1.Efficacy and safety of triple therapy containing berberine, amoxicillin, and vonoprazan for Helicobacter pylori initial treatment: A randomized controlled trial.
Shasha CHEN ; Weina SHEN ; Yuhuan LIU ; Qiang DONG ; Yongquan SHI
Chinese Medical Journal 2023;136(14):1690-1698
BACKGROUND:
With the development of traditional Chinese medicine research, berberine has shown good efficacy and safety in the eradication of Helicobacter pylori (H. pylori). The present study aimed to evaluate the efficacy and safety of triple therapy containing berberine, amoxicillin, and vonoprazan for the initial treatment of H. pylori.
METHODS:
This study was a single-center, open-label, parallel, randomized controlled clinical trial. Patients with H. pylori infection were randomly (1:1:1) assigned to receive berberine triple therapy (berberine 500 mg, amoxicillin 1000 mg, vonoprazan 20 mg, A group), vonoprazan quadruple therapy (vonoprazan 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, colloidal bismuth tartrate 220 mg, B group), or rabeprazole quadruple therapy (rabeprazole 10 mg, amoxicillin 1000 mg, clarithromycin 500 mg, colloidal bismuth tartrate 220 mg, C group). The drugs were taken twice daily for 14 days. The main outcome was the H. pylori eradication rate. The secondary outcomes were symptom improvement rate, patient compliance, and incidence of adverse events. Furthermore, factors affecting the eradication rate of H. pylori were further analyzed.
RESULTS:
A total of 300 H. pylori-infected patients were included in this study, and 263 patients completed the study. An intention-to-treat (ITT) analysis showed that the eradication rates of H. pylori in berberine triple therapy, vonoprazan quadruple therapy, and rabeprazole quadruple therapy were 70.0% (70/100), 77.0% (77/100), and 69.0% (69/100), respectively. The per-protocol (PP) analysis showed that the eradication rates of H. pylori in these three groups were 81.4% (70/86), 86.5% (77/89), and 78.4% (69/88), respectively. Both ITT analysis and PP analysis showed that the H. pylori eradication rate did not significantly differ among the three groups (P >0.05). In addition, the symptom improvement rate, overall adverse reaction rate, and patient compliance were similar among the three groups (P >0.05).
CONCLUSIONS
The efficacy of berberine triple therapy for H. pylori initial treatment was comparable to that of vonoprazan quadruple therapy and rabeprazole quadruple therapy, and it was well tolerated. It could be used as one choice of H. pylori initial treatment.
Humans
;
Amoxicillin/therapeutic use*
;
Helicobacter pylori
;
Anti-Bacterial Agents
;
Clarithromycin/therapeutic use*
;
Rabeprazole/therapeutic use*
;
Berberine/therapeutic use*
;
Bismuth
;
Helicobacter Infections/drug therapy*
;
Drug Therapy, Combination
;
Treatment Outcome
;
Proton Pump Inhibitors/therapeutic use*
2.Clinical audit of current Helicobacter pylori treatment outcomes in Singapore.
Tiing Leong ANG ; Kim Wei LIM ; Daphne ANG ; Yu Jun WONG ; Malcolm TAN ; Andrew Siang YIH WONG
Singapore medical journal 2022;63(9):503-508
INTRODUCTION:
H. pylori eradication reduces the risk of gastric malignancies and peptic ulcer disease. First-line therapies include 14-day PAC (proton pump inhibitor [PPI], amoxicillin, clarithromycin) and PBMT (PPI, bismuth, metronidazole, tetracycline). Second-line therapies include 14-day PBMT and PAL (PPI, amoxicillin, levofloxacin). This clinical audit examined current treatment outcomes in Singapore.
METHODS:
Clinical data of H. pylori-positive patientswho underwent empirical first- and second-line eradication therapies from 1 January 2017 to 31 December 2018 were reviewed. Treatment success was determined by 13C urea breath test performed at least 4 weeks after treatment and 2 weeks off PPI.
