BACKGROUND:Radiation therapy to the head and neck region can be an effective form of treatment for malignancies. Unfortunately damage to salivary glands may occur. Treatment of resultant dry mouth is at present very poor. The purpose of this pilot study was to investigate whether pilocarpine dissolved in artificial saliva and administered in a mouth spray would be effective in relieving such symptoms. METHODS:Twenty-three patients with radiation induced hyposalivation were recruited for this randomized, double-blind investigation. Subjects were randomly allocated to placebo or control medicaments used for eight weeks. All subjects were evaluated for the severity of their xerostomia associated symptoms prior to administration of the spray and again eight weeks later. RESULTS: The questionnaire and the visual analogue scale did not reveal any improvements in the dry mouth symptoms between cases and controls. Side-effects were reported among cases, mostly mild and tolerable. All patients taking pilocarpine (with base salivary flow rates > 0ml/min) demonstrated improvement in stimulated and unstimulated salivary flow rates. Candida counts decreased among the cases and controls although decrease among the cases was much greater. CONCLUSIONS: The results obtained indicate that provided residual functioning salivary tissue exists, pilocarpine used as formulated is effective and warrants further investigation.
RCT Entities:
BACKGROUND: Radiation therapy to the head and neck region can be an effective form of treatment for malignancies. Unfortunately damage to salivary glands may occur. Treatment of resultant dry mouth is at present very poor. The purpose of this pilot study was to investigate whether pilocarpine dissolved in artificial saliva and administered in a mouth spray would be effective in relieving such symptoms. METHODS: Twenty-three patients with radiation induced hyposalivation were recruited for this randomized, double-blind investigation. Subjects were randomly allocated to placebo or control medicaments used for eight weeks. All subjects were evaluated for the severity of their xerostomia associated symptoms prior to administration of the spray and again eight weeks later. RESULTS: The questionnaire and the visual analogue scale did not reveal any improvements in the dry mouth symptoms between cases and controls. Side-effects were reported among cases, mostly mild and tolerable. All patients taking pilocarpine (with base salivary flow rates > 0ml/min) demonstrated improvement in stimulated and unstimulated salivary flow rates. Candida counts decreased among the cases and controls although decrease among the cases was much greater. CONCLUSIONS: The results obtained indicate that provided residual functioning salivary tissue exists, pilocarpine used as formulated is effective and warrants further investigation.