Pilot randomised controlled trial of community pharmacy administration of buprenorphine versus methadone

Objectives The established regime for opiate substitute prescribing for drug misusers is daily methadone administered under supervision in community pharmacies. Buprenorphine has recently been introduced as an alternative. However there is a lack of evidence of the effectiveness of buprenorphine maintenance therapy (BMT) in the UK treatment setting. This study aimed to assess methods for a randomised controlled trial (RCT) and the feasibility of pharmacy‐based supervised self‐administration (SSA) of buprenorphine compared to methadone. Setting Specialist substance misuse service, general practices and community pharmacies in Aberdeen, Scotland. Method The design was a pilot RCT. Opiate‐dependent drug misusers, newly referred for maintenance treatment were randomised to receive BMT or methadone maintenance therapy (MMT). Clients and pharmacists were interviewed at baseline and at the end of a 12‐week intervention period. Clients completed the quality of life measure EQ‐5D. Pharmacy activities were timed. Key findings Twenty‐one opiate‐dependent clients were recruited (BMT = 11, MMT = 10). Recruitment levels improved as the trial progressed. Clients' treatment preferences were evident. Withdrawals occurred early with BMT. Clients found SSA of buprenorphine acceptable, but found daily administration more manageable than three times weekly. Pharmacists found the dispensing of buprenorphine to be an acceptable role, but felt less certain of ensuring against diversion with buprenorphine than they were with methadone. Pharmacy activities associated with buprenorphine took longer than those associated with methadone (mean = 7 min 25 s versus mean = 3 min 27 s, respectively). Conclusion Recruitment to a trial comparing MMT to BMT for opiate‐dependent clients within a UK treatment setting is feasible. Clients and pharmacists found buprenorphine acceptable.     

The long-term effects of tibolone on aortic stiffness and endothelial function.

OBJECTIVE: To investigate the effect of 10 years of treatment with tibolone on aortic stiffness and endothelial function. DESIGN: Cross-sectional study of women currently participating in an open-label, non-randomized study of the long-term efficacy of tibolone. A total of 113 recently postmenopausal women were recruited in 1988. Fifty-eight agreed to take tibolone 2.5 mg daily and 55 were followed during the study as matched controls (who chose not to take any form of hormone replacement therapy (HRT) for the duration of the study). The groups were matched for age, weight and time since last menstrual period. SETTING: A Central London Teaching Hospital. SUBJECTS: After 10 years, 60 women remained in the study, 32 in the tibolone group and 28 in the control group. All of these women were invited to participate in this pilot study and attend the Menopause Research Unit. Fourteen women from each group agreed to attend. The main outcome measures were aortic stiffness, measured by pulse wave velocity, and endothelial function, as assessed by flow-mediated dilatation of the brachial artery. RESULTS: Pulse wave velocity was significantly lower in the tibolone group (10.4 +/- 1.2) than in the control group (11.6 +/- 1.2), p = 0.042. The flow-mediated dilatations were similar in both groups. CONCLUSION: In this study, long-term use of tibolone over 10 years has a beneficial effect on aortic stiffness. The differences seen in brachial artery vasoreactivity failed to reach statistical significance. Whether this is a true indication of the effects of long-term tibolone on brachial artery vasoreactivity will only be determined by performing a larger, placebo-controlled, randomized study.     

Application of draft European Commission reference levels to a regional CT dose survey

A survey of CT doses in Northern Ireland in the period between October 1995 and March 1997 was carried out. The survey included all but one of the 10 scanners in use at the time, and, additionally, two others that were replacement machines. The method used was to study standard protocols and calculate doses to the NRPB mathematical phantom, so that a direct comparison could be made with other surveys carried out in a similar fashion elsewhere. The survey addressed the patient radiation dose but not image quality or clinical outcomes. It is estimated that in Northern Ireland the contribution to collective dose to the population from CT is about 40% of that from all medical X-rays. The proposed European Commission reference quantities, weighted CT dose index and dose-length product were computed and their potential use evaluated. A full study of mean values of effective dose per examination revealed the average dose per examination was not significantly different from that found in the 1989 UK survey, although several procedures gave rise to doses that were high enough to be investigated with a view to justification or reduction. One of the scanners was found to give consistently high doses. It is likely that a revision of the mAs values used on this scanner will produce a significant reduction in patient doses without compromising image quality. When compared with the draft EC reference levels, fewer procedures were found to have excessively high dose values. The proposed EC reference levels would therefore be useful for continual monitoring of CT dose status, but do not appear to provide as comprehensive an assessment of patient exposure as that given by consideration of effective doses.     

Double posterior labyrinthotomy technique: results in three Med-El patients with common cavity.

HYPOTHESIS: This study reports on the use of the double posterior labyrinthotomy surgical technique and a custom-designed electrode to ensure better positioning of stimulating electrodes within the common cavity and thus demonstrate suitable outcomes in patients. BACKGROUND: Cochlear implantation has proven beneficial for numerous children with congenital malformations of the inner ear. Several studies show good auditory perception outcomes in children with common cavity. However, there have been risks involved with surgical techniques used in the actual implantation. These include possible aberrant facial nerve and the strong potential for a cerebrospinal fluid gusher. Improved surgical techniques and electrode design could allow for better electrode contact and avoid electrode placement in the internal auditory meatus. METHOD: The double posterior labyrinthotomy technique was carried out in three cases using a custom made MED-EL COMBI 40+ electrode. RESULTS: Surgery was carried out with no complications and is no more technically demanding than other standard surgical approaches. The speech processor program remains stable over time, and auditory perception results are similar to those obtained from children with no cochlear abnormalities. CONCLUSION: These results demonstrate the success of the double posterior labyrinthotomy approach with modified cochlear implant, and this could be recommended as the procedure of choice in children presenting to an implant team with a common cavity.     

A 1-year follow-up study of dynamic magnetic resonance imaging in early rheumatoid arthritis reveals synovitis to be increased in shared epitope-positive patients and predictive of erosions at 1 year

OBJECTIVES: Dynamic magnetic resonance imaging (MRI) allows visualization of the synovial membrane and measurement of synovitis within the joint. A cohort of patients with early rheumatoid arthritis (RA) were studied using MRI of the dominant wrist and clinical assessments. Associations between synovitis and the shared epitope genotype (SE) were looked for and synovitis as a predictor of joint erosion was examined. METHODS: Gadolinium-enhanced MRI scans of the dominant wrist were performed in 42 early RA patients at baseline (median disease duration = 4 months) and after 1 yr. Images were obtained at 42-s intervals over the first 6 min after gadolinium-diethylenetriamine pentaacetic acid injection using six cuts in the coronal plane, 2 mm apart. The site of maximal synovial enhancement was selected as the region of interest (ROI). The rate of enhancement (E-rate) was calculated and compared with synovitis scores from static MRI scans, clinical disease activity scores and HLA-DRB1*04/01 genotyping [sequence-specific primer polymerase chain reaction (SSP-PCR) and DNA sequencing]. RESULTS: Reproducibility of the E-rate measurement was assessed by re-evaluating 10 randomly selected scans in a blinded fashion. Intra-observer reliability was high with an intraclass correlation coefficient of 0.91, 95% confidence interