Short-term efficacy of rofecoxib and diclofenac in acute shoulder pain: a placebo-controlled randomized trial.

OBJECTIVES: To evaluate the short-term symptomatic efficacy of rofecoxib and diclofenac versus placebo in acute episodes of shoulder pain. DESIGN: Randomized controlled trial of 7 days. SETTING: Rheumatologists and/or general practitioners totaling 47. PARTICIPANTS: Acute shoulder pain. INTERVENTIONS: Rofecoxib 50 mg once daily, diclofenac 50 mg three times daily, and placebo. OUTCOME MEASURES: Pain, functional impairment, patient's global assessment of his/her disease activity, and local steroid injection requirement for persistent pain. The primary variable was the Kaplan-Meier estimates of the percentage of patients at day 7 fulfilling the definition of success (improvement in pain intensity and a low pain level sustained to the end of the 7 days of the study; log-rank test). RESULTS: There was no difference in the baseline characteristics between the three groups (rofecoxib n = 88, placebo n = 94, and diclofenac n = 89). At day 7, the Kaplan-Meier estimates of successful patients was higher in the treatment groups than in the placebo (54%, 56%, and 38% in the diclofenac, rofecoxib, and placebo groups respectively, p = 0.0070 and p = 0.0239 for placebo versus rofecoxib and diclofenac, respectively). During the 7 days of the study, there was a statistically significant difference between placebo and both active arms (rofecoxib and diclofenac) in all the evaluated outcome measures A local steroid injection had to be performed in 33 (35%) and 19 (22%) patients in the placebo and rofecoxib group respectively. Number needed to treat to avoid such rescue therapy was 7 patients (95% confidence interval 5-15). CONCLUSION: This study highlights the methodological aspects of clinical trials, e.g., eligibility criteria and outcome measures, in acute painful conditions. The data also establish that diclofenac and rofecoxib are effective therapies for the management of acute painful shoulder and that they reduce the requirement for local steroid injection.

Effect of neonatal phototherapy on melanocytic nevus count in children.

BACKGROUND: Melanocytic nevus is the strongest risk factor for the development of cutaneous melanoma. Fair skin and exposure to UV light, especially in childhood, are correlated with the development of childhood nevi. OBJECTIVE: To assess the role of blue light neonatal phototherapy used to treat hyperbilirubinemia in nevus acquisition in childhood. DESIGN: Case-control prospective study. SETTING: University hospital. PARTICIPANTS: Fifty-eight children were included in this study. Selection criteria included the following: age, 8 to 9 years; and skin type, less than IV by Fitzpatrick classification (ie, brown, always tans, rarely burns). The case group consisted of 18 children exposed to neonatal phototherapy (mostly intensive phototherapy) retrospectively found by review of consecutive neonatal medical records at Saint-Antoine Hospital, Paris, France. The control group was composed of 40 nonexposed children consecutively recruited from a public school in the same geographic area. MAIN OUTCOME MEASURES: Total body nevus count in children, phenotypic characteristics, solar exposure, and demographic data were assessed by the same dermatologist. RESULTS: A comparison of both groups showed that the number of nevi larger than 2 mm was significantly higher in the exposed group. The mean (SD) nevus count was 3.5 (3.05; median, 3.0) per child in the exposed group, compared with 1.45 (1.99; median, 1.0) per child in the nonexposed group (P(mean) = .02 and P(median) = .01). Multivariate analysis confirmed these results, with a statistically significant correlation with nevus count, especially with nevi 2 to 5 mm in greatest diameter. The association between neonatal phototherapy and nevus count was not significant for nevi smaller than 2 mm or larger than 5 mm. Solar exposure, especially during vacations, was strongly associated with total nevus count and all nevus sizes (2-5 mm, <2 mm, and >5 mm). At univariate analysis, hair color was significantly associated with nevus size smaller than 2 mm (P(mean) = .03). CONCLUSIONS: Intensive neonatal phototherapy is a strong risk factor for nevus development in childhood. While childhood development of nevi is correlated with fair skin and solar light exposure, and having many nevi is a recognized risk factor in persons with melanoma, we must be careful not to equate childhood nevi development in response to neonatal phototherapy with an individual's risk of developing melanoma. The treatment of hyperbilirubinemia remains neonatal phototherapy. Exposed children should undergo dermatologic preventive measures and surveillance for the development of melanoma.

