn 9, Issue 5, 2018, Pages 561-571

Perspective: Fundamental limitations of the randomized controlled trial method in nutritional research: The example of probiotics

Author keywords

Nutrition; Probiotics; RCT limitations; Study design

Indexed keywords

PROBIOTIC AGENT;

EID: 85057653417     PISSN: 21618313     EISSN: 21565376     Source Type: Journal    
DOI: 10.1093/ADVANCES/NMY046     Document Type: Article
Times cited : (52)

References (62)
  • 1
    • 80052098636 scopus 로고    scopus 로고
    • Deming, data and observational studies
    • Young SS, Karr A. Deming, data and observational studies. Significance [Internet] 2011;8:116-20.
    • (2011) Significance [Internet] , vol.8 , pp. 116-120
    • Young, S.S.1    Karr, A.2
  • 2
    • 84888253863 scopus 로고    scopus 로고
    • Implausible results in human nutrition research
    • Ioannidis JPA. Implausible results in human nutrition research. BMJ [Internet] 2013;347:f6698.
    • (2013) BMJ [Internet] , vol.347
    • Ioannidis, J.P.A.1
  • 3
    • 84903548362 scopus 로고    scopus 로고
    • Limitations of observational evidence: implications for evidence-based dietary recommendations
    • Maki KC, Slavin JL, Rains TM, Kris-Etherton PM. Limitations of observational evidence: implications for evidence-based dietary recommendations. Adv Nutr [Internet] 2014;5:7-15.
    • (2014) Adv Nutr [Internet] , vol.5 , pp. 7-15
    • Maki, K.C.1    Slavin, J.L.2    Rains, T.M.3    Kris-Etherton, P.M.4
  • 5
    • 85042602556 scopus 로고    scopus 로고
    • Diet and cardiovascular disease: advances and challenges in population-based studies
    • Pan A, Lin X, Hemler E, Hu FB. Diet and cardiovascular disease: advances and challenges in population-based studies. Cell Metab [Internet] 2018;27:489-96.
    • (2018) Cell Metab [Internet] , vol.27 , pp. 489-496
    • Pan, A.1    Lin, X.2    Hemler, E.3    Hu, F.B.4
  • 11
    • 33845341453 scopus 로고    scopus 로고
    • The effect of chromium picolinate and biotin supplementation on glycemic control in poorly controlled patients with type 2 diabetes mellitus: a placebo-controlled, doubleblinded, randomized trial
    • Singer GM, Geohas J. The effect of chromium picolinate and biotin supplementation on glycemic control in poorly controlled patients with type 2 diabetes mellitus: a placebo-controlled, doubleblinded, randomized trial. Diabetes Technol Ther [Internet] 2006;8: 636-43.
    • (2006) Diabetes Technol Ther [Internet] , vol.8 , pp. 636-643
    • Singer, G.M.1    Geohas, J.2
  • 12
    • 38749135432 scopus 로고    scopus 로고
    • Chromium picolinate and biotin combination improves glucose metabolism in treated, uncontrolled overweight to obese patients with type 2 diabetes
    • Albarracin CA, Fuqua BC, Evans JL, Goldfine ID. Chromium picolinate and biotin combination improves glucose metabolism in treated, uncontrolled overweight to obese patients with type 2 diabetes. Diabetes Metab Res Rev [Internet] 2008;24:41-51.
    • (2008) Diabetes Metab Res Rev [Internet] , vol.24 , pp. 41-51
    • Albarracin, C.A.1    Fuqua, B.C.2    Evans, J.L.3    Goldfine, I.D.4
  • 13
    • 51049085594 scopus 로고    scopus 로고
    • Nutrients, endpoints, and the problem of proof
    • Heaney RP. Nutrients, endpoints, and the problem of proof. J Nutr [Internet] 2008;138:1591-5.
    • (2008) J Nutr [Internet] , vol.138 , pp. 1591-1595
    • Heaney, R.P.1
  • 14
    • 84941365231 scopus 로고    scopus 로고