RESULTS:
A total of 963 patients (862 PAC, 36 PMC [PPI, metronidazole, clarithromycin], 18 PBMT, 13 PBAC [PAC with bismuth], 34 others) and 98 patients (62 PMBT, 15 PAL, 21 others) received first-and second-line therapies respectively. A 14-day treatment duration was appropriately prescribed for first- and second-line therapies in 65.2% and 82.7% of patients, respectively. First-line treatment success rates were noted for PAC (seven-day: 76.9%, ten-day: 88.3%, 14-day: 92.0%), PMC (seven-day: 0, ten-day: 75.0%, 14-day: 69.8%), PBMT (ten-day: 100%, 14-day: 87.5%) and PBAC (14-day: 100%). 14-day treatment was superior to seven-day treatment (90.8% vs. 71.4%; P = 0.028). PAC was superior to PMC (P < 0.001) but similar to PBMT (P = 0.518) and PBAC (P = 0.288) in 14-day therapies. 14-day second-line PAL and PBMT had similar efficacy (90.9% vs. 82.4%; P = 0.674).
CONCLUSION
First-line empirical treatment using PAC, PBMT and PBAC for 14 days had similar efficacy. Success rates for second-line PBMT and PAL were similar.
Humans
;
Helicobacter pylori
;
Clarithromycin/therapeutic use*
;
Helicobacter Infections/drug therapy*
;
Metronidazole/therapeutic use*
;
Bismuth/therapeutic use*
;
Singapore
;
Drug Therapy, Combination
;
Amoxicillin/therapeutic use*
;
Proton Pump Inhibitors/therapeutic use*
;
Anti-Bacterial Agents/therapeutic use*
;
Treatment Outcome
;
Clinical Audit
3.Efficacy of clarithromycin in the adjuvant treatment of chronic periodontitis: a Meta-analysis.
Yin BAI ; Yuan-Liang BAI ; Jing LAI ; Jiao HUANG
West China Journal of Stomatology 2020;38(3):290-296
OBJECTIVE:
To evaluate the clinical efficacy of clarithromycin (CLM) in the adjuvant treatment of chronic periodontitis systematically, obtain reasonable conclusions through evidence-based medicine, and provide guidance for clinical rational drug use.
METHODS:
Literature about CLM in the adjuvant treatment of chronic periodontitis was searched in CNKI, VIP, Wanfang, Chinese Biomedical Literature Database, PubMed, ScienceDirect, and Embase databases from inception to February 2019 using a computer. Meta-analysis was performed on the homogeneous study using RevMan 5.3 software after two independent reviewers screened the literature, evaluated the quality of the study, extracted the data, and evaluated the risk of bias in the included studies.
RESULTS:
Six randomized controlled trials were included in 316 subjects. The meta-analysis showed that compared with the scaling and root planning (SRP) group, the probing depth (PD) was reduced in patients with CLM and SRP [MD=-1.00, 95%CI (-1.55, -0.45), P=0.000 04]. Clinical attachment loss was obtained [MD=-0.03, 95%CI (0.43, 0.65), P<0.000 01], and the difference between the groups was statistically significant. The modified sulcus bleeding index (mSBI) was reduced [MD=-0.01, 95%CI (-0.14, 0.19), P=0.66]. No significant difference was observed between the groups, but the decrease in mSBI was more significant in CLM combined with SRP group.
CONCLUSIONS
CLM combined with subgingival SRP can achieve remarkable results in treating chronic periodontitist.
Anti-Bacterial Agents
;
therapeutic use
;
Chronic Periodontitis
;
drug therapy
;
Clarithromycin
;
Dental Scaling
;
Humans
;
Periodontal Index
;
Root Planing
;
Treatment Outcome
4.Amoxicillin-Clarithromycin-Containing Bismuth Quadruple Therapy for Primary Eradication of Helicobacter pylori.
Tao GUO ; Qiang WANG ; Xi WU ; Xiao Qing LI ; Yue LI ; Gui Jun FEI ; Hui Jun SHU ; Jing Nan LI ; Jia Ming QIAN
Acta Academiae Medicinae Sinicae 2019;41(1):75-79
Objective To evaluate the efficacy and safety of amoxicillin-clarithromycin-containing bismuth quadruple regimen as a primary therapy for Helicobacter pylori (Hp) eradication.Methods A total of 102 Hp-infected outpatients diagnosed by C-or C-urea breath test from December 2015 to June 2017 were enrolled and received 14-day bismuth quadruple therapy (esomeprazole 20 mg bid,bismuth potassium citrate 220 mg bid,amoxicillin 1000 mg bid,and clarithromycin 500 mg bid for 14 days). Hp status was assessed by C-or C-urea breath test 4 weeks,8 weeks,6 months,and 12 months after the treatment. The primary outcome was Hp eradication rate,which was analyzed by intention-to-treat (ITT) and per-protocol (PP) analyses. The second outcomes were Hp infection recurrence,symptomatic benefit from Hp eradication,and safety. Results A total of 101 patients,of which 65 patients had dyspeptic symptoms before eradication,completed the study. Hp eradication rates by ITT analysis and by PP analysis were 88.2% and 89.1%,respectively. Only in two of 84 patients,who were followed for 8 weeks after eradication,Hp became positive. No Hp recurrence happened at the 6-month and 12-month follow-up and the annual recurrence rate was 2.4%. The symptomatic relief rates at the 4-week,8-week,6-month and 12-month follow-up were 81.5%,75.4%,71.2%,and 70.2% respectively. Eleven of 101 patients had mild and similar side-effects,which were well tolerated.Conclusion Amoxicillin-clarithromycin-containing bismuth quadruple regimen can be used as the standard therapy for Hp eradication.