Spinal tuberculosis: a longitudinal study with clinical, laboratory, and imaging outcomes.

OBJECTIVES: To study imaging changes associated with spinal tuberculosis (ST) over time and evaluate their association with clinical and laboratory data. METHODS: Between 1997 and 2004, patients with proven ST in our institution were prospectively enrolled and treated for 1 year. Clinical and laboratory data were collected at baseline and every 3 months. Computed tomography (CT) and magnetic resonance imaging (MRI) were performed at baseline. MRI was performed at least twice during treatment and at the end of treatment. RESULTS: Nineteen patients were enrolled; neurological signs were present at baseline in 14 patients (74%). Initial MRI/CT findings comprised (in percentages of patients) the following: paravertebral abscesses (100/100); intradiscal abscesses (47/0); and epidural abscesses (82/24) with spinal cord compression (64/18) or radicular compression (36/0). Edema of the vertebral body was observed on initial MRI in all the patients. Full follow-up data were available for 15 patients: all were cured with a mean follow-up of 25 months after the end of treatment. Weight gain was nearly maximal at 6 months, and pain relief was achieved within 9 months. C-reactive protein returned to normal after 3 months. On MRI, all epidural abscesses disappeared within 9 months; paravertebral abscesses disappeared after 3, 6, and 12 months in 45, 50, and 85% of patients, respectively. Vertebral body signal converted to a fatty signal in 75% of cases at 12 months. CONCLUSIONS: Significant imaging abnormalities can persist after successful treatment of ST. These findings suggest that MRI need not be repeated in patients with clinical and laboratory improvement.

Quality of reporting of noninferiority and equivalence randomized trials.

CONTEXT: Noninferiority and equivalence trials aim to show that the experimental treatment is not clinically worse than (noninferior) or clinically similar to (equivalent) a control active treatment. These study objectives imply particular planning and analysis. OBJECTIVE: To assess the methodologic quality of reports of randomized controlled trials of noninferiority and equivalence. DESIGN: We searched MEDLINE and the Cochrane Central Register of Controlled Trials for reports of randomized controlled trials of noninferiority and equivalence hypotheses published between January 1, 2003, and December 31, 2004. MAIN OUTCOME MEASURES: Data extracted by use of a standardized form involved assessment of choice of noninferiority or equivalence margins, sample size calculation, sets of patients analyzed, method of statistical testing and reporting results, and conclusions. RESULTS: A total of 162 reports were included in the analysis (116 reports of noninferiority and 46 of equivalence). The margin defining noninferiority or equivalence was described in most reports (156 [96.3%]), with justification of the margin in only 33 (20.4%). Almost one quarter of the reports (35 [21.6%]) did not describe a sample size calculation, and an additional 11 (6.8%) did not take into account a prespecified noninferiority or equivalence margin. Less than half of the reports (69 [42.6%]) described both an intent-to-treat (ITT; all randomized patients are included in the analysis) or modified ITT (patients who never received treatment are excluded) and per-protocol (patients who did not complete the treatment are excluded) analysis, and only about half of those (39 [56.5%]) described both types of results. Results were displayed with confidence intervals in 136 reports (84.0%). Only 33 articles (20.3%) fulfilled reporting requirements specific to noninferiority and equivalence trials, 4 of them (12.1%) with misleading conclusions. CONCLUSIONS: Reporting of noninferiority and equivalence trials has important deficiencies: absence of noninferiority or equivalence margin, only an ITT (or a per-protocol) analysis performed, and results not adequately reported. Moreover, even for articles fulfilling these requirements, conclusions are sometimes misleading.