1	The Public wants a Family Doctor Who Can Manage Simple Fractures, See Children, Deliver a Baby, Counsel a Single Parent, Go to the Hospital[EGD], Do Minor Surgery in the Office[EGD], Run a lab in office[H. pylori-UBT] and More This physician could go from the nursery to the nursing home without taking the patient to the poorhouse along the way Wm. MacMillan Rodney MD 1989
2	The Dyspepsia/H. pylori Saga 1987-2007: To EGD or not to EGD? Rodney WM. The credentialing arms race in gastrointestinal endoscopy and the need for family physician faculty with endoscopic skills? JABFP 1998; 11(6):492-495. Subspecialist opinions are frequently incomplete or inappropriate for Family Medicine. -- Wm. MacMillan Rodney MD Clinical Professor of Family Medicine Vanderbilt School of Medicine Clinical Professor of Surgery/Emergency Medicine Meharry Medical College Medicos para la Familia Memphis and Nashville Tennessee
3	Background and Current Practice: Wm. MacMillan Rodney MD,FAAFP Designed first the AAFP colonoscopy course 1984 and EGD 1989. Published 20-25 studies. Implemented GI endoscopy services in a number of adversarial university and residency settings. Since 1999 I have been in private practice, performing FAMILY MEDICINE-er-ob including EGD. Special acknowledgement to my mentors—Mary MacMillan Rodney MD, H. MacMillan Rodney MD, Skip Felmar MD, James Weber MD, Bill Coleman MD, and others Special Recognition to--John Haynes MD; La.
4	Publications on EGD and Patients with Dyspepsia-wmr Rodney WM, Hocutt JE, Coleman WH, Weber JR, Swedberg JA, et al. Esophagogastroduodenoscopy by family physicians: A national multisite study of 717 procedures. J Am Bd Fam Pract 1990; 3:73-79. Rodney WM, Weber JR, Swedberg JA, Gelb DM, Coleman WH, Hocutt JE, Huston T. Esophagogastroduodenoscopy by family physicians Phase II: a national multisite study of 2,500 procedures. Fam Pract Res J 1993; 13(2):121-131. Conwell CF, Lyell R, Rodney WM. Prevalence of Helicobacter pylori in family practice patients with refractory dyspepsia: a comparison of tests available in the office. J Fam Pract 1995; 41(3):245-249. Silverstein, MD, Rodney WM. Initial endoscopy or empirical therapy with or without testing for Helicobacter pylori for dyspepsia: a decision analysis. Gastroenterol Med Today 1996; 1(1):12-13. Kuritzky L, Rodney, WM. GERD management. Strategies recommended for primary care practice. Post Grad Med A Special Report. October 2001: 11-18. Rodney WM. “Gastrointestinal Disorders” Chapter 44 in Rakel RE (editor). Textbook of Family Practice--6th Edition, WB Saunders, Philadelphia, 2002, pp 1159-1192. Rodney WM. H pyori Eradication Options for Peptic Ulcer. Monthly Prescribing Reference 2007. Haymarket Media Publlishing. New York, NY
5	Procedural Skills and Office Technology Data from the Upper GI Endoscopy Demonstration Project n==2,500 With the AAFP course and another 2-3 hours John Haynes, Paul Davis, John Cullen, and I could teach you to do EGD in your office. Opinion WMR Rodney WM, Weber Jim, Coleman Bill, Hocutt J, Swedberg J, Gelb, D.,et al. FP Res J 1993 Family physicians from 7 states Virtual Endsocpy Simulators and the Credentialing Arms Race in GI Endoscopy.Rodney WM. J Am Board Fam Pract December 1998
6	Definitions of Dyspepsia A vague grouping of upper abdominal symptoms that may be manifested by various underlying illnesses and pathophysiological findings Health and Public Policy Committee American College of Physicians Ann Int Med Feb 1985 Differentiated from gastroenteritis by a lack of diarrhea Differentiated from GI illnesses with fever AGA 2005 guidelines distinguish dyspepsia from GERD—I disagree[note Prilosec, Nexium ads DTC for “heartburn”]
7	Peptic Disease Syndrome 1995 not-Peptic Ulcer Disease 1970 “At sometime during their lives more than 1 in 10 Americans will suffer from duodenal ulcer.” This means that 4 to 8 million adults in the United States are estimated to have active or current duodenal ulcer.” When patients with documented healing are discontinued treatment at 6 weeks, the 12 month recurrence rate is about 60-90%.”
