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Reverse Hybrid Therapy is Effective As The First Line Therapy For Helicobacter Pylori Infection

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Reverse hybrid Therapy Replaced Standard Triple Therapy as The First Line Therapy For Helicobacter Pylori Infection

Background Information

Reverse hybrid therapy is a single-step double-phase treatment for Helicobacter pylori (H. pylori) infection with less cost than standard triple therapy. We conducted a randomized, controlled study to compare the efficacies of standard triple therapy and reverse hybrid therapy in the treatment of H. pylori infection.

The H. pylori-infected subjects were randomly allocated to receive either a reverse hybrid therapy (pantoprazole plus amoxicillin for 12 days and clarithromycin plus metronidazole for the initial 7 days) or a standard triple therapy (pantoprazole plus amoxicillin and clarithromycin for 12 days). H. pylori status was assessed 6 weeks after treatment. Additionally, antibiotic resistances and host CYP2C19 genotypes were examined and analyzed.

Reverse hybrid therapy can be considered for first-line treatment of H. pylori infection since the new therapy achieves a higher eradication rate than standard triple therapy with similar tolerability and less pharmaceutical cost.

Methods

All consecutive H. pylori-infected adult patients with endoscopically proven peptic ulcer diseases or gastritis were eligible for recruitment. The diagnosis of H. pylori was based on at least 2 positive results of rapid urease test, histology, and culture. Exclusion criteria were as follows: age younger than 20 years; prior H. pylori eradication, allergy to any of the medications used in the trial, presence of severe comorbidities (for example, decompensated liver cirrhosis, uremia), ingestion of antibiotics or bismuth within the prior 4 weeks, and pregnancy.

Randomization

Using a computer-generated number sequence, we randomly allocated patients at a 1:1 ratio to either a 12-day reverse hybrid therapy (pantoprazole 40 mg plus amoxicillin 1 g twice daily for 12 days, and clarithromycin 500 mg plus metronidazole 500 mg twice daily for the first 7 days) or a 12-day standard triple therapy (pantoprazole 40 mg plus clarithromycin 500 mg and amoxicillin 1 g twice daily for 12 days). All drugs were taken 1 hour before breakfast and dinner. An independent research assistant at the Kaohsiung Veterans General Hospital generated the computerized random number sequence. She prepared the study medicines and instructions for drug administration according to the number sequence and concealed them in an opaque envelope. The opaque envelopes labeled with sequence numbers outside were kept by research nurses at each study hospital.

Results

From October 2012 to March 2015, a total of 440 H. pylori-infected patients were recruited for the study and randomly allocated to the reverse hybrid (n = 220) or standard triple group (n = 220). There were no differences in all parameters between groups. In the reverse hybrid therapy group, 10 participants were excluded from PP analysis for loss to follow-up (n = 4) or poor compliance (n = 6). In the standard triple therapy group, 6 participants were excluded from PP analysis for loss to follow-up (n = 3), poor compliance (n = 2), or both (n = 1).

Discussion

With the rising prevalence of antimicrobial resistance, the treatment success of standard triple therapy has recently declined to less than 80% in many countries. An ideal treatment for H. pylori infection should be highly effective, well tolerated, simple, and inexpensive. This study is the first to conduct a head-to-head, randomized, controlled trial to assess the efficacy of 12-day standard triple therapy and that of 12-day reverse hybrid therapy for H. pylori eradication. The results clearly showed that 12-day reverse hybrid therapy achieved a higher eradication rate than 12-day triple therapy, whether by ITT (93.6% vs. 86.8%), modified ITT (95.4% vs. 88.4%), or PP analyses (95.7% vs. 88.3%). The 2 treatments were well tolerated and shared comparable total adverse events (14.1% and 9.5%) and compliance (96.8% and 98.6%). With regard to pharmaceutical cost, 12-day reverse hybrid therapy was cheaper than 12-day triple therapy (0.37.2 vs. 0.44.0 in Taiwan). The data support the use of reverse hybrid therapy as the standard first-line treatment for H. pylori infection.

Reference:

Ping-I Hsu et al. A Randomized Controlled Study Comparing Reverse Hybrid Therapy and Standard Triple
Therapy for Helicobacter pylori Infection. Medicine (Baltimore). 2015 Dec; 94(48)

Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4674196/

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