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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spirulina | Experimental | Active treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days |
|
| Placebo | Placebo Comparator | Placebo in capsules, 1 capsule orally each 8 hours, for 60 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spirulina platensis | Combination Product | Active treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dyspeptic symptoms | Relapse of dyspeptic symptoms after PPIs cessation | 60 days |
| Number of participants with typical GERD symptoms | Relapse of typical GERD symptoms | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of new endoscopic lesions | Endoscopic lesions in the esophagus, stomach and duodenum, after PPIs cessation | 60 days |
| Number of participants with microscopic changes in the stomach | number of participants with new or worsened gastric inflammation after PPIs cessation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Fornari, Professor | University of Passo Fundo | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38401078 | Derived | Gronevalt ATM, Bertolin TE, Forcelini CM, Polletto PHM, Pasetti BW, Graeff DB, Rodriguez R, Fornari F. Spirulina Platensis Attenuates Rebound Dyspeptic Symptoms After Proton Pump Inhibitors' Discontinuation: Phase 2 Placebo-controlled Trial. Altern Ther Health Med. 2024 Feb;30(2):18-24. |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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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.
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Capsules containing Spirulina and placebo were identical
| Placebo comparator | Other | Placebo in capsules, 1 capsule orally each 8 hours, for 60 days |
|
|
| 60 days |
| Number of participants with side effects | Side effects potentially secondary to Spirulina platensis and placebo | 60 days |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |