[Efficacy of domperidone and pyridostigmine in the treatment of patients with functional dyspepsia: a randomized clinical trial]

The majority of dyspeptic patients do not have identifiable disease, which is also known as functional dyspepsia. The therapeutic approach to patients with functional dyspepsia is still a matter of debate; prokinetic agents are commonly used for symptom relief. This study aims to evaluate the efficacy of domperidone and pyridostigmine [an inhibitor of cholinesterase] in patients with functional dyspepsia. This was a single-blind, randomized clinical trial performed on 117 patients [December 2007 to November 2009] diagnosed with functional dyspepsia according to ROME II criteria. The effects of 4 weeks of treatment with domperidone [10 mg tid], yridostigmine [60 mg tid], and placebo were compared. We scored each patient according to VAS to rank the severity of 8 different upper GI symptoms [epigastric fullness, early satiety, gnawing, nausea, vomiting, belching, bloating, and epigastric pain] both before and at the end of treatment. Data were entered into SPSS software version 16 and analyzed. P<0.05 was considered significant. At the end of treatment, the total dyspeptic symptom score decreased from 24 to 13. According to ANOVA, there were significant differences between the 3 groups in 3 out of 8 symptom scores of bloating [p=0.039], early satiety [p=0.006], and nausea [p=0.016]. The post hoc test determined that domperidone was more effective than pyridostigmine and placebo in improvement of early satiety [p=0.038 and p=0.014, respectively]. Domperidone was more effective than pyridostigmine in the control of nausea [p=0.024]. Domperidone [p=0.023] and pyridostigmine [p=0.042] were superior in relieving bloating symptoms compared to placebo. Overall, in the control of GI symptoms domperidone was more effective than placebo [p=0.045]. domperidone and pyridostigmine are useful in improving bloating, early satiety, and nausea. However they are similar to placebo in controlling epigastric pain, fullness, belching and gnawing

Efficacy of hepatitis B vaccine in those who lost hepatitis B surface antigen during follow-up

The level of HBsAg in some chronic hepatitis B virus [HBV]-infected individuals may decline over time so that it is not detectable in serum. To assess the efficacy of HBV vaccine in those who lost their HBsAg without seroconverssion to anti-HBs antibody. From April 1993 to December 2008, of 1603 chronic HBV-infected individuals, 34 [22 men and 12 women] became HBsAg-negative in follow-up visits, with no detectable anti-HBs antibody and HBV DNA in their sera. They received HBV vaccination at 0, 1 and 6 months [case group]. Fifty-two subjects [30 men and 22 women] who were negative for HBsAg, anti-HBs and anti-HBc antibody, received HBV vaccination according to the said schedule [control group]. Anti-HBs antibody was assessed one month after the last dose of vaccination in the both groups. The mean +/- SD age of the case and control groups was 38 +/- 12.7 and 33.4 +/- 8.6 years, respectively [p=0.07]. The sex distribution between these two groups were similar [p=0.652]. The mean +/- SD years of follow-up for the case group was 7.6 +/- 4.5 years. Anti-HBs antibody level >/= 10 IU/L was found in 8 [24%] subjects in the case group and in 45 [87%] in the control group [p<0.001]. The mean +/- SD anti-HBs antibody level in the case group was 68 +/- 32.66 and in the control group 344.6 +/- 38.9 IU/L [p<0.001]. We found that nearly 24% of chronic HBsAg-positive subjects who lost their HBsAg responded to HBV and the remaining cases need to be followed for occult HBV infection

Interferon monotherapy in major thalassemic patients with hepatitis C infection

Major thalassemia is the most common form of anemia requiring blood transfusion in Iran. Since ribavirin provokes anemia in the treated patients, interferon monotherapy may be an appropriate treatment in major thalassemic patients. The aim of this study was to determine the safety and efficacy of interferon monotherapy in thalassemic patients with hepatitis C virus infection. Forty major thalassemic patients [20 male], with hepatitis C infection [detectable HCV RNA* by qualitative PCR** amplification assay] and elevated liver enzymes were enrolled. Liver biopsy was done for all patients. Then the patients were treated with interferon [3 MU, three times per week] for six months. They were followed by HCV RNA at the end of treatment, and at 6, 12, 24, 36, and 48 months later. Primary outcome measure was sustained virologic response defined by undetectable serum HCV RNA 6 months after end of treatment. Secondary endpoint was negative HCV RNA at the end of follow up [48 months posttreatment]. Mean age of the patient at the beginning of the study was 17.37 +/- 5 years. Three patients discontinued treatment because of interferon side effects. Twenty six [65% on intention to treat analysis] had undetectable HCV RNA 6 months after end of treatment but eleven of them became HCV RNA positive on follow up. Finally, 15 patients [37.5%] had undetectable HCV RNA at the end of follow up. Interferon monotherapy is an effective treatment for major thalassemic patients with HCV infection. Definition of sustained virologic response for hepatitis C may require revision in high risk patients