Effectiveness of an ‘half elemental diet’ as maintenance therapy for Crohn's disease: a randomized‐controlled trial

Takagi, Sho; Utsunomiya, Keita; Kuriyama, Shinichi; Yokoyama, Hiroyuki; Takahashi, Seiichi; Iseki, Masahiro; Takahashi, Hiroki; Kinouchi, Yoshitaka; Hiwatashi, Nobuo; Funayama, Yuji; Sasaki, Iwao; Tsuji, Ichiro; Shimosegawa, Tooru

doi:10.1111/j.1365-2036.2006.03120.x

Cited by 248 publications

(233 citation statements)

References 33 publications

(30 reference statements)

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“…The full text of the remaining 36 records was examined, of which 12 (representing eight unique studies) were included in the review. 28,[50][51][52][53][54][55][56][57][58][59][60] Of the eight included studies, one RCT [52][53][54] and one nRCT 28,59,60 were represented in multiple publications. Throughout this review, these two studies will be cited according to their corresponding original publications.…”

Section: Literature Searchmentioning

confidence: 99%

“…The study and participant characteristics of the three included RCTs 50,52,55 are summarised in Table 1. Of three RCTs, two were conducted in Japan 50,52 and one in the UK.…”

Section: Randomised Controlled Trialsmentioning

confidence: 99%

“…Of three RCTs, two were conducted in Japan 50,52 and one in the UK. 55 A total of 179 participants were randomised across three RCTs with individual trial sample size ranging from 33 55 to 95 50 participants.…”

Section: Randomised Controlled Trialsmentioning

confidence: 99%

“…55 A total of 179 participants were randomised across three RCTs with individual trial sample size ranging from 33 55 to 95 50 participants. The mean age of participants across the three trials ranged from 29 52 to 44 years 55 and the proportion of females from 23% 52 to 68%. 55 The length of follow-up of the studies ranged from 12 52,55 to 24 months.…”

Section: Randomised Controlled Trialsmentioning

confidence: 99%

“…Throughout this review, these two studies will be cited according to their corresponding original publications. 28,52 The search of on-going trials in the UKCRN Portfolio and WHO ICTRP databases, which includes Clinical Trials.gov and Current Controlled Trials, (carried out in September 2013), retrieved 26 potentially relevant records, none of which was deemed relevant for inclusion in the review.…”

Section: Literature Searchmentioning

confidence: 99%

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Clinical effectiveness and cost-effectiveness of elemental nutrition for the maintenance of remission in Crohn’s disease: a systematic review and meta-analysis

Tsertsvadze

Gurung

Court

et al. 2015

Health Technology Assessment

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BackgroundAlthough enteral nutrition has been shown to be a viable treatment option for the management of active Crohn’s disease (CD), the evidence regarding its clinical benefits compared with standard treatments (e.g. steroids) for maintaining remission in patients with CD has been inconsistent. If enteral nutrition was to be effective, the use of drugs such as steroids and immunosuppressive drugs could be reduced, thereby reducing the likelihood of adverse events associated with these medications.ObjectivesThis systematic review aimed to assess the clinical effectiveness and cost-effectiveness of elemental nutrition (a type of enteral nutrition) for maintenance of remission in patients with CD.Data sourcesMajor bibliographic databases (e.g. MEDLINE, EMBASE, Cochrane Database of Systematic Reviews) were searched from inception to August/September 2013. Searches were not limited by study design, language or publication date. Websites for relevant organisations and references of included studies were checked.MethodsExperimental randomised and non-randomised controlled trials (RCTs and nRCTs) reporting clinical effectiveness and cost-effectiveness of elemental nutrition in the maintenance of remission in patients with CD were eligible. Study selection, data extraction and risk of bias (RoB) assessment were performed independently. Risk ratios (RRs) and mean differences (MDs) were pooled using a random-effects model. Heterogeneity was assessed via forest plots, Cochran’sQand theI2statistics. Overall, quality of evidence for each outcome was rated using the Grading of Recommendations, Assessment, Development, and Evaluation approach.ResultsEight studies (three RCTs and five nRCTs) were included in the review. RCTs indicated a significant benefit of elemental nutrition vs. no intervention (an unrestricted diet) in maintaining remission at 24 months [one RCT; RR 2.06, 95% confidence interval (CI) 1.00 to 4.43; very low-grade evidence] and preventing relapse at 12–24 months post baseline (two RCTs; pooled RR 0.57, 95% CI 0.38 to 0.84;I2 = 0%; high-grade evidence). Similarly, three nRCTs showed significant benefits of elemental nutrition over no intervention in maintaining remission at 12–48 months and preventing relapse at 12 months post baseline (MD 1.20 months, 95% CI 0.35 to 2.04 months). The incidence of mucosal healing was not significantly different in the intervention and control groups (RR 2.70, 95% CI 0.62 to 11.72). Adherence to an elemental nutrition regime was significantly worse than adherence to polymeric nutrition (RR 0.68, 95% CI 0.50 to 0.92) and, when compared with other active treatments (medications, polymeric nutrition or a combination), elemental nutrition yielded non-significant results with wide 95% CIs, rendering these results inconclusive. Complications and adverse events were too sparse to allow meaningful comparisons. None of the studies reported cost-effectiveness of elemental nutrition. Owing to scarcity of data, subgroup and sensitivity analyses could not be performed to explore methodological and clinical sources of heterogeneity.LimitationsThe findings warrant cautious interpretation given the limitations of the evidence in methodological quality (small samples, short follow-up) and the RoB in individual studies (lack of blinding, confounding).ConclusionsLimited evidence indicates potential benefits of elemental nutrition against no intervention in the maintenance of remission and prevention of relapse in adult patients with CD. There was a lack or insufficient evidence on adverse events and complications. Future large and long-term randomised trials are warranted to draw more definitive conclusions regarding the effects of elemental nutrition in maintaining remission in CD.Trial registrationThis study is registered as PROSPERO CRD42013005134.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Literature Searchmentioning

