Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Mohan Z Mani

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Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2023 | Month : June | Volume : 17 | Issue : 6 | Page : FC09 - FC13 Full Version

Treatment Reconciliation in Parkinson's Disease Patients with Particular Reference to Wearing-off and Motor fluctuations: A Registry-based, Prospective, Observational Study


Published: June 1, 2023 | DOI: https://doi.org/10.7860/JCDR/2023/61854.18099
Satyabrata Sahoo, Asutosh Pal, Syed Mohammad Naser, Chiranjib Bagchi, Santanu Munshi, Santanu Kumar Tripathi, Mrinal Acharya, Shambo Samrat Samajdar

1. Senior Resident, Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, West Bengal, India. 2. Assistant Professor, Department of Neuromedicine, Medical College, Kolkata, West Bengal, India. 3. Professor, Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, West Bengal, India. 4. Associate Professor, Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, West Bengal, India. 5. Professor, Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, West Bengal, India. 6. Professor, Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, West Bengal, India. 7. Independent Neurologist (Neuromedicine), Private Clinic, Howrah, West Bengal, India. 8. Senior Resident, Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, West Bengal, India.

Correspondence Address :
Dr. Chiranjib Bagchi,
Associate Professor, Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata-700073, West Bengal, India.
E-mail: bchiranjib@yahoo.co.in

Abstract

Introduction: Parkinson’s Disease (PD) is the second most frequent neurodegenerative disease and dopaminergic agents are frequently used as a treatment while ‘end of dose deterioration’ or ‘Wearing-Off (WO)’ phenomenon is common with these agents. Treatment reconciliation may be helpful in this situation and there is dearth of studies especially in India.

Aim: To study the WO effects in patients of PD, their pharmacotherapy and outcome.

Materials and Methods: This registry-based, prospective, observational, outcomes-based study was conducted in the Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, West Bengal, India, in collaboration with Department of Neuromedicine of Kolkata Medical College and private clinics of a Neurologist from January 2020 to December 2021. An attempt was also undertaken to make a registry of Idiopathic Parkinson’s Disease (IPD) patients. WO Questionnaire 19-items (WOQ-19), Movement Disorder Society- Unified Parkinson’s Disease Rating Scale (MDS-UPDRS Scale), The 39-items Parkinson’s Disease Questionnaire (PDQ-39 questionnaire), The 8-items Morisky Medication Adherence Scale (MMAS scale), suspected Adverse Drug Reaction (ADR) Reporting Form of Indian Pharmacoepia commission (version 1.3), World Health Organisation- Uppsala Monitoring Centre (WHO-UMC) Scale, Naranjo causality assessment scale, Hartwig and Seigel’s Severity Assessment Scale were used in the present study. The study was commenced after obtaining approval from institutional ethics committee. The data was then analysed with parametric or non parametric tests using (mean±Standard Deviation (SD), median, Fisher’s-exact test, Friedman’s Analysis of Variance (ANOVA) test, Wilcoxon matched pair signed-rank test). Data collected and then statistically analysed by using WPS Excel version 2021 and GraphPad Prism version 9 software.

Results: Total IPD patients were found to be 111 in the present study with a mean age of IPD patients as 61.85±7.20 years. Incidence of WO in the present study was found to be 40.5% among IPD patients. Most common characteristic of WO was found to be tremor in 104 (28.8%) patients followed by slowness of movement in 63 (17.5%) patients. WHO-UMC scale and Naranjo causality assesment scale both revealed 36.4% ADRs were probable category and 63.6% were possible category. MDS-UPDRS Score, PDQ-39 Score, MMAS-8 score significantly (p-value <0.05) improved during the course of treatment.

Conclusion: Dose adjustment of syndopa was mostly used in the management of WO phenomenon and significant improvement in the quality of life of the patients was seen.

Keywords

Co-morbidity, Life quality, Pathology, Synuclein, Tremors, Tolerability

The PD is the second most frequent neurodegenerative disease, affecting 1% of the population aged >60 years [1,2]. Neuropathological hallmarks of PD are striatal dopamine deficiency. PD characteristic features are bradykinesia, rigidity, rest tremor and Non Motor Symptoms (NMS) (3). Dopamine replacement with oral levodopa is still the gold standard of symptomatic therapy (4). Levodopa long-term use can lead to ‘WO’ or ‘end of dose’ deterioration (5). WO management usually by levodopa, levodopa plus Carbidopa. Addition of other drugs like doßpamine agonist, anticholinergics, N-methyl-D-aspartate (NMDA) antagonist, Catechol- O-methyltransferase (COMT) inhibitor, Monoamine Oxidase type B (MAO-B) inhibitors may improve the symptoms (6),(7),(8),(9). Registry-based study can either be a clinical trials or non interventional study (10),(11).

