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. 2000;1998(2):CD001084.
doi: 10.1002/14651858.CD001084.

Pharmacotherapy for Behcet's syndrome

A Saenz  1 , M Ausejo, B Shea, G Wells, V Welch, P Tugwell
Affiliations

Pharmacotherapy for Behcet's syndrome

A Saenz et al. Cochrane Database Syst Rev. 2000.

Abstract

Objectives: To determine the effects of available pharmacological interventions in treating the different clinical features of Behcet's syndrome.

Search strategy: We searched the Cochrane Musculoskeletal Group's trials register, the Cochrane Controlled Trials Register, and Medline up to January 1998. The computer search was complemented by a hand search of all bibliographic references from the reference lists of included trials. Principal investigators were contacted to seek unpublished literature. All languages were included.

Selection criteria: Studies were eligible if they fulfilled all of the four following criteria: 1. Randomized controlled trials, single or double-blind; 2. Participants were patients with Behcet's Syndrome as defined by the International Study Group, 1990 (Int Study Group, 1990); 3. Interventions included any pharmacological therapy compared to placebo or some other pharmacological intervention for the treatment of Behcet's syndrome. 4. Outcome measures included active ocular inflammatory processes, arthritis, mucocutaneous manifestations (oral ulcer, genital ulcer, erythema nodosum), laboratory changes and major events such as adverse effects and death.

Data collection and analysis: The 32 potentially relevant references were assessed by two independent reviewers (MA, AS) according to the inclusion criteria. Ten trials fit the inclusion criteria and were included in this review. From the 10 included trials, data were independently extracted by the same two observers and crosschecked. The quality of the included trials was assessed independently by two observers (MA, AS) using a validated scale (Jadad 1996). For dichotomous measures, the treatment effect for each trial was calculated using a fixed effect model [Peto model (Petitti 1994)]. The weighted mean differences were based, if available, on end-of-trial results. The analysis was conducted separately for each different intervention. Since the trials could not be pooled it was not possible to carry out a sensitivity analysis by quality scores or a subgroup analysis by drug dosages. Because of this lack of comparability across trials and the small number of trials, we could not conduct a heterogeneity test or a funnel plot.

Main results: Ten trials and 679 patients were included. The main results were the lack of efficacy of some of the classic treatments for Behcet's syndrome, including colchicine, cyclophosphamide and steroids for eye involvement, azapropazone and colchicine for arthritis and acyclovir, colchicine and topical interpheron for aphthas. The results confirm the protective effects of cyclosporine and azathioprine for eye involvement and benzathine-penicillin for arthritis.

Reviewer's conclusions: We conclude that further randomized, placebo-controlled, double-blind trials should be carried out to compare cyclosporine, azathioprine and benzathine-penicillin versus placebo in order to make the results generalizable and comparable.

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Conflict of interest statement

None known.

Figures

1.1
1.1. Analysis
Comparison 1 Azathioprine vs Placebo. No previous eye involvement., Outcome 1 Necessitating withdrawal.
1.2
1.2. Analysis
Comparison 1 Azathioprine vs Placebo. No previous eye involvement., Outcome 2 New eye disease.
1.3
1.3. Analysis
Comparison 1 Azathioprine vs Placebo. No previous eye involvement., Outcome 3 Hypopyon uveitis.
1.4
1.4. Analysis
Comparison 1 Azathioprine vs Placebo. No previous eye involvement., Outcome 4 Pulsed intravenous corticosteroid treatment.
1.5
1.5. Analysis
Comparison 1 Azathioprine vs Placebo. No previous eye involvement., Outcome 5 Oral corticosteroid treatment.
2.1
2.1. Analysis
Comparison 2 Azathioprine vs Placebo. Previous eye involvement., Outcome 1 Necessitating withdrawal..
2.2
2.2. Analysis
Comparison 2 Azathioprine vs Placebo. Previous eye involvement., Outcome 2 New eye disease..
2.3
2.3. Analysis
Comparison 2 Azathioprine vs Placebo. Previous eye involvement., Outcome 3 Involvement of previously unaffected eye..
2.4
2.4. Analysis
Comparison 2 Azathioprine vs Placebo. Previous eye involvement., Outcome 4 Hypopyon uveitis.
2.5
2.5. Analysis
Comparison 2 Azathioprine vs Placebo. Previous eye involvement., Outcome 5 Pulsed intravenous corticosteroid treatment..
2.6
2.6. Analysis
Comparison 2 Azathioprine vs Placebo. Previous eye involvement., Outcome 6 Oral Corticosteroid treatment..
3.1
3.1. Analysis
Comparison 3 Azathioprine vs placebo, Outcome 1 Visual acuity [first minus last visit] mean sd.
3.2
3.2. Analysis
Comparison 3 Azathioprine vs placebo, Outcome 2 GI side effects.
3.3
3.3. Analysis
Comparison 3 Azathioprine vs placebo, Outcome 3 Low WCC (<4,000/ml).
3.4
3.4. Analysis
Comparison 3 Azathioprine vs placebo, Outcome 4 IV steroids neccessity.
4.1
4.1. Analysis
Comparison 4 Colchicine plus Benzathine Penicillin vs Colchicine. Arthritis, Outcome 1 Incidence of arthritis episodes.
4.2
4.2. Analysis
Comparison 4 Colchicine plus Benzathine Penicillin vs Colchicine. Arthritis, Outcome 2 Patients with arthritis episodes.
4.3
4.3. Analysis
Comparison 4 Colchicine plus Benzathine Penicillin vs Colchicine. Arthritis, Outcome 3 Mean of arthritis episodes per patient.
4.4
4.4. Analysis
Comparison 4 Colchicine plus Benzathine Penicillin vs Colchicine. Arthritis, Outcome 4 Duration of episode.
4.5
4.5. Analysis
Comparison 4 Colchicine plus Benzathine Penicillin vs Colchicine. Arthritis, Outcome 5 Severe arthritis attacks.
4.6
4.6. Analysis
Comparison 4 Colchicine plus Benzathine Penicillin vs Colchicine. Arthritis, Outcome 6 Polyarticular joint involvement.
4.7
4.7. Analysis
Comparison 4 Colchicine plus Benzathine Penicillin vs Colchicine. Arthritis, Outcome 7 Prednisone dosage/day.
4.8
4.8. Analysis
Comparison 4 Colchicine plus Benzathine Penicillin vs Colchicine. Arthritis, Outcome 8 Prednisone duration/days.
4.9
4.9. Analysis
Comparison 4 Colchicine plus Benzathine Penicillin vs Colchicine. Arthritis, Outcome 9 Duration of arthritis episode‐free period.
4.10
4.10. Analysis
Comparison 4 Colchicine plus Benzathine Penicillin vs Colchicine. Arthritis, Outcome 10 Colchicine gastro‐intestinal side effects..
5.1
5.1. Analysis
Comparison 5 Topical alpha interpheron vs placebo, Outcome 1 New oral ulcers (per group).
5.2
5.2. Analysis
Comparison 5 Topical alpha interpheron vs placebo, Outcome 2 Total oral ulcers (per patient).
6.1
6.1. Analysis
Comparison 6 Azaproprazone vs placebo, Outcome 1 Persistence of arthritis.
6.2
6.2. Analysis
Comparison 6 Azaproprazone vs placebo, Outcome 2 New arthritis.
6.3
6.3. Analysis
Comparison 6 Azaproprazone vs placebo, Outcome 3 Duration of arthritis (mean±sd days).
6.4
6.4. Analysis
Comparison 6 Azaproprazone vs placebo, Outcome 4 Joint swelling day 7.
6.5
6.5. Analysis
Comparison 6 Azaproprazone vs placebo, Outcome 5 Joint swelling day 21.
6.6
6.6. Analysis
