This article requires a subscription to view the full text. If you have a subscription you may use the login form below to view the article. Access to this article can also be purchased.
To the Editor:
The editorial by Drs. Chadwick and Privitera1 that accompanied our report of a placebo-control monotherapy trial of oxcarbazepine for partial seizures2 carries forward the recent spirited discussion in the literature about the design and importance of monotherapy studies in epilepsy.3-5 However, we feel compelled to respond to their assertions concerning the clinical value and ethics of our study.
Was our study clinically valuable? Absolutely. Because of its placebo-controlled design, our study convincingly established the antiseizure activity of oxcarbazepine. This demonstration has significant value because proof of efficacy is justifiably essential for a drug to be licensed in the United States. In addition, our study showed that oxcarbazepine can be safely titrated over one day and that its antiseizure effects begin rapidly. This finding is meaningful to clinicians because of the paucity of other controlled studies that show antiepileptic drug (AED) efficacy in an acute setting.
Was our study ethical? The principal investigators, co-investigators, and sub-investigators, all of whom were associated with leading academic medical centers, as well as their institutional review boards and their clinical research center scientific advisory boards (where applicable) would not have otherwise performed or approved this study. However, Chadwick and Privitera argue that our study compromised two of Beauchamp and Childress’ principles of medical ethics—beneficence and nonmaleficence6—and their balance, or equipoise.7 We strongly disagree. Equipoise existed in our study because beneficence for oxcarbazepine had not been previously established, in our opinion. Yes, oxcarbazepine is indeed widely licensed for the treatment of epilepsy in Europe and is structurally similar to carbamazepine. But in this era of evidence-based medicine, how convincing is the previously published data that oxcarbazepine is effective?
As clinicians, we agree that comparative monotherapy trials, such as the widely influential Veterans Administration Cooperative Study, …
AAN Members
We have changed the login procedure to improve access between AAN.com and the Neurology journals. If you are experiencing issues, please log out of AAN.com and clear history and cookies. (For instructions by browser, please click the instruction pages below). After clearing, choose preferred Journal and select login for AAN Members. You will be redirected to a login page where you can log in with your AAN ID number and password. When you are returned to the Journal, your name should appear at the top right of the page.
AAN Non-Member Subscribers
Purchase access
Letters: Rapid online correspondence
REQUIREMENTS
You must ensure that your Disclosures have been updated within the previous six months. Please go to our Submission Site to add or update your Disclosure information.
Your co-authors must send a completed Publishing Agreement Form to Neurology Staff (not necessary for the lead/corresponding author as the form below will suffice) before you upload your comment.
If you are responding to a comment that was written about an article you originally authored:
You (and co-authors) do not need to fill out forms or check disclosures as author forms are still valid
and apply to letter.
Submission specifications:
- Submissions must be < 200 words with < 5 references. Reference 1 must be the article on which you are commenting.
- Submissions should not have more than 5 authors. (Exception: original author replies can include all original authors of the article)
- Submit only on articles published within 6 months of issue date.
- Do not be redundant. Read any comments already posted on the article prior to submission.
- Submitted comments are subject to editing and editor review prior to posting.
