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Background and Objective
This updated systematic review evaluated the efficacy, tolerability and safety of opioids compared to placebo in non‐malignant chronic low back pain.
Databases and Data Treatment
Clinicaltrials.gov, CENTRAL, MEDLINE and PsycINFO were searched from October 2013 to May 2019. Randomized controlled trials comparing opioids with placebo and at least 4 weeks of double‐blinded duration were analysed. Primary outcomes were pain relief of 50% or greater, disability, tolerability and safety. Effects were summarized by a random effects model using risk differences or standardized mean differences. We added nine new studies with 2,980 participants for a total of 21 studies with 7,650 participants. Study duration ranged between 4 and 15 weeks. Studies with a parallel and cross‐over design: Based on very low to low‐quality evidence, opioids provided no clinically relevant pain relief of 50% or greater, but a clinically relevant reduction of disability compared to placebo. Enriched enrolment randomized withdrawal (EERW) design: Based on very low to low‐quality evidence, opioids provided a clinically relevant pain relief of 50% or greater, but not a clinically relevant reduction of disability compared to placebo. There was no clinically relevant harm with regard to serious adverse events by opioids compared to placebo in studies with parallel/cross‐over and EERW design. There was a relevant harm with regard to drop out rates due to adverse events in studies with parallel/cross‐over, but not in studies with EERW design.
Conclusions
Opioids may provide a safe and clinically relevant pain relief for 4–15 weeks in highly selected patients.
Significance
Within the context of randomized controlled trials of 4–15 weeks, opioids provided a clinically relevant pain relief of 30% or greater and a clinically relevant reduction of disability compared to placebo in non‐malignant chronic low back pain. Number needed to treat for an additional drop out due to side effects was 11 (95% confidence interval: 6–33). Assessment of abuse and addiction was incomplete. The frequency of serious adverse events including deaths did not differ from placebo.
Background and objectives:
Urticaria is a frequent skin condition, but reliable prevalence estimates from population studies particularly of the chronic form are scarce. The objective of this study was to systematically evaluate and summarize the prevalence of chronic urticaria by evaluating population‐based studies worldwide.
Methods:
We performed a systematic search in PUBMED and EMBASE for population‐based studies of cross‐sectional or cohort design and studies based on health insurance/system databases. Risk of bias was assessed using a specific tool for prevalence studies. For meta‐analysis, we used a random effects model.
Results:
Eighteen studies were included in the systematic evaluation and 11 in the meta‐analysis including data from over 86 000 000 participants. Risk of bias was mainly moderate, whereas the statistical heterogeneity (I\(^{2}\)) between the studies was high. Asian studies combined showed a higher point prevalence of chronic urticaria (1.4%, 95%‐CI 0.5‐2.9) than those from Europe (0.5%, 0.2‐1.0) and Northern American (0.1%, 0.1‐0.1). Women were slightly more affected than men, whereas in children < 15 years we did not find a sex‐specific difference in the prevalence. The four studies that examined time trends indicated an increasing prevalence of chronic urticaria over time.
Conclusions:
On a global level, the prevalence of chronic urticaria showed considerable regional differences. There is a need to obtain more sex‐specific population‐based and standardized international data particularly for children and adolescents, different chronic urticaria subtypes and potential risk and protective factors.