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Irrigation of the salivary gland using a corticosteroid is one of the most successful approaches to improving xerostomia in patients with Sjögren’s syndrome, yielding longlasting effects associated with minimal side effects.1 However, the treatment procedures are complicated, and the extent of improvement in salivary function is inversely related to the clinical severity of the disease, with the patients with most advanced disease not responding to the treatment.
Recently, cevimeline hydrochloride hydrate (Evoxac or Saligren) has been clinically applied to patients with Sjögren’s syndrome for the treatment of xerostomia.2 Oral doses of cevimeline significantly improved subjective symptoms of dry mouth and dry eyes, and increased salivary flow. However, adverse effects were frequently reported, such as nausea and abdominal pain. Unless properly managed, these adverse effects would negatively affect the continued administration of cevimeline.
To overcome these disadvantages of oral doses of cevimeline, we evaluated the efficacy of cevimeline gargle for the treatment of xerostomia in patients with Sjögren’s syndrome. We first evaluated the effect of the gargle in 11 healthy female volunteers (mean (SD) age 39 (13) years, range 19–57), after approval from the ethical committee of our hospital. The volunteers were asked to gargle three times a day before meals using 30 mg cevimeline dissolved in 100 ml of water for each session. The effects of treatment were evaluated daily by a Saxon test performed at around 3 00 pm. Most of the healthy subjects responded well to the cevimeline gargle, and the salivary flow rate gradually increased, reaching an 81% increase on average by day 5. Some subjects showed more than twofold increases in salivary flow after cevimeline gargle. No adverse effect was seen. Simple gargles without cevimeline had no effect.
Given the satisfactory efficacy and safety of the cevimeline gargle in healthy subjects, we next tested whether the same treatment was effective in patients with Sjögren’s syndrome. These patients fulfilled the criteria proposed by Fox et al3 and were also refractory to corticosteroid irrigation (table 1). Cevimeline gargle markedly increased salivary flow rates in two of the five patients. However, in the remaining three patients the effect of treatment was negligible. In three of these five patients clinical symptoms improved subjectively. No adverse effects were seen.
The exact mechanism of salivary flow stimulation by cevimeline gargle is not clear. Possibly, cevimeline binds directly to the muscarinic receptors of the minor salivary gland acini that communicate with the oral cavity. The observed inconsistency in treatment effects in the patients with Sjögren’s syndrome may be due to severely damaged salivary acini. Further studies are necessary to evaluate cevimeline gargle treatment in a large cohort including more mildly affected patients.