Dyspepsia, Gastro Esophageal Reflux Disease, Rebound Acid Hypersecretion
Conditions
Keywords
Gastroesophageal reflux disease, Dyspepsia, Proton Pump Inhibitors, Spirulina platensis
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTSpirulina platensis
Active treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days
OTHERPlacebo comparator
Placebo in capsules, 1 capsule orally each 8 hours, for 60 days
Sponsors
Universidade de Passo Fundo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Capsules containing Spirulina and placebo were identical
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Chronic use of any PPIs, either original brand or generic * Absence of conditions that contraindicate the cessation of PPIs, such as active or recent peptic ulcer, active or recent upper digestive bleeding, regular use of salicylates or non-steroidal anti-inflammatory drugs, moderate to severe reflux esophagitis, and sliding hiatal hernia greater than 3 cm * Formal agreement to participate
Exclusion criteria
* Uncompensated acute and chronic morbidities * Gastroesophageal surgery * Cognitive deficit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with dyspeptic symptoms | 60 days | Relapse of dyspeptic symptoms after PPIs cessation |
| Number of participants with typical GERD symptoms | 60 days | Relapse of typical GERD symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of new endoscopic lesions | 60 days | Endoscopic lesions in the esophagus, stomach and duodenum, after PPIs cessation |
| Number of participants with microscopic changes in the stomach | 60 days | number of participants with new or worsened gastric inflammation after PPIs cessation |
| Number of participants with side effects | 60 days | Side effects potentially secondary to Spirulina platensis and placebo |
Outcome results
None listed