Evidence map›Paper›PMID 28658799›Full record

ArticleJournal of clinical and diagnostic research : JCDR2017

A Prospective Study of Adverse Drug Reactions in Patients with Bipolar Disorder in Psychiatry Outpatient Department of a Tertiary Care Hospital.

Aashal Shah, Preeti P Yadav, Mayur Chaudhari, Ankit Vataliya, N D Kantharia, Ritambhara Mehta

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical and diagnostic research : JCDR, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.2field-weighted citation impact, top 45% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Aashal ShahResident, Department of Pharmacology, Government Medical College, Surat, Gujarat, India.
Preeti P YadavAssociate Professor, Department of Pharmacology, Government Medical College, Surat, Gujarat, India.
Mayur ChaudhariAssistant Professor, Department of Pharmacology, Government Medical College, Surat, Gujarat, India.
Ankit VataliyaResident, Department of Pharmacology, Government Medical College, Surat, Gujarat, India.
N D KanthariaHead, Department of Pharmacology, Government Medical College, Surat, Gujarat, India.
Ritambhara MehtaHead, Department of Psychiatry, Government Medical College, Surat, Gujarat, India.
Government Medical College · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBipolar disorder is a chronic, debilitating psychiatric disorder. Mood stabilizers and atypical antipsychotics are first line drugs for bipolar disorder. They have significant adverse effects.

aimThe study was conducted with an aim to evaluate the pattern of occurrence of Adverse Drug Reactions (ADRs) in the patients with bipolar disorder and to assess their causality, severity and preventability. MATERIALS AND

methodsA prospective and observational study - carried out in the psychiatry outpatient department of New Civil Hospital, Surat for 15 months. All patients diagnosed with bipolar disorder and receiving pharmacotherapy were included. Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale and Abnormal Involuntary Movement Scale (AIMS) were used for documenting ADRs and tardive dyskinesia, respectively. Assessment of causality, severity and preventability of recorded ADRs was done using Naranjo's algorithm and WHO-UMC scale, modified Hartwig and Seigel Scale and modified Schumock and Thornton scale, respectively. Descriptive statistics was used (percentage, mean±standard deviation) for presentation of demographics and other numerical data; Chi Square test and Fisher's exact test were used to assess association between variables. A p-value < 0.05 was considered significant.

resultsA total of 703 ADRs were recorded from 175 patients. The most common ADRs observed were asthenia (11.95%) and sedation (10.24%). Majority of ADRs were mild on assessment with UKU scale. Mood stabilizers (59.46%) were most frequently associated with ADRs and lithium was most common single drug responsible. Upon causality assessment, majority of the reactions were probable (54.77% with WHO-UMC scale, and 56.33% with Naranjo's algorithm). The association of results between the two scales was statistically significant (p<0.001). Majority of ADRs (70.27%) were assessed as mild and 64.30% of the ADRs were not preventable.

conclusionADRs are a frequent occurrence in patients with bipolar disorder which are mild in most cases. Incidence of ADRs can be decreased and compliance as well as quality of life of patient can be improved by early detection and management.

Indexed as

Antipsychotic agentsCausality assessmentLithiumPharmacovigilanceValproate

Identifiers

PMID28658799
PMCPMC5483701
OpenAlexW2621640162

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.