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The current International Association for the Study of Pain (IASP) definition of pain as "An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage" was recommended by the Subcommittee on Taxonomy and adopted by the IASP Council in 1979. This definition has become accepted widely by health care professionals and researchers in the pain field and adopted by several professional, governmental, and nongovernmental organizations, including the World Health Organization. In recent years, some in the field have reasoned that advances in our understanding of pain warrant a reevaluation of the definition and have proposed modifications. Therefore, in 2018, the IASP formed a 14-member, multinational Presidential Task Force comprising individuals with broad expertise in clinical and basic science related to pain, to evaluate the current definition and accompanying note and recommend whether they should be retained or changed. This review provides a synopsis of the critical concepts, the analysis of comments from the IASP membership and public, and the committee's final recommendations for revisions to the definition and notes, which were discussed over a 2-year period. The task force ultimately recommended that the definition of pain be revised to "An unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage," and that the accompanying notes be updated to a bulleted list that included the etymology. The revised definition and notes were unanimously accepted by the IASP Council early this year.

The principal goals of health care are to help people “live longer and live better,” that is, to optimize both survival and health. In the American Heart Association’s (AHA) special report, “Defining and setting national goals for cardiovascular health promotion and disease reduction: the American Heart Association’s strategic Impact Goal through 2020 and beyond,” the AHA set the following goal: > “By 2020, to improve the cardiovascular health of all Americans by 20% while reducing deaths from cardiovascular diseases and stroke by 20%.” 1 The emphasis on improving cardiovascular health is laudable, yet it raises the question of how cardiovascular health is best measured. Indeed, the metrics of cardiovascular health have not been well delineated compared with other cardiovascular mortality and morbidity outcomes. The AHA’s strategic goals primarily focus on ideal health behaviors (eg, not smoking) and ideal health factors (eg, blood pressure control) as metrics of cardiovascular health.1 Although these are of clear import, they do not directly address the World Health Organization’s definition of health as “… a state of complete physical, mental and social well-being.”2 Moreover, the Institute of Medicine identified patient-centered care as 1 of the 6 domains of high-quality health care, wherein patient-centered care supports clinicians in “attending to their patients’ physical and emotional needs, and maintaining or improving their quality of life.”3 The Patient-Centered Outcomes Research Institute emphasizes the goal of “focusing on outcomes that people notice and care about such as survival, function, symptoms, and health related quality of life.”4 Recent concepts of value in health care and the “triple aim” center on improving patients’ health and experience with health care while reducing costs; each reinforces the importance of assessing the impact of disease and medical treatment on patients’ functional status and quality of life.5,6 The definition …

Health care in the USA faces a double challenge, the crisis of chronic pain and the crisis of opioid misuse and overdose. Patients have been prescribed opioids at high doses with unclear indications for long periods of time, putting them at high risk for morbidity and mortality. A significant proportion of these patients have comorbid psychiatric or substance use disorders complicating their pain conditions. The challenges to treating these patients adequately are discussed, along with potential solutions to these issues at the level of the individual provider, healthcare systems, and society.

Diabet. Med. 29, e67–e74 (2012) Abstract Aims Post-hoc evaluation of relationships between first-year change in glycaemic control (HbA1c) and change in patient-reported outcomes among ACCORD health-related quality of life (HRQoL) substudy participants. Methods Data from 2053 glycaemia-trial subjects were analysed. We assessed physical and mental health status (36-Item Short Form Health Survey, Version-2), symptom count and severity (Diabetes Symptoms Distress Checklist) and treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire). Linear mixed models were used to test relationships between 1-year changes in HbA1c and patient reported outcomes sequentially adjusting for correlates (baseline characteristics, baseline patient reported outcomes, treatment assignment, frequency of clinical contact and post-randomization weight change plus new complications). Results Poorer baseline control of HbA1c and cardiovascular disease risk factors predicted greater one-year improvements in treatment satisfaction. Similarly, poorer baseline patient reported outcome scores all individually predicted greater 1-year improvement in that same outcome. Accounting for baseline and post-randomization characteristics and treatment arm, 1-year change in HbA1c was unrelated to changes in overall physical or mental health; however, every one percentage-point (10.9 mmol/mol) reduction in HbA1c was associated with lower symptom count (β = 0.599; P = 0.012), lower symptom distress (β = 0.051; P = 0.001), and higher treatment satisfaction (β = −2.514; P

To report chronic opioid therapy discontinuation rates after five years and identify factors associated with discontinuation.Medical and pharmacy claims records from January 2000 through December 2005 from a national private health network (HealthCore), and Arkansas (AR) Medicaid were used to identify ambulatory adult enrollees who had 90 days of opioids supplied. Recipients were followed until they discontinued opioid prescription fills or disenrolled. Kaplan Meier survival models and Cox proportional hazards models were estimated to identify factors associated with time until opioid discontinuation.There were 23,419 and 6,848 chronic opioid recipients followed for a mean of 1.9 and 2.3 years in the HealthCore and AR Medicaid samples. Over a maximum follow up of 4.8 years, 67.0% of HealthCore and 64.9% AR Medicaid recipients remained on opioids. Recipients on high daily opioid dose (greater than 120 milligrams morphine equivalent (MED)) were less likely to discontinue than recipients taking lower doses: HealthCore hazard ratio (HR) = 0.66 (95%CI: 0.57-0.76), AR Medicaid HR = 0.66 (95%CI: 0.50-0.82). Recipients with possible opioid misuse were also less likely to discontinue: HealthCore HR = 0.83 (95%CI: 0.78-0.89), AR Medicaid HR = 0.78 (95%CI: 0.67-0.90).Over half of persons receiving 90 days of continuous opioid therapy remain on opioids years later. Factors most strongly associated with continuation were intermittent prior opioid exposure, daily opioid dose ≥ 120 mg MED, and possible opioid misuse. Since high dose and opioid misuse have been shown to increase the risk of adverse outcomes special caution is warranted when prescribing more than 90 days of opioid therapy in these patients.

The use of chronic opioid therapy (COT) for chronic non-cancer pain (CNCP) has increased dramatically in the past two decades. There has also been a marked increase in the abuse of prescribed opioids and in accidental opioid overdose. Misuse of prescribed opioids may link these trends, but has thus far only been studied in small clinical samples. We therefore sought to validate an administrative indicator of opioid misuse among large samples of recipients of COT and determine the demographic, clinical, and pharmacological risks associated with possible and probable opioid misuse. A total of 21,685 enrollees in commercial insurance plans and 10,159 in Arkansas Medicaid who had at least 90 days of continuous opioid use 2000-2005 were studied for one year. Criteria were developed for possible and probable opioid misuse using administrative claims data concerning excess days supplied of short-acting and long-acting opioids, opioid prescribers and opioid pharmacies. We estimated possible misuse at 24% of COT recipients in the commercially insured sample and 20% in the Medicaid sample and probable misuse at 6% in commercially insured and at 3% in Medicaid. Among non-modifiable factors, younger age, back pain, multiple pain complaints and substance abuse disorders identify patients at high risk for misuse. Among modifiable factors, treatment with high daily dose opioids (especially >120 mg MED per day) and short-acting Schedule II opioids appears to increase the risk of misuse. The consistency of the findings across diverse patient populations and the varying levels of misuse suggest that these results will generalize broadly, but await confirmation in other studies.

Objective To report trends and characteristics of long-term opioid use for non-cancer pain. Methods CONSORT (CONsortium to Study Opioid Risks and Trends) includes adult enrollees of two health plans serving over 1 per cent of the US population. Using automated data, we constructed episodes of opioid use between 1997 and 2005. We estimated age–sex standardized rates of opioid use episodes beginning in each year (incident) and on-going in each year (prevalent), and the per cent change in rates annualized (PCA) over the 9-year period. Long-term episodes were defined as > 90 days with 120+ days supply or 10+ opioid prescriptions in a given year. Results Over the study period, incident long-term use increased from 8.5 to 12.1 per 1000 at Group Health (GH) (6.0% PCA), and 6.3 to 8.6 per 1000 at Kaiser Permanente of Northern California (KPNC) (5.5% PCA). Prevalent long-term use doubled from 23.9 to 46.8 per 1000 at GH (8.5% PCA), and 21.5 to 39.2 per 1000 at KPNC (8.1% PCA). Non-Schedule II opioids were the most commonly used opioid among patients engaged in long-term opioid therapy, particularly at KPNC. Long-term use of Schedule II opioids also increased substantially at both health plans. Among prevalent long-term users in 2005, 28.6% at GH and 30.2% at KPNC were also regular users of sedative hypnotics. Conclusion Long-term opioid therapy for non-cancer pain is increasingly prevalent, but the benefits and risks associated with such therapy are inadequately understood. Concurrent use of opioids and sedative-hypnotics was unexpectedly common and deserves further study. Copyright © 2009 John Wiley & Sons, Ltd.

Objectives: This paper describes characteristics of opioid use episodes for noncancer pain and defines thresholds for de facto long-term opioid therapy. Methods: CONSORT (CONsortium to Study Opioid Risks and Trends) includes adult members of 2 health plans serving over 1% of the US population. Opioid use episodes beginning in the years 1997 to 2005 were classified as acute, episodic, long-term/ lower dose, or long-term/higher dose. Results: On the basis of evaluation of the likelihood of opioid use continuing, long-term opioid therapy was defined by episodes lasting longer than 90 days with 10+ opioid prescriptions or 120+ days supply of opioids dispensed. Long-term/ higher dose episodes ( < 1.5% of all opioid use episodes) were characterized by daily or near daily use, a mean duration of about 1000 days, and an average daily dose of about 55mg. They accounted for more than half the total morphine equivalents dispensed from the years 1997 to 2006. Short-acting, non-Schedule II opioids (eg, hydrocodone with acetaminophen) were, by far, the most commonly prescribed medications for acute, episodic, and long-term episodes. Long-acting (sustained- release) opioids were the predominately prescribed medication in a minority of long-term episodes (6% to 12%). Discussion: Long-term opioid therapy was characterized by the diversity in medications prescribed, dosage levels, and frequency of use. The proposed threshold for long-term opioid therapy provides a checkpoint for physicians to review whether an explicit decision to sustain opioid therapy has been reached, and to ensure that a documented treatment plan and provisions for monitoring medication use and patient outcomes are in place.

Most patients with type 2 diabetes mellitus develop cardiovascular disease (CVD), with substantial loss of life expectancy. Nonfatal CVD contributes greatly to excess healthcare costs and decreased quality of life in patients with diabetes. The current epidemic of obesity has raised expectations that CVD associated with type 2 diabetes will become an even greater public health challenge. Despite the importance of this health problem, there is a lack of definitive data on the effects of the intensive control of glycemia and other CVD risk factors on CVD event rates in patients with type 2 diabetes. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial is a randomized, multicenter, double 2 x 2 factorial design study involving 10,251 middle-aged and older participants with type 2 diabetes who are at high risk for CVD events because of existing CVD or additional risk factors. ACCORD is testing the effects of 3 medical treatment strategies to reduce CVD morbidity and mortality. All participants are in the glycemia trial, which is testing the hypothesis that a therapeutic strategy that targets a glycosylated hemoglobin (HbA1c) level of6.0% will reduce the rate of CVD events more than a strategy that targets an HbA1c level of 7.0%-7.9%. The lipid trial includes 5,518 of the participants, who receive either fenofibrate or placebo in a double-masked fashion to test the hypothesis of whether, in the context of good glycemic control, a therapeutic strategy that uses a fibrate to increase high-density lipoprotein cholesterol and lower triglyceride levels together with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) to lower low-density lipoprotein cholesterol will reduce the rate of CVD events compared with a strategy that uses a statin plus a placebo. The blood pressure trial includes the remaining 4,733 participants and tests the hypothesis that a therapeutic strategy that targets a systolic blood pressure of120 mm Hg in the context of good glycemic control will reduce the rate of CVD events compared with a strategy that targets a systolic blood pressure of140 mm Hg. The primary outcome measure for all 3 research questions is the first occurrence of a major CVD event, specifically nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Upon the expected completion of participant follow-up in 2009, the ACCORD trial should document for the first time the benefits and risks of intensive glucose control, intensive blood pressure control, and the combination of fibrate and statin drugs in managing blood lipids in high-risk patients with type 2 diabetes.

A central question in prescribing opioids for chronic non-cancer pain (CNCP) is how to best balance the risk of opioid abuse and dependence with the benefits of pain relief. To achieve this balance, clinicians need an understanding of the risk factors for opioid abuse, an issue that is only partially understood. We conducted a secondary data analysis of regional VA longitudinal administrative data (years 2000-2005) for chronic users of opioids for CNCP (n=15,160) to investigate risk factors for the development of clinically recognized (i.e., diagnosed) opioid abuse or dependence among these individuals. We analyzed four broad groups of possible risk factors: (i) non-opioid substance abuse disorders, (ii) painful physical health disorders, (iii) mental health disorders, and (iv) socio-demographic factors. In adjusted models, a diagnosis of non-opioid substance abuse was the strongest predictor of opioid abuse/dependence (OR=2.34, p

The recently proposed Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION)-American Pain Society (APS) Pain Taxonomy (AAPT) provides an evidence-based, multidimensional, chronic pain classification system. Psychosocial factors play a crucial role within several dimensions of the taxonomy. In this article, we discuss the evaluation of psychosocial factors that influence the diagnosis and trajectory of chronic pain disorders. We review studies in individuals with a variety of persistent pain conditions, and describe evidence that psychosocial variables play key roles in conferring risk for the development of pain, in shaping long-term pain-related adjustment, and in modulating pain treatment outcomes. We consider “general” psychosocial variables such as negative affect, childhood trauma, and social support, as well as “pain-specific” psychosocial variables that include pain-related catastrophizing, self-efficacy for managing pain, and pain-related coping. Collectively, the complexity and profound variability in chronic pain highlights the need to better understand the multidimensional array of interacting forces that determine the trajectory of chronic pain conditions. Perspective The AAPT is an evidence-based chronic pain classification system in which psychosocial concepts and processes are essential in understanding the development of chronic pain and its effects. In this article we review psychosocial processes that influence the onset, exacerbation, and maintenance of chronic pain disorders.

Calls to respect patient autonomy and produce patient-centered outcomes have recently brought the patient's point of view back into the center of clinical medicine. Bioethics has argued that patient values must be respected in health care decisions. But it has generally not questioned medicine's goals, including its definition of health. For bioethics, health has remained an objective biological fact. However, pressures to improve the cost-effectiveness of medical care have increased interest in the subjective health and quality of life of patients. Perceived health, health-related quality of life, and health-state utilities bring health assessment progressively closer to the patient's perspective. Now even death's harm to patients is qualified by the value patients place on their health state. Medicine's epidemiological transition from acute to chronic disease is thus prompting an epistemological transition from primarily objective to primarily subjective evidence of health and health care effectiveness. Now some of the most important patient outcomes, like patient choices before them, are valid because they are subjective. Pathophysiology is appropriately becoming a means to produce health as it is defined from the patient's point of view. The physicians' job description will be changed to focus on patients' lives rather than patients' bodies. Definitive evaluations of medical effectiveness will occur within patients' lives rather than within doctors' hospitals. This further incorporation of patient subjectivity should carry us well beyond informed consent and the other protections for patient autonomy bequeathed to us by bioethics.

Background Shared decision-making is not widely implemented in healthcare. We aimed to set a research agenda about promoting shared decision-making through continuing professional development. Methods Thirty-six participants met for two days. Results Participants suggested ways to improve an environmental scan that had inventoried 53 shared decision-making training programs from 14 countries. Their proposed research agenda included reaching an international consensus on shared decision-making competencies and creating a framework for accrediting continuing professional development initiatives in shared decision-making. Conclusions Variability in shared decision-making training programs showcases the need for quality assurance frameworks.

Dizziness is a common patient symptom and often remains medically unexplained even after an extensive work-up. The otologic disorders, psychiatric disorders, and functional disability of 75 patients presenting with dizziness to a community otolaryn gology practice were assessed in 1991. The patients were classified according to the presence or absence of at least one current DSM-III-R psychiatric disorder and the presence or absence of a peripheral vestibular disorder. Decrements in mental health and role functioning, and increases in bodily pain and hypochondriacal focus were significantly associated with the presence of a psychiatric disorder and whether the etiology of dizziness was due to a peripheral vestibular dysfunction.

Background Long-term opioid therapy for chronic noncancer pain is becoming increasingly common in community practice. Concomitant with this change in practice, rates of fatal opioid overdose have increased. The extent to which overdose risks are elevated among patients receiving medically prescribed long-term opioid therapy is unknown. Objective To estimate rates of opioid overdose and their association with an average prescribed daily opioid dose among patients receiving medically prescribed, long-term opioid therapy. Design Cox proportional hazards models were used to estimate overdose risk as a function of average daily opioid dose (morphine equivalents) received at the time of overdose. Setting HMO. Patients 9940 persons who received 3 or more opioid prescriptions within 90 days for chronic noncancer pain between 1997 and 2005. Measurements Average daily opioid dose over the previous 90 days from automated pharmacy data. Primary outcomes--nonfatal and fatal overdoses--were identified through diagnostic codes from inpatient and outpatient care and death certificates and were confirmed by medical record review. Results 51 opioid-related overdoses were identified, including 6 deaths. Compared with patients receiving 1 to 20 mg/d of opioids (0.2% annual overdose rate), patients receiving 50 to 99 mg/d had a 3.7-fold increase in overdose risk (95% CI, 1.5 to 9.5) and a 0.7% annual overdose rate. Patients receiving 100 mg/d or more had an 8.9-fold increase in overdose risk (CI, 4.0 to 19.7) and a 1.8% annual overdose rate. Limitations Increased overdose risk among patients receiving higher dose regimens may be due to confounding by patient differences and by use of opioids in ways not intended by prescribing physicians. The small number of overdoses in the study cohort is also a limitation. Conclusion Patients receiving higher doses of prescribed opioids are at increased risk for overdose, which underscores the need for close supervision of these patients. Primary funding source National Institute of Drug Abuse.

Opioids are widely prescribed for non-cancer pain conditions (NCPC), but there have been no large observational studies in actual clinical practice assessing patterns of opioid use over extended periods of time. The TROUP (Trends and Risks of Opioid Use for Pain) study reports on trends in opioid therapy for NCPC in two disparate populations, one national and commercially insured (HealthCore Blue Cross and Blue Shield plans) and one state-based and publicly-insured (Arkansas Medicaid) population over a six year period (2000-2005). We track enrollees with the four most common NCPC conditions: arthritis/joint pain, back pain, neck pain, headaches, as well as HIV/AIDS. Rates of NCPC diagnosis and opioid use increased linearly during this period in both groups, with the Medicaid group starting at higher rates and the HealthCore group increasing more rapidly. The proportion of enrollees receiving NCPC diagnoses increased (HealthCore 33%, Medicaid 9%), as did the proportion of enrollees with NCPC diagnoses who received opioids (HealthCore 58%, Medicaid 29%). Cumulative yearly opioid dose (in mg. morphine equivalents) received by NCPC patients treated with opioids increased (HealthCore 38%, Medicaid 37%) due to increases in number of days supplied rather than dose per day supplied. Use of short-acting Drug Enforcement Administration Schedule II opioids increased most rapidly, both in proportion of NCPC patients treated (HealthCore 54%, Medicaid 38%) and in cumulative yearly dose (HealthCore 95%, Medicaid 191%). These trends have occurred without any significant change in the underlying population prevalence of NCPC or new evidence of the efficacy of long-term opioid therapy and thus likely represent a broad-based shift in opioid treatment philosophy.