    • Understanding nutritional epidemiology and its role in policy
    • Satija A, Yu E, Willett WC, Hu FB. Understanding nutritional epidemiology and its role in policy. Adv Nutr [Internet] 2015;6:5-18.
    • (2015) Adv Nutr [Internet] , vol.6 , pp. 5-18
    • Satija, A.1    Yu, E.2    Willett, W.C.3    Hu, F.B.4
  • 16
    • 84891705800 scopus 로고    scopus 로고
    • Your microbes, your health
    • Your microbes, your health. Science [Internet] 2013;342:1440-1.
    • (2013) Science [Internet] , vol.342 , pp. 1440-1441
  • 18
    • 84869421349 scopus 로고    scopus 로고
    • Metchnikoff and the microbiome
    • Podolsky SH. Metchnikoff and the microbiome. The Lancet [Internet] 2012;380:1810-11.
    • (2012) The Lancet [Internet] , vol.380 , pp. 1810-1811
    • Podolsky, S.H.1
  • 22
    • 0038730917 scopus 로고    scopus 로고
    • Probiotics and prevention of atopic disease: 4-year follow-up of a randomised placebo-controlled trial
    • Kalliomäki M, Salminen S, Poussa T, Arvilommi H, Isolauri E. Probiotics and prevention of atopic disease: 4-year follow-up of a randomised placebo-controlled trial. The Lancet [Internet] 2003;361:1869-71.
    • (2003) The Lancet [Internet] , vol.361 , pp. 1869-1871
    • Kalliomäki, M.1    Salminen, S.2    Poussa, T.3    Arvilommi, H.4    Isolauri, E.5
  • 23
    • 40949124307 scopus 로고    scopus 로고
    • Randomized, double-blind, placebo-controlled trial of probiotics for primary prevention: no clinical effects of Lactobacillus GG supplementation
    • Kopp MV, Hennemuth I, Heinzmann A, Urbanek R. Randomized, double-blind, placebo-controlled trial of probiotics for primary prevention: no clinical effects of Lactobacillus GG supplementation. Pediatrics [Internet] 2008;121:e850-6.
    • (2008) Pediatrics [Internet] , vol.121 , pp. e850-e856
    • Kopp, M.V.1    Hennemuth, I.2    Heinzmann, A.3    Urbanek, R.4
  • 25
    • 0035822324 scopus 로고    scopus 로고
    • Assessing the quality of controlled clinical trials
    • Jüni P, AltmanDG, Egger M. Assessing the quality of controlled clinical trials. BMJ [Internet] 2001;323:42-6.
    • (2001) BMJ [Internet] , vol.323 , pp. 42-46
    • Jüni, P.1    Altman, D.G.2    Egger, M.3
  • 26
    • 34547172234 scopus 로고    scopus 로고
    • Limitations of the randomized controlled trial in evaluating population-based health interventions
    • Sanson-Fisher RW, Bonevski B, Green LW, D'Este C. Limitations of the randomized controlled trial in evaluating population-based health interventions. Am J Prev Med [Internet] 2007;33:155-61.
    • (2007) Am J Prev Med [Internet] , vol.33 , pp. 155-161
    • Sanson-Fisher, R.W.1    Bonevski, B.2    Green, L.W.3    D'Este, C.4
  • 27
    • 0029912547 scopus 로고    scopus 로고
    • Whywe need observational studies to evaluate the effectiveness of health care
    • BlackN.Whywe need observational studies to evaluate the effectiveness of health care. BMJ [Internet] 1996;312:1215-18.
    • (1996) BMJ [Internet] , vol.312 , pp. 1215-1218
    • Black, N.1
  • 30
    • 77950655948 scopus 로고    scopus 로고
    • Boca Raton, FL: Chapman & Hall/CRC; forthcoming [cited 2018 Apr 25]
    • Hernán MA, Robins JM. Causal inference [Internet]. Boca Raton, FL: Chapman & Hall/CRC; forthcoming [cited 2018 Apr 25]. Available from: https://www.hsph.harvard.edu/miguel-hernan/causal-inferencebook/.
    • Causal inference [Internet]
    • Hernán, M.A.1    Robins, J.M.2
