Article in PDF
How to Cite
Citation Manager
Readers' Comments (0)
Audio Visual Article Statistics
Link
to PUBMED
Print this Article
Send to a Friend
Advertisers
Access Statistics Resources
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
Original article / research
Full Version
Efficacy and Safety of Oral Eplerenone in Acute Central Serous Chorioretinopathy: A Randomised Controlled Study
Correspondence Address :
Avik Dey Sarkar,
Room No. 214, PG Hostel, Aravind Eye Hospital, 1, Annanagar, Madurai-625020, Tamil Nadu, India.
E-mail: avikds24@gmail.com
Introduction: Acute Central Serous Chorioretinopathy (CSCR) is an important form of acquired maculopathy that usually presents as localised serous detachment of the neurosensory retina. Although, the disease is typically self limiting over a period of 2-3months, a percentage of patients ultimately develop chronic RPE changes. Eplerenone, a potential Mineralocorticoid Receptor (MR) antagonist, may play a role in regulating choroidal vascularity and modifying the disease in chronic CSCR.
Aim: To assess the safety and efficacy of oral eplerenone medication in acute CSCR.
Materials and Methods: This was a randomised controlled trial that included 162 eyes of 162 patients with acute CSCR. Patients were divided into two groups– Group-A, which received oral Eplerenone, and Group-B, which received Placebo therapy. Each group comprised 81 eyes. Best Corrected Visual Acuity (BCVA), Central Macular Thickness (CMT), and serum potassium (K+) levels were measured at baseline and monthly intervals for three consecutive months. Statistical analysis was performed using Statistical Package for Social Sciences (SPSS) Statistics version 20 software (IBM Corp., Armonk, NY, USA). A p-value less than 0.05 was considered statistically significant.
Results: The differences in CMT in Group-A and Group-B were 279±56.41μm and 207±68.88 μm (p<0.01) at the end of the first month and 361±33.56 μm and 278±46.27 μm at three months (p<0.01), respectively. The average BCVA improvement in Group-A and Group-B was 6.05 lines and 4.21 LogMAR lines, respectively, at the conclusion (p=0.002). Deterioration to chronicity was seen in 3.7% of the eyes in Group A and 17.3% of the eyes in Group B. The increase in Serum K+ at three months was 0.61±0.27 mg/dL in Group-A and 0.1±0.21 mg/dL in Group-B (p=0.03).
Conclusion: Eplerenone is a safe and effective first-line treatment option for acute CSCR, leading to faster and higher resolution with protection from progression to chronicity.
Central macular thickness, Serum potassium, Spectral domain optical coherence tomography
The CSCR is defined as serous retinal detachment and/or RPE detachment, where changes most often are confined to the macula and associated with leakage of fluid through the RPE into the subretinal space (1),(2). It is the fourth most common non-surgical exudative retinopathy after age-related macular degeneration, diabetic retinopathy, and retinal vein occlusion (3). It affects Asian and Caucasian populations more commonly than other ethnicities (4).
Acute CSCR predominantly affects males, and the incidence among middle-aged adults is the highest (5). It is typically an innocuous retinopathy that resolves spontaneously in 2 to 3 months (2),(6). Patients with documented Sub-Retinal Fluid (SRF), with or without RPE detachment on OCT, and with persistent or progressive visual symptoms for more than three months were considered as chronic CSCR in an earlier study (7). Previous literature suggests that 15% of acute cases may progress to chronic CSCR, causing irreversible damage to the photoreceptors and resulting in subnormal visual gain (8),(9). Therefore, considering that young adults have the highest incidence, a rapid, safe, and efficient method of treatment is required for acute CSCR.
