Opioids For Chronic Noncancer Pain Research Articles

Short-term androgen therapy for men treated regularly with opioids for chronic noncancer pain: time will tell.

Short-term androgen therapy for men treated regularly with opioids for chronic noncancer pain: time will tell.

Prescription of Long-Acting Opioids and Mortality in Patients With Chronic Noncancer Pain.

Long-acting opioids increase the risk of unintentional overdose deaths but also may increase mortality from cardiorespiratory and other causes. To compare all-cause mortality for patients with chronic noncancer pain who were prescribed either long-acting opioids or alternative medications for moderate to severe chronic pain. Retrospective cohort study between 1999 and 2012 of Tennessee Medicaid patients with chronic noncancer pain and no evidence of palliative or end-of-life care. Propensity score-matched new episodes of prescribed therapy for long-acting opioids or either analgesic anticonvulsants or low-dose cyclic antidepressants (control medications). Total and cause-specific mortality as determined from death certificates. Adjusted hazard ratios (HRs) and risk differences (difference in incidence of death) were calculated for long-acting opioid therapy vs control medication. There were 22,912 new episodes of prescribed therapy for both long-acting opioids and control medications (mean [SD] age, 48 [11] years; 60% women). The long-acting opioid group was followed up for a mean 176 days and had 185 deaths and the control treatment group was followed up for a mean 128 days and had 87 deaths. The HR for total mortality was 1.64 (95% CI, 1.26-2.12) with a risk difference of 68.5 excess deaths (95% CI, 28.2-120.7) per 10,000 person-years. Increased risk was due to out-of-hospital deaths (154 long-acting opioid, 60 control deaths; HR, 1.90; 95% CI, 1.40-2.58; risk difference, 67.1; 95% CI, 30.1-117.3) excess deaths per 10,000 person-years. For out-of-hospital deaths other than unintentional overdose (120 long-acting opioid, 53 control deaths), the HR was 1.72 (95% CI, 1.24-2.39) with a risk difference of 47.4 excess deaths (95% CI, 15.7-91.4) per 10,000 person-years. The HR for cardiovascular deaths (79 long-acting opioid, 36 control deaths) was 1.65 (95% CI, 1.10-2.46) with a risk difference of 28.9 excess deaths (95% CI, 4.6-65.3) per 10,000 person-years. The HR during the first 30 days of therapy (53 long-acting opioid, 13 control deaths) was 4.16 (95% CI, 2.27-7.63) with a risk difference of 200 excess deaths (95% CI, 80-420) per 10,000 person-years. Prescription of long-acting opioids for chronic noncancer pain, compared with anticonvulsants or cyclic antidepressants, was associated with a significantly increased risk of all-cause mortality, including deaths from causes other than overdose, with a modest absolute risk difference. These findings should be considered when evaluating harms and benefits of treatment.

Geographic Variation in Health Service Use and Perceived Access Barriers for Australian Adults with Chronic Non-Cancer Pain Receiving Opioid Therapy.

Rates of chronic non-cancer pain are increasing worldwide, with concerns regarding poorer access to specialist treatment services in remote areas. The current study comprised the first in-depth examination of use and barriers to access of health services in Australia according to remoteness. A cohort of Australian adults prescribed pharmaceutical opioids for chronic non-cancer pain (n = 1,235) were interviewed between August 2012 and April 2014, and grouped into 'major city' (49%), 'inner regional' (37%), and 'outer regional/remote' (14%) according to the Australian Standard Geographical Classification based on postcode. Multinomial logistic regression analyses were conducted to determine geographical differences in socio-demographic and clinical characteristics, health service use, and perceived barriers to health service access. The 'inner regional group' and 'outer regional/remote group' were more likely to be male (relative risk ratio (RRR)=1.38,95%CI 1.08-1.77 and RRR = 1.60, 95%CI 1.14-2.24) and have no private health insurance (RRR = 1.53, 95%CI 1.19-1.97 and RRR = 1.65, 95%CI 1.16-2.37) than the 'major city group' (49%). However, the 'inner regional group' reported lower pain severity and better mental health relative to the 'major city group' = 0.92, 95%CI 0.86-0.98 and RRR = 1.02, 95%CI 1.01-1.03, respectively). Although rates of health service access were generally similar, the 'outer regional/remote group' were more likely to report client-practitioner communication problems (RRR = 1.57, 95%CI 1.03-2.37), difficulties accessing specialists (RRR = 1.56, 95%CI 1.01-2.39), and perception of practitioner lack of confidence in prescribing pain medication (RRR = 1.73, 1.14-2.62), relative to both groups. Perceived communication, access, and financial barriers to healthcare indicate the need for increased efforts to address geographic inequality in pain treatment.

