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This study aimed to evaluate the effectiveness of the antidepressant sertraline in treating functional dyspepsia. 193 patients meeting Rome II criteria for functional dyspepsia were randomly assigned to receive either sertraline 50mg or placebo daily for 8 weeks. The primary outcome was the Hong Kong Dyspepsia Index (HKDI) score. Intention-to-treat analysis found no significant difference in HKDI scores between the sertraline and placebo groups. Per protocol analysis found a statistically significant difference in HKDI scores between groups at week 8, favoring sertraline. However, there were no differences in quality of life, anxiety, or depression measures. The study concluded that sertraline was
This study aimed to evaluate the effectiveness of the antidepressant sertraline in treating functional dyspepsia. 193 patients meeting Rome II criteria for functional dyspepsia were randomly assigned to receive either sertraline 50mg or placebo daily for 8 weeks. The primary outcome was the Hong Kong Dyspepsia Index (HKDI) score. Intention-to-treat analysis found no significant difference in HKDI scores between the sertraline and placebo groups. Per protocol analysis found a statistically significant difference in HKDI scores between groups at week 8, favoring sertraline. However, there were no differences in quality of life, anxiety, or depression measures. The study concluded that sertraline was
This study aimed to evaluate the effectiveness of the antidepressant sertraline in treating functional dyspepsia. 193 patients meeting Rome II criteria for functional dyspepsia were randomly assigned to receive either sertraline 50mg or placebo daily for 8 weeks. The primary outcome was the Hong Kong Dyspepsia Index (HKDI) score. Intention-to-treat analysis found no significant difference in HKDI scores between the sertraline and placebo groups. Per protocol analysis found a statistically significant difference in HKDI scores between groups at week 8, favoring sertraline. However, there were no differences in quality of life, anxiety, or depression measures. The study concluded that sertraline was
placebo-controlled pilot study dr.Radias Zasra 1st Journal Reading Abstract
Aim To evaluate sertraline, a selective serotonin reuptake inhibitor in the treatment of patients with functional dyspepsia
METHODS Diagnosis of functional dyspepsia
Rome II criteria with Hongkong dyspepsia index (HKDI) greater than 16
PATIENTS
ethnic chiness HKDI symptom score normal upper endoscopy quality of life helicobacter pylori negatif hospital anxiety and depression (HAD) scale and global symptom relief receive -sertraline 50 mg - placebo -evaluated before,during and after treatment. - adverse effect were monitored during and after treatment. RESULT patients
no difference in the primary outcome of global dyspepsia symptoms between the sertraline and placebo groups intention to treat (ITT) 193 patients per protocol (PP) analysis 150 patients sertraline ( 98 patients ) placebo ( 95 patients ) w 0 :HKDI 26.086.19 w 8 :HKDI 22.416.36 HKDI 26.705.89 HKDI 23.257.30 ITT PP analysis sertraline ( 74 patients ) placebo ( 76 patients ) HKDI : 25.836.313 HKDI : 20.536.917 HKDI : 27.195.929 HKDI : 23.347.199 in the PP analysis by week 8 patients in the sertraline group --> statistically significant difference in HKDI no statistically significant difference in overall quality of life measure or the HAD scale related to treatment in either the ITT or PP analysis at week 8 CONCLUSION
This pilot study, the first to examine sertraline a selective serotonine reuptake inhibitor , for the management of FD did not find that it was superior to placebo INTRODUCTION
persistent or recurrent pain and/or discomfort centered in the upper abdomen for at least 12 wk in the preceding 12 mo according to the Rome criteria in the absence if structural disease.
FUNGTIONAL DYSPEPSIA (FD) The Rome criteria, published in 2006, further refines FD into epigastric pain syndrome and/or postprandial distress syndrome with the criteria fulfilled in the last 3 mo with symptoms onset at least 6 mo prior to diagnosis, again in the absence of structural disease The pathogenesis of FD is not known. A number of studies have shown an important role of psychological factors in the pathogenesis of this condition. We have demonstrated previously that anxiety and depression are important co-factors in its pathogenesis. There is no definitive treatment for this condition. Visceral hypersensitivity appears to be important in the pathogenesis of FD antidepressants were investigated in FD for their ability to modulate visceral hypersensitivity. selective serotonin reuptake inhibitors (SSRIs) are more commonly used in clinical practice. The precise mechanism of action of SSRIs in the treatment of depression is not fully understood. MATERIALS AND METHODS
Patient enrollment Patients aged 18-80 years with symptoms of dyspepsia within two weeks prior to the endoscopy visit were eligible for the study.
Informed written consent was obtained from all patients.
Patients were also required to have a dyspepsia score of greater than 16 by our validate questionnaire. and have had no prior investigations performed for this episode of dyspepsia within the 6 mo prior to the study. EXCLUSION CRITERIA
EXCLUSION CRITERIA
1. Pregnant or breast feeding 2. Had a history of alcohol or drug abuse 3. Recent malignancy or significant medical illnesses or concurrent medication 4. Patients with a history of or current anti-depressant use 5. Patients with classical heartburn or acid regurgitation as their only symptom without epigastric discomfort or pain Study protocol Patients were randomized to receive either sertraline 50 mg or placebo once daily for eight weeks.
Both the investigators and patients were blinded to the assigned treatment throughout the study.
Patients were given a diary in which they recorded side effects and symptoms during therapy.
After enrolment by gastroenterologists,patients returned for follow up at four and eight weeks Study intervention
The SSRI utilized in this study was sertraline at a dose of 50 mg orally daily.
Study participants were provided with pre-sealed boxes containing either sertraline or placebo and were asked to take a capsule per day for 8 wk in total.
Patient compliance was checked by counting returned study medications.
Dyspepsia scores
DISCUSSION there was a statistically significant improvement in the mean HKID score at week 8 in the sertraline group compared to the placebo group in the PP but not the ITT analysis.
There were also no differences in measures of quality of life, depression and anxiety and subjective global symptom resolution. the majority of the drop outs in the sertraline group occurred at week four, which could possibly be explained by the short term side effects of sertraline usually seen during the run in period of SSRIs.
We assert that our findings are important given that clinicians not uncommonly are utilizing SSRIs to treat FD despite the fact that to date, our study included, there is no strong justification for its use. In conclusion, our data suggest that an SSRI, sertraline was not superior to placebo for the management of FD in Chinese patients CRITICAL APPRAISAL
Is the evidence of this therapeutic aspect valid? Is the patient allocation of the treatment randomized? yes Is the observation of the patient done for enough time and completely? No Are all of the patient be analyzed? No Are the doctor and patient blind in the study? Yes Do all of the groups get the same action? No Are the control and treatment group similar in the initial of the study? Yes
Is the evidence of this valid therapeutic aspect important? Sertraline Plasebo
NTT 1.96 ((a/a+b) x (1-(a/a+b)) + ((c/c+d) x (1-(c/c+d)) a+b c+d
= 16.67 1.96 ((98/193) x (1-98/193)) + ((74/150) x (1-74/150)) 193 150
= 16.67 0.003
= 16.667 - 16.673 Can we applied the evidence of these valid and important therapeutic aspect to our patient? Are our patients different from patients in the study? No Can therapy applicated to our patients? Yes Do our patients have beneficial potential effect for the patients if this therapy applicated? Yes What is the value and expectation for the patients if the result offered? Sertraline for the management of FD, did not find that it was superior to placebo
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