Use of opioids for chronic noncancer pain is increasing, but standards of care for this practice are poorly defined. Psychiatric disorders are associated with increased physical symptoms such as pain and may be associated with opioid use, but no prospective population-based studies have addressed this issue.Analysis of longitudinal data from 6439 participants in the 1998 and 2001 waves of Healthcare for Communities, a nationally representative telephone community survey.Two hundred thirty-seven subjects (3.6%) reported regular prescription opioid use in 2001. In unadjusted logistic regression models, respondents with a common mental health disorder in 1998 (1165 [12.6%]; major depression, dysthymia, generalized anxiety disorder, or panic disorder) were more likely to report opioid use in 2001 than those without any of these disorders (odds ratio [OR], 4.43; 95% confidence interval [CI], 3.64-5.38; P.001). Risk was increased for initiation (OR, 3.26; 95% CI, 2.44-4.34; P.001) and continuation (OR, 2.30; 95% CI, 1.02-5.17; P = .04) of opioids. Respondents reporting problem drug use (136 [2.0%]; OR, 3.57; 95% CI, 2.32-5.50; P.001) but not problem alcohol use (401 [6.5%]; OR, 0.73; 95% CI, 0.43-1.24; P = .25) reported higher rates of prescribed opioid use than those without problem use. In multivariate logistic regression models controlling for 1998 demographic and clinical variables, common mental health disorder (OR, 1.96; 95% CI, 1.47-2.62; P.001) and problem drug use (OR, 2.98; 95% CI, 1.68-5.30; P.001) remained significant predictors of opioid use in 2001.Common mental health disorders and problem drug use are associated with initiation and use of prescribed opioids in the general population. Attention to psychiatric disorders is important when considering opioid therapy.

Background— Heart failure has an annual mortality rate ranging from 5% to 75%. The purpose of the study was to develop and validate a multivariate risk model to predict 1-, 2-, and 3-year survival in heart failure patients with the use of easily obtainable characteristics relating to clinical status, therapy (pharmacological as well as devices), and laboratory parameters. Methods and Results— The Seattle Heart Failure Model was derived in a cohort of 1125 heart failure patients with the use of a multivariate Cox model. For medications and devices not available in the derivation database, hazard ratios were estimated from published literature. The model was prospectively validated in 5 additional cohorts totaling 9942 heart failure patients and 17 307 person-years of follow-up. The accuracy of the model was excellent, with predicted versus actual 1-year survival rates of 73.4% versus 74.3% in the derivation cohort and 90.5% versus 88.5%, 86.5% versus 86.5%, 83.8% versus 83.3%, 90.9% versus 91.0%, and 89.6% versus 86.7% in the 5 validation cohorts. For the lowest score, the 2-year survival was 92.8% compared with 88.7%, 77.8%, 58.1%, 29.5%, and 10.8% for scores of 0, 1, 2, 3, and 4, respectively. The overall receiver operating characteristic area under the curve was 0.729 (95% CI, 0.714 to 0.744). The model also allowed estimation of the benefit of adding medications or devices to an individual patient’s therapeutic regimen. Conclusions— The Seattle Heart Failure Model provides an accurate estimate of 1-, 2-, and 3-year survival with the use of easily obtained clinical, pharmacological, device, and laboratory characteristics.

