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

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On Sep 2018




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"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."



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




Dr. Rajendra Kumar Ghritlaharey

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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.
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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 : 2012 | Month : February | Volume : 6 | Issue : 1 | Page : 85 - 88

Efficacy of Fluticasone and Oxymetazoline as the Treatment for Allergic Rhinitis

Prithpal S. Matreja, Vipan Gupta, Jaspreet Kaur, Sunder Singh

1. Department of Pharmacology, 2. Department of Otorhinolaryngology, 3. Department of Pharmacology, 4. Department of Otorhinolaryngology, Gian Sagar Medical College and Hospital, Village Ram Nagar, District Patiala, Punjab, India-140601.

Correspondence Address :
Dr Prithpal S Matreja,
Assistant Professor, Department of Pharmacology,
Gian Sagar Medical College and Hospital, Village Ram Nagar,
Tehsil Rajpura, District Patiala, Punjab, India - 140601.
Phone No.: +91-1762-507118, Mobile No.: +91-9855001847
Fax No.: +91-1762-520024
E-mail: drpsmatreja@yahoo.co.in

Abstract

Background: The intranasal steroids remain the most effective treatment as all major symptoms of allergic rhinitis are effectively attenuated. However, addition of decongestant increases the response obtained along with intranasal steroids. The data on effect of addition of Oxymetazoline to fluticasone is limited. Hence, this study was done to compare the efficacy of fluticasone combined with oxymetazoline and fluticasone alone for a 4-week treatment course of allergic rhinitis.

Methodology: In this randomized, open, parallel study, out of 123 patients randomly assigned to receive fluticasone with oxymetazoline (Group 1) or fluticasone alone (Group 2), 91 patients completed the entire 4 weeks of study. The primary outcome measure was mean change of the daytime nasal symptom score (PDTS) and secondary outcome measure was mean change of nighttime nasal symptom score (PNTS) and composite symptom score (PCS).

Results: The change in total daytime nasal symptom, composite symptom, nightime nasal symptom score was significantly (p<0.05) greater in Group 1 as compared to Group 2. Sub-group analysis showed a significantly (p<0.05) greater improvement in congestion score from 2nd week onwards in Group 1.

Conclusion: Oxymetazoline combined with fluticasone was effective in reducing daytime, night time, and composite symptom score as compared to fluticasone alone.

Keywords

Allergic rhinitis, Oxymetazoline, Fluticasone, Congestion

Introduction
Allergic rhinitis is a highly prevalent chronic condition which presents an enormous global health burden. It has been estimated that at least 500 million individuals have allergic rhinitis (AR) and it is one of the most common reasons for the appointment with a primary care practitioner (1), (2). According to the Allergic Rhinitis and its Impact on Asthma (ARIA) document, it is classified by severity, which is based on the duration of the symptoms (i.e. intermittent versus persistent) and the quality of life (mild, or moderate/ severe) (2),(3),(4). The terms “seasonal” and “perennial” allergic rhinitis were previously categorized as allergic rhinitis on the basis of the clinically significant aeroallergens. Perennial allergic rhinitis is associated with the all year round and indoor allergens which includes mould spores, cockroaches, dust mite faecal particles, animal dander, and occupational exposure. Seasonal allergic rhinitis is commonly referred to as “hay fever”, which develops during a defined pollen season and is usually intermittent as a result of allergic reactions to outdoor aeroallergens, which includes mould spores and pollens of trees, grasses, and weeds which depend on the wind for cross-pollination. Commonly, there is an overlap of the “perennial” and “seasonal” symptoms in some geographical regions, which has resulted in the decreased use of and confusion regarding these terms (3), (4). Apart from infections, allergic disorders affect the nasal mucosa. The inflammatory response of the nasal mucosa involves the engorgement of the venous sinusoids, and the obstruction of the nasal airflow to a variable degree, leading to a significant impairment of the daily living activities e.g. mouth breathing through a dry mouth, stuffy nose feeling, and headache (5). On physical examination, the patients classically can have a pale nasal Original Article ENT Section mucosa, with swollen, oedematous turbinates and clear nasal secretions (rhinorrhoea) (3). The drug therapy for allergic rhinitis should be guided by the type and the severity of the individual patient’s symptoms and it should reduce nasal congestion, sneezing, and rhinorrhoea over the course of the entire day and night and the physician preferences (4),(6). Oral and intranasal antihistamines, mast cell stabilizers, leukotriene inhibitors, decongestants and intranasal anticholinergics, in addition to intranasal steroids (INS), are all established evidence-based therapeutic interventions for AR (1). The intranasal steroids are significantly more effective than the oral or intranasal antihistamines and the anti-leukotrienes and are equal to the combination of antihistamine plus anti-leukotriene (2), (7),(8),(9). For a mild disease, either a second-generation antihistamine or a topical nasal corticosteroid (INS) is recommended (1), (2), (10). For a moderate to severe disease or when the nasal congestion is predominant, INSs are the first line of treatment (2), (11), (12). For a majority of the patients with allergic rhinoconjunctivitis, intranasal steroids remain the most effective treatment, since all the major symptoms which are associated with AR are effectively attenuated after their administration (2). 60 % of the subjects reported an excellent response to the intranasal steroids. Steroids work by penetrating the plasma membrane and binding to the cytosolic glucocorticoid receptor (GR). Upon GR binding, the steroid-GR complex translocates into the nucleus and binds the DNA at the glucocorticoid response elements (GRE) in the 5′-upstream region of the steroid responsive genes. The transcriptional activation of the anti-inflammatory genes or the repression of the pro-inflammatory and other mechanisms which regulate inflammation like via protein–protein sequestration via binding to other pro-inflammatory transcription factors such as the activator protein (AP-1), lead to the inhibition of the transcription of the inflammatory genes (2). On the other hand, oxymetazoline has a predominant α-2 adrenergic activity and an α-1 adrenergic activity at higher concentrations. Both the effects result in vasoconstriction and if oxymetazoline is applied topically to the nasal mucosa, it results in decongestion, facilitates the drainage of the paranasal sinuses and leads to an improved quality of life (5). Few studies have reported a significant increase in the response to the add-on therapy of fluticasone with oxymetazoline as compared to either of the drugs given alone; there was also a better mucociliary clearance in patients who received a combination of both the drugs (13), (14). Since data on the Indian population is lacking, we considered it worthwhile to assess the efficacy of fluticasone furoate with oxymetazoline in the Indian population.

