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Are probiotics more efficacious than placebo at preventing radiotherapy-induced diarrhoea in adults with cancer

Published online by Cambridge University Press:  17 May 2013

Marco Tullio Suadoni*
Affiliation:
St Luke's Hospice, London, UK
*
Correspondence to: Marco Tullio Suadoni, St Luke's Hospice, Kenton Grange, Kenton Road, Harrow, Middlesex HA3 0YG, UK. Tel: 020 8382 8013. E-mail: [email protected]

Abstract

Background

Patients with cancer undergoing radiotherapy often develop diarrhoea, causing distress and hindering treatment. As probiotics have favourable effects on the gut flora, they are potentially good candidates in the prevention of radiotherapy-induced diarrhoea (RID).

Purpose

The outcome of interest of this systematic review was the efficacy of probiotics in preventing RID.

Materials and methods

Medline and Embase databases were systematically searched. Four randomised controlled trials (RCTs) were finally selected.

Results

Three RCTs showed beneficial results, which were statistically significant. One RCT showed non-beneficial results, which were not statistically significant. The quality of the studies was mixed, and serious limitations were found.

Conclusion

While the indications are towards a benefit of the use of probiotics in preventing RID, more robust evidence is required in the form of well-designed RCTs.

Type
Literature Review
Copyright
Copyright © Cambridge University Press 2013 

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References

1.Williams, M V, Summers, E T, Drinkwater, K, Barrett, A. Radiotherapy dose fractionation, access and waiting times in the countries of the UK in 2005. Clin Oncol (R Coll Radiol) 2007; 19 (5): 273286.CrossRefGoogle ScholarPubMed
2.Blanarova, C, Galovicova, A, Petrasova, D. Use of probiotics for prevention of radiation-induced diarrhea. Bratisl Lek Listy 2009; 110 (2): 98104.Google Scholar
3.Bismar, M M, Sinicrope, F A. Radiation enteritis. Curr Gastroenterol Rep 2002; 4 (5): 361365.Google Scholar
4.Andreyev, J. Gastrointestinal complications of pelvic radiotherapy: are they of any importance? Gut 2005; 54 (8): 10511054.Google Scholar
5.Salminen, E, Elomaa, I, Minkkinen, J, Vapaatalo, H, Salminen, S. Preservation of intestinal integrity during radiotherapy using live Lactobacillus acidophilus cultures. Clin Radiol 1988; 39 (4): 435437.Google Scholar
6.Visich, K L, Yeo, T P. The prophylactic use of probiotics in the prevention of radiation therapy-induced diarrhea. Clin J Oncol Nurs 2010; 14 (4): 467473.Google Scholar
7.Timko, J. Probiotics as prevention of radiation-induced diarrhoea. J Radiother Pract 2010; 9 (4): 201208.Google Scholar
8.Muehlbauer, P M, Thorpe, D, Davis, A, Drabot, R, Rawlings, B L, Kiker, E. Putting evidence into practice: evidence-based interventions to prevent, manage, and treat chemotherapy- and radiotherapy-induced diarrhea. Clin J Oncol Nurs 2009; 13 (3): 336341.Google Scholar
9.Maria-Aggeliki, K S, Nikolaos, K L, Kyrias, G M, Vassilis, K E. The potential clinical impact of probiotic treatment for the prevention and/or anti-inflammatory therapeutic effect against radiation induced intestinal mucositis. A review. Recent Pat Inflamm Allergy Drug Discov 2009; 3 (3): 195200.Google Scholar
10.Fuccio, L, Guido, A, Eusebi, L Het al. Effects of probiotics for the prevention and treatment of radiation-induced diarrhea. J Clin Gastroenterol 2009; 43 (6): 506513.Google Scholar
11.Urbancsek, H, Kazar, T, Mezes, I, Neumann, K. Results of a double-blind, randomized study to evaluate the efficacy and safety of Antibiophilus in patients with radiation-induced diarrhoea. Eur J Gastroenterol Hepatol 2001; 13 (4): 391396.Google Scholar
12.Joint FAO/WHO Working Group on Drafting Guidelines for the Evaluation of Probiotics in Food. Guidelines for the Evaluation of Probiotics in Food. London, Ontario, Canada: FAO/WHO, 2002.Google Scholar
