Kosin Medical Journal

Original article

Clinical efficacy and safety of autologous serum intramuscular injection in patients with mild-to-moderate atopic dermatitis: a prospective, open-label, uncontrolled study: Gil-Soon Choi, Jong Bin Park, Young-Ho Kim, Hee-Kyoo Kim; Kosin Med J. 2024;39(1):51-59. Published online March 19, 2024; DOI: https://doi.org/10.7180/kmj.24.101

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Background
Autologous blood therapy (ABT) has been used to treat atopic dermatitis (AD) for over a century, even though evidence supporting its efficacy is lacking. We aimed to investigate the effectiveness and safety of autologous serum intramuscular injection (ASIM), which is a modified form of ABT, in treating mild-to-moderate AD.
Methods
This study was a 12-week, open-label, prospective, uncontrolled trial. Following a 4-week run-in period, 22 out of 25 screened patients received ASIM once a week for 4 weeks in conjunction with standard treatment. The primary outcome measure was the Eczema Area and Severity Index (EASI), while the secondary outcomes included the Scoring Atopic Dermatitis (SCORAD) score, Dermatologic Life Quality Index (DLQI), and patient ratings of pruritus, sleep difficulty, disease status, and treatment effectiveness. Safety parameters were also assessed.
Results
EASI scores showed a non-statistically significant trend toward improvement during ASIM intervention. Patients with at least a 50% improvement in the EASI score at 4 weeks were older and had lower peripheral eosinophil counts (p<0.05). Secondary endpoints, including the SCORAD score, pruritus, sleep difficulty, and DLQI, demonstrated statistically significant improvements at week 4 compared to baseline (p<0.05). No significant adverse reactions were observed.
Conclusions
This pioneering study suggests that repeated ASIM may improve the clinical symptoms of mild-to-moderate AD, particularly in terms of pruritus and overall quality of life. However, further research with a larger sample size is required to establish the clinical significance of these findings.

Citations

Citations to this article as recorded by

What are the clinical usefulness and scientific value of intramuscular injection of autologous serum (autologous serum therapy) in patients with atopic dermatitis?
Dong-Ho Nahm
Kosin Medical Journal.2024; 39(1): 1. CrossRef

Review article

How to conduct well-designed clinical research: Da Jung Kim, Song Yi Kil, Jongwon Son, Ho Sup Lee; Kosin Med J. 2022;37(3):187-191. Published online September 27, 2022; DOI: https://doi.org/10.7180/kmj.22.122

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Abstract PDF PubReader ePub

Clinicians and healthcare decision-makers conduct their clinical practice based on the results of clinical trials. However, some health problems remain unresolved; in such cases, further research is required. To ensure reliable research results, it is important to understand the study design and conduct well-designed clinical trials. Many study designs can be chosen within the two broad categories of observational and interventional. Clinical studies have a variety of designs, including case series, case-control, cross-sectional, and prospective and retrospective cohort studies. Well-designed clinical studies can clarify important differences between treatment options and provide data on long-term drug efficacy and safety. Interpreting the results of clinical trials can be difficult because weaknesses in research design, data collection methods, analytic methods, and reporting can compromise their value and usefulness. However, although randomized controlled trials are limited owing to ethical and practical issues, they are optimal for investigating the effects of therapy and establishing causality. Here we present an overview of different clinical research designs and review their advantages and limitations.

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