The multifactorial pathogenesis of CSCR is complex and involves choroidal vascular dysregulation, which has been recently blamed for its occurrence (10). This is confirmed by the choroidal hyperpermeability changes shown by fluorescein angiography and/or indocyanine green angiography (10). New insights into the pathogenesis have revealed that glucocorticoid and mineralocorticoid dysfunction also significantly contribute to the pathogenesis (9). In animal models, choroidal MR activation prompted choroidal vasodilation and subsequent leakage, while MR antagonism nullified the effect (9). This has led to investigations regarding the utility of mineralocorticoid antagonists as a potential medication for treating CSCR, particularly eplerenone, which was found to be free from significant anti-testosterone side-effects (4),(11).
The efficacy of eplerenone in chronic CSCR treatment has already been well documented (3),(10),(11),(12). However, its effect on acute CSCR has been rarely studied to date (9),(10),(11). A few studies have analysed the efficacy of oral eplerenone on acute CSCR previously (4),(10). Ours is the first prospective, randomised, placebo-controlled study to investigate the role of oral eplerenone in acute CSCR.
This was a randomised controlled trial that included a consecutive series of patients with acute CSCR attending the Ophthalmology Outpatient Department (OPD) in a tertiary care hospital from 1st April 2021 to 30th March 2023 who met the inclusion criteria. Institutional Ethical Clearance (IEC) was received prior to initiating the study (IEC approval letter no.- IEC/2021/04). This study protocol followed the principles of the Declaration of Helsinki. Written informed consent was obtained from all individual patients included in the study.
Based on the CSCR cases in the OPD of the previous year, a minimum sample size of 150 was required. Initially, 198 patients were screened for this study. However, finally, 162 were included based on the eligibility criteria (Table/Fig 1).
The subjects attaining 18 years of age with a clinical diagnosis of acute CSCR for the first occurrence were included in the study.
Here, acute CSCR is defined as the presence of subretinal fluid on Spectral Domain-OCT (SD-OCT) and duration of visual symptoms for less than 12 weeks (7). Patients were excluded from the study if there were the presence of features of chronic CSCR or recurrent CSCR (patients with a history of at least one previous episode CSCR attack), presence of Choroidal Neovascular Membrane (CNVM) identified by Fundus Fluorescein Angiography (FFA) and/or SD-OCT, any history of treatment for vitreoretinal disease, patients under treatment with steroids in any form, history of other chorioretinal disorders that would influence the results of the current study (e.g., pathological myopia, diabetic retinopathy, choroiditis, age-related macular degeneration, etc.,), and the presence of any other systemic disorder for which eplerenone was used or contraindicated. Patients who fulfilled the inclusion criteria were assigned to either the treatment group named Group-A, treated with Oral Eplerenone, or Group-B, which was the placebo group. A computer-generated table was used to randomise the cases into two groups.
The previous study had mentioned optimal dosages of Oral Eplenerone (12), but the dosage regimen considered for patients of Group-A was inspired by the VICI trial dosing schedule (13). Group-A patients were treated with tab. eplerenone (25 mg/day), a single tablet daily for one week, followed by 50 mg/day as a single tablet daily afterward until complete resolution of SRF or until the completion of three months, whichever came earlier. A known complication of hyperkalemia is associated with the use of eplerenone (10). Therefore, after initiating the treatment, we regularly checked the serum potassium levels in both groups. Serum potassium levels were measured at the initiation of the treatment and then after every month until the conclusion of the study. In case of any episode of drug intolerance, the treatment was decided to be discontinued.
In Group-B, patients were on oral medication of tablet multivitamins, a single tablet once daily after dinner. The follow-up study period was three months.
At baseline, for all diagnosed acute CSCR cases, BCVA on standard Snellen’s Charts was measured, followed by a complete ophthalmological examination and imaging by fundus photography and SD-OCT. Patients included in the study were followed-up every month with BCVA, slit lamp bio-microscopy, and SD-OCT examinations.
