Nineteen studies were included, the majority of which were uncontrolled studies or case series. Three were randomised controlled trials (RCT). Although of higher quality than the uncontrolled studies, these three trials also had methodological shortcomings. Two of the trials were not blind and the other had a total of only six patients. The results for these three RCTs are summarised below.
One double blind RCT of six migraine patients who were ergotamine overusers compared rapid withdrawal of headache drugs and 4 mg subcutaneous (SC) sumatriptan versus placebo. All sumatriptan treated patients had complete headache relief for six to 12 hours, versus none in placebo group.
One unblinded RCT compared four interventions in 200 patients with MIH due to drugs including paracetamol, aspirin, barbiturates, opiates, sedatives and muscle relaxants. The treatment groups were:
1. abrupt discontinuation of analgesics
2. abrupt discontinuation of analgesics plus amitriptyline 50 mg per day
3. continued analgesic use
4. continued analgesic use plus amitriptyline 50 mg per day.
At four weeks the most effective intervention was abrupt withdrawal plus amitriptyline with 72% reduction in HI. Abrupt withdrawal was more effective (60% reduction in HI) than continued use of usual meds, and amitriptyline (45% reduction in HI) which was better than continued use of usual meds alone (25% reduction in HI). There was a high dropout rate (62%) in both abrupt withdrawal groups therefore the reported benefit of this treatment is based on a small minority of the patients.
One unblinded RCT compared naproxen 500 mg twice daily with symptomatic medications only (antiemetics, simple analgesics, hydration) in 22 patients with MIH due to ergotamine overuse. The naproxen group had less headache over eight days (p<0.001), however at follow-up there was no difference between groups for HI. Three patients on naproxen withdrew due to adverse effects.
Comment
This does not amount to a significant body of evidence. Few trials, relatively poor quality, and few patients.