Battling the Burp and Burn of Functional Dyspepsia

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1 Battling the Burp and Burn of Functional Dyspepsia Geneva Briggs, PharmD, BCPS Live Activity Handout 4 slides per page

2 Battling the Burp and Burn of Functional Dyspepsia ACTIVITY DESCRIPTION Functional dyspepsia is a disorder of the upper digestive tract that results in significant painful symptoms. Many lifestyle changes, supplements, medical foods, and prescription medications can be tried to manage this condition but none are FDA approved. Patients frequently seek self treatment for this condition but may think they have GERD. Pharmacists are ideally positioned to provide appropriate counseling on the management of functional dyspepsia. TARGET AUDIENCE The target audience for this activity is pharmacists, pharmacy technicians, and nurses in hospital, community, and retail pharmacy settings. LEARNING OBJECTIVES After completing this activity, the pharmacist will be able to: List the common symptoms of functional dyspepsia. Explain the proposed mechanism and cause of functional dyspepsia. List the possible treatments for this disorder including lifestyle, medical foods, supplements, and prescription. Analyze a patient case to make a recommendation for managing this disorder. After completing this activity, the pharmacy technicians will be able to: List the common symptoms of functional dyspepsia. Explain the proposed mechanism and cause of functional dyspepsia. List the possible treatments for this disorder including lifestyle, medical foods, supplements, and prescription. ACCREDITATION Pharmacy PharmCon, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Nursing PharmCon, Inc. is approved by the California Board of Registered Nursing (Provider Number CEP 13649) and the Florida Board of Nursing (Provider Number ). Activities approved by the CA BRN and the FL BN are accepted by most State Boards of Nursing. CE hours provided by PharmCon, Inc. meet the ANCC criteria for formally approved continuing education hours. The ACPE is listed by the AANP as an acceptable, accredited continuing education organization for applicants seeking renewal through continuing education credit. For additional information, please visit: Universal Activity No.: L01-P Credits: 1.0 Release Date: 2/13/2017 freece Expiration Date: 2/13/2020 ACPE Expiration Date: 2/13/2020 ACTIVITY TYPE Knowledge-Based Live Webinar FINANCIAL SUPPORT BY PharmCon

Virginia. Additionally, she is the owner of Briggs and Associates. Dr.

3 Geneva Briggs, PharmD, BCPS President, Briggs and Associates ABOUT THE AUTHOR Dr. Geneva Clark Briggs, a board-certified Pharmacotherapy Specialist, received her Doctor of Pharmacy and Bachelor of Science in Pharmacy degree from Virginia Commonwealth University, Medical College of Virginia. Additionally, she is the owner of Briggs and Associates. Dr. Briggs was the Chief of Pharmacotherapy at McGuire Veterans Affairs Medical Center and was an Assistant Clinical Professor of Pharmacy and Pharmaceutics at Virginia Commonwealth University, Medical College of Virginia. Prior to becoming Chief of Pharmacotherapy, she was a clinical pharmacy specialist in geriatrics. After she left the Veterans Administration, she worked for MedOutcomes, Inc training pharmacists to provide clinical services in community pharmacies. She has authored numerous articles and textbook chapters. She currently speaks around the country on various topics, and develops continuing education products. FACULTY DISCLOSURE It is the policy of PharmCon, Inc. to require the disclosure of the existence of any significant financial interest or any other relationship a faculty member or a sponsor has with the manufacturer of any commercial product(s) and/or service(s) discussed in an educational activity. Casey Trest reports no actual or potential conflict of interest in relation to this activity. Peer review of the material in this CE activity was conducted to assess and resolve potential conflict of interest. Reviewers unanimously found that the activity is fair balanced and lacks commercial bias. Please Note: PharmCon, Inc. does not view the existence of relationships as an implication of bias or that the value of the material is decreased. The content of the activity was planned to be balanced and objective. Occasionally, faculty may express opinions that represent their own viewpoint. Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not intended as a substitute for the participant s own research, or for the participant s own professional judgement or advice for a specific problem or situation. Conclusions drawn by participants should be derived from objective analysis of scientific data presented from this activity and other unrelated sources. Neither freece/pharmcon nor any content provider intends to or should be considered to be rendering medical, pharmaceutical, or other professional advice. While freece/pharmcon and its content providers have exercised care in providing information, no guarantee of it s accuracy, timeliness or applicability can be or is made. You assume all risks and responsibilities with respect to any decisions or advice made or given as a result of the use of the content of this activity.

