Insomnia Changes in England Over 15 Years-Calem et al of Finnish populations found evidence of an increase in the reporting of insomnia symptoms over a 10-year period. 4 The authors also found evidence of increased self-reported consumption of hypnotic medication, but not in the prevalence of hypnotic use, implying increased use in people already receiving these agents. An analysis of medication use based on data from the National Psychiatric Morbidity Surveys of 1993 and 2000 found an increase in the prevalence of use of hypnotic medication. 5 There have been concerns that sleep medication use has increased in spite of limited benefits and considerable drawbacks to its use. 6 Comparing insomnia prevalence between places and populations is made difficult by differences in the definition of insomnia, 7 which vary from self-reported symptoms of sleeplessness to the stricter DSM-IV criteria. Changes in insomnia over time can only genuinely be inferred from repeated surveys of single populations which have used comparable sampling methods and measurements. The aim of this paper was to investigate changes in prevalence in insomnia over a 15-year period, as well as the stability of its associations with demographic characteristics, use of hypnotic medication and subjective reasons given for sleep disturbance by participants. To achieve this we used data from 3 national surveys 8 carried out in the UK in 1993, 2000, and 2007, all employing the same measurements and definitions of insomnia, allowing for comparisons based on identical data across time.
dementia is substantially more common in care homes than recorded diagnoses would suggest, but studies using brief screening instruments may overestimate prevalence. High prevalences of depressive and/or behavioural symptoms and psychotropic use suggest significant unmet need.
Medical Research Council/National Institute for Health Research Efficacy and Mechanism Evaluation Program, Pain Relief Foundation, and Biotest United Kingdom.
SummaryThis article reviews the research into anxiety disorders in adults aged 65 years and older that has been published over the past ten years. The topics covered include: the construct of anxiety and its disorders in this age group; epidemiology, including prevalence, incidence, course, outlook, and risk factors; assessment scales; co-morbidity and differential diagnosis (depression, dementia, physical illness); and management, both pharmacological and non-pharmacological. There has been a significant improvement in our understanding of these disorders in older adults over this period, but evidence to support their treatment and prevention is still quite sparse.
Background
Complex regional pain syndrome (CRPS) is a rare, severe post-traumatic pain condition affecting distal limbs. Patients who do not spontaneously improve in 12 months are classed as having ‘long-standing CRPS’ and often cannot be effectively treated, leading to a poor prognosis. CRPS is associated with functional autoantibodies. Two small trials, including a randomised controlled trial, have suggested that low-dose intravenous immunoglobulin (IVIg) may be an effective treatment for some patients.
Objective
We hypothesised that low-dose IVIg is effective for reducing pain in long-standing CRPS.
Methods
A randomised, double blinded placebo-controlled multicentre trial in seven UK pain management centres. Patients were eligible if they had moderate or severe long-standing CRPS that they had experienced for up to 5 years. Participants were randomly allocated to receive 0.5 g/kg IVIg, the active intervention, or visually indistinguishable 0.1% albumin in saline placebo. Randomisation was initiated by study sites via an independent online randomisation system and was 1 : 1 with varying block sizes, stratified by study centre. Participants, investigators and assessors were blinded to group assignment. The study drug/placebo was infused intravenously at the study centres on day 1 and day 23 after randomisation. The primary outcome was the 24-hour average pain intensity between day 6 and day 42, on an 11-point (0–10) numeric rating scale, compared between the groups. Outcomes were analysed using a mixed-effects regression model that used 37 measurements of pain intensity (the primary outcome) per participant. All patients who received an infusion and provided any outcome were included in the intention-to-treat analysis.
Results
A total of 111 patients were recruited and assigned between 27 August 2013 and 28 October 2015. Three patients were excluded because they had been inappropriately randomised, five patients were withdrawn from the primary analysis because they provided no outcomes and 103 patients were analysed for the primary outcome. The average pain score in the IVIg group was 0.27 units (95% confidence interval –0.24 to 0.80 units) higher than in the placebo group. Therefore, there is no significant evidence of a treatment effect at the 5% level and there was no significant difference between groups. Six serious adverse events but no suspected unexpected serious adverse reactions were reported during the blinded and open-label phase.
Conclusion and future work
Low-dose immunoglobulin was not effective in relieving pain in patients with moderate to severe CRPS of 1–5 years’ duration. Better drug treatments for long-standing CRPS are urgently required.
Trial registration
Current Controlled Trials ISRCTN42179756.
Funding
This project was funded by the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health Research partnership. Additional funding was obtained by the Pain Relief Foundation. Biotest UK Ltd provided the active study medication at no cost.
Background
Sublingual tablet buprenorphine (BUP-SL) and oral liquid methadone (MET) are the daily, standard-of-care (SOC) opioid agonist treatment medications for opioid use disorder (OUD). A sizable proportion of the OUD treatment population is not exposed to sufficient treatment to attain the desired clinical benefit. Two promising therapeutic technologies address this deficit: long-acting injectable buprenorphine and personalised psychosocial interventions (PSI). This study will determine (A) the effectiveness and cost-effectiveness — monthly injectable, extended-release (BUP-XR) in a head-to-head comparison with BUP-SL and MET, and (B) the effectiveness of BUP-XR with adjunctive PSI versus BUP-SL and MET with PSI. Safety, retention, craving, substance use, quality-adjusted life years, social functioning, and subjective recovery from OUD will be also evaluated.
Methods
This is a pragmatic, multi-centre, open-label, parallel-group, superiority RCT, with a qualitative (mixed-methods) evaluation. The study population is adults. The setting is five National Health Service community treatment centres in England and Scotland. At each centre, participants will be randomly allocated (1:1) to BUP-XR or SOC. At the London study co-ordinating centre, there will also be allocation of participants to BUP-XR with PSI or SOC with PSI. With 24 weeks of study treatment, the primary outcome is days of abstinence from non-medical opioids during study weeks 2–24 combined with up to 12 urine drug screen tests for opioids. For 90% power (alpha, 5%; 15% inflation for attrition), 304 participants are needed for the BUP-XR versus SOC comparison. With the same planning parameters, 300 participants are needed for the BUP-XR and PSI versus SOC and PSI comparison. Statistical and health economic analysis plans will be published before data-lock on the Open Science Framework. Findings will be reported in accordance with the Consolidated Standards of Reporting Trials and Consolidated Health Economic Evaluation Reporting Standards.
Discussion
This pragmatic randomised controlled trial is the first evaluation of injectable BUP-XR versus the SOC medications BUP-SL and MET, with personalised PSI. If there is evidence for the superiority of BUP-XR over SOC medication, study findings will have substantial implications for OUD clinical practice and treatment policy in the UK and elsewhere.
Trial registration
EU Clinical Trials register 2018-004460-63.
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