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Nutrición Hospitalaria

versión On-line ISSN 1699-5198versión impresa ISSN 0212-1611

Nutr. Hosp. vol.29 no.3 Madrid mar. 2014

https://dx.doi.org/10.3305/NH.2014.29.3.7184 

ORIGINAL / Pediatría

 

PRESENT; PREScription of Enteral Nutrition in pediaTric Crohn´s disease in Spain

PRESENT; PREScripción de NUtrición Enteral en la enfermedad de Crohn pediátrica en España

 

 

Víctor Manuel Navas-López1, Javier Martín-de-Carpi2, Oscar Segarra3, José Ignacio García-Burriel4, Juan José Díaz-Martín5, Alejandro Rodríguez6, Enrique Medina7, Mercedes Juste8; on behalf of the PRESENT Working Group of SEGHNP (Sociedad Española de Gastroenterología Hepatología y Nutrición Pediátrica)

1Pediatric Gastroenterology and Nutrition Unit. H Materno. Málaga
2H. Sant Joan de Deu. Barcelona
3H. Vall de Hebrón. Barcelona
4Complexo Hospitalario Universitario de Vigo
5Hospital Universitario Central de Asturias
6Hospital Universitario Virgen del Rocío. Sevilla
7Hospital Doce de Octubre. Madrid
8Hospital Clínico Universitario San Juan de Alicante. Spain

Correspondence

 

 


ABSTRACT

Objectives: Exclusive enteral nutrition (EEN) is one of the therapeutic strategies used to induce remission in pediatric Crohn's disease (CD). Although its use is recommended in clinical practice guidelines and consensus documents, the frequency of this practice in Spain is unknown.
Methods: A 70-item questionnaire (PRESENT: PREScription of Enteral Nutrition in pediaTric Crohn's disease in Spain) was drafted and distributed through the SEGHNP (Spanish Society for Pediatric Gastroenterology, Hepatology and Nutrition) e-mail list.
Results: We received information from 51 Pediatric Gastroenterology Units. Of the 287 patients newly diagnosed with CD in 2011-2012 at these centres (139 in 2011, 148 in 2012), 182 (63%) received EEN (58% in 2011 and 68% in 2012). 26% of the patients who received EEN in the period studied (64/246) did so during relapses. All the physicians (100%) who responded to the questionnaire believe that EEN is effective in inducing clinical remission in mild to moderate CD. However, 24.5% of respondents never use EEN during relapses. The enteral formulas used most often used were polymeric formulas specific for CD (70.6%) and the preferred administration route was oral, with 60.8% using flavouring and 9.3% allowing a variable percentage of calories in the form of other foods. 65% use 5-ASA together with EEN, 69% use antibiotics and 95% immunomodulators (thiopurines). The duration of EEN tends to be 8 weeks (47.1%), and transition to regular diet was achieved sequentially over a variable period of time. Regarding barriers and limiting factors for the use of EEN, those most frequently reported include lack of acceptance by the patient and/or family (71%), lack of time and/or ancillary staff (69%) and difficulty in convincing the patient and/or family of the suitability of treatment (43%).
Conclusions: EEN use rates are similar to those of other European questionnaires. Tools that facilitate acceptance by the patient and family are needed. Increasing the time dedicated to this therapeutic modality is likewise important. Given the disparity of criteria for indicating treatment with EEN, it would be useful to have widely accepted clinical practice guidelines or protocols that facilitate the decision to use it.

Key words: Exclusive enteral nutrition. Pediatric Chron's disease. Pediatric inflammatory bowel disease. Survey. Prescription.


RESUMEN

Objetivos: La nutrición enteral exclusiva (NEE) es una de las estrategias terapéuticas empleadas para inducir la remisión en niños con enfermedad de Crohn (EC). Pese a que la NEE se recomienda en las guías de práctica clínica y en los documentos de consenso, la frecuencia real de su empleo en España es desconocida.
Métodos: Encuesta compuesta por 70-items (PRESENT: PREScription of Enteral Nutrition in pediaTric Crohn's disease in Spain) que se distribuyó a través de la lista de distribución de Sociedad Española de Gastroenterología, Hepatología y Nutrición Pediátrica (SEGHNP).
Resultados: Se recibieron los datos de 51 unidades de Gastroenterología Pediátrica del territorio español. De los 287 pacientes recién diagnosticados de EC durante los años 2011-12 en esos centros (139 en 2011 y 148 en 20212), 182 (63%) recibieron NEE (58% en 2011 y 68% en 2012). El 26% de los pacientes que recibieron NEE estaban en recaída. Todos los facultativos que respondieron pensaban que la NEE es efectiva para inducir la remisión clínica en los brotes leves-moderados. El 24,5% no emplean la NEE durante las recaídas. Las formulas enterales empleadas más frecuentemente fueron las específicas para EC (70,6%), la vía oral fue la más utilizada, el 60,8% utilizaron saborizantes y el 9,8% de las unidades permitían un porcentaje variable de calorías en forma de otros alimentos durante el periodo de NEE. El 65% emplearon 5-ASA junto con la NEE, el 69% antibióticos y hasta un 95% inmunomoduladores. La duración de la NEE fue de 8 semanas en el 47,1% de los casos, la transición hacia una dieta normal se realizó de forma secuencial. En relación a las barreras y factores limitantes encontrados por los respondedores para instaurar la NEE destacaban la falta de aceptación por el paciente y/o la familia (71%), falta de tiempo o de personal auxiliar (69%) y la dificultad para convencer al paciente o su familia de la idoneidad del tratamiento (43%).
Conclusiones: La frecuencia de empleo de la NEE en pacientes con EC es similar a la de otros cuestionarios europeos. Se precisan herramientas y recursos que faciliten la aceptación por parte del paciente y de su familia así como disponer de más tiempo a dedicar para instaurar esta modalidad terapéutica. Dada la disparidad de criterios para la indicación de la EEN, sería útil disponer de guías de práctica clínica ampliamente aceptadas o protocolos que facilitan la decisión de utilizarla.

Palabras clave: Nutrición enteral exclusiva. Enfermedad de Crohn pediátrica. Enfermedad inflamatoria intestinal pediátrica. Encuesta. Prescripción.


 

Introduction

Exclusive enteral nutrition (EEN) has been shown to be more effective than corticosteroids inducing mucosal healing in children with Crohn's disease (CD), without the side effects.1-3 Although its use in pediatric CD is recommended in clinical practice guidelines4 and consensus documents, the frequency of this practice in Spain, where the incidence of inflammatory bowel disease (IBD) has been on the rise in recent years,5 is unknown. The aim of this study was to investigate the frequency and characteristics of the use of EEN in pediatric gastroenterology units in Spain through the use of a questionnaire prepared for this purpose.

 

Materials and methods

The questionnaire was based on other published6-9 studies, together with other previously unpublished items. The study was conducted by the IBD working group of the Spanish Society for Pediatric Gastroenterology, Hepatology and Nutrition (SEGHNP) and supported by the SEGHNP. All Pediatric Gastroenterology Units in Spain were contacted but participation was, of course, voluntary. Although not all Pediatric Gastroenterology Units have included their patients, all of the reference hospitals across Spain have participated.

The questionnaire (PRESENT: PREScription of Enteral Nutrition in pediaTric Crohn's disease in Spain) sent out consisted of 70 items that include general aspects of IBD and specific aspects of EEN for pediatric CD (Appendix II). The period for receiving the questionnaires was from May 2012 until January 2013. All questionnaires were reviewed and the authors were contacted personally if any errors were detected or if any items were not completed in order to request the pertinent clarifications.

Statistical analysis

The qualitative variables are expressed as a percentage. The chi-square test was used to contrast variables. Values of p < 0.05 were considered to be statistically significant.

Ethical considerations

The study was approved by the Ethic's Committee of the first author's center, as representative of the rest of the hospitals. The authors do not have conflicts of interest.

 

Results

Data were received from 51 Pediatric Gastroenterology Units distributed across Spain. During the 2011-2012 period, 287 cases of CD were newly diagnosed (139 in 2011 and 148 in 2012) at these units; 246 received treatment with EEN in these two years, 182 (63.4%) patients as first-line therapy and 64 during relapses. All the patients who received EEN during relapses had responded previously to EEN at the onset of the disease. The frequency of EEN use as first-line therapy increased from 58% (81/139) in 2011 to 68% (101/148) in 2012 (p = 0.08).

Efficacy of EEN to induce remission

With regard to newly diagnosed CD, all those polled believe that EEN is effective in inducing clinical remission, having likewise verified such efficacy at some point. Ninety-six point one per cent (96.1%) maintained that it enables mucosal healing and 84.3%, histological remission. Of the 36 units that had performed endoscopy after EEN, 17 (47.2%) reported mucosal healing and 15 (41.6%) histological remission in some case. In response to whether EEN is effective in relapses, 83.4% contended that it induces clinical remission, 80.4% mucosal healing and 74.5% histological remission. Seventy-six point five per cent (76.5%) use or have used EEN in relapses, having confirmed clinical remission and endoscopic and histological remission in up to 69.2% and 36% of patients, respectively.