Disclosures FACULTY: 2/2/2017 Geneva Briggs, PharmD, BCPS 1 1 2/2/2017 2 Overview Case Study Maria Common symptoms of functional dyspepsia Proposed

4 Disclosures FACULTY: 2/2/2017 Geneva Briggs, PharmD, BCPS 1 1 2/2/ Overview Case Study Maria Common symptoms of functional dyspepsia Proposed mechanism and cause Treatments Making recommendations to patients Maria is a 45-year-old woman who is purchasing an assortment of GI meds. She says she is having stomach trouble. 3 months of vague abdominal discomfort predominantly epigastric in location Sometimes accompanied by a sense of "fullness" that makes it difficult for her to eat burning sensation in her upper abdomen but not her throat Feels queasy after eating 2/2/ /2/

5 Dyspepsia Known Causes of Dyspepsia Painful, difficult, or disturbed digestion, which may be accompanied by symptoms such as nausea and vomiting, heartburn, bloating, and stomach discomfort. Affects ~30% of population Most don t seek physician care 40-50% - underlying cause 40-50% - no identifiable cause on diagnostic evaluation Gastroenterology. 2005;129(5): International Foundation for Functional Gastrointestinal Disorders. Disease Peptic ulcer disease Gastroesophageal reflux (GERD) Gastric malignancy Biliary Medication-induced dyspepsia Helicobacter pylori Gastroparesis Typical Symptoms/comments Food or empty stomach provoked pain Upper abdominal pain, postprandial belching Retrosternal burning pain and regurgitation, cough, hoarseness Vague epigastric pain, fatigue, weight loss Episodic acute and severe upper abdominal pain, May radiate to the back or scapula, Often associated with restlessness, sweating, or vomiting No pain between episodes NSAIDs, Aspirin, COX 2 inhibitors With or without ulcers Postprandial fullness, early satiety, vomiting, nausea diabetes, nervous system disease Gastroenterology. 2005;129(5): Access Medicine 2/2/ /2/ Dyspeptic Symptoms Dyspepsia without obvious GERD or NSAID Age > 55 or alarm symptoms* Age < 55 No alarm symptoms Heartburn and/or regurgitation (predominant/frequent) Manage as GERD (acid suppression) Regular NSAID/ COX-2 use Discontinue NSAID if possible, switch to another agent, or add acid suppression (PPI) Dyspepsia without obvious GERD or NSAID Am J Gastroenterol 2005;100: Gastroenterology. 2005;129(5): Upper endoscopy No Self Treatment *weight loss, progressive dysphagia, recurrent vomiting, evidence of gastrointestinal bleeding, or family history of cancer. negative PPI trial 2-6 wks fails Reassurance, stop PPI Reassess diagnosis Consider upper endoscopy Test for H pylori fails positive Treat H pylori fails PPI trial 2-4 wks N Engl J Med 2015;373: /2/ /2/

Functional Dyspepsia (non-ulcer, idiopathic) Symptoms No evidence of structural disease Symptoms for 3 of last 6 months (ROME III criteria) Postprandial distress syndrome postprandial fullness early

appetite Weight loss Burping Gastroenterology. 2006;130(5):1466-79. N Engl J Med 2015;373:1853-63. Mayo Clin Proc. 2016;91(8):1118-32.