Pre-treatment and post-treatment visual acuity were measured with a Snellen’s chart. For statistical analysis, visual acuity measurements were converted to logMAR values using appropriate formulae (14),(15). At baseline and monthly follow-up visits, the SD-OCT radial macular scan protocol was performed every time. SD-OCT evaluation included CMT analysis and the presence of Sub Retinal Fluid (SRF) using macular thickness maps. We included the machine-generated CMT results for all the calculations to avoid errors related to measurements performed manually.
Comparisons of BCVA, CMT, and serum potassium levels between the treatment and control groups were considered as the main outcomes. Safety analyses were recorded at each visit. The trial was made double-blinded so that the patients were supplied with nearly similar-looking tablets from the hospital’s dispensary for both groups, and at the same time, the OCT images of two arms were kept masked to the clinicians while grading the results.
Any patient lost to follow-up in the middle of the study has been excluded from the final calculations. Patients where SD-OCT scan has shown erroneous results due to segmentation error were also not taken into account.
Safety analysis: Safety was assessed through the collection and summary of ocular and non-ocular Adverse Events (AEs), Systemic Adverse Events (SAEs), and ocular assessments as detailed in the patient’s medical record.
Statistical Analysis
The SPSS Statistics version 20 software (IBM Corp., Armonk, NY, USA) was used for performing necessary statistical calculations. All quantitative variables were denoted as means±standard deviations. Counts and percentages were used to express categorical variables. Categorical variables were analysed using the Chi-square test, while the t-test was used for quantitative variables. A p-value less than 0.05 was considered statistically significant.
This study included 162 eyes of 162 patients who presented with acute CSCR and underwent a complete evaluation. All the patients were randomly divided into two groups, Group-A and Group-B as mentioned earlier. Both groups were similar in terms of age, gender, laterality, and other baseline parameters. The demographic distribution of the study population and other parameters at baseline is given in (Table/Fig 2).
In Group-A and Group-B, the baseline CMT was 580±126.02 μm and 579±107.97 μm, respectively. After the 1st month in Group-A, a change of 279±56.41 μm in CMT was noticed compared to 207±68.88 μm in Group-B (p<0.01). At the end of the 3rd month, Group-A patients experienced a total change of 361±33.56 μm compared to 278±46.27 μm in Group-B (p<0.01) (Table/Fig 3).
Regarding BCVA, there was an average improvement of 3.45±1.08 LogMAR lines in Group-A compared to 2.72±0.93 lines in Group-B at the end of the first month. This improved to 5.12±1.17 LogMAR lines and 3.83±1.04 lines in Group-A and Group-B, respectively, at the end of the second month. Finally, at the end of three months, the improvement was 6.05±1.45 and 4.21±1.23 LogMAR lines in Group-A and Group-B (p=0.002) (Table/Fig 4).
The cure rate and improvement of BCVA have been given in (Table/Fig 5). The serum potassium level at the conclusion of three months of oral eplerenone therapy in Group-A was increased by 0.61±0.27 mEq/L, while there was minimal change in serum potassium in Group-B (0.1±0.21 mEq/L) during the study period (Table/Fig 5). There were no AEs that occurred as a result of eplerenone treatment.
In the study, a significantly better outcome was observed in the treatment group compared to the observation group. Both anatomical and functional parameters were evaluated for intergroup analysis, providing statistically significant results.
Chatziralli I et al., conducted a meta-analysis of studies published until 2017 regarding oral eplerenone’s role in treating CSCR (11). Summarising the results of 15 studies, they concluded that oral eplerenone in the dose of 25-50 mg/day is effective and well-tolerated for the treatment of chronic CSCR, which aligns with the results of the current study (11). They also concluded that there was no significant difference between the two dosages (11).
Acute CSCR is usually a self-limiting disorder (9),(16). Patients, even without any treatment, often undergo complete resolution of symptoms in three months or less (9),(16). So, close observation is generally considered the first line of therapy (9). Nevertheless, a few patients who do not achieve spontaneous recovery can progress to chronic disease, with irreversible visual deterioration and persistent anatomical alterations (9).
Zucchiatti I et al., compared oral eplerenone versus observation in the treatment of acute CSCR in 15 patients (9). While the treatment group experienced significantly improved BCVA at the 1st month (p=0.018) and over three months of follow-up (p=0.011), the observation group could not achieve the same. In the treatment group, SRF and CMT were significantly reduced at the one-month follow-up (p=0.014, p=0.028, respectively) and the three-month follow-up (p<0.001 for both analyses), while in the observation group, the changes were not statistically significant (9). They concluded that patients with acute CSCR treated with eplerenone experienced better resolution compared to the observation group (9). In this study, a significantly better outcome was achieved in both groups, but the treatment group achieved a higher cure rate with faster recovery compared to the observation group.
Venkatesh R et al., conducted a prospective randomised study to evaluate the role of oral eplerenone in 58 eyes with acute CSCR (10). Patients were divided by alternate random sampling into treatment (Table Eplerenone 50 mg/day for a minimum of 1 month) and observation groups, with each group having 29 eyes (10). BCVA improvement to 6/6 was seen in 92%, 100%, and 100% of cases in the treatment group and 74%, 86%, and 100% in the control group at each visit, respectively, up to three months (10). Complete SRF resolution in the treatment group was noted in 45%, 55%, and 62% of cases at each respective monthly visit (10). In the observation group, complete SRF resolution was noted in 10%, 21%, and 31% at 1-, 2-, and 3-month visits, respectively (10). The p-values between the two groups were statistically significant at all visits (10). SRF height reduction was significant in both treatment (p<0.001) and control groups (p<0.001) (10). They concluded that oral eplerenone achieves faster SRF resolution and vision improvement in acute CSCR (10).
Though there was a rise in serum potassium levels, it was well tolerated by patients, and there were no significant adverse effects. Zucchiatti I et al., in their study also did not find any treatment-related side-effects (9). The same was observed in the study by Venkatesh R et al., (10). Although none of these articles mentioned any objective serum potassium value in their results.
The advantages of our study were that it was a prospective randomised placebo-controlled study with one of the largest sample sizes compared to other studies.
Limitation(s)
The main limitation of the present study was the short follow-up. Therefore, any data regarding recurrence in long-term follow-up was not recorded for analysis.
This study showed that patients affected by acute CSCR and treated with Eplerenone achieved higher and faster resolution of the disease compared to those receiving placebo therapy. Oral eplerenone significantly decreased CMT and improved BCVA in comparison to the placebo group in patients with acute CSCR. Results of this study also indicate that patients undergoing Eplerenone therapy show protection from progressing towards chronic CSCR with permanent RPE changes. Although this study has some limitations, the results of this study showed that eplerenone is an effective non-invasive treatment option for acute CSCR. However, it caused a significant increase in serum potassium levels, and hence close monitoring may be required while prescribing eplerenone to patients with high levels of serum potassium. We believe our effort will encourage future researchers to explore the use of eplerenone in acute CSCR in a more specific way. In conclusion, eplerenone may represent an attractive new first-line treatment option for acute CSCR.
DOI: 10.7860/JCDR/2024/68431.19108
Date of Submission: Nov 02, 2023
Date of Peer Review: Dec 07, 2023
Date of Acceptance: Jan 15, 2024
Date of Publishing: Mar 01, 2024
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. NA
PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Nov 08, 2023
• Manual Googling: Dec 15, 2023
• iThenticate Software: Jan 13, 2024 (23%)
ETYMOLOGY: Author Origin
EMENDATIONS: 7
- Emerging Sources Citation Index (Web of Science, thomsonreuters)
- Index Copernicus ICV 2017: 134.54
- Academic Search Complete Database
- Directory of Open Access Journals (DOAJ)
- Embase
- EBSCOhost
- Google Scholar
- HINARI Access to Research in Health Programme
- Indian Science Abstracts (ISA)
- Journal seek Database
- Popline (reproductive health literature)
- www.omnimedicalsearch.com