Journal of Clinical & Experimental Pharmacology

Impact of Helicobacter pylori eradication on therapeutic outcomes and quality of life among patients with parkinson's disease: A randomized placebo-controlled trial

36^th World Congress on Pharmacology

July 25, 2023 | Webinar

Gopal Vishwas

Rajendra Memorial Research Institute of Medical Sciences, India

Posters & Accepted Abstracts: J Clin Exp Pharmacol

Abstract:

Background: Helicobacter pylori (H. pylori) infection was found quite prevalent among patients with Parkinson’s disease. This infection decreases the levodopa absorption which could affect the clinical response. Hence, we aimed to evaluate the H. pylori eradication on therapeutic outcomes and quality of life among patients with Parkinson’s disease (PD). Methods: This was a double blinded placebo controlled randomized interventional study conducted in PGIMER, Chandigarh in 2019-2020 for duration of 2 years. A total of 30 H. pylori positive PD patients were allocated into two groups i.e., Group A: H. pylori eradication therapy and Group B: Placebo in the ratio of 1:1. The standard eradication therapy consist of omeprazole 20 mg; amoxicillin 1000 mg and clarithromycin 500 mg twice daily for two weeks. H. pylori detection in gut was done by using 14-C urea breath test. The randomization was done by using computer generated permuted block randomization. These patients were followed up at 4,8 and 12 weeks. Motor symptoms were assessed by using Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) score; non-motor symptoms were assessed by using Parkinson’s Disease Non-Motor Symptoms Scale (PDNMSS) and quality of life was assessed by using Parkinson’s Disease Questionnare-39 (PDQ-39). The primary outcome was to compare mean value of percentage change in ON medication UPDRS-III (motor) score at the end of 12 weeks from baseline. The secondary outcomes were to compare mean value of percentage change in ON medication total UPDRS score; levodopa onset time; levodopa ON duration time; PD NMS score; PDQ-39 score and daily ON time at the end of 12 weeks from baseline. Results: The baseline and clinical parameter were similar in both the groups. At the end of 12 weeks there was no significant difference observed in mean value of percentage improvement in ON medication UPDRS-III score (mean difference 16.44; Cohen’s d=0.55; p=0.17); ON medication total UPDRS score (mean difference 8.72; Cohen’s d=0.61; p=0.07); levodopa ON duration time (mean difference 16.2; Cohen’s d=-0.007; p=0.12); PD NMS score (mean difference -0.06; Cohen’s d=-0.007; p=0.983), PDQ-39 score (mean difference 0.906; Cohen’s d=-0.004; p=0.906) and daily ON time (mean difference 16.60; Cohen’s d=0.54; p=0.150). But the mean value of percentage change in levodopa onset time (mean difference -44.7; Cohen’s d=-0.96; p=0.013) was found significantly lower in eradication therapy arm as compared to placebo. Conclusion: A short term follow up of 12 week it was found that H. pylori eradication therapy produces significant improvement (in %) in levodopa onset time as compared to placebo which could be due to improvement of levodopa absorption after bacterial clearance from gut. But eradication therapy was found as good as placebo in term of improvement of motor and non-motor symptoms along with quality of life. Also, levodopa ON duration time; daily ON time were also found comparable in both the groups.

Biography :

Gopal Vishwas is currently working as Scientist-B in Department of Pharmacology; ICMR-RMRIMS, Agamkuan Patna. He has completed his MD in Pharmacology from PGIMER, Chandigarh in 2020. He pursued his MBBS from Calcutta National Medical College and Hospital, Kolkata in 2016. He had completed his Senior Residency from ESIC-Medical College, Faridabad. He had 6 publications in national and international journal. He had both teaching and research experience. His major thrust area of interest is patients care; drug repurposing; pre-clinical studies and Clinical trials. Also; antibiotic stewardship and pharmacovigilance are the heart touching domains for him. As a young researcher; he is involved in many national and international projects.