Efficiency and Safety of GABA Derivatives for Treatment of Functional Dyspepsia in Children - EAP 2019 Congress and MasterCourse Porto Palacio Hotel

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¹Shupyk National Medical Academy of Postgraduate Education, PhD student, MD, Ukraine
²Shupyk National Medical Academy of Postgraduate Education, Professor, Dean of Pediatric Faculty, MD, PhD, DMs, Ukraine
³Shupyk National Medical Academy of Postgraduate Education, Assistant Professor of CEMSIT, PhD, MD, Ukraine
⁴Kyiv City Children's Clinical Hospital, Head of the Department of General Pediatrics, MD, Ukraine
⁵Kyiv City Children's Clinical Hospital, MD, Ukraine
⁶Shupyk National Medical Academy of Postgraduate Education, Professor, Vice-Rector for Clinical Work, MD, PhD, DMs, Ukraine

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.