Oral pilocarpine for the treatment of ocular symptoms in patients with Sjögren's syndrome: a randomised 12 week controlled study

N Tsifetaki, G Kitsos, C A Paschides, Y Alamanos, V Eftaxias, P V Voulgari, K Psilas, A A Drosos, N Tsifetaki, G Kitsos, C A Paschides, Y Alamanos, V Eftaxias, P V Voulgari, K Psilas, A A Drosos

Abstract

Objective: To evaluate the efficacy and side effects of oral pilocarpine for the treatment of ocular symptoms in patients with primary Sjögren'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and vomiting in the pilocarpine group, while one patient in the inferior puncta occlusion group had blepharitis and was withdrawn from the study.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.

Figures

Figure 1
Figure 1
Flow of patients and trial profile.
Figure 2
Figure 2
Subjective improvement of occular symptoms in patients with primary SS.

References

    1. Clin Immunol Immunopathol. 1994 Aug;72(2):162-5
    1. Drugs. 1995 Jan;49(1):143-55
    1. Clin Exp Rheumatol. 1996 Sep-Oct;14(5):555-8
    1. Eur J Pharmacol. 1997 Nov 19;339(1):1-9
    1. Oral Dis. 1997 Jun;3(2):93-8
    1. J Rheumatol. 1998 May;25(5):896-9
    1. Ophthalmology. 1998 Sep;105(9):1715-20
    1. Arch Intern Med. 1999 Jan 25;159(2):174-81
    1. J Interferon Cytokine Res. 1999 Aug;19(8):943-51
    1. J Rheumatol. 1999 Sep;26(9):2051-61
    1. Arthritis Rheum. 2000 Jul;43(7):1647-54
    1. Curr Opin Rheumatol. 2000 Sep;12(5):391-8
    1. Arch Ophthalmol. 2000 Nov;118(11):1489-96
    1. Am J Ophthalmol. 2001 Jan;131(1):30-6
    1. Scand J Rheumatol Suppl. 2001;115:1-9; discussion 9-13
    1. Arthritis Rheum. 2002 Mar;46(3):748-54
    1. Ann Rheum Dis. 2002 Jun;61(6):554-8
    1. Scand J Rheumatol Suppl. 2002;116:3-13
    1. Ann Rheum Dis. 1986 Sep;45(9):732-5
    1. Am J Med. 1988 Oct 14;85(4A):62-7
    1. Oral Surg Oral Med Oral Pathol. 1992 Sep;74(3):315-8
    1. Cytopathology. 1993;4(6):347-55

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel