Dyspepsia medical therapy: Difference between revisions
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__NOTOC__ | __NOTOC__ | ||
{{Dyspepsia}} | {{Dyspepsia}} | ||
{{CMG}} | {{CMG}} {{AE}} {{Ajay}} | ||
==Overview== | ==Overview== | ||
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==Medical Therapy== | ==Medical Therapy== | ||
===Pharmacotherapy=== | ===Pharmacotherapy=== | ||
* [[Antacids]] neutralize excess stomach acid, and can provide temporary relief of indigestion | *The medical therapy of the dyspepsia is as follows: <ref name="Monkemuller" /><ref>Anonymous. Information regarding withdrawal of Propulsid (cisapride) by Janssen Pharmaceutica. From FDA website (http://www.fda.gov/medwatch/safety/2000/safety00.htm#propul).</ref><ref>Veldhuyzen van Zanten SJ, Chiba N, Armstrong D, Barkun A, Thomson A, Smyth S, Escobedo S, Lee J, Sinclair P. A randomized trial comparing omeprazole, ranitidine, cisapride, or placebo in ''Helicobacter pylori'' negative, primary care patients with dyspepsia: the CADET-HN Study. Am J Gastroenterol. 2005 Jul;100(7):1477-88.</ref><ref>Talley NJ, Meineche-Schmidt V, Pare P, Duckworth M, Raisanen P, Pap A, Kordecki H, Schmid V. Efficacy of omeprazole in functional dyspepsia: double-blind, randomized, placebo-controlled trials (the Bond and Opera studies). Aliment Pharmacol Ther. 1998 Nov;12(11):1055-65.</ref><ref>Meineche-Schmidt V, Talley NJ, Pap A, Kordecki H, Schmid V, Ohlsson L, Wahlqvist P, Wiklund I, Bolling-Sternevald E. Impact of functional dyspepsia on quality of life and health care consumption after cessation of antisecretory treatment. A multicentre 3-month follow-up study. Scand J Gastroenterol. 1999 Jun;34(6):566-74.</ref> | ||
** [[Antacids]] neutralize excess stomach acid, and can provide temporary relief of indigestion, antacids are taken 4 hours prior to exercise. | |||
* Digestive enzymes capsules | * Digestive enzymes capsules | ||
* If symptoms persist, immediate referral to physician to rule out more serious abdominal conditions or diseases. | * If symptoms persist, immediate referral to a physician to rule out more serious abdominal conditions or diseases. | ||
* Hydration | * Hydration | ||
* [[Antacids]] and [[sucralfate]] were found to be no better than placebo in a literature review. | |||
* H2-RAs have been shown to have marked benefit in poor quality trials (30% relative risk reduction), but only a marginal benefit in good quality trials. | |||
[[Antacids]] and [[sucralfate]] were found to be no better than placebo in a literature review. H2-RAs have been shown to have marked benefit in poor quality trials (30% relative risk reduction), but only a marginal benefit in good quality trials | * Prokinetic agents would empirically seem to work well since delayed gastric emptying is considered a major pathophysiological mechanism in functional dyspepsia. | ||
* They have been shown in a meta-analysis to produce a relative risk reduction of up to 50%, but the studies evaluated to come to this conclusion used the drug Cisapride which has since been removed from the market (now only available as an investigational agent) due to serious adverse events such as torsades, and publication bias has been cited as a potential partial explanation for such a high benefit. | |||
Currently, [[PPIs]] are, depending on the specific drug, FDA indicated for erosive esophagitis, [[gastroesophageal reflux disease]] (GERD), [[Zollinger-Ellison syndrome]], eradication of [[H. pylori]], duodenal and gastric ulcers, and NSAID-induced ulcer healing and prevention, but not functional dyspepsia. | * Modern pro-kinetic agents such as metoclopramide, erythromycin and tegaserod have little or no established efficacy and often result in substantial side effects. | ||
* Simethicone has been found to be of some value, as one trial suggests potential benefit over placebo and another shows equivalence with cisapride. | |||
The CADET study was the first to compare a PPI (omeprazole 20mg daily) to both an H2-RA (ranitidine 150mg BID) as well as a prokinetic agent (cisapride 20mg BID) alongside placebo | * So, with the somewhat recent advent of the proton pump inhibitor (PPI) class of medications, the question of whether these new agents are superior to traditional therapy has arisen. | ||
