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. Author manuscript; available in PMC: 2018 Sep 1.
Published in final edited form as: Cancer Treat Rev. 2017 Jul 18;59:79–92. doi: 10.1016/j.ctrv.2017.07.003

Table 1.

Cholinergic agonists for radiotherapy-induced xerostomia in patients with head and neck cancer: randomized-controlled studies

Study No. of patients
Doses & therapy duration Results (drug vs. placebo)
Total Drug Placebo
Johnson et al., 1993 (31) 207 142 65 Pilocarpine,
5 mg t.i.d. for 12 weeks (73 patients)
or
10 mg t.i.d. for 12 weeks (69 patients)
  • improvement in overall condition of xerostomia: 53.5% vs. 42.9% vs. 25%, p=0.010

  • improvement in saliva production at weeks 4 and 8; did not correlate with symptomatic relief

  • withdrawal from the study (adverse experience): 5.5% vs. 29% vs. 3.1%

  • no serious drug-related adverse events

LeVeque et al., 1993 (32) 162 75 87 Pilocarpine,
Weeks 1–4: 2.5 mg t.i.d.
Weeks 5–8: 5 mg t.i.d.
Weeks 9–12: 10 mg t.i.d.
  • improvement in overall condition of xerostomia: 48.7% vs. 28.1%, p=0.015

  • improvement in whole saliva and unstimulated parotid saliva flow

  • withdrawal from the study (adverse experience, lack of efficacy): 14.67% vs. 13.75%

  • no serious drug-related adverse events

  • best results: doses >2.5 mg t.i.d., continuous treatment for 8–12 weeks

Chambers et al., 2007 (39)
  • global xerostomia improvement: 47.4% vs. 33.3%, p=0.0162

  • improvement in unstimulated saliva flow: p<0.0001 vs. p=0.942

 Study 003 284 139 145 Cevimeline,
30 mg t.i.t. for 12 weeks
  • withdrawal from the study (adverse experience): 14.6% vs. 3.5%

  • treatment-related adverse effects: 41.6% vs. 17.4% (mild to moderate)

 Study 004 286 139 147  If no improvement in dry mouth: escalation of dose to 45 mg t.i.d. at week 6
  • global xerostomia improvement: 48.9% vs. 47.6%, p=0.9565

  • improvement in unstimulated saliva flow: p=0.0002 vs. p=0.0928

  • withdrawal from the study (adverse experience): 13.9% vs. 5.5%

  • treatment-related adverse effects: 38% vs. 18.6% (mild to moderate)