Background and Aims: The quality of life (QL) in children with functional dyspepsia (FD) is often impaired due to the psychological disorders and cognitive dysfunction seen in these patients. The aim of this study was to evaluate the efficacy and safety of phenibut in children with FD.
Methods: 40 children with FD were randomized to 1 month of symptomatic treatment+phenibut (n=20, 400 mg/d 4 times per day according to the instructions) or exclusively symptomatic treatment (n=20, Rome IV). QL was determined by a questionnaire “PedsQL”. The memory was evaluated by method of "Memory for Numbers" and "RAM". The attention was determined by the method of "Proofreading" and "Technique of Münstenberg".
Results: At 1 month, the active group demonstrated: the improvement of physical functioning (p=0.007) and vs control group (p=0.043): increasing of the emotional functioning (p=0.043) and vs the control (p=0.033); getting better in the functioning at the school (p=0.016) and vs the control (p=0.045). The phenibut group reported the increasing of the level of selective attention (p=0.023) and vs control group (p=0.041). The productivity and consistency of attention in the phenibut group was higher after treatment (p=0.001) and vs control (p=0.009). The level of short-term visual memory in the active group improved significantly after treatment (p=0.047) and vs control (p=0.038). RAM in the phenibut group was higher after treatment (p=0.007) and vs control group (p=0.013).
Conclusions: Phenibut was associated with appropriate therapeutic response in cognitive function and QL in children with FD. It was safe and well tolerated in used dosage.