Symposium 9. Evidence based or gut reaction

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1 Symposium 9 Ch i E t l F d Choosing Enteral Feeds Evidence based or gut reaction

2 All enteral feeds should contain fibre Ceri Green Global Medical Department Numico Clinical Nutrition Division Schiphol, The Netherlands BAPEN, 28th November 2007, Harrogate, UK

3 The argument is based on four platforms Recommendations Evidence base 3

4 Fibre is recognised as an essential part of the normal diet Australia Austria Belgium Canada C. America Columbia Denmark Finland France Germany India Ireland Italy Dietary recommendations for fibre are available in many countries, such as. Japan Mexico Netherlands Norway Puerto Rico South Africa Spain Sweden Switzerland Venezuela UK USA WHO/FAO 4

5 Fibre has many physiological effects which are relevant for enterally fed patients Dietary component FIBRE Physiological effect Stool bulking Fermentation to produce SCFA Microflora balance Mode of action Water holding Microbial mass Speed transit time Mucosal fuel source H 2 0/Na reabsorption Prebiotic effect Gut barrier Health Improved Metabolic benefit Control Maintenance of normal bowel function and gut health/integrity 5

6 Use of fibre-containing enteral formulas is growing in clinical practice (but still room for improvement ) Fibre-free Fibre

7 Systematic review and meta-analysis: the clinical and physiological effects of fibre-containing enteral formulae Elia M, Engfer MB, Green CJ, Silk DBA. Aliment Pharmacol Ther, in press Enteral nutrition as primary source of nutrition Fibre vs fibre free formula Minimum 3 days Studies included Outcomes 51 studies (43 RCTs) 38 in patients (n = 1591) Intensive care/critically ill Surgical/post-operative operative Medical Chronic care Paediatrics 13 in healthy volunteers (n = 171) Incidence diarrhoea, constipation, stool consistency, GI symptoms Transit time, stool weight, bowel frequency QUORUM Guidelines (1999) 7

8 FIbre significantly reduces the incidence of diarrhoea compared with fibre-freefree enteral feeds Study name Spapen et al Guenter et al Frankenfield & Beyer 1989 Dobb & Towler 1990 Schultz et al Schultz et al Schultz et al Hart & Dobb 1988 Khalil et al Reese et al Reese et al Homann et al de Kruif et al Richardson et al Belknap et al Hofman et al Group by: /non- Ward Fiber type Odds ratio and 95% CI non- non- non- non- non- non- non- non- non- Overall Surgical Surgical Surgical Surgical Surgical Surgical Medical Pediatric Guar Soy Soy Soy Fiber mixture* Pectin Fiber mixture* + pectin Soy Soy + oat Soy (7 g/l)) Soy (14 g/l) Guar Soy Soy Psyllium Fiber mixture** 16 studies (13 RCTs) fibre n = 338 non-fibre n = 345 OR % CI p= 0.03 non- OR Favors fiber Favors fiber free 8

9 Fibre reduces laxative use in the acute and chronic settings compared wth fibre-free free feeds Type of setting Reduced use of elimination aids with fibre (no. studies) Acute 3 out of 4 Chronic 2* out of 4 * NS in one study 9

10 Fibre improves objective parameters of bowel function compared with fibre-freefree feeds in healthy volunteers Bowel frequency Transit time Faecal mass (times/day) (hours) (g/day) Number RCTs 9 (14) 7 (14) 7 (12) (data sets) Fibre/no fibre 154/ / /129 (no. patients) Result fibre versus fibre free (SE 0.05) (p=0.005) (SE 2.29) (p<0.001) + 35 (p<0.001) Conclusion Favours Favours Favours fibre fibre fibre 10

11 Meta-regression shows modulating effect of fibre on bowel function means Difference in Bowel frequency in fiber-free free group (times/day) 11

12 Meta-regression shows modulating effect of fibre on bowel function Difference in means Fibre increases bowel frequency when it is low (constipation) Bowel frequency in fiber-free group (times/day) Fibre decreases bowel frequency when it is high (diarrhoea) 12

13 Fibre is safe and generally well-tolerated in patients Total number of patient studies = 38 (1591 patients) Tolerance (GI symptoms including nausea, vomiting, flatulence, abdominal cramps, bloating) Reported (No. of studies) No difference between fibre and fibre-free free (No. of studies) Difference between fibre and fibre-free free (No. of studies) flatulence (2) distension (1) vomiting (1) Feed intake intake (2) intake (1) 13

14 Fibre is safe and generally well-tolerated in patients Total number of patient studies = 38 (1591 patients) Tolerance (GI symptoms including nausea, vomiting, flatulence, abdominal cramps, bloating) 6 patients on Reported No inulin; difference Difference between fibre and between fibre and 11 patients on fibre-free free fibre-free free (No. of studies) hydrolysed (No. of studies) guar (No. of studies) gum flatulence (2) distension (1) vomiting (1) Feed intake intake (2) intake (1) 14

15 Fibre is safe and generally well-tolerated in patients Total number of patient studies = 38 (1591 patients) Tolerance (GI symptoms including nausea, vomiting, flatulence, abdominal cramps, bloating) 6 patients on Reported No difference Difference 2 patients on inulin; between fibre and between Fybogel fibre and 11 patients on fibre-free free fibre-free free (No. of studies) hydrolysed (No. of studies) guar (No. of studies) gum flatulence (2) distension (1) vomiting (1) Feed intake intake (2) intake (1) 15

16 Fibre is safe and generally well-tolerated in patients Total number of patient studies = 38 (1591 patients) Tolerance (GI symptoms including nausea, vomiting, flatulence, abdominal cramps, bloating) 6 patients on Reported No difference Difference 2 patients on inulin; between fibre and between Fybogel fibre and 11 patients on fibre-free free fibre-free free (No. of studies) hydrolysed (No. of studies) guar (No. of studies) gum flatulence (2) distension (1) 7 patients on vomiting (1) fibre Feed intake intake (2) intake (1) 16