8	Diagnostic Accuracy of Dyspepsia is Enhanced with Endoscopy “It has been taught that there are classic symptoms that differentiate different types of peptic ulcer disease. Theories regarding types of meals, pain, personality, and treatment have been strongly held. With endoscopy, all of these concepts have been dramatically revised. We have detected patients with large ulcers who had minimal, if any, symptoms. Other patients have had disabling symptoms with a totally normal endoscopic examination. Arvey Roers MD Practical Gastroenterology July/August 1986; 10[4]:37-45
9	Does This Patient Need H. pylori Testing?
10	Treat Ulcers Empirically 1.For practical management of uncomplicated duodenal ulcer (without NSAID use), empiric antibiotic therapy is a reasonable alternative to H. pylori testing because of the high prevalence of H. pylori infection and the poor predictive value of negative test results.--JAMA 1996; 275:623. 2. Empirical Eradication Scenarios—with Acid Suppression a. No alarming signs or symptoms. b. Age less than 45-AGA 2005 says 55 c. High Credibilty story of ulcer--personal or immediate family c. Hematemesis, stable VS, stable Hct, f/u 1 day
11	The Dyspepsia/H. pylori Saga 1977-2007: To EGD or not to EGD? Dyspepsia indicates risk for ulcers, bleeding, hospitalization, transfusion, and surgery. Specific alarm features suggest cancer 1979 Simultaneous arrival of H2RA—cimetidine and esophagogastroduodenoscopy[EGD} 1989 First AAFP course on EGD; 1993 H. pylori arrives The medical industrial business develops during the 80’s A multitude of “me too” drugs and tests[Reglan,Propulsid, Zegerid Scientific studies as the foundation of marketing-- A new generation of highly trained salesmen arrive in your office AGA/ASGE hire attorneys to warn hospitals about credentialing family physicians to do EGD
12	H. Pylori-What is rarely helpful Serologies, stool antigens, and cultures Reflex referral to a subspecialist for EGD Treating the family and contacts with antibiotics to “prevent cancer”. HPV saga is similar-Unsubstantiated spin, sensationalistic reporting of visible cases, but no science proving causality AGA 2005—eradication therapy…”because this MAY reduce the risk of subsequent PUD and GASTRIC MALIGNACNY” Promising a cure
13	Urea Breath Test Issues A scientifically sound test for the detection of H. pylori confounded by Bayes Theorem of predictive values and unstudied comorbidities “ Equipment available in your office without CLIA” Reimbursement purported to be $100 per event. If you are routinely successful I have a job for you in my billing department. Heavily marketed despite the nonulcer dyspepsia and patient preference studies which are selectively absent from the 2005 AGA guidelines. Charges $120 if uninsured but if insured it “costs nothing” Good luck in Guatemala!
14	The Tough Questions on H. pylori Is the empiric treatment of dyspepsia with antibiotics to see “what happens” Wrong? No The standard of care? NO Is mandatory H pylori testing before treating a standard of care?—NO Is it acceptable to treat the average dyspepsia patient with PPI/H2RA before you require EGD or H. pylori testing—YES When the experts disagree, the country doc can decide. --Mary MacMillan Rodney MD, AAGP
15	Will H. pylori eradication help here?
16	Update on H pylori Treatment Ables AZ, Simon J, Melton ER. Am Fam Physician 2007; 75: 351-358 Adds new data on shorter courses of antibiotics ranging from 1-7days.[Agree] Shorten post eradication acid suppression to 2 weeks[Agree with a disclaimer] Supports the “test and treat” strategy using IgG serologies, stool antigen tests, and/or urea breath tests.[Disagree] Mildly supports empirical H pylori eradication for nonulcer dyspepsia[Disagree] No eradication treatment for GERD[Agree] Eradication to prevent gastric cancer is not recommended[Agree]
17	Why not EGD by Family Physicians? A natural reaction to the excesses of subspecialty medicine which seems to drive American health care costs over $2 TRILLION in 2007. Average EGD bill from MD and hospital in Memphis is over $2000 AGA 2005—”Endoscopy appears not to be cost-effective…” Medicos provides EGD to uninsured patients for $200 total. Medicaid pays us about $300. The churning of patients by underemployed endoscopists fragments care and avoids many of the nonGI illnesses which cause dyspepsia. Family Medicine residencies are not politically strong enough to tech it. Family Medicine lacks consensus to demand accountabalility on the adoption of new technologies which are “procedural”
18	Eradication Rates for H pylori Long Course 10-14 days range from 80-86% Short Course 1-7 days range from 80-83% All studies generally exclude: Patients living in areas where reinfection rates commonly over 75%[ Native Americans and developing countries] Patients with comorbidities such as anxiety, depression and numerous other psychosocial barriers to care[over a third of FP patients.] Patients who demand EGD immediately or later
19	What to do when the symptoms persist A. Prescribe another course of antibiotics B. Add a PPI to the H2Ra or vice versa C. Call the Department of Health to see where all of this H pylori is coming from. Request that the patients provide a copious stool specimen at the reference laboratory. Request a Urea Breath Test from somebody who has one. Repeat q 3 months as needed Tell the anxiety prone patient that AGA 2005 doesn’t recommend EGD because they won’t feel better if the EGD is negative. EGD
20	State-of-the-Art H. pylori 2007 Since most patients with H. pylori infection never develop clinically significant disease and treated patients are exposed to the risk of antibiotic associated implications. . . Widespread use of antibiotics may promote antibiotic resistance, making eradication of H. pylori even more difficult in the future. Am Fam Phys 1997; 55:2765 The empiric use of H. pylori eradication in the treatment of dyspepsia has been promoted by test vendors and the AGA 2005 guidleines, but some disagree ………
21	Dyspepsia/H. pylori Standards 1. Patients over the age of 50 should have documented ulcer disease before empirical anti H. pylori therapy is started. 2.Patients who do not respond to acid suppression in 2 weeks should be investigated by EGD.Am Fam Phys 1997; 55:2765 3. AGA 2005 suggests that it’s “recommendations” constitute a “standard of care” but they do not. 4.One option is to H pylori test another is empirical Rx antibiotics and another is EGD. Only EGD minimizes the medicolegal risk from “failure to diagnose…..”