Registry-based study can be used to find out effectiveness, safety and tolerability, quality of life, adherence (12),(13),(14). Aims of clinical pharmacology reconciliation are to check for valid clinical indication for each prescribed drug and to have a clear therapeutic goal and evidence base for each prescribed drug (15). There are few studies conducted in India (Obering CD et al., Perepezko K et al., and Shah J et al.,) regarding treatment reconciliation in WO and no such similar studies in West Bengal, India (16),(17),(18). Hence, the present study was designed to investigate the WO effects in patients of PD, their pharmacotherapy and outcomes in a Tertiary Care Hospital of West Bengal, India and private clinics of one practicing neurologist.

Material and Methods

This was a registry-based, prospective, observational, outcomesbased study conducted at the Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, West Bengal, India, in collaboration with Neuromedicine of Kolkata Medical College and private clinics of one consultant neurologist in Kolkata/suburban areas, West Bengal, India, from January 2020 to December 2021. Study was conducted after approval by the Institutional Ethics Committee of School of Tropical Medicine, Kolkata (CREC STM/595) and Ethics Committee of Medical College and Hospital, Kolkata (MC/KOL/IEC/NON SPON/771/08/20). An attempt was also undertaken to make a registry of IPD patients.

Due to sudden demise of one renowned neurologist of Kalyani, West Bengal, India, authors excluded this private clinic and enrolled data from three private clinics of only one neurologist of Howrah, West Bengal, India. Subject enrollment was done six months, follow-up was done 12 months, data analysis and report writing was done for four months.

Inclusion criteria: Adult subjects of either sex, IPD cases duly diagnosed, attending neurology clinic regularly, receiving drug therapy for PD for atleast one year, patients willing to take part in the study, and consented to participate were included in the study.

Exclusion criteria: Those who had a history of WO and did not give informed consent were excluded from the study.

Study Procedure

Patients were enrolled from Neuromedicine OPD of Medical College and Hospital, Kolkata, as well as from private clinics of one neurologist in Howrah, West Bengal according to inclusion and exclusion criteria after taking the informed consent. Patient’s data were filled in the Case Record Form (CRF) at baseline and then followed-up for three visits (at one month, three month and six month). The basic demographic details (age, sex), presenting complaints along with the medications history in a prestructured data collection form were noted. Cognitive assessment, rigidity, tremor according to MDS-UPDRS scale were assessed (16). The MDS-UPDRS scale was developed for the assessmsent of various aspects of PD such as non motor and motor experiences of daily living and motor complications (16). MDS-UPDRS scale comprises of four parts with the response bearing lower score than positive response using 5-point Likert scale. Those patients who developed WO in subsequent follow-ups were diagnosed by neurologists. Then patient’s WO onset and duration, were observed and noted. WOQ19 Questionnaire used to screen for WO symptoms in patients with PD (17). WOQ19 is a 19 items self-report measure to screen for end-of-dose (WO) symptoms in PD patients. Characteristics of WO among IPD patients, distribution of antiparkinsonian drugs among WO patients and co-morbidities among IPD patients were also observed.

Quality of life evaluated by PDQ-39 at baseline and three follow-up periods (18). PDQ-39 is a 39-item self-report questionnaire, which assesses PD specific health related quality of life. Medication adherence was assessed by using Morisky medication adherence scale (19),(20),(21),(22),(23),(24),(25). Medication adherence was assessed by MMAS-8 scale which is a structured self-reporting tool accepted globally.

In both of the scales negative responses had higher scores in comparison to positive responses and totaling into 11 and 195, respectively. PDQ-39 uses 5-point Likert scale whereas, MMAS-8 scale having score 1 with negative response. The study questionnaires and scales were administered in English mostly among the study subjects. In case of defaulters, authors have translated those forms and scales in local vernacular and presented before them after validating it with back translation. Safety of antiparkinsonian medications was analysed by monitoring suspected adverse drug reactions by using suspected ADR Reporting Form of Indian Pharmacopeia commission (version 1.3) (6),(26). Causality of such reactions were assessed using WHO-UMC Causality Assessment Scale, Naranjo’s Algorithm (6),(26). Severity of the reactions were assessed using Hartwig and Seigel’s Severity Assessment Scale (6),(26). Different parameters were recorded at baseline, first follow-up, second follow-up and third follow-up. (Permission was sought for using the Morisky’s Adherence Scale and before International Parkinson and Movement Disorder Society for MDS-UPDRS scale and other questionnaires. Being a member of International Parkinson and Movement Disorder Society, the first author got the access of those questionnaires).

