Therapeutic opioids: a ten-year perspective on the complexities and complications of the escalating use, abuse, and nonmedical use of opioids

Therapeutic opioid use and abuse coupled with the nonmedical use of other psychotherapeutic drugs has shown an explosive growth in recent years and has been a topic of great concern and controversy. Americans, constituting only 4.6% of the world's population, have been consuming 80% of the global opioid supply, and 99% of the global hydrocodone supply, as well as two-thirds of the world's illegal drugs. With the increasing therapeutic use of opioids, the supply and retail sales of opioids are mirrored by increasing abuse in patients receiving opioids, nonmedical use of other psychotherapeutic drugs (in this article the category of psychotherapeutics includes pain relievers, tranquilizers, stimulants, and sedatives, but does not include over-the-counter drugs), emergency department visits for prescription controlled drugs, exploding costs, increasing incidence of side effects, and unintentional deaths. However, all these ills of illicit drug use and opioid use, abuse, and non-medical use do not stop with adults. It has been shown that 80% of America's high school students, or 11 million teens, and 44% of middle school students, or 5 million teens, have personally witnessed, on the grounds of their schools, illegal drug use, illegal drug dealing, illegal drug possession, and other activities related to drug abuse. The results of the 2006 National Survey on Drug Use and Health showed that 7.0 million or 2.8% of all persons aged 12 or older had used prescription type psychotherapeutic drugs nonmedically in the past month, 16.387 million, or 6.6% of the population, had used in the past year, and 20.3%, or almost 49.8 million, had used prescription psychotherapeutic drugs nonmedically during their lifetime. Sadly, the initiates of psychotherapeutic drugs used for nonmedical purposes were highest for opioids. Therapeutic opioid use has increased substantially, specifically of Schedule II drugs. Apart from lack of effectiveness (except for short-term, acute pain) there are multiple adverse consequences including hormonal and immune system effects, abuse and addiction, tolerance, and hyperalgesia. Patients on long-term opioid use have been shown to increase the overall cost of healthcare, disability, rates of surgery, and late opioid use

Comparative Effectiveness Research: An Empirical Study of Trials Registered in ClinicalTrials.gov

Background The $1.1 billion investment in comparative effectiveness research will reshape the evidence-base supporting decisions about treatment effectiveness, safety, and cost. Defining the current prevalence and characteristics of comparative effectiveness (CE) research will enable future assessments of the impact of this program. Methods We conducted an observational study of clinical trials addressing priority research topics defined by the Institute of Medicine and conducted in the US between 2007 and 2010. Trials were identified in ClinicalTrials.gov. Main outcome measures were the prevalence of comparative effectiveness research, nature of comparators selected, funding sources, and impact of these factors on results. Results 231 (22.3%; 95% CI 19.8%–24.9%) studies were CE studies and 804 (77.7%; 95% CI, 75.1%–80.2%) were non-CE studies, with 379 (36.6%; 95% CI, 33.7%–39.6%) employing a placebo control and 425 (41.1%; 95% CI, 38.1%–44.1%) no control. The most common treatments examined in CE studies were drug interventions (37.2%), behavioral interventions (28.6%), and procedures (15.6%). Study findings were favorable for the experimental treatment in 34.8% of CE studies and greater than twice as many (78.6%) non-CE studies (P<0.001). CE studies were more likely to receive government funding (P = 0.003) and less likely to receive industry funding (P = 0.01), with 71.8% of CE studies primarily funded by a noncommercial source. The types of interventions studied differed based on funding source, with 95.4% of industry trials studying a drug or device. In addition, industry-funded CE studies were associated with the fewest pediatric subjects (P<0.001), the largest anticipated sample size (P<0.001), and the shortest study duration (P<0.001). Conclusions In this sample of studies examining high priority areas for CE research, less than a quarter are CE studies and the majority is supported by government and nonprofits. The low prevalence of CE research exists across CE studies with a broad array of interventions and characteristics.National Library of Medicine (U.S.) (5G08LM009778)National Institutes of Health (U.S.

Incomplete reporting of baseline characteristics in clinical trials: an analysis of randomized controlled trials and systematic reviews involving patients with chronic low back pain

OBJECTIVE: The aim of this study was to evaluate the reporting of relevant prognostic information in a sample of randomized controlled trials (RCTs) that investigated treatments for patients with chronic low back pain (LBP). We also analysed how researchers conducting the meta-analyses and systematic reviews addressed the reporting of relevant prognostic information in RCTs. METHODS: We searched the Cochrane Database to identify systematic reviews that investigated non-surgical treatments for patients with chronic LBP. The reported prognostic information was then extracted from the RCTs included in the reviews. We used a purpose-defined score to assess the quantity of information reported in the RCTs. We also determined how the authors of systematic reviews addressed the question of comparability of patient populations between RCTs. RESULTS: Six systematic reviews met our inclusion criteria, and we analysed 84 RCTs. Based on the scores, the reporting of important prognostic variables was incomplete in almost half of the 84 RCTs. Information regarding patients' general health, social support, and work-related conditions was rarely reported. Almost half of the studies included in one of the meta-analyses provided insufficient information that did not allow us to determine whether patients in the primary trials were comparable. CONCLUSIONS: Missing prognostic information potentially threatens the external validity (i.e. the generalizability or applicability) not only of primary studies but also of systematic reviews that investigate treatments for LBP. A detailed description of baseline patient characteristics that includes prognostic information is needed in all RCTs to ensure that clinicians can determine the applicability of the study or review results to their patients