22	NIH Guidelines for Antimicrobial Treatment for H. pylori Infection Patient H. pylori H. pylori Status Negative Positive 1. Asymptomatic No No 2. Non-ulcer dyspepsia No No 3. Gastric ulcer No [disagree] Yes 4. Duodenal ulcer No [disagree] Yes
23	Medicos Guidelines for Antimicrobial Treatment for H. pylori Infection Patient H. pylori H. pylori Status Negative Positive 1. Asymptomatic No No 2. Non-ulcer dyspepsia No No 3. Gastric ulcer Yes Yes 4. Duodenal ulcer Yes Yes 5. Biopsy proven Cancer Yes Yes
24	Leukoplakia in the Stomach-H. pylori eradication?
25	H. pylori Update 2007 In the absence of NSAIDs or alcohol, men or women with the following should be considered for H. pylori eradication: Erosive, hemorrhagic gastritis. Unexplained iron deficiency anemia. Yip R., et al. JAMA 1997; 277:1135-1139 Would H., Feldman M. JAMA 1997; 277:1166-1177
26	Eradication of H. pylori Doesn’t End Dyspepsia: Empiric Therapy Called into Question In patients randomized to placebo or two weeks of H. pylori eradication therapy. Symptom scores were similar in the two groups at six weeks and six months after therapy. Van Deventer V., et al 1995 DDW, San Diego
27	"SEE AND TREAT LOGIC 1995-2007" SEE AND TREAT LOGIC 1995-2007 Since its very easy and safe to treat for H. pylori, why not empirically prescribe H. pylori eradication therapies in all cases of dyspepsia? COROLLARY: WHY PERFORM ANY TESTS AT ALL? o
28	Non-ulcer Dyspepsia in a Dutch Population and H. pylori History of ulcers as an explanation of an apparent association. CONCLUSION: In the Dutch working population, non-ulcer dyspepsia is not related to H. pylori infection; whereas, for duodenal ulcer, the relationship is clear. Schlemper RJ. Arch Int Med 1995; 155:82-87
29	H. pylori gastroduodenal disease, and recurrent abdominal pain in children “In summary, there is strong and consistent evidence that H. pylori infection is associated with antral gastritis children, although the clinical significance of this condition is unclear. For example, the majority of infected children and adults are asymptomatic.” MacArthur C, et al. JAMA 1995; 273:729-33
30	“Maria’s ‘ulcer’ caused her to be left back in school” 14 years old no other significant PMH No Fam Hx Went to the other doctors. She was H plylori postive. Took the antibiotics they didn’t help No alarm symptoms, Preg test negative How Family Medicine is different from GI
31	Eradication of H. pylori Doesn’t End Dyspepsia: Empiric Therapy Called into Question In patients randomized to placebo or two weeks of H. pylori eradication therapy. Symptom scores were similar in the two groups at six weeks and six months after therapy. Van Deventer V., et al 1995 DDW, San Diego
32	The Physician-Patient Relationship Expectations for Investigation Patients may expect tests and feel dissatisfied when they are not suggested.
