Pilocarpine arm

Patients in the pilocarpine group also began treatment within 14 days of enrollment. They were given 5 mg of pilocarpine orally three times a day for 12 weeks. If they missed a dose of medication it was not made up. In this group 53 patients (73%) completed more than 85% of the treatments.1

Fewer adverse effects with ALTENS

There was no significant difference between the three highest grade adverse treatment-related events (headache, dry mouth, and blurred vision) between the two groups. Only 15 patients in the ALTENS arm reported adverse events of grade 3 or less. By contrast, 45 patients in the pilocarpine arm reported comparable adverse events.1


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Symptom improvement

For both arms of the trial, the patients’ xerostomia symptoms were assessed before treatment and at 4, 6, 9, and 15 months thereafter. The patients completed self-evaluations utilizing the University of Michigan’s Xerostomia-Related Quality of Life Scale (XeQOLS). This scale contains 15 items that measure four areas: physical functioning, pain/discomfort, personal/psychologic functioning, and social functioning. The investigators averaged all of the responses on a scale of zero to four where the higher the score, the more severe the xerostomia. Of the 96 subjects who were eligible for study analysis, those in the ALTENS arm demonstrated a slightly better quality of life than the patients in the pilocarpine group. According to the researchers: “The proportions of patients who had 20% or more improvement from their baseline XeQOLS scores were consistently higher in the ALTENS arm and the difference was significant at 15 months from randomization… Some patients in the ALTENS group demonstrated lasting response and indicated the possibility to induce salivary gland tissue regeneration.”1

The Canadian group calls for randomized, controlled placebo trials to confirm that ALTENS is as effective for the treatment of radiation-induced dry mouth as their work has demonstrated.


Bette Weinstein Kaplan is a medical writer based in Tenafly, New Jersey. 


References

1. Wong RK, Deshmukh S, Wyatt G, et al. Acupuncture-like transcutaneous electrical nerve stimulation versus pilocarpine in treating radiation-induced xerostomia: results of RTOG 0537 phase 3 study. Int J Radiat Oncol Biol Phys. 2015;92(2):220-227.

2. Wong RK, Jones GW, Sagar SM, et al. A Phase I-II study in the use of acupuncture-like transcutaneous nerve stimulation in the treatment of radiation-induced xerostomia in head-and-neck cancer patients treated with radical radiotherapy. Int J Radiat Oncol Biol Phys. 2003; 57: 472-480.

3. Wong RK, James JL, Sagar S, et al. Phase 2 results from radiation therapy oncology group study 0537: A phase 2/3 study comparing acupuncture-like transcutaneous electrical nerve stimulation versus pilocarpine in treating early radiation-induced xerostomia. Cancer. 2012; 118: 4244-4252.