Statistical Analysis

Data was collected and then statistically analysed. Qualitative data was represented as frequencies and percentages. Quantitative data was presented as mean±SD or median and Interquartile range. The data was then analysed with parametric or non parametric tests using (Mean±SD, Median, Fisher’s-exact test, Friedman’s ANOVA test, Wilcoxon matched pair signed-rank test) using WPS Excel version 2021 and GraphPad prism version 9 software. The data were entered into WPS Excel sheet and the master chart was taken as the patient registry.

Results

Total IPD patients were found to be 111 in the present study. Incidence of WO in the present study found to be 45 (40.5%) among IPD patients and the mean age of IPD was 61.85±7.20 years in the present study. Median age of IPD was 62 years. A total of 27(60%) WO patients were in age group <65 years and a total of 18 (40%) WO patients were in age group ≥65 years. A total of 39 (86.7%) WO patients were found in males and a total of 6 (13.3%) WO patients were found in females.

Total WO developed among IPD patients (111) were 45 (40.5%) in the present study. (Table/Fig 1) depicts WO developed among Idiopathic Parkinson patients. At baseline there was no WO. The WO in first follow-up period was 16 (14.4%), in second follow-up were 20 (18%) and in third follow-up were 9 (8.1%). (Table/Fig 1) also depicts descriptive statistics of WO onset at baseline and follow-ups. At baseline, WO onset time mean and median both was 0. At first follow-up mean was 91.23 minutes and median was 85 minutes. At second follow-up mean was 96 minutes and median was 100 minutes. At third follow-up mean was 107.2 minutes and median was 120 minute. Only mean and median value evaluated for WO onset time in different follow-ups.

(Table/Fig 2) depicts co-morbidities among IPD patients. Most common co-morbidities were hypertension 8 (33.3%) patients and diabetes mellitus type 2 (n=8, 33.3%). (Table/Fig 3) depicts characteristics of WO among the patients of IPD. Most common characteristic of WO was found to be tremor (n=104, 28.8%) followed by slowness of movement (n=63, 17.5%). The other motor complaints reported were difficulty in getting out of chair (13.6%), muscle cramping (4.4%) and general stiffness (2.5%). While chief non motor complaints were weakness (15.2%), dificuly in speech (9.1%), pain (4.7%), experiencing hot and cold (4.2%). (Table/Fig 4) shows the distribution of antiparkinson’s drugs among WO patients. Syndopa mostly used alone or along with added drugs in patients to treat WO. Syndopa>Trihexyphenidyl (THP)>pramipexole>ropinirole>amantadine, rasagiline. Patients were treated by usual regimen antiparkinsonian drugs regimen. (Table/Fig 5) shows different parameters at baseline and follow-ups (MDS-UPDRS, MMAS, PDQ-39 scales).

(Table/Fig 6) depicts suspected drugs causing ADRs and their causality assessment by WHO-UMC scale and Naranjo causality assessment scale among IPD patients. WHO-UMC Scale and Naranjo causality assessment scale both revealed 36.4% ADRs were probable category and 63.6% were possible category. (Table/Fig 7) Shows Hartwig’s severity scale, according to it 11 (100%) ADRs were in level one of mild intensity.

Discussion

The present study was designed to assess WO onset and its pharmacotherapy, to evaluate patient’s outcomes in terms of MDS-UPDRS score, safety and tolerability, medication adherence and quality of life and to explore treatment in emergency situations. Also, an attempt was made to form a registry of such patients, but due to Coronavirus Disease-2019 (COVID-19) it could not be completed. In the present study, the chief motor complaints were tremor (28.8%), slowness of movement (17.5%), difficulty in getting out of chair (13.6%), muscle cramping (4.4%), general stiffness (2.5%). while chief non motor complaints were weakness (15.2%), dificuly in speech (9.1%), pain (4.7%), experiencing hot and cold (4.2%). A study by Perepezko K et al., study revealed that the most common WO symptom was tremor (69.5%) (17).

In the present study, incidence of WO was found to be 40.5% among IPD patient which was nearly similar with Perepezko K et al., in which WO was 40% among IPD patients (17). About 70 (63%) and 41 (37%) of IPD patients were in age group of <65 years and ≥65 years, respectively. In the present study, mean age was found to be 61.85±7.20 years corroborating with Shah J et al., where the mean age was 61.88±11.93 years (18).

