Background: Rebound acid hypersecretion after proton pump inhibitors (PPIs) discontinuation may be accompanied by dyspepsia. Aim: To assess whether Spirulina platensis, by its anti-inflammatory properties, could minimize rebound symptoms after PPIs withdrawal.
Forty-five regular users of PPIs entered in a 28-day run-in phase of pantoprazole 40 mg/day, followed by clinical and endoscopic evaluation. In the absence of large hiatal hernia, peptic ulcer, or moderate to severe reflux esophagitis, patients stopped PPIs and were randomly assigned to receive Spirulina (1.6 g/day) or placebo for 2 months, when evaluation was repeated. Primary outcomes were dyspepsia and typical reflux symptoms (either appearance or maintenance of symptoms \> 50% from baseline). Intention-to-treat analysis was applied.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
Active treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days
Placebo in capsules, 1 capsule orally each 8 hours, for 60 days
Number of participants with dyspeptic symptoms
Relapse of dyspeptic symptoms after PPIs cessation
Time frame: 60 days
Number of participants with typical GERD symptoms
Relapse of typical GERD symptoms
Time frame: 60 days
Rate of new endoscopic lesions
Endoscopic lesions in the esophagus, stomach and duodenum, after PPIs cessation
Time frame: 60 days
Number of participants with microscopic changes in the stomach
number of participants with new or worsened gastric inflammation after PPIs cessation
Time frame: 60 days
Number of participants with side effects
Side effects potentially secondary to Spirulina platensis and placebo
Time frame: 60 days
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