45-year-old woman Symptoms 3 months of vague abdominal discomfort, predominantly epigastric in location, sometimes accompanied by a sense of "fullness" that makes it difficult for her to eat, burning

6 Functional Dyspepsia (non-ulcer, idiopathic) Symptoms No evidence of structural disease Symptoms for 3 of last 6 months (ROME III criteria) Postprandial distress syndrome postprandial fullness early satiety Epigastric pain syndrome epigastric pain or burning Most Common Upset stomach Discomfort or pain near stomach Bloating Feeling full quickly when eating Less Common Nausea Vomiting Lack of appetite Weight loss Burping Gastroenterology. 2006;130(5): N Engl J Med 2015;373: Mayo Clin Proc. 2016;91(8): Up To Date Approach to the Adult with Dyspepsia 2/2/ /2/ Case Study Maria What Causes It? 45-year-old woman Symptoms 3 months of vague abdominal discomfort, predominantly epigastric in location, sometimes accompanied by a sense of "fullness" that makes it difficult for her to eat, burning sensation in her upper abdomen but not her throat, feels queasy after eating No medications Visceral hypersensitivity (fat, H+, wall distension) Vagal neuropathy Inflammation (H. pylori, altered biome/flora) Delayed gastric emptying/ Antral hypomobility CNS Modulation (stress, illness behavior, etc) Genetic mutations in voltage-gated sodium channels Decreased fundic accommodation Over-distended antrum Duodenal hypersensitivity Small bowel dysmotility Therap Adv Gastroenterol ; 3(3): /2/ /2/

7 What Causes It? Impact of Functional Dyspepsia (FD) Impaired gastric accommodation fullness, stomach pressure Delayed gastric emptying early satiety, nausea Visceral hypersensitivity - pain 75% were women 52% of respondents rated their FD as moderate. 3 visits to their PCP over 1 yr for FD 75% blood work, 92% EGD, 59% ultrasound, 40% CT scan 89% tried dietary changes, 89% OTC med, 87% RX med, 25% alternative therapies. Mean of 1.4 h absence from work in last 7 days Aliment Pharmacol Ther. 2013;38(2): /2/ /2/ Impact of FD Treatment Impact on QOL equals that of asthma or IBS Folate deficiency 34% B12 deficiency 23 % Estimated total costs: $18.4 Billion/year (2009 dollars) BMC 2012;5:206. Aliment Pharmacol Ther. 2013;38(2): /2/ /2/

Questions to Ask Before Self Treatment Is the pain "gnawing" or worse when you are hungry? [PUD] Is the pain worse when you move in certain ways or press on certain areas of the abdomen?

8 Questions to Ask Before Self Treatment Is the pain "gnawing" or worse when you are hungry? [PUD] Is the pain worse when you move in certain ways or press on certain areas of the abdomen? [PUD, gallbladder] Do you take medicines for pain, such as aspirin, ibuprofen (Advil, Motrin), or naproxen (Aleve)? Do you have a history of ulcers? Do you also have heartburn or does acid come up into your mouth? [GERD] Questions to Ask Before Self Treatment Do you have intense pain in the upper right or middle of the abdomen? Does the pain shoot into your back or between the shoulder blades? Does this happen periodically, along with vomiting, sweating, or feeling restless? [Gallbladder] Have there been changes in your bowel movements (new constipation or diarrhea)? [IBD, IBS, colon cancer, lactose intolerance] Have you recently unintentionally lost weight, vomited repeatedly, or had difficulty swallowing? [gastric/esophageal obstruction or cancer] 2/2/ /2/ Questions to Ask Before Self Treatment Don t Self Treat Is discomfort located in the upper abdomen? Are symptoms related to eating (within 60 minutes of a meal)? Vomiting that will not stop Vomiting blood Losing weight or have no appetite Bloody or dark-colored, tarry bowel movements Pain or difficulty with swallowing Symptoms worsen or don t get better with 8 weeks of treatment Age > 55 and new onset Up To Date Approach to the Adult with Dyspepsia 2/2/ /2/

9 Case Study Maria Lifestyle/Dietary Changes Symptoms of FD No medications No Alarm symptoms, <55 Is discomfort located in the upper abdomen? Yes Are symptoms related to eating (within 60 minutes of a meal)? Yes Avoid fatty foods Eat small, frequent meals Avoid foods that cause or worsen symptoms milk, alcohol, caffeine, mint, tomatoes, citrus fruits, and spicy foods Avoid laying down after meals Lose weight if overweight Diet diary can help identify problem foods Is self treatment appropriate? Up To Date Approach to the Adult with Dyspepsia 2/2/ /2/ Placebo Response in FD Acid Reduction Important that any study in FD has a placebo arm! Peppermint Oil/Caraway Oil Placebo Proton pump inhibitors (PPI) & histamine blockers (H2RA) Marginally better than placebo for epigastric pain Tend not to improve other dyspeptic symptoms PPI 14% response over placebo, H2RA 23% Issues with long term use PPI C difficile colitis, community acquired pneumonia, hip fractures, B12 & magnesium deficiency H2RA - B12 & magnesium deficiency 0 Abd pain Fullness Aliment Pharmacol Ther 2000;14: Therap Adv Gastroenterol ; 3(3): Up To Date Approach to the Adult with Dyspepsia 2/2/ /2/

