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At least 757 records · Page 42Linked to original sources
PubMed2006

Sexual counseling improved erectile rehabilitation after non-nerve-sparing radical retropubic prostatectomy or cystectomy--results of a randomized prospective study.

AIM: The efficacy of prostaglandin E1 (PGE1)-intracavernous injection (ICI) therapy for erectile dysfunction (ED) after non-nerve-sparing (NNS) radical pelvic surgery depends on patient compliance. The purpose of this study was to verify the utility of sexual counseling in ICI in terms of treatment efficacy, compliance, and dropout rate. METHODS: In this prospective randomized study, 57 patients with ED after NNS radical prostatectomy or cystectomy were divided: 29 patients (group SC+) were treated with sexual counseling and PGE1-ICI therapy; the others 28 (group SC-) were treated with only ICI. At the start of the study all patients were administered the International Index of Erectile Function (IIEF) questionnaire and ICI training test; follow-up (at 3, 6, 9, 12, 18 months) was achieved by home Sildenafil test and ambulatory IIEF test; sexual counseling was provided only to group SC+. RESULTS: The mean IIEF score at the end of study was 26.5 (SC+) vs. 24.3 (SC-) (P < 0.05); eight patients (SC+, 27.5%) became responders to home Sildenafil vs. five (SC-, 17.8%) (P < 0.05); no dropout cases occurred (SC+) vs. eight (SC-, 28.5%) (P < 0.05). Moreover, we recorded best IIEF scores in group SC+ in sexual satisfaction (P < 0.05), sexual desire (P < 0.05), orgasmic function, and general satisfaction. Mean PGE1 doses were better in group SC+ (P < 0.05). ICI-oriented sexual counseling was utilized to motivate couples, to improve sexual intercourses, to correct mistakes in ICI administration. At the end of follow-up 21 patients (SC+) declared themselves satisfied vs. 12 (SC-). CONCLUSIONS: ICI-oriented sexual counseling in ICI increased the efficacy of treatment, the compliance, and Sildenafil responders rate, decreased the dropout rate.

Aged↗
PubMed1993

Treatment of tinea unguium with medium and high doses of ultramicrosize griseofulvin compared with that with itraconazole.

Toenail tinea is a very recalcitrant dermatosis. Griseofulvin at > or = 500 mg/day is the current medication of choice, but it is minimally successful. In a controlled open trial ultramicrosize griseofulvin (UMSG) at doses of 660 and 990 mg/day was compared with itraconazole at 100 mg/day in 109 patients. At 4-week intervals, the patients were evaluated for their clinical and mycological statuses and adverse reactions. Treatment was given for up to 18 months. Compliance was checked by tablet counting. Response (cure, partial cure, marked improvement) was analyzed by the intent-to-treat method. Cured and partially cured patients were followed up. Except for one early dropout, the toenails (mean, 6 to 7) were involved. Cure or partial cure was found in 6% (UMSG at 660 mg), 14% (UMSG at 990 mg), and 19% (itraconazole at 100 mg) of patients (P = 0.2097); marked improvement was found in 36, 44, and 39% of patients in the three treatment groups, respectively. Most patients had to be treated for 18 months. Failure was related to short medication periods (adverse drug reactions, dropout). While stable cure was not obtained with UMSG at 660 mg, the higher dose of UMSG and itraconazole gave stable cures in the other patients. Side effects of nausea, diarrhea, and headache were found in 20, 26, and 11 patients, respectively (P = 0.0028), and the numbers in whom medication had to be discontinued differed, too (P = 0.0137). While there was no major difference with glutamic-pyruvic transaminase and gamma-GT, total and low-density lipoprotein cholesterol levels declined slightly in the itraconazole group (P = 0.0357 and P = 0.0639, respectively, at 3 months). More than 70% of the patients had an average compliance of > or = 90%; four patients (two dropouts) were poor compliers. In conclusion, it appears questionable whether griseofulvin can continue to be considered the "gold standard" in the treatment of toenail tinea. At present, itraconazole at 100 mg shows better efficacy and is better tolerated.

