Acupuncture For Functional Dyspepsia: A Multi-center Randomized Controlled Trial

Object:This trial is aimed to objectively evaluate the therapeutic efficacy of acupuncture, shame acupuncture and itopride in treating functional dyspepsia. The results of effect assessment are helpful to preliminarily clarify the diffrences among acupuncture, shame acupuncture and itopride in treating FD.Methods:To design a multicenter, randomized, blind, controlled clinical trial inorder to evaluate the clinical therapeutic effect of acupuncture in treating functional dyspepsia.There are 354 patients involved in this trial.14 patients were missing. All patients were randomly divided into the acupuncture groups(A group), non-acupoint group(B group) or itopride group(C group).Patients in group A and B were received electric acupuncture treatment, points Patients in group C were informed to take itopride orally,50mg tid. The treatment is consisted a period of 4 weeks. The assessment would be made at baseline 2 and 4 weeks after treatment, 1months and 3months after treatment. The outcomes were Patients' global assessments of efficacy, the life quality change of NDI, and dyspepsia symptom score index.Results:(1) This trial was well completed and the characteristics of three groups were comparable in baseline (P>0.05).(2) The results at 2 weeks after recruitment, the end of treatment and fellow-up as well as the scores of postprandial distension, early satiety, epigastric pain showed that there was significant difference between A and B group in all domains of QOL scores of NDI (P<0.05).(3) The results at the end of treatment and fellow-up showed that there was significant difference between A and C group in interference and eat and drink domains of QOL scores of NDI (P<0.05).(4) The results showed that there was significant difference between B and Cgroup in interference and Sleep disturb domains of QOL scores of NDI at each assessment time (P<0.05),in eat and drink domains at 2 weeks after recruitment and the end of treatment (P<0.05), in knowledge/control domains at at each assessment time except the fellow-up (P<0.0).(5) The analysis shows there was significant difference between the three groups in Patients' global assessments of efficacy (P<0.05).Conclusion:(1) The QOL scores of NDI in all domains of group A was superior to that of group B; and the A and C group has similar effect in knowledge/control domains at 2 weeks after recruitment, the end of treatment and fellow-up,while the effect of group A was superior to the group B and C at fellow-up;ln the other 3 domains, the group A and C group has the similar effect at 2weeks after recruitment,while the A group was superior to the group at the end of treatment and fellow-up.(2) The effect of improvement in postprandial distension, early satiety, epigastric pain in A group was superior to that of B and C group. (3)The Patients' global assessments of efficacy of the A group was superior to that of group B and C.