Objective: Previous research has shown high prevalence rates of depression in multiple sclerosis patients seen in specialty clinics. The relationships among depressive symptoms and severity, duration, and course of multiple sclerosis are controversial. Method: A survey was mailed to members of the Multiple Sclerosis Association of King County (Wash.). Of the 1,374 eligible participants, 739 returned the survey, a response rate of 53.8%. Data about demographic characteristics, employment, and duration and course of multiple sclerosis were collected. Severity of multiple sclerosis was determined by the Expanded Disability Status Scale, self-report version. Severity of depressive symptoms was evaluated with the Center for Epidemiologic Studies Depression Scale (CES-D Scale). Analysis of covariance was used to compare mean CES-D Scale scores across categories of multiple sclerosis, and logistic regression was used to identify variables associated with clinically significant depression. Results: Clinically significant depressive symptoms (CES-D Scale score ≥16) were found in 41.8% of the subjects, and 29.1% of the subjects had moderate to severe depression (score ≥21). Subjects with advanced multiple sclerosis were much more likely to experience clinically significant depressive symptoms than subjects with minimal disease. Shorter duration of multiple sclerosis was associated with a greater likelihood of significant depressive symptoms, but the pattern of illness progression was not. Conclusions: In this large community sample, the severity of multiple sclerosis was more strongly associated with depressive symptoms than was pattern of illness. Clinicians should evaluate depression in patients with recent diagnoses of multiple sclerosis, major changes in functioning, or limited social support.

ContextInsufficient evidence exists for recommendation of specific effective treatments for older primary care patients with minor depression or dysthymia.ObjectiveTo compare the effectiveness of pharmacotherapy and psychotherapy in primary care settings among older persons with minor depression or dysthymia.DesignRandomized, placebo-controlled trial (November 1995–August 1998).SettingFour geographically and clinically diverse primary care practices.ParticipantsA total of 415 primary care patients (mean age, 71 years) with minor depression (n = 204) or dysthymia (n = 211) and a Hamilton Depression Rating Scale (HDRS) score of at least 10 were randomized; 311 (74.9%) completed all study visits.InterventionsPatients were randomly assigned to receive paroxetine (n = 137) or placebo (n = 140), starting at 10 mg/d and titrated to a maximum of 40 mg/d, or problem-solving treatment–primary care (PST-PC; n = 138). For the paroxetine and placebo groups, the 6 visits over 11 weeks included general support and symptom and adverse effects monitoring; for the PST-PC group, visits were for psychotherapy.Main Outcome MeasuresDepressive symptoms, by the 20-item Hopkins Symptom Checklist Depression Scale (HSCL-D-20) and the HDRS; and functional status, by the Medical Outcomes Study Short-Form 36 (SF-36) physical and mental components.ResultsParoxetine patients showed greater (difference in mean [SE] 11-week change in HSCL-D-20 scores, 0.21 [0.07]; P = .004) symptom resolution than placebo patients. Patients treated with PST-PC did not show more improvement than placebo (difference in mean [SE] change in HSCL-D-20 scores, 0.11 [0.13] ; P = .13), but their symptoms improved more rapidly than those of placebo patients during the latter treatment weeks (P = .01). For dysthymia, paroxetine improved mental health functioning vs placebo among patients whose baseline functioning was high (difference in mean [SE] change in SF-36 mental component scores, 5.8 [2.02]; P = .01) or intermediate (difference in mean [SE] change in SF-36 mental component scores, 4.4 [1.74]; P = .03). Mental health functioning in dysthymia patients was not significantly improved by PST-PC compared with placebo (P≥.12 for low-, intermediate-, and high-functioning groups). For minor depression, both paroxetine and PST-PC improved mental health functioning in patients in the lowest tertile of baseline functioning (difference vs placebo in mean [SE] change in SF-36 mental component scores, 4.7 [2.03] for those taking paroxetine; 4.7 [1.96] for the PST-PC treatment; P = .02 vs placebo).ConclusionsParoxetine showed moderate benefit for depressive symptoms and mental health function in elderly patients with dysthymia and more severely impaired elderly patients with minor depression. The benefits of PST-PC were smaller, had slower onset, and were more subject to site differences than those of paroxetine.