Adult↗
PubMed2002

Meta-analysis of effects and side effects of low dosage tricyclic antidepressants in depression: systematic review.

OBJECTIVE: To compare the effects and side effects of low dosage tricyclic antidepressants with placebo and with standard dosage tricyclics in acute phase treatment of depression. DESIGN: Systematic review of randomised trials comparing low dosage tricyclics (< or =100 mg/day) with placebo or with standard dosage tricyclics in adults with depression. MAIN OUTCOME MEASURES: Relative risk of response in depression (random effects model), according to the original authors' definition but usually defined as 50% or greater reduction in severity of depression. Relative risks of overall dropouts and dropouts due to side effects. RESULTS: 35 studies (2013 participants) compared low dosage tricyclics with placebo, and six studies (551 participants) compared low dosage tricyclics with standard dosage tricyclics. Low dosage tricyclics, mostly between 75 and 100 mg/day, were 1.65 (95% confidence interval 1.36 to 2.0) and 1.47 (1.12 to 1.94) times more likely than placebo to bring about response at 4 weeks and 6-8 weeks, respectively. Standard dosage tricyclics failed, however, to bring about more response but produced more dropouts due to side effects than low dosage tricyclics. CONCLUSIONS: Treatment of depression in adults with low dose tricyclics is justified. However, more rigorous studies are needed to definitively establish the relative benefits and harms of various dosages.

Adult↗
PubMed2006

[Alcoholism and immigration. Adherence of immigrant patients to group therapy].

BACKGROUND AND OBJECTIVE: Group therapy (GT) is considered a cornerstone in the treatment of alcohol dependence. Increasing numbers of foreigners are accessing alcohol treatment facilities, but efficacy of TG in those patients has not been studied. This work focuses on the influence of ethnicity and language in the compliance of GT. PATIENTS AND METHOD: 1856 consecutive patients who were referred to GT for alcohol dependence were followed until discharge or dropout. Time on treatment and final endpoint were compared according to place of birth. RESULTS: 31% of patients born in Barcelona, 39% born in Catalonia, 27% from the rest of Spain and 14.5% of foreigners (20% from Europe, 4% from America and none born in Africa (p = 0.02) completed successfully GT. The probability to stay in GT was 351, 412, 320 and 212 days (p = 0.000), respectively. DISCUSSION: Patients born abroad have lower chances to complete GT successfully, presenting with higher dropout rates and shorter treatments. The low compliance found in South American patients (who share a common language) and the better compliance found in Europeans (who are also a bit older) suggest that dropout is probably more related to social integration than to language problems.

Adult↗
PubMed2003

Facial recognition using simulated prosthetic pixelized vision.

PURPOSE: To evaluate a model of simulated pixelized prosthetic vision using noncontiguous circular phosphenes, to test the effects of phosphene and grid parameters on facial recognition. METHODS: A video headset was used to view a reference set of four faces, followed by a partially averted image of one of those faces viewed through a square pixelizing grid that contained 10x10 to 32x32 dots separated by gaps. The grid size, dot size, gap width, dot dropout rate, and gray-scale resolution were varied separately about a standard test condition, for a total of 16 conditions. All tests were first performed at 99% contrast and then repeated at 12.5% contrast. RESULTS: Discrimination speed and performance were influenced by all stimulus parameters. The subjects achieved highly significant facial recognition accuracy for all high-contrast tests except for grids with 70% random dot dropout and two gray levels. In low-contrast tests, significant facial recognition accuracy was achieved for all but the most adverse grid parameters: total grid area less than 17% of the target image, 70% dropout, four or fewer gray levels, and a gap of 40.5 arcmin. For difficult test conditions, a pronounced learning effect was noticed during high-contrast trials, and a more subtle practice effect on timing was evident during subsequent low-contrast trials. CONCLUSIONS: These findings suggest that reliable face recognition with crude pixelized grids can be learned and may be possible, even with a crude visual prosthesis.

Adult↗
PubMed1980

Psychological induction into the large-group: findings from a modern religious sect.

The author studied the psychological aspects of religious conversion during structured 21-day workshop sequences designed to introduce people to the Unification Church. Subjects were given a battery of tests at different times during the sequence. After the initial 2-day workshop, 71% dropped out; the 29% who chose to continue had greater affiliative feelings toward the group and greater acceptance of the church's creed than these early dropouts. The 9% who ultimately joined the church had weaker outside personal ties than the later dropouts, although their beliefs in and cohesiveness toward the church were the same as the late dropouts. These results are also compared with long-standing members of the church and matched nonmembers. The induction procedures used by the church are discussed with regard to those used by large therapeutic groups, such as self-help organizations.

Group Processes↗
PubMed2006

Duloxetine compared with fluoxetine and venlafaxine: use of meta-regression analysis for indirect comparisons.

BACKGROUND: Data comparing duloxetine with existing antidepressant treatments is limited. A comparison of duloxetine with fluoxetine has been performed but no comparison with venlafaxine, the other antidepressant in the same therapeutic class with a significant market share, has been undertaken. In the absence of relevant data to assess the place that duloxetine should occupy in the therapeutic arsenal, indirect comparisons are the most rigorous way to go. We conducted a systematic review of the efficacy of duloxetine, fluoxetine and venlafaxine versus placebo in the treatment of Major Depressive Disorder (MDD), and performed indirect comparisons through meta-regressions. METHODS: The bibliography of the Agency for Health Care Policy and Research and the CENTRAL, Medline, and Embase databases were interrogated using advanced search strategies based on a combination of text and index terms. The search focused on randomized placebo-controlled clinical trials involving adult patients treated for acute phase Major Depressive Disorder. All outcomes were derived to take account for varying placebo responses throughout studies. Primary outcome was treatment efficacy as measured by Hedge's g effect size. Secondary outcomes were response and dropout rates as measured by log odds ratios. Meta-regressions were run to indirectly compare the drugs. Sensitivity analysis, assessing the influence of individual studies over the results, and the influence of patients' characteristics were run. RESULTS: 22 studies involving fluoxetine, 9 involving duloxetine and 8 involving venlafaxine were selected. Using indirect comparison methodology, estimated effect sizes for efficacy compared with duloxetine were 0.11 [-0.14;0.36] for fluoxetine and 0.22 [0.06;0.38] for venlafaxine. Response log odds ratios were -0.21 [-0.44;0.03], 0.70 [0.26;1.14]. Dropout log odds ratios were -0.02 [-0.33;0.29], 0.21 [-0.13;0.55]. Sensitivity analyses showed that results were consistent. CONCLUSION: Fluoxetine was not statistically different in either tolerability or efficacy when compared with duloxetine. Venlafaxine was significantly superior to duloxetine in all analyses except dropout rate. In the absence of relevant data from head-to-head comparison trials, results suggest that venlafaxine is superior compared with duloxetine and that duloxetine does not differentiate from fluoxetine.

Antidepressive Agents↗
PubMed2004

The effect of correlation structure on treatment contrasts estimated from incomplete clinical trial data with likelihood-based repeated measures compared with last observation carried forward ANOVA.

Valid analyses of longitudinal data can be problematic, particularly when subjects dropout prior to completing the trial for reasons related to the outcome. Regulatory agencies often favor the last observation carried forward (LOCF) approach for imputing missing values in the primary analysis of clinical trials. However, recent evidence suggests that likelihood-based analyses developed under the missing at random framework provide viable alternatives. The within-subject error correlation structure is often the means by which such methods account for the bias from missing data. The objective of this study was to extend previous work that used only one correlation structure by including several common correlation structures in order to assess the effect of the correlation structure in the data, and how it is modeled, on Type I error rates and power from a likelihood-based repeated measures analysis (MMRM), using LOCF for comparison. Data from four realistic clinical trial scenarios were simulated using autoregressive, compound symmetric and unstructured correlation structures. When the correct correlation structure was fit, MMRM provided better control of Type I error and power than LOCF. Although misfitting the correlation structure in MMRM inflated Type I error and altered power, misfitting the structure was typically less deleterious than using LOCF. In fact, simply specifying an unstructured matrix for use in MMRM, regardless of the true correlation structure, yielded superior control of Type I error than LOCF in every scenario. The present and previous investigations have shown that the bias in LOCF is influenced by several factors and interactions between them. Hence, it is difficult to precisely anticipate the direction and magnitude of bias from LOCF in practical situations. However, in scenarios where the overall tendency is for patient improvement, LOCF tends to: 1) overestimate a drug's advantage when dropout is higher in the comparator and underestimate the advantage when dropout is lower in the comparator; 2) overestimate a drug's advantage when the advantage is maximum at intermediate time points and underestimate the advantage when the advantage increases over time; and 3) have a greater likelihood of overestimating a drug's advantage when the advantage is small. In scenarios in which the overall tendency is for patient worsening, the above biases are reversed. In the simulation scenarios considered in this study, which were patterned after acute phase neuropsychiatric clinical trials, the likelihood-based repeated measures approach, implemented with standard software, was more robust to the bias from missing data than LOCF, and choice of correlation structure was not an impediment to its implementation.

Analysis of Variance↗
PubMed1990

Mood and self-motivation in successful and unsuccessful female rowers.

Mood state (POMS) and self-motivation (SMI) were assessed in 84 women vying for a position on a collegiate freshman rowing team. Forty-four of these rowers also completed a standardized rowing ergometer task. Mood state was assessed three additional times during the season with 22 rowers who adhered to training throughout the entire season. No differences (P greater than 0.05) in baseline mood state were observed between the dropouts (N = 62) and those who adhered to the training (N = 22). However, the dropouts possessed significantly lower self-motivation (P less than 0.05) and took longer to complete the rowing task than did the adherers (P less than 0.05). Near the end of the season, rowers were chosen by the coaching staff to compete in regional competition (i.e., successful adherers). Initial self-motivation and ergometer performance did not differ significantly (P greater than 0.05) between the successful and unsuccessful adherers. Repeated measures ANOVA revealed that global mood disturbance (P less than 0.05) increased during the training season in both groups. At the end of the training season, the unsuccessful adherers still possessed significantly (P less than 0.05) elevated mood disturbance, whereas the mood of the successful group had returned to baseline. It is concluded that female rowers who adhere to a season of competitive training have higher self-motivation and superior ergometer performances at the outset than do the eventual dropouts.

Affect↗
PubMed2001

[Prognostic factors for pulmonary tuberculosis outcome in Recife, Pernambuco, Brazil].

OBJECTIVE: The objective of this case-control study was to identify prognostic factors for the outcome of pulmonary tuberculosis among 297 patients who were treated between 1994 and 1999 at the Federal University of Pernambuco Clinics Hospital, in Recife, Pernambuco, Brazil. METHODS: The cases were defined as individuals whose treatment ended in death, dropout, or failure. The controls were persons whose treatment ended in cure. The following independent variables were submitted to uni- and multivariate analyses: sex, age, schooling, being a smoker, consuming alcohol, previous treatment for tuberculosis, response to the tuberculin test, HIV serology, resistance to antimicrobial agents, results of direct investigation of alcohol- and acid-resistant bacilli, and treatment approach used. After that, the uni- and multivariate analyses were repeated, including as cases only deaths and individuals with treatment failure. RESULTS: Four risk factors for tuberculosis treatment failure were found: excessive alcohol intake (odds ratio (OR) = 2.58; P = 0.014), co-infection with HIV (OR = 3.40; P = 0.028), previous tuberculosis treatment (OR = 4.89; P < 0.001), and resistance to two or more antituberculosis drugs (OR = 3.49; P = 0.017). In the second multivariate analysis, which excluded dropout cases, no association was found between treatment outcome and excessive alcohol consumption, but the other associations remained. This result suggests a close relationship between alcoholism and treatment dropout. CONCLUSIONS: In the group that was studied the prognostic factors for failure of pulmonary tuberculosis treatment were interrelated and were of a biological, clinical, and social character. These factors should be identified at the beginning of treatment in order to allow implementation of specific follow-up procedures such as the strategy of directly observed treatment. This would strengthen tuberculosis control at the local level.

