THE GI COCKTAIL IS NO MORE EFFECTIVE THAN PLAIN LIQUID ANTACID A randomized, double blind clinical t

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THE GI COCKTAIL IS NO MORE EFFECTIVE THAN
PLAIN LIQUID ANTACIDA randomized, double blind
clinical trial

• ?????
• Dean A. Berman et al
• The Journal of Emergency Medicine
• Vol. 25, No. 3, pp. 239-244, 2003

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INTRODUCTION?

• Liquid antacids have lone been used for symptoms
  of stomach discomfort.
• Hospitals and EDs often prescribe a GI Cocktail
  for dyspepsia Pts. And the most common one
  contains a liquid antacid, an antispasmodic, and
  a topical anesthetic.
• Little research was done prove it beneficial.

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INTRODUCTION?

• Kagan and Rose (1977, 1988)the addition of
  dicyclomine (antispasmotic anticholinergic) to
  an antacid improves efficacy.
• Stephens et al. (1988)an antacid alone is as
  effective as a dicyclomine and antacid
  combination.
• Donnatal and lidocaine were both with minimal
  side effects and of fairly low cost.

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METHODS ?

• Study design
• A double blind, randomized study.
• Comparing adult Pts in the ED.
• No placebo control group.
• Study group
• Conducted in the ED of an urban, tertiary care
  center with an annual visit of 55,000. (150/day)
• Sampling adult Pts for whome the treating
  Emergency Physician ordered a GI Cocktail

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METHODS ?Inclusion and Exclusion Criterias
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METHODS ?Protocol

• Include patient
• Randomized grouping
• Obtaining written informed consent
• Obtain baseline data
• Name, age, gender, ethnicity, GI history
  (previously Dx peptic ulcer, gastritis, acid
  reflux, or dyspepsia), current medications,
  previous antacid use, and current symptomes.
• Pt rate their discomfort on a visual Analog
  Scale 1 (VAS)
• After 30 mins VAS 2

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The group characteristics
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METHODS ?

• Outcomes
• Primary outcomeVAS1 ? VAS2 ???
• Significant response defined as gt 13mm
• Data analysis
• 40 subjects per group would be necessary to
  demonstrate a 13mm difference with C.I. 0.8
• Baseline dataone-way ANOVA
• VAS change within each groupStudents t-test.
• VAS change between groupsone-way ANOVA

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RERULTS

• 120 Pts enrolled, 113 completed the protocol.
• There was no statistically significant differency
  between the groups in terms of age, gender, GI
  history, previous antacid use, or initial degree
  of pain.
• 3 within-group differences were statistically
  significant for each group.
• There was no statistically significant difference
  between the 3 treatment groups.

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RESPONSE TO STUDY DRUG
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DISCUSSION?

• In this study, there were no standerized criteria
  for receiving a GI Cocktail. However, it
  matches standard EM practice in which treatment
  of dyspepsia is initiated before a specific
  etiology has been elucidated.
• Numerous studies have shown that Antacids are
  beneficial in the treatment of dyspepsia.

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DISCUSSION ?-Lidocaine combination-

• Only one study by Welling and Watson in 1990
  evaluated the use of antacid combined with
  viscous lidocaine.
• The difference was statistically significant.
  (Combined 40mm?, Antacid 9mm?)
• No attempt to blind the interviewers to the
  agents.
• Failed to show a clinically significant benefit
  toe the plain antacid.

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DISCUSSION?-Donnatal-

• Donnatal for dyspepsia has not yet been evaluated
  in any controlled studyes.
• In FDA approval, it was used as adjunctive
  therapy for IBS, and was not approved for
  dyspepsia.
• Previous studies revealed 30-80 of patients
  with dyspepsia actually present with delayed
  gastric emptying or intestinal dysmotility.
• Adverse effects of Donnatal
• Phenobarbitaldrowsiness, blurred vision,
• Atropineurinary retention, glaucoma exacerbation.

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CONCLUSIONS

• Liquid antacid provided significant relief of
  dyspepsia.
• The addition of Donnatal or viscous lidocain did
  not enhance the degree of relief.
• Thus, the administration of antacid alone is
  appropriate for the treatment of dyspepsia in ED.

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