"This is the study that everyone's been waiting for," Dr. Mark Obermann of Asklepios Hospitals Schildautal in Seesen, Germany, the study's first author, told Reuters Health by phone.
Prednisone is often prescribed to cluster-headache patients in the first few days of an episode, he noted, but there have been no large randomized controlled trials to determine whether prednisone is actually effective and at what dosage.
Patients with cluster headache suffer excruciating head and face pain that can last for 15 minutes to three hours, Dr. Obermann and his colleagues explain in The Lancet Neurology. Attacks may occur every other day or up to eight times a day, and episodes can last for months.
In episodic cluster headache, episodes are interspersed with headache-free intervals lasting months to years, typically following a circadian and circannual pattern.
One placebo-controlled clinical trial found verapamil efficacious for episodic cluster headache, the authors note, but it can take 10 to 14 days to work, and must be titrated slowly so patients can tolerate it.
In the new study, investigators at 10 headache centers across Germany randomized 116 patients with episodic cluster headache to 100 mg of oral prednisone for five days and 20 mg tapering every three days, for a total of 17 days of drug exposure, or a placebo. All patients were within the first 30 days of a current pain episode. Study participants also started 40 mg of oral verapamil three times a day, titrated up to 120 mg three times a day by day 19.
During the first week, according to a modified intention-to-treat analysis in 109 patients, the 53 patients on prednisone had 7.1 attacks, on average, versus a mean of 9.5 attacks for the 56 placebo patients (P=0.002).
In each group, 71% reported 135 adverse events, most frequently headache, palpitations, dizziness and nausea with prednisone, and nausea, dizziness and headache with placebo. Two serious adverse events occurred, both in the placebo group.
Cluster headaches completely stopped after the first week of treatment in 35% of patients on prednisone versus 7% of those on placebo (P<0.001). By day 28, there was no longer any significant difference in cessation rates (61% vs. 67%, respectively).
Forty-nine percent of patients on prednisone had at least a 50% drop in the frequency of headache attacks by day seven, compared to 15% of the placebo group. By day 28, 71% of patients on prednisone and 45% of those on placebo reported a reduction of at least half in attack frequency (P=0.01).
"We decided on this particular regimen because that's actually what most headache experts would use," Dr. Obermann noted. Treatment can vary widely, he added, with some centers prescribing 500 mg of corticosteroids intravenously for five days.
"We can't really say that the 100 mg oral prednisone works better than IV or anything else, but it does work, and it's the lowest dose that's generally been used," he said. "If that's working, it's most likely that patients don't need any more than that."
The study did not have commercial funding. The researchers report ties to multiple drugmakers.
SOURCE: https://bit.ly/3okyc9k The Lancet Neurology, online November 24, 2020.
By Anne Harding
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