ORAL PILOCARPINE FOR POSTIRRADIATION XEROSTOMIA IN PATIENTS WITH HEADAND NECK-CANCER

Background and Methods. We evaluated pilocarpine hydrochloride for the treatment of radiation-induced xerostomia, a common complication of i rradiation of the head and neck. A prospective, randomized, double-bli nd, placebo-controlled trial was undertaken to test the safety and eff icacy of pilocarpine, particularly in reversing the decrease in the pr oduction of saliva and other manifestations of xerostomia. Patients re ceived either placebo or pilocarpine (5 mg or 10 mg orally three times a day) for 12 weeks and were evaluated at base line and every 4 weeks . Results. We studied 207 patients who had each received greater-than- or-equal-to 4000 cGy of radiation to the head and neck. In the patient s receiving the 5-mg dose of pilocarpine, oral dryness improved in 44 percent, as compared with 25 percent of the patients receiving placebo (P = 0.027). There was overall improvement in 54 percent of the 5-mg group as compared with 25 percent of the placebo group (P = 0.003), an d 31 percent of the 5-mg group had improved comfort of the mouth and t ongue, as compared with 10 percent of the placebo group (P = 0.002). S peaking ability improved in 33 percent of the 5-mg group as compared w ith 18 percent of the placebo group (P = 0.037). Saliva production was improved, but it did not correlate with symptomatic relief. There wer e comparable improvements in the group receiving the 10-mg dose. The p rimary adverse effect was sweating, in addition to other minor choline rgic effects. Six and 29 percent of the patients in the 5-mg and 10-mg groups, respectively, withdrew from the study because of adverse effe cts. There were no serious adverse effects related to pilocarpine. Con clusions. Pilocarpine improved saliva production and relieved symptoms of xerostomia after irradiation for cancer of the head and neck, with minor side effects that were predominantly limited to sweating.