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Discontinuation rates in clinical trials in musculoskeletal pain: meta-analysis from etoricoxib clinical trial reports
R Andrew Moore, Sheena Derry, Henry J McQuay
Arthritis Research & Therapy , 2008, DOI: 10.1186/ar2422
Abstract: We examined company clinical trial reports of trials involving etoricoxib in four musculoskeletal conditions: osteoarthritis, rheumatoid arthritis, chronic low back pain and ankylosing spondylitis. Information was available from 18 randomized trials (10,143 patients) lasting 4 to 12 weeks (one 4 weeks, three 6 weeks, one 8 weeks and seven 12 weeks) and from three trials with a mean duration of about 80 weeks (34,695 patients). These clinical trial reports contain over 73,000 pages of information.Over 12 weeks, lack of efficacy and adverse event discontinuations were similar between osteoarthritis, rheumatoid arthritis and back pain, with lack of efficacy discontinuation rates some three times higher than for adverse events. All-cause and lack of efficacy discontinuations were lower with etoricoxib (all doses combined) and traditional nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) than with placebo, although NSAIDs produced higher rates of clinical adverse events and gastrointestinal discontinuations than did placebo. Etoricoxib had fewer discontinuations than NSAIDs for lack of efficacy, clinical adverse events, and laboratory and gastrointestinal adverse events, but with more discontinuations because of hypertension and oedema. Comparison with two similar meta-analyses of other cyclo-oxygenase-2 selective inhibitors (more than 80,000 patients in total) revealed consistency between analyses.Examining discontinuation data from clinical trials, even when the numbers of patients are very large, does not necessarily predict what will happen in the real world, where clinical effectiveness may differ from clinical efficacy assessed in trials. Data from these analyses appears to agree with findings from real world practice.Clinical trials most often measure efficacy – the ability of an intervention to produce the desired result. They tend not to measure effectiveness, which are the actual results found in clinical practice – a product of efficacy and adherence
Prevalence of opioid adverse events in chronic non-malignant pain: systematic review of randomised trials of oral opioids
R Andrew Moore, Henry J McQuay
Arthritis Research & Therapy , 2005, DOI: 10.1186/ar1782
Abstract: Opioids are advocated by WHO for cancer pain [1], but their role in chronic non-cancer pain is more controversial. It has been argued that certain types of chronic pain, like neuropathic pain, do not respond to opioids [2], although some patients with neuropathic pain have been shown to respond well to opioids, as do patients with chronic nociceptive pain [3]. Concerns have been expressed about the safety of long-term opioid administration [4] because of adverse effects [5], development of tolerance to the analgesic effect [6], addiction, and drug diversion [7]. Guidelines for responsible use of opioids in chronic non-cancer pain [8-10] reflect concern over these problems.At least one recent systematic review has investigated efficacy and safety of oral opioids in placebo-controlled randomised trials in chronic non-malignant pain [11]. It included 11 trials in which patients received different oral opioids, doses, and dosing regimens, over varying periods of time, and in patients with arthritis, musculoskeletal pain, neuropathic pain, and mixed conditions. Adverse event rates could be calculated for several adverse events, and numbers needed to harm were calculated, which were as low as 3 for constipation, and 5 for nausea and somnolence. Constipation (affecting 41%), nausea (32%) and somnolence (29%) were the most common adverse events.The fact that only placebo-controlled trials were included meant that any trials of different opioids, or different dosing regimens, or different formulations that did not have a placebo group were not analysed. The study was additionally limited to opioids (fentanyl, hydromorphone, methadone, morphine, oxycodone, oxymorphone) used to treat severe pain according to the WHO three-step ladder, and did not include other opioids, like codeine, dextropoxyphene, or tramadol, often used to treat moderate pain. The limited number of trials also meant that sensitivity analysis for different conditions (arthritis, musculoskeletal, or neuropath
Numbers needed to treat calculated from responder rates give a better indication of efficacy in osteoarthritis trials than mean pain scores
R Andrew Moore, Owen A Moore, Sheena Derry, Henry J McQuay
Arthritis Research & Therapy , 2008, DOI: 10.1186/ar2394
Abstract: Merck supplied the number of patients who, by 6 weeks, had achieved pain relief compared with a baseline of 0% or more, 10% or more, 20% or more, and so on at equal intervals up to 90% or more. These different levels of pain relief were used to distinguish different definitions of responders, for example at least 50% pain relief from baseline. Numbers and percentages of patients achieving each level were identified. Information was sought from a dose–response trial over 6 weeks in osteoarthritis using placebo and using etoricoxib at 5, 10, 30 and 60 mg daily.With placebo, the proportions of patients achieving at least 20%, 50% and 70% pain relief over baseline at 6 weeks were 30%, 11% and 2%. With 60 mg etoricoxib the equivalent percentages were 74%, 49% and 29%. The numbers needed to treat for 30 mg and 60 mg etoricoxib to produce at least 50% pain relief at 6 weeks compared with placebo were 4.2 (95% confidence interval 3.8 to 8.6) and 2.6 (2.0 to 3.9), respectively. Levels of pain relief of 50% and above discriminated best between different doses of etoricoxib.Responder analysis seemed to be more sensitive than examination of average changes in VAS pain scores. Validation would require calculations to be performed on a set of trials using individual patient data not available in publications.In recent years, meta-analyses of randomised trials in osteoarthritis have suggested that the benefits of some well-established therapies – oral non-steroidal anti-inflammatory drugs (NSAIDs), topical NSAIDs, intra-articular steroid injections, and opioids – are small and limited to the first 2 to 3 weeks after the start of treatment [1]. The argument is that, with 10 mm out of 100 mm average difference over placebo, the benefits just reach a threshold for minimal perceptible improvement, and barely achieve the threshold for a slight improvement. Criticism of these therapies even suggests 'that it is time to reconsider the place of these drug therapies in OAK [osteoarthritis
Topical NSAIDs for chronic musculoskeletal pain: systematic review and meta-analysis
Lorna Mason, R Andrew Moore, Jayne E Edwards, Sheena Derry, Henry J McQuay
BMC Musculoskeletal Disorders , 2004, DOI: 10.1186/1471-2474-5-28
Abstract: Studies were identified by searching electronic databases, and writing to manufacturers. We identified randomised, double blind trials comparing topical NSAID with either placebo or another active treatment, in adults with chronic pain. The primary outcome was a reduction in pain of approximately 50% at two weeks, and secondary outcomes were local and systemic adverse events and adverse event-related withdrawals. Relative benefit and number-needed-to-treat (NNT), and relative harm and number-needed-to-harm (NNH) were calculated, and the effects of trial quality, validity and size, outcome reported, and condition treated, were examined by sensitivity analyses.Twelve new trials were added to 13 trials from a previous review. Fourteen double blind placebo-controlled trials had information from almost 1,500 patients. Topical NSAID was significantly better than placebo with relative benefit 1.9 (95% confidence interval 1.7 to 2.2), NNT 4.6 (95% confidence interval 3.8 to 5.9). Results were not affected by trial quality, validity or size, outcome reported, or condition treated. Three trials with 764 patients comparing a topical with an oral NSAID found no difference in efficacy. Local adverse events (6%), systemic adverse events (3%), or the numbers withdrawing due to an adverse event were the same for topical NSAID and placebo.Topical NSAIDs were effective and safe in treating chronic musculoskeletal conditions for two weeks. Larger and longer trials are necessary to fully elucidate the place of topical NSAIDs in clinical practice.A systematic review of topical NSAIDs reported that they were effective for relieving pain in both acute and chronic conditions [1]. Number-needed-to-treat (NNT), the number of patients that need to be treated for one to benefit from a particular drug, who would not have benefited from placebo, was used to estimate efficacy. In chronic conditions, NNT for topical NSAIDs at two weeks was 3.1 (2.7 to 3.8).There are three reasons why an updated re
Role of calcitonin in management of musculoskeletal pain  [cached]
Lars Arendt-Nielsen,Hans Christian Hoeck,Morten A Karsdal,Claus Christiansen
Rheumatology Reports , 2009, DOI: 10.4081/rr.2009.e12
Abstract: Calcitonin was discovered more than 40 years ago and the scientific community continues to debate the primary and secondary pharmacological actions of calcitonin. Presently calcitonin is accepted by agencies only for treatment of osteoporosis, but many studies have indicated an effect on pain in many different experimental settings both pre-clinically and clinically. The effects of calcitonin on clinical pain conditions have received increasing attention in the past decades, although a consensus on mode of action and potential indications still has to be reached. Several key advances in the pain field may enable a deeper understanding of the putative analgesic effects of calcitonin. Most studies have focused on the effect of calcitonin on musculoskeletal pain problems. Ample lines of independent evidence suggest that calcitonin exerts putative analgesic effects. Well-designed clinical trials, particularly in the field of musculoskeletal pain, are needed to validate fragmented evidence of analgesic actions. This in combination with advanced mechanism-based pain assessment tools can provide new insight into the role of calcitonin, alone or in combination with other compounds, in management of pain.
