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Randomized, Double-Blind, Placebo-Controlled Trial of Meriva (Curcuminoids) as a Candidate Chemoprevention Agent for
Maria Gonzalez-Pons1, Ricardo L Dominguez2, Eleazar E Montalvan-Sanchez3
1University of Puerto Rico Comprehensive Cancer Center, San Juan, Puerto Rico.
Abstract:
Globally, gastric adenocarcinoma is the fourth leading cause of cancer mortality and a major cancer disparity in the United States. Chemoprevention strategies are lacking for high-risk individuals with gastric premalignant conditions (GPMC). Curcumin, the principal curcuminoid in turmeric, exerts immunomodulatory effects in the epithelium and against Helicobacter pylori, and studies suggest chemoprevention potential. We conducted a double-blind, phase IIa randomized controlled trial in high-risk populations in Puerto Rico and Honduras. We investigated the utility of a bioavailable formulation of curcumin (Meriva) among individuals with H. pylori-negative GPMC, specifically, multifocal atrophic gastritis (MAG) or gastric intestinal metaplasia (GIM). Patients were 1:1 randomized to 1,000 mg Meriva daily or placebo for a 6-month intervention with endoscopy at baseline and 6 months. Outcomes included assessment of epithelial cytokine and chemokine levels, histology, and DNA damage as assessed by γ-H2AX phosphorylation IHC. Of the 110 subjects screened, 50 participants were randomized, and 48 completed the trial. A significant reduction in gastric mucosal IL1β levels from baseline in the gastric body, the primary endpoint, was observed in the Meriva group (P = 0.032). Changes in epithelial IL8, TNFα, and inducible protein 10 levels and gastric mucosal histology and DNA damage (secondary endpoints) were similar between arms. Curcumin (Meriva) was safe, well-tolerated, and showed potential as a curcuminoid chemoprevention agent in H. pylori-negative patients with GPMC. A potential reduction in gastric inflammation as measured by gastric mucosal IL1β levels was observed. Further studies are warranted, including studies in H. pylori-positive individuals, based upon the curcuminoid direct effects on H. pylori.
Prevention Relevance:
Gastric adenocarcinoma is a leading cause of cancer mortality worldwide. Chemoprevention candidates for GPMCs are limited. This randomized phase IIa trial evaluated a bioavailable curcumin formulation in high-risk individuals with MAG and GIM. The results support further study of curcuminoids for gastric cancer risk reduction. See related Spotlight, p. 387 See related article by Morgan et al., p. 391.
Insights
Curcumin (Meriva®) may reduce gastric inflammation in individuals with premalignant gastric conditions. This chemoprevention study found a significant reduction in IL-1β levels, suggesting potential for gastric cancer prevention.
Area of Science:
- Gastroenterology
- Oncology
- Pharmacology
Background:
- Gastric adenocarcinoma (GC) is a leading cause of cancer mortality globally and a significant health disparity in the U.S.
- Effective chemoprevention strategies for individuals with gastric premalignant conditions (GPMC) are currently lacking.
- Curcumin, a compound in turmeric, has demonstrated immunomodulatory effects and potential for cancer chemoprevention.
Purpose of the Study:
- To investigate the chemoprevention potential of a bioavailable curcumin formulation (Meriva®) in individuals with H. pylori-negative GPMC.
- To assess the effects of Meriva® on epithelial cytokine and chemokine levels, histology, and DNA damage.
- To evaluate the safety and tolerability of Meriva® in this high-risk population.
Main Methods:
- A double-blind, phase IIa randomized controlled trial was conducted in Puerto Rico and Honduras.
- Participants with H. pylori-negative GPMC (multifocal atrophic gastritis or intestinal metaplasia) were randomized 1:1 to receive 1000 mg Meriva® daily or placebo for 6 months.
- Outcomes included endoscopic assessment of gastric mucosal IL-1β levels (primary endpoint), other cytokines, histology, and DNA damage (pH2AX IHC).
Main Results:
- A significant reduction in gastric mucosal IL-1β levels from baseline was observed in the Meriva® group (p=0.032), indicating a potential decrease in gastric inflammation.
- Changes in other epithelial cytokines (IL-8, TNFα, IP-10), gastric mucosal histology, and DNA damage were similar between the Meriva® and placebo groups.
- The Meriva® formulation was found to be safe and well tolerated by the study participants.
Conclusions:
- Curcumin (Meriva®) shows potential as a chemoprevention agent for H. pylori-negative GPMC patients, primarily by reducing gastric inflammation.
- Further research is warranted to explore curcumin's chemopreventive effects, including studies in H. pylori-positive individuals.
- The study highlights the need for effective chemoprevention strategies to address the high mortality associated with gastric adenocarcinoma.
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