‘Encouraging’ results
Commenting on the study, Brian E. McGeeney, MD, a neurologist at the John R. Graham Headache Center, Brigham and Women’s Faulkner Hospital, Boston, noted that the PGI-I is an “easy-to-understand” outcome that has been widely used in headache medicine.
“Patient-assessed outcomes have become increasingly important and are an important complement to other outcomes,” said Dr. McGeeney, who was not involved in the research. However, a disadvantage is that “it is entirely subjective and may or may not reflect a change on other outcome measures that reflect the disorder itself,” he said.
“It can be difficult to demonstrate how much usefulness a treatment has with the helpful but simple outcome measures that are seen in CGAL and CGAR,” Dr. McGeeney added. “This is due to the nature of cluster headache and not to any methodological shortcomings of those studies.”
He said this is a core problem in general with cluster headache studies, “of which there are very few.”
In addition, CGAR only included episodic cluster headache, and the study period was relatively short; and CGAL only explored one cluster period per patient, Dr. McGeeney noted.
The current research attempts to provide insight that was previously unavailable, he said. “Many headache medicine clinical trial results reflect only one episode, and in general, we infer repeated usefulness – although it is not demonstrated in clinical trials,” said Dr. McGeeney.
“In this recent presentation, the authors attempt to go further and demonstrate some consistency across multiple cluster periods. The results are encouraging and what one might expect,” he said. However, “the small numbers and ad hoc nature preclude much inference from this study alone.”
Dr. Plato has received honoraria for speaking from Allergan, Amgen/Novartis, and Eli Lilly. He has also received research grants and support from Electrocore and Teva. Dr. McGeeney has consulted for Upsher-Smith and Theranica.
A version of this article originally appeared on Medscape.com.