Objectives There is conflicting evidence on the efficacy of Traditional Chinese Acupuncture (TCA), and the role of placebo effects elicited by acupuncturists’ behavior has not been elucidated. We conducted a 3-month randomized clinical trial in patients with knee osteoarthritis to compare the efficacy of TCA to sham acupuncture, and examine the effects of acupuncturists’ communication style. Methods Acupuncturists were trained to interact in one of two communication styles: ‘high’ or ‘neutral’ expectations. Patients were randomized to one of 3 groups: waiting list, ‘high’ or ‘neutral’, and nested within style, TCA or sham acupuncture over 6 weeks. Sham acupuncture was performed in non-meridian points, with shallow needles and minimal stimulation. Primary outcome measures were: Joint-specific Multidimensional Assessment of Pain (J-MAP), Western Ontario McMaster Osteoarthritis Index (WOMAC), and satisfaction. Results 455 patients who received treatment (TCA or sham) and 72 controls were included. No statistically significant differences were observed between TCA or sham acupuncture, but both groups had significant reductions in J-MAP and WOMAC pain compared to the waiting group (-1.1, -1.0, and -0.1, p<0.001; -13.7, -14, -1.7, p<0.001). Statistically significant differences were observed in J-MAP pain reduction and satisfaction, favoring the ‘high’ expectations group. Fifty-two percent and 43% in the TCA and sham groups thought they had received TCA (kappa=0.05), suggesting successful blinding. Conclusion TCA was not superior to sham acupuncture. However, acupuncturists’ style had significant effects on pain reduction and satisfaction, suggesting that the analgesic benefits of acupuncture can be partially mediated through placebo effects related to the acupuncturist's behavior.
This study assessed self-reported adherence in patients with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) from underserved healthcare settings. We conducted a cross-sectional survey of 102 ethnically diverse patients--70 with RA and 32 with SLE--attending rheumatology clinics at publicly funded hospitals in Houston, Texas; 43% were Hispanic, 32% African-American, and 25% White. Treatment adherence was evaluated using the compliance questionnaire rheumatology (CQR; 0, low adherence and 100, high adherence) and the questionnaire of the Adult AIDS Clinical Trials Group (AACTG). The patients were also asked how often they forgot to take their prescribed medications or discontinued them on their own. Mean patient age was 48.5 years; 75% were female, 32% were African-American, 43% Hispanic, and 25% White. Only one third reported never forgetting to take their medications; 40% reported having stopped their medications on their own because of side effects, and 20% because of lack of efficacy. Mean CQR score was 69.1 +/- 10.5, suggesting moderate adherence overall. Differences were also observed across ethnic groups: 23% of ethnic minority patients had problems taking their medications at specified times compared to 11% of Whites (p = 0.03). Lower education and side effects were associated with lower adherence. No differences were observed between RA and SLE patients. Many patients with RA and SLE report problems with treatment adherence. These appear to be more prevalent in African Americans and Hispanics than Whites; the impact of decreased adherence on outcomes could be significant and should be considered when treating patients with RA and SLE.
Background To quantify adherence to oral therapies in ethnically diverse and economically disadvantaged patients with rheumatoid arthritis (RA) using electronic medication monitoring, and to evaluate the clinical consequences of low adherence. Methods 107 patients with RA enrolled in a 2-year prospective cohort study agreed to have their oral RA drug therapy intake electronically monitored, with the Medication Events Monitoring System (MEMS®). Adherence to disease-modifying antirheumatic drugs (DMARDs) and prednisone were determined as the percentage of days (or weeks for methotrexate) in which the patient took the correct dose as prescribed by the physician. Patient outcomes were assessed including the Modified Health Assessment Questionnaire (MHAQ), the Disease Activity Index 28 (DAS28), quality of life and radiological damage using Sharp-van der Heijde scores. Results Adherence to the treatment regimen as determined by percent of correct doses was 64% for DMARDs and 70% for prednisone. Patients who had better mental health were statistically more likely to be adherent. Only 23 (21%) of the patients had an average adherence to DMARDs ≥ 80%. These patients showed significantly better disease activity scores across 2 years of follow-up than those who were less adherent (DAS28 3.3±1.3 vs. 4.1±1.2, p<0.02). Radiological scores were also worse in non-adherent patients at baseline and 12 months. Conclusions Only one fifth of the RA patients had an overall adherence of at least 80%. Less than two thirds of the prescribed DMARD doses were correctly taken. Adherent patients had lower disease activity and radiological damage scores across the 2 years of follow-up.
Our objective was to examine the impact of a videobooklet patient decision aid supplemented by an interactive values clarification exercise on decisional conflict in patients with knee osteoarthritis (OA) considering total knee arthroplasy. 208 patients participated in the study (mean age 63 years; 68% female; 66% White). Participants were randomized to 1 of 3 groups: (1) Educational booklet on OA management (control); (2) Patient decision aid (videobooklet) on OA management; and (3) Patient decision aid (videobooklet) + adaptive conjoint analysis ACA tool. The ACA tool enables patients to consider competing attributes (i.e. specific risks/benefits) by asking them to rate a series of paired-comparisons. The primary outcome was the decisional conflict scale ranging from 0 to 100. Differences between groups were analyzed using analysis of variance (ANOVA) and Tukey's honestly significant difference tests. Overall, decisional conflict decreased significantly in all groups (p<0.05). The largest reduction in decisional conflict was observed for participants in the videobooklet decision aid group (21 points). Statistically significant differences in pre vs. post-intervention total scores favored the videobooklet group compared to the control group (21 vs. 10) and to the videobooklet plus ACA group (21 vs. 14; p<0.001). Changes in the decisional conflict score for the control compared to the videobooklet decision aid + ACA group were not significantly different. In our study, an audiovisual patient decision aid decreased decisional conflict more than printed material alone, or than the addition of a more complex computer-based ACA tool requiring more intense cognitive involvement and explicit value choices.
Severe obesity is an independent risk factor for slow recovery over 3 years for both hip and knee arthroplasties.
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