Amoxicillin
;
therapeutic use
;
Anti-Bacterial Agents
;
Bismuth
;
Clarithromycin
;
therapeutic use
;
Drug Therapy, Combination
;
Helicobacter Infections
;
drug therapy
;
Helicobacter pylori
;
Humans
;
Treatment Outcome
5.Efficacy of bismuth containing quadruple therapies on Helicobacter pylori eradication in patients with history of antibiotic treatment.
Dan TANG ; Lingzhi YUAN ; Chun YUE ; Ting CAI ; Yao YAO ; Fen WANG
Journal of Central South University(Medical Sciences) 2018;43(7):772-778
To investigate the efficacy of bismuth containing quadruple therapies on Helicobacter pylori (Hp) eradication in patients with history of antibiotic treatment.
Methods: Hp infected patients (n=327) were allocated into 3 groups. Group A (n=52), patients had no antibiotic history and they took medicine of proton pump inhibitors (PPI) and livzon triple (clarithromycin, tinidazole, and bismuth); group B (n=80), patients had the antibiotic history except for amoxicillin and clarithromycin, and they were treated with PPI, amoxicillin, clarithromycin, and bismuth; group C (n=195), patients suffered failures of Hp therapy or with history of antibiotic abuse, and they were treated with PPI, doxycycline, furazolidone, and bismuth.
Results: Both the intention-to-treat (ITT) analysis (group A 63.5%, group B 76.2%, group C 82.6%, P<0.05) and the pre-protocol (PP) analysis (group A 76.7%, group B 92.4%, group C 96.4%, P<0.05) showed significant difference among the 3 groups, revealing higher elimination in group B and C. The side-effects (20.2%) were mild and tolerable (group A, 28.0%; group B, 10.7%; group C, 22.0%).
Conclusion: Proton pump inhibitors together with the livzon triple regimen have a low rate of Hp eradication and a higher incidence of adverse reactions. The quadruple therapy containing clarithromycin and metronidazole drugs can achieve the satisfactory outcomes based on patient's antibiotic history. For patients with multiple antibiotics, the quadruple therapy containing furazolidone and doxycycline may achieve the satisfactory outcomes, but the adverse resction would be relatively higher.
Amoxicillin
;
therapeutic use
;
Anti-Bacterial Agents
;
therapeutic use
;
Bismuth
;
therapeutic use
;
Clarithromycin
;
therapeutic use
;
Drug Therapy, Combination
;
methods
;
Furazolidone
;
therapeutic use
;
Helicobacter Infections
;
drug therapy
;
Helicobacter pylori
;
Humans
;
Metronidazole
;
therapeutic use
;
Proton Pump Inhibitors
;
therapeutic use
;
Tinidazole
;
therapeutic use
;
Treatment Outcome
6.Trends in Helicobacter pylori eradication rates by first-line triple therapy and related factors in eradication therapy.