  • 31
    • 11444261579 scopus 로고    scopus 로고
    • External validity of randomised controlled trials: "to whom do the results of this trial apply?"
    • Rothwell PM. External validity of randomised controlled trials: "to whom do the results of this trial apply?" The Lancet [Internet] 2005;365:82-93.
    • (2005) The Lancet [Internet] , vol.365 , pp. 82-93
    • Rothwell, P.M.1
  • 32
    • 55549113585 scopus 로고    scopus 로고
    • Causal inference from longitudinal studies with baseline randomization
    • Toh S, Hernán MA. Causal inference from longitudinal studies with baseline randomization. Int J Biostat [Internet] 2008;4(1):22.
    • (2008) Int J Biostat [Internet] , vol.4 , Issue.1 , pp. 22
    • Toh, S.1    Hernán, M.A.2
  • 35
    • 85021742498 scopus 로고    scopus 로고
    • Effect modification, interaction and mediation: an overview of theoretical insights for clinical investigators
    • Corraini P, Olsen M, Pedersen L, Dekkers OM, Vandenbroucke JP. Effect modification, interaction and mediation: an overview of theoretical insights for clinical investigators. Clin Epidemiol [Internet] 2017;9:331-8.
    • (2017) Clin Epidemiol [Internet] , vol.9 , pp. 331-338
    • Corraini, P.1    Olsen, M.2    Pedersen, L.3    Dekkers, O.M.4    Vandenbroucke, J.P.5
  • 38
    • 84856209089 scopus 로고    scopus 로고
    • Bioactivity and chemical composition of blackcurrant (Ribes nigrum) cultivars with and without pesticide treatment
    • Khoo GM, Clausen MR, Pedersen HL, Larsen E. Bioactivity and chemical composition of blackcurrant (Ribes nigrum) cultivars with and without pesticide treatment. Food Chem 2012;132:1214-20.
    • (2012) Food Chem , vol.132 , pp. 1214-1220
    • Khoo, G.M.1    Clausen, M.R.2    Pedersen, H.L.3    Larsen, E.4
  • 39
    • 83655201459 scopus 로고    scopus 로고
    • Production of bioactive substances by intestinal bacteria as a basis for explaining probiotic mechanisms: bacteriocins and conjugated linoleic acid
    • O'Shea EF, Cotter PD, Stanton C, Ross RP, Hill C. Production of bioactive substances by intestinal bacteria as a basis for explaining probiotic mechanisms: bacteriocins and conjugated linoleic acid. Int J Food Microbiol 2012;152:189-205.
    • (2012) Int J Food Microbiol , vol.152 , pp. 189-205
    • O'Shea, E.F.1    Cotter, P.D.2    Stanton, C.3    Ross, R.P.4    Hill, C.5
  • 41
    • 84862276328 scopus 로고    scopus 로고
    • Structure, function and diversity of the healthy human microbiome
    • Consortium THMP. Structure, function and diversity of the healthy human microbiome. Nature [Internet] 2012;486:207-14.
    • (2012) Nature [Internet] , vol.486 , pp. 207-214
    • Consortium, T.H.M.P.1
  • 43
    • 83855165652 scopus 로고    scopus 로고
    • Emerging molecular insights into the interaction between probiotics and the host intestinal mucosa
    • Bron PA, van Baarlen P, Kleerebezem M. Emerging molecular insights into the interaction between probiotics and the host intestinal mucosa. Nat Rev Microbiol [Internet] 2012;10:66-78.
    • (2012) Nat Rev Microbiol [Internet] , vol.10 , pp. 66-78
    • Bron, P.A.1    van Baarlen, P.2    Kleerebezem, M.3
  • 45
    • 84861980130 scopus 로고    scopus 로고
    • Interactions between the microbiota and the immune system
    • Hooper LV, Littman DR, Macpherson AJ. Interactions between the microbiota and the immune system. Science [Internet] 2012;336:1268- 73.
