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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
Effect of Ursodeoxycholic Acid on Unconjugated Hyperbilirubinemia in the Term Neonates Treated with Phototherapy: A Prospective Interventional Study
Correspondence Address :
Dr. Raghavendra H Gobbur,
Professor, Department of Paediatrics, BLDE Medical College and Research Institute, Vijayapura-586103, Karnataka, India.
E-mail: rhgobbur@gmail.com
Introduction: Neonatal hyperbilirubinemia affects 60–80% of term neonates in the first week of life. Phototherapy (PT) is the standard treatment; however, prolonged PT has limitations. Ursodeoxycholic Acid (UDCA) is a potential adjuvant therapy to enhance bilirubin clearance.
Aim: To evaluate UDCA as a safe and useful adjuvant to PT in term neonates with Unconjugated Hyperbilirubinemia (UCHB) by comparing bilirubin reduction, PT duration, and length of hospital stay.
Materials and Methods: A prospective interventional study was conducted at the Level 3 Neonatal Intensive Care Unit (NICU) of Shri BM Patil Medical College, Hospital and Research Institute, Vijayapura, Karnataka, India, from January 2024 to January 2025. Total 100 term neonates were allocated into two groups: Group 1 (n=50) received oral UDCA (10-15 mg/kg/day) with PT, and Group 2 (n=50) received standard PT alone. Total Serum Bilirubin (TSB) levels were measured at admission, 24 hours, and 48 hours. PT duration, NICU stay, and adverse effects were assessed. The independent samples t-test or the Mann–Whitney U test was used to compare continuous variables, and the Chi-square test or Fisher’s-exact’s test was used to assess categorical variables. A p-value <0.05 was considered significant.
Results: Baseline characteristics such as gestational age (38.4±1.2 vs 38.2±1.3 weeks), birth weight (2.79±0.43 vs 2.76±0.40 kg), and gender distribution were comparable between groups. The decline in TSB at 48 hours was 9.3±1.75 mg/dL in the UDCA+PT group versus 9.8±1.90 mg/dL in the PT-only group (p=0.175). The mean PT duration was 47.84±2.50 hours in the UDCA group and 48.22±5.50 hours in the control group (p=0.66). UDCA was well tolerated, with only mild vomiting observed in three neonates.
Conclusion: The UDCA may modestly enhance bilirubin clearance, but differences in bilirubin reduction, PT duration, and NICU stay were not statistically significant. Larger randomised controlled trials are needed.
Bilirubin clearance, Neonatal care, Neonatal jaundice, Phototherapy duration
Neonatal Unconjugated Hyperbilirubinemia (UCHB) affects 60-80% of term neonates and an even higher percentage of preterm infants in the first week of life (1). Accumulation of Unconjugated Bilirubin (UCB) leads to jaundice, which can progress to severe hyperbilirubinemia (TSB >20 mg/dL), increasing the risk of Acute Bilirubin Encephalopathy (ABE) and kernicterus, leading to irreversible neurological damage (2). Timely management is essential to prevent these complications.
Neonatal jaundice arises due to increased bilirubin production from the shorter lifespan of foetal erythrocytes (70-90 days vs. 120 days in adults) (3), immature hepatic conjugation due to low Uridine Diphosphate-Glucuronosyltransferase (UGT1A1) activity (4), and increased enterohepatic circulation due to high β-glucuronidase levels in the gut (5). While most cases resolve spontaneously, severe cases require medical intervention.
The American Academy of Paediatrics (AAP) recommends Phototherapy (PT) as the primary treatment (6). PT converts UCB into water-soluble isomers for excretion but has complications such as dehydration, electrolyte imbalance, oxidative stress, and potential disruption of maternal-infant bonding (7). Exchange transfusion, used in severe cases, carries risks such as haemodynamic instability, infections, and Necrotising Enterocolitis (NEC) (8). These challenges have driven interest in adjuvant therapies to enhance bilirubin clearance and reduce PT duration.
Several pharmacological agents have been explored, including phenobarbital (induces bilirubin conjugation but is sedative) (9), clofibrate (a Peroxisome Proliferator-activated Receptor (PPAR) agonist) with unclear neonatal safety (10), D-penicillamine (limited efficacy) (11), and probiotics (inconclusive impact on bilirubin recycling) (12). UDCA, a hydrophilic bile acid used in cholestatic liver diseases (13), has emerged as a promising adjuvant. It enhances biliary bilirubin excretion via Bile Salt Export Pump (BSEP) and Multidrug Resistance-associated Protein 2 (MRP2) transporters (14), reduces enterohepatic circulation, and has anti-inflammatory and antioxidant properties [15,16].
