title: Efficacy and safety of cinitapride in functional dyspepsia.
abstract: OBJECTIVE
  To study the efficacy and safety of cinitapride in the treatment of functional dyspepsia, and to evaluate the improvement of patients' quality of life.
  
  
  METHODS
  The prospective cross-sectional multi-centre phase IV study was conducted at Jinnah Hospital, Lahore, Ziauddin Medical University, Karachi and Pakistan Railways General Hospital, Rawalpindi, from July 2009 to June 2010 and comprised 121 patients of functional dyspepsia who were given cinitapride 1mg thrice daily 15 minutes before meals and were followed up for four weeks. Primary clinical response was assessed by using the Global Index Score. Secondary response was seen by percentage change of the total score as well as of each dyspepsia symptom compared with baseline and the overall subjective assessment of patients by using the 7-point Likert's scale. Reduction in Nepean Dyspepsia Index-Short Farm was used to evaluate the improvement in quality of life of patients at week 2 and 4. SPSS 15 used for statistical analysis.
  
  
  RESULTS
  After 4 weeks of treatment, the Global Index Score showed statistically significant reduction in 58 (48.92%) patients (p<0.01). Similar reduction (p<0.01) was seen in individual dyspepsia symptoms; early satiety, post-prandial fullness, and abdominal distension. The 7 point Likert's scale also showed similar improvement in subjective response (p<0.01).The quality of life also improved significantly at week 2 and 4 (p<0.01). No abnormal results were seen in vital signs, physical and laboratory examination except an unexplained rise in globulin level. Only one adverse event (sore throat) was reported during the study.
  
  
  CONCLUSIONS
  The drug was effective in minimising dyspepsia symptoms, and improving the quality of life of patients. It was well tolerated and was almost free of side effects.
authors.affiliation: Department of Medicine, lslamic International Medical College, Rawalpindi, Muhammad.Tariq@riphah.edu.pk
authors.forename: Muhammad Tariq
authors.initials: MT
authors.lastname: Baqai
authors.forename: Mahmood Nasir
authors.initials: MN
authors.lastname: Malik
authors.forename: Faisal
authors.initials: F
authors.lastname: Ziauddin
mesh_terms: D000284:Administration, Oral; D000328:Adult; D001549:Benzamides / Q000008:administration & dosage / Q000627:therapeutic use*; D003430:Cross-Sectional Studies; D004305:Dose-Response Relationship, Drug; D004415:Dyspepsia / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D005260:Female; D006801:Humans; D008297:Male; D010154:Pakistan / Q000453:epidemiology; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D001549:Benzamides; C045316:cinitapride