Using opioids in general practice for chronic non-cancer pain: an overview of current evidence.

Chronic non-cancer pain (lasting more than 3 months) is highly prevalent in Australia (17% of males and 20% of females) and its optimal management is crucial to the health and wellbeing of the community. For 5% of the population, such pain interferes markedly with daily function. Part of the treatment for acute non-cancer pain for many people will include opioid analgesics at least for days to weeks. However, as pain becomes chronic, evidence to support ongoing prescription of opioids is lacking. There is increasing pressure to ensure that prescribing opioid analgesics is minimised to reduce not only the risk of dependence and illicit diversion but also the potential harms associated with tolerance, side effects and complications. Frameworks for considering opioid prescribing include assessing suitability of the patient for opioids; initiating a trial of therapy; and monitoring long term use. There is limited evidence of the long term efficacy of opioids for chronic non-cancer pain, and documented clinical consequences beyond addiction include acceleration of loss of bone mineral density, hypogonadism and an association with increased risk of acute myocardial infarction. Careful clinical selection of patients can help optimise the evidence-based use of opioids for chronic non-cancer pain: only treat pain that has been as well defined as possible when non-opioid therapies have not been effective; consider referral to specialist services for assessment if doses are above 100 mg oral morphine equivalent per 24 hours or the duration of therapy is longer than 4 weeks; limit prescribing to only one practitioner; seek an agreement with the patient for the initiation and potential withdrawal of opioids if the therapeutic trial is not effective.

Sleep Quality Among People Living With Chronic Noncancer Pain: Findings From the Pain and Opioids IN Treatment (POINT) Cohort.

To examine sleep disturbances in the POINT cohort study consisting of participants prescribed long-term opioids for chronic noncancer pain (CNCP), and to examine the relationship between sleep and measures of pain, physical and mental health, substance use, and medication use at the baseline interview. A convenience sample of 1243 participants with current CNCP and prescription opioid use were recruited from community settings and underwent a structured interview examining subjective sleep symptoms (Medical Outcomes Study [MOS] Sleep Scale and the Sleep Problems Index [SLP-9]), the pain severity and interference using the Brief Pain Inventory (BPI), mental and physical health symptoms, and recent substance and medication use. Linear regression models assessed independent predictors of SLP-9 scores. The median hours of sleep per night was 6 (IQR, 5 to 7.5), with 26% reporting optimal sleep (7 to 8 hours), and a mean SLP-9 score of 47.3 (SD=20.9). In multivariate analysis, age, frequent/severe headaches, BPI pain severity and pain interference scores, moderate to severe anxiety or depression, daily tobacco use, and benzodiazepine use in the past week were significant predictors of SLP-9 scores and sleep quality. Higher MOS respiratory impairment was observed in men, in those with a high body mass index, frequent/severe headaches, and high pain interference scores, and in patients taking anticonvulsants and antipsychotic medications. Opioid use was not associated with SLP-9 or respiratory sleep impairment. High levels of sleep problems were reported in this community sample of CNCP patients prescribed long-term opioids, and were associated with mental health problems and increased medication use. Nonmedication approaches to addressing sleep problems should be prioritized in this population.

049 A Cohort Study to Investigate Long-Term Opioids for Chronic Non-Cancer Pain in Women and Associated Hypothalamic–Pituitary–Gonadal Side Effects

049 A Cohort Study to Investigate Long-Term Opioids for Chronic Non-Cancer Pain in Women and Associated Hypothalamic–Pituitary–Gonadal Side Effects

Characterization of Chronic Pain and Opioid Usage in Adult Sickle Cell Disease Patients Referred to a Comprehensive Pain Clinic

Dear Editor, The adult Sickle Cell Disease (SCD) program at our tertiary academic hospital network developed a collaborative approach with the Comprehensive Pain Program to better assess and manage pain in their SCD population. We followed 16 consecutive SCD patients referred to our pain program due to poor pain control over a 4-year period (2010–2013). Data collected included demographics, types and doses of opioids prescribed, use of other than opioid drugs, and verbal pain ratings on a numerical rating scale (NRS) ranging from 0 to 10. The average prescribed daily dose (in milligrams) of oral morphine or equivalent was calculated for each patient in Morphine Equivalent Dose (MED). Opioid users were classified as HOU (High Opioid Users) or LOU (Low Opioid Users), depending on whether the exceeded 200 mg of morphine equivalent per day the “watchful dose” recommended by the Canadian Guideline for Safe and Effective Use of Opioids in Chronic Non-Cancer Pain. At this dose, the Guideline recommends reconsideration of effectiveness of opioid treatment in a given patient if he/she has failed to respond adequately [1]. In terms of demographics, 62.5% of the patients were Canadian born primarily of African or Caribbean decent, female/male ratio …

Dependence on Prescription Opioids.

The incidence of initial prescriptions of opioids for chronic non-cancer pain rose by 37% in Germany from 2000 to 2010. Prescribing practice does not always conform with the recommendations of current guidelines. In the USA, 8-12% of patients with chronic non-cancer pain are opioid-dependent. This review is based on publications retrieved by a selective PubMed search and on the German S3 guideline on the long-term use of opioids in non-cancer pain. Patients must be informed and counseled about the effects and risks of opioids before these drugs are prescribed. All opioid prescriptions for patients with chronic non-cancer pain should be regularly reviewed. The risk of abuse is high in young adults (odds ratio [OR] = 6.74) and in those with a history of substance abuse (OR = 2.34). Any unusual medication-related behavior, e.g., loss of prescriptions or increasing the dose without prior discussion with the physician, calls for further assessment by the physician in conversation with the patient. Urine testing for drugs and their metabolites is helpful as well. The goal of treatment of opioid abuse is opioid abstinence by gradual reduction of the dose. If this is not possible on an outpatient basis, hospitalization for drug withdrawal or substitution-based addiction therapy can be offered. Physicians who know the indications and risks of opioid therapy and the typical behavior of drug-dependent patients will be better able to identify patients at risk and to prevent dependence. Studies on the prevalence of opioid abuse and dependence in German patients with chronic pain can help provide better estimates of the current extent and implications of this problem in Germany.

Prevalence and Correlates of Suicidal Thoughts and Suicide Attempts in People Prescribed Pharmaceutical Opioids for Chronic Pain.

