Background and Methods We evaluated pilocarpine hydrochloridefor the treatment of radiation-induced xerostomia, a commoncomplication of irradiation of the head and neck. A prospective,randomized, double-blind, placebo-controlled trial was undertakento test the safety and efficacy of pilocarpine, particularlyin reversing the decrease in the production of saliva and othermanifestations of xerostomia. Patients received either placeboor pilocarpine (5 mg or 10 mg orally three times a day) for12 weeks and were evaluated at base line and every 4 weeks.
Results We studied 207 patients who had each received 4000cGy of radiation to the head and neck. In the patients receivingthe 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 ofthe 5-mg group as compared with 25 percent of the placebo group(P = 0.003), and 31 percent of the 5-mg group had improved comfortof the mouth and tongue, as compared with 10 percent of theplacebo group (P = 0.002). Speaking ability improved in 33 percentof the 5-mg group as compared with 18 percent of the placebogroup (P = 0.037). Saliva production was improved, but it didnot correlate with symptomatic relief. There were comparableimprovements in the group receiving the 10-mg dose. The primaryadverse effect was sweating, in addition to other minor cholinergiceffects. Six and 29 percent of the patients in the 5-mg and10-mg groups, respectively, withdrew from the study becauseof adverse effects. There were no serious adverse effects relatedto pilocarpine.
Conclusions Pilocarpine improved saliva production and relievedsymptoms of xerostomia after irradiation for cancer of the headand neck, with minor side effects that were predominantly limitedto sweating.
Source Information
From the Department of Otolaryngology, University of Pittsburgh, Pittsburgh (J.T.J.); the University of Kentucky, Lexington (G.A.F.); Loma Linda University, Loma Linda, Calif. (W.J.N.); the Clinical Investigations and Patient Care Branch, National Institute of Dental Research, Bethesda, Md. (I.H.V., P.C.F.); Pharmaco Dynamics Research, Austin, Tex. (D.N.); and MGI Pharma, Minneapolis (C.C.M., S.C.G.).
Address reprint requests to Dr. Johnson at the Department of Otolaryngology, University of Pittsburgh School of Medicine, 203 Lothrop St., Suite 500, Pittsburgh, PA 15213.
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4000 cGy of radiation to the head and neck. In the patients 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), and 31 percent of the 5-mg group had improved comfort of the mouth and tongue, as compared with 10 percent of the placebo group (P = 0.002). Speaking ability improved in 33 percent of the 5-mg group as compared with 18 percent of the placebo group (P = 0.037). Saliva production was improved, but it did not correlate with symptomatic relief. There were comparable improvements in the group receiving the 10-mg dose. The primary adverse effect was sweating, in addition to other minor cholinergic effects. Six and 29 percent of the patients in the 5-mg and 10-mg groups, respectively, withdrew from the study because of adverse effects. There were no serious adverse effects related to pilocarpine. 
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