Oral pilocarpine for the treatment of ocular symptoms in patients with Sjogren's syndrome

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Ann Rheum Dis. 2003 Dec;62(12):1204-7.

Oral pilocarpine for the treatment of ocular symptoms in patients with

Sjogren's syndrome: a randomised 12 week controlled study.

Tsifetaki N, Kitsos G, Paschides CA, Alamanos Y, Eftaxias V, Voulgari

PV, Psilas K, Drosos AA.

Rheumatology Clinic, Department of Internal Medicine, Medical School,

University of Ioannina, Ioannina, Greece.

OBJECTIVE: To evaluate the efficacy and side effects of oral pilocarpine

for the treatment of ocular symptoms in patients with primary Sjogren's

syndrome (SS). METHODS: A 12 week, single centre, randomised controlled

study was performed. Twenty nine patients were randomly assigned to

receive oral pilocarpine (5 mg twice a day), 28 only artificial tears,

and 28 inferior puncta occlusion. Patients receiving oral pilocarpine

and those with inferior puncta occlusion also received artificial tears.

Patients were evaluated at baseline and throughout the study for their

subjective global assessment of dry eyes and for their objective

assessment of dry eyes (Schirmer's-I test, rose bengal test, and imprint

test). RESULTS: Patients taking oral pilocarpine had significant

improvement in subjective global assessment of dry eyes, as was

evaluated by improvement of >55 mm on a visual analogue scale (VAS) for

responses to the eye questionnaire, compared with patients treated with

artificial tears (p<0.001) and those with inferior puncta occlusion

(p<0.05). Furthermore, patients receiving oral pilocarpine also showed

greater objective improvement, as measured by the rose bengal test

(p<0.05), while Schirmer's-I test showed no differences between the

treated groups. Commonly reported adverse events were headache,

increased sweating, nausea, and vomiting in the pilocarpine group, while

one patient in the inferior puncta occlusion group had blepharitis and

was withdrawn from the study.

CONCLUSION: 10 mg of pilocarpine daily given to patients with SS for 12

weeks had a beneficial effect on subjective eye symptoms, as evaluated

by improvement >55 mm on a VAS. Additionally, an improvement of rose

bengal staining was noted, but an increase in tear production, as

measured by the Schirmer-I test, was not substantiated.

Publication Types:

a.. Clinical Trial

b.. Randomized Controlled Trial

PMID: 14644860

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