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Probióticos para el tratamiento del eccema

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Referencias

Referencias de los estudios incluidos en esta revisión

Ir a:

Brouwer 2006 {published and unpublished data}

Brouwer ML, Wolt‐Plompen SAA, Dubois AEJ, Van der Heide S, Jansen DF, Hoijer MA, et al. No effects of probiotics on atopic dermatitis in infancy: a randomized placebo‐controlled trial. Clinical and Experimental Allergy 2006;36:899‐906.

Folster‐Holst 2006 {published data only}

Folster‐Holst R, Muller F, Schnopp N, Abeck D, Kreiselmaier I, Lenz T, et al. Prospective, randomized controlled trial on Lactobacillus rhamnosus in infants with moderate to severe atopic dermatitis. British Journal of Dermatology 2006;155:1256‐61.

Gruber 2007 {published data only (unpublished sought but not used)}

Gruber C, Wendt M, Sulser C, Lau S, Kulig M, Wahn U, et al. Randomised placebo‐controlled trial of Lactobacillus rhamnosus GG as treatment of atopic dermatitis in infancy. Allergy 2007;62:1270‐1276.

Isolauri 2000 {published data only}

Isolauri E, Arvola T, Sutas Y, Moilanen E, Salminen S. Probiotics in the management of atopic eczema. Clinical and Experimental Allergy 2000;30:1604‐10.

Kirjavainen 2003 {published data only}

Kirjavainen PV, Salminen SJ, Isolauri E. Probiotic bacteria in the management of atopic disease: underscoring the importance of viability. Journal of pediatric gastroenterology and nutrition 2003;36:223‐7.

Majamaa 1997 {published data only}

Majamaa H, Isolauri E. Probiotics: a novel approach in the management of food allergy. Journal of Allergy and Clinical Immunology 1997;99:179‐85.

Passeron 2006 {published and unpublished data}

Passeron T, Lacour J‐P, Fontas E, Ortonne J‐P. Prebiotics and synbiotics: two promising approaches for the treatment of atopic dermatitis in children above 2 years. Allergy 2006;61:431‐7.

Rosenfeldt 2003 {published and unpublished data}

Rosenfeldt V, Benfeldt E, Nielsen SD, Michaelsen KF, Jeppesen DL, Valerius NH, et al. Effect of probiotic Lactobacillus strains in children with atopic dermatitis. Journal of Allergy and Clinical Immunology 2003;111:389‐95.

Sistek 2006 {published and unpublished data}

Sistek D, Kelly R, Wickens K, Stanley T, Fitzharris P, Crane J. Is the effect of probiotics on atopic dermatitis confined to food sensitized children?. Clinical and Experimental Allergy 2006;36:629‐33.

Taniuchi 2005 {published data only}

Hattori K, Yamamoto A, Sasai M, Taniuchi S, Kojima, T. Kobayashi Y, et al. Effects of administration of bifidobacteria on fecal microflora and clinical symptoms in infants with atopic dermatitis. Arerugi ‐ Japanese Journal of Allergology 2003;52(1):20‐30.
Taniuchi S, Hattori K, Yamamoto A, Sasai M, Hatano Y, Kojima T, et al. Administration of Bifidobacterium to infants with atopic dermatitis: changes in fecal microflora and clinical symptoms. The Journal of Applied Research 2005;5(2):387‐96.

Viljanen 2005 {published and unpublished data}

Viljanen M, Savilahti E, Haahtela T, Juntunen‐Backman K, Korpela R, Poussa T, et al. Probiotics in the treatment of atopic eczema/dermatitis syndrome in infants: a double‐blind placebo‐controlled trial. Allergy 2005;60:494‐500.

Weston 2005 {published and unpublished data}

Weston S, Dunstan J, Roper J, Breckler L, Halbert A, Richmond P, et al. Probiotics provide clinical benefit in moderate and severe atopic dermatitis: a randomised controlled trial. The Journal of Investigative Dermatology 2005;125:596.
Weston S, Halbert A, Richmond P, Prescott SL. Effects of probiotics on atopic dermatitis: a randomised controlled trial. Archives of Disease in Childhood 2005;90(9):892‐7.
Weston S, Richmond P, Halbert A, Prescott SL. Effects of probiotics in infants with atopic dermatitis: a randomised double blind placebo controlled trial. Australasian Journal of Dermatology 2004;45:A13.

Referencias de los estudios excluidos de esta revisión

Ir a:

Arvola 2006 {published data only}

Arvola T, Ruuska T, Keranen J, Hyoty H, Salminen S, Isolauri E. Rectal bleeding in infancy: clinical, allergological, and microbiological examination. Pediatrics 2006;117(4):760‐8.

Ikezawa 2004 {published data only}

Ikezawa Z, Kondo M, Okajima M, Nishimura Y, Kono M. Clinical usefulness of oral itraconazole, an antimycotic drug, for refractory atopic dermatitis. European Journal of Dermatology 2004;14(6):400‐6.

Kalliomaki 2003 {published data only}

Kalliomaki 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. Lancet 2003;361(9372):1869‐71.

Laitinen 2005 {published data only}

Laitinen K, Kalliomaki M, Poussa T, Lagstrom H, Isolauri E. Evaluation of diet and growth in children with and without atopic eczema: follow‐up study from birth to 4 years. British Journal of Nutrition 2005;94(4):565‐74.

Leung 2004 {published data only}

Leung TF, Ma KC, Cheung LTF, Lam CWK, Wong E, Wan H, et al. A randomized, single‐blind and crossover study of an amino acid‐based milk formula in treating young children with atopic dermatitis. Pediatric Allergy and Immunology 2004;15(6):558‐61.

Ogawa 2006 {published data only}

Ogawa T, Hashikawa S, Asai Y, Sakamoto H, Yasuda K, Makimura Y. A new synbiotic, Lactobacillus casei subsp. casei together with dextran, reduces murine and human allergic reaction. FEMS Immunology & Medical Microbiology 2006;46(3):400‐9.

Pohjavuori 2004 {published data only}

Pohjavuori E, Viljanen M, Korpela R, Kuitunen M, Tiittanen M, Vaarala O, et al. Lactobacillus GG effect in increasing IFN‐gamma production in infants with cow's milk allergy. Journal of Allergy and Clinical Immunology 2004;114(1):131‐6.

Prescott 2005 {published data only}

Prescott SL, Dunstan JA, Hale J, Breckler L, Lehmann H, Weston S, et al. Clinical effects of probiotics are associated with increased interferon‐gamma responses in very young children with atopic dermatitis. Clinical and Experimental Allergy 2005;35(12):1557‐64.

Rosenfeldt 2004 {published data only}

Rosenfeldt V, Benfeldt E, Valerius NH, Paerregaard A, Michaelsen KF. Effect of probiotics on gastrointestinal symptoms and small intestinal permeability in children with atopic dermatitis. Journal of Pediatrics 2004;145(5):612‐6.

Viljanen 2005b {published data only}

Viljanen M, Pohjavuori E, Haahtela T, Korpela R, Kuitunen M, Sarnesto A, et al. Induction of inflammation as a possible mechanism of probiotic effect in atopic eczema‐dermatitis syndrome. Journal of Allergy & Clinical Immunology 2005;115(6):1254‐9.

Viljanen 2005c {published data only}

Viljanen M, Kuitunen M, Haahtela T, Juntunen‐Backman K, Korpela R, Savilahti E. Probiotic effects on faecal inflammatory markers and on faecal IgA in food allergic atopic eczema/dermatitis syndrome infants. Pediatric Allergy and Immunology 2005;16(1):65‐71.

Referencias de los estudios en espera de evaluación

Ir a:

Matsumoto 2007 {published data only}

Matsumoto M, Aranami A, Ishige A, Watanabe K, Benno Y. LKM512 yoghurt consumption improves the intestinal environment and induces the T‐helper type 1 cytokine in adult patients with intractable atopic dermatitis. Clinical and Experimental Allergy 2007;37:358‐370.

