By Antonella Macerollo
For January 2021, we have selected: M. Obermann et al. Safety and efficacy of prednisone versus placebo in short-term prevention of episodic cluster headache: a multicentre, double-blind, randomised controlled trial. Lancet Neurol 2020, November 24, 2020. https://doi.org/10.1016/S1474-4422(20)30363-X.
Cluster headache is very common disorder in general neurology clinical practice and it is a challenging disease to treat. Preventive treatments for clusters may require a few days before becoming effective. Therefore, clinicians may try a steroid, such as prednisone, during this interval of time until the preventive agent shows benefit. However, this approach has never been investigated in a systematic way.
Our paper of the month is multicentre, randomised, double-blind, placebo-controlled trial involving ten specialised headache centres in Germany. The researchers recruited 116 patients between 2013 and 2018.
Inclusion criteria were age between 18 and 65 years and an active pain episode lasting no more than 30 days at the time of recruitment.
Participants received 100 mg oral prednisone for 5 days followed by tapering of 20 mg every 3 days or matching placebo (17 days total exposure). Patients were included in one of these two groups through computer-generated randomisation.
All patients received oral verapamil as preventive medication, starting with 40 mg three times daily and increasing to 120 mg three times daily by day 19; patients then continued with this dose of verapamil throughout the study.
The primary outcome of the study was to compare the mean number of attacks within the first week of treatment with prednisone compared with placebo.
The mean number of attacks was 7.1 within the first week in the prednisone group compared with 9.5 in the placebo group (difference –2.4 attacks, 95% CI –4.8 to –0.03; p=0.002). Adverse events were equally distributed in both groups.
The study registered 270 adverse events: in the prednisone group, 37 (71%) of 52 patients reported 135 adverse events (most common were headache, palpitations, dizziness, and nausea) and in the placebo group, 39 (71%) of 55 patients had 135 adverse events (most common were nausea, dizziness, and headache).
In conclusion, our research paper of the month supports the use of prednisone as a short term treatment for attacks of cluster headache together with verapamil as longer term preventive treatment. However, there is still a need to study the use of prednisone in conjunction with other preventive treatments, that might be required in patients who are not able to take Verapamil.