Prednisone is effective as an initial short-term therapy for episodic cluster headaches, according to results from a prospective, randomized, controlled trial described in an abstract featured as part of the 2020 AAN Science Advances.
The findings could help reassure clinicians and patients on the use of prednisone for these headaches, said Mark Obermann, MD, professor of neurology at Asklepios Hospitals in Seesen, Germany.
"Even though prednisone is widely used, treating physicians were never quite sure on whether it actually works or not, so that some uncertainty always remained, and there was a lively discussion among headache specialists and general physicians on whether prednisone should be used or not in cluster headache," Dr. Obermann said. Patients, not distinguishing between short- and long-term use, can also have major concerns about prednisone's side effects, and these findings could help alleviate those concerns, he said.
Researchers enrolled 118 patients, 18- to 65-years-old; 109 were included in the analysis of intent-to-treat patients. Fifty-three patients were randomized to receive prednisone and 56 to placebo. Patients in the prednisone group received 100 mg of oral prednisone for five days, and then they were tapered by 20 mg every three days. This was done in parallel with an increasing dose of verapamil for maintenance, starting with 40 mg three times a day.
In the first week, the average number of cluster headache attacks in the prednisone group was 7.1, compared with 9.5 in the placebo group, a significant difference (p=0.02). Researchers found that 17 patients, or 34 percent, in the prednisone group reported a complete cessation of their cluster headaches after the first week, compared to just four (7.4 percent), in the placebo group. The researchers reported a reduction of at least 50 percent in headache attacks in 25 patients (49 percent) who were receiving prednisone, compared with eight (14.5 percent) receiving placebo (p<0.01). Researchers observed no relevant side effects, Dr. Obermann said.
"The main effect is the establishment of treatment certainty for patients as well as for physicians," he said. "This will reassure prednisone as a gold standard for the short-term prevention of episodic cluster headache."
He said a lack of evidence had also led to some "confusion and concern" about the use of prednisone, with fear of side effects without proof of benefit. A major question, he said, was the dosage that is needed and the duration of treatment.
"We tried to solve these uncertainties by introducing a strict dosage regimen, and thus get rid of all the proposed dosages ranging from 100 mg to 1,000 mg per day applied orally or IV," he said.
He said that diabetic patients might need close blood-sugar monitoring during treatment, but beyond that, he doesn't see a need for reservations in treating these patients with prednisone for short-term benefit until preventive treatment becomes effective.
Commenting on the abstract, Matthew S. Robbins, MD, FAAN, associate professor of neurology specializing in headache at Weill Cornell Medicine, said the trial replicated what is done in the real world with respect to using steroids as a kind of bridge therapy before preventive medication begins to work, and produced affirming results, including its findings of no relevant side effects.
"This abstract brings results that reinforce that our longstanding approach in managing patients with cluster headache with a short-term preventive treatment that is valid in a randomized trial," he said.
His group has found that greater occipital nerve injection with steroid is also an effective short-term strategy, although those on oral steroids generally did better. But the injection could be a better option in certain patients, he said.
"Of course, we all worry about rare adverse events with steroid bursts that would take a huge sample size to potentially uncover—such as avascular necrosis of the hip," he said. "Patients who could be at a particular risk of such adverse effects from steroids, such as people with diabetes or osteoporosis, would be better candidates for an alternative treatment like a greater occipital nerve injection with a steroid."
Disclosures: Dr. Obermann has received scientific support, travel support, and/or honoraria from Biogen Idec, Novartis, Sanofi/Genzyme, Pfizer, Teva, Lilly, Schwarz, and Heel. He has received research grants from Allergan, Electrocore, Heel, and the German Ministry for Education and Research. Dr. Robbins had no relevant disclosures.
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AAN Abstract 4645: Obermann M, Holle D. Prednisone in short-term prevention of episodic cluster headache.