Roessler 2007 {published data only}

Roessler A, Friedrich U, Vogelsang H, Bauer A, Kaatz M, Hipler UC, et al. The immune system in healthy adults and patients with atopic dermatitis seems to be affected differently by a probiotic intervention. Clinical and Experimental Allergy 2007;38:93‐102.

CAMEL {published and unpublished data}

Hol. Cow's milk allergy mediated by elimination and probiotics. ISRCTN 04799749. [ISRCTN 04799749]

Goossens {published data only}

Goossens. Effects of synbiotics in infants with atopic dermatitis. ISRCTN 69085979. [ISRCTN 69085979]

Land {published data only}

Land. The effects of probiotics in atopic dermatitis. NCT00378300.

Murray {published data only}

Murray. Probiotics in Atopic Dermatitis in Infancy. ISRCTN 41490500. [ISRCTN 41490500]

Allen 2003

Allen SJ, Okoko B, Martinez E, Gregorio G, Dans LF. Probiotics for treating infectious diarrhoea. Cochrane Database of Systematic Reviews 2003, Issue 4. [DOI: 10.1002/14651858.CD003048.pub2]

Archer 2000

Archer CB. The pathophysiology and clinical features of atopic dermatitis. In: Williams H editor(s). Atopic Dermatitis. The epidemiology, causes and prevention of atopic eczema. 1st Edition. Cambridge: Cambridge University Press, 2000:25‐40.

Baum 2002

Baum WF, Schneyer U, Lantzsch AM, Kloditz E. Delay of growth and development in children with bronchial asthma, atopic dermatitis and allergic rhinitis. Experimental & Clinical Endocrinology & Diabetes 2002;110(2):53‐9.

Beck 2000

Beck LA, Leung DY. Allergen sensitization through the skin induces systemic allergic responses. Journal of Allergy & Clinical Immunology 2000;106(5 Suppl):S258‐63.

Besselink 2008

Besselink MGH, van Santvoort HC, Buskens E, Boermeester MA, van Goor H, Timmerman HM, et al. Probiotic prophylaxis in predicted severe acute pancreatitis: a randomised double‐blind placebo‐controlled trial. Lancet 2008;371:651‐9.

Bjorksten 2001

Bjorksten B, Sepp E, Julge K, Voor T, Mikelsaar M. Allergy development and the intestinal microflora during the first year of life. Journal of Allergy andClinical Immunology 2001;108(4):516‐20.

Bohme 2001

Bohme M, Svensson A, Kull I, Nordvall SL, Wahlgren CF. Clinical features of atopic dermatitis at two years of age: a prospective, population‐based case‐control study. Acta Dermato‐Venereologica 2001;81(3):193‐7.

Borriello 2003

Borriello SP, Hammes WP, Holzapfel W, Marteau P, Schrezenmeir J, Vaara M, et al. Safety of probiotics that contain lactobacilli or bifidobacteria. Clinical Infectious Diseases 2003;36(6):775‐80.

Boyle 2006

Boyle RJ, Robins‐Browne RM, Tang ML. Probiotic use in clinical practice: what are the risks?. American Journal of Clinical Nutrition 2006;83(6):1256‐64.

Burton 2006

Burton JP, Wescombe PA, Moore CJ, Chilcott CN, Tagg JR. Safety assessment of the oral cavity probiotic Streptococcus salivarius K12. Applied & Environmental Microbiology 2006;72(4):3050‐3.

Caffarelli 1998

Caffarelli C, Cavagni G, Deriu FM, Zanotti P, Atherton DJ. Gastrointestinal symptoms in atopic eczema. Archives of Disease in Childhood 1998;78(3):230‐4. [MEDLINE: 9613352]

Charman 2000

Charman C, Williams HC. Outcome measures of disease severity in atopic eczema. Archives of Dermatology 2000;136:763‐9.

Charman 2002

Charman C, Williams HC. Epidemiology. In: Thomas Bieber, Donald YM Leung editor(s). Atopic Dermatitis. 1st Edition. New York: Marcel Dekker Inc, 2002:21‐42.

Cherifi 2004

Cherifi S, Robberecht J, Miendje Y. Saccharomyces cerevisiae fungemia in an elderly patient with Clostridium difficile colitis. Acta Clinica Belgica 2004;59(4):223‐4.

Chren 1997

Chren MM, Lasek RT, Flocke SA, Zyzanski SJ. Improved discriminative and evaluative capability of a refined version of SKINDEX, a quality‐of‐life instrument for patients with skin diseases. Archives of Dermatology 1997;133:1433‐40.

Christensen 2002

Christensen HR, Frokiaer H, Pestka JJ. Lactobacilli differentially modulate expression of cytokines and maturation surface markers in murine dendritic cells. Journal of Immunology 2002;168(1):171‐8.

Connolly 2005

Connolly E, Abrahamsson T, Bjorksten B. Safety of D(‐)‐lactic acid producing bacteria in the human infant. Journal of Pediatric Gastroenterology & Nutrition 2005;41(4):489‐92.

Cookson 2002

Cookson W. Genetics and genomics of asthma and allergic diseases. Immunological Review 2002;190:195‐206.

De Groote 2005

De Groote MA, Frank DN, Dowell E, Glode MP, Pace NR. Lactobacillus rhamnosus GG bacteremia associated with probiotic use in a child with short gut syndrome. The Pediatric Infectious Disease Journal 2005;24(3):278‐80.

Ellis 2002

Ellis CN, Drake LA, Prendergast MM, Abramovits W, Boguniewicz M, Daniel CR, et al. Cost of atopic dermatitis and eczema in the United States. Journal of the American Academy of Dermatology 2002;46(3):361‐70.

Emerson 1998

Emerson RM, Williams HC, Allen BR. Severity distribution of atopic dermatitis in the community and its relationship to secondary referral. British Journal of Dermatology 1998;139(1):73‐6.

Ernst 2000

Ernst E, Pittler MH, Stevinson C. Complementary/alternative medicine in dermatology: evidence‐assessed efficacy of two diseases and two treatments. American Journal of Clinical Dermatology 2000;3(5):341‐8.

FAOWHO 2002

Report FAOWHO. Guidelines for the evaluation of probiotics in food. www.who.int/entity/foodsafety/ fs_management/en/probiotic_guidelines.pdf. London, Ontario, Canada, 2002.

Fennessy 2000

Fennessy M, Coupland S, Popay J, Naysmith K. The epidemiology and experience of atopic eczema during childhood: a discussion paper on the implications of current knowledge for health care, public health policy and research. Journal of Epidemiology & Community Health 2000;54(8):581‐9.

Finlay 1996

Finlay AY. Measurement of disease activity and outcome in atopic dermatitis. The British Journal of Dermatology 1996;135:509‐15.

Flohr 2004

Flohr C, Johansson SGO, Wahlgren C‐F, Williams H. How atopic is atopic dermatitis?. The Journal of Allergy and Clinical Immunology 2004;114:150‐8.

Gionchetti 2000

Gionchetti P, Rizzello F, Venturi A, Brigidi P, Matteuzzi D, Bazzocchi G, et al. Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: a double‐blind, placebo‐controlled trial. Gastroenterology 2000;119(2):305‐9.

Hennequin 2000

Hennequin C, Kauffmann‐Lacroix C, Jobert A, Viard JP, Ricour C, Jacquemin JL, et al. Possible role of catheters in Saccharomyces boulardii fungemia. European Journal of Clinical Microbiology and Infectious Diseases 2000;19(1):16‐20.

Hoare 2000

Hoare C, Li Wan Po A, Williams H. Systematic review of treatments for atopic eczema. Health Technology Assessment (Winchester, England) 2000;4(37):1‐191.