Sung Eun KIM ; Moo In PARK ; Seun Ja PARK ; Won MOON ; Youn Jung CHOI ; Ji Hyun CHEON ; Hye Jung KWON ; Ki Hwan KU ; Chang Hun YOO ; Jae Hyun KIM ; Gyu Won LEE ; Sung Eun SONG
The Korean Journal of Internal Medicine 2015;30(6):801-807
BACKGROUND/AIMS: Trends in successful eradication of Helicobacter pylori using first-line triple therapy, consisting of a proton pump inhibitor, amoxicillin, and clarithromycin, have been understudied. We evaluated H. pylori eradication rates at a single center over the last 10 years and identified risk factors related to eradication failure. METHODS: This study included 1,413 patients who were diagnosed with H. pylori infection and received 7 days of triple therapy between January 2003 and December 2012. We investigated H. pylori eradication rates retrospectively with respect to the year of therapy, as well as demographic and clinical factors. H. pylori eradication was confirmed by a 13C-urea breath test or a rapid urease test at least 4 weeks after the completion of triple therapy. RESULTS: The overall H. pylori eradication rate was 84.9%. Annual eradication rates from 2003 to 2012 were 93.5%, 80.0%, 87.2%, 88.5%, 92.0%, 88.3%, 85.7%, 84.1%, 83.7%, and 78.8%, respectively, by per-protocol analysis. The eradication rate with first-line triple therapy decreased during the last 10 years (p = 0.015). Multivariate analysis showed that female gender (odds ratio [OR], 1.69; 95% confidence interval [CI], 1.12 to 2.55) and smoking (OR, 1.61; 95% CI, 1.05 to 2.47) were associated with the failure of H. pylori eradication therapy. CONCLUSIONS: The efficacy of first-line triple therapy for H. pylori infection has decreased over the last 10 years, suggesting an increase in antibiotic-resistant H. pylori strains. Thus, other first-line therapies may be necessary for H. pylori eradication in the near future.
Adolescent
;
Adult
;
Aged
;
Aged, 80 and over
;
Amoxicillin/therapeutic use
;
Anti-Bacterial Agents/adverse effects/*therapeutic use
;
Breath Tests
;
Chi-Square Distribution
;
Clarithromycin/therapeutic use
;
Drug Resistance, Bacterial
;
Drug Therapy, Combination
;
Female
;
Helicobacter Infections/diagnosis/*drug therapy/microbiology
;
Helicobacter pylori/*drug effects
;
Humans
;
Linear Models
;
Logistic Models
;
Male
;
Middle Aged
;
Multivariate Analysis
;
Odds Ratio
;
Proton Pump Inhibitors/adverse effects/*therapeutic use
;
Republic of Korea
;
Retrospective Studies
;
Risk Factors
;
Sex Factors
;
Smoking/adverse effects
;
Time Factors
;
Treatment Failure
;
Young Adult
8.Additive Effect of Pronase on the Eradication Rate of First-Line Therapy for Helicobacter pylori Infection.
Chang Seok BANG ; Yeon Soo KIM ; Sang Hyun PARK ; Jin Bong KIM ; Gwang Ho BAIK ; Ki Tae SUK ; Jai Hoon YOON ; Dong Joon KIM
Gut and Liver 2015;9(3):340-345
BACKGROUND/AIMS: Helicobacter pylori colonizes on the apical surface of gastric surface mucosal cells and the surface mucous gel layer. Pronase is a premedication enzyme for endoscopy that can disrupt the gastric mucus layer. We evaluated the additive effects of pronase combined with standard triple therapy for H. pylori eradication. METHODS: This prospective, single-blinded, randomized, controlled study was conducted between June and October 2012. A total of 116 patients with H. pylori infection were enrolled in the study (n=112 patients, excluding four patients who failed to meet the inclusion criteria) and were assigned to receive either the standard triple therapy, which consists of a proton pump inhibitor with amoxicillin and clarithromycin twice a day for 7 days (PAC), or pronase (20,000 tyrosine units) combined with the standard triple therapy twice a day for 7 days (PACE). RESULTS: In the intention-to-treat analysis, the eradication rates of PAC versus PACE were 76.4% versus 56.1% (p=0.029). In the per-protocol analysis, the eradication rates were 87.5% versus 68.1% (p=0.027). There were no significant differences concerning adverse reactions between the two groups. CONCLUSIONS: According to the interim analysis of the trial, pronase does not have an additive effect on the eradication of H. pylori infection (ClinicalTrial.gov: NCT01645761).
Adult
;
Amoxicillin/therapeutic use
;
Anti-Bacterial Agents/*therapeutic use
;
Clarithromycin/therapeutic use
;
Drug Administration Schedule
;
Drug Therapy, Combination/methods
;
Female
;
Gastric Mucosa/drug effects/microbiology
;
Helicobacter Infections/*drug therapy
;
Helicobacter pylori/*drug effects
;
Humans
;
Male
;
Middle Aged
;
Pronase/*therapeutic use
;
Prospective Studies
;
Proton Pump Inhibitors/*therapeutic use
;
Single-Blind Method
;
Treatment Outcome
9.Ten Day Concomitant Therapy Is Superior to Ten Day Sequential Therapy for Helicobacter pylori Eradication.
