2020 Sep 12;12:1759720X20951733. Because it aimed at determining the effect of an active moiety of SSZ in AS and did little help to our objectives, we excluded this study from the analysis. Among 469 patients receiving SSZ, severe adverse reaction was reported in one patient who developed a generalized, erythematous, raised, pruritic eruption which was associated nausea, anorexia and insomnia (Clegg 1996). No noticeable difference in treatment was observed between groups. Efficacy of sulfasalazine in patients with inflammatory back pain due to undifferentiated spondyloarthritis and early ankylosing spondylitis: a multicentre randomised controlled trial. 2020 Oct 30;12:1759720X20969260. The difference in occiput‐to‐wall test (WMD 0.70 cm, 95 CI 0.32 to 1.08 cm) (Comparison 01.16,17), however, favoured placebo over SSZ. 2020 Nov 28;12:1759720X20975912. For EMBASE (Ovid), the search strategy is in Appendix 2. Sensitivity analysis, however, found no obvious difference between selection and deselection of this trial in the pooled result. Patients with IBP and a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >3 from 12 centres were randomly assigned to 24 weeks' treatment with SSZ 2 g/day or placebo. Silver: A systematic review or randomised trial that does not meet the above criteria. Marcus RW "Sulfasalazine … For allocation concealment, we scored as A (adequate), B (unclear), C (inadequate) and D (not used). But participants' characteristics were different (see Additional Table 01). Comparison 2 SSZ vs placebo (AS with peripheral arthritis, end point values), Outcome 5 Fingers‐to‐floor test (cm). Sulfasalazine (SSZ) is the best studied DMARD in AS, but its efficacy remains unclear. 230 patients (50% men, age range 18-64 years, 67% human leucocyte antigen B27 positive) were treated with either SSZ 2x1 g/day or placebo for 6 months. Comparison 1 SSZ vs placebo, Outcome 3 Improvement in back pain. The origins of heterogeneity, if present, were analyzed according to differences in methodological quality, characteristics of participants and intervention. Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 3 Chest expansion (cm). They assessed about 30 outcomes and found that ESR declined in SSZ compared with placebo group (P < 0.0001) (Comparison 01.40,41 in our analysis). Side effects occur in some people and include stomach upset, skin rashes and mouth sores which may occasionally stop people from taking sulfasalazine. TNF inhibitors (eg, infliximab, etanercept, adalimumab, certolizumab, golimumab) In a study of adult patients with recent-onset peripheral spondyloarthritis (symptom … Version published: 20 April 2005 Version history. Seven of them (Clegg 1999, Dougados 1987, Dougados 1990, Nissila 1994, Reda 1995, Schmidt 2000, Taggart 1995) were duplicate publications. Eleven trials treated a total of 895 patients, 469 receiving SSZ and 426 placebo. Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 7 Duration of morning stiffness (hr). However, attrition bias was strongly suspected here because more patients dropped out in SSZ than in placebo group (RR 2.42, 95% CI 1.14 to 5.15). The other 11 trials (Clegg 1996, Corkill 1990, Davis 1989, Dougados 1986, Feltelius 1986, Kirwan 1993, Krajnc 1990, Nissila 1988, Schmidt 2002, Taylor 1991, Winkler 1989) compared SSZ with placebo. Relevant randomised and quasi‐randomised trials in any language were sought using the following sources: CENTRAL (Cochrane Central Register of Controlled Trials, Issue 2, 2003), MEDLINE (1966 to June Week 4 2003), EMBASE (1980 to 2003 Week 26), CINAHL (1982 to June Week 3 2003) and the reference section of retrieved articles. Comparison 2 SSZ vs placebo (AS with peripheral arthritis, end point values), Outcome 1 Back pain (VAS‐100mm, 0=no pain, 100=severe). Conclusion: Clinical management of the most common extra-intestinal manifestations in patients with inflammatory bowel disease focused on the joints, skin and eyes. Comparison 1 SSZ vs placebo, Outcome 13 Forced vital volume (change from baseline) (L/min). In Dougados 1986, most outcomes were given as medians and 95% CIs for each intervention groups. Twelve studies met the inclusion criteria. Results were combined using both random and fixed effects models as weighted mean difference (WMD) or standardised mean difference (SMD) (depending on comparability of scales) for continuous data and relative risk (RR) for dichotomous data (given the event is not rare). 