Ishibashi 2001

Ishibashi N, Yamazaki S. Probiotics and safety. American Journal of Clinical Nutrition 2001;73(2 Suppl):S465‐70.

Johansson 2001

Johansson SGO, Hourihane J, Bousquet J, Bruijnzeel‐Koomen C, Dreborg S, Haahtela T, et al. A revised nomenclature for allergy: an EAACI position statement from the EAACI nomenclature task force. Allergy 2001;56:813‐24.

Johansson 2004

Johansson SGO, Bieber T, Dahl R, Friedmann PS, Lanier BQ, Lockey RF, et al. Revised nomenclature for allergy for global use: Report of the Nomenclature Review Committee of the World Allergy Organization, October 2003. The Journal of Allergy and Clinical Immunology 2004;113:832‐6.

Juni 2001

Juni P, Altman DG, Egger M. Assesing the quality of controlled clinical trials. BMJ 2001;323:42‐6.

Kalliomaki 2001

Kalliomaki M, Kirjavainen P, Eerola E, Kero P, Salminen S, Isolauri E. Distinct patterns of neonatal gut microflora in infants in whom atopy was and was not developing. Journal of Allergy and Clinical Immunology 2001;107(1):129‐34.

Kemp 1999

Kemp AS. Atopic eczema: its social and financial costs. Journal of Paediatrics and Child Health 1999;35(3):229‐31.

Kukkonen 2007

Kukkonen K, Savilahti E, Haahtela T, Juntunen‐Backman K, Korpela R, Poussa T, et al. Probiotics and prebiotic galacto‐oligosaccharides in the prevention of allergic diseases: a randomized, double‐blind, placebo‐controlled trial. Journal of Allergy and Clinical Immunology 2007;119(1):192‐8. [MEDLINE: 17208601]

Kunz 1997

Kunz B, Oranje AP, Labreze L, Stalder JF, Ring J, Taieb A. Clinical validation and guidelines for the SCORAD index: consensus report of the European Task Force on Atopic Dermatitis. Dermatology 1997;195(1):10‐9.

Lamb 2002

Lamb SR, Rademaker M. Pharmacoeconomics of drug therapy for atopic dermatitis. Expert Opinion on Pharmacotherapy 2002;3(3):249‐55.

Land 2005

Land MH, Rouster‐Stevens K, Woods CR, Cannon ML, Cnota J, Shetty AK. Lactobacillus sepsis associated with probiotic therapy. Pediatrics 2005;115(1):178‐81.

Lawson 1998

Lawson V, Lewis‐Jones MS, Finlay AY, et al. The family impact of childhood atopic dermatitis: the Dermatitis Family Impact Questionnaire. British Journal of Dermatology 1998;138(1):107‐13.

Lestin 2003

Lestin F, Pertschy A, Rimek D. Fungemia after oral treatment with Saccharomyces boulardii in a patient with multiple comorbidities [Fungamie nach oraler Gabe]. Deutsche Medizinische Wochenschrift 2003;128(48):2531‐3.

Makelainen 2003

Makelainen H, Tahvonen R, Salminen S, Ouwehand AC. In vivo safety assessment of two Bifidobacterium longum strains. Microbiology & Immunology 2003;47(12):911‐4.

McHenry 1995

McHenry PM, Williams HC, Bingham EA. Management of atopic eczema. Joint Workshop of the British Association of Dermatologists and the Research Unit of the Royal College of Physicians of London. BMJ 1995;310(6983):843‐7.

Moro 2006

Moro G, Arslanoglu S, Stahl B, Jelinek J, Wahn U, Boehm G. A mixture of prebiotic oligosaccharides reduces the incidence of atopic dermatitis during the first six months of age. Archives of Disease in Childhood 2006;91(10):814‐9. [MEDLINE: 16873437]

Murray 2005

Murray CS, Tannock GW, Simon MA, Harmsen HJ, Welling GW, Custovic A, et al. Fecal microbiota in sensitized wheezy and non‐sensitized non‐wheezy children: a nested case‐control study. Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology 2005;35(6):741‐5.

Osborn 2007

Osborn DA, Sinn JK. Probiotics in infants for prevention of allergic disease and food hypersensitivity. Cochrane Database of Systematic Reviews 2007, Issue 4. [DOI: 10.1002/14651858.CD006475.pub2]

Pessi 2000

Pessi T, Sutas Y, Hurme M, Isolauri E. Interleukin‐10 generation in atopic children following oral Lactobacillus rhamnosus GG. Clinical and Experimental Allergy 2000;30(12):1804‐8.

Polosa 2001

Polosa R. The interaction between particulate air pollution and allergens in enhancing allergic and airway responses. Current Allergy & Asthma Reports 2001;1(2):102‐7.

Proksch 2003

Proksch E, Jensen JM, Elias PM. Skin lipids and epidermal differentiation in atopic dermatitis. Clinical Dermatology 2003;21(2):134‐44.

Riquelme 2003

Riquelme AJ, Calvo MA, Guzman AM, Depix MS, Garcia P, Perez C, et al. Saccharomyces cerevisiae fungemia after Saccharomyces boulardii treatment in immunocompromised patients. Journal of Clinical Gastroenterology 2003;36(1):41‐3.

Robertson 2004

Robertson CF, Roberts MF, Kappers JH. Asthma prevalence in Melbourne schoolchildren: have we reached the peak?. Medical Journal of Australia 2004;180(6):273‐6.

Ruden 1999

Ruden U, Wahn U, Kehrt, R. [Entwicklung und Validierung eines krankheitsspezifischen Fragebogens zur Erfassung der Lebensqualitat von Eltern neurodermitiskranker Kinder]. Z Gesundheitswiss 1999;4:335‐350.

Salminen 1998

Salminen S, von Wright A, Morelli L, Marteau P, Brassart D, de Vos WM, et al. Demonstration of safety of probiotics ‐ a review. International Journal of Food Microbiology 1998;44(1‐2):93‐106.

Sepp 1993

Sepp E, Mikelsaar M, Salminen S. Effect of lactobacillus casei strain GG administration on the gastrointestinal microbiota of newborns. Microbial Ecology in Health and Disease 1993;6:309‐14.

Smethurst 2002

Smethurst D. Atopic eczema. Clinical Evidence. London: BMJ, 2002:1664‐82.

Spanhaak 1998

Spanhaak S, Havenaar R, Schaafsma G. The effect of consumption of milk fermented by lactobacillus casei strain Shirota on the intestinal microflora and immune parameters in humans. European Journal of Clinical Nutrition 1998;52(12):899‐907.

Srinivasan 2006

Srinivasan R, Meyer R, Padmanabhan R, Britto J. Clinical safety of Lactobacillus casei shirota as a probiotic in critically ill children. Journal of Pediatric Gastroenterology & Nutrition 2006;42(2):171‐3.

Su 1997

Su JC, Kemp AS, Varigos GA, Nolan TM. Atopic eczema: its impact on the family and financial cost. Archives of Diseases in Childhood 1997;76(2):159‐62.

Thestrup 2002

Thestrup‐Pedersen K. Treatment principles of atopic dermatitis. Journal of the European Academy of Dermatology & Venereology 2002;16(1):1‐9.

Van Bever 2002

Van Bever HP. Early events in atopy. European Journal of Pediatrics 2002;161(10):542‐6.

Werfel 2004

Werfel T, Breuer K. Role of food allergy in atopic dermatitis. Current Opinions in Allergy and Clinical Immunology 2004;4(5):379‐85.

Williams 1999

Williams H, Robertson C, Stewart A, Ait‐Khaled N, Anabwani G, Anderson R, et al. Worldwide variations in the prevalence of symptoms of atopic eczema in the International Study of Asthma and Allergies in Childhood. Journal of Allergy and Clinical Immunology 1999;103(1 Pt 1):125‐38.

