A Double-Blind, Placebo-Controlled, Crossover, Study to Evaluate the Efficacy of Subcutaneous Sumatriptan in the Treatment of Atypical Facial Pain

Abstract

A double-blind, placebo-controlled crossover study was undertaken to assess the efficacy and tolerability of sumatriptan in patients with atypical facial pain. Patients were aged 18-65 years and had at least a 6 months history of atypical facial pain. A total of 19 patients were recruited and assessed for pain scores (total, sensory and affective) by using a short form McGill pain questionnaire preinjection and at 60 and 120 minutes after subcutaneous injection of sumatriptan (6mg) or placebo. Safety and tolerability was assessed by recording adverse events during and after the injection. One patient received only one treatment since her pain symptoms resolved after the first treatment. Rest of the patients returned to the clinic 3-6 weeks later and received alternate treatment for atypical facial pain in the same fashion as on the first occasion. Treatment of patients with sumatriptan produced significant relief in sensory, affective and total pain at 120 minutes postinjection (P <.05). Sumatriptan failed to produce a significant reduction in sensory and total pain scores at 60 minutes following treatment, however the result was statistically significant for the affective pain score (P <.05). No death or other serious adverse events were reported. No patient was withdrawn from the study due to an adverse event. However, all the patients treated with sumatriptan experienced one or more adverse events. The most common reported adverse symptoms during the sumatriptan treatment period were injection site reactions, headache, feeling of heaviness, warm or hot sensation and disorders of mouth or tongue. However, most of these side effects were mild and transient. In conclusion, this study points towards some beneficial effect of a single subcutaneous injection of sumatriptan in the treatment of atypical facial pain. However, this data is not sufficient to suggest the clinical utility of subcutaneous sumatriptan (6mg) for the management of atypical facial pain. Further studies are necessary to test the effects of prolonged subcutaneous and oral multiple dose administration of sumatriptan for the treatment of atypical facial pain.

Key Words:

• Atypical facial pain
• sumatriptan
• efficacy
• safety
• double-blind trial