Adult↗
PubMed1999

Discontinuation rates of Helicobacter pylori treatment regimens: a meta-analysis.

We conducted a meta-analysis to determine what factors in treatment regimens for Helicobacter pylori are associated with increased discontinuation rates. Studies were selected from the 1990-1996 MEDLINE data base, and references in published articles and reviews were obtained. Each article was uniformally abstracted for factors that could potentially affect dropout rates. Drug regimens with high numbers of doses per day had highest dropout rates (p=0.0001). The total dropout rate was lowest for regimens containing a proton pump inhibitor (OR = 0.75, CI 0.57, 0.98). The rate was high in regimens containing a bismuth compound due to side effects (OR = 2.79, CI 1.78, 4.36). The main finding was that drug regimens for eradication of H. pylori that have a high number of doses per day result in higher discontinuation rates than regimens with fewer doses per day.

Antacids↗
PubMed2006

Renal bone morphogenetic protein-7 protects against diabetic nephropathy.

Longstanding diabetes causes renal injury with early dropout of podocytes, albuminuria, glomerular and tubulointerstitial fibrosis, and progressive renal failure. The renal pathology seems to be driven, in part, by TGF-beta and is associated with a loss of renal bone morphogenic protein-7 (BMP-7) expression. Here, the hypothesis that maintenance of renal (especially podocyte) BMP-7 by transgenic expression reduces diabetic renal injury was tested. Diabetic mice that expressed the phosphoenolpyruvate carboxykinase promoter-driven BMP-7 transgene and nondiabetic, transgenic mice as well as diabetic and nondiabetic wild-type controls were studied for up to 1 yr. Transgenic expression of BMP-7 in glomerular podocytes and proximal tubules prevents podocyte dropout and reductions in nephrin levels in diabetic mice. Maintenance of BMP-7 also reduces glomerular fibrosis and interstitial collagen accumulation as well as collagen I and fibronectin expression. Diabetic wild-type mice develop progressive albuminuria, which is substantially reduced in transgenic mice. These effects of the BMP-7 transgene occur without changing renal TGF-beta levels. It is concluded that maintenance of renal BMP-7 during the evolution of diabetic nephropathy reduces diabetic renal injury, especially podocyte dropout. The findings also establish a role for endogenous glomerular BMP-7 as an autocrine regulator of podocyte integrity in vivo.

Animals↗
PubMed1995

Effects of self-efficacy and dispositional optimism on adherence to step aerobic exercise classes.

This study investigated the effects of generalized and domain-specific expectancies on participation in 8 weeks of step aerobic-exercise classes. 154 university students and staff who registered for step aerobic classes completed measures of aerobic self-efficacy and dispositional optimism prior to attending their first class. Attendance was taken at each session by the instructors. A split at the median on attendance classified participants as dropouts or adherers. Analysis indicated that adheres scored significantly higher on self-efficacy that did dropouts. Adherers and dropouts did not differ on dispositional optimism.

Adolescent↗
PubMed1999

[Compliance in use of external protectors for hip fractures among the community elderly in Japan].

To protect femoral neck fractures which are the most serious complication of osteoporosis and are increasing in frequency in Japan, an external hip protector (EHP) fixed in special underwear has been proven to absorb a direct impact to the greater trochanter during a fall from standing height. In this study, we investigated compliance concerning the use of EHPs, for six months using two types of EHP, i.e., hard pad type (Hip Protector, Sahvatex) from Denmark (Fig. 1) and soft pad type (Safety Pants, Rounomo Oy) from Finland. The subjects were 20 elderly women aged 70 years or more who had at least one experience of falling within the year preceding the baseline survey in September of 1997. The compliance rate is shown in Fig. 2. Though the soft type EHP had relatively better compliance than the hard type EHP, there was no significant difference between them. The main reason for early dropout (one or two weeks after base-line) was "difficulty to remove especially with regard to using the toilet". The main reason for later dropout was "too tight to wear in winter". There were no significant differences with regard to anthropometric measurements, physical activity, ADL, and rate of falls between compliers and dropouts except age (73.6 vs 78.5 yrs). Sufficient explanation at baseline and generatively good motivation for wearing the EHP will maintain a high compliance which may result in the effective prevention of hip fractures among the community elderly.