Williams 2005

Williams HC. Clinical practice. Atopic dermatitis. New England Journal of Medicine 2005;352(22):2314‐24.

Wolf 1998

Wolf BW, Wheeler KB, Ataya DG, Garleb KA. Safety and tolerance of Lactobacillus reuteri supplementation to a population infected with the human immunodeficiency virus. Food & Chemical Toxicology 1998;36(12):1085‐94.

Yoshioka 1983

Yoshioka H, Iseki K, Fujita K. Development and differences of intestinal flora in the neonatal period in breast‐fed and bottle‐fed infants. Pediatrics 1983;72(3):317‐21.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ir a:

Brouwer 2006

Methods

Three month parallel group randomised controlled trial.

Participants

Fifty infants under five months age with mild/moderate eczema diagnosed using Hanifin and Rajka criteria, and a clinical history suggestive of cow's milk allergy. All participants were exclusively formula fed, and received an extensively hydrolysed formula for three to five weeks prior to receiving the study intervention. Infants receiving antihistamines, oral corticosteroids or any probiotic/antibiotic/antimycotic in the preceding four weeks were excluded, as were those with a congenital gastrointestinal malformation. Setting primary care in the Netherlands. One participant lost to follow‐up.

Interventions

Extensively hydrolysed whey‐based formula given alone, with Lactobacillus rhamnosus at 5x109 cfu/100mls or with Lactobacillus GG at 5x109 cfu/100mls. The study formula was offered at all feeds during the intervention period.

Outcomes

SCORAD assessed at baseline, one, two and three months.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear
Folster‐Holst 2006

Methods

Eight week parallel group randomised controlled trial.

Participants

Fifty‐three children aged 1 to 55 months with eczema diagnosed using Hanifin and Rajka criteria. Setting German Dermatology Centre. Six participants lost to follow‐up.

Interventions

Lactobacillus GG at 1010 cfu/day as a twice daily dose, or microcrystalline cellulose placebo. Interventions given as capsules, which were mixed with milk if bottle fed, or mixed with water if not bottle fed.

Outcomes

1. Parent global assessment of disease severity
2. Quality of life score Ruden 1999
3. SCORAD
4. Use of topical corticosteroid and systemic antihistamine treatment. Assessments were made at two, four, six and eight weeks after the start of the study.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear
Gruber 2007

Methods

Twelve week parallel group randomised controlled trial.

The last observation carried forward approach was used for missing continuous data.

Participants

106 children aged 3 to12 months with mild/moderate eczema and SCORAD 15 to 40, not receiving antiinflammatory treatment. Four participants excluded from analysis after randomisation due to protocol breaches.

Interventions

Lactobacillus GG at 1010 cfu/day as a twice daily dose, or placebo.

Outcomes

1. SCORAD
2. Use of 1% hydrocortisone ointment

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear
Isolauri 2000

Methods

Parallel group three arm randomised controlled trial. Duration of treatment unclear.

Participants

Twenty‐seven infants ‐ ages not stated ‐ with eczema diagnosed using the Hanifin and Rajka criteria. All infants were exclusively breast fed, and were tolerant of the study formula without added probiotic. Setting paediatric service in Finland. Unclear how many participants lost to follow‐up.

Interventions

Extensively hydrolysed whey‐dominant cow's milk formula with no probiotic added, with Lactobacillus GG added at 3x108 cfu/g or with Bifidobacterium lactis Bb‐12 added at 1x109 cfu/g.

Outcomes

SCORAD ‐ interval of assessment unclear.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear
Kirjavainen 2003

Methods

Parallel group randomised controlled trial. Intended duration of treatment not clear.

Participants

Twenty‐seven infants (mean age 5.5 months) with eczema and suspected cow's milk allergy. Method for diagnosing eczema not described. Setting Hospital Paediatric department in Finland. Unclear how many participants lost to follow‐up.

Interventions

Lactobacillus GG at 3x1010 cfu/kg/day, mixed with extensively hydrolysed whey formula, or the same formula without probiotic. A third treatment arm (excluded from this review) used heat‐inactivated LGG at 3x1010 cfu/kg/day, mixed with extensively hydrolysed whey formula.

Outcomes

SCORAD

Notes

Study terminated early due to adverse effects in a third treatment arm. The third treatment arm was not included in this systematic review since it involved the use of killed bacteria.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear
Majamaa 1997

Methods

One month parallel group randomised controlled trial.

Participants

Thirty‐one children aged 2 to 16 months with eczema diagnosed using the Hanifin and Rajka criteria, and a history suggestive of cow's milk allergy. Children currently receiving systemic corticosteroid treatment were excluded. Setting of a paediatric clinic in Finland. Unclear how many participants lost to follow‐up.

Interventions

Cow's milk elimination diet, topical eczema treatment and extensively hydrolysed cow's milk formula with or without addition of probiotic Lactobacillus GG. Probiotic given at 5x108 cfu/g formula.

Outcomes

SCORAD assessed at one and two months.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear
Passeron 2006

Methods

Three month parallel group randomised controlled trial.

Participants

Forty‐eight children aged 2 to 12 years with moderate/severe eczema diagnosed by UK Working Party Criteria and total SCORAD over 14. Exclusion criteria were current flare of eczema, exposure to systemic corticosteroids or immunosuppressants in the previous three months or other known immune deficiency. Setting hospital dermatology clinic in France. Nine participants lost to follow‐up.

Interventions

Skim milk powder, potato starch and lactose containing prebiotic, with or without Lactobacillus rhamnosus Lcr35 at 3.6x109 cfu/day given as a three times daily dose mixed with cold water or other liquid.

Outcomes

1. Parent or participant global assessment of eczema severity
2. SCORAD
3. Investigator global assessment of eczema severity
Assessments were at baseline, one, two and three months.

Notes

Three episodes of mild abdominal pain reported ‐ Two in probiotic group, one in placebo (prebiotic alone) group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate
Rosenfeldt 2003

Methods

Six week randomised controlled cross‐over trial.

Participants

Fifty‐eight children aged 1 to 13 years with eczema diagnosed using the UK Working Party Criteria. Children who had received systemic corticosteroids at any time were excluded. Setting: hospital paediatric and dermatology departments in Denmark. 15 participants lost to follow‐up.

Interventions

Skimmed milk powder with dextrose anhydrate 2 g/day or a mix of Lactobacillus rhamnosus 19070‐2 and Lactobacillus reuteri DSM12246 at 2x1010 cfu/day of each strain. Both placebo and probiotic preparations administered twice daily with 2.5 to 5ml water.

Outcomes

1. Global self assessment by participant or parent
2. SCORAD
3. Need for other treatment ‐ topical corticosteroid

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear
Sistek 2006

Methods

Twelve week parallel group randomised controlled trial.

Participants

Sixty children aged 1to 10 years with eczema diagnosed by UK Working Party criteria, SCORAD of at least ten at recruitment and a positive skin prick or RAST test to at least one common evironmental or food allergen. Exclusion criteria were oral corticosteroid, immunosuppressant or antibiotic in the previous month, previous immune deficiency or malignancy and greater than ten point improvement in SCORAD during two weeks prior to commencing study treatment. Setting hospital clinic in New Zealand. One participant lost to follow‐up.

Interventions

Microcrystalline cellulose placebo or Lactobacillus rhamnosus and Bifidobacterium lactis given together once daily at a combined total dose of 2x1010 cfu/day. Treatment capsules administered as either a powder mixed with food or drink, or taken in capsule form.

Outcomes

SCORAD assessed at two weeks before treatment, on commencing treatment, then 2, 12 and 16 weeks later.

Notes

One participant noted to be taking other non‐investigational probiotic.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate
Taniuchi 2005

Methods

Three month parallel group randomised controlled trial.

