The elderly were under-represented in osteoarthritis clinical trials.
ABSTRACT Osteoarthritis is the most common disease affecting joints in the elderly. We aimed to evaluate if elderly patients are properly represented in clinical trials of diverse osteoarthritis interventions.
Clinical trials of osteoarthritis interventions were retrieved from Cochrane Library systematic reviews (2006, issue 2). We examined the age distribution of the trial participants and eligibility criteria.
We analyzed data from 219 eligible trials from 18 systematic reviews. The average mean age of the participants was 63 years. Only 13 trials (6.4%) had a mean age between 71 and 80 years and only one trial had a mean age exceeding 80 years. Among trials where the age range of participants was available or could be approximately inferred, we estimated that 66 (38%) trials had not included any patients over 80 years old. Only 23 trials specifically excluded patients over 70 based on reported eligibility criteria, but 168 trials excluded patients with various comorbidities and 142 trials excluded patients receiving other specific treatments.
Elderly patients are considerably under-represented in clinical trials of osteoarthritis. This causes an important deficit in the utility, relevance, and generalizability of trial results for this very common condition.
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ABSTRACT: This paper examines the prevalence and severity of comorbid pain, insomnia, and depression in a population sample of older adults with osteoarthritis (OA), and assesses characteristics distinguishing participants from non-participants in a randomized clinical trial to improve pain and sleep. Potential subjects were Group Health Cooperative members, aged 60+, who had an electronic medical record OA diagnosis in the prior 3 years. Participants were recruited using a low-cost mailed survey. Fifty-five percent of surveys were completed and returned (n=3321). Persons with Grade II-IV arthritis pain on the Graded Chronic Pain Scale and reporting sleep difficulties 3+ nights/week during the past month with daytime dysfunction (n=834) were invited to participate in one of three group-format behavioral self-management interventions. A total of 367 participants attended the first group class. One-third (36.4%) of survey respondents had clinically elevated levels of OA pain and insomnia. Group participants and non-participants did not differ in ratings of pain severity, sleep disturbance, depression, or receipt of prescription medications for pain or sleep. Participants were significantly older (p<.001) and more likely to be retired (p<.001) than subjects who were eligible to participate but did not. Participation in a group-format behavioral intervention for pain and insomnia was not related to participant clinical characteristics, but only to factors associated with ability to attend a daytime class (age and retirement status). We conclude that population-based recruitment yielded randomized trial participants who are clinically generalizable to the population of OA patients with significant pain and insomnia.Journal of psychosomatic research 11/2011; 71(5):296-9. · 2.91 Impact Factor
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ABSTRACT: Sphaeralcea angustifolia Cavanilles & Don (Malvaceae), known in Mexico as "Vara de San José", is used in Mexican Traditional Medicine as an anti-inflammatory and, more specifically, for treating rheumatism. Anti-inflammatory properties have been demonstrated in different pharmacological models. AIM OF THE STUDY: The therapeutic effectiveness and tolerability of the topical administration of a gel elaborated with a standardized Sphaeralcea angustifolia extract applied to patients with Hand osteoarthritis (HOA) was evaluated. MATERIALS AND METHODS: A pharmaceutical formulation in a gel presentation that contained a standardized extract (hydroxycoumarin content) of S. angustifolia was elaborated and later evaluated in a double-blind, randomized study controlled with a similar formulation containing 2% diclofenac. Treatments were administered topically for 4 weeks on the affected hand(s). Clinical evolution was followed weekly by means of the Algofunctional Index (AFI) and the Visual Analog Scale (VAS). RESULTS AND DISCUSSION: A total of 130 participants were included in the study. Among these, 113 were considered in the analysis (55 in the experimental group and 58 in the control group). In both groups, important improvement in the patients' symptomatology was noted. Therapeutic effectiveness was 89 and 91.3% in the two groups, respectively, without a statistically significant difference between the groups. None of the treatments presented any adverse effects. CONCLUSION: The 4-week topical administration of a gel formulation elaborated with a 1% standardized extract of Sphaeralcea angustifolia showed therapeutic effectiveness and tolerability when administered to patients with HOA, without exhibiting significant differences when compared with the effect observed in patients treated with 2% diclofenac.Journal of ethnopharmacology 03/2013; · 2.32 Impact Factor
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ABSTRACT: We aimed to determine the representation of elderly people in published reports of randomized controlled trials (RCTs). We focused on trials of 4 medications--pioglitazone, rosuvastatin, risedronate, and valsartan-frequently used by elderly patients with chronic medical conditions. We selected all reports of RCTs indexed in PubMed from 1966 to April 2008 evaluating one of the 4 medications of interest. Estimates of the community-based "on-treatment" population were from a national health insurance database (SNIIR-AM) covering approximately 86% of the population in France. From this database, we evaluated data claims from January 2006 to December 2007 for 1,958,716 patients who received one of the medications of interest for more than 6 months. Of the 155 RCT reports selected, only 3 studies were exclusively of elderly patients (2 assessing valsartan; 1 risedronate). In only 4 of 37 reports (10.8%) for pioglitazone, 4 of 22 (18.2%) for risedronate, 3 of 29 (10.3%) for rosuvastatine and 9 of 67 (13.4%) for valsartan, the proportion of patients aged 65 or older was within or above that treated in clinical practice. In 62.2% of the reports for pioglitazone, 40.9% for risedronate, 37.9% for rosuvastatine, and 70.2% for valsartan, the proportion of patients aged 65 or older was lower than half that in the treated population. The representation of elderly people did not differ by publication date or sample size. Elderly patients are poorly represented in RCTs of drugs they are likely to receive.PLoS ONE 01/2012; 7(3):e33559. · 3.53 Impact Factor