The effects of exercise and education, individually or combined, in women with fibromyalgia.

OBJECTIVE: To examine the effectiveness of a supervised aerobic exercise program, a self-management education program, and the combination of exercise and education for women with fibromyalgia (FM). METHODS: One hundred fifty-two women were randomized into one of 4 groups: exercise-only, education-only, exercise and education, or control. The duration of the study was 12 weeks. All subjects were analyzed at 3 times: before study, immediately upon completion, and 3 months after completion of the intervention program on measures of disability, self-efficacy, fitness, tender point count, and tender point tenderness. Of the 152 women, complete data were available for 95 and 69 who complied with the protocol. In order to determine the group time interaction, a 2 way analysis of variance with repeated measures was used for each measure. RESULTS: The only significant group time interaction was reported with the compliance analysis for the Self-Efficacy Coping with Other Symptoms subscale and the Six Minute Walk. If the program was followed, the combination of a supervised exercise program and group education provided persons with FM with a better sense of control over their symptoms. Fitness improved in the 2 groups undergoing supervised aerobic exercise programs. However, the improvement in fitness was maintained at followup in the exercise-only group and not the combined group. Conclusion. Subjects receiving the combination of exercise and education and who complied with the treatment protocol improved their perceived ability to cope with other symptoms. In addition, a supervised exercise program increased walking distance at post-test, an increase that was maintained at followup in the exercise-only group. Results demonstrate the challenges with conducting exercise and education studies in persons with FM.

Predictors of success of intervention programs for persons with fibromyalgia.

OBJECTIVE: To determine which sociodemographic, psychological, and behavioral characteristics of persons with fibromyalgia (FM) will predict a positive response to treatment; and to determine if subjects classified according to the Multidimensional Pain Inventory (MPI) responded differently to the interventions. METHODS: One hundred twenty-eight women with FM underwent baseline testing and were randomized into one of 3 intervention groups or a control group. After the 12 week program, the subjects were reexamined on the same pretest measures. Stepwise regression analyses were conducted to determine the variables that could significantly predict the change in the dependent variables. A reliability of change index was calculated to determine the proportion of responders and nonresponders. RESULTS: The stepwise regression revealed significant predictor variables for change for all dependent variables except the Fibromyalgia Impact Questionnaire; however, the percentage of the variance in the change scores explained by the independent variables ranged from 4 to 15%. Results from the reliability of change index indicated that no MPI subgroup responded more than another group on any measure. CONCLUSION: Select sociodemographic and psychosocial variables and type of intervention were not strong predictors of improvement in a variety of measures after a treatment program. The low percentage of explained variance may be due to the heterogeneity of FM. Additionally, the low percentage of responders suggests that current forms of treatment are not effective for a large portion of the FM population.

A six-month randomized, controlled, double-blind, dose-response comparison of intravenous pamidronate (60 mg versus 10 mg) in the treatment of nonsteroidal antiinflammatory drug-refractory ankylosing spondylitis.

OBJECTIVE: To determine the safety and efficacy of intravenous (IV) pamidronate treatment in ankylosing spondylitis (AS) patients who have had a suboptimal response to nonsteroidal antiinflammatory drugs (NSAIDs). METHODS: Pamidronate at 60 mg was compared with pamidronate at 10 mg rather than placebo in view of the high incidence of transient arthralgias upon first IV exposure to the drug. The drug were given monthly for 6 months in a randomized double-blind, controlled trial. The inclusion criterion was active disease (Bath AS Disease Activity Index [BASDAI] of > or = 4 or morning stiffness of > or = 45 minutes) despite stable NSAID therapy. The primary outcome measure was the BASDAI, and secondary outcomes included the Bath AS Functional Index (BASFI), Bath AS Global Index (BASGI), Bath AS Metrology Index (BASMI), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) level, and percentage of patients achieving a reduction of > or = 25% in the BASDAI. Outcome assessments were done at -2, 0, 12, and 24 weeks, and analysis was by intent to treat. RESULTS: Eighty-four AS patients (67 men and 17 women; mean age 39.6 years and mean disease duration 15.1 years) were enrolled. Dosage groups were well matched at baseline for demographics, disease activity, and functional indices. At 6 months, the mean BASDAI had decreased by 2.22 (34.5%) in the 60-mg group and by 0.93 (15%) in the 10-mg group (P = 0.002). Significantly greater reductions in the 60-mg group were also noted for the BASFI (P < 0.001), BASGI (P = 0.01), and BASMI (P = 0.03). Significantly more patients achieved a reduction of > or = 25% in the BASDAI in the 60-mg group versus the 10-mg group (63.4% versus 30.2%; P = 0.004). Differences in ESR/CRP were not significant (NS). Withdrawals included 9 (20.9%) from the 10-mg group and 3 (7.3%) from the 60-mg group (P NS). Adverse events were confined to transient arthralgias/myalgias after the first IV infusion, occurring in 68.3% and 46.5% of patients in the 60-mg and 10-mg groups, respectively (P NS). CONCLUSION: Pamidronate has dose-dependent therapeutic properties in AS.