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Patients with advanced cancer who have pain that responds poorly to opioid therapy pose a clinical challenge. Nabiximols (Nabiximols is the US Adopted Name [USAN] for Sativex [GW Pharma Ltd, Wiltshire, UK], which does not yet have an INN), a novel cannabinoid formulation, is undergoing investigation as add-on therapy for this population. In a randomized, double-blind, placebo-controlled, graded-dose study, patients with advanced cancer and opioid-refractory pain received placebo or nabiximols at a low dose (1-4 sprays/day), medium dose (6-10 sprays/day), or high dose (11-16 sprays/day). Average pain, worst pain and sleep disruption were measured daily during 5 weeks of treatment; other questionnaires measured quality of life and mood. A total of 360 patients were randomized; 263 completed. There were no baseline differences across groups. The 30% responder rate primary analysis was not significant for nabiximols versus placebo (overall P = .59). A secondary continuous responder analysis of average daily pain from baseline to end of study demonstrated that the proportion of patients reporting analgesia was greater for nabiximols than placebo overall (P = .035), and specifically in the low-dose (P = .008) and medium-dose (P = .039) groups. In the low-dose group, results were similar for mean average pain (P = .006), mean worst pain (P = .011), and mean sleep disruption (P = .003). Other questionnaires showed no significant group differences. Adverse events were dose-related and only the high-dose group compared unfavorably with placebo. This study supports the efficacy and safety of nabiximols at the 2 lower-dose levels and provides important dose information for future trials. PERSPECTIVE: Nabiximols, a novel cannabinoid formulation, may be a useful add-on analgesic for patients with opioid-refractory cancer pain. A randomized, double-blind, placebo-controlled, graded-dose study demonstrated efficacy and safety at low and medium doses. [ABSTRACT FROM AUTHOR]

Access to medical care is a major national issue, and several surveys suggest that racial and ethnic differences influence access to care for chronic pain problems. To evaluate the influence of race and ethnicity on access to treatment for chronic pain, a cross-sectional telephone survey was performed in a nationally representative sample of 454 white, 447 African-American, and 434 Hispanic subjects with pain for > or =3 months. Questions explored demographics, pain and its treatment, and perceived access to care. A composite 'access' variable combined actual consultation with perceived access. Hispanics were younger, least likely to be insured, and had the least education and lowest income; 61% spoke Spanish at home. Hispanics were significantly less likely to have consulted a primary care practitioner for pain (70%) than whites (84%) or African-Americans (85%). A lower likelihood of consultation also was associated with speaking Spanish, being male, being relatively young (18-34 years old) or single, having limited education, and not being employed. Low 'access' to care was associated with being Hispanic and speaking Spanish, being younger or male, having low income or limited education, being employed, and agreeing that financial concerns prevented pain treatment. High 'access' was associated with being white or African-American; being older or female or living in a suburban area; having insurance, higher income, or college education; and being unemployed. In multivariate models, low 'access' was associated with Hispanic ethnicity and agreement that financial concerns prevented pain treatment. High 'access' was associated with more severe pain, having insurance or an income of US 25,000 dollars to US 74,000 dollars, and agreeing that 'A doctor or other health care provider is the first person I would go to to discuss my pain.' These data suggest that race/ethnicity, other demographic characteristics, and socioeconomic factors influence access to pain care. Hispanic ethnicity predicts limited access. PERSPECTIVE: The influence of race and ethnicity on access to health care is a major issue in the United States. A national telephone survey suggests that race and ethnicity, along with other demographic and socioeconomic factors, influence access to care for chronic pain. [ABSTRACT FROM AUTHOR]