* Currently, [[PPIs]] are, depending on the specific drug, FDA indicated for erosive esophagitis, [[gastroesophageal reflux disease]] (GERD), [[Zollinger-Ellison syndrome]], eradication of [[H. pylori]], duodenal and gastric ulcers, and NSAID-induced ulcer healing and prevention, but not functional dyspepsia. | |||
The ENCORE study, which was a follow-up of patients from the OPERA study, showed responders to omeprazole therapy had fewer clinic visits than non-responders (1.5 vs 2.0) over a three month period (p < 0.001) | * There are, however, evidence-based guidelines and literature that evaluate the use of PPIs for this indication. | ||
* A helpful chart summarizing the major trials is available from the functional dyspepsia guidelines published in the World Journal of Gastroenterology in 2006. | |||
* The '''CADET''' study was the first to compare a PPI (omeprazole 20mg daily) to both an H2-RA (ranitidine 150mg BID) as well as a prokinetic agent (cisapride 20mg BID) alongside placebo. | |||
* The study evaluated these agents in patients at 4 weeks and 6 months and noted that omeprazole had a significantly better response at 6 months (31%) than cisapride (13%) or placebo (14%) (p = 0.001) while it was just above the cutoff for being statistically significantly better than ranitidine (21%) (p = 0.053). | |||
* Omeprazole also showed a significant increase in quality of life scores over the other agents and placebo in all but one category measured (p = 0.01 to 0.05). | |||
* The '''ENCORE''' study, which was a follow-up of patients from the '''OPERA''' study, showed responders to omeprazole therapy had fewer clinic visits than non-responders (1.5 vs 2.0) over a three month period (p < 0.001). | |||
===Non-Pharmacotherapy=== | ===Non-Pharmacotherapy=== | ||
* Activity modification | * Activity modification | ||
* Rest | * Rest | ||
* Traditional therapies used for this diagnosis include lifestyle modification, antacids, [[h2-receptor antagonist|H2-receptor antagonists (H2-RAs)]], [[prokinetic]] agents, and [[antiflatulent]]s. | |||
Traditional therapies used for this diagnosis include lifestyle modification, antacids, [[h2-receptor antagonist|H2-receptor antagonists (H2-RAs)]], [[prokinetic]] agents, and [[antiflatulent]]s. It is has been noted that one of the most frustrating aspects of treating functional dyspepsia is that these traditional agents have been shown to have little or no efficacy<ref name="Monkemuller">Monkemuller K, Malfertheiner P. Drug treatment of functional dyspepsia. World J Gastroenterol. 2006 May 7;12(17):2694-700.</ref> | * It is has been noted that one of the most frustrating aspects of treating functional dyspepsia is that these traditional agents have been shown to have little or no efficacy.<ref name="Monkemuller">Monkemuller K, Malfertheiner P. Drug treatment of functional dyspepsia. World J Gastroenterol. 2006 May 7;12(17):2694-700.</ref> | ||
==References== | ==References== | ||
{{Reflist|2}} | {{Reflist|2}} | ||
{{WH}} | |||
{{WS}} | |||
[[Category:Gastroenterology]] | [[Category:Gastroenterology]] | ||
[[Category:Digestive disease symptoms]] | [[Category:Digestive disease symptoms]] | ||
Latest revision as of 21:30, 29 July 2020
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief: Ajay Gade MD[2]]
Overview
Functional and undifferentiated dyspepsia have similar treatments. Decisions around the use of drug therapy are difficult because trials included heartburn in the definition of dyspepsia. This led to the results favoring proton pump inhibitors (PPIs), which are questionably effective for the treatment of heartburn.
Medical Therapy
Pharmacotherapy
- The medical therapy of the dyspepsia is as follows: [1][2][3][4][5]
- Antacids neutralize excess stomach acid, and can provide temporary relief of indigestion, antacids are taken 4 hours prior to exercise.
- Digestive enzymes capsules
- If symptoms persist, immediate referral to a physician to rule out more serious abdominal conditions or diseases.
- Hydration
- Antacids and sucralfate were found to be no better than placebo in a literature review.
