5 Things to Know About Irritable Bowel Syndrome

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5 Things to Know About Irritable Bowel Syndrome Mike Kolber MD, CCFP, MSc PEIP 2017 Faculty/Presenter Disclosure Presenter: Mike Kolber Relationships that may introduce potential bias and/or conflict

1 5 Things to Know About Irritable Bowel Syndrome Mike Kolber MD, CCFP, MSc PEIP 2017 Faculty/Presenter Disclosure Presenter: Mike Kolber Relationships that may introduce potential bias and/or conflict of interest: Grants/Research Support: Program/project funding received from non profit sources Alberta College of Family Physicians, other provincial chapters of the CFPC, Toward Optimized Practice Speakers Bureau/Honoraria: Mike Kolber has received a speaker fee and expense support from the Alberta College of Family Physicians. Consulting Fees: N/A Other: Paid by University of Alberta, Alberta Health 1

2 Clinical Decision Making Evidence + Experience + Patient Values and Expectations + Cost of intervention / medication = Clinical decision 5 Things to Know about IBS Be confident in your diagnosis Placebo Response in IBS Diets: fibre, elimination, GFP, FODMAPs Medications with efficacy Healthy Skepticism with new meds 2

3 Diagnosing IBS: Kahoot.it Other Diagnosis to Consider: Celiac Disease Celiac is 2 3xs more common in patients with IBS symptoms Am J Gastro 2017; 112:65 3

4 Other Diagnosis to consider: Inflammatory Bowel Disease CRP: Normal in ~50% with IBD Higher CRP more likely IBD Fecal Calprotectin If < 100: LR <0.1 rules out IBD If > 250: LR+ >10 helps diagnose IBD Recent studies: media FCALs IBS: IBD: Normal FCal or CRP < 1% chance IBD BMJ 2010;341:c3369, HTA 2013;17(55) Am J Gastro 2015; 110:444 Placebo Response in IBS patients Open label placebo RCT 1 : 80 pts, 70% All got 3 visits: placebo arm got 2 placebo pills bid Outcomes at 3 weeks: IBS SSS: (out of 500): placebo=92, control=46 Adequate relief: 59% placebo vs 35%: NNT = 5 intensity of the problem was validated taken seriously was able to discuss my IBS Placebo (listening, reassurance) Works ~ 25 50% in IBS! 1,2 1 Kaptchuk, PLoS One 2010; 5: e15591, 2 World J Gastro 2017; 23(12):

Diets for IBS Diet Evidence RCT Outcome and Findings Fibre SRs: inconsistent 1 care RCT: 56% IBS C: psyllium, bran or placebo x 3/12 Adequate Pain Relief Psyllium better early, bran later Evidence

SR: inconsistent RCT: IBS SS (/500) : 100 ED vs 60 sham 70% no diff in sx BMs, Symptoms Surrogates Findings Inconsistent!

5 Diets for IBS Diet Evidence RCT Outcome and Findings Fibre SRs: inconsistent 1 care RCT: 56% IBS C: psyllium, bran or placebo x 3/12 Adequate Pain Relief Psyllium better early, bran later Evidence Limitation 40% LTFU (felt worse / lack of benefit) Summary Consider fibre: IBS C Elimination Diet (ED) Gluten Free Diet 8 cohorts: 12 60% better 1 RCT: true vs sham ED Cohort: ~70% improve 3 (2) RCTs SR: inconsistent RCT: IBS SS (/500) : 100 ED vs 60 sham 70% no diff in sx BMs, Symptoms Surrogates Findings Inconsistent! 1/3 unable to tolerate dropped out Re challenge pts improved w GFD Small #s, ~20% likely had celiac ED may help some patients Rule out celiac n of 1 trial in patients with IBS D +/ FHx of Celiac Fibre: Cochrane 2011: CD003460, BMJ 2008;337:a2313, Aliment Pharm Ther 2004;19:245 BMJ 2009; 339:b3154 Elimination Diet: Brandt AM J Gastro 2009, Gut 2004;53:1459. GFD: Aliment Pharm Ther 2015: 807 Am J Gastro 2012; 107:1898, GASTRO 2013;145:320, GASTRO 2013; 144: 903, Clin Gastro Hepatology 2016;14:696 Fibre Diet Elimination Diet BMJ 2009; 339:b3154 Wheat Sensitive patients: anemia, weight loss because they have undiagnosed CD! Am J Gastro 2012; 107:1898 5

(cabbage, onions, beans) Stanford FODMAP diet FODMAP Evidence (All from Secondary Care) Best RCT 1 : 6 weeks, open label, 123 IBS

FODMAP vs mnice diet frequent small meals, avoid triggers, ++ alcohol, caffeine Adequate pain relief: 4 weeks: FODMAP 52 vs 41%

6 What the $%&# is the FODMAP Diet? Fermentable oligo, di, monosaccharides, and polyols [FODMAPs] Diet pops (artificial sweeteners), gluten, dairy, FARTY FOODS (cabbage, onions, beans) Stanford FODMAP diet FODMAP Evidence (All from Secondary Care) Best RCT 1 : 6 weeks, open label, 123 IBS pts IBSS: FODMAP 150 > probio cs, normal diet Best in IBS D Other RCTs 2 4 : small #s, time (2 days), COI ($) 2016 RCT IBS D: 5 FODMAP vs mnice diet frequent small meals, avoid triggers, ++ alcohol, caffeine Adequate pain relief: 4 weeks: FODMAP 52 vs 41% mnice: NSS abdominal pain: 51 vs 23% (NNT =4) 1 World JGastro 2014;20(43): Gastroenterology 2014; 146: 67 3 J Nutr 2012:142:151 4 J Gastro Hepato 2010; 25: 1366 TFP #142 Can Fam Phys 2015, Am J Gastro 2016; 111(12):

