Twelve studies (n=526) were included in the review: 3 RCTs (n=201), 1 randomised crossover trial (n=49), 4 CCTs (n=180) and 4 non-randomised crossover trials (n=96).
Management of acute attacks.
Oxygen (7 L/minute for 15 minutes) delivered by face mask was evaluated in one small, non-randomised crossover trial. The results indicated that 6 of the 19 patients treated reported an improvement.
Sumatriptan was investigated in a randomised crossover trial. When sumatriptan 6 mg was given subcutaneously, there was complete or nearly complete relief of headache and a reduction of conjunctival injection in 80% of the patients. A further study was then conducted to evaluate the dosage: sumatriptan 6 mg was compared with 12 mg subcutaneously. There appeared to be no advantage in the higher dose in terms of relief of symptoms, and more adverse reactions were noted.
Dihydroergotamine nasal spray was investigated in one small CCT. Half of the patients improved with treatment, but half also improved in the placebo group.
Intranasal capsaicin was evaluated in one RCT and one CCT. There were no data available on individual patients from the RCT. Six of the 19 patients with chronic cluster headache in the CCT reported either no attacks or a 50% reduction in pain.
Prophylactic management.
Pizotifen was evaluated in one non-randomised crossover trial. The results showed that 6 out of 28 patients indicated complete remission of their headaches, while a further 10 showed a 50% improvement.
Prednisolone was assessed in one non-randomised crossover trial. The outcomes provided in the trial were not defined clearly and there were insufficient data on the number of patients that responded to treatment.
Lithium and verapamil were assessed in a non-randomised crossover trial. The results indicated that half of the patients reported an improvement with verapamil, while 9 out of 24 patients reported an improvement with lithium.
Leuprolide was assessed in a CCT. Twenty-six out of 39 patients reported a global improvement in their headaches.
Melatonin was evaluated in one small RCT. The results showed that 5 out of 10 patients with episodic cluster headache reported an improvement, but neither of the patients with chronic headache reported any relief.
Lithium was assessed in one CCT. The results showed that 8 out of 13 patients showed an improvement of at least 50%.