confidence: 99%

“…The study and participant characteristics of the three included RCTs 50,52,55 are summarised in Table 1. Of three RCTs, two were conducted in Japan 50,52 and one in the UK.…”

Section: Randomised Controlled Trialsmentioning

confidence: 99%

Section: Randomised Controlled Trialsmentioning

confidence: 99%

Section: Randomised Controlled Trialsmentioning

confidence: 99%

Section: Literature Searchmentioning

confidence: 99%

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Clinical effectiveness and cost-effectiveness of elemental nutrition for the maintenance of remission in Crohn’s disease: a systematic review and meta-analysis

Tsertsvadze

Gurung

Court

et al. 2015

Health Technology Assessment

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Enteral nutritional therapy for induction of remission in Crohn's disease

Narula

Dhillon

Zhang

et al. 2018

Cochrane Database of Systematic Reviews

165

243

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BackgroundCorticosteroids are often preferred over enteral nutrition (EN) as induction therapy for Crohn's disease (CD). Prior meta-analyses suggest that corticosteroids are superior to EN for induction of remission in CD. Treatment failures in EN trials are often due to poor compliance, with dropouts frequently due to poor acceptance of a nasogastric tube and unpalatable formulations. This systematic review is an update of a previously published Cochrane review. ObjectivesTo evaluate the effectiveness and safety of exclusive EN as primary therapy to induce remission in CD and to examine the importance of formula composition on effectiveness. Search methodsWe searched MEDLINE, Embase and CENTRAL from inception to 5 July 2017. We also searched references of retrieved articles and conference abstracts. Selection criteriaRandomized controlled trials involving patients with active CD were considered for inclusion. Studies comparing one type of EN to another type of EN or conventional corticosteroids were selected for review. Data collection and analysisData were extracted independently by at least two authors. The primary outcome was clinical remission. Secondary outcomes included adverse events, serious adverse events and withdrawal due to adverse events. For dichotomous outcomes, we calculated the risk ratio (RR) and 95% confidence interval (CI). A random-effects model was used to pool data. We performed intention-to-treat and perprotocol analyses for the primary outcome. Heterogeneity was explored using the Chi 2 and I 2 statistics. The studies were separated into two comparisons: one EN formulation compared to another EN formulation and EN compared to corticosteroids. Subgroup analyses were based on formula composition and age. Sensitivity analyses included abstract publications and poor quality studies. We used the Cochrane risk of bias tool to assess study quality. We used the GRADE criteria to assess the overall quality of the evidence supporting the primary outcome and selected secondary outcomes. 1 Enteral nutritional therapy for induction of remission in Crohn's disease (Review)

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Enteral nutrition for maintenance of remission in Crohn's disease

Akobeng

Thomas²

2007

Cochrane Database of Systematic Reviews

103

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Effectiveness of an ‘half elemental diet’ as maintenance therapy for Crohn's disease: a randomized‐controlled trial

Abstract: SUMMARY BackgroundAlthough thiopurines have a proven role in maintenance therapy for Crohn's disease, an alternative therapy is needed for patients intolerant or resistant to thiopurines.

Cited by 248 publications

References 33 publications

Clinical effectiveness and cost-effectiveness of elemental nutrition for the maintenance of remission in Crohn’s disease: a systematic review and meta-analysis

Clinical effectiveness and cost-effectiveness of elemental nutrition for the maintenance of remission in Crohn’s disease: a systematic review and meta-analysis

Enteral nutritional therapy for induction of remission in Crohn's disease

Enteral nutrition for maintenance of remission in Crohn's disease

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