Participants

Seventeen children aged 3 to 18 months with eczema diagnosed by Hanifin and Rajka criteria, and cows milk hypersensitivity diagnosed by suggestive history plus evidence of cow milk specific IgE. All participants had reduced levels of Bifidobacteria in their faeces (under 30% of total bacteria) and were receiving extensively hydrolysed cow's milk formula for at least two weeks prior to randomisation. Setting unclear. Unclear how many participants lost to follow‐up.

Interventions

Raffinose prebiotic containing extensively hydrolysed cow's milk formula with or without Bifidobacterium breve M‐16V at 5‐15x109cfu/day.

Outcomes

Investigator‐rated eczema scoring system

Notes

No numerical outcome data available.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear
Viljanen 2005

Methods

Four week parallel group randomised controlled trial.

Participants

252 infants aged under 12 months with a clinical diagnosis of eczema and a clinical history suggestive of cow's milk allergy. Infants who had received a probiotic preparation for over a week in the preceding six weeks were excluded. Participants were selected from primary care referrals to a hospital clinic in Finland. Twenty‐two participants lost to follow‐up.

Interventions

Cow's milk elimination diet, extensively hydrolysed formula and capsules of either microcrystalline cellulose placebo, Lactobacillus GG (1010 cfu/day) or probiotic mix (Lactobacillus GG 1010 cfu/day, Bifidobacterium breve Bbi 99 at 4x108 cfu/day, Lactobacillus rhamnosus LC705 at 1010 cfu/day and Propionibacterium JS 4x109 cfu/day). Capsules were mixed with food twice daily.

Outcomes

SCORAD assessed at the end of treatment and four weeks later.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate
Weston 2005

Methods

Eight week parallel group block randomised controlled trial.

Participants

Fifty‐six children aged 6 to 18 months with moderate/severe eczema diagnosed by Hanifin and Rajka criteria and modified SCORAD score of at least 25 at enrolment. Those previously exposed to probiotics, currently receiving antibiotics or with other major medical problems were excluded. Community and hospital outpatient clinic setting in Australia. Three participants lost to follow‐up.

Interventions

Lactobacillus fermentum VR1‐003PCC 2x109cfu/day as a sachet reconstituted by parents with 5 to 10 ml water twice daily, or maltodextrin placebo.

Outcomes

1. Global self assessment by parent
2. Dermatitis Family Impact Questionnaire Lawson 1998
3. SCORAD
4. Need for other eczema treatment ‐ topical corticosteroid. Assessments made at baseline, 2, 4, 8 and 16 weeks.

Notes

One probiotic treated participant withdrew due to gastrointestinal illness (vomiting).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

SCORAD ‐ Scoring Atopic Dermatitis
UK ‐ United Kingdom

cfu ‐ Colony Forming Units

Characteristics of excluded studies [ordered by study ID]

Ir a:

Study

Reason for exclusion

Arvola 2006

Participants didn't have eczema.

Ikezawa 2004

Intervention was not a probiotic.

Kalliomaki 2003

Participants didn't have eczema.

Laitinen 2005

Study did not report changes in eczema symptoms or severity

Leung 2004

Intervention was not a probiotic

Ogawa 2006

Study did not report changes in eczema symptoms or severity

Pohjavuori 2004

Study did not report changes in eczema symptoms or severity

Prescott 2005

Study did not report changes in eczema symptoms or severity

Rosenfeldt 2004

Study did not report changes in eczema symptoms or severity

Viljanen 2005b

Study did not report changes in eczema symptoms or severity

Viljanen 2005c

Study did not report changes in eczema symptoms or severity

Characteristics of ongoing studies [ordered by study ID]

Ir a:

CAMEL

Trial name or title

Cow's milk allergy mediated by elimination and probiotics

Methods

Participants

118 infants under 6 months with proven cow's milk allergy

Interventions

Casein hydrolysate formula with or without probiotics

Outcomes

Starting date

Contact information

Dr. Jeroen Hol, [email protected], Tel +31 104636946

Notes

ISRCTN 04799749; Trial due to complete 2008
Goossens

Trial name or title

Effects of synbiotics in infants with atopic dermatitis

Methods

Multicenter randomised double blind placebo controlled parallel group intervention study

Participants

Infants aged 0 to7 months with eczema

Interventions

Infant formula with or without synbiotics

Outcomes

SCORAD change after 12 weeks treatment

Starting date

1st September 2005

Contact information

Dr DAM Goossens, Numico Research B.V., PO Box 7005, 6700 CA, Alkmaar, Netherlands

Notes

ISRCTN 69085979
Land

Trial name or title

The effects of probiotics in atopic dermatitis

Methods

Randomised double blind placebo controlled parallel group intervention study

Participants

Children aged six months to three years with moderate to severe eczema

Interventions

An oral probiotic

Outcomes

SCORAD one month after commencing treatment with probiotic or placebo

Starting date

July 2007

Contact information

Michael H Land, UCLA Medical Center, Los Angeles, California, 90095

Notes

NCT00378300

Murray

Trial name or title

Probiotics in Atopic Dermatitis in Infancy

Methods

Randomised double blind placebo controlled parallel group intervention study

Participants

Infants aged three to six months with eczema

Interventions

Lactobacillus paracasei and Bifidobacterium lactis

Outcomes

SCORAD at the end of treatment

Starting date

1st March 2002

Contact information

Dr. Clare Murray, North West Lung Research Centre, Wythenshawe Hospital, Southmoor Road, Manchester M23 9LT [email protected]

Notes

ISRCTN 41490500 Trial completed

Data and analyses

Open in table viewer
Comparison 1. Probiotic vs Placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Participant or parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment Show forest plot

5

Mean difference (Random, 95% CI)

‐0.90 [‐2.84, 1.04]
Analysis 1.1
Comparison 1 Probiotic vs Placebo, Outcome 1 Participant or parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment.

Comparison 1 Probiotic vs Placebo, Outcome 1 Participant or parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment.

1.1 Parallel group trials

4

Mean difference (Random, 95% CI)

‐0.68 [‐3.07, 1.71]

1.2 Cross‐over trials

1

Mean difference (Random, 95% CI)

‐1.80 [‐3.59, ‐0.01]

2 Participant or parent‐rated global change in eczema symptoms during treatment Show forest plot

3

Odds ratio (Random, 95% CI)

0.40 [0.14, 1.15]
Analysis 1.2
Comparison 1 Probiotic vs Placebo, Outcome 2 Participant or parent‐rated global change in eczema symptoms during treatment.

Comparison 1 Probiotic vs Placebo, Outcome 2 Participant or parent‐rated global change in eczema symptoms during treatment.

2.1 Parallel group trials

2

Odds ratio (Random, 95% CI)

0.70 [0.27, 1.77]

2.2 Cross‐over trials

1

Odds ratio (Random, 95% CI)

0.18 [0.05, 0.60]

3 Parent or participant‐rated eczema severity (SCORAD part C) (Long term) Show forest plot

2

102

Mean Difference (IV, Random, 95% CI)

‐2.27 [‐3.97, ‐0.58]
Analysis 1.3
Comparison 1 Probiotic vs Placebo, Outcome 3 Parent or participant‐rated eczema severity (SCORAD part C) (Long term).

Comparison 1 Probiotic vs Placebo, Outcome 3 Parent or participant‐rated eczema severity (SCORAD part C) (Long term).

4 Global eczema severity score (Total SCORAD) (Short term) Show forest plot

7

Mean difference (Random, 95% CI)

‐2.46 [‐7.45, 2.53]
Analysis 1.4
Comparison 1 Probiotic vs Placebo, Outcome 4 Global eczema severity score (Total SCORAD) (Short term).

Comparison 1 Probiotic vs Placebo, Outcome 4 Global eczema severity score (Total SCORAD) (Short term).

