We recently read with great interest the article titled “Opicapone to Treat Early Wearing‐Off in Parkinson's Disease Patients: The Korean ADOPTION Trial” 1 published in your esteemed journal. This study offers detailed insights into the potential benefits of opicapone, a catechol‐O‐methyltransferase inhibitor, for managing early wearing‐off symptoms in patients with Parkinson's disease (PD), and provides valuable data comparing its efficacy to that of additional doses of levodopa. Although we commend the authors for their contributions, we believe there are aspects of the study that warrant further discussion and improvement.
First, there is a concern regarding sample selection bias. Although the study initially recruited 193 patients, it concluded with a smaller sample size for the final analysis, potentially lacking sufficient statistical power to detect differences in treatment effects. Moreover, the exclusive inclusion of patients with early wearing‐off symptoms of PD may limit the generalizability of the results to those with more severe or advanced symptoms. Future studies should consider conducting a priori power calculations 2 to determine appropriate sample sizes and include a broader range of disease stages. This approach would enhance the representativeness and generalizability of the findings.
Second, the 4‐week duration of the study is relatively brief, potentially insufficient for fully assessing the long‐term efficacy and safety of the drug. We recommend extending the study duration to include long‐term follow‐up and multiple assessment points. This would provide more comprehensive data for clinical decisions.
Third, regarding the experimental design, the absence of a placebo control group represents a significant limitation. Without such a control, it is difficult to distinguish the effects of opicapone from placebo effects or other external variables, potentially leading to an overestimation of the drug's benefits. Future studies should include a placebo control group and employ double‐blind trial designs 3 to ensure a more accurate assessment of opicapone's efficacy in treating early wearing‐off symptoms in PD patients, thereby providing more robust clinical evidence.
Furthermore, the study is impacted by the presence of missing data. The authors have attempted to mitigate this issue by utilizing a complete analysis set and analysis of covariance models that include only patients with available data in the descriptive statistical analysis. However, to further address concerns related to missing data, we recommend incorporating advanced statistical techniques such as multiple imputation and sensitivity analyses. 4 Implementing these methods would not only enhance the robustness of the study results but also increase the credibility of the findings.
Finally, in emergency management, we suggest early identification, continuous monitoring, optimized drug therapy, and opicapone incorporation for PD. Establishing a multidisciplinary team approach and patient education programs can improve disease management for patients and their families, and can significantly enhance treatment outcomes and quality of life.
We appreciate the authors' contributions to advancing the treatment of PD. We look forward to future studies that address these issues, as they will help refine the management of PD patients.
Author Roles
(1) Research Project: A. Conception, B. Organization, C. Execution; (2) Statistical Analysis: A. Design, B. Execution, C. Review and Critique; (3) Manuscript Preparation: A. Writing of the First Draft, B. Review and Critique.
S.L.:1A, 1C, 2A, 2B, 2C, 3B
X.G.: 1C, 2C, 3A
Z.Z.: 3A
Disclosures
Ethical Compliance Statement: We confirm that the approval of an institutional review board was not required for this work. We confirm that informed patient consent was not required for this work. We confirm that we have read the journal's position on issues involved in ethical publication and affirm that this work is consistent with those guidelines.
Funding Sources and Conflicts of Interest: This work was supported by People’s Livelihood Science andTechnology Special‐Social Development Topic (No.2021‐004‐SF0‐0079), and Gansu Province Excellent Doctor Fund Project (23JRRA1320).
Financial Disclosures for the Past 12 Months: The authors declare that there are no additional disclosures to report.
Acknowledgment
None.
Sheng Li and Xiaolong Guo are co‐first authors.
Data Availability Statement
Data sharing not applicable to this article as no datasets were generated or analysed during the current study.
References
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Data sharing not applicable to this article as no datasets were generated or analysed during the current study.