17 Fibre is safe and generally well-tolerated in patients Total number of patient studies = 38 (1591 patients) Tolerance (GI symptoms including nausea, vomiting, flatulence, abdominal cramps, bloating) 6 patients on Reported No difference Difference 2 patients on inulin; between fibre and between Fybogel fibre and 11 patients on fibre-free free fibre-free free (No. of studies) hydrolysed (No. of studies) guar (No. of studies) gum flatulence (2) distension (1) 7 patients on vomiting (1) fibre Feed intake intake (2) 9 patients on soy polysaccharide intake (1) 17

18 Reasons why all enteral formulas should contain fibre Recognised as essential part of normal diet Many physiological effects relevant for enterally fed patients Increasingly used in clinical practice Reduces diarrhoea Improves objective measures of bowel function Safe and well-tolerated 18

19 Conclusion Recognised as essential part of normal diet There is a clear rationale to support the inclusion of fibre Many physiological effects relevant for enterally fed patients Increasingly used in clinical practice (preferably from mixed sources) in all enteral feeds Reduces diarrhoea Improves objective measures of bowel function Safe and well-tolerated 19

21 ALL ENTERAL FEEDS SHOULD CONTAIN FIBRE *** AGAINST THE MOTION *** Tim Maximum Impaction Bowling or Tim Bowel Bowling or Tim Full of s**t Bowling

22 Why are we asking this question? For improvement in bowel function as perceived ed by the patient and/or carer No other reason Transit time, microflora, marginal changes in bowel frequency are of academic interest but little practical relevance to the individual patient

23 2 different patient populations Acute Critical care, post-op, neurological event, supplement intake during acute illness Catabolic (Often) younger Medication (antibiotics, analgesics) Low albumin Bed bound/immobile Dietary intake different from normal Chronic Clinically/metabolically (more) stable (Often) older Bed bound/immobile/lack of exercise in the long term Depressed ± antidepressants Rationalised (?) medication Rti Rationale for feeding } Aetiology for bowel disturbance Arguments for fibre } } Very different

24 Diarrhoea in the acute setting Study name Group by Ward Fibre type Odds ratio and 95% C non- Spapen et al 2001 Guar Guenter et al 1991 Soy Frankenfield & Beyer Soy Dobb & Towler 1990 Soy Schultz et al 2000 Fiber mixture* Schultz et al Pectin Schultz et al Fiber mixture* + pectin Hart & Dobb 1988 Soy Khalil et al 1998 non- Surgical Soy + oat Reese et al 1996 non- Surgical Soy Reese et al non- Surgical Soy Homann et al 1994 non- Surgical Guar Kruif et al 1993 non- Surgical Soy Richardson et al 1987 non- Surgical Soy Belknap et al 1997 non- Medical Psyllium Hofman et al 2001 non- Pediatric. Fiber mixture** non- Overall Favors fiber 16 RCT s: 13 NS, 2 favour fibre, 1 favours fibre-free: CI ! alone NS Heterogeneity of patients Elia Favors et fiber-free al, in press Publication bias Heterogeneity of φ of diarrhoea (rates 9-92%) Maybe if you looked hard enough you could find a subgroup that would benefit, but overall not persuasive

25 Diarrhoea in the chronic setting Studies of diarrhoea in chronic illness setting = 0 ARGUMENT FOR FIBRE IN PREVENTING DIARRHOEA?*@!!*?$&?

26 Constipation Definition - hard stool? -difficulty defaecating Acute setting: - BO? - abdo pain etc etc 7 RCT s (2, 3 surgical, 2 medical: n=293) no differences Chronic setting: 1 study no difference 5 studies looking at laxative use. Only 1 study showed significant ARGUMENT FOR FIBRE IN PREVENTING CONSTIPATION?*@!!*?$&?

27 1. Stool frequency Other possibly relevant factors Acute: 3 studies = bowels 0.22/day Chronic: 6 studies = bowels 0.27/day Significant figures in meta-analysis, but how relevant for the patient? 2. Stool consistency Chronic care: 3 studies: 3= no difference : 6 studies: 2 = no difference 4 = more formed stool (?important in ) Surgery: 1 study: 1 = no difference Medicine 5 studies: 3 = no difference 2 = softer formed stool 3. Tolerance No differences overall. Some flatulence, abdo distension with fibre

28 1. Human volunteer studies 2. Transit time Only 3 studies: All = no difference 3. Faecal mass with fibre BIG DEAL! 4. Microflora/SCFA s Irrelevant factors Interesting, but understanding and interpretation of normality, clinical relevance etc g, g p y, is rudimentary

29 Conclusions Acute Chronic Diarrhoea Constipation?? slight benefit with fibre in some patients No difference No difference/evidence Stool frequency bowels 0.22/day bowels 0.27/day Consistency Tolerance Overall no difference. No difference? more formed stool in No difference

30 You might say Well, why not add fibre no harm done? You might, but this would not be practising evidence-based medicine R b th ti i ALL t l f d h ld Remember the motion is ALL enteral feeds should contain fibre

31 So. SHOULD ALL ENTERAL FEEDS CONTAIN FIBRE? NO

32 Great height

33 Great height

Systematic review and meta-analysis: the clinical and physiological effects of fibre-containing enteral formulae

Alimentary Pharmacology & Therapeutics Systematic review and meta-analysis: the clinical and physiological effects of fibre-containing enteral formulae M. ELIA*, M. B. ENGFER, C.J.GREEN &D.B.A.SILKà *Institute