Cuperus FJ et al., (2009) found that UDCA accelerated bilirubin metabolism in Gunn rats (7), and Mendez-Sanchez N et al., (1998) observed enhanced bilirubin turnover in rodents (8). However, clinical evidence remains limited. Bhardwaj S et al., (2020) showed that UDCA with PT led to faster bilirubin decline than PT alone (3). Honar N et al., (2016) found that UDCA reduced PT duration by 24 hours (5), while Hasan AM et al., (2015) reported significant reductions in TSB levels and hospitalisation (4). Large-scale trials are needed to confirm UDCA’s efficacy and safety before routine use.
Given PT limitations, the risks of prolonged bilirubin exposure, and the economic burden of extended hospital stays, an effective adjuvant therapy is necessary. UDCA’s potential cost-effectiveness and non invasiveness make it a promising candidate.
Hence, the present study was conducted to assess UDCA’s role in term neonates with UH receiving PT, evaluating its impact on bilirubin reduction, PT duration, and hospitalisation, particularly in resource-limited settings where advanced PT and exchange transfusion may be inaccessible.
The present prospective interventional study was conducted at the Level 3 NICU of Shri BM Patil Medical College, Hospital and Research Institute, Vijayapura, Karnataka, India, over a period of one year, from January 2024 to January 2025. The study was approved by the Institutional Ethics Committee (ref. no.: BLDE(DU)/IEC/963/2022-23). It adhered to the Declaration of Helsinki guidelines, with informed parental consent obtained.
Inclusion criteria: Full-term neonates (>37 weeks gestation), birth weight >2 kg, clinically stable, diagnosed with UCHB (TSB >13 mg/dL requiring PT as per AAP guidelines (6)) were included.
Exclusion criteria: Neonates with congenital anomalies, systemic sepsis, metabolic disorders, haemolytic disease, or direct hyperbilirubinemia (>20% of TSB) were excluded.
Sample size calculation: A total of 100 neonates (50 per group) were enrolled, determined using G*Power 3.1.9.4 with power 80% and a 5% level of significance, based on Hasan AM et al., (4).
Randomisation was performed using a computer-generated allocation sequence created with random-number software.
Study Procedure
Participants were assigned to either the intervention (UDCA+PT) or control (PT only) group in a 1:1 ratio.
UDCA+Phototherapy (PT) group: Received oral UDCA (10 mg/kg/day) with standard PT.
Control group: Received standard PT alone.
Term neonates on exclusive breastfeeding with TSB >13 mg/dL were treated with double-surface Light-emitting Diode (LED) phototherapy. UDCA (10 mg/kg/day for 2 days) was administered orally or via nasogastric tube with breast milk or sterile water. Phototherapy was administered per AAP guidelines (6), with TSB monitored every 24 hours until levels fell below 10 mg/dL. Exchange transfusion was to be considered if bilirubin exceeded critical thresholds. Collected data included birth weight, gestational age, Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) scores, bilirubin levels (baseline and serial measurements), PT duration, hydration status, and adverse effects (diarrhoea, vomiting).
Statistical Analysis
Statistical Packages of Social Sciences (SPSS) version 20.0 was used to analyse the data. The independent samples t-test or Mann-Whitney U test was used to compare continuous data, and the Chi-square test or Fisher’s-exact’s test was used to assess categorical variables. A p-value <0.05 was considered significant.
There is no significant differences in gestational age, birth weight, APGAR scores, gender distribution, or maternal blood group between the two groups (p>0.05) has been depicted in (Table/Fig 1). The comparable baseline characteristics ensure homogeneity of the study population, strengthening the reliability of outcome analysis.
Clinical parameters such as heart rate, respiratory rate, oxygen saturation, and capillary refill time showed no statistically significant differences between the groups (p>0.05), indicating comparable physiological status at admission (Table/Fig 2).
The mean TSB and UCB levels were compared over different time points between the two groups. TSB and UCB were compared in both groups (UDCA+PT and PT alone) at admission, 24 hours, and 48 hours; the results showed no statistically significant differences (p>0.05) (Table/Fig 3).
