OBJECTIVE: To observe the efficacy of Jinghuaweikang gelatin pearls plus proton pump inhibitor (PPI)-based triple regimen in the treatment of chronic atrophic gastritis (CAG) patients with Helicobacter pylori (H.pylori) infection. METHODS: For this multicenter, randomized, controlled clinical study, 90 patients of endoscopically confirmed CAG with positive H.pylori ((13)C or (14)C-urea breath test (UBT) or rapid urease test) were enrolled. There were 46 males and 44 females with an age range of (54 ± 10) years. None of them had H.pylori eradication background. They were randomly divided into 2 groups, Group LACJ (n = 45) received lansoprazole 30 mg+amoxicillin 1000 mg+clarithromycin 500 mg + jinghuaweikang gelatin pearls 240 mg, twice daily, for 10 days (d1-10) plus another 14 days (d11-24) only with jinghuaweikang gelatin pearls 240 mg, twice daily. Group LACB (n = 45) had standard quadruple regimen treatment: lansoprazole 30 mg+amoxicillin 1000 mg+clarithromycin 500 mg+bismuth potassium citrate 220 mg, twice daily for 10 days (d1-10). The status of H.pylori was detected by (13)C-UBT at least 28 days after therapy. RESULTS: The eradication rates in Groups LACJ and LACB were as follows: per-protocol (PP): 70.5% (31/44) and 83.3% (35/42), intention-to-treat (ITT): 68.9% (31/45) and 77.8% (35/45) (both P > 0.05). The symptomatic improvements of bloating in upper abdomen, belching and epigastric pain after treatment in both groups. And those in Group LACJ was higher than those of Group LACB, but no statistical difference existed between two groups (all P > 0.05). CONCLUSIONS: The efficacy of LACJ for the treatment of CAG patients with H.pylori infection is similar to LACB. And the symptomatic improvement of patients is better than LACB.
RCT Entities:
OBJECTIVE: To observe the efficacy of Jinghuaweikang gelatin pearls plus proton pump inhibitor (PPI)-based triple regimen in the treatment of chronic atrophic gastritis (CAG) patients with Helicobacter pylori (H.pylori) infection. METHODS: For this multicenter, randomized, controlled clinical study, 90 patients of endoscopically confirmed CAG with positive H.pylori ((13)C or (14)C-urea breath test (UBT) or rapid urease test) were enrolled. There were 46 males and 44 females with an age range of (54 ± 10) years. None of them had H.pylori eradication background. They were randomly divided into 2 groups, Group LACJ (n = 45) received lansoprazole 30 mg+amoxicillin 1000 mg+clarithromycin 500 mg + jinghuaweikang gelatin pearls 240 mg, twice daily, for 10 days (d1-10) plus another 14 days (d11-24) only with jinghuaweikang gelatin pearls 240 mg, twice daily. Group LACB (n = 45) had standard quadruple regimen treatment: lansoprazole 30 mg+amoxicillin 1000 mg+clarithromycin 500 mg+bismuth potassium citrate 220 mg, twice daily for 10 days (d1-10). The status of H.pylori was detected by (13)C-UBT at least 28 days after therapy. RESULTS: The eradication rates in Groups LACJ and LACB were as follows: per-protocol (PP): 70.5% (31/44) and 83.3% (35/42), intention-to-treat (ITT): 68.9% (31/45) and 77.8% (35/45) (both P > 0.05). The symptomatic improvements of bloating in upper abdomen, belching and epigastric pain after treatment in both groups. And those in Group LACJ was higher than those of Group LACB, but no statistical difference existed between two groups (all P > 0.05). CONCLUSIONS: The efficacy of LACJ for the treatment of CAG patients with H.pylori infection is similar to LACB. And the symptomatic improvement of patients is better than LACB.