Indications for EEN

Table I shows the results for EEN indications.

Comparative analysis of the indications for EEN according to patient treated in units that providing follow-up to a high number of patients (> 50 patients/ year) or a small number (< 50) revealed no significant differences.

Specific aspects of EEN

The most common response with regard to the duration of EEN was 8 weeks, chosen by 47.1% of the respondents, followed by 6-8 weeks (22.5%), 6 weeks (19.6%) and others (7.8%). None of those polled use it for periods under 6 weeks or greater than 12 weeks. The oral administration route was preferred in all cases, with nasogastric-feeding only being used when taking enteral formula by mouth was not possible. The response time to assess the efficacy of EEN was 2-3 weeks in 21.6%, 2-4 weeks in 18.4%, 3-4 weeks in 17.6% and 2 weeks in 15.7% of subjects polled.

Regarding which enteral formula was used, in 70.6% of the cases (36/51) polymeric formulas specific for IBD were used, enriched with TGF-β (Modulen IBD® or Resource IBD®); 29.4% indicated other formulas different from the specific ones (flavoured normal- or hypercaloric polymeric formulas or flavoured elemental formulas). The choice of formula was mainly influenced by factors such as taste, cost, availability, nutritional composition, evidence and experience. Table II shows that the most frequent reason for indicating specific formulas was their composition, with particular reference to TGF-β. In the group that used other formulas, 100% declared that there was no evidence that formulas made specifically for IBD were superior to standard polymeric formulas, and that the EEN itself is responsible for the patients' improvement; such effect cannot be specifically attributed to any of the ingredients.

Another aspect we wished to enquire about involved liquids, foods and amount of calories the patients were allowed to eat during the EEN treatment period; 90.2% answered only water and the remaining 9.8% indicated between 5-20% of all the calories estimated in the day. At all the centres, the physician in charge of the patient participates in the decision about the formula to be administered. Of subjects polled, 60.8% allow the use of flavouring; of these, 48.4% mention the flavouring provided by Nestlé Nutrition (with banana or strawberry flavour), 22.6% cocoa powder, 3.2% syrups of different flavours and 25.8% a variety of the aforementioned. Once the induction period has been completed, 94.2% progress to a normal diet in the following 2-4 weeks (7.6% follow their own protocol and the remaining 92.4% do not follow any protocols) and 5.8% change to a normal diet quickly, with no specific order when introducing the food groups.

After the induction period, 88.4% provides systematic enteral formula supplementation to all patients during a variable time period that depends on several factors (adherence, nutritional state, etc.). The majority of units opt to supplement with 20-30% of the total calories, which tend to range from 500-750 ml, depending on the patient. The remaining 11.6% only supplement if required for nutritional recovery.

Combination of EEN with pharmacological treatment

Regarding the drugs used concomitantly during the induction of remission with EEN, the results reported by respondents are found in table III.

Professionals involved in the administration of EEN and follow-up

The professionals involved in assessing and indicating therapeutic support via EEN vary according to centre (table IV).

 

The physician is solely responsible for the follow-up of these patients in 80.4% of the cases. In 9.8% the physician works with a dietician, in 5.8% with a nurse, in 2% with a nurse and psychologist and in the remaining 2% with a nurse, dietician and psychologist. Follow-up is primarily done via telephone and outpatient visits (74.6%) or exclusively by visits (25.4%). The frequency with which the patient is contacted during nutritional treatment is weekly in 56.3% of the centres, fortnightly in 33.3%, monthly in 6.3% and variable in the remaining 4.1%.

Assessment of response to EEN

The PCDAI was the most frequent index used (98%) followed by the wPCDAI.12 Regarding the biochemical parameters to assess response after EEN, 100% use complete blood count (CBC) and albumin, 98% eryth-rocyte sedimentation rate (ESR), 78% faecal calpro-tectin, 35% C-reactive protein (CRP), 22% iron metabolism, and 8% fibrinogen and procalcitonin (PCT); 70.6% use endoscopy and 66.7% use radiological tests to assess the response to treatment.

Advantages and disadvantages of EEN

The results regarding advantages and disadvantages with EEN are shown in table V.

Difficulties

Multiple choice questions were used to explore the objections or difficulties reported by the professionals for establishing EEN; 14% of the respondents reported no difficulties, 36% only one difficulty, another 36% reported two difficulties and up to 14%, more than three difficulties (table VI).