7 3 FODMAP Meta Analysis = 3 Different Conclusions More research required to establish LT efficacy 1 is efficacious in treating functional GI symptoms 2.FODMAP diet RCTS characterized by high risk of bias risk that effects reported are driven primarily by a placebo response. 3 1 Aliment Pharm Ther 2015; 41: Eur J Nutr 2015; DOI Aliment Pharma Ther. 2017;1 FODMAP Summary May improve symptoms in IBS D patients Healthy Skepticism: possibly try n of 1 trial 7

IBS Meds with RCT evidence Medication Outcome # trials Treatment Control NNT Anti spasmotics 1,2 Global Symptoms 22 60% 39% 5 Pain 58% 46% 6 Hyoscine 2 Global Symptoms 3 71% 54% 6 Peppermint 1,2,3

8 IBS Meds with RCT evidence Medication Outcome # trials Treatment Control NNT Anti spasmotics 1,2 Global Symptoms 22 60% 39% 5 Pain 58% 46% 6 Hyoscine 2 Global Symptoms 3 71% 54% 6 Peppermint 1,2,3 Global Symptoms 5 69% 31% 3 Anti depressants 4,5 Global Symptoms 17 56% 35% 4 Pain 54% 37% 6 Placebo 6 Adequate Relief 1 59% 35% 5 SSRIs: improve global assessment TCAs: improve abdo pain, global assessment and symptoms 1 Cochrane 2011, No.: CD BMJ 2008;337:a231, 3 J Clin Gastro 2014;48(6):505, 4 Am J Gastroenterol 2014; 109:1350, 5 Brandt, Am J Gastro 2009, 6 PLoS one 2010; 5: e15591 IBS C: Treat the Constipation 1. Hold the Colace: similar to placebo, inferior to other products 1 2. Use osmotic agents 2 Constipation relief NNT = 2 3, 1 3 BMs / week 3. Consider a clean out 3 Evidence Free Zone 4. Stimulants are OK 4 global sx improvement NNT = 3 5. Don t use Prucalopride 5 potential LT AEs (5 HT), PEG superior 1 TFP #161, 2016, 2 TFP # , 2015, 3 Kolber personal comm, 4 Gut 2011;60:209, 5 HTAs 2011 DOI:

9 Linaclotide for IBS C 2 strikingly similar industry RCTs: Linaclotide 290mcg vs placebo x 12 weeks Same authors, ~800 patients, 44 yo, 78% and white, same Outcome: 30% pain and 1 BM FDA responder ~34% vs ~16% placebo; NNT = 7 Both pain < MCID AEs: diarhrea DC: NNH = 21 Randomized Withdrawal: sx worsened Over publication: these studies >40xs Publication Bias: two > 1 year safety studies (1557, 1743 pts) completed not published Am J Gastro 2012;107(11):1714 Am J Gastro. 2012;107(11):1702 Comparative Shopping: Price per Poop Bisacodyl: 10 mg od = $10 /month = $0.65 /poop Lactulose*: 15ml qd = $12 /month = $1.00 /poop PEG 3350: 17g qd = $20 /month = $1.70 /poop Linaclotide: 145ug qd = $120 /month = $10 /poop Prucalopride: 2mg qd = $125 / month = $30 /poop *covered by Alberta Blue Cross 9

10 Other IBS Treatments Probiotics 1 3 : inconsistent results high quality studies no diff in symptoms Bile Acid Binders: IBS D: surrogates studied Lubiprostone: women, IBS C Not in Canada Rifaximin: IBS D, bloating Early benefit, diminishes with time,?resistance, $$$ Only treat twice (FDA) Probiotics: 1 Brant Am J. Gastro Moayyedi, Gut 2010;59:325e332, 3 van Zanten, ACP 2010 Lubiprostone: Expert Opinion Drug Safety 2017; 16 (11): 1243 Rifaximin: Ther Adv Gastro 2017; 10(2):253 IBS Summary Be confident in your diagnosis: ATTG, CRP +/ Fecal Calprotectin Placebo response listening, reassurance IBS C: Fibre IBS D: FODMAPs, GFD Interventions that work: Anti spasmotics, Anti depressants TCA: IBS D, SSRI: IBS C Treat constipation: traditional agents: PEG, stimulants Healthy Skepticism with new meds: Linaclotide, Prucalopride 10

11 Thank you 11

Slide #43. Functional Disorders - An Update 11/8/ MA ACP Annual Scientific Meeting. Functional Disorders: An Update

Slide #43. Functional Disorders - An Update 11/8/ MA ACP Annual Scientific Meeting. Functional Disorders: An Update Functional Disorders: An Update Anthony Lembo, M.D. Associate Professor of Medicine Beth Israel Deaconess Medical Center Harvard Medical School Boston, MA Disclosure of Financial Relationships Anthony