To the Editor We read with interest the work of Anton and colleagues1 evaluating gabapentin in the treatment of alcohol use disorder. We are concerned that the authors report a positive primary outcome even though the original preregistered primary outcome was nonsignificant, suggesting that gabapentin is not effective in the way the authors assert.
The authors report a statistically significant decrease in percentage of participants with no heavy drinking days. They define this by 2 criteria: (1) self-report of no heavy drinking days and (2) no reading on the percentage of disialo carbohydrate-deficient transferrin (%dCDT) greater than 1.7% at any point in the trial. However, in both the original preregistered outcome and the supplementary protocol, a %dCDT threshold is not part of the primary outcome definition. There was no significant difference between gabapentin and placebo using the self-report criterion. Only when the %dCDT threshold was applied did the difference between the groups become statistically significant.
Identify all potential conflicts of interest that might be relevant to your comment.
Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.
Err on the side of full disclosure.
If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.
Not all submitted comments are published. Please see our commenting policy for details.
Kleinman RA, Ostacher MJ. Changed Primary Outcome Between Trial Registration and Publication. JAMA Intern Med. Published online July 13, 2020. doi:10.1001/jamainternmed.2020.2183
Customize your JAMA Network experience by selecting one or more topics from the list below.
Create a personal account or sign in to: