Background Beneficial effects from placebo have been documented in many diseases, such as osteoarthritis and Parkinson's disease (1), but how effective placebo is in the treatment of fibromyalgia (FM) is unknown. Many published randomised controlled trials (RCTs) have compared a variety of treatments to placebo in participants with FM. It is feasible to study the magnitude of the placebo effect observed within these trials. Objectives [1] to determine whether placebo is effective for FM; [2] to identify the possible determinants of the magnitude of the placebo effect Methods We searched Medline, PubMed, Web of Science, EMBASE, and CINAHL for RCTS in FM that included either a placebo group or a no treatment (observation only) group. The placebo effect was measured as a standard mean change, or effect size (ES) of pain and other outcomes from baseline (ie, mean change from baseline divided by the standard division of the change) and compared to change in these outcomes in no treatment control groups. Meta-analysis was undertaken to combine data from different studies. Subgroup analysis was conducted to identify possible determinants of the magnitude of the placebo effect. Results 3375 studies were found from the literature search. After scrutiny, 204 trials met the inclusion criteria. In total 13,968 participants were included from all trials, (mean age 49.2 years; 95.4% women). Participants who took placebo in the trials had significant improvements in pain, fatigue, sleep quality, physical function, and other main outcomes, while participants in the no treatment controlled group remained unchanged. The overall ES of placebo for pain is clinically moderate (ES=0.47, 95%CI 0.37 to 0.56). The ES increased with increasing strength of the active treatment, older age and higher baseline pain severity, but was lower in women than men and lower in RCTs with longer treatment periods. Conclusions Although considered a hard-to-treat condition, people with FM treated with placebo can show significant improvement in pain and other outcomes. Several variables influence the magnitude of this effect. Optimisation of such contextual response could have relevance to clinical care. References Zhang W, Robertson J, Jones AC, Dieppe PA, Doherty M. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials. Annals of the Rheumatic Diseases 2008;67(12):1716-23. Acknowledgements I'd like to thank Dr. Weiya Zhang and Prof. Michael Doherty for their supervision and Arthritis Research UK for sponsoring this research. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.3172
12.15% [95% CI (À2.71, 27.12; P ¼ 0.12)]. Considering the higher dropout rate in the Control group (20%) compared to the Intervention group (6%), and imputing the missing observations at week 32 as "Not in remission", changes the remission rate to 36.78% for the intervention, and 21.43% for the control group. That alters the mean difference to 15.35% (P ¼ 0.027). Significant difference between groups (control n ¼ 76, intervention n ¼ 82) was achieved in change of pain e 10.8 (95% CI 4.0, 17.7), and function e 10.1 (95% CI 4.7, 15.6) from baseline to 20weeks. While this significant difference in change between groups was maintained for function from 20 to 32-weeks (control n ¼ 67, intervention n ¼ 82), 6.2 (95% CI 0.35, 12.1), the difference in pain was not significant e 3.5 (95% CI À4.4, 11.5). Interestingly, 4 participants in the control group have undergone total knee arthroplasty during the study, compared to no participants from the intervention group. Conclusions: Although the rate of disease remission was higher for the stepped care approach strategy, it fell slightly short of statistical significance on ITT analysis. The intervention significantly improved KOOS function scores for the duration of the study, while pain decreased significantly at the first study follow-up but became non-significant at the final follow up (Fig. 2). These results are encouraging, and further research using a stepped care approach for the management of OA should be considered.
Background:Non-pharmacological interventions are recommended as first-line treatment options in the management of fibromyalgia (FM)1. However, whether one intervention is more effective than another for specific patient-centred outcomes in FM is unknown.Objectives:To compare the relative efficacy of non-pharmacological interventions on FM impact questionnaire (FIQ), pain, fatigue, sleep and depression in people with FM.Methods:A Bayesian network meta-analysis was conducted. Randomised controlled trials (RCTs) assessing any non-pharmacological intervention versus usual care, placebo or active controls in patients with FM aged >16 years were searched for in seven databases. A common comparator was identified between interventions to develop a network (Figure 1). Standardised mean difference (SMD) and 95% credible interval (CrI) was estimated between interventions. Direct and indirect evidence were pooled using the random effect model. Modified Cochrane‘s tool was used to assess risk of bias.Figure 1.Network map of different interventions evaluating FIQResults:78 studies (n = 5,639 participants) met the inclusion criteria. There was a high risk of bias on blinding and most trials had small sample size (n<50).While multidisciplinary treatment (MDT) was the best for improving pain [-1.28 (-1.84, -0.72)], sleep [-1.14 (-2.38, 0.07)] and depression [-1.20 (-1.99, -0.46)], balneotherapy and exercise were the most effective treatments for FIQ [-1.06 (1.51, -0.61)] and fatigue [-0.75 (-1.35, -0.25)], respectively (Figure 2).Figure 2.Standardised mean difference (SMD) versus usual care in descending order for different outcomesData from 47 exercise trials (n = 3,271 participants) were analysed to examine comparative efficacy of different exercise types. Strengthening showed the greatest benefits for FIQ [-0.76 (-1.39, -0.15)], pain [-0.94 (-1.58, -0.29)] and depression [-0.83 (-1.53, -0.14)], whereas aerobic exercise was the best for fatigue [-0.98 (-2.33, 0.18)] and sleep [-0.96 (-2.08, 0.13)] (Table 1).Table 1.Relative effect size between types of exercisesFIQAerobic-0.58(-1.13, -0.03)-0.09(-0.55, 0.36)0.18(-0.44, 0.80)0.12(-0.36, 0.57)-0.57(-0.95, -0.24)-0.60(-1.36, 0.18)Flexibility0.49(-0.23, 1.20)0.76(-0.07, 1.58)0.70(-0.04, 1.41)0.004(-0.67, 0.64)-0.10(-0.74, 0.53)0.49(-0.50, 1.49)Mind-body0.27(-0.37, 0.91)0.20(-0.24, 0.65)-0.49(-0.85, -0.15)0.05(-0.59, 0.70)0.65(-0.35, 1.63)0.16(-0.53, 0.85)Mixed-0.06(-0.73, 0.59)-0.69(-1.06, -0.34)0.21(-0.42, 0.84)0.80(-0.19, 1.79)0.31(-0.41, 1.02)-0.06(-0.73, 0.59)Strengthening-0.76(-1.39, -0.15)-0.73(-1.16, -0.30)-0.13(-1.02, 0.74)-0.62(-1.15, -0.11)-0.78(-1.31, -0.26)-0.94(-1.58, -0.29)Usual carePainData are standard mean difference (95% credible intervel) between exercises, pairwised from the top left to the bottom right. The negative value indicates that the first exercise is more effective than the second exercise. For example, aerobic is better than flexibility for FIQ -0.58 (-1.13, -0.13), but not pain -0.60 (-1.36, 0.18).Conclusion:Several non-pharmacological interventions are beneficial for FM. However, the effect size varies between interventions and outcomes. All types of exercises are effective for FIQ and pain apart from flexibility exercise. The results of this study may be used to guide the selection of the most effective non-pharmacological interventions according to the predominant symptom in individual patients.References:[1]Macfarlane GJ et al. Ann Rheum Dis 2017;76(2):3-8-28.Disclosure of Interests: :None declared
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