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Helicobacter pylori Eradication in Parkinson's Disease: A Randomized Placebo-Controlled Trial.
Mov Disord. 2020 12; 35(12):2250-2260.MD

Abstract

BACKGROUND

Helicobacter pylori (HP) infection has been associated with worse motor function in Parkinson's disease (PD).

OBJECTIVE

We aimed to evaluate the effects of HP eradication on PD symptoms.

METHODS

In this parallel-group, double-blind, randomized placebo-controlled, single-center trial, patients with PD with positive HP urea breath test and serology were block randomized (1:1) to receive standard eradication triple therapy or identically appearing placebo capsules for 1 week. Prespecified motor (International Parkinson and Movement Disorder Society Unified PD Rating Scale [MDS-UPDRS], timed tests, and home-based wearable sensor measurements), nonmotor (Leeds Dyspepsia Questionnaire and Montreal Cognitive Assessment), and quality-of-life (Parkinson's Disease Questionnaire-39) outcome measures were assessed at weeks 6, 12, 24, and 52. The primary outcome was the baseline-to-week 12 change in ON medication MDS-UPDRS motor scores. Lactulose-hydrogen breath testing for concomitant small intestinal bacterial overgrowth was performed at baseline and repeated at week 24, together with the urea breath test.

RESULTS

A total of 310 patients were screened for eligibility and 80 were randomly assigned, of whom 67 were included in the full-analysis set (32 treatment group patients, 35 placebo patients). HP eradication did not improve MDS-UPDRS motor scores at week 12 (mean difference 2.6 points in favor of placebo, 95% confidence interval: -0.4 to 5.6, P = 0.089). There was no significant improvement in any motor, nonmotor, or quality-of-life outcome at weeks 12 and 52. Both the full-analysis and per-protocol analyses (based on eradication status) supported these conclusions. Small intestinal bacterial overgrowth status did not influence treatment results.

CONCLUSIONS

HP eradication does not improve clinical outcomes in PD, suggesting that there is no justification for routine HP screening or eradication with the goal of improving PD symptoms. © 2020 International Parkinson and Movement Disorder Society.

Authors+Show Affiliations

Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Gastroenterology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Department of Medical Microbiology, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.Department of Medical Microbiology, University of Malaya, Kuala Lumpur, Malaysia.Division of Neurology, Edmond J. Safra Program in Parkinson's Disease and the Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.Division of Neurology, Edmond J. Safra Program in Parkinson's Disease and the Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.Division of Neurology, Edmond J. Safra Program in Parkinson's Disease and the Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32894625

