OBJECTIVE: To determine whether study sponsor, chemical formulation, brand of glucosamine, and/or risk of bias explain observed inconsistencies in trials of glucosamine's efficacy for treating pain in osteoarthritis (OA).

METHODS: A systematic review and stratified meta-analysis of randomized placebo-controlled trials was performed, and random-effects models were applied with inconsistency (I(2) ) and heterogeneity (tau(2) ) estimated using Review Manager and SAS, respectively. The major outcome was reduction of pain; the standardized mean difference (SMD [95% confidence interval (95% CI)]) served as effect size.

RESULTS: The inclusion criteria yielded 25 trials (3,458 patients). Glucosamine moderately reduced pain (SMD -0.51 [95% CI -0.72, -0.30]), although a high level of between-trial inconsistency was observed (I(2) = 88%). The single most important explanation (i.e., covariate) was brand, reducing heterogeneity by 41% (P = 0.00032). Twelve trials (1,437 patients) using the Rottapharm/Madaus product resulted in significant pain reduction (SMD -1.07 [95% CI -1.47, -0.67]), although a sensitivity analysis of 3 low risk of bias trials using the Rottapharm/Madaus product showed less promising results (SMD -0.27 [95% CI -0.43, -0.12]), which is only a small effect size. Thirteen trials (1,963 patients) using non-Rottapharm/Madaus products consistently failed to show a reduction in pain (SMD -0.11 [95% CI -0.46, 0.24]). The second most important explanation was overall risk of bias (reducing heterogeneity by 32%).

CONCLUSION: Most of the observed heterogeneity in glucosamine trials is explained by brand. Trials using the Rottapharm/Madaus glucosamine product had a superior outcome on pain in OA compared to other preparations of glucosamine. Large inconsistency was found, however. Low risk of bias trials, using the Rottapharm/Madaus product, revealed a small effect size.

OBJECTIVE: Patients suffering from chronic obstructive pulmonary disease (COPD) experience problems in the performance of activities of daily living (ADL) tasks. The objective was to examine the self-reported quality of ADL task performance among COPD patients, and to investigate whether age, gender, and routine COPD characteristics correlate with the self-reported ADL ability.

METHODS: Eighty patients admitted to hospital with COPD exacerbations participated. In a cross-sectional study, the patients' self-reported ADL ability was assessed using the ADL-Interview (ADL-I) instrument. Data concerning age, gender, and routine COPD characteristics were drawn from the patients' medical records.

RESULTS: The patients reported being inefficient to markedly inefficient when performing ADL tasks within the personal hygiene, toileting, dressing, household, mobility, and transportation domains. While more than 90% of the participants reported increased effort and/or fatigue when performing the ADL tasks, up to 88% of the participants relied on help from others in the performance of general household chores like cooking and shopping. Self-reported ADL ability did not correlate with age, gender, or routine COPD characteristics.

CONCLUSIONS: Decreased quality of ADL task performance seemed to be extremely common among COPD patients. Therefore, addressing the problems in individually tailored pulmonary rehabilitation programmes may be advantageous.

Our objective was to investigate the efficacy of "energy/spiritual healing" in rheumatoid arthritis (RA). Eligible patients were women with RA on stable medication. The design was a randomised, blinded, sham-controlled trial; the third group included an external unblinded control of the natural course of RA. Participants in both groups received 8 sessions with "perceived healing" over 21 weeks with 8 weeks of follow-up. Active healing (AH) treatment comprised healing with no physical contact, and sham healing (SH) included exactly the same healing with a sham healer. During intervention, participants wore hearing protectors and were blindfolded. No healing (NH) only had their outcomes assessed. Coprimary outcomes were disease activity score (DAS) for 28 joints and Doppler ultrasound. All 96 patients randomised were handled as the intention-to-treat population, using a baseline-carried forward approach to replace the missing data. Eighty-two (85%) participants completed the 29-week trial. At end point (week 29), mean difference in DAS28 between AH versus SH was statistically but not clinically significant in favour of AH (0.62 DAS28 points; 95% CI: 0.13 to 1.11; P = 0.014), while no differences between groups occurred in Doppler ultrasound. There are no clear physiological or psychological explanations for the findings in this tightly controlled study. The trial data indicates a need for independent replication.

