Rifabutin in Patients With 3 H. Pylori Eradication Failures
Rifabutin in Patients With 3 H. Pylori Eradication Failures
One-hundred patients were included in the study, 31 with peptic ulcer disease and 69 with uninvestigated or functional dyspepsia. Mean age ± standard deviation was 50 ± 13 years, 39% were men, and 31% were smokers.
All patients returned for their follow-up visit (no patient was lost to follow-up). All but eight (8%) patients complied with the protocol (that is, reported that they took 100% of the prescribed medication). Of those who did not comply, six were due to adverse effects. A CONSORT flow diagram of subjects' progress through the phases of the study is shown in Figure 1.
(Enlarge Image)
Figure 1.
CONSORT flow diagram of subjects' progress through the phases of the study.
Adverse effects were reported in 30/100 (30%) patients: nausea/vomiting (13%), asthenia/anorexia (8%), abdominal pain (7%), diarrhoea (5%), fever (4%), metallic taste (4%), myalgia (4%), hypertransaminasemia (2%), leucopenia (<1500 neutrophils) (2%), thrombopenia (<150 000 platelets) (2%), headache (1%) and aphthous stomatitis (1%). In most cases, symptoms were only present while the patient was taking medication. Myelotoxicity resolved spontaneously, in few days, in all cases. In 5% (5/100) of the cases, adverse effects were classified as severe (based on the intensity), and included nausea (2%), vomiting (2%) and myalgia (1%).
Per-protocol eradication was achieved in 52% (48/92; 95% CI, 41–63%) of the patients, while intention-to-treat eradication rate was 50% (50/100; 95% CI, 40–60%). Cure rates were similar in patients with peptic ulcer disease and in those with uninvestigated or functional dyspepsia [intention-to-treat eradication rate of 52% (16/31) and 49% (34/69) respectively].
Results
Demographic Variables
One-hundred patients were included in the study, 31 with peptic ulcer disease and 69 with uninvestigated or functional dyspepsia. Mean age ± standard deviation was 50 ± 13 years, 39% were men, and 31% were smokers.
Compliance With the Protocol and Loss to Follow-up
All patients returned for their follow-up visit (no patient was lost to follow-up). All but eight (8%) patients complied with the protocol (that is, reported that they took 100% of the prescribed medication). Of those who did not comply, six were due to adverse effects. A CONSORT flow diagram of subjects' progress through the phases of the study is shown in Figure 1.
(Enlarge Image)
Figure 1.
CONSORT flow diagram of subjects' progress through the phases of the study.
Tolerance to Eradication Therapy
Adverse effects were reported in 30/100 (30%) patients: nausea/vomiting (13%), asthenia/anorexia (8%), abdominal pain (7%), diarrhoea (5%), fever (4%), metallic taste (4%), myalgia (4%), hypertransaminasemia (2%), leucopenia (<1500 neutrophils) (2%), thrombopenia (<150 000 platelets) (2%), headache (1%) and aphthous stomatitis (1%). In most cases, symptoms were only present while the patient was taking medication. Myelotoxicity resolved spontaneously, in few days, in all cases. In 5% (5/100) of the cases, adverse effects were classified as severe (based on the intensity), and included nausea (2%), vomiting (2%) and myalgia (1%).
Efficacy of Eradication Therapy
Per-protocol eradication was achieved in 52% (48/92; 95% CI, 41–63%) of the patients, while intention-to-treat eradication rate was 50% (50/100; 95% CI, 40–60%). Cure rates were similar in patients with peptic ulcer disease and in those with uninvestigated or functional dyspepsia [intention-to-treat eradication rate of 52% (16/31) and 49% (34/69) respectively].
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