Material and Methods

Study Design
This prospective, randomized, open, parallel group study (with a 4 week treatment period) was conducted in the Outpatients Department of the Gian Sagar Medical College and Hospital, Patiala District from December 2010 to May 2011. The study protocol and informed consent were reviewed and approved by the Institutional Ethics Committee of Gian Sagar Medical College and Hospital before the initiation of the study and a written informed consent was obtained from each subject prior to his/her enrollment in the study. This study was conducted in accordance with the ICH-GCP guidelines.
Patient Selection
Patients with allergic rhinitis, of both sexes, in the age group of 18 to 55 years, were recruited for the study. The exclusion criteria included the following: pregnancy and/or lactation; physical signs and symptoms which were suggestive of renal, hepatic or cardiovascular disease; subjects who were treated with systemic steroids or topical steroids during the previous 30 days; subjects who were treated with oral/ topical anti-histamines/decongestants during the past 7 days; subjects with polyps in the nose or a significantly displaced septum; and subjects with upper respiratory tract infection within 14 days of the start of the study.
Procedure
The subjects who fulfilled the inclusion and exclusion criteria and who were willing to give an informed consent were recruited for the study. Their clinic visits were scheduled at screening (visit 1), and after every 2 weeks of treatment according to the randomization for 4 weeks (visit 2 and 3). The subjects were randomized into two groups by using a random number table. Group 1 received Oxymetazoline (0.05%) nasal drop for 1 week, 2 puffs of Fluticasone furoate nasal spray (100μg/ day) in each nostril every evening and early morning daily for 4 weeks, whereas Group 2 received only Fluticasone furoate nasal spray (100μg/day) early morning daily for 4 weeks. A physical examination for nasal secretion and turbinate swelling was also done at each visit.
Outcome Measurements
The primary outcome measure was the mean change of the total daytime nasal symptom scores (PDTS), which was defined as the average score of four daytime nasal symptoms. The secondary outcomes were the mean changes of the night time nasal symptom scores (PNTS), and the composite symptom scores (PCS) (average score of day and night time nasal symptom score). The same observer examined all the patients and at various intervals of time. The credibility of the nasal examinations of the subjects was markedly enhanced by the single-observer design of this trial for every patient, which eliminated the inter-observer reliability issue.
Daily Rhinitis Diary Card
As was recorded on the daily diary card, the allergic rhinitis and conjunctivitis symptoms were assessed on a 4-point scale (0 to 3) for both the day time (diary card completed in the evening) and the night time (diary card completed on awakening). The daytime nasal (rhinorrhoea, sneezing, itching, and congestion) and the night time nasal (nasal congestion upon awakening, difficulty in going to sleep, and night time awakening) symptoms and their rating were described to every patient by the same technician. The ratings of the symptoms were: 0 = not noticeable, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. The rating had to be performed by the patients themselves to increase the creditability of the subjective scale. The safety evaluation included spontaneously reported adverse events throughout the study.
Statistical Analysis
The data was tabulated as mean ± standard deviation (SD). The results were analyzed by using non-parametric tests (the Chi- Square Test, the Wilcoxon Sign Ranked Test and the Mann Whitney U Test) and parametric tests (two tailed student t-test). A p value of < 0.05 was considered as statistically significant. The nominal variables were compared by using Chi-square analysis. The Student’s t-test was used for the comparison of the group means for the normally distributed data and the Mann-Whitney U test/Wilcoxon Sign Rank Test was used for the non-normally distributed data.

Results

Patients
A total of 155 patients with allergic rhinitis were screened for the study. Out of the 155 screened patients, 123 were eligible for the study. All the eligible patients were invited to participate in the study. 11 patients in group 1 and 12 patients in group 2 were excluded from the study due to the withdrawal of their written informed consent for participation in the study. 9 patients did not complete the entire 4 weeks of follow-up and hence, were excluded from the study. 4 patients (1 in group 1 and 3 in group 2) did not report for follow-up after 2 weeks of therapy and 5 patients (3 in group 1 and 2 in group 2) did not report for follow-up after 4 weeks of therapy. 91 patients completed the entire 4 weeks of follow-up of the study.
Efficacy
The patients in both the groups had comparable demographic and clinical profiles, as shown in (Table/Fig 1). The PDTS, PNTS, and the PCS scores were found to be reduced significantly as compared to the baseline in both the groups. The PDTS score (mean ± SD) at baseline was 2.16 ± 0.32, which reduced significantly to 1.31 ± 0.27 at the end of 4 weeks in group 1. Similarly, the PDTS score was found to be reduced significantly from 2.18 ± 0.35 to 1.60 ± 0.26 at the end of 4 weeks in group 2 (Table/Fig 2). The PNTS score (mean ± SD) was found to be decreased significantly from 2.15 ± 0.34 to 1.26 ± 0.30 in group 1 and from 2.13 ± 0.38 to 1.59 ± 0.33 in group 2 at the end of 4 weeks (Table/Fig 3). The PCS score (mean ± SD) was found to be decreased significantly from 2.16 ± 0.22 to 1.29 ± 0.18 in group 1 and from 2.15 ± 0.26 to1.60 ± 0.24 in group 2 at the end of 6 weeks (Table/Fig 4). The improvement in group 1 was significantly (p < 0.05) more as compared to that in group 2 from the 2nd week onwards in the PDTS score (1.71 ± 0.24 Vs 1.89 ± 0.21), the PCS scores (1.66 ± 0.28 Vs 1.89 ± 0.17), and the PNTS score (1.61 ± 0.28 Vs 1.89 ± 0.24). The sub-group analysis showed a significant (p < 0.05) improvement in the congestion scores in group 1 from the second week onwards and a significant (p < 0.05) improvement in itching, sneezing, rhinorrhoea, difficulty in going to sleep and the night time awakening scores in group 1 from the fourth week onwards, as compared to group 2.
Safety
No serious adverse event was reported in both the groups. The incidence of adverse events which were reported in group 1 was more as compared to that in group 2, but none of the adverse events which were reported were so severe that the termination of the treatment was required. The adverse events which were reported in both the groups did not require a reduction in the dose or any therapy for their treatment. The patients complained about watering of the eyes, burning and stinging sensations and bad taste or sneezing. Two patients in group 1 complained of watering of the eyes, whereas one patient in group 1 reported of a bad taste, sneezing and a stinging and burning sensation. There was no prolongation of hospitalization in any patient.

