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Original Investigation |

Association Between Acute Neuropsychiatric Events and Helicobacter pylori Therapy Containing Clarithromycin

Angel Y. S. Wong, BSc1; Ian C. K. Wong, PhD1,2; Celine S. L. Chui, MSc1; Edwin H. M. Lee, FHKCPsych3; W. C. Chang, FHKCPsych3; Eric Y. H. Chen, MD3; Wai K. Leung, MD4; Esther W. Chan, PhD1
[+] Author Affiliations
1Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China
2Research Department of Practice and Policy, School of Pharmacy, University College London, London, England
3Department of Psychiatry, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China
4Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China
JAMA Intern Med. 2016;176(6):828-834. doi:10.1001/jamainternmed.2016.1586.
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Importance  There is a concern that Helicobacter pylori therapy containing clarithromycin might be associated with acute neuropsychiatric events.

Objective  To examine the association between H pylori therapy containing clarithromycin and acute neuropsychiatric events.

Design, Setting, and Participants  A self-controlled case series study was conducted using the Clinical Data Analysis and Reporting System database in Hong Kong to explore any association. The exposure of interest was H pylori therapy containing clarithromycin in the outpatient setting. Study patients, 18 years or older at cohort entry, must have had both exposure to H pylori therapy containing clarithromycin and their first recorded neuropsychiatric events between January 1, 2003, and December 31, 2012. A post hoc nested case-control analysis was also performed in patients receiving H pylori therapy containing clarithromycin.

Main Outcomes and Measures  The primary outcome was composite neuropsychiatric events, while secondary outcomes were psychotic events and cognitive impairment. Risk periods in the self-controlled case series analysis were defined as 14-day preexposure period, current use (days 1-14 since prescription start date) and recent use (days 15-30). Age-adjusted incidence rate ratios (IRR) were estimated using the conditional Poisson regression.

Results  Of 66 559 patients who had at least 1 outpatient prescription of H pylori therapy containing clarithromycin. Their mean (SD) age at cohort entry was 50.8 (14.8 years); their mean age at first exposure was 55.4 (14.8) years, and 30 910 were male (46.4%). A total of 1824 patients had their first recorded composite neuropsychiatric events during the study period. An increased IRR of 4.12 (35 composite neuropsychiatric events during 72 person-years; 95% CI, 2.94-5.76) during current use was observed but not in recent use (9 events during 82 person-years; IRR, 0.95; 95% CI, 0.49-1.83) and 14-day preexposure period (14 events during 72 person-years; IRR, 1.63; 95% CI, 0.96-2.77) vs baseline (1766 events during 16 665 person-years). Similarly, both the risk of psychotic events and cognitive impairment increased during current use vs baseline, although this subsequently returned to baseline incidence levels during recent use. The crude absolute risks of composite neuropsychiatric events, psychotic events, and cognitive impairment during current use were 0.45, 0.12, and 0.12 per 1000 prescriptions, respectively. The nested case-control analysis also gave similar results to that of the self-controlled case series analysis.

Conclusions and Relevance  This study shows evidence of a short-term increased risk of neuropsychiatric events associated with H pylori therapy containing clarithromycin.

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Figure.
Study Analyses

A, The observation period started 1 year after patients entered the database, and follow-up was censored at the study end date, death, or any censoring events. Two risk periods were defined as follows: current use (days 1-14 since prescription start date) and recent use (days 15-30). To correct the estimates if the exposures are event dependent, we also separated a 14-day preexposure period from the baseline. B, The follow-up started from the date of first outpatient prescription until study end date, death, occurrence of event, or any censoring events described in the self-controlled case series analysis. We defined current and recent exposure periods similar to the self-controlled case series analysis.

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Overlooking Neuropsychiatric Inherited Real Risk, such a research is fundamentally biased.
Posted on May 9, 2016
Sergio Stagnaro, Marco Marchionni, Simone Caramel
Quantum Biopysical Semeiotic Research Laboratory
Conflict of Interest: None Declared
Unfortunately, not all Authors know till now that the individuals aren't born equal, in the sense that quantum-biophysical semeiotic constitutions really exist, bringing about relative Inherited Real Risk, bedside diagnosed from birth with a common stethoscope, and removed by mitochondrial restructuring quantum Therapy (1, 2). As a matter of facts, neurpsychiatric Inherited Real Risks exist, including that of Alzheimer Disease (3, 4), one of us has discovered formerly and we have described in details in previous papers (3-6). As a consequence, to ascertain the role played of Clarithromicyn in causing neuropsichyatric disorders, Authors have to enroll in the research exclusively individuals involved by the related Inherited Real Risk.

References.
1) Caramel S., Marchionni M., Stagnaro S. Morinda citrifolia Plays a Central Role in the Primary Prevention of Mitochondrial-dependent Degenerative Disorders. Asian Pac J Cancer Prev. 2015;16(4):1675. http://www.ncbi.nlm.nih.gov/pubmed/25743850[MEDLINE]
2) Sergio Stagnaro, Marco Marchionni, Simone Caramel. Early recognition of high risk patients using Biophysical Semeiotics Tests. Neurology, Published October 2, 2014, http://www.neurology.org/content/83/9/776/reply#neurology_el_61750
3) . Sergio Stagnaro. A fundamental bias of the research: Overlooking Congenital Acidosic Enzyme-Metabolic Histangiopaty-Dependent Brain Inherited Real Risk. Journal of Neurology, Neurosurgery & Psychiatry with practical Neurology, 5 May, 2009. http://jnnp.bmj.com/content/80/11/1206/reply
4) Marco Marchionni, Simone Caramel, Sergio Stagnaro. Inherited Real Risk of Alzheimer’s Disease: bedside diagnosis and primary prevention.Frontiers in Neuroscience, in http://www.frontiersin.org/Aging_Neuroscience/10.3389/fnagi.2013.00013/full
5) Marco Marchionni, Simone Caramel, Sergio Stagnaro. The Role of ‘Modified Mediterranean Diet’ and Quantum Therapy In Alzheimer’s Disease Primary Prevention. Letter to the Editor, The Journal of Nutrition, Health & Aging, Volume 18, Number 1, 2014, Springer Ed. http://link.springer.com/article/10.1007/s12603-013-0435-7 [Medline]
6) Marco Marchionni, Simone Caramel, Sergio Stagnaro. The Auscultatory Percussion of the Stomach Plays a Central Role in Bedside Diagnosis and Primary Prevention of Neurodegenerative Diseases and their Inherited Real Risks. 5th Annual World Congress Neotalk, Nijang, China, http://www.bitlifesciences.com/neurotalk2014/program_path1.asp#p1-2
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