10 Metoclopramide No Benefit in Functional Dyspepsia Dopamine D2 receptor antagonist Increases lower esophageal tone Gastroprokinetic increase gastric emptying Not used often Adverse effects dystonia, restlessness, movement disorder, neuroleptic malignant syndrome, depression Lack of studies FDA approved for gastroparesis Antacids Bismuth Sucralfate Antispasmodics No better than placebo 2/2/ /2/ Case Study Maria Antidepressant/Pain Medication None are FDA approved for FD Self treatment appears appropriate Discuss with her and she decides to try ranitidine 150 mg bid 2 week trial if working continue another 2 weeks then try stopping If no better in 4 weeks, see PCP Tell PCP at next visit and ask about continuing Also suggested instituting lifestyle/dietary changes Mood disorders are common in FD Target pain sensitivity Norepinephrine Tricyclic antidepressants Low dose Amitriptyline, nortriptyline, and desipramine? Might they work Duloxetine (Cymbalta) and Milnaciprin (Savella) FDA indication for fibromyalgia Gastroenterology. 2015;149(2):340-9.e2 PLoS One. 2016;11(6):e /2/ /2/

11 Overall Benefit in FD Medical Foods and Supplements Treatment Response rate (over placebo) NNT PPI 14% 10 H2RA 23% 7 H pylori eradication 8% 18 Metoclopramide 48% 4 TCA 24% 7 NNT, number needed to treat Therap Adv Gastroenterol ; 3(3): PLoS One. 2016; 11(6): e /2/ /2/ Probiotics Peppermint Oil (Mentha x piperita) Those with FD have different stomach flora compared with those w/out FD 2 small trials Lactobacillus gasseri yogurt (4 oz/day, 1 billion colony forming units) x 8-12 weeks improved postprandial distress symptoms and restored normal flora Single probiotic - Swanson (3 billion CFU) Multiples Biggest Loser Probiotic Pearls (?), Phillips Colon Health (?) MOA: Inhibition of smooth muscle contractions due to direct interaction with smooth muscle calcium channels May decrease gastric emptying time Rated PE AE: dyspepsia, heartburn, anal/perianal burning Caution: Excess intake is toxic; avoid in pregnancy, nursing, less than 8 years old DI: cyclosporine, antacids/ppi/h2 blockers 2/2/ Gastroenterol Res Pract 2016; 2016: BMJ Open Gastroenterol 2016;3(1):e /2/ Natural Medicine Database J Gastroenterol 2007;42:

12 Caraway Oil (Carum carvi ) FDgard MOA: increased motility of the proximal stomach and antrum Rated PE (in combo with peppermint oil) AE:? DI(?): Diabetes medications, diuretics, sedatives Marketed as medical food in US Combo of caraway oil (9d-carvone, d-limonene, 25 mg) & peppermint oil (l-menthol, mg ) in delayed release capsule 5 randomized, placebo controlled trials (n=700) 21% reduction in postprandial symptoms 18% reduction in epigastric pain = to cisapride 2/2/ Phytomedicine. 2006;13 Suppl 5: Natural Medicine Database 2/2/ Aliment Pharmacol Ther 2002;16: Aliment Pharmacol Ther 2000;44: Fdgard (caraway oil/peppermint oil) Fdgard (caraway oil/peppermint oil) Dose: 2 capsules bid or as needed Max: 6 per day Take at least 30 minutes before or after food, with water Swallow whole or mix capsule contents with applesauce Do not chew Separate from antacid/h2ra - take 1-2 hours before Labeling says can take at same time as PPI Adverse effects: none reported in trials Burping (fragrant) Mild tingling sensation in upper GI tract Medical food Both are GRAS No wheat, yeast, gluten, soy or lactose Expensive - $4 or more per day Fdgard.com Natural Medicines Database 2/2/ /2/