Aged↗
PubMed2003

Improving adherence to antidepressants: a systematic review of interventions.

BACKGROUND: Effectiveness of antidepressant medication is reduced by patients' nonadherence. Several interventions to improve adherence in patients diagnosed with unipolar depression have been tested. OBJECTIVE: To systematically review the effectiveness of interventions that aimed to improve adherence to antidepressant medication in patients with unipolar depression. METHOD: Systematic review of English-language articles of randomized controlled trials obtained by a computerized literature search of MEDLINE (1966-January 2002) using the terms patient compliance, patient dropout, treatment refusal, patient education, adherence, clinical trial, randomized controlled trial, controlled trial, depressive disorder, and depression; PSYCINFO (1984-January 2002) using the terms random, clinical, control, trial, adherence, compliance, noncompliance, dropouts, patient education, depression, major depression, affective disorders, and dysthymic disorder; EMBASE (1980-January 2002) using the terms patient compliance, patient dropouts, illness behavior, treatment refusal, patient education, clinical trial, controlled study, randomized controlled trial, and depression; and the Cochrane Controlled Trials Register (no restrictions) using the terms random*, complian*, adheren*, pharmacotherapy, regimen*, educat*, medicat*, depression, and depressive disorder. RESULTS: Educational interventions to enhance adherence failed to demonstrate a clear benefit on adherence and depression outcome. However, collaborative care interventions tested in primary care demonstrated significant improvements in adherence during the acute and continuation phase of treatment and were associated with clinical benefit, especially in patients suffering from major depression who were prescribed adequate dosages of antidepressant medication. CONCLUSION: We found evidence to support the introduction of interventions to enhance adherence with antidepressant medication in primary care, not only because of better adherence but also because of better treatment results. Because collaborative care interventions require additional resources, a better understanding of the mode of action of different programs is needed to reduce avoidable costs. The effectiveness of educational interventions needs more evidence.

Antidepressive Agents↗
PubMed1999

Altered mRNA levels of antioxidant enzymes in pre-apoptotic pericytes from human diabetic retinas.

Because programmed cell death (PCD) is an important mode of pericyte dropout in human diabetic retinopathy, whether increased oxidative stress in cells with diminished antioxidant defenses plays a causative role in the PCD process in diabetic pericytes has been studied. Ten diabetic and eight non-diabetic eye-bank eyes from 5 diabetic and 4 non-diabetic patients were included in this study. From individual neural retinas pericytes were isolated by a newly developed immunomagnetic technique. Total mRNA of the purified pericytes was isolated for quantitative reverse transcriptase (RT)-PCR assay. mRNA levels of a death protease (CPP32), the major enzyme that initiates the proteolytic cascade leading to cell death, were determined in association with the expression of antioxidative enzymes including glutathione peroxidase (GSH-Px), glutathione reductase, CuZn superoxide dismutase (SOD), MnSOD and catalase genes in pericytes. In comparison with pericytes from non-diabetic retinas, pericytes from diabetic retinas highly expressed CPP32 genes (4 +/- 0.6 fold increase, p < 0.01, n = 9). In diabetic pericytes, up-regulation of glutathione peroxidase (GSH-Px) (8.2 +/- 0.9 fold increase, p < 0.01, n = 9) and down-regulation of glutathione reductase (Gr) (4.1 +/- 0.4 fold decrease, p < 0.05, n = 9) and CuZnSOD (2.1 +/- 0.7 fold decrease, p < 0.05, n = 9) were observed. mRNA levels of MnSOD and catalase of diabetic pericytes did not differ significantly from those of non-diabetic pericytes. Overexpression of a member of interleukin-1 beta-converting enzyme (ICE) family, CPP32, indicated that the pericytes from diabetic retinas are in a "pre-PCD" state. This is the first evidence that the ICE family of death proteases is involved in pericyte dropout in diabetes. In these pre-PCD cells, the expression of antioxidant enzyme genes also was changed. Up-regulation of GSH-Px indicates a compensation mechanism to meet the demand of excessive glutathione in reduced form. Decreased levels of both glutathione reductase and CuZnSOD, despite the oxidative stress in the diabetic condition, suggest the breakdown of the antioxidant defense in pericytes. Most importantly, the altered gene profile of scavenging enzymes under diabetic conditions, correlating with overexpression of the cell death protease gene, together suggest increased oxidative stress as an etiological agent of pericyte dropout in diabetic retinopathy.

