Effects of N-acetylcysteine on First-Line Sequential Therapy for Helicobacter pylori Infection: A Randomized Controlled Pilot Trial.
OBJECTIVE
To evaluate the adjuvant effects of N-acetylcysteine (NAC) on first-line sequential therapy (SQT) for Helicobacter pylori infection.


METHODS
Patients with H. pylori infections were randomly assigned to receive sequential therapy with (SQT+NAC group, n=49) or without (SQT-only group, n=50) NAC. Sequential therapy consisted of rabeprazole 20 mg and amoxicillin 1 g for the first 5 days, followed by rabeprazole 20 mg, clarithromycin 500 mg and metronidazole 500 mg for the remaining 5 days; all drugs were administered twice daily. For the SQT+NAC group, NAC 400 mg bid was added for the first 5 days of sequential therapy. H. pylori eradication was evaluated 4 weeks after the completion of therapy.


RESULTS
The eradication rates by intention-to-treat analysis were 58.0% in the SQT-only group and 67.3% in the SQT+NAC group (p=0.336). The eradication rates by per-protocol analysis were 70.0% in the SQT-only group and 80.5% in the SQT+NAC group (p=0.274). Compliance was very good in both groups (SQT only/SQT+NAC groups: 95.2%/100%, p=0.494). There was no significant difference in the adverse event rates between groups (SQT-only/SQT+NAC groups: 26.2%/26.8%, p=0.947).


CONCLUSIONS
The H. pylorieradication rate was numerically higher in the SQT+NAC group than in the SQT-only group. As our data did not reach statistical significance, larger trials are warranted.
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Hyuk
H
Yoon
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.|Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Dong Ho
DH
Lee
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Eun Sun
ES
Jang
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Jaihwan
J
Kim
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Cheol Min
CM
Shin
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Young Soo
YS
Park
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Jin-Hyeok
JH
Hwang
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Jin-Wook
JW
Kim
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Sook-Hayng
SH
Jeong
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.|Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Nayoung
N
Kim
D000111:Acetylcysteine / Q000008:administration & dosage*; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D017291:Clarithromycin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage; D008875:Middle Aged; D010865:Pilot Projects; D064750:Rabeprazole / Q000008:administration & dosage; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D008795:Metronidazole; D064750:Rabeprazole; D000658:Amoxicillin; D017291:Clarithromycin; D000111:Acetylcysteine
Eradication; Helicobacter pylori; N-acetylcysteine; Sequential therapy