13 Alternatives to FDgard Enteric coated peppermint oil 0.2 ml tid Studied for IBS Likely effective (LE) for IBS Example products Pepogest (Nature s Way, $0.70/day) A lot have ginger, fennel, & other stuff Enteric coated peppermint oil & caraway oil 0.2 ml of each tid Example products Regiment (Life Extension, $1/day) Iberogast (STW5) Proprietary blend German chamomile (Matricaria recutita), clown s mustard/bitter candytuft (Iberis amara), angelica root and rhizome (Angelica archangelica), caraway fruit (Carum carvi), milk thistle fruit (Silbum marianum) lemon balm leaf (Melissa officinalis), celandine aerial part (Chelidonium majus), licorice root (Glycyrrhiza glabra), peppermint leaf (Mentha x piperita) 31% alcohol Natural Medicines Database 2/2/ /2/ Iberogast Studies Iberogast More effective than placebo in 3 small trials Equal efficacy to cisapride in one trial Rated Possibly Effective (PE) At 8 wks, 43.3% vs 3.3% on placebo had complete relief of symptoms Liquid Dose: TID before or after meals Age Dose 12 and over 20 drops (1 ml) drops 2/2/ Z Gastroenterol. 2001;39(7): Z Gastroenterol. 2002;40(6): Digestion. 2004;69(1):45-52 Natural Medicine Database drops 3 months to 3 years 8 drops 2/2/ Iberogast Label 10

14 Iberogast - Possible Adverse Effects Iberogast Drug Interactions German chamomile allergic reaction Clown s mustard (bitter candy tuft) nausea, diarrhea, rash Angelica photosensitivity Milk thistle fruit - nausea, diarrhea, dyspepsia symptoms Lemon balm leaf - thyroid hormone inhibition, nausea, vomiting, abdominal pain Celandine hepatitis, hemolytic anemia, diarrhea, nausea Licorice root - hypertension and hypokalemia In addition to issues with peppermint & caraway German chamomile - CNS depressants, 2C9/2D6/3A4 substrates, estrogens, tamoxifen, warfarin Celandine immunosuppressants, hepatotoxins Lemon balm - CNS depressants, anti-diabetics Licorice antihypertensives, cisplatin, steroids, 2C9/2B6/3A4 substrates, digoxin, warfarin (major) 2/2/ Natural Medicines Database 2/2/ Natural Medicines Database Case Study Maria Stop or Go Her symptoms were not helped by H2RA. Started on amitriptyline 10 mg hs - 40% reduction in symptoms Would like to feel better. She inquires about trying something natural for her FD She was recently diagnosed with hypertension taking enalapril 10 mg qd 64 year old male who complains of burning stomach pain 56 year old female with burning pain near stomach that does not radiate, much worse after eating, frequent belching and bloating, no nausea/vomiting/wt loss/etc 72 year old male with severe upset stomach and shortness of breath, puts his fist right in center of chest when asked where it hurts 2/2/ /2/

15 Resources Bottom Line Review article Guidelines American College of Gastroenterology s3.gi.org/physicians/guidelines/dyspepsia.pdf American Gastroenterological Association Patient education uptodate.com/contents/upset-stomach-functional-dyspepsia-in-adults-beyond-the-basics Alternative/Complementary Medicine National Center for Complementary and Integrative Health nccih.nih.gov Natural Medicines Database naturalmedicines.therapeuticresearch.com Consumer Labs consumerlabs.com Functional dyspepsia is common Self treatment is ok for many Refer those with new dyspepsia over 55 or with alarm symptoms Lifestyle/dietary changes Non Rx options OTC PPI/H2RA 2 weeks EC Peppermint oil/caraway oil (PE) EC Peppermint oil 2/2/ /2/

Functional Dyspepsia

Functional Dyspepsia American College of Gastroenterology Boston Massachusetts, June 2015 Brian E. Lacy, PhD, MD, FACG Professor of Medicine Geisel School of Medicine at Dartmouth Chief, Section of Gastroenterology