33	To EGD or Not to EGD? Patients Prefer EGD Immediate Endoscopy Group Immediate Medication Group (f/u endoscopy prn) Lancet Apr 2, 1994; 343:811
34	Patients’ Perceived Quality of Dyspepsia Care. A Randomized Study Endoscopy Medication Outcomes Group Group___ Symptoms = = Quality of Life = = Satisfaction More (p>0.05) Less Days of Work Lost x(p<0.05) 2 x’s more Lancet Apr 2, 1994; 343:811
35	Endoscopy Demonstration Projects Verify the Psychosocial Benefits Colonoscopy Esophagogastroduodenoscopy Colposcopy ENT Endoscopy Flexible Sigmoidoscopy Limited Colonoscopy Others
36	Features Suggestive of Gastric Carcinoma Age over 45 Short History (less than 1 year) Daily Pain/Discomfort/Persistently Awakened in the Night Blood in Vomitus Back Pain Weight Loss-significant and unplanned
37	Diagnostic Strategies in the Management of Acute Upper GI Bleeding, Patient and Physician Preferences 1. Upper GI bleeding resolves uneventfully in 25% of patients treated only with standard medical therapy. 2. Endoscopy (EGD) does not improve outcomes in low risk patients. 3. Patients prefer endoscopy over less invasive upper GI x-rays (2-3 days after the bleeding has stopped) or no diagnostic tests (unless bleeding continues or restarts). Dolan JG, Bordley Dr, Miller J. J Gen Int Med 1993; 8:525-29
38	Diagnostic Strategies in the Management of Acute Upper GI Bleeding: Patient and Physician Preferences 4. Among 25 recovering patients, 92% preferred having the procedure (EGD) done, primarily to find out the site of the bleeding. Only 55% of their primary physicians preferred having the endoscopy done. 5. Patients regarded knowledge of the bleeding site as important, even though this information does not affect management or prognosis. 6. The study concludes the current rate of diagnostic endoscopy is higher than would be expected based on physician preference, but quite consistent with patient preference. Dolan JG, Bordley Dr, Miller J. J Gen Int Med 1993; 8:525-29
39	H. PYLORI ERADICATION STRATEGIES 2000; Updated 2007 1. N Engl J Med 1996; 334:474. a. Omeprazole, 20mg bid x 7 days. b. Metronidazole, 250mg qid x 7 days. c. Clarithromycin, 500mg bid x 7 days. d. Continue acid suppression for 2-8 additional weeks with H₂ receptor antagonist or Proton pump inhibitor. 2. “I will be back” Arnold Schwarzenegger in The Terminator
40	H. pylori and Drug Resistance 1. Resistance not reported: Tetracycline, Amoxicillin. 2. Widespread usage fosters resistance: Metronidazole (Flagyl), Clarithromycin (Biaxin), Fluoroquinolones, Rifampin. 3. Do Not use these drugs as single therapy in any given patient. Am Fam Phys 1997; 55:2765
41	TREATMENT STANDARDS Treatment for 7 days is the gold standard, although in many patients H. pylori “will be back”. Those who have not completed one full week of therapy probably should be switched to an alternate regimen. Damianos AJ, McGarrity TJ. Am Fam Phys 1997; 55:2765.
42	Endoscopic Diagnosis of Inflammation and the H. pylori Dilemma Mucosal abnormalities and H. pylori tests are non-specific Diagnosis and tx relies on the clinical context An H. pylori aerosol covers planet Earth, and most H.pylori positive patients never have disease. Empiric eradication is rarely the first choice or a lasting solution. Continuity of care physicians have a significant advantage when they obtain their own endoscopic information. This is a major benefit in multifactorial syndromes such as Peptic Disease Syndrome among H. pylori positive patients. WMR 1991; 1995; 2007
43	Why not EGD by Family Physicians? A natural reaction to the excesses of subspecialty medicine which drives American health care costs over $2 TRILLION in 2007. Average EGD bill from GI and hospital in Memphis is over $2000 AGA 2005—”Endoscopy appears not to be cost-effective…” Medicos provides EGD to uninsured patients for $200-300 total. Medicaid pays Medicos about $300. FP EGD is cost effective. The churning of patients by underemployed endoscopists fragments care and avoids many of the nonGI illnesses which cause dyspepsia. Family Medicine residencies are not politically strong enough to teach it. Family Medicine lacks consensus to demand accountability on the adoption of new technologies which are “procedural”
44	Predictions for the Future One of the hidden megatrends within the health care system is the continued resurgence of broad-based, technologically-assisted diagnostic skills within the medical specialty of Family Practice. This advance continues despite lukewarm academic support and outright suppression in some urban areas. Wm. Rodney, M.D. PSOT 1994; 7(5):106
45	The Dyspepsia/H. pylori Saga 1987-2007: To EGD or not to EGD? Rodney WM. Will virtual reality simulators end the credentialing arms race in gastrointestinal endoscopy or the need for family physician faculty with endoscopic skills? JABFP 1998; 11(6):492-495. Subspecialist opinions are frequently iincomplete or inappropriate for Family Medicine. -- Wm. MacMillan Rodney MD Clinical Professor of Family Medicine Vanderbilt School of Medicine Clinical Professor of Surgery/Emergency Medicine Meharry Medical College Medicos para la Familia Memphis and Nashville Tennessee