Post-radiation severe xerostomia relieved by pilocarpine: a prospective French cooperative study.
OBJECTIVE
The aim of the study was: (1) to confirm the action of pilocarpine hydrochloride (Salagen) against xerostomia: (2) to correlate the response to dose/volume radiotherapy parameters.


METHODS
From June 1995 to February 1996, 156 patients with severe radiation induced xerostomia received pilocarpine hydrochloride orally. IS mg per day with a 5 mg optional increase at S weeks up to a daily dose of 25 mg beyond 9 weeks.


RESULTS
One hundred and forty five patients are fully evaluable. Treatment compliance was 75%. Thirty eight patients (26%) stopped treatment before week 12 for acute intolerance (sweating, nausea, vomiting) or no response. No severe complication occurred. Ninety ses en patients (67%) reported a significant relief of symptoms of xerostomia at 12 weeks. Within 12 weeks, the size of the subgroup ith normal food intake almost doubled (13-24 patients) while the size of the subgroup with (nearly) impossible solid food ingestion decreased by 38% (47 vs. 29 patients). The impact on quality of life was considered important or very important by 77% of the responders.


CONCLUSIONS
No difference was found according to dose/volume radiotherapy parameters suggesting that oral pilocarpine hydrochloride: (1) acts primarily by stimulating minor salivary glands: (2) can be of benefit to patients suffering of severe xerostomia regardless of radiotherapy dose/volume parameters: (3) all responders are identified at 12 weeks.
Horiot
J C
JC
Radiation Therapy Department, Centre Georges-François Leclerc, Dijon, France.
Lipinski
F
F
Schraub
S
S
Maulard-Durdux
C
C
Bensadoun
R J
RJ
Ardiet
J M
JM
Bolla
M
M
Coscas
Y
Y
Baillet
F
F
Coche-Dequéant
B
B
Urbajtel
M
M
Montbarbon
X
X
Bourdin
S
S
Wibault
M
M
Alfonsi
M
M
Calais
G
G
Desprez
P
P
Pene
F
F
Lapeyre
M
M
Vinke
J
J
Maral
J
J
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D018721:Muscarinic Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D010862:Pilocarpine / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D011832:Radiation Injuries / Q000188:drug therapy* / Q000209:etiology; D011878:Radiotherapy / Q000009:adverse effects; D012463:Saliva / Q000378:metabolism; D012469:Salivary Glands / Q000187:drug effects / Q000378:metabolism / Q000528:radiation effects*; D012720:Severity of Illness Index; D014987:Xerostomia / Q000188:drug therapy* / Q000209:etiology
D018721:Muscarinic Agonists; D010862:Pilocarpine