OBJECTIVE: To compare structural knee joint changes in obese patients with knee osteoarthritis (OA) that after an intensive weight loss therapy were randomized to continuous dietetic support, a specialized knee exercise program, or 'no attention' for 1 year.

METHODS: 192 obese individuals with knee OA underwent an intensive 16-week weight loss program with subsequent randomization to one of the three treatment groups. Changes in cartilage loss, bone marrow lesions (BMLs), synovitis, and effusion were assessed using semi quantitative assessments of magnetic resonance imaging (MRI) obtained at weeks 0 and 68 applying the BLOKS score.

RESULTS: During the 52 weeks maintenance period the continuous dietary maintenance group support on average gained 1.1 kg (95% CI: -0.3:2.5) body mass, the exercise group gained 6.6 kg (95% CI 5.4:7.8) and the no-attention group gained 4.8 kg (95% CI: 2.9:6.7). There were no statistically significant between-group differences in changes in cartilage loss, synovitis or effusion at the follow-up (analysis of covariance; ANCOVA, P > 0.16), while there was an increased number of medial tibiofemoral BMLs in the exercise group (ANCOVA, P = 0.015) compared to both diet (difference: -0.21 [95%CI -0.40:-0.03]) and "no attention" (difference: -0.26 [95%CI -0.44:-0.07]) groups.

CONCLUSION: In this 1 year follow-up after weight-loss in obese knee OA patients, we found a potentially increased number of BMLs in the exercise group compared to the diet and no attention groups, with no between-group differences in changes in cartilage loss, synovitis or effusion. These findings should be interpreted with caution for exercise compliance, MRI methodology and follow-up time. (ClinicalTrials.gov identifier: NCT00655941).

BACKGROUND: Knee osteoarthritis (OA) is a mechanically driven disease, and it is suggested that medial tibiofemoral knee-joint load increases with pharmacologic pain relief, indicating that pharmacologic pain relief may be positively associated with disease progression. Treatment modalities that can both relieve pain and reduce knee-joint load would be preferable. The knee-joint load is influenced by functional alignment of the trunk, pelvis, and lower-limb segments with respect to the knee, as well as the ground-reaction force generated during movement. Neuromuscular exercise can influence knee load and decrease knee pain. It includes exercises to improve balance, muscle activation, functional alignment, and functional knee stability. The primary objective of this randomized controlled trial (RCT) is to investigate the efficacy of a NEuroMuscular EXercise (NEMEX) therapy program, compared with optimized analgesics and antiinflammatory drug use, on the measures of knee-joint load in people with mild to moderate medial tibiofemoral knee osteoarthritis.

METHOD/DESIGN: One hundred men and women with mild to moderate medial knee osteoarthritis will be recruited from general medical practices and randomly allocated (1:1) to one of two 8-week treatments, either (a) NEMEX therapy twice a week or (b) information on the recommended use of analgesics and antiinflammatory drugs (acetaminophen and oral NSAIDs) via a pamphlet and video materials. The primary outcome is change in knee load during walking (the Knee Index, a composite score of the first external peak total reaction moment on the knee joint from all three planes based on 3D movement analysis) after 8 weeks of intervention. Secondary outcomes include changes in the external peak knee-adduction moment and impulse and functional performance measures, in addition to changes in self-reported pain, function, health status, and quality of life.

DISCUSSION: These findings will help determine whether 8 weeks of neuromuscular exercise is superior to optimized use of analgesics and antiinflammatory drugs regarding knee-joint load, pain and physical function in people with mild to moderate knee osteoarthritis.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01638962 (July 3, 2012).

In the United States, access to care is the number one issue facing our patients with dermatological conditions. In part, this is because we do not have outcome measures that are useful in clinical practice and available in databases where payers and governmental agencies can compare the performance of physicians and treatments. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials and subsequently in clinical practice. The International Dermatology Outcome Measures group includes all willing stakeholders: patients, physicians, payers, and pharmaceutical scientists. As reported herein, the group's goal is to develop outcome measures in dermatology that address the needs of all involved.