13.Famularo, G, De Simone, C, Matteuzzi, D, Pirovano, F. Traditional and high potency probiotic preparations for oral bacteriotherapy. BioDrugs 1999; 12 (6): 455470.Google Scholar
14.National Institute for Health and Clinical Excellence. The Guidelines Manual. London: NICE, 2009.Google Scholar
15.Griffiths, P. Evidence informing practice: introducing the mini-review. Br JCommunity Nurs 2002; 7 (1): 3839.Google Scholar
16.Wong, S S, Wilczynski, N L, Haynes, R B. Comparison of top-performing search strategies for detecting clinically sound treatment studies and systematic reviews in MEDLINE and EMBASE. J Med Libr Assoc 2006; 94 (4): 451455.Google Scholar
17.Kaptchuk, T J. The double-blind, randomized, placebo-controlled trial: gold standard or golden calf? J Clin Epidemiol 2001; 54 (6): 541549.Google Scholar
18.OCEBM Levels of Evidence Working Group. The Oxford 2011 Levels of Evidence. Oxford: Oxford Centre for Evidence-Based Medicine, 2011.Google Scholar
19.Delia, P, Sansotta, G, Donato, Vet al. Use of probiotics for prevention of radiation-induced diarrhea. World J Gastroenterol 2007; 13 (6): 912915.Google Scholar
20.Germain, I, Desjardins, J, Demers, M, Dagnault, A. Phase III study: impact of probiotics on diarrhea in patients treated with pelvic radiation. Int J Radiat Oncol Biol Phys 2011; 1: S667SS68.Google Scholar
21.Giralt, J, Regadera, J P, Verges, Ret al. Effects of probiotic Lactobacillus casei DN-114 001 in prevention of radiation-induced diarrhea: results from multicenter, randomized, placebo-controlled nutritional trial. Int J Radiat Oncol Biol Phys 2008; 71 (4): 12131219.Google Scholar
22.Chitapanarux, I, Chitapanarux, T, Traisathit, P, Kudumpee, S, Tharavichitkul, E, Lorvidhaya, V. Randomized controlled trial of live lactobacillus acidophilus plus bifidobacterium bifidum in prophylaxis of diarrhea during radiotherapy in cervical cancer patients. Radiat 2010; 5: 31.Google ScholarPubMed
23.Huwiler-Muntener, K, Juni, P, Junker, C, Egger, M. Quality of reporting of randomized trials as a measure of methodologic quality. J Am Med Assoc 2002; 287 (21): 28012804.Google Scholar
24.Schulz, K F, Altman, D G, Moher, D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Br Med J 2010; 340: c332.Google Scholar
25.National Institute for Health and Clinical Excellence. The Guidelines Manual. Appendices. London: NICE, 2009.Google Scholar
26.Guyatt, G H, Oxman, A D, Vist, Get al. GRADE guidelines: 4. Rating the quality of evidence – study limitations (risk of bias). J Clin Epidemiol 2011; 64 (4): 407415.Google Scholar
27.Greenhalgh, T. Assessing the methodological quality of published papers. Br Med J 1997; 315 (7103): 305308.Google Scholar
28.Hollis, S, Campbell, F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. Br Med J 1999; 319 (7211): 670674.CrossRefGoogle ScholarPubMed
29.Altman, D G. Clinical trials and meta-analyses. In: Altman DG, Machin D, Bryant TN, Gardner MJ (eds). Statistics with Confidence: Confidence Intervals and Statistical Guidance, 2nd edition. Bristol: British Medical Journal Books, 2000: 120138.Google Scholar
30.Newcombe, R G, Altman, D G. Proportions and their differences. In: Altman DG, Machin D, Bryant TN, Gardner MJ (eds). Statistics with Confidence: Confidence Intervals and Statistical Guidance, 2nd edition. Bristol: British Medical Journal Books, 2000.Google Scholar
31.Guyatt, G H, Oxman, A D, Kunz, Ret al. GRADE guidelines 6. Rating the quality of evidence – imprecision. J Clin Epidemiol 2011; 64 (12): 12831293.Google Scholar
32.Cook, R J, Sackett, D L. The number needed to treat: a clinically useful measure of treatment effect. Br Med J 1995; 310 (6977): 452454.Google Scholar
33.Altman, D G. Confidence intervals for the number needed to treat. Br Med J 1998; 317 (7168): 13091312.Google Scholar
