Crohn's disease and Modulen® IBD

Evaluation of Modulen IBD based on evidence in literature

Crohn's disease and Modulen® IBD

Crohn's disease (CD) is a chronic disease associated with inflammations of the digestive tract [1]. However, most often the lower part of the intestine (the ileum) is affected [1]. CD is characterized by periods of remission and exacerbations [1]. Currently, there is no remedy for CD; inducing and maintaining remission of disease activity is one of the most predominant objectives of treatment [1].

Nestlé's Modulen® IBD, a casein-based formula that is rich in transforming growth factor-beta (TGF-β2), is especially composed for the treatment of CD [2]. This nutritionally complete polymeric formula can be given either by the nasogastric route or orally as the sole source of nutrition or as a supplement [2]. According to Nestlé, Modulen® IBD is ‘suitable for patients over five years' and ‘can be reconstituted to a variety of caloric densities' [2].

Evaluation of Modulen® IBD based on evidence in literature

Both corticosteroids as enteral nutrition (EN) are used in the treatment of CD. However, the effectiveness of EN compared to the use of conventional steroids is controversial [3]. Both the ‘effectiveness of exclusive EN therapy as primary therapy to induce remission in Crohn's disease' [3] as well as ‘the efficacy of EN for the maintenance of remission in Crohn's disease' [1] are recently evaluated.

In a Cochrane meta-analysis of six trails including 192 patients in the EN group and 160 patients in the steroid group, it was concluded that EN can induce remission of active CD [3]. However, this effect was inferior to steroids [3]. These findings are in line with past meta-analyses [3]. In contrary, it is indicated that the effectiveness of EN diverges between adults and children; an abstract and a pediatric trial, with a total of 58 patients, and a previous meta-analysis with 147 children showed that EN equals the efficacy of steroids to induce remission in pediatric CD [3]. Moreover, no dissimilarities in the effectiveness of elemental and non-elemental nutrition were found based on 10 trials including 344 patients [3].

A recent Cochrane review of Akobeng and Thomas (2007) showed that supplementary EN can be effective for maintenance of remission in CD. Data is based on two recent randomized clinical trials, however, sample sizes were too small to provide statistical power [1].

Recommendations

It is strongly indicated that steroids are more effective in inducing remission in CD compared to EN [3]. Additionally, compliance might be less for exclusive nutritional intervention compared to the use of steroids; several studies demonstrated a higher withdrawal rate among patients that were treated with EN compared to patients receiving steroids [3]. Nonetheless, the use of steroids as a first line treatment in children should be carefully considered for several reasons. First, it is shown that EN in children is equally effective as steroids in inducing remission [3]. Second, the use of steroids is often associated with side effects in children such as impaired growth and bone mineral density [1, 3]; the use of EN is regarded as safe [1]. A long-term pediatric trial of 37 patients showed that withdrawal rates were comparable in the group of children receiving EN as well as in the group receiving steroid treatment [3]; withdrawal rates in the EN group were even inferior to those observed in adults [3]. Accordingly, it is recommended to use EN to induce clinical remission in the growing child suffering from CD. Furthermore, adults can be treated with EN as an alternative for conventional steroid use if they suffer from intolerances to steroids or if they denote to prefer the use of EN above steroids. Since elemental and non-elemental diets are suggested to be equally effective, it is advisable to implement a polymeric diet such as Modulen® IBD; polymeric diets are more palatable compared to elemental diets [3] and therefore compliance is expected to be improved.

Current evidence suggests that supplementary EN may be effective for maintaining remission in CD, though, this evidence is not indisputable and further studies are desired to confirm these findings [1]. Thereby uncertainties exists regarding the optimal daily quantity of EN required to sustain remission, costs-effectiveness of supplementation and the impact on the quality of life [1]. Moreover, the compliance of supplementation is expected to be low since the endpoint of treatment is unclear for patients.

In conclusion, EN is advised as first line treatment in pediatric CD during exacerbations to avoid steroid side-effects such as an impaired growth. In special cases, Modulen® IBD can be prescribed to adults. At the time being, the use of Modulen® IBD supplementation to maintain remission is not advised.

References

1. Akobeng, A.K. and A.G. Thomas, Enteral nutrition for maintenance of remission in Crohn's disease. Cochrane Database Syst Rev, 2007(3): p. CD005984.

2. Nutritional composition chart Nestlé, Modulen IBD. URL: http://www.nestlenutrition.com/NR/rdonlyres/8B8E7D22-646A-44E7-ACFD-AAE900508CB2/0/ModulenIBD.pdf.

3. Zachos, M., M. Tondeur, and A.M. Griffiths, Enteral nutritional therapy for induction of remission in Crohn's disease. Cochrane Database Syst Rev, 2007(1): p. CD000542.

Appendix I

Literature scheme

1. Article

Enteral nutritional therapy for induction of remission in Crohn's disease. Zachos M, Tondeur M, Griffiths AM. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD000542.

Aim

To evaluate the effectiveness of exclusive enteral nutrition (EN) as primary therapy to induce remission in Crohn's disease and to examine the importance of formula composition on effectiveness.

Design

Meta-analysis, literature review

Conclusion

Corticosteroid therapy is more effective than enteral nutrition for inducing remission of active Crohn's disease as was found in previous systematic reviews. Protein composition does not influence the effectiveness of EN in the treatment of active CD. A non significant trend favouring very low fat and/or very low long chain triglyceride content exists but larger trials are required to explore the significance of this finding.

Search

Pubmed search: Crohn's disease AND treatment AND enteral nutrition AND polymeric

Limits activated: Humans, Meta-Analysis, Review, English, published in the last 10 years

Comment

The 2008 impact factor of the Cochrane Database of Systematic Reviews was 5.182 and ranked in the ISI category Medicine, General & International as 12th out of 107.

2.Article

Enteral nutrition for maintenance of remission in Crohn's disease. Akobeng AK, Thomas AG. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD005984.

Aim

To summarize the available evidence concerning the use of enteral nutrition for the maintenance of remission in Crohn's disease.

Conclusion

The available evidence suggests that supplementary enteral nutritional may be effective for maintenance of remission in Crohn's disease. Whilst larger studies are needed to confirm these findings, enteral nutritional supplementation could be considered as an alternative or as an adjunct to maintenance drug therapy in Crohn's disease.

Search

Pubmed search: "Crohn Disease"[Mesh] AND prevention AND therapy AND enteral nutrition

Limits activated: Humans, Meta-Analysis, Review, English, published in the last 5 years

Comment

The 2008 impact factor of the Cochrane Database of Systematic Reviews was 5.182 and ranked in the ISI category Medicine, General & International as 12th out of 107.

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