An evidence-based systematic review of acai (Euterpe oleracea) by the Natural Standard Research Collaboration.

An evidence-based systematic review of acai (Euterpe oleracea) by the Natural Standard Research Collaboration consolidates the safety and efficacy data available in the scientific literature using a validated, reproducible grading rationale. This article includes written and statistical analysis of clinical trials, plus a compilation of expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

Typologies of prescription opioid use in a large sample of adults assessed for substance abuse treatment.

BACKGROUND: As a population, non-medical prescription opioid users are not well-defined. We aimed to derive and describe typologies of prescription opioid use and nonmedical use using latent class analysis in an adult population being assessed for substance abuse treatment. METHODS: Latent class analysis was applied to data from 26,314 unique respondents, aged 18-70, self-reporting past month use of a prescription opioid out of a total of 138,928 cases (18.9%) collected by the Addiction Severity Index-Multimedia Version (ASI-MV®), a national database for near real-time prescription opioid abuse surveillance. Data were obtained from November 2005 through December 2009. Substance abuse treatment, criminal justice, and public assistance programs in the United States submitted data to the ASI-MV database (n = 538). Six indicators of the latent classes derived from responses to the ASI-MV, a version of the ASI modified to collect prescription opioid abuse and chronic pain experience. The latent class analysis included respondent home ZIP code random effects to account for nesting of respondents within ZIP code. RESULTS: A four-class adjusted latent class model fit best and defined clinically interpretable and relevant subgroups: Use as prescribed, Prescribed misusers, Medically healthy abusers, and Illicit users. Classes varied on key variables, including race/ethnicity, gender, concurrent substance abuse, duration of prescription opioid abuse, mental health problems, and ASI composite scores. Three of the four classes (81% of respondents) exhibited high potential risk for fatal opioid overdose; 18.4% exhibited risk factors for blood-borne infections. CONCLUSIONS: Multiple and distinct profiles of prescription opioid use were detected, suggesting a range of use typologies at differing risk for adverse events. Results may help clinicians and policy makers better focus overdose and blood-borne infection prevention efforts and intervention strategies for prescription opioid abuse reduction.

Health care provider perceptions of pain treatment in Hispanic patients.

Despite increasing numbers of Hispanic patients in the United States, this group continues to face disparities in access and quality of pain treatment. Although previous surveys have examined treatment disparities experienced by minority patients, none have provided a provider-centric perspective on issues and concerns surrounding pain relief among pain patients of Hispanic/Latino origin. The goal of this study was to assess the relationship between provider characteristics (ie, Spanish fluency, Hispanic caseload size, and experience with Hispanic pain patients) and their perceptions of pain treatment in these patients. One hundred eighty-seven health professionals completed an online survey. The major findings indicated that: (1) less than 20% of health professionals treating Hispanic pain patients reported Spanish proficiency at an advanced level; (2) surveyed health professionals were involved treating a significant proportion of Hispanic patients in their caseloads, but reported a lack of cultural competence training; (3) Spanish fluency and experience with Hispanic pain patients exerts a strong effect on the use of established pain treatment practices; (4) providers with greater Spanish fluency report a significantly greater effect of patients' cultural beliefs and attitudes on treatment; and (5) providers did not regard cultural or language barriers as significantly impacting opioid prescribing or patient compliance.

Polyvalent AIDS vaccines.

A major hurdle in the development of a global HIV-1 vaccine is viral diversity. For close to three decades, HIV vaccine development has focused on either the induction of T cell immune responses or antibody responses, and only rarely on both components. After the failure of the STEP trial, the scientific community concluded that a T cell-based vaccine would likely not be protective if the T cell immune responses were elicited against only a few dominant epitopes. Similarly, for vaccines focusing on antibody responses, one of the main criticisms after VaxGen's failed Phase III trials was on the limited antigen breadth included in the two formulations used. The successes of polyvalent vaccine approaches against other antigenically variable pathogens encourage implementation of the same approach for the design of HIV-1 vaccines. A review of the existing HIV-1 vaccination approaches based on the polyvalent principle is included here to provide a historical perspective for the current effort of developing a polyvalent HIV-1 vaccine. Results summarized in this review provide a clear indication that the polyvalent approach is a viable one for the future development of an effective HIV vaccine.

An evidence-based systematic review of stevia by the Natural Standard Research Collaboration.

The objective of this study was to evaluate the scientific evidence on stevia, including expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing. This review serves as a clinical support tool. Electronic searches were conducted in 10 databases, 20 additional journals (not indexed in common databases), and bibliographies from 50 selected secondary references. No restrictions were placed on the language or quality of the publications. All literature collected pertained to efficacy in humans, dosing, precautions, adverse effects, use in pregnancy and lactation, interactions, alteration of laboratory assays, and mechanisms of action. Standardized inclusion and exclusion criteria were used for selection. Grades were assigned using an evidence-based grading rationale. Based on the availability of scientific data, two indications are discussed in this review: hypertension and hyperglycemia. Evaluation of two long-term studies (1 and 2 years in length, respectively) indicates that stevia may be effective in lowering blood pressure in hypertensive patients, although data from shorter studies (1-3 months) did not support these findings. A pair of small studies also report positive results with respect to glucose tolerance and response, although the relatively low methodological rigor of these experiments limits the strength of these findings. Further investigation is warranted in both indications.