Pain assessment strategies in patients with musculoskeletal conditions  [cached]
F. Salaffi,A. Ciapetti,M. Carotti
Reumatismo , 2012, DOI: 10.4081/reumatismo.2012.216
Abstract: Valid and reliable assessment of pain is fundamental for both clinical trials and effective pain management. The nature of pain makes objective measurement impossible. Chronic musculoskeletal pain assessment and its impact on physical, emotional and social functions require multidimensional qualitative tools and healthrelated quality of life instruments. The recommendations concerning outcome measurements for pain trials are useful for making routine assessments that should include an evaluation of pain, fatigue, disturbed sleep, physical functioning, emotional functioning, patient global ratings of satisfaction, and quality of life. Despite the growing availability of instruments and theoretical publications related to measuring the various aspects of chronic pain, there is still little agreement and no unified approach has been devised. There is, therefore, still a considerable need for the development of a core set of measurement tools and response criteria, as well as for the development and refinement of the related instruments, standardized assessor training, the cross-cultural adaptation of health status questionnaires, electronic data capture, and the introduction of valid, reliable and responsive standardized quantitative measurement procedures into routine clinical care. This article reviews a selection of the instruments used to assess chronic musculoskeletal pain, including validated newly developed and well-established screening instruments, and discusses their advantages and limitations.
Musculoskeletal pain in elderly patient
M. Cannone,D. Cova
Pathos : Trimestrale di Algologia , 2010,
Abstract: Musculoskeletal pain in arthritic and osteoporotic elderly patients is very diffused; if not adequately treated, can constitute cause of permanent invalidity with loss of autonomy, and, in the most serious cases, deaths' cause.The underestimation and the inadequate treatment of pain in the elderly have been object of many studies, whose data are reported in this review.
Estimating the number needed to treat from continuous outcomes in randomised controlled trials: methodological challenges and worked example using data from the UK Back Pain Exercise and Manipulation (BEAM) trial
Robert Froud, Sandra Eldridge, Ranjit Lall, Martin Underwood
BMC Medical Research Methodology , 2009, DOI: 10.1186/1471-2288-9-35
Abstract: We used data from the UK BEAM trial (n = 1, 334) of physical treatments for back pain; originally reported as showing, at best, small to moderate benefits. Participants were randomised to receive 'best care' in general practice, the comparator treatment, or one of three manual and/or exercise treatments: 'best care' plus manipulation, exercise, or manipulation followed by exercise. We used established consensus thresholds for improvement in Roland-Morris disability questionnaire scores at three and twelve months to derive NNTs for improvements and for benefits (improvements gained+deteriorations prevented).At three months, NNT estimates ranged from 5.1 (95% CI 3.4 to 10.7) to 9.0 (5.0 to 45.5) for exercise, 5.0 (3.4 to 9.8) to 5.4 (3.8 to 9.9) for manipulation, and 3.3 (2.5 to 4.9) to 4.8 (3.5 to 7.8) for manipulation followed by exercise. Corresponding between-group mean differences in the Roland-Morris disability questionnaire were 1.6 (0.8 to 2.3), 1.4 (0.6 to 2.1), and 1.9 (1.2 to 2.6) points.In contrast to small mean differences originally reported, NNTs were small and could be attractive to clinicians, patients, and purchasers. NNTs can aid the interpretation of results of trials using continuous outcomes. Where possible, these should be reported alongside mean differences. Challenges remain in calculating NNTs for some continuous outcomes.UK BEAM trial registration: ISRCTN32683578.Measurement, and reporting, of clinical outcomes is crucial to interpretation of randomised controlled trials. The clinical importance of some outcomes, such as death, is usually fairly clear. However, the clinical importance of differences found in patient-reported continuous outcomes, used to assess chronic disorders with variable courses, such as low back pain, is often less clear. With ever-larger trials, and meta-analyses of data from multiple trials, we have the statistical power to demonstrate quite small mean differences in these outcome measures that are unlikely to have ar
