Placebo effect: its role in adherence,treatment effectiveness and patient outcomes

Research on the placebo effect and its hypothetical relationship to adherence and improved patient outcomes is reviewed. Future research for pharmacists is highlighted. Clinicians and researchers have alternately attempted to suppress, control for and maximise the placebo response. Much research has been conducted to identify the placebo responder. The placebo response is seldom uniform, constant or predictable, and neither sex, age, intelligence, ethnic, cultural or social factors are predictive of it. However, no research has investigated the relationship of adherence, placebo effects and patient outcomes. Adherence to therapy and its role in activating the placebo response is described. Efforts to increase adherence may increase treatment effectiveness by activating the placebo response. The pharmacist may be in an ideal position to better understand the placebo effect and its role in enhancing patient outcomes. The placebo effect, thus, may be a useful part of the care giver's armamentarium.     

Anxiolytics and the alcoholic patient

There is a growing appreciation of the heterogeneity of alcoholic patients with implications for treatment intervention. Several recent studies suggest that a minority of alcoholic patients suffer from diagnosable anxiety disorders, although symptoms of anxiety may be present in alcoholics while drinking and in the acute, subacute and protracted periods of abstinence from alcohol. In addition, recent research on biological mechanisms of anxiety may suggest a testable model for examining the existence of an altered biological state associated with symptoms of protracted abstinence in alcoholics, and may suggest an additional rationale for studying newer anxiolytic drugs in the postwithdrawal management of alcoholic patients. In the mid-1970s, Benjamin Kissin made three points regarding the optimal qualities for a tranquilizing drug in the treatment of alcoholism: it should be effective in maintaining individuals in treatment, it should have a low potential for abuse and it should not potentiate the effects of alcohol. Buspirone, a new anxiolytic drug, fulfills the second two criteria. The case for examining anxiolytics with low abuse potential in alcoholic patients is reviewed.     

Effect of oral testosterone treatment on serum concentrations of sex steroids, gonadotrophins and prolactin in alcoholic cirrhotic men

The aim of this study was to examine the serum concentrations of sex steroids and pituitary hormones in a randomly selected group of alcoholic cirrhotic men participating in a randomized, placebo-controlled study on the efficacy of oral testosterone treatment on the liver. Before treatment, patients (n = 25) had median serum concentrations of testosterone, oestradiol, non-protein bound oestradiol, non-sex hormone binding globulin (SHBG) bound oestradiol and oestrone sulphate which did not differ significantly from those of healthy controls (n = 16), but the patients had significantly (P less than 0.01) higher median serum concentrations of oestrone, luteinizing hormone (LH), follicle-stimulating hormone (FSH) and prolactin. The patients were randomized to treatment with either oral micronized testosterone (200 mg t.d.s.) or placebo for a median duration of 1 year. In the placebo group (n = 8), hormone concentrations at follow-up were not significantly different from those at entry apart from a significant (P less than 0.05) increase in FSH concentrations. Median concentrations of testosterone, oestrone, and oestrone sulphate increased significantly (P less than 0.05) in the testosterone-treated group (n = 17) when compared with concentrations at entry and concentrations in the placebo group. The testosterone-treated group had significantly (P less than 0.05) higher serum concentrations of non-protein bound and non-SHBG bound oestradiol when compared with concentrations at entry, but no significant changes were observed regarding serum oestradiol and prolactin concentrations. Both LH and FSH concentrations decreased significantly (P less than 0.05) in the testosterone-treated group when compared with concentrations at entry and concentrations in the placebo group.     

Fluvoxamine in the treatment of the older depressed patient; double-blind, placebo-controlled data

Fluvoxamine was given in placebo-controlled trials to 33 severely depressed patients of between 60 and 71 years, 29 received imipramine and 14 placebo. At week 4 of treatment fluvoxamine and imipramine were superior to placebo on the HAMD and CGI scales (P less than 0.05). There was indication of an earlier onset of antidepressant activity in the fluvoxamine group. There was no evidence of systematic changes in laboratory variables in any treatment group. Fluvoxamine and placebo had similar effects on heart rate and blood pressure. Imipramine was associated with significant postural falls in mean systolic pressure. The most frequent unwanted symptom with fluvoxamine was mild nausea, with imipramine, dry mouth. Toxic confusion was the major reason for dropout in the imipramine (n = 4) and nausea (n = 3) in the fluvoxamine-treated group.     

Temporal patterns of adherence to medications and behavioral treatment and their relationship to patient characteristics and treatment response

Background

The primary analyses of the COMBINE Study revealed significant naltrexone and Combined Behavioral Intervention (CBI) main effects on drinking outcomes but failed to find additional benefits of the combination of treatments. Investigating differences in patterns of adherence over time may shed light on the treatment effects in COMBINE. The goals of the study were to identify trajectories of medication adherence and participation in CBI, to estimate predictive and moderating effects of adherence trajectories on drinking outcomes and to characterize subjects in adherence trajectories. The results of these analyses may suggest approaches to improving adherence in order to ultimately improve treatment outcome.

Methods

We used a trajectory-based approach to identify patterns of treatment adherence separately for naltrexone, acamprosate and CBI adherence. Logistic regression and general linear models assessed associations among adherence trajectories, drinking outcomes and patient characteristics.

Results

Three trajectories of adherence were identified for each treatment: “excellent adherers”, “late non-adherers” and “early non-adherers” and there was good agreement among adherence trajectories with different treatments. “Excellent adherers” had significantly higher percent days abstinent (PDA) and lower percent heavy drinking days (PHDD). CBI significantly decreased PHDD for subjects on acamprosate in the “early non-adherers with medication” trajectory (p = 0.01). Either naltrexone or acamprosate was associated with lower PHDD than placebo for “early non-adherers with CBI” (p < 0.01). Receiving active medication decreased the likelihood to be in the excellent medication adherence trajectory. Younger age, greater drinking severity, dissatisfaction with the medicine and session frequency, adverse events and lack of benefit were related to less favorable medication adherence trajectories. “Excellent adherers with CBI” were significantly more satisfied with the CBI counselor.

Conclusions

Patterns of treatment adherence appear to be a participant characteristic. Individuals who fail to adhere early in treatment have worse outcomes regardless of treatment. However, treatment outcomes of participants who exhibit early problems with adherence to one treatment modality could potentially be improved by offering an alternative behavioral or pharmacologic treatment.     

Discriminating drug-dependent women from alcoholic women and drug-dependent men

The authors compared 99 drug-dependent women to 162 alcoholic women and 66 drug-dependent men entering an outpatient treatment program. They were assessed by a semistructured interview for demography, progression of dependence prior to entering treatment, prior suicidal behavior, and baseline functioning in different areas (alcohol/drug use, occupation, family relationships, and leisure activities). Discriminant analysis techniques were good at predicting group membership for all groups, with an overall correct classification of 69%; though at a lesser degree for the group of drug-dependent women (55%). Among those drug-dependent women misclassified, two-thirds were reclassified into the drug-dependent men group and the remaining third into the alcoholic women group. Taken together, these findings suggest that the drug-dependent women are a distinct group of substance users, who show more heterogeneous characteristics, as well as sharing more features with the drug-dependent men. This should be taken into account when devising treatment strategies for this specific population.     

A 6 month,prospective, observational study of PDE5 inhibitor treatment persistence and adherence in Latin American men with erectile dysfunction

Abstract

Objectives:

To assess persistence/adherence rates of phosphodiesterase type-5 inhibitor (PDE5I) on-demand dosing in Latin American men with erectile dysfunction (ED), and explore patient characteristics and treatment factors that may be predictive for PDE5I persistence and adherence.     

综合护理干预对寻常型天疱疮患者治疗依从性及焦虑心理的影响

目的 探讨综合护理干预对寻常型天疱疮患者治疗依从性及焦虑心理的影响.方法 选取本院收治的56例寻常型天疱疮患者作为研究对象,按照随机数字表法分为对照组和观察组.对照组采用常规护理,观察组采用综合护理干预,使用焦虑自评量表(SAS)评价患者的心理状态,比较两组的治疗依从性和干预前后1周的SAS评分.结果 观察组干预后的治疗依从性显著优于对照组,差异有统计学意义(P＜0.05).两组干预前的SAS评分比较,差异无统计学意义(P＞0.05),观察组干预后的SAS评分为(44.13±6.97)分,显著低于对照组的(50.25±4.61)分,差异有统计学意义(P＜0.05).结论 综合护理干预应用于寻常型天疱疮患者效果确切,可有效缓解患者的焦虑心理,提高治疗依从性,促进疾病恢复,值得临床推广应用.     

氯沙坦治疗老年单纯收缩期高血压的临床研究

目的研究氯沙坦对老年收缩期高血压的临床作用。方法对比68例老年单纯性收缩期高血压患者应用氯沙坦治疗前及治疗2周、4周、8周后的血压及心率变化;治疗前后血浆内血管紧张素Ⅱ(AngⅡ)、醛固酮、内皮素的变化;治疗前后血、尿常规、肝肾功、血脂、血糖、电解质、心电图变化。结果降压总有效率为85.3%。治疗后AngⅡ显著增高(P<0.01),醛固酮、内皮素显著降低(P<0.05)。血、尿常规、肝肾功、血脂、血糖、电解质及心电图均无明显变化。不良反应发生率低。结论氯沙坦治疗老年收缩期高血压疗效好,降压作用持续稳定,耐受性良好,不良反应轻微。     