The main objectives of the paper were (1) to examine the prevalence of suicidality in a large community-based chronic pain sample taking prescribed opioids for chronic pain; and (2) to examine general and pain-specific factors that predict such ideation, and the transition from ideation to making a suicide attempt (ideation-to-action). Baseline data from the Pain and Opioids IN Treatment (POINT) study with a cohort of 1514 community-based people prescribed opioids for chronic noncancer pain across Australia. Past 12-month suicidal ideation was reported by 36.5% of the cohort and 16.4% had made a lifetime suicide attempt (2.5% in the last 12 mo), after the onset of their pain condition. Suicidal ideation in the past 12 months was independently associated with a past suicide attempt [adjusted odds ratio (AOR)=4.82; 95% confidence interval, 2.43-9.56] and past 12-month depression (AOR=4.07, 95% confidence interval, 1.88-8.78). Only a lower pain self-efficacy score was independently associated with past 12-month ideation-to-action (AOR=0.98, 95%CI0.88-0.99). Notably, only general-suicide risk factors were associated with 12-month suicidal ideation; but for past year ideation-to-action, pain-specific factors also had independent associations. The study is one of the first to comprehensively examine general and pain-specific risk factors for suicidality in a large chronic pain sample in which suicidal ideation was common. A low pain self-efficacy score was the only factor independently associated past 12-month ideation-to-action.

Defining problematic pharmaceutical opioid use among people prescribed opioids for chronic noncancer pain: do different measures identify the same patients?

The International Classification of Diseases (ICD) and the Diagnostic and Statistical Manual (DSM) are routinely used in diagnosing illicit substance use disorders, but for people taking prescribed opioids they remain controversial. In pain medicine, the concept of "Addiction" is preferred with reduced emphasis on tolerance and withdrawal. This article examines the prevalence and characteristics of pharmaceutical opioid dependence/disorder according to ICD, DSM, and the pain medicine concept of "Addiction," among chronic noncancer pain (CNCP) patients prescribed opioids. In the current study, we used data from a national sample of 1134 people prescribed opioids for CNCP. Past 12-month "Addiction" (based on Pain Medicine definition), DSM, and ICD dependence definitions were assessed using the Composite International Diagnostic Interview. Twenty-four percent of the cohort met the criteria for "Addiction," 18% for DSM-5 use disorder and 19% for ICD-11 dependence. There was "substantial" concordance between "Addiction" and both DSM-5 use disorder and ICD-11 dependence, although concordance was much greater with ICD-11 dependence (kappa = 0.63 and 0.79, respectively). Participants meeting the criteria for "Addiction" only were older, less likely to engage in nonadherent behaviours, self-reported fewer problems or concerns with their medication, and had lower rates of psychological distress than those who also met the DSM-5 and ICD-11 criteria. The definition of "Addiction" captures a larger group of patients than other classification systems and includes people with fewer "risk" behaviours. Despite removal of tolerance and withdrawal for prescribed opioid use for DSM-5, we found that "Addiction" was more closely related to an ICD-11 diagnosis of pharmaceutical opioid dependence.

Use of Opioids in Latin America: The Need of an Evidence-Based Change.

The subject of this publication has been focused on local considerations for facilitating regional best practice, including identifying and uniformly adopting the most relevant international guidelines on opioid use (OU) in chronic pain management. The Change Pain Latin America (CPLA) Advisory Panel conducted a comprehensive, robust, and critical analysis of published national and international reviews and guidelines of OU, considering those most appropriate for Latin America. A PubMed search was conducted using the terms "opioid," "chronic," and "pain" and then refined using the filters "practice guidelines" and "within the last 5 years" (2007-2012). Once the publications were identified, they were selected using five key criteria: "Evidence based," "Comprehensive," "From a well-recognized source," "Current publications," and "Based on best practice" and then critically analyzed considering 10 key criteria for determining the most relevant guidelines to be applied in Latin America. The initial PubMed search identified 177 reviews and guidelines, which was reduced to 16 articles using the five preliminary criteria. After a secondary analysis according to the 10 key criteria specific to OU in Latin America, 10 publications were selected for critical review and discussion. The CPLA advisory panel considered the "Safe and effective use of opioids for chronic non-cancer pain" (published in 2010 by the NOUGG of Canada) to be valid, relevant to Latin America, practical, evidence-based, concise, unambiguous, and sufficiently educational to provide clear instruction on OU and pain management and, thus, recommended for uniform adoption across the Latin America region.

Predictors of higher-risk chronic opioid prescriptions in an academic primary care setting

ABSTRACTBackground: Patients with chronic noncancer pain treated with higher doses of opioids or concurrent substance use are at increased risk of adverse events. Although several national guidelines recommend maximum dosing thresholds and urine drug testing, adherence to these guidelines is inconsistent. Methods: To identify predictors of higher-risk opioid prescriptions in 2 academic primary care clinics, the authors developed a retrospective cohort of 842 patients who were prescribed ≥5 opioid prescriptions for noncancer pain between March 2012 and March 2013. The authors evaluated odds of higher-dose opioid prescriptions and urine drug testing using multivariate logistic models. Results: Among study subjects, 47% received prescriptions for the equivalent of ≥50 mg morphine per day. After adjustment for confounders, patients with a resident primary care provider were less likely to receive higher-dose prescriptions compared with faculty providers (odds ratio = 0.66, 95% confidence interval [CI]: 0.46–0.94), whereas patients with a nonlocal home address were more likely to be prescribed higher doses (odds ratio = 2.1, 95% CI: 1.5–2.9). Hispanic, Asian, and older patients were also less likely to be prescribed higher doses. Urine drug testing was not regularly completed (35% over 2 years), but odds of testing were higher for patients who self-identified as black, had resident primary care providers, lived locally, or were prescribed higher opioid doses. Conclusions: In this academic clinical setting, patients with a resident primary care provider are less likely to receive higher-risk opioid prescriptions, as are Hispanic, Asian, and older patients. Black patients complete urine drug tests more frequently independent of other patient and provider characteristics. Additional studies are needed to assess why patients who travel larger distances to their primary care clinic are prescribed higher doses of opioids for chronic noncancer pain.

The Opioid Challenge.

The Opioid Challenge.

Prevention of Opioid Misuse: A Summary with Suggestions from a Pain Working Group.

On November 6, 2014, a multidisciplinary group of experts and stakeholders attended a Prevention of Opioid Misuse Study Day in Toronto funded by the Canadian Institutes of Health Research (CIHR) under a Canada Research Initiative in Substance Misuse (CRISM, grant number CSM-133338). The goals were to clarify issues surrounding opioid medications, including a discussion of current facts and myths, produce a summary of evidence based information to guide health professionals on the best practices in managing acute and chronic pain, inform clinicians, government, and other stakeholders about opioid use/misuse and pain management issues. Specific Principles That Guided the Summary. The following are the specific principles that guided the summary: We recognize the rise in morbidity and mortality associated with opioid misuse and the risk of addiction. We recognize the importance of the International Association for Study of Pain, Montreal, 2010 declaration on the right of person with pain to get relief: http://www.iasp-pain.org/DeclarationofMontreal. We recognize that available alternatives to opioids should be used in first intention (e.g., nonsteroidal analgesics, pregabalin, mood related medication such as duloxetine, and physical and behavioral approaches). We endorse the 2010 Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain: http://nationalpaincentre.mcmaster.ca/opioid/. These are solid and remain valid. We also deplore the low access to pain experts and other management options in Canada (mainly in rural areas or low income urban ones) and the absence of newer medications with high effectiveness and low harm. 2. Review of Current Issues on Pain and Its Relief One in five Canadians suffers from chronic pain [1, 2]. Many people living with chronic pain are “invisible” sufferers. Their quality of life is seriously compromised, and if their pain is not managed they are at greater risk of additional problems. Importantly, an association between opioid medication misuse and mood problems including depression and anxiety has been reported [3]. Furthermore, in the absence of adequate pain relief, the risk for suicide increases [4, 5]. Unfortunately, there are no magic cures for chronic pain. When all other alternatives have failed to provide acceptable control of pain, opioid analgesics (e.g., morphine, oxycodone, hydromorphone, and fentanyl) are increasingly being prescribed to relieve pain and improve the quality of life for people living with chronic pain so they can continue working and carrying out routine daily tasks. However, opioids if used inappropriately come with definite serious risks: addiction, fatal overdose, and harmful or even deadly effects when combined with other drugs or substances (particularly alcohol and antianxiety medications). The prevention of opioid misuse requires careful screening by educated prescribers, increased safety education to patients and population, and increased access to addiction and mental health services across all age groups and regions in Canada with a special attention to access to pain management and its prevention in nonurban sites [6]. It is important to distinguish between abuse, addiction, and physical dependence (see page 124 of the Canadian Guidelines: http://nationalpaincentre.mcmaster.ca/documents/opioid_guideline_part_b_v5_6.pdf): Abuse is any use of an illegal drug or the intentional self-administration of a medication for a nonmedical purpose such as altering one's state of consciousness, for example, “getting high.” Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Misuse of opioid is use of an opioid in ways other than those intended by a prescribing health professional. Physical dependence is a state of adaptation manifested by a drug class-specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. The nonmedical use of any prescription medication, including opioids, is a major concern. All medications have adverse effects, but if opioids are inappropriately used they are potentially life-threatening due primarily to sedation and respiratory depression. It is important to address this problem and to implement appropriate solutions. The national Canadian Alcohol and Drug Use Monitoring Survey (CADUMS) of the general population aged 15 years and older included nonmedical users who acknowledged using pain relievers more than they were supposed to or without a prescription. Starting in 2009, CADUMS has also asked respondents if they had used the medication “to get high.” The findings indicated that the prevalence of any use of a prescription opioid analgesic (POA) in Canada had decreased from roughly 20% to 17%, with use without a prescription at about 4.8–5% and use to get high at about 0.3%.

Health service utilisation by people living with chronic non-cancer pain: findings from the Pain and Opioids IN Treatment (POINT) study.

Objective The aims of the present study were to describe the use, and barriers to the use, of non-medication pain therapies and to identify the demographic and clinical correlates of different non-opioid pain treatments. Methods The study was performed on a cohort (n=1514) of people prescribed pharmaceutical opioids for chronic non-cancer pain (CNCP). Participants reported lifetime and past month use of healthcare services, mental and physical health, pain characteristics, current oral morphine equivalent daily doses and financial and access barriers to healthcare services. Results Participants reported the use of non-opioid pain treatments, both before and after commencing opioid therapy. Services accessed most in the past month were complementary and alternative medicines (CAMs; 41%), physiotherapy (16%) and medical and/or pain specialists (15%). Higher opioid dose was associated with increased financial and access barriers to non-opioid treatment. Multivariate analyses indicated being younger, female and having private health insurance were the factors most commonly associated with accessing non-opioid treatments. Conclusions Patients on long-term opioid therapy report using multiple types of pain treatments. High rates of CAM use are concerning given limited evidence of efficacy for some therapies and the low-income status of most people with CNCP. Financial and insurance barriers highlight the importance of considering how different types of treatments are paid for and subsidised. What is known about the topic? Given concerns regarding long-term efficacy, adverse side-effects and risk of misuse and dependence, prescribing guidelines recommend caution in prescribing pharmaceutical opioids in cases of CNCP, typically advising a multidisciplinary approach to treatment. There is a range of evidence supporting different (non-drug) treatment approaches for CNCP to reduce pain severity and increase functioning. However, little is known about the non-opioid treatments used among those with CNCP and the demographic and clinical characteristics that may be associated with the use of different types of treatments. Understanding the use of non-drug therapy among people with CNCP is crucial given the potential to improve pain control for these patients. What does this paper add? The present study found that a wide range of non-opioid treatments was accessed by the study sample, both before and after commencing opioids, indicating that in this sample opioids were not the sole strategy used for pain management. The most common treatment (other than opioids) was CAM, reported by two-fifths of the sample. Having private health insurance was associated with increased use of non-opioid treatments for pain, highlighting the importance of considering how treatments are paid for and potential financial barriers to effective treatments. What are the implications for practitioners? Patients' beliefs and financial barriers may affect the uptake of different treatments. Many patients may be using complementary and alternative approaches with limited evidence to support their use, highlighting the need for clinicians to discuss with patients the range of prescribed and non-prescribed treatments they are accessing and to help them understand the benefits and risks of treatments that have not been tested sufficiently, or have inconsistent evidence, as to their efficacy in improving pain outcomes.