4.1 Parallel group studies

6

Mean difference (Random, 95% CI)

‐1.68 [‐7.15, 3.80]

4.2 Cross‐over studies

1

Mean difference (Random, 95% CI)

‐6.27 [‐11.21, ‐1.32]

5 Global eczema severity score (Total SCORAD) ‐ Sensitivity analysis ‐ Change score Show forest plot

5

Mean difference (Random, 95% CI)

‐2.47 [‐4.72, ‐0.21]
Analysis 1.5
Comparison 1 Probiotic vs Placebo, Outcome 5 Global eczema severity score (Total SCORAD) ‐ Sensitivity analysis ‐ Change score.

Comparison 1 Probiotic vs Placebo, Outcome 5 Global eczema severity score (Total SCORAD) ‐ Sensitivity analysis ‐ Change score.

5.1 Parallel group trial

4

Mean difference (Random, 95% CI)

‐2.15 [‐4.64, 0.34]

5.2 Cross‐over trial

1

Mean difference (Random, 95% CI)

‐3.93 [‐9.25, 1.40]

6 Investigator‐rated eczema severity (SCORAD parts A/B) (Long term) Show forest plot

2

102

Mean Difference (IV, Fixed, 95% CI)

‐8.11 [‐13.14, ‐3.09]
Analysis 1.6
Comparison 1 Probiotic vs Placebo, Outcome 6 Investigator‐rated eczema severity (SCORAD parts A/B) (Long term).

Comparison 1 Probiotic vs Placebo, Outcome 6 Investigator‐rated eczema severity (SCORAD parts A/B) (Long term).

7 Participant/parent‐rated symptoms of eczema (SCORAD part C)(Short term)‐Stratified by Age group Show forest plot

5

Mean difference (Random, 95% CI)

Subtotals only
Analysis 1.7
Comparison 1 Probiotic vs Placebo, Outcome 7 Participant/parent‐rated symptoms of eczema (SCORAD part C)(Short term)‐Stratified by Age group.

Comparison 1 Probiotic vs Placebo, Outcome 7 Participant/parent‐rated symptoms of eczema (SCORAD part C)(Short term)‐Stratified by Age group.

7.1 Age under 2 years

2

Mean difference (Random, 95% CI)

‐0.13 [‐4.18, 3.91]

7.2 Age 2‐12 years

1

Mean difference (Random, 95% CI)

0.33 [‐1.94, 2.60]

7.3 Age not categorised

2

Mean difference (Random, 95% CI)

‐2.23 [‐3.71, ‐0.74]

8 Participant/parent‐rated global change in symptoms of eczema (Short term) ‐ Stratified by Age Show forest plot

3

Odds ratio (Random, 95% CI)

Totals not selected
Analysis 1.8
Comparison 1 Probiotic vs Placebo, Outcome 8 Participant/parent‐rated global change in symptoms of eczema (Short term) ‐ Stratified by Age.

Comparison 1 Probiotic vs Placebo, Outcome 8 Participant/parent‐rated global change in symptoms of eczema (Short term) ‐ Stratified by Age.

8.1 Age under 2 years

1

Odds ratio (Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Age 2‐ 12 years

1

Odds ratio (Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Age not categorised

1

Odds ratio (Random, 95% CI)

0.0 [0.0, 0.0]

9 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Age group Show forest plot

7

Mean difference (Random, 95% CI)

Subtotals only
Analysis 1.9
Comparison 1 Probiotic vs Placebo, Outcome 9 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Age group.

Comparison 1 Probiotic vs Placebo, Outcome 9 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Age group.

9.1 Age under 2 years

3

Mean difference (Random, 95% CI)

0.74 [‐5.06, 6.54]

9.2 Age 2 ‐ 12 years

1

Mean difference (Random, 95% CI)

‐3.28 [‐13.78, 7.22]

9.3 Age not categorised

3

Mean difference (Random, 95% CI)

‐5.66 [‐14.82, 3.50]

10 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Presence of Atopy Show forest plot

7

Mean difference (Random, 95% CI)

Subtotals only
Analysis 1.10
Comparison 1 Probiotic vs Placebo, Outcome 10 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Presence of Atopy.

Comparison 1 Probiotic vs Placebo, Outcome 10 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Presence of Atopy.

10.1 Participants with atopy

2

Mean difference (Random, 95% CI)

‐5.50 [‐23.87, 12.87]

10.2 Participants with unknown atopic status

5

Mean difference (Random, 95% CI)

‐1.73 [‐7.29, 3.83]

11 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Challenge‐Proven Food Allergy Show forest plot

6

Mean Difference (IV, Random, 95% CI)

Subtotals only
Analysis 1.11
Comparison 1 Probiotic vs Placebo, Outcome 11 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Challenge‐Proven Food Allergy.

Comparison 1 Probiotic vs Placebo, Outcome 11 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Challenge‐Proven Food Allergy.

11.1 Food allergy present

1

120

Mean Difference (IV, Random, 95% CI)

1.15 [‐3.20, 5.50]

11.2 Unknown food allergic status

5

300

Mean Difference (IV, Random, 95% CI)

‐3.19 [‐10.59, 4.20]

12 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Eczema Severity Show forest plot

4

Mean Difference (IV, Random, 95% CI)

Subtotals only
Analysis 1.12
Comparison 1 Probiotic vs Placebo, Outcome 12 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Eczema Severity.

Comparison 1 Probiotic vs Placebo, Outcome 12 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Eczema Severity.

12.1 Severe eczema (SCORAD over 40)

3

70

Mean Difference (IV, Random, 95% CI)

‐7.00 [‐15.34, 1.34]

12.2 Moderate eczema (SCORAD 15‐40)

4

175

Mean Difference (IV, Random, 95% CI)

‐3.45 [‐10.34, 3.45]

12.3 Mild eczema (SCORAD under 15)

1

8

Mean Difference (IV, Random, 95% CI)

‐5.53 [‐15.29, 4.23]

13 Global eczema severity (Total SCORAD) (Short term)‐Stratified by Probiotic Show forest plot

7

Mean difference (Random, 95% CI)

Subtotals only
Analysis 1.13
Comparison 1 Probiotic vs Placebo, Outcome 13 Global eczema severity (Total SCORAD) (Short term)‐Stratified by Probiotic.

Comparison 1 Probiotic vs Placebo, Outcome 13 Global eczema severity (Total SCORAD) (Short term)‐Stratified by Probiotic.

13.1 Lactobacillus rhamnosus GG, either alone or in combination with different probiotic bacteria

3

Mean difference (Random, 95% CI)

3.37 [0.55, 6.20]

13.2 Other Lactobacillus strains, either alone or in combination with different probiotic bacteria

4

Mean difference (Random, 95% CI)

‐7.64 [‐11.65, ‐3.62]

14 Adverse events (Short term) Show forest plot

5

Odds Ratio (M‐H, Random, 95% CI)

Subtotals only
Analysis 1.14
Comparison 1 Probiotic vs Placebo, Outcome 14 Adverse events (Short term).

Comparison 1 Probiotic vs Placebo, Outcome 14 Adverse events (Short term).

14.1 Gastrointestinal symptoms

5

304

Odds Ratio (M‐H, Random, 95% CI)

1.57 [0.78, 3.15]

Comparison 1 Probiotic vs Placebo, Outcome 1 Participant or parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment.
Figuras y tablas -
Analysis 1.1

Comparison 1 Probiotic vs Placebo, Outcome 1 Participant or parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment.

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Comparison 1 Probiotic vs Placebo, Outcome 2 Participant or parent‐rated global change in eczema symptoms during treatment.
Figuras y tablas -
Analysis 1.2

Comparison 1 Probiotic vs Placebo, Outcome 2 Participant or parent‐rated global change in eczema symptoms during treatment.

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Comparison 1 Probiotic vs Placebo, Outcome 3 Parent or participant‐rated eczema severity (SCORAD part C) (Long term).
Figuras y tablas -
Analysis 1.3

Comparison 1 Probiotic vs Placebo, Outcome 3 Parent or participant‐rated eczema severity (SCORAD part C) (Long term).