Estimating attractiveness for abuse of a not-yet-marketed "abuse-deterrent" prescription opioid formulation.

OBJECTIVE: The present study builds on research to model abusers' perceptions of particular analgesics' attractiveness for abuse and extends these methods to derive an estimate of attractiveness for abuse of a not-yet-marketed abuse-deterrent formulation (ADF) of a prescription opioid (Remoxy), Pain Therapeutics, Inc., San Mateo, CA, and King Pharmaceuticals, Inc., Bristol, TN). In a previous study, the Opioid Attractiveness Technology Scaling (OATS) method identified, from a drug abuser's point of view, the particular features of a prescription opioid relevant to its attractiveness for recreational use. A second online sample rated the extent to which these features applied to particular products they had actually used/abused. These data were used to model the abusers' overall preference for prescription opioids they had used/abused. DESIGN: In the present study, this method was applied to a not-yet-marketed ADF using substance abuse counselors as proxies for prescription opioid abusers. Thirty-eight counselors were given materials describing the new ADF along with four known products. RESULTS: Thirty-two counselors demonstrated sufficient agreement with abusers' ratings of the overall attractiveness of these drugs. The overall model yielded a significant pseudo R(2) of 0.15 (P < 0.001), with increasing model fit based on preferred route of administration, from swallowing whole (pseudo R(2) = 0.06; P < 0.001) and best for those who preferred to inject (pseudo R(2) = 0.40; P < 0.001). Data from a cross-validation group of 16 counselors/proxies were used to calculate the OATS scores for the five rated drugs and revealed significant differences between the ADF and OxyContin (Purdue Pharma LP, Stamford, CT), Percocet (Endo Pharmaceuticals, Chadds Ford, PA), and Vicodin (Abbott Laboratories, Abbott Park, IL), but not Talwin NX (Sanofi-aventis, Bridgewater, NJ), which was identified in the prior study as a highly unattractive drug for recreational purposes. CONCLUSIONS: The OATS method shows promise for providing pre-marketing estimates of attractiveness for abuse of not-yet-marketed ADFs.

Can abuse deterrent formulations make a difference? Expectation and speculation.

It is critical that issues surrounding the abuse and misuse of prescription opioids be balanced with the need for these medications for the treatment of pain. One way to decrease the abuse of prescription opioid medications is to develop abuse deterrent formulations (or ADFs) that in some way prevent drug abusers from extracting out the active ingredient in order to employ alternate routes of administration, such as injection, snorting, and smoking. Several factors including the pharmacokinetic profile of the drug, the features of the drug formulation that make it attractive or unattractive for abuse, the type of drug abuser, the progression of one's addiction pathway, and one's social environment may all play a role in the abuse of prescription opioids and what methods are used to abuse these drugs. This paper will examine these factors in order to understand how they affect the abuse of prescription opioids and routes of administration, and how the development of ADFs may alter these patterns.

Women who abuse prescription opioids: findings from the Addiction Severity Index-Multimedia Version Connect prescription opioid database.

BACKGROUND: Evidence suggests gender differences in abuse of prescription opioids. This study aimed to describe characteristics of women who abuse prescription opioids in a treatment-seeking sample and to contrast gender differences among prescription opioid abusers. METHODS: Data collected November 2005 to April 2008 derived from the Addiction Severity Index Multimedia Version Connect (ASI-MV Connect) database. Bivariate and multivariable logistic regression examined correlates of prescription opioid abuse stratified by gender. RESULTS: 29,906 assessments from 220 treatment centers were included, of which 12.8% (N=3821) reported past month prescription opioid abuse. Women were more likely than men to report use of any prescription opioid (29.8% females vs. 21.1% males, p<0.001) and abuse of any prescription opioid (15.4% females vs. 11.1% males, p<0.001) in the past month. Route of administration and source of prescription opioids displayed gender-specific tendencies. Women-specific correlates of recent prescription opioid abuse were problem drinking, age <54, inhalant use, residence outside of West US Census region, and history of drug overdose. Men-specific correlates were age <34, currently living with their children, residence in the South and Midwest, hallucinogen use, and recent depression. Women prescription opioid abusers were less likely to report a pain problem although they were more likely to report medical problems than women who abused other drugs. CONCLUSIONS: Gender-specific factors should be taken into account in efforts to screen and identify those at highest risk of prescription opioid abuse. Prevention and intervention efforts with a gender-specific approach are warranted.

Current progress of DNA vaccine studies in humans.

Despite remarkable progress in the field of DNA vaccine research since its discovery in the early 1990 s, the formal acceptance of this novel technology as a new modality of human vaccines depends on the successful demonstration of its safety and efficacy in advanced clinical trials. Although clinical trials conducted so far have provided overwhelming evidence that DNA vaccines are well tolerated and have an excellent safety profile, the early designs of DNA vaccines failed to demonstrate sufficient immunogenicity in humans. However, studies conducted over the last few years have led to promising results, particularly when DNA vaccines were used in combination with other forms of vaccines. Here, we provide a review of the data from reported DNA vaccine clinical studies with an emphasis on the ability of DNA vaccines to elicit antigen-specific, cell-mediated and antibody responses in humans. The majority of these trials are designed to test candidate vaccines against several major human pathogens and the remaining studies tested the immunogenicity of therapeutic vaccines against cancer.