Quality of life is an important measure for PD, in terms of physical and mental health outcomes. Quality of life in the present study was measured by using PDQ-39 Score. In the present study, authors evaluated quality of life by using PDQ-39 questionaire. Mean PDQ-39 score was found to be 180.7±6.35 at baseline that was found to be improved in follow-ups. In a study by Saha J et al., study , mean total PDQ-39 score was 130.45, nearly approximate to the present study (18). Higher score indicates better quality of life. In the present study, WO in males was found to be 86.7% and in females 13.3%. Colombo D et al., revealed 61.9% WO in males which was higher than females (38.1%). Majority of studies also showed WO mostly in males (27). In the present study, mean MDS-UPDRS score was found to be 15.02±7.24 which is nearly similar to Obering CD et al., with MDS-UPDRS score of 15.78±11.53 (16).

Antiparkinson’s drugs are usually well tolerated and adverse events range from mild to moderate found in a study by Carbone F et al., (6). Another study by Thaha F et al., also revealed that majority of ADRs in their study was mild in intensity (26). In the present study, authors assessed safety and tolerability to antiparkinson’s drugs and adverse drug reactions from patients complaint, physical examinations by neurologists. According to modified Hartwig’s Severity scale, all the ADRs were mild in intensity as no drug withdrawal or no drug modification needed to treat the ADRs.

This showed the improvement of adherence from baseline to further follow-ups. It also revealed improvement of quality of life from baseline to further follow-up visits. Multiple drugs are now available to treat IPD patients such as levodopa plus carbidopa combination, dopamine agonists like ropinirole, pramipexole, bromocriptine, cabergoline, apomorphine, MAO-B inhibitors like selegiline, rasagiline, NMDA antagonist like amantadine, other drugs like safinamide, rotigotine etc., (28). The effectiveness of these drugs can be evaluated by using MDS-UPDRS score of international movement disorder society. In the present study, authors evaluated effectiveness of antiparkinson drugs by using MDS-UPDRS score in follow-ups.

Shah J et al., study revealed the effectiveness of antiparkinson medications by using MDS-UPDRS score (18). WHO-UMC scale showed 7 (63.6%) cases in possible category and 4 (36.4%) cases in probable category, Naranjo scale showed 7 (63.6%) cases in possible category and 4 (36.4%) cases in probable category.

Thaha F et al., study revealed that 72.5% ADRs were found to be possible category and 27.5% were found to be in unlikely category (26). Hartwig’s Severity scale showed 11 (100%) cases were of mild in intensity. Thaha F et al., revealed that majority of ADRs in their study were mild in intensity that was nearly similar to the present study (26). Medication adherence is an important parameter to assess the quality of life and it’s improvement. In the present study, authors evaluated medication adherence by using MMAS score. Mean MMAS score was found to be 7.15±0.91 at baseline and was also improved as follow-ups progressed (19). Clinical pharmacological reconciliation was very important for improving medication adherence and quality of life (29). In the present study, all patients have good adherence except few, who are poorly adherent to drugs, that might be due to COVID-19 pandemic and economic background of such patients.

Limitation(s)

Patients were followed-up for a period of six months due to the COVID-19 pandemic which is a very short duration to evaluate the outcomes and maintenance of registry. Entire spectrum of the disease and quality of life correlation could not be done. Because of time constraint other parkinson’s tools could not be used and as the present study is registry-based study it was difficult to do this type of study in short period. Authors attempt to make a complete patient registry has been interrupted due to COVID-19 pandemic and work is ongoing.

Conclusion

In the present study, syndopa was mostly associated with WO phenomenon. Overall, antiparkinson drugs were safe, well tolerated and effective in the management of WO phenomenon. Moreover, dose adjustment of syndopa or addition of newer drugs helped in significant improvement in quality of life. Additional treatment reconciliation service by clinical pharmacologist can improve the medication adherence, quality of life and therapeutic outcome among PD patients.

Acknowledgement

The authors would like to thank to their teachers, colleagues, Dr. Sumalya Sen, Dr. Sougata Sarkar, Dr. Kaustav Saha, Dr. Shreyashi Dasgupta, Dr. Arijit Kayal, Dr. Dipan Saha, Dr. Sahoo and family for their kind support and blessings.

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DOI and Others

DOI: 10.7860/JCDR/2023/61854.18099

Date of Submission: Nov 24, 2022
Date of Peer Review: Jan 19, 2023
Date of Acceptance: Apr 13, 2023
Date of Publishing: Jun 01, 2023

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. No

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Dec 12, 2022
• Manual Googling: Feb 23, 2023
• iThenticate Software: Mar 13, 2023 (8%)

ETYMOLOGY: Author Origin

EMENDATIONS: 7

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