Citation

Tan, Ai Huey, et al. "Helicobacter Pylori Eradication in Parkinson's Disease: a Randomized Placebo-Controlled Trial." Movement Disorders : Official Journal of the Movement Disorder Society, vol. 35, no. 12, 2020, pp. 2250-2260.
Tan AH, Lim SY, Mahadeva S, et al. Helicobacter pylori Eradication in Parkinson's Disease: A Randomized Placebo-Controlled Trial. Mov Disord. 2020;35(12):2250-2260.
Tan, A. H., Lim, S. Y., Mahadeva, S., Loke, M. F., Tan, J. Y., Ang, B. H., Chin, K. P., Mohammad Adnan, A. F., Ong, S. M. C., Ibrahim, A. I., Zulkifli, N., Lee, J. K., Lim, W. T., Teo, Y. T., Kok, Y. L., Ng, T. Y., Tan, A. G. S., Zulkifle, I. M., Ng, C. K., ... Lang, A. E. (2020). Helicobacter pylori Eradication in Parkinson's Disease: A Randomized Placebo-Controlled Trial. Movement Disorders : Official Journal of the Movement Disorder Society, 35(12), 2250-2260. https://doi.org/10.1002/mds.28248
Tan AH, et al. Helicobacter Pylori Eradication in Parkinson's Disease: a Randomized Placebo-Controlled Trial. Mov Disord. 2020;35(12):2250-2260. PubMed PMID: 32894625.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Helicobacter pylori Eradication in Parkinson's Disease: A Randomized Placebo-Controlled Trial. AU - Tan,Ai Huey, AU - Lim,Shen-Yang, AU - Mahadeva,Sanjiv, AU - Loke,Mun Fai, AU - Tan,Jiun Yan, AU - Ang,Ban Hong, AU - Chin,Kok Ping, AU - Mohammad Adnan,Amni Fatihah, AU - Ong,Shawna Mei Chien, AU - Ibrahim,Aimi Izzah, AU - Zulkifli,Nusyaibah, AU - Lee,Jing Kun, AU - Lim,Wan Ting, AU - Teo,Yong Teck, AU - Kok,Yong Leng, AU - Ng,Tze Ying, AU - Tan,Aaron Guan Siang, AU - Zulkifle,Intan Maisara, AU - Ng,Chin Khoon, AU - Ee,Soon Sean, AU - Arafin,Shuhaina, AU - Mohamad Shukori,Khairunnisa, AU - Vadivelu,Jamunarani S, AU - Marras,Connie, AU - Fox,Susan H, AU - Lang,Anthony E, Y1 - 2020/09/07/ PY - 2020/03/30/received PY - 2020/06/22/revised PY - 2020/07/27/accepted PY - 2020/9/8/pubmed PY - 2021/4/28/medline PY - 2020/9/7/entrez KW - Helicobacter pylori KW - Parkinson's disease KW - gastrointestinal dysfunction KW - gut microbiota KW - small intestinal bacterial overgrowth SP - 2250 EP - 2260 JF - Movement disorders : official journal of the Movement Disorder Society JO - Mov Disord VL - 35 IS - 12 N2 - BACKGROUND: Helicobacter pylori (HP) infection has been associated with worse motor function in Parkinson's disease (PD). OBJECTIVE: We aimed to evaluate the effects of HP eradication on PD symptoms. METHODS: In this parallel-group, double-blind, randomized placebo-controlled, single-center trial, patients with PD with positive HP urea breath test and serology were block randomized (1:1) to receive standard eradication triple therapy or identically appearing placebo capsules for 1 week. Prespecified motor (International Parkinson and Movement Disorder Society Unified PD Rating Scale [MDS-UPDRS], timed tests, and home-based wearable sensor measurements), nonmotor (Leeds Dyspepsia Questionnaire and Montreal Cognitive Assessment), and quality-of-life (Parkinson's Disease Questionnaire-39) outcome measures were assessed at weeks 6, 12, 24, and 52. The primary outcome was the baseline-to-week 12 change in ON medication MDS-UPDRS motor scores. Lactulose-hydrogen breath testing for concomitant small intestinal bacterial overgrowth was performed at baseline and repeated at week 24, together with the urea breath test. RESULTS: A total of 310 patients were screened for eligibility and 80 were randomly assigned, of whom 67 were included in the full-analysis set (32 treatment group patients, 35 placebo patients). HP eradication did not improve MDS-UPDRS motor scores at week 12 (mean difference 2.6 points in favor of placebo, 95% confidence interval: -0.4 to 5.6, P = 0.089). There was no significant improvement in any motor, nonmotor, or quality-of-life outcome at weeks 12 and 52. Both the full-analysis and per-protocol analyses (based on eradication status) supported these conclusions. Small intestinal bacterial overgrowth status did not influence treatment results. CONCLUSIONS: HP eradication does not improve clinical outcomes in PD, suggesting that there is no justification for routine HP screening or eradication with the goal of improving PD symptoms. © 2020 International Parkinson and Movement Disorder Society. SN - 1531-8257 UR - https://www.unboundmedicine.com/medline/citation/32894625/Helicobacter_pylori_Eradication_in_Parkinson's_Disease:_A_Randomized_Placebo_Controlled_Trial_ L2 - https://doi.org/10.1002/mds.28248 DB - PRIME DP - Unbound Medicine ER -