Comparison 6 Azaproprazone vs placebo, Outcome 6 Tender joint score 7.
6.7
6.7. Analysis
Comparison 6 Azaproprazone vs placebo, Outcome 7 Tender joint score 21.
6.8
6.8. Analysis
Comparison 6 Azaproprazone vs placebo, Outcome 8 Visual analogue scale for pain day 7.
6.9
6.9. Analysis
Comparison 6 Azaproprazone vs placebo, Outcome 9 Visual analogue score for pain day 21.
6.10
6.10. Analysis
Comparison 6 Azaproprazone vs placebo, Outcome 10 Mean C reactive protein (mg/dl) day 21.
6.11
6.11. Analysis
Comparison 6 Azaproprazone vs placebo, Outcome 11 Mean erythrocyte sedimentation rate day 21.
7.1
7.1. Analysis
Comparison 7 Cyclosporine vs cyclophosphamide, Outcome 1 Visual acuity.
7.2
7.2. Analysis
Comparison 7 Cyclosporine vs cyclophosphamide, Outcome 2 Number of ocular attacks/patient/month up to 6 months..
7.3
7.3. Analysis
Comparison 7 Cyclosporine vs cyclophosphamide, Outcome 3 Number of ocular attacks/patient/month from 6 months to unmasking..
8.1
8.1. Analysis
Comparison 8 Autologous salive vs placebo, Outcome 1 Oral aphtas improvement.
8.2
8.2. Analysis
Comparison 8 Autologous salive vs placebo, Outcome 2 Genital aphtas improvement.
8.3
8.3. Analysis
Comparison 8 Autologous salive vs placebo, Outcome 3 Arthritis improvement.
9.1
9.1. Analysis
Comparison 9 Cyclosporine vs conventional therapy., Outcome 1 Drop‐outs due to severe eye involvement.
9.2
9.2. Analysis
Comparison 9 Cyclosporine vs conventional therapy., Outcome 2 Visual acuity at 1st month.
9.3
9.3. Analysis
Comparison 9 Cyclosporine vs conventional therapy., Outcome 3 Visual acuity at 24 month.
9.4
9.4. Analysis
Comparison 9 Cyclosporine vs conventional therapy., Outcome 4 Mouth ulcers: 0‐24 months.
9.5
9.5. Analysis
Comparison 9 Cyclosporine vs conventional therapy., Outcome 5 Genital ulcers:0‐24 months.
10.1
10.1. Analysis
Comparison 10 Colchicine vs placebo, Outcome 1 Aphtas not improved.
10.2
10.2. Analysis
Comparison 10 Colchicine vs placebo, Outcome 2 Eye not improved.
10.3
10.3. Analysis
Comparison 10 Colchicine vs placebo, Outcome 3 Genital ulcers not improved.
10.4
10.4. Analysis
Comparison 10 Colchicine vs placebo, Outcome 4 Erythema nodosum not improved.
10.5
10.5. Analysis
Comparison 10 Colchicine vs placebo, Outcome 5 Pyoderma not improved.
10.6
10.6. Analysis
Comparison 10 Colchicine vs placebo, Outcome 6 Arthritis not improved.
10.7
10.7. Analysis
Comparison 10 Colchicine vs placebo, Outcome 7 Arthralgia not improved.
10.8
10.8. Analysis
Comparison 10 Colchicine vs placebo, Outcome 8 Bilateral eye involvement.
11.1
11.1. Analysis
Comparison 11 Cyclosporine vs Colchicine, Outcome 1 Ocular attacks frequency:not improvemed.
11.2
11.2. Analysis
Comparison 11 Cyclosporine vs Colchicine, Outcome 2 Ocular attacks severity:not improved.
11.3
11.3. Analysis
Comparison 11 Cyclosporine vs Colchicine, Outcome 3 Dermal lesions not improved.
11.4
11.4. Analysis
Comparison 11 Cyclosporine vs Colchicine, Outcome 4 Aphtas not improved.
11.5
11.5. Analysis
Comparison 11 Cyclosporine vs Colchicine, Outcome 5 Clinical symptoms aggravated.
12.1
12.1. Analysis
Comparison 12 Acyclovir vs placebo., Outcome 1 Frequency new oral ulcers..
12.2
12.2. Analysis
Comparison 12 Acyclovir vs placebo., Outcome 2 Frequency new genital ulcers..
12.3
12.3. Analysis
Comparison 12 Acyclovir vs placebo., Outcome 3 Erythrocyte sedimentation rate mm/h..
12.4
12.4. Analysis
Comparison 12 Acyclovir vs placebo., Outcome 4 Hemoglobine g/dl..
12.5
12.5. Analysis
Comparison 12 Acyclovir vs placebo., Outcome 5 White cell count, 10*9/l..
12.6
12.6. Analysis
Comparison 12 Acyclovir vs placebo., Outcome 6 Inmunoglobulin G, g/l..
See this image and copyright information in PMC

References

References to studies included in this review

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Abdalla 1973 {published data only}
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