The duration of PT was shorter in the UDCA+PT group; however, the differences in PT duration and NICU stay were not statistically significant (Table/Fig 4).
There were no adverse effects such as diarrhoea or abdominal distension; only three cases had vomiting in the UDCA+PT group.
The present study compared UDCA+PT versus PT alone in term neonates. Baseline characteristics, including gestational age (38.4±1.2 vs. 38.2±1.3 weeks) and birth weight (2.79±0.43 vs. 2.76±0.40 kg), were similar (p>0.05). Findings align with Bhardwaj S et al., (2020) and Honar N et al., (2016), who also reported no significant pretreatment differences (3),(5). Vital signs at admission included heart rate (142±9 vs. 143±8 bpm, p=0.621) and respiratory rate (51±6 vs. 50±5 breaths/min, p=0.543). Our findings are consistent with Hasan AM et al., (2015) (4), indicating that UDCA does not impact early clinical stability.
Serial bilirubin measurements indicated a modest reduction in UCB levels in the UDCA+PT group compared to the PT alone group. At admission, UCB levels were 18.2±3.12 mg/dL in the UDCA+PT group versus 18.42±2.40 mg/dL in the PT group (p=0.693). At 24 hours, the levels were 13.1±2.25 mg/dL in the UDCA+PT group versus 13.9±2.19 mg/dL in the PT group (p=0.07). At 48 hours, UCB levels decreased to 9.3±1.75 mg/dL in the UDCA+PT group versus 9.8±1.90 mg/dL in the PT group (p=0.175).
The PT duration (47.84±2.5 vs 48.22±5.5 hours, p=0.66) and NICU stay (3.02±0.24 vs 3.0±0.2 days, p=0.651) were similar in both groups.
In a study performed by Honar N et al., the mean total bilirubin in the intervention group was 12±1.6, 10±1.1, and 9.8±0.2 mg/dL at 12, 24, and 48 hours after the beginning of PT, respectively (5). By contrast, these measures were 14.4±1.3, 12.5±1.4, and 10.1±1.1 mg/dL in the control group, respectively (p<0.05). The mean time required for PT to decrease bilirubin to <10 mg/dL was 15.5±6 and 44.6±13.3 hours in the case and control groups, respectively (p=0.001).
Another study by Hasan AM et al., reported that the mean TSB in group A was 11.7±1.5, 8.8±1.1, and 7.6±0.9 mg/dL at 12, 24, and 36 hours after the start of Ursodiol plus PT, while in group B these measures were 14.6±1.6, 13.2±5.8, 10.2±1.4, and 9.1±0.8 mg/dL at 12, 24, 36, and 48 hours, respectively (p<0.001). The duration of PT in groups A and B was 23.2±5.6 and 41.1±7.2 hours, respectively (p<0.001) (4).
Both of the above studies reported statistically significant reductions in bilirubin, but their groups did not have similar baseline TSB values; bilirubin levels were lower in those groups compared with controls. In our study, similar TSB ranges were observed in both groups to avoid bias.
The UDCA was well tolerated, with only three cases of mild vomiting consisting of a few milliliters of milk after the first dose, subsiding spontaneously without intervention. No severe adverse effects were noted, consistent with UDCA+PT studies by Bhardwaj S et al., (2020) and Mohammed S et al., (2020) (3),(17).
Limitation(s)
The present study is a single-centre study and findings may not be generalisable to diverse healthcare settings. Confounding variables like uncontrolled factors (feeding patterns, genetic variations, maternal health) may influence outcomes.
The UDCA used as an adjunct to PT in term neonates with unconjugated hyperbilirubinemia was found to be safe and well-tolerated, with only mild vomiting observed in a few cases. The mean reduction in TSB at 24 and 48 hours was slightly higher in the UDCA group compared with the PT-only group, but this difference was not statistically significant. Similarly, no significant differences were observed in PT duration or NICU stay. However, the trend toward faster bilirubin decline and reduced PT duration suggests a potential clinical advantage that warrants further investigation. Future studies with larger sample sizes, diverse populations, and longer follow-up periods are recommended to validate these findings and determine the optimal clinical utility of UDCA in neonatal jaundice management.
DOI: 10.7860/JCDR/2025/80533.22074
Date of Submission: May 12, 2025
Date of Peer Review: Jun 26, 2025
Date of Acceptance: Aug 09, 2025
Date of Publishing: Dec 01, 2025
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
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