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Comparison 1 Probiotic vs Placebo, Outcome 4 Global eczema severity score (Total SCORAD) (Short term).
Figuras y tablas -
Analysis 1.4

Comparison 1 Probiotic vs Placebo, Outcome 4 Global eczema severity score (Total SCORAD) (Short term).

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Comparison 1 Probiotic vs Placebo, Outcome 5 Global eczema severity score (Total SCORAD) ‐ Sensitivity analysis ‐ Change score.
Figuras y tablas -
Analysis 1.5

Comparison 1 Probiotic vs Placebo, Outcome 5 Global eczema severity score (Total SCORAD) ‐ Sensitivity analysis ‐ Change score.

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Comparison 1 Probiotic vs Placebo, Outcome 6 Investigator‐rated eczema severity (SCORAD parts A/B) (Long term).
Figuras y tablas -
Analysis 1.6

Comparison 1 Probiotic vs Placebo, Outcome 6 Investigator‐rated eczema severity (SCORAD parts A/B) (Long term).

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Comparison 1 Probiotic vs Placebo, Outcome 7 Participant/parent‐rated symptoms of eczema (SCORAD part C)(Short term)‐Stratified by Age group.
Figuras y tablas -
Analysis 1.7

Comparison 1 Probiotic vs Placebo, Outcome 7 Participant/parent‐rated symptoms of eczema (SCORAD part C)(Short term)‐Stratified by Age group.

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Comparison 1 Probiotic vs Placebo, Outcome 8 Participant/parent‐rated global change in symptoms of eczema (Short term) ‐ Stratified by Age.
Figuras y tablas -
Analysis 1.8

Comparison 1 Probiotic vs Placebo, Outcome 8 Participant/parent‐rated global change in symptoms of eczema (Short term) ‐ Stratified by Age.

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Comparison 1 Probiotic vs Placebo, Outcome 9 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Age group.
Figuras y tablas -
Analysis 1.9

Comparison 1 Probiotic vs Placebo, Outcome 9 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Age group.

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Comparison 1 Probiotic vs Placebo, Outcome 10 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Presence of Atopy.
Figuras y tablas -
Analysis 1.10

Comparison 1 Probiotic vs Placebo, Outcome 10 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Presence of Atopy.

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Comparison 1 Probiotic vs Placebo, Outcome 11 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Challenge‐Proven Food Allergy.
Figuras y tablas -
Analysis 1.11

Comparison 1 Probiotic vs Placebo, Outcome 11 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Challenge‐Proven Food Allergy.

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Comparison 1 Probiotic vs Placebo, Outcome 12 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Eczema Severity.
Figuras y tablas -
Analysis 1.12

Comparison 1 Probiotic vs Placebo, Outcome 12 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Eczema Severity.

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Comparison 1 Probiotic vs Placebo, Outcome 13 Global eczema severity (Total SCORAD) (Short term)‐Stratified by Probiotic.
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Analysis 1.13

Comparison 1 Probiotic vs Placebo, Outcome 13 Global eczema severity (Total SCORAD) (Short term)‐Stratified by Probiotic.

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Comparison 1 Probiotic vs Placebo, Outcome 14 Adverse events (Short term).
Figuras y tablas -
Analysis 1.14

Comparison 1 Probiotic vs Placebo, Outcome 14 Adverse events (Short term).

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Table 1. Terms used to categorise trial participants with eczema

Forms of eczema included

Forms of eczema excluded

Atopic eczema

Seborrheic eczema

Atopic dermatitis

Contact eczema

Besnier's prurigo

Allergic contact eczema

Neurodermatitis atopica (German)

Irritant contact eczema

Flexural eczema/ dermatitis

Discoid/ nummular eczema

Periorbital eczema

Asteatotic eczema

Childhood eczema

Varicose/ stasis eczema

Infantile eczema

Photo‐/ light‐sensitive eczema

'Eczema' unspecified

Chronic actinic dermatitis

Constitutional eczema

Dishydrotic eczema

Endogenous eczema

Pompholyx eczema

Chronic eczema

Hand eczema

Neurodermatitis

Frictional lichenoid dermatitis

Neurodermatitis (German)

Lichen simplex

Occupational dermatitis

Prurigo
Figuras y tablas -
Table 1. Terms used to categorise trial participants with eczema
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Table 2. Methodological quality of included studies

Study

Treatment allocation

Blinding

Loss to follow‐up

Clarity of methods

Compliance

Dietary management

Brouwer 2006

Method not described

Unclear

One1 participant lost to follow‐up after randomisation. Available case analysis used, with no exclusions after randomisation and no imputation of data.

Clear

No compliance measures described

Adequate exclusion of other probiotics during study

Gruber 2007

Method not described

Described as 'double blind' but no details given

No loss to follow‐up. Four participants excluded from analysis after randomisation.

Unclear what the placebo was; otherwise clear

92.5% of doses taken by probiotic group; 94.4% by placebo group

Not stated, other than an encouragement to avoid allergens

Isolauri 2000

Method not described

Described as 'double blind' but no details given

Loss to follow‐up not stated. Not clear whether available case analysis was used.

Unclear ‐ dose and duration of probiotic treatment received not clearly described. Severity of participant eczema at baseline not described.

No compliance measures reported

Not stated

Majamaa 1997

Method not described

Described as 'double blind' but no details given

Loss to follow‐up data not given. Not clear whether available case analysis was used. Four participants excluded from analysis after randomisation, based on later negative food challenge.

Unclear ‐ precise dose of probiotic received by participants not stated

No compliance measures described

Not stated

Passeron 2006

Treatment allocated by hospital pharmacy according to a computer generated randomisation sequence.

Participants, clinicians and outcome assessers were all blinded

Nine participants lost to follow‐up. Available case analysis used, with no exclusions after randomisation. A secondary analysis was performed by the authors using imputation of missing data, but was not included in this meta‐analysis.

Clear

No compliance measures described

Not stated

Rosenfeldt 2003

Method not described

Described as 'double blind' but no details given

Fifteen participants excluded from analysis after randomisaton, for reasons including poor compliance, exacerbation of eczema and loss to follow‐up. No available case analysis performed.

Clear

No compliance measures described

Adequate exclusion of other probiotics during study

Sistek 2006

Treatment allocated by a third party according to a computer generated randomisation sequence. Third party not otherwise involved in the study.

Participants, clinician and outcome assessor blind

One study withdrawal. Available case analysis was used, with no exclusions after randomisation and no imputation of data.

Clear

Assessed by two telephone calls

One participant noted to have taken non‐study probiotic

Taniuchi 2005

Method not described

Unclear

Loss to follow‐up not reported. Not clear whether available case analysis was used.

Clear

No compliance measure described

Not stated

Viljanen 2005

Treatment allocated by a remote third party according to a computer generated randomisation sequence.

Participants, clinicians and outcome assessor blinded

Twenty‐two participants were lost to follow‐up. Analysis was by 'treatment received' because four participants who did not tolerate the study formula were excluded from analysis.

Method for diagnosing eczema not described

No compliance measures described

Not stated

Weston 2005

Treatment allocated by hospital pharmacy according to a computer generated randomisation sequence.

Outcome assessor blind, and also stated 'double blind'

Three participants lost to follow‐up. Available case analysis was used, with no exclusions after randomisation and no imputation of data.

Clear

Sachet counts and parent‐completed sachet administration chart. Good compliance.

Adequate exclusion of other probiotics during study

Kirjavainen 2003

Method not described

Described as 'double blind' but no details given

No loss to follow‐up data given. Analysis was by 'treatment received' because five participants who did not tolerate the study formula were excluded from analysis after randomisation.

Unclear ‐ intended duration of study treatment not stated

No compliance measures reported

Not stated

Folster‐Holst 2006

Method not described

Described as 'double blind' but no details given

Six participants lost to follow‐up. Available case analysis was used.