    • (2012) Science [Internet] , vol.336 , pp. 1268-1273
    • Hooper, L.V.1    Littman, D.R.2    Macpherson, A.J.3
  • 47
    • 85060916713 scopus 로고    scopus 로고
    • [cited 2017 Mar 5]
    • International Probiotics Association. 2017 best practices guidelines [Internet]. [cited 2017 Mar 5]. Available from: http:// internationalprobiotics.org/resources/guidelines/2017-best-practicesguidelines/.
    • 2017 best practices guidelines [Internet]
  • 51
    • 84928789447 scopus 로고    scopus 로고
    • Personalized medicine: time for one-person trials
    • Schork NJ. Personalized medicine: time for one-person trials. Nature [Internet] 2015;520:609-11.
    • (2015) Nature [Internet] , vol.520 , pp. 609-611
    • Schork, N.J.1
  • 52
    • 84928808881 scopus 로고    scopus 로고
    • Rockville, MD: Agency for Healthcare Research and Quality, US Department for Health and Human Services; 2014
    • Kravitz R, Duan N, editors. Design and implementation of nof-1 trials: a user's guide. Rockville, MD: Agency for Healthcare Research and Quality, US Department for Health and Human Services; 2014. Available from: https://effectivehealthcare.ahrq.gov/topics/n-1- trials/research-2014-5/.
    • Design and implementation of nof-1 trials: a user's guide
    • Kravitz, R.1    Duan, N.2
  • 53
    • 43049146530 scopus 로고    scopus 로고
    • N of 1 trials in diabetes: making individual therapeutic decisions
    • Tsapas A, Matthews DR. N of 1 trials in diabetes: making individual therapeutic decisions. Diabetologia [Internet] 2008;51:921-5.
    • (2008) Diabetologia [Internet] , vol.51 , pp. 921-925
    • Tsapas, A.1    Matthews, D.R.2
  • 55
    • 84875646817 scopus 로고    scopus 로고
    • The inevitable application of big data to health care
    • Murdoch TB,Detsky AS. The inevitable application of big data to health care. JAMA [Internet] 2013;309:1351-2.
    • (2013) JAMA [Internet] , vol.309 , pp. 1351-1352
    • Murdoch, T.B.1    Detsky, A.S.2
  • 56
    • 84878979335 scopus 로고    scopus 로고
    • Biology: the big challenges of big data
    • Marx V. Biology: the big challenges of big data. Nature [Internet] 2013;498:255-60.
    • (2013) Nature [Internet] , vol.498 , pp. 255-260
    • Marx, V.1
  • 58
    • 84940789933 scopus 로고    scopus 로고
    • Systematic review with meta-analysis: Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea
    • Szajewska H, Kolodziej M. Systematic review with meta-analysis: Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea. Aliment Pharmacol Ther [Internet] 2015;42:793-801.
    • (2015) Aliment Pharmacol Ther [Internet] , vol.42 , pp. 793-801
    • Szajewska, H.1    Kolodziej, M.2
  • 59
    • 84877278637 scopus 로고    scopus 로고
    • Implementing personalized cancer genomics in clinical trials
    • Simon R, Roychowdhury S. Implementing personalized cancer genomics in clinical trials.Nat RevDrugDiscov [Internet] 2013;12:358- 69.
    • (2013) Nat RevDrugDiscov [Internet] , vol.12 , pp. 358-369
    • Simon, R.1    Roychowdhury, S.2
  • 62
    • 60749112322 scopus 로고    scopus 로고
    • The effect of fruit in different forms on energy intake and satiety at a meal
    • Flood-Obbagy JE, Rolls BJ. The effect of fruit in different forms on energy intake and satiety at a meal. Appetite [Internet] 2009;52: 416-22.
    • (2009) Appetite [Internet] , vol.52 , pp. 416-422
    • Flood-Obbagy, J.E.1    Rolls, B.J.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.