Current Opinion in Gastroenterolgy's update on Gastroesophageal Reflux Disease (GERD) continues to push treating the symptoms with stronger meds and does not discuss getting to the root of the cause. At least they agree that GERD is not a one-size-fits all issue. "The main focus for drug development in refractory GERD patients is more potent, early and consistent acid suppression. However, due to the diverse causes of PPI failure, one therapeutic strategy may not be the solution for all patients. It is likely that individually tailored therapy will be the best management approach."
Between 10 and 40% of patients with GERD who are not responding to proton pump inhibitors (PPIs) given once daily are very common. These therapy-resistant patients have become the new face of GERD in the last decade and presently pose a significant therapeutic challenge to gastroenterologists. In addition, gastroenterologists are beginning to find polyps in the stomach, in addition to the colon, which is very disturbing. They are attributing this to chronic PPI use.
One would think that research would focus more on lifestyle changes of the dietary nature. Their evaluation of this is laughable. Of course, there is no mention of the slew of negative data that has come out within the last year regarding the myriad of issues long-term PPI use causes.
Newest Findings
- Commonly, doubling the PPI dose or switching to another PPI will be offered to patients who failed PPI once daily. Failure of such therapeutic strategies is commonly followed by transient lower esophageal sphincter relaxation reducers.
- During a period of only 7 years (1997–2004), there was an increase by almost 50% in the usage of at least double-dose PPI in patients with GERD. Approximately 42.1% of all patients supplemented their prescription PPIs with other antireflux therapies, including over-the-counter antacids and H2-receptor antagonists. More than 85% of the patients still experienced GERD-related symptoms. Bonnie comment - this is a staggering statistic.
- In the 2000 Gallup Study of Consumers' Use of Stomach Relief Products, 36% reported taking nonprescription medication in addition to a prescription medication for GERD. Of those, 56% stated that they used their prescription medication daily but still needed to supplement with nonprescription medication for breakthrough symptoms. Bonnie - the nonprescription is mostly taken without the physician's knowledge, creating a whole host of other potential issues.
- Recently, weakly acidic and alkaline reflux has been implicated as a cause for refractory GERD-related symptoms. The mechanism by which weakly acidic reflux causes symptoms remains poorly understood. Bonnie - what is poorly understood? Your stomach needs an acidic environment to break down food and repel bacteria. When PPIs are consistently blocking acid production, what do they think is going to happen?
- Inflammation of the esophageal lining is not limited to GERD: it can be found in up to 30% of asymptomatic patients, as well as in patients with esophageal candidiasis, food allergy, food intolerance, eosinophilic esophagitis, and esophageal cancer. Bonnie - food allergy, food intolerance, and candida: bingo!
- Evaluation for proper compliance and optimal dosing time should be the first management step in assessing patients with heartburn not responding to PPI therapy. The physician should emphasize the need to take PPIs half an hour before a meal.
- The benefit of lifestyle modifications in GERD patients who fail PPI treatment has yet to be elucidated. In a recent systematic review of reports on lifestyle modifications for GERD, the authors determined that only weight loss and elevation of head of the bed appear to be effective. There were insufficient data to support any of the other commonly prescribed lifestyle modifications. Nevertheless, in patients with PPI-refractory heartburn, it seems reasonable to recommend avoidance of specific lifestyle activities that appear to trigger GERD symptoms. Bonnie - reasonable? I'd say so. If you did exhaustive research on cutting out the dietary and environmental offenders, the results would render most of the drug trials irrelevant.
- For GERD patients on PPI twice daily who still exhibit symptoms, histamine 2 receptor antagonist (H2RA) at bedtime significantly reduced the frequency and duration of symptoms. Although no studies document any clinical correlation, the addition of H2RA at bedtime has become common practice in GERD patients who fail PPI treatment. However, patients rapidly develop tolerance (within 1 week) to the antisecretory effects of H2RAs given at bedtime. Bonnie - another off-label use where their is no sufficient data and the drug loses efficacy rather shortly.
- Whereas doubling the PPI dose might be considered the standard of care, there is no evidence to support any further escalation of the PPI dose for symptom control or healing of erosive esophagitis. For double-dose therapy, the PPI should be taken before breakfast and before dinner. Bonnie - in other words, they are flying blind.
- A recent study has suggested that a minority of GERD patients may lose PPI efficacy after 2 years of continuous treatment with one or two PPIs per day. Bonnie - many of that "minority" will stay on it for much longer than two years with awful consequences.
- Transient Lower Esophageal Sphincter Relaxation Reducers
The most promising of these agents appear to be the gamma-aminobutyric acid B (GABAB) receptor agonists and metabotropic glutamate receptor 5 (mGluR5) antagonists, which can achieve a high level of TLESR inhibition. As a potential add-on treatment for patients who failed PPI therapy, early results shows the drugs reduce the TLESR rate by 40–60%, reduces reflux episodes by 43%, increases lower esophageal sphincter basal pressure, and accelerates gastric emptying. Bonnie - however, because the drug crosses the blood–brain barrier, a variety of central nervous system-related side effects have been reported including somnolence, confusion, dizziness, lightheadedness, drowsiness, weakness, and trembling.
- Visceral Pain Modulators
To date, there are no studies that have specifically evaluated visceral pain modulators in refractory GERD patients. However, given the fact that most patients who fail PPI treatment, the use of pain modulators is highly attractive. Pain modulators such as tricyclic antidepressants, trazodone (a tetracyclic antidepressants), and selective serotonin reuptake inhibitors (SSRIs) have all been shown to improve esophageal pain in patients with noncardiac chest pain. Bonnie - antidepressant side effects are well known and will limit the usage of these modulators.
- Botulinum Toxin Injection
In one recent study, botulinum toxin was administered by pyloric injection to 11 patients who had refractory GERD associated with gastroparesis. There was marked improvement in GERD-related symptoms, which correlated with improvements in gastroparesis-related symptoms and in gastric-emptying as assessed by scintigraphy. The mean duration of response is approximately 5 months. Bonnie - Botox is the newest substance likely to be touted for every chronic health issue. Of course it will disperse everything in its path...it is one of the deadliest toxins on earth! But the question is, at what long-term price? nobody knows.
A recent surgical study reported that overall, 82% of patients reported that the preoperative reflux symptom completely resolved, and 94% were satisfied with the results of the surgery. In another study, at the end of 1 year follow-up after surgery, all patients reported complete heartburn relief and 86% reported resolution of the regurgitation symptom. Patients' satisfaction rate with surgery was 87%. Bonnie - when in doubt, operate (I am being facetious).
Alternative Medicine
The value of acupuncture has been evaluated in GERD patients who failed PPI once daily. When compared to doubling the PPI dose, adding acupuncture was significantly better in controlling regurgitation as well as daytime and night-time heartburn. This is the first study to suggest that alternative approaches for treating visceral pain may have a role in GERD patients with PPI-refractory heartburn. Bonnie - finally, we get to something safe!
Psychological Treatment
Patients with poor correlation of symptoms and acid reflux events display a higher level of anxiety and hysteria than those who have a close correlation between symptoms and acid-reflux. Anxiety and depression have been shown to increase GERD-related symptoms report in population-based studies. A recent study provided the first evidence that response to PPI treatment may be dependent on the level of psychological distress. Thus, it has been proposed that patients who do not respond to PPIs are more likely to have a psychological comorbidity than those who respond.
Bonnie - after reading this, please at least explore dietary and lifestyle modification. You can see the viscous cycle that sets up for you if you do not.
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