 

Discussion

Although EEN has been proven to be beneficial in the treatment of pediatric CD, there are some questions that remain unanswered. We had access to data from different surveys regarding the use of this therapeutic modality in the United States, Canada, Europe, Israel and Australia,6-9,13 (table VII) but we did not know the real situation regarding EEN use in Spain.

The use of EEN is widespread in Spain, since all of the respondents confirm regular use of EEN, at a rate much higher than that published by other authors (table VII). Although the studies shown in table 7 have been published recently, much of the data were collected before a meta-analysis regarding the efficacy of EEN was published. Nevertheless, it is true that series with the greater number of patients and better design are subsequent to 2005, when the best evidence for EEN in the treatment of CD was published. One of the possible reasons for this difference in use may be related to the fact that the Spanish National Healthcare System subsidizes enteral formulas for the treatment of CD. This is a key factor, since EEN has been shown to be superior to steroids in achieving mucosal healing,1,2,14 a situation that determines better prognosis in the following years, lower hospitalisation rate and less use of biological drugs.15

Despite the fact that the efficacy of EEN for controlling CD relapses is 50%,14,16 and even if there is not remission, there is a decrease in inflammatory activity and an improvement in nutritional state, only 24.5% use EEN in this scenario, which is likely conditioned by the difficulty for re-establishing and maintaining the EEN again for another 6-8 week period.

Initial studies revealed that EEN was less effective than steroids in exclusively colonic CD,17 although this was not corroborated by later studies.18,19 This is an important issue because 37.3% of the respondents do not use EEN in this clinical setting on the basis of their own previous experience. In our opinion, more studies along these lines are needed to clarify the real response according to disease extension.

Regarding the enteral formula used, there are two clearly differentiated groups: those who use specific formulas for IBD (Resource IBD® or Modulen IBD®) as it contains TGF-p and due to the motivating effect of taking a formula adapted to a specific disease, and another group that sustains, as made clear by the studies published, that there are no differences between formulas,20-23 attributing the improvement experienced by patients to the EEN and the administration conditions and not to any of their components. Another factor is compliance, which seems to be superior in the case of flavoured polymeric formulas. One reason for the 3% of survey respondents who used specific formulas for IBD patients was the price although the average price of a specific formula for IBD in Spain is 17 €/1,000 kcal, similar to non-specific pediatric normocaloric formulas; slightly more expensive than pediatric hypercaloric formulas (14,6 €/1,000 kcal) and more expensive than adults hypercaloric (9.3 €/1,000 kcal) and normocaloric (9,7 €/1,000 kcal) formulas.

The optimal method for introducing normal diet after EEN has not been established, and there is no data to suggest that progressing to a hypoallergenic diet, gradual or sudden introduction of diet following EEN influence the maintenance of remission.9,24

The majority of respondents identified various difficulties in re-establishing diet, despite having no doubts about the efficacy of EEN. Almost three-quarters of those polled consider the lack of acceptance by the patient and/or family to be the main difficulty in establishing EEN. A more proactive attitude in the professional involved might have led to higher acceptance rates; not initially offering any other therapeutic option could also be considered a valid approach.

Added to this preliminary difficulty is the second most frequent barrier: lack of time and/or ancillary staff (dieticians, nutritionists, psychologists, etc.) to help in the follow-up and support of these patients. In our opinion, this greatly conditions prescription since, unlike steroids, EEN patients require a lot of motivation to achieve their goals and must be followed-up more frequently and closely.

Our study is the first of its kind to be conducted in Spain. The data were collected over a short period of time, at a time when the evidence regarding the beneficial effects of EEN is on the rise.

A limitation of all surveys is the fact that results reflect the opinions of a selected population, pediatric gastroenterologists, who usually use EEN, willing to participate in the study.

To summarize, 8 weeks of EEN is the most frequent therapeutic option in newly diagnosed CD children in Spain. Formulas made specifically for IBD are used the most. The advantages of EEN compared to other therapeutic modalities are mucosal healing without side effects. The difficulties most frequently found were lack of acceptance by the patient and/or family and lack of time and/or ancillary staff to help in the follow-up and support of these patients.

Tools to facilitate acceptance by the patient and family are needed. Increasing the time dedicated to this therapeutic modality is likewise important. Given the disparity of criteria for indicating treatment with EEN, it would be useful to have widely accepted clinical practice guidelines or protocols that facilitate the decision to start with EEN.

 

Appendix I

The following investigators participated in the PRESENT study:

Masiques Mas ML(Hospital General de Granollers Barcelona), Guallarte Alias MP (Corporació Sanitaria Universitaria Parc Tauli Sabadell), Donat Aliaga E (Hospital Universitario La Fe Valencia), Sánchez Sánchez C(Hospital General Universitario Gregorio Marañón), Martínez Gómez MJ (Hospital Universitario Niño Jesús de Madrid), Pociello Almiñana N (Hospital Arnau de Vilanova de Lleida), Barrio Torres J (Hospital Universitario de Fuenlabrada Madrid), Pérez Parras MA (Complejo Hospitalario de Jaén), Argüelles Martin F (Hospital Universitario Virgen Macarena Sevilla), García Martín M (Hospital Universitario Virgen Macarena Sevilla), Rivero de la Rosa MC (Hospital Universitario Virgen Macarena Sevilla), Arévalo Garrido A (Complejo Hospitalario de Jaén), Sánchez Valverde-Visus F (Complejo Hospitalario de Navarra, Pamplona), López Ruzafa E (Hospital Universitario Torrecárdenas, Almería), Rodríguez Salas M (Hospital Universitario Reina Sofía, Córdoba), García Blanca JA (Hospital Universitario Puerta del Mar Cádiz), Galera Martínez R (Hospital Universitario Torrecárdenas, Almería), Suarez Cortina L (Hospital Ramón y Cajal de Madrid), Cortes Mora P (Hospital Universitario Santa Lucía de Cartagena), Rosell Camps A (Hospital Universitario Son Espases, Mallorca), Navalón Rubio M (Hospital Universitario Virgen de la Arrixaca, Murcia), Irastorza Terradillos I (Hospital Universitario Cruces, Bilbao), Ros Arnal I (Hospital Infantil Miguel Servet, Zaragoza), Ramos Boluda E (Hospital Universitario La Paz, Madrid), Gutiérrez Junquera C (Hospital Universitario Puerta de Hierro-Majadahonda, Madrid), Leis Trabazo R (Hospital Clínico Universitario de Santiago, Santiago de Compostela), Bartolomé Porro JM (Complejo Asistencial de Palencia), Peña Quintana L (Hospital Materno-Infantil. Las Palmas de Gran Canaria), Balmaseda Serrano E (Hospital General Universitario de Albacete), Solar Boga A (Complejo Hospitalario Universitario A Coruña), Moreno Álvarez A (Complejo Hospitalario Universitario A Coruña), Eizaguirre Arocena FJ (Hospital Universitario Donostia, San Sebastián), Botija Arcos G (Hospital Universitario Fundación Alcorcón, Madrid), Lorenzo Garrido H (Hospital Universitario de Basurto), Armas Ramos H (Hospital Universitario de Canarias, Tenerife), Reyes Abreu G (Hospital Universitario de Canarias, Tenerife), López Casado MA (Hospital Materno Infantil Virgen de las Nieves, Granada), Salcedo Lobato E (Hospital Universitario de Getafe, Madrid), Rodríguez Martínez C (Hospital Vega Baja, Orihuela, Alicante), Ortigosa del Castillo L (Hospital Universitario Nuestra Señora de la Candelaria, Tenerife), Alberto R (Hospital Universitario Nuestra Señora de la Candelaria, Tenerife), Torres Peral R (Hospital Universitario de Salamanca), Martín Martínez B (Hospital de Terrasa), López MJ (Hospital de Terrasa), García Casales Z (Hospital de Txangorritxu, Araba), Chicano Marín FJ (Hospital Universitario Los Arcos del Mar Menor, Murcia), Pérez-Moneo Agapito B (Hospital Infanta Leonor, Madrid), Barros García P (Hospital San Pedro de Alcántara, Cáceres), Marugán de Miguelsanz JM (Hospital Clínico Universitario de Valladolid), Calvo Romero C (Hospital Clínico Universitario de Valladolid), Manzano Infante MJ (Instituto Hispalense de Pediatría Sevilla), Rodríguez Herrera A (Instituto Hispalense de Pediatría Sevilla).

 

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Correspondence:
Víctor Manuel Navas-López
Pediatric Gastroenterology and Nutrition Unit
Hospital Materno Infantil
Avda. Arroyo de los Ángeles, s/n
29011 Málaga. Spain
E-mail: victor.navas@gmail.com

Recibido: 31-X-2013
1.a Revisión: 1-XII-2013
Aceptado: 1-XII-2013

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