Binge drinkers have greater vulnerability to engage in risky behaviors in traffic and drug use

Binge drinkers have greater vulnerability to engage in risky behaviors in traffic and drug use

Baseline Characteristics Associated With Response to Lubiprostone Treatment in Patients With Opioid-Induced Constipation

Introduction: Lubiprostone, a ClC-2 chloride channel activator, is indicated for the treatment of opioidinduced constipation (OIC) in adults with chronic non-cancer pain. Straining, stool consistency, and constipation severity at baseline (BL) were examined to determine clinical characteristics that might be associated with treatment response to lubiprostone. Methods: Data were pooled from three 12-week, randomized, placebo-controlled, double-blind studies of lubiprostone (24 mcg twice daily) in patients ≥18 years old with OIC treated with non-methadone opioids for chronic non-cancer pain. Overall responders had ≥1 additional spontaneous bowel movement (SBM) compared with BL each week that data were available and ≥3 SBMs/week for ≥9 weeks. Differences in SBM response rates between patients treated with lubiprostone or placebo were analyzed by the Cochran-Mantel-Haenszel test, stratified by pooled site. Median values for changes from BL in SBM frequency were analyzed between groups using the Wilcoxon rank sum test. Results: With lubiprostone treatment vs placebo, patients with moderate or worse straining for ≥25% of SBMs at BL had higher treatment response rates (23.7% vs 17.2%; P=0.013) and higher median increases from BL in SBM frequency (2.3 vs 1.8; P=0.003), respectively. Patients with severe or very severe straining at BL likewise experienced significantly higher treatment response rates (Figure 1) and median changes in SBM frequency (Figure 2) with lubiprostone. Treatment response rates (24.1% vs 17.7%; P=0.034) and median increases in SBMs from baseline (2.4 vs 1.8; P < 0.001) were higher with lubiprostone treatment vs placebo, respectively, in patients with hard or very hard stool consistency for ≥25% of SBMs at BL; change in SBM frequency was significantly higher in patients with very hard stool consistency at BL who were treated with lubiprostone(Figure 2). Patients with absent/normal constipation severity at BL had higher treatment response rates with lubiprostone vs placebo (25.5% vs 16.8%; P=0.006; Figure 1), whereas significant increases in SBM frequency occurred with lubiprostone treatment in patients with absent/normal and severe constipation at BL (Figure 1).Figure 1Figure 2Conclusion: More severe straining, harder stool consistency, and less severe constipation at BL were associated with treatment response to lubiprostone.

Resisting Prescribed Opioids: A Qualitative Study of Decision Making in Patients Taking Opioids for Chronic Noncancer Pain.

Opioids are increasingly prescribed for chronic noncancer pain across the developed world. Clinical guidelines for management of these patients focus on over-use. However, research into other types of long-term medication indicates that many patients minimize drug use whenever possible. To identify the varying influences on patients' decisions about their use of prescribed opioids and explore whether concepts of resistance and minimization of intake apply to these patients. A multiprofessional team performed a qualitative interview study using the constant-comparative method. Patient's decision making was explored in depth and with a thematic analysis utilizing a published "Model of medicine-taking." A purposive sample of 20 participants drawn from two pain clinics in Melbourne, Australia. The sample was biased toward patients interested in nonmedication pain management options. Patients' needs to obtain relief from severe pain, maintain function, and minimize side effects could lead to under-use as well as over-use of prescribed opioids. In keeping with the published Model of medicine-taking, resistance to taking opioids was a common and important influence on behavior. In the face of severe chronic pain, many participants used a variety of strategies to evaluate, avoid, reduce, self-regulate, and replace opioids. Furthermore, participants perceived a resistance to opioids within the system and among some healthcare professionals. This sometimes adversely affected their adherence. Both patients and doctors exhibit aspects of resistance to the use of prescribed opioids for chronic noncancer pain, suggesting that this shared concern could be the basis of a productive therapeutic alliance to improve communication and shared decision making. Clinical guidelines for opioids use for chronic noncancer pain focus on over-use. Our qualitative interview study found that many patients resisted and minimized the use of opioids. Using a published "Model of medicine-taking," we identified various influences on patient decision making. Both patients and doctors had concerns about using opioids for chronic noncancer pain. These could be the basis of a productive therapeutic alliance to improve communication and shared decision making.

Reporting of IMMPACT-recommended core outcome domains among trials assessing opioids for chronic non-cancer pain.

The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) has recommended that trialists evaluating treatments for chronic pain should consider reporting 9 patient-important outcome domains. We examined the extent to which clinical trials evaluating the effect of opioids for chronic non-cancer pain (CNCP) report outcome domains recommended by IMMPACT. We systematically searched electronic databases for English-language studies that randomized patients with CNCP to receive an opioid or a non-opioid control. In duplicate and independently, reviewers established the eligibility of each identified study and recorded all reported outcome domains from eligible trials. We conducted a priori regression analyses to explore factors that may be associated with IMMPACT-recommended outcome domains. Among 156 eligible trials, reporting of IMMPACT-recommended outcome domains was highly variable, ranging from 99% for pain to 7% for interpersonal functioning. Recently published trials were more likely to report the effect of treatment on physical functioning, emotional functioning, role functioning, sleep and fatigue, and participant disposition. Trials for which the corresponding author was from North America were more likely to report treatment effects on physical functioning and participant ratings of improvement and satisfaction with treatment. Trials published in higher impact journals were more likely to report treatment effects on emotional function, but less likely to report participant ratings of improvement and satisfaction with treatment. Most IMMPACT domains showed an increased rate of reporting over time, although many patient-important outcome domains remained unreported by over half of all trials evaluating the effects of opioids for CNCP.

Pharmaceutical Opioid Use and Dependence among People Living with Chronic Pain: Associations Observed within the Pain and Opioids in Treatment (POINT) Cohort.

There is increasing concern about the appropriateness of prescribing pharmaceutical opioids for chronic non-cancer pain (CNCP), given the risks of problematic use and dependence. This article examines pharmaceutical opioid dose and dependence and examines the correlates of each. Baseline data were obtained from a national sample of 1,424 people across Australia (median 58 years, 55% female and experiencing pain for a median of 10 years), who had been prescribed opioids for CNCP. Current opioid consumption was estimated in oral morphine equivalent (OME; mg per day), and ICD-10 pharmaceutical opioid dependence was assessed using the Composite International Diagnostic Interview. Current opioid consumption varied widely: 8.8% were taking <20 mg OME per day, 52.1% were taking 21-90 mg OME, 24.3% were taking 91-199 mg OME, and 14.8% were taking >= 200 mg OME. Greater daily OME consumption was associated with higher odds of multiple physical and mental health issues, aberrant opioid use, problems associated with opioid medication and opioid dependence. A significant minority, 8.5%, met criteria for lifetime ICD-10 pharmaceutical opioid dependence and 4.7% met criteria for past year ICD-10 pharmaceutical opioid dependence. Multivariate analysis found past-year dependence was independently associated with being younger, exhibiting more aberrant behaviors and having a history of benzodiazepine dependence. In this population of people taking opioids for CNCP, consumption of higher doses was associated with increased risk of problematic behaviors, and was more likely among people with a complex profile of physical and mental health problems.