- H2-RAs have been shown to have marked benefit in poor quality trials (30% relative risk reduction), but only a marginal benefit in good quality trials.
- Prokinetic agents would empirically seem to work well since delayed gastric emptying is considered a major pathophysiological mechanism in functional dyspepsia.
- They have been shown in a meta-analysis to produce a relative risk reduction of up to 50%, but the studies evaluated to come to this conclusion used the drug Cisapride which has since been removed from the market (now only available as an investigational agent) due to serious adverse events such as torsades, and publication bias has been cited as a potential partial explanation for such a high benefit.
- Modern pro-kinetic agents such as metoclopramide, erythromycin and tegaserod have little or no established efficacy and often result in substantial side effects.
- Simethicone has been found to be of some value, as one trial suggests potential benefit over placebo and another shows equivalence with cisapride.
- So, with the somewhat recent advent of the proton pump inhibitor (PPI) class of medications, the question of whether these new agents are superior to traditional therapy has arisen.
- Currently, PPIs are, depending on the specific drug, FDA indicated for erosive esophagitis, gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, eradication of H. pylori, duodenal and gastric ulcers, and NSAID-induced ulcer healing and prevention, but not functional dyspepsia.
- There are, however, evidence-based guidelines and literature that evaluate the use of PPIs for this indication.
- A helpful chart summarizing the major trials is available from the functional dyspepsia guidelines published in the World Journal of Gastroenterology in 2006.
- The CADET study was the first to compare a PPI (omeprazole 20mg daily) to both an H2-RA (ranitidine 150mg BID) as well as a prokinetic agent (cisapride 20mg BID) alongside placebo.
- The study evaluated these agents in patients at 4 weeks and 6 months and noted that omeprazole had a significantly better response at 6 months (31%) than cisapride (13%) or placebo (14%) (p = 0.001) while it was just above the cutoff for being statistically significantly better than ranitidine (21%) (p = 0.053).
- Omeprazole also showed a significant increase in quality of life scores over the other agents and placebo in all but one category measured (p = 0.01 to 0.05).
- The ENCORE study, which was a follow-up of patients from the OPERA study, showed responders to omeprazole therapy had fewer clinic visits than non-responders (1.5 vs 2.0) over a three month period (p < 0.001).
Non-Pharmacotherapy
- Activity modification
- Rest
- Traditional therapies used for this diagnosis include lifestyle modification, antacids, H2-receptor antagonists (H2-RAs), prokinetic agents, and antiflatulents.
- It is has been noted that one of the most frustrating aspects of treating functional dyspepsia is that these traditional agents have been shown to have little or no efficacy.[1]
References
- ↑ 1.0 1.1 Monkemuller K, Malfertheiner P. Drug treatment of functional dyspepsia. World J Gastroenterol. 2006 May 7;12(17):2694-700.
- ↑ Anonymous. Information regarding withdrawal of Propulsid (cisapride) by Janssen Pharmaceutica. From FDA website (http://www.fda.gov/medwatch/safety/2000/safety00.htm#propul).
- ↑ Veldhuyzen van Zanten SJ, Chiba N, Armstrong D, Barkun A, Thomson A, Smyth S, Escobedo S, Lee J, Sinclair P. A randomized trial comparing omeprazole, ranitidine, cisapride, or placebo in Helicobacter pylori negative, primary care patients with dyspepsia: the CADET-HN Study. Am J Gastroenterol. 2005 Jul;100(7):1477-88.
- ↑ Talley NJ, Meineche-Schmidt V, Pare P, Duckworth M, Raisanen P, Pap A, Kordecki H, Schmid V. Efficacy of omeprazole in functional dyspepsia: double-blind, randomized, placebo-controlled trials (the Bond and Opera studies). Aliment Pharmacol Ther. 1998 Nov;12(11):1055-65.
- ↑ Meineche-Schmidt V, Talley NJ, Pap A, Kordecki H, Schmid V, Ohlsson L, Wahlqvist P, Wiklund I, Bolling-Sternevald E. Impact of functional dyspepsia on quality of life and health care consumption after cessation of antisecretory treatment. A multicentre 3-month follow-up study. Scand J Gastroenterol. 1999 Jun;34(6):566-74.