Psychosocial profiles of older adolescent MDMA users

PURPOSE: Using a case-control design, patterns of drug use, psychological symptoms, and behavioral characteristics associated with 3,4-methylenedioxymethamphetamine (MDMA ) use were surveyed in a sample of older adolescents (median age 20). METHODS: One hundred (42 MDMA users; 58 non-MDMA users) older adolescents were recruited using the "snowball" technique and interviewed regarding their use of MDMA and other drugs. The Brief Symptom Inventory (BSI), the Problem Oriented Screening Instrument for Teenagers (POSIT), the HIV/sexually transmitted diseases (STD) risk scale, and the Childhood Trauma Questionnaire (CTQ) were also administered. RESULTS: MDMA users were more likely to use other substances, endorse more symptoms of psychological distress, and had more problems in functional lifestyle areas. They also reported more childhood experiences of physical abuse, emotional neglect, and physical neglect than non-MDMA users. MDMA users also reported more sexually risky behaviors. CONCLUSIONS: Occasional MDMA use among older adolescents was associated with polydrug use, multiple social difficulties, psychological symptoms, and health risk behaviors. Further research is warranted to understand the long term psychosocial consequences of chronic MDMA and polydrug usage.     

Insulin delivery with FlexPen: dose accuracy, patient preference and adherence

The introduction of insulin pens has helped improve adherence in Type 1 or 2 diabetes, and reduce inaccurate dosing, fear of injection, and social embarrassment associated with vial and syringe. This report presents the published evidence base for the accuracy, patient preference and economic evaluation of one prefilled pen, FlexPen (Novo Nordisk A/S, Bagsvaerd, Denmark) and discusses recent changes to the design of this pen. Primary research publications that included the study of FlexPen were identified from various sources. Several studies have shown that FlexPen delivers high, medium and low doses of insulin significantly more accurately than vial and syringe, SoloStar (sanofi-aventis, Paris, France) or OptiClik (sanofi-aventis, Paris, France). Patients have also found FlexPen easier to use than vial and syringe. A Next Generation FlexPen has been developed, which maintains the demonstrated accuracy of FlexPen and is accompanied by a reduced injection force for simpler and more comfortable use, and clear colour scheme for insulin type to avoid medication errors.     

The special treatment team: An inpatient approach to the mentally ill alcoholic patient

We review the problems unique to the diagnosis and treatment of patients who suffer both major mental illness and alcohol/drug abuse. We describe the experience and the approach evolved in the Special Treatment Team, a State Hospital unit that has specialized in this work. We discuss in detail the assessment and stabilization of such patients, including psychosocial and pharmacologic strategies, giving special attention to the problem of the unmotivated patient. Several case vignettes illustrate our approach.     

A 6-month,prospective, observational study of PDE5 inhibitor treatment persistence and adherence in Middle Eastern and North African men with erectile dysfunction

Abstract

Background:

Erectile dysfunction (ED) negatively impacts quality of life. Phosphodiesterase type 5 inhibitors (PDE5Is) are effective in treating ED; however, rates of discontinuation remain high.     

酒精性心肌病的诊治总结

目的：总结酒精性心肌病的诊治与预后。方法：回顾性分析2003年2月～2008年2月本院收治的16例酒精性心肌病患者的临床资料,随诊1年,观察患者预后情况。结果：16例患者经严格戒酒、积极纠正心力衰竭及心律失常,全部患者心功能恢复至Ⅱ级以上;随诊1年,16例患者心功能维持在Ⅱ级以上,左室射血分数均大于50%。结论：酒精性心肌病预后的关键因素是早期诊断、彻底戒酒。     

Antiretroviral treatment adherence and its correlates in Addis Ababa, Ethiopia

OBJECTIVE: To assess the degree of adherence with highly active antiretroviral therapy (HAART), and its correlates among adults with HIV/AIDS in Addis Ababa. PATIENTS AND METHODS: Cross-sectional survey of consecutive patients attending three ART centers in Addis Ababa complemented by semi-structured audiotaped in-depth interviews with 10 purposively sampled patients on HAART Treatment adherence was defined as self-report of taking > or =95% of therapy correctly in a specified time period, depression measured using Beck's depression inventory, clinical data recorded by reviewing patients' charts, and knowledge about HAART assessed by questions in "Yes"/"No "format. RESULTS: 431 patients on HAART responded 81.2% of patients were > or =95% adherent by self report in the week before the assessment. The major reasons for non-adherence were: being too busy or simply forgot (33.9%) and being away from home (27.5%). Correlates of adherence included having regular follow-up, not being depressed having no side effects, a regimen that fitted the daily routine and satisfaction with the relationship with doctors. CONCLUSIONS: Self-reported adherence in our study was higher than that seen in developed countries. Recommendations to improve adherence include: provision of regular follow-up for patients, management of depression, forewarning of side effects of HAART, and creating medication schedules appropriate to patients' daily routines.