34.Heselmans, M, Reid, G, Akkermans, L M, Savelkoul, H, Timmerman, H, Rombouts, F M. Gut flora in health and disease: potential role of probiotics. Curr Issues Intest Microbiol 2005; 6 (1): 17.Google Scholar
35.Whorwell, P J, Altringer, L, Morel, Jet al. Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome. Am J Gastroenterol 2006; 101 (7): 15811590.Google Scholar
36.Del Piano, M, Carmagnola, S, Ballare, Met al. Is microencapsulation the future of probiotic preparations? The increased efficacy of gastro-protected probiotics. Gut Microbes 2011; 2 (2): 120123.Google Scholar
37.Lee, M C, Lin, L H, Hung, K L, Wu, H Y. Oral bacterial therapy promotes recovery from acute diarrhea in children. Acta Paediatr Taiwan 2001; 42 (5): 301305.Google Scholar
38.Rerksuppaphol, S, Rerksuppaphol, L. Lactobacillus acidophilus and Bifidobacterium bifidum stored at ambient temperature are effective in the treatment of acute diarrhoea. Ann Trop Paediatr 2010; 30 (4): 299304.Google Scholar
39.Lin, H C, Su, B H, Chen, A Cet al. Oral probiotics reduce the incidence and severity of necrotizing enterocolitis in very low birth weight infants. Pediatrics 2005; 115 (1): 14.Google Scholar
40.Wall, G C, Schirmer, L L, Anliker, L E, Tigges, A E. Pharmacotherapy for acute pouchitis. Ann Pharmacother 2011; 45 (9): 11271137.Google Scholar
41.Tursi, A, Brandimarte, G, Papa, Aet al. Treatment of relapsing mild-to-moderate ulcerative colitis with the probiotic VSL#3 as adjunctive to a standard pharmaceutical treatment: a double-blind, randomized, placebo-controlled study. Am J Gastroenterol 2010; 105 (10): 22182227.Google Scholar
42.Frohmader, T J, Chaboyer, W P, Robertson, I K, Gowardman, J. Decrease in frequency of liquid stool in enterally fed critically ill patients given the multispecies probiotic VSL#3: a pilot trial. Am J Crit Care 2010; 19 (3): e1e11.Google Scholar
43.Joint Formulary Committee. British National Formulary. London: BMJ Group and Pharmaceuticals Press, 2011.Google Scholar
44.Hickson, M, D'Souza, A L, Muthu, Net al. Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomised double blind placebo controlled trial. Br Med J 2007; 335 (7610): 80.Google Scholar
45.Pedone, C A, Arnaud, C C, Postaire, E R, Bouley, C F, Reinert, P. Multicentric study of the effect of milk fermented by Lactobacillus casei on the incidence of diarrhoea. Int J Clin Pract 2000; 54 (9): 568571.Google Scholar
46.Turchet, P, Laurenzano, M, Auboiron, S, Antoine, J M. Effect of fermented milk containing the probiotic Lactobacillus casei DN-114001 on winter infections in free-living elderly subjects: a randomised, controlled pilot study. J Nutr Health Aging 2003; 7 (2): 7577.Google Scholar
47.Balshem, H, Helfand, M, Schunemann, H Jet al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol 2011; 64 (4): 401406.Google Scholar
48.Delia, P, Sansotta, G, Donato, Vet al. Prophylaxis of diarrhoea in patients submitted to radiotherapeutic treatment on pelvic district: personal experience. Dig Liver Dis 2002; 34 (suppl 2): S84S86.CrossRefGoogle ScholarPubMed
49.Delia, P, Sansotta, G, Donato, Vet al. Prevention of radiation-induced diarrhea with the use of VSL#3, a new high-potency probiotic preparation. Am J Gastroenterol 2002; 97 (8): 21502152.Google Scholar
50.Delia, P, Sansotta, G, Donato, Vet al. Use of probiotics for prevention of radiation-induced diarrhea. Tumori 2007; 93 (suppl 2): 16.Google Scholar
51.Henriksson, R, Franzen, L, Sandstrom, K, Nordin, A, Arevarn, M, Grahn, E. Effects of active addition of bacterial cultures in fermented milk to patients with chronic bowel discomfort following irradiation. Support Care Cancer 1995; 3 (1): 8183.CrossRefGoogle ScholarPubMed
52.Okawa, T, Kita, M, Arai, Tet al. Phase II randomized clinical trial of LC9018 concurrently used with radiation in the treatment of carcinoma of the uterine cervix. Its effect on tumor reduction and histology. Cancer 1989; 64 (9): 17691776.Google Scholar