Aged↗
PubMed1998

Training and retaining Shasthyo Shebika: reasons for turnover of community health workers in Bangladesh.

Shasthyo Shebikas (SS) are community health workers forming the core of BRAC's Essential Health Care (EHC) programme. The SS dropout was 44 percent for study area and 32 percent for EHC programme. The SS discontinued their work due to lack of time, lack of "profit", and family's disapproval. The effects of the dropouts were decreased achievement of targets, and a loss of money in the amount of $24 (U.S.) per dropout SS for their training and supervision. The SS retention may increase if EHC strictly adheres to its existing guidelines when selecting trainees, and if it highlights during SS training that SS; s first and foremost role will be as that of a volunteer and then of a salesperson.

Allied Health Personnel↗
PubMed1999

Sulfasalazine treatment for rheumatoid arthritis: a metaanalysis of 15 randomized trials.

OBJECTIVE: To assess the efficacy and safety of sulfasalazine (SSZ) compared to placebo and other disease modifying drugs. METHODS: A metaanalysis was performed on 15 randomized clinical trials of rheumatoid arthritis (RA) that included SSZ (2 g/day average dose, 36 weeks average followup) as a treatment. Eight trials included a placebo group (PL), 2 hydroxychloroquine (HCQ) (350 mg/day average dose), 3 D-penicillamine (D-Pen) (667 mg/day average dose), and 4 gold sodium thiomalate or aurothioglucose (GST) (25 mg, 1 g/wk). RESULTS: Compared to PL, SSZ was superior for improvement in erythrocyte sedimentation rate (ESR) (SSZ 37%, PL 14%; p < 0.0001), morning stiffness duration (SSZ 61%, PL 33%; p = 0.008), pain visual analog scale (SSZ 42%, PL 15%; p < 0.0001), articular index (SSZ 46%, PL 20%; p < 0.0001), number of swollen joints (SSZ 51%, PL 26%; p < 0.0001), number of painful joints (SSZ 59%, PL 33%; p = 0.004), and patient global assessment (SSZ 26%, PL 14%; p = 0.02). Withdrawals from study because of adverse drug reactions were increased (SSZ 24%, PL 7%; p < 0.0001), but lack of efficacy dropouts were decreased (SSZ 8%, PL 21%; p < 0.0001). Compared to HCQ, SSZ tended to have fewer lack of efficacy dropouts (SSZ 5%, HCQ 15%; p = 0.055) and improved ESR (SSZ 43%, HCQ 26%; p = 0.10) and morning stiffness duration (SSZ 59%, HCQ 40%; p = 0.09). Compared to GST, adverse drug reaction dropouts were significantly fewer (SSZ 12%, GST 29%; p < 0.0001), while withdrawals due to lack of efficacy were greater (SSZ 13%, GST 4%; p = 0.006). More patients tended to complete treatment taking SSZ (SSZ 69%, GST 61%; p = 0.09). CONCLUSION: Over all, the metaanalysis provides data that support the effectiveness of SSZ as a treatment for RA.

Antirheumatic Agents↗