dyspepsia: patient web educ dec EGDs

 A patient-centered educational intervention decreased the unnecessary use of upper GI endoscopy (see dyspepsia web educ dec egd jamaintmed2021 in dropbox or doi:10.1001/jamainternmed.2021.1408)

 

Details: 

-- open-label RCT, multicenter study at 4 teaching hospitals in the Netherlands from 2017-2019, sponsored by the Dutch Ministry of Health

-- 119 patients aged 18 to 69 with uninvestigated dyspeptic symptoms

-- median age 48, 40% men, BMI 25, 50% alcohol users, 15% smokers, 80% employed/8% disabled,

-- medications: 70% PPI/3% H2-blockers/12% antidepressants/6% NSAIDs sporadically

    -- those on antacid therapy were on them for a mean of 80 weeks

-- 23% had prior upper GI endoscopy/18% abdominal ultrasound

-- excluded patients: those with red flag symptoms, including signs of upper GI hemorrhage (hematemesis, melena, hematochezia, anemia), unintentional weight loss of 5% or higher during a period of 6 to 12 months, or persistent vomiting/dysphagia/jaundice, as well as those with any 1^st or 2^nd degree relative with a history of upper GI tract malignancy

-- patients were randomized to an educational intervention vs upper GI endoscopy (the control group)

    -- the educational intervention was a web-based, self-managed education with information on gastric function, dyspepsia, and upper GI endoscopy. The patients in the intervention group were encouraged to complete this educational program at home before making an appointment for the endoscopy (patients in both groups were free to make an endoscopy appointment at any time and for any reason). No restriction in the use of any drugs, including herbal supplements or NSAIDs

-- 56% were tested for the presence of H pylori

-- 56% fulfilled the Rome IV criteria for functional dyspepsia

-- follow-up 52 weeks after randomization

 

--main outcome: difference in the proportion of patients receiving upper GI tract endoscopy, comparing those in the educational intervention vs control, at 12 weeks and at 52 weeks after randomization; secondary outcomes: quality of life (Nepean Dyspepsia Index), and symptom severity (Patient Assessment of Gastrointestinal Disorders Symptom Severity Index) at baseline and at 12 weeks

-- health anxiety level was measured at baseline and at 12 weeks after randomization using the Short Health Anxiety Inventory

-- upper endoscopy results were categorized as: no abnormality, not clinically relevant findings (all findings that did not require further investigation or treatment, including non-erosive gastritis, hiatal hernia, reflux esophagitis Grade A), or clinically relevant findings (including Barrett’s esophagus, reflux esophagitis of a higher grade, H pylori gastritis, gastric ulcer, or malignancy)

 

Results:

-- no patient developed red flag symptoms during the study

-- endoscopy rates:

    -- intervention group: 24 participants (39%)

    -- control group: 47 participants (89%), including 10 patients who elected not to have endoscopy

    -- relative risk 54% lower with intervention, RR 0.46 (0.33-0.64), p<0.001

-- one additional patient in the intervention group required upper GI endoscopy during follow-up

-- these rates of endoscopy screening were maintained for at least 52 weeks after randomization

-- symptom severity and quality of life improved equivalently in both groups

-- health anxiety improved in the intervention group but not in the control group; a higher level of health anxiety did not explain why people elected subsequent endoscopy after education

-- endoscopy results:

    -- no clinically relevant findings: 82% (no difference between those with or without prestudy PPI use)

    -- 3 patients had H pylori-associated gastritis

    -- one patient had confirmed short segment Barrett’s esophagus, a patient in the control group who had been on PPIs

    -- 5 patients had higher grades of reflux esophagitis

    -- one patient had gastric ulcer (with complete resolution on follow-up endoscopy)

    -- no biopsies found celiac disease or malignant neoplasms

 

Commentary: 

-- dyspepsia is typically defined as symptoms referable to the upper GI tract present for at least 4 weeks and including upper abdominal pain or discomfort, nausea, or vomiting. These symptoms occur in >20% of the population 

-- as a baseline, the prevalence of H pylori in the Netherlands is <20% 

    -- in other countries, an H pylori test-and-treat strategy significantly decreased upper GI endoscopies, though overuse of endoscopy was still evident 

    -- of note, there is an overall trend to decreasing H pylori incidence, especially in Europe. There are pretty clear correlations between H pylori infection as well as reinfection rates with sociodemographic conditions/”human development” . many countries have not seen any reduction. (eg see H pylori epidemiology Helicobac2018 in dropbox, or DOI: 10.1111/hel.12514 [and, yes, there is a journal called Helicobacter]

-- the web-based intervention was developed in the Netherlands for this study, through focus groups with patients and clinicians (and is not generally available) 

-- roughly one in 3 upper GI endoscopies are done for dyspeptic symptoms, with overall a very low yield for esophageal or gastric cancer (< 1%) 

-- there are harms associated with this procedure, with hospitalization-required complications in about 0.1%. The major harms are complications related to sedation (most common), a low rate of cardiopulmonary complications (0.3 to 0.5 per 1000 cases), methemoglobinemia from topical anesthetics, bleeding (increased with esophageal dilatation, percutaneous endoscopic gastrostomy tube placement, or endoscopic mucosal resection), esophageal perforation, and infection 

-- a 2009 patient questionnaire of people felt to have functional dyspepsia found that 48% thought they were at increased risk of developing an ulcer and 32% that there was an increased risk of developing stomach or colon cancer [ie, an exaggerated fear from the symptoms, perhaps leading patients to request endoscopy]

-- the general recommendations for endoscopy for those under 60 years old are pretty much as in the study (see dyspepsia guidelines ACG2017 in dropbox, or doi: 10.1038/ajg.2017.154), or http://gmodestmedblogs.blogspot.com/2017/07/dyspepsia-guidelines.html (those >60 years old should get endoscopy): 

    --those with >1 alarm feature, GI bleeding (including unexplained iron deficiency anemia), unintended weight loss >5% over 6 to 12 months, rapid progression of alarm features, palpable mass or lymphadenopathy, or family history of upper GI cancer (in the guidelines alarm features should not automatically precipitate endoscopy)

    -- the next step is typically checking for H pylori infection and treating if present. stop here if symptoms resolve and test-of-cure is negative

    -- then treat empirically with a PPI for 4-8 weeks

    -- if symptoms persist, trial of 8 to 12 weeks of a tri-cyclic antidepressant; if that doesn’t work then a trial of a prokinetic agent for 4 weeks (eg metoclopramide)

    -- endoscopy if symptoms continue, with consideration for gastric emptying study (especially where gastroparesis is strongly suspected), or psychotherapy for patients with functional dyspepsia

-- part of the issue here is that primary care clinicians can often order upper GI endoscopies directly, without the need for a GI consult. Though I personally support direct access to many specialty tests, including this one, I do think that these are overutilized. And, this may be the case even in patients who see specialists, as is found in cardiology were 30% of catheterizations are considered unnecessary [ie, this is not just a primary care issue....]

-- it is notable that the health anxiety level was lower in the intervention group; and that for those who did have subsequent upper GI tract endoscopy, it was not explained by a higher level of health anxiety [ie the web-based education decreased health anxiety levels considerably]

 

Limitations:

-- There are obvious limitations in generalizing this approach to the United States, which has so much diversity both in languages as well as know-how/access to the Internet

-- this study was done in the Netherlands which has a very low rate of H pylori infections, and the results may not be generalizable to other countries [longstanding H pylori infection is carcinogenic: see http://gmodestmedblogs.blogspot.com/2019/06/h-pylori-eradication-and-decreased.html ]

-- there was a remarkably low usage of NSAIDs in this population, which also might limit the generalizability. For example, in the US where NSAID use is rather high, I believe most clinicians would recommend stopping NSAIDs (and alcohol) prior to further investigation for upper GI symptoms.

-- also, the amount of alcohol consumed was not specified in this Netherlands report, which could also affect generalizability to other countries or populations

 

So, this web-based intervention impressively decreased upper GI endoscopies. A few comments:

-- in primary care, it is not uncommon for patients to request endoscopy for upper GI problems. And, it is likely that many of us simply order these tests, likely for a variety of reasons (eg it is easier/takes less time to simply order the test in a patient who has multiple problems we are dealing with, lack of knowledge of clear guidelines of when to order the tests, insistence by the patients to relieve their anxiety about a serious problem perhaps related to the fact that they do not have a long-term relationship with their clinician....

-- these tests are not just costly and lead to increased healthcare costs for all of us, but also are associated with time off work, anxiety, and the small degree of potentially serious complications

-- the concept of engaging patients and providing them with a self-directed educational intervention seems like a good one: it provides education, empowers and enhances patients’ decision-making, and seems to decrease health anxiety levels

-- I would add that many patients do not require long-term PPI therapy. Many with milder symptoms do just fine with calcium or H2 blockers, which often can take them in an as-needed manner. or those on PPIs (they are over-the-counter) can often be downtitrated to less aggressive acid suppression with these other meds. the population studies on longterm PPIs are quite mixed, but there are some finding many different sorts of problems (eg see http://gmodestmedblogs.blogspot.com/2017/04/risks-and-benefits-of-longterm-ppis_26.html ). and, in general, probably best for people to be on no meds or the minimal needed for symptom control

-- this education issue is likely generalizable to other similar situations, such as patients coming in requesting MRIs of their back

    -- there is high prevalence of abnormal back MRIs (even in those who have never had back pain), and an abnormal finding may generate anxiety, further perceived concerns/anxiety about health, more dysfunction, and even potentially unnecessary surgery (eg see http://gmodestmedblogs.blogspot.com/2021/02/low-back-pain-dangerous-to-get-early.html )

geoff

 

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