Clear

No compliance measures reported

Not stated
Figuras y tablas -
Table 2. Methodological quality of included studies
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Table 3. Quality of Life Measures (Weston 2005)

Probiotic 8 weeks

Placebo 8 weeks

Probiotic 16 weeks

Placebo 16 weeks

N

26

27

26

27

Median

‐2

‐2

‐2.5

‐3

IQR

‐5 to ‐0.7

‐6 to +2

‐5 to ‐1

‐7.2 to +2
Figuras y tablas -
Table 3. Quality of Life Measures (Weston 2005)
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Table 4. Non‐parametric analyses of SCORAD scores

Majamaa 1month LGG

Majamaa 1month Place

Majamaa 2mo LGG

Majamaa 2mo Placebo

Isolauri 2mo LGG

Isolauri 2mo Bb12

Isolauri 2mo Placebo

N

13

14

13

14

9

9

9

Median

15

19

16

14

1

0

13.4

IQR

7‐28

13‐31

6‐25

2‐38

0.1‐8.7

0‐3.8

4.5‐18.2

IQR = Interquartile range
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Table 4. Non‐parametric analyses of SCORAD scores
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Table 5. Assessments of need for topical corticosteroid treatment during study

Rosenfeldt Probiotic

Rosenfeldt Placebo

Gruber Probiotic

Gruber Placebo

Weston Probiotic

Weston Placebo

Folster‐H Probiotic

Folster‐H Placebo

N

39

39

Median grams hydrocortisone butyrate applied

7.8

6.0

Range

0 to 67

0 to 59

Mean grams 1% hydrocortisone applied

0.8

3.5

Standard deviation

45.0

29.8

Median change in topical corticosteroid use score

0.25

‐1.0

IQR for change in corticosteroid score

‐6.7 to +7.0

‐8.0 to +0.7

Mean applications per week

3.0

3.2

Standard deviation

0.6

0.9
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Table 5. Assessments of need for topical corticosteroid treatment during study
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Comparison 1. Probiotic vs Placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Participant or parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment Show forest plot

5

Mean difference (Random, 95% CI)

‐0.90 [‐2.84, 1.04]

1.1 Parallel group trials

4

Mean difference (Random, 95% CI)

‐0.68 [‐3.07, 1.71]

1.2 Cross‐over trials

1

Mean difference (Random, 95% CI)

‐1.80 [‐3.59, ‐0.01]

2 Participant or parent‐rated global change in eczema symptoms during treatment Show forest plot

3

Odds ratio (Random, 95% CI)

0.40 [0.14, 1.15]

2.1 Parallel group trials

2

Odds ratio (Random, 95% CI)

0.70 [0.27, 1.77]

2.2 Cross‐over trials

1

Odds ratio (Random, 95% CI)

0.18 [0.05, 0.60]

3 Parent or participant‐rated eczema severity (SCORAD part C) (Long term) Show forest plot

2

102

Mean Difference (IV, Random, 95% CI)

‐2.27 [‐3.97, ‐0.58]

4 Global eczema severity score (Total SCORAD) (Short term) Show forest plot

7

Mean difference (Random, 95% CI)

‐2.46 [‐7.45, 2.53]

4.1 Parallel group studies

6

Mean difference (Random, 95% CI)

‐1.68 [‐7.15, 3.80]

4.2 Cross‐over studies

1

Mean difference (Random, 95% CI)

‐6.27 [‐11.21, ‐1.32]

5 Global eczema severity score (Total SCORAD) ‐ Sensitivity analysis ‐ Change score Show forest plot

5

Mean difference (Random, 95% CI)

‐2.47 [‐4.72, ‐0.21]

5.1 Parallel group trial

4

Mean difference (Random, 95% CI)

‐2.15 [‐4.64, 0.34]

5.2 Cross‐over trial

1

Mean difference (Random, 95% CI)

‐3.93 [‐9.25, 1.40]

6 Investigator‐rated eczema severity (SCORAD parts A/B) (Long term) Show forest plot

2

102

Mean Difference (IV, Fixed, 95% CI)

‐8.11 [‐13.14, ‐3.09]

7 Participant/parent‐rated symptoms of eczema (SCORAD part C)(Short term)‐Stratified by Age group Show forest plot

5

Mean difference (Random, 95% CI)

Subtotals only

7.1 Age under 2 years

2

Mean difference (Random, 95% CI)

‐0.13 [‐4.18, 3.91]

7.2 Age 2‐12 years

1

Mean difference (Random, 95% CI)

0.33 [‐1.94, 2.60]

7.3 Age not categorised

2

Mean difference (Random, 95% CI)

‐2.23 [‐3.71, ‐0.74]

8 Participant/parent‐rated global change in symptoms of eczema (Short term) ‐ Stratified by Age Show forest plot

3

Odds ratio (Random, 95% CI)

Totals not selected

8.1 Age under 2 years

1

Odds ratio (Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Age 2‐ 12 years

1

Odds ratio (Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Age not categorised

1

Odds ratio (Random, 95% CI)

0.0 [0.0, 0.0]

9 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Age group Show forest plot

7

Mean difference (Random, 95% CI)

Subtotals only

9.1 Age under 2 years

3

Mean difference (Random, 95% CI)

0.74 [‐5.06, 6.54]

9.2 Age 2 ‐ 12 years

1

Mean difference (Random, 95% CI)

‐3.28 [‐13.78, 7.22]

9.3 Age not categorised

3

Mean difference (Random, 95% CI)

‐5.66 [‐14.82, 3.50]

10 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Presence of Atopy Show forest plot

7

Mean difference (Random, 95% CI)

Subtotals only

10.1 Participants with atopy

2

Mean difference (Random, 95% CI)

‐5.50 [‐23.87, 12.87]

10.2 Participants with unknown atopic status

5

Mean difference (Random, 95% CI)

‐1.73 [‐7.29, 3.83]

11 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Challenge‐Proven Food Allergy Show forest plot

6

Mean Difference (IV, Random, 95% CI)

Subtotals only

11.1 Food allergy present

1

120

Mean Difference (IV, Random, 95% CI)

1.15 [‐3.20, 5.50]

11.2 Unknown food allergic status

5

300

Mean Difference (IV, Random, 95% CI)

‐3.19 [‐10.59, 4.20]

12 Global eczema severity score (Total SCORAD) (Short term) ‐ Stratified by Eczema Severity Show forest plot

4

Mean Difference (IV, Random, 95% CI)

Subtotals only

12.1 Severe eczema (SCORAD over 40)

3

70

Mean Difference (IV, Random, 95% CI)

‐7.00 [‐15.34, 1.34]

12.2 Moderate eczema (SCORAD 15‐40)

4

175

Mean Difference (IV, Random, 95% CI)

‐3.45 [‐10.34, 3.45]

12.3 Mild eczema (SCORAD under 15)

1

8

Mean Difference (IV, Random, 95% CI)

‐5.53 [‐15.29, 4.23]

13 Global eczema severity (Total SCORAD) (Short term)‐Stratified by Probiotic Show forest plot

7

Mean difference (Random, 95% CI)

Subtotals only

13.1 Lactobacillus rhamnosus GG, either alone or in combination with different probiotic bacteria

3

Mean difference (Random, 95% CI)

3.37 [0.55, 6.20]

13.2 Other Lactobacillus strains, either alone or in combination with different probiotic bacteria

4

Mean difference (Random, 95% CI)

‐7.64 [‐11.65, ‐3.62]

14 Adverse events (Short term) Show forest plot

5

Odds Ratio (M‐H, Random, 95% CI)

Subtotals only

14.1 Gastrointestinal symptoms

5

304

Odds Ratio (M‐H, Random, 95% CI)

1.57 [0.78, 3.15]
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Comparison 1. Probiotic vs Placebo
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