Su Young KIM ; Dong Kyun PARK ; Kwang An KWON ; Kyoung Oh KIM ; Yoon Jae KIM ; Jun Won CHUNG
The Korean Journal of Gastroenterology 2014;64(5):260-267
BACKGROUND/AIMS: Because the efficacy of standard triple therapy for Helicobacter pylori eradication has declined, new regimens such as sequential therapy (ST) and concomitant therapy (CoCTx) have been introduced. The aim of this study was to compare the efficacy of 10-day ST and 10-day CoCTx for H. pylori eradication. METHODS: We retrospectively reviewed the medical records of 316 patients with proven H. pylori infection. They were assigned to one of 2 regimens; ST (n=191) consisted of, lansoprazole 30 mg and amoxicillin 1 g for 5 days followed by lansoprazole 30 mg, metronidazole 500 mg, and clarithromycin 500 mg for 5 days, and CoCTx (n=125) consisted of lansoprazole 30 mg, amoxicillin 1 g, metronidazole 500 mg, and clarithromycin 500 mg for 10 days. All drugs were administered twice a day. Bacterial eradication was checked by using a 13C-urea breath test at least 4 weeks after completion of treatment. RESULTS: The mean age and male to female ratio was 51.74 and 1.03, respectively. Baseline characteristics were not different in both groups. Ten day CoCTx group (94.4%, 118/125) showed better eradication rate than ST group (82.2%, 157/191) (p=0.002). Drug compliances were not statistically different between the two groups (p=0.19). Side effects were more frequently reported in the CoCTx group than in the ST group (p=0.03). CONCLUSIONS: Ten-day CoCTx was superior to ST in terms of eradicating H. pylori infection. Although the CoCTx producing more side effects than ST, CoCTx can be thought to be a promising alternative to ST as a treatment regimen for H. pylori eradication.
Adult
;
Aged
;
Amoxicillin/therapeutic use
;
Anti-Bacterial Agents/*therapeutic use
;
Breath Tests
;
Clarithromycin/therapeutic use
;
Drug Administration Schedule
;
Drug Therapy, Combination
;
Female
;
Helicobacter Infections/diagnosis/*drug therapy
;
*Helicobacter pylori
;
Humans
;
Lansoprazole/therapeutic use
;
Logistic Models
;
Male
;
Metronidazole/therapeutic use
;
Middle Aged
;
Proton Pump Inhibitors/*therapeutic use
;
Retrospective Studies
;
Risk Factors
;
Treatment Outcome
10.Future Trends of Helicobacter pylori Eradication Therapy in Korea.
The Korean Journal of Gastroenterology 2014;63(3):158-170
The prevalence of Helicobacter pylori infection in Korea shows a decreasing trend and has changed to that of developed country, especially for those below 30 years old. However, the primary antibiotic resistance rates are higher than those of developed countries. The reason for the decrease in the efficacy of standard triple therapy is mainly due to the increase in the resistance against clarithromycin. Sequential therapy seems to be more effective than the standard triple therapy, but the intention-to-treat eradication rate of sequential therapy in Korea, which is mostly under 80.0%, is still not satisfactory. Therefore, a promising regimen is needed. Recently, the Japanese health insurance system admitted 'H. pylori-infected gastritis' as an indication of eradication. Furthermore, the Kyoto Consensus Meeting on H. pylori Gastritis held from January 30th to February 1st, 2014, proposed that 'all H. pylori positive patients should be offered to receive H. pylori eradication'. This suggests that the concept of eradication has been changed from 'treatment' to 'prevention'. Various individualized tailored therapy based on the polymorphism, age and other demographic factors and antibiotic resistance has been attempted to maximize H. pylori eradication therapy. The aim of this article is to review the current epidemiology, H. pylori resistance state, treatment guideline, and to assess the possible future strategy and treatment for H. pylori infection in Korea.
Anti-Bacterial Agents/pharmacology/*therapeutic use
;
Aryl Hydrocarbon Hydroxylases/genetics/metabolism
;
Clarithromycin/pharmacology/therapeutic use
;
Disease Eradication/trends
;
Drug Resistance, Bacterial
;
Drug Therapy, Combination
;
Guidelines as Topic
;
Helicobacter Infections/*drug therapy/epidemiology
;
*Helicobacter pylori/drug effects
;
Humans
;
Quinolones/pharmacology/therapeutic use
;
Republic of Korea
;
Treatment Failure

Result Analysis
Print
Save
E-mail