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Original ArticleOpen Access
Randomized Double Bling, Placebo-Controlled Study of Pilocarpine Administered During Head and Neck Irradiation to Reduce Xerostomia
Purpose : Pilocarpine hydrochloride administered during head and neck irradiation
was evaluated for its ability to relieve xerostomia and its adverse effects.
Material and Method : A total of 60 head and neck cancer patients were enrolled in
a randomized, double blind, placebo -controlled trial. Each patient had both parotid glands
treated with a radiation dose of at least 50 Gy. Patients received jelly containing pilocarpine
or placebo 5.0 mg (1 cc.) tid at meal times during radiation. Pilocarpine was administered
beginning on the first day of radiation and continued until radiation was completed.
Patients were evaluated for symptomatic relief by responding to questionnaires using a
Visual Analogue Scale (VAS). Questionnaires measured relief of oral dryness, oral discomfort,
difficulty in chewing and swallowing, speaking, and sleeping. Evaluation was conducted
preradiation as a baseline, weekly during radiation and monthly until 6 months after
radiation was completed.
Results : The baseline characteristics, disease and radiation technique including
field arrangement and total dose, were not significantly different between the two groups.
There was no statistically significant subjective difference in xerostomia, including
oral dryness, oral discomfort, inability to chew and swallow, speak and sleep,
during and postradiation between the two groups. The adverse effects were non-specific
symptoms such as nausea, vomitting, dizziness, urinary frequency, palpitation, sweating
and tearing. The adverse effects during radiation and postradiation were not significantly
different between the . two groups.
Conclusion : It was concluded that pilocarpine hydrochloride administered during
head and neck irradiation produced subjectively insignificant benefit in relieving xerostomia
with acceptable side effects.
เธ—
Key word : Pilocarpine, Xerostomia, Radiation Therapy, Head and Neck, Cancer
was evaluated for its ability to relieve xerostomia and its adverse effects.
Material and Method : A total of 60 head and neck cancer patients were enrolled in
a randomized, double blind, placebo -controlled trial. Each patient had both parotid glands
treated with a radiation dose of at least 50 Gy. Patients received jelly containing pilocarpine
or placebo 5.0 mg (1 cc.) tid at meal times during radiation. Pilocarpine was administered
beginning on the first day of radiation and continued until radiation was completed.
Patients were evaluated for symptomatic relief by responding to questionnaires using a
Visual Analogue Scale (VAS). Questionnaires measured relief of oral dryness, oral discomfort,
difficulty in chewing and swallowing, speaking, and sleeping. Evaluation was conducted
preradiation as a baseline, weekly during radiation and monthly until 6 months after
radiation was completed.
Results : The baseline characteristics, disease and radiation technique including
field arrangement and total dose, were not significantly different between the two groups.
There was no statistically significant subjective difference in xerostomia, including
oral dryness, oral discomfort, inability to chew and swallow, speak and sleep,
during and postradiation between the two groups. The adverse effects were non-specific
symptoms such as nausea, vomitting, dizziness, urinary frequency, palpitation, sweating
and tearing. The adverse effects during radiation and postradiation were not significantly
different between the . two groups.
Conclusion : It was concluded that pilocarpine hydrochloride administered during
head and neck irradiation produced subjectively insignificant benefit in relieving xerostomia
with acceptable side effects.
เธ—
Key word : Pilocarpine, Xerostomia, Radiation Therapy, Head and Neck, Cancer
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