Natural history of patients with symptomatic severe carotid sinus hypersensitivity is not clearly known. In order to evaluate the effectiveness of pacing therapy in these patients we performed a randomized treatment/no-treatment prospective study in 35 patients. They were randomly assigned to two groups: 19 patients received no therapy, 16 patients received a VVI (#11) or DDD (#5) pacemaker implant. During the 8.4 +/- 4.3 month follow-up period patients receiving no therapy had recurrence of syncope in 9 cases (47%) and minor symptoms in 13 (68%); at the 16th month, actuarial curve showed absence of syncope in 36% of patients and of any symptoms in 30%. During the 7.2 +/- 4.1 month follow-up period, the patients receiving the pacemaker implant had no recurrence of syncope, minor symptoms in three (19%); at the 16th month, actuarial curve showed absence of syncope in 100% of patients and of any symptoms in 78%. During follow-up, 12 patients in no-treatment group received a pacemaker implant because of the recurrence of severe symptoms; successively they had a strong reduction of symptoms. In conclusion, this study definitively demonstrates that patients with severe symptomatic carotid sinus hypersensitivity had a high rate of recurrence of spontaneous symptoms and that in these patients cardiac pacing is a useful therapy.