Musculoskeletal pain in Dentistry students  [PDF]
Gisela Rocha de Siqueira,Anniele Martins Silva,Ricardo Alexandre GuerraVieira,Rosane Batista e Silva
Revista Brasileira em Promo??o da Saúde , 2010,
Abstract: Objective: To investigate the frequency of musculoskeletal pain in dental students. Methods: A descriptive study of observational and cross-sectional approach in which was used an Ergonomics and Posture Questionnaire for Dentists adapted by the researchers, associated with the Cooler Quiz. The sample comprised 43 students who attended between the 6th, 8th and 10th academic periods. The data were submitted to descriptive analysis and expressed as percentages, means and standard deviations, also maximum and minimum. For the comparative analysis between the variables, we used the chi-square test, chi-square test with Yates correction or Fisher exact test, when necessary, considering the significance level of 5%. Results: Among the students surveyed 20 (46.51%) were men and 23 (53.5%) women with a mean age of 23.14 ± 10.24 years, maximum of 35 years and minimum of 19. It was found that 40 (93.02%) reported pain in some part of the body, 23 (53.5%) in the upper limbs, 20 (46.5%) in the lower limbs and 37 (86%) in axial skeleton, with no difference between genders (p = 0.59). Pain intensity was classified as mild 10 (25%), moderate 21(52.5%) and severe 7 (17.5%). In the assessment we evidenced the direct correlation between the hours of trainning and the intensity of pain. Conclusions: The results of the survey showed that the students assessed developed high frequency of musculoskeletal pain and that pain was associated with hours of daily training held during graduation at the dental clinic.
Subgroups of musculoskeletal pain patients and their psychobiological patterns – The LOGIN study protocol  [cached]
Gerhardt Andreas,Hartmann Mechthild,Tesarz Jonas,Janke Susanne
BMC Musculoskeletal Disorders , 2012, DOI: 10.1186/1471-2474-13-136
Abstract: Background Pain conditions of the musculoskeletal system are very common and have tremendous socioeconomic impact. Despite its high prevalence, musculoskeletal pain remains poorly understood and predominantly non-specifically and insufficiently treated. The group of chronic musculoskeletal pain patients is supposed to be heterogeneous, due to a multitude of mechanisms involved in chronic pain. Psychological variables, psychophysiological processes, and neuroendocrine alterations are expected to be involved. Thus far, studies on musculoskeletal pain have predominantly focused on the general aspects of pain processing, thus neglecting the heterogeneity of patients with musculoskeletal pain. Consequently, there is a need for studies that comprise a multitude of mechanisms that are potentially involved in the chronicity and spread of pain. This need might foster research and facilitate a better pathophysiological understanding of the condition, thereby promoting the development of specific mechanism-based treatments for chronic pain. Therefore, the objectives of this study are as follows: 1) identify and describe subgroups of patients with musculoskeletal pain with regard to clinical manifestations (including mental co-morbidity) and 2) investigate whether distinct sensory profiles or 3) distinct plasma levels of pain-related parameters due to different underlying mechanisms can be distinguished in various subgroups of pain patients. Methods/Design We will examine a population-based chronic pain sample (n = 100), a clinical tertiary care sample (n = 100) and pain-free patients with depression or post-traumatic stress disorder and pain-free healthy controls (each n = 30, respectively). The samples will be pain localisation matched by sex and age to the population-based sample. Patients will undergo physical examination and thorough assessments of mental co-morbidity (including psychological trauma), perceptual and central sensitisation (quantitative sensory testing), descending inhibition (conditioned pain modulation, the diffuse noxious inhibitory control-like effect), as well as measurement of the plasma levels of nerve growth factor and endocannabinoids. Discussion The identification of the underlying pathophysiologic mechanisms in different subgroups of chronic musculoskeletal pain patients will contribute to a mechanism-based subgroup classification. This will foster the development of mechanism-based treatments and holds promise to treat patients more sufficient.
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