4. were the care providers blinded? Ankylosing spondylitis (AS) is a type of arthritis usually in the joints and ligaments of the spine. Please enable it to take advantage of the complete set of features! Clipboard, Search History, and several other advanced features are temporarily unavailable. Sulfasalazine reduces spinal stiffness, peripheral arthritis, and the erythrocyte sedimentation rate (ESR), but there is no evidence that it improves spinal mobility, enthesitis, or … 4. The data available are protected by copyright and may only be used in accordance with the Terms and Conditions. Efficacy of sulfasalazine in patients with inflammatory back pain due to undifferentiated spondyloarthritis and early ankylosing spondylitis: a multicentre randomised … In the present analysis, the effectiveness of SSZ was confirmed only in Nissila 1988 study where severity of pain, chest expansion, patient general well‐being, morning stiffness and ESR were significantly improved although more success of treatment (judged by patients) was also confirmed in Dougados 1986 study. In addition, many trials used patient's subjective assessment as markers, eg duration of morning stiffness, pain severity which is liable to investigators' intention. For patients refractory or intolerant to NSAIDs, the disease modifying antirheumatic drugs (DMARDs) have been used as a second line approach. (see Additional Table 01). Curr Rheumatol Rep. 2007 Oct;9(5):349-50. Objectives: Non‐steroidal anti‐inflammatory drugs (NSAIDs) are the main treatment for AS and can improve the symptoms of AS. First, we examined those trials with high methodological quality, larger sample size and longer period of treatment. Cochrane Database Syst Rev. The dosage of SSZ (or placebo) were 2.0 g/d or up to 3.0 g/d depending on the efficacy and tolerance. To assess the effect of sulfasalazine (SSZ) on inflammatory back pain (IBP) due to active undifferentiated spondyloarthritis (uSpA) or ankylosing spondylitis in patients with symptom duration <5 years. Spinal pain (p = 0.03) and morning stiffness (p = 0.05) improved with SSZ in these patients, but other secondary outcomes were not markedly different. A grading of the evidence was performed using the grading system described in the 2004 book Evidence‐based Rheumatology (Tugwell 2004) and recommended by the Musculoskeletal Group: Platinum: A published systematic review that has at least two individual controlled trials each satisfying the following: Sample sizes of at least 50 per group ‐ if these do not find a statistically significant difference, they are adequately powered for a 20% relative difference in the relevant outcome. Two of them (Davis 1989, Krajnc 1990) based the comparisons between the initial and end point results. Ankylosing spondylitis (AS) is a chronic inflammatory disease of unknown cause and affects mainly the spine, but can also affect other joints. June 17, 2011 — A new study has confirmed etanercept efficacy in early, active ankylosing spondylitis (AS) but did not quite knock sulfasalazine out of contention. Sulfasalazine is an anti-inflammatory drug and is also used to treat rheumatoid arthritis and ulcerative colitis, a type of inflammatory bowel disease. 1. Five studies (Davis 1989, Dougados 1986, Feltelius 1986, Krajnc 1990, Nissila 1988) reported that SSZ was beneficial. On the whole, Nissila 1988 was the only trial which showed SSZ demonstrated improvement in primary outcome analyses, including back pain, chest expansion, occiput‐to‐wall test and patient's general well being. Comparison 2 SSZ vs placebo (AS with peripheral arthritis, end point values), Outcome 4 Schober's test (cm). Lee TH, Koo BS, Nam B, Oh JS, Park SY, Lee S, Joo KB, Kim TH. Sulfasalazine (SSZ) has been used in rheumatoid arthritis (RA) and AS for decades. Comparison 2 SSZ vs placebo (AS with peripheral arthritis, end point values), Outcome 8 Patient assessment of disease severity (VAS‐100mm, 0=very good, 100=very poor). Peripheral joints/entheses were assessed in several studies (Clegg 1996, Dougados 1986, Kirwan 1993, Nissila 1988, Schmidt 2002). Sulfasalazine in undifferentiated spondyloarthropathies. Comparison 1 SSZ vs placebo, Outcome 14 (Modified) Schober's test (cm). WMD of end point was ‐7.07 mm/hr and 95% CI ‐14.39 to 0.25 (insignificant statistically). Ther Adv Musculoskelet Dis. Improvements in movement of the spine, pain, function (physical ability) and overall‐well being was about the same whether people took sulfasalazine or fake pills. For other outcomes, however, no pooled data showed significant difference between intervention groups. Significant heterogeneity was also found among the included studies in Schober's test (Comparison 01.14,15), occiput‐to‐wall test (Comparison 01.16,17), improvement in patient and physician global assessment (Comparison 01.31,34). Etanercept, a fully human tumor necrosis factor soluble receptor, is effective in treatment of ankylosing spondylitis (AS). Morning stiffness decreased by 14 more points on a scale of 0 to 100 when taking sulfasalazine than fake pills. Secondary outcomes Five trials (Clegg 1996, Krajnc 1990, Nissila 1988, Schmidt 2002, Winkler 1989) assessed duration of morning stiffness. eCollection 2020. Among them one study (Taggart 1996) compared efficacy of SSZ with its two moieties, 5‐aminosalicylic acid and sulfapyridine. Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 5 Fingers‐to‐floor test (cm). Select your preferred language for the Cochrane Library website. Current guidelines suggest sulfasalazine (SSZ) treatment as initial therapy for the … Mean Difference (IV, Random, 95% CI), 22 Joint pain/tenderness score (2nd analysis) (0‐198, the higher score the more severe disease) Show forest plot, 23 Joint swelling score (0‐198, the higher score the more severe disease) or number Show forest plot, 24 Joint swelling score (2nd analysis) (0‐198, the higher score the more severe disease) Show forest plot, 25 Dactylitis score (0‐3, 0=normal, 3=severe) Show forest plot, 26 Dactylitis score (2nd analysis) (0‐3, 0=normal, 3=severe) Show forest plot, 27 Enthesopathy index (0‐90, 0‐66, 0‐90? On the other hand, a wide range of adverse effects related to SSZ have been reported, including malaise, nausea, vomiting, anorexia, heartburn, epigastric distress, serious skin reactions, hepatitis and blood dyscrasias (Moreland 2001). A randomised trial with a 'head‐to‐head' comparison of agents would be considered silver level ranking unless a reference were provided to a comparison of one of the agents to placebo showing at least a 20% relative difference. Methods: Braun J, Zochling J, Baraliakos X, et al. Comparison 1 SSZ vs placebo, Outcome 25 Dactylitis score (0‐3, 0=normal, 3=severe). Two trials (Nissila 1988, Taylor 1991) assessed morning stiffness VAS‐100 mm (where 0=no stiffness, 100=severe). Current guidelines suggest sulfasalazine (SSZ) treatment as initial therapy … 2002 Apr;61(2):159-67. doi: 10.1007/s003930200024. Only outcomes specified above were included in the review. Can M, Aydın SZ, Niğdelioğlu A, Atagündüz P, Direskeneli H. Int J Rheum Dis. Comparison 1 SSZ vs placebo, Outcome 4 Back pain (VAS‐100 mm, 0=no ppain, 100=severe). 6. was there a description of withdrawals and drop‐outs? Abstract. 1. was the study described as randomised? Sulfasalazine is a slow-acting anti-rheumatic drug (SAARD) that may be used to treat certain people with ankylosing spondylitis (AS). Adverse effects Significant differences between intervention groups were found in pooled data of withdrawal for side effects (RR 1.50, 95% CI 1.04 to 2.15, NNH 23, 95% CI 10 to 288) and withdrawal for any reason (RR 1.33, 95% CI 1.03 to 1.73, NNH 17, 95% CI 8 to 180), favouring placebo group (Comparison 01.44,46, Additional table 3). Pooled data showed a similar result. (2) SSZ management might be beneficial in patients with higher ESR (possibly > 30 mm/hr). doi: 10.1177/1759720X20951733. Primary outcomes Three trials (Dougados 1986, Nissila 1988, Schmidt 2002) showed statistically significant differences between treatment groups (Additional Table 01). About 86% of participants were males (Taylor 1991 study did not present the information on the sex distribution of participants). Difference of selection criteria is likely one reason why SSZ demonstrated benefit in some trials but not in others. All the dichotomous data presented in Table comparisons and data were according to intention‐to‐treat analysis. Significantly more withdrawals for side effects (RR 1.50, 95% CI 1.04 to 2.15, NNH 23, 95% CI 10 to 288) and for any reason (RR 1.33, 95% CI 1.03 to 1.73, NNH 17, 95% CI 8 to 180) were found in SSZ compared with placebo group although severe side effects were rare (1 of the 469 patients taking SSZ). Several studies presented their results in a form that did not allow analysis in RevMan. Here Schmidt 2002, a trial with more than 30% of drop‐outs, played more than 80% weight. For ESR, four trials (Clegg 1996, Krajnc 1990, Nissila 1988, Schmidt 2002) found statistically significant differences between intervention groups favouring SSZ over placebo. The methodological quality of included trials was independently assessed by the same reviewers against the following criteria. In 1990, Ferraz (Ferraz 1990) conducted a meta‐analysis of five randomized controlled trials involving 272 patients and concluded that sulfasalazine significantly relieved pain and morning stiffness, compared with placebo. Comparison 1 SSZ vs placebo, Outcome 7 Score of sleep disturbance (end point) (0‐4, 0=no disturbance, 4=severe disturbance). Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 4 Schober's test (cm). How safe is it? We evaluated randomised and quasi‐randomised trials examining the efficacy of sulfasalazine on ankylosing spondylitis. The outcomes in continuous data were presented as either end point values or change from baseline or both. Comparison 1 SSZ vs placebo, Outcome 37 Duration of morning stiffness (2nd analysis) (hr). Standardized outcome measures are necessary to allow for comparison across trials. 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