Two recent reports have found associations between fibromyalgia and sexual victimization but had methodologic characteristics that limited their interpretation. The authors compared 36 patients with fibromyalgia and 33 patients with rheumatoid arthritis by using structured interviews for sexual physical and emotional victimization histories as well as dimensional self-report measures of victimization severity. Compared with the patients with rheumatoid arthritis those with fibromyalgia had significantly higher lifetime prevalence rates of all forms of victimization both adult and adulthood as well as combinations of adult and childhood trauma. Although childhood maltreatment was found to be a general risk factor for fibromyalgia particular forms of maltreatment (e.g. sexual abuse per se) did not have specific effects. Experiences of physical assault in adulthood however showed a strong and specific relationship with unexplained pain. Trauma severity was correlated significantly with measures of physical disability psychiatric distress illness adjustment personality and quality of sleep in-patients with fibromyalgia but not in those with rheumatoid arthritis. Fibromyalgia seems to be associated with increased risk of victimization particularly adult physical abuse. Sexual physical and emotional trauma may be important factors in the development and maintenance of this disorder and its associated disability in many patients. (authors)

Previous studies have shown that severe tinnitus is associated with current major depression, and that tricyclic antidepressant therapy reduces tinnitus disability, at least compared to brief placebo treatment. We are completing a randomized clinical trial of nortriptyline, stratified by presence or absence of current major depression, in 100 patients with severe chronic tinnitus. Preliminary analysis of global outcome on the first 52 patients reveals that those receiving nortriptyline were more likely to feel that their drug had been helpful (74% vs. 36%, p less than 0.01), but were equally likely to report that their tinnitus was improved (37% vs. 32%, NS). So far, neither audiometric nor self-report measures of tinnitus have demonstrated statistically significant differences between active drug and placebo. Simply administered visual rating scales, if externally-referenced, correlated better with global outcome than did the Iowa Tinnitus Handicap Questionnaire. As expected, nortriptyline was significantly superior to placebo with respect to reductions in the Hamilton Depression Scale, especially in depressed patients. Paradoxically, depressed patients reported more disability and loudness on all scales, but had lower 1 kHz tinnitus intensity matches and dynamic ranges. Our preliminary conclusions are that: 1) nortriptyline reduces depression in patients with severe tinnitus, 2) placebo effects are very important in the treatment of tinnitus, 3) depression may be associated with decreased tolerance for both internal and external sounds, and 4) it is still difficult to specify the appropriate measures of tinnitus loudness and disability for use in therapeutic trials.

Community studies have shown that stressful life events, psychological distress, and depressive and anxiety disorders are associated with 1) a range of medical symptoms without identified pathology, 2) increased health care utilization, and 3) increased costs. In both primary care and medical specialty samples, patients who have syndromes with ill-defined pathologic mechanisms (such as the irritable bowel syndrome and fibromyalgia) have been shown to have significantly higher rates of anxiety and depressive disorders than do patients with comparable, well-defined medical diseases and similar symptoms. Other studies show that after adjustment for severity of medical illness, patients with depression or anxiety and comorbid medical disease have significantly more medical symptoms without identified pathology than do patients with a similar medical disease alone. Both childhood maltreatment and psychological trauma in adulthood have been associated with increased vulnerability to psychiatric illness and more medical symptoms. The substantial functional impairment, distress, and costs associated with medical symptoms without identified pathology suggest that research studies promoting a better understanding of the biopsychosocial cause of these symptoms may yield pragmatic, cost-effective approaches to treatment in medical settings.