Discussion

There are a number of therapeutic choices which are available for the treatment of allergic rhinitis, which include oral and intranasal H1 anti-histamines, intranasal corticosteroids, oral and intranasal decongestants, intranasal anticholinergics and intranasal cromolyn and leukotriene receptor antagonists (3), (4), (15). Intranasal steroids are more effective as compared to a combination of anti-histamine plus anti-leukotriene. For a moderate to severe disease or when the nasal congestion is predominant, intranasal steroids are very effective, as all the major symptoms which are associated with allergic rhinitis are attenuated after their administration (2). The addition of oxymetazoline to fluticasone furoate adds to the efficacy in the treatment of allergic rhinitis (13). In the present study, a combination of oxymetazoline and fluticasone furoate was effective in improving the PDTS, PNTS and the PCS scores in patients with allergic rhinitis. The therapy of oxymetazoline with fluticasone furoate significantly improved these scores as compared to fluticasone furoate alone. These results are in agreement with those of earlier studies, which have demonstrated a significant improvement in the nasal symptom scores of the patients who were on a combination of oxymetazoline and fluticasone furoate, who were suffering from allergic rhinitis (13), (14). The sub-group analysis demonstrated a significantly greater improvement in the congestions score in patients who received oxymetazoline with fluticasone furoate. The adverse effects which were reported in our study were similar to those which were reported in earlier studies (13), (14). The adverse events which were reported were mainly watering of the eyes, sneezing and/or a burning and stinging sensation. There was no report of any clinically significant effect on the HPA-axis, bone growth, or cataract formation/glaucoma after the use of steroid therapy. This reflection was due to the low systemic bioavailability following the intranasal administration of steroids (2). Our results confirm and extend those of earlier studies, that oxymetazoline withfluticasone furoate is effective and safe in Indian patients with allergic rhinitis and that this combination may be of more clinical utility for the alleviation of the residual symptoms and for an improvement in the quality of life which is associated with allergic rhinitis (2), (5), (13), (14). The limitations of our study were that firstly the sample size was so small that the number of adverse events which were reported was not significantly more as compared to that which was related to the use of fluticasone furoate alone. May be a larger sample size may show a significant difference. Secondly, the duration of the study which was 4 weeks, which was small. May be a longer duration of the study would show variable results. Thirdly, this was an open label study, with the limitations of funds. A double-blind study would have been ideal. To conclude, the patients in both the groups tolerated the treatment well and showed a significant improvement from the baseline. There was a significant improvement in the PDTS, PNTS and the PCS scores in the patients who received oxymetazoline with fluticasone furoate versus fluticasone furoate alone at all intervals of time. The subgroup analysis showed a significant improvement in the congestions score.
Abbreviati ons
PDTS: Daytime Nasal Symptom Score
PNTS: Nighttime Nasal Symptom Score
PCS: Composite Symptom Score
INS: Intranasal Steroids
AR: Allergic rhinitis

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DOI and Others

ID: JCDR/2012/3457:1846

FINANCIAL OR OTHER COMPETING INTERESTS: NONE.

Date of Submission: Sep 13, 2011
Date of Peer Review: Oct 17, 2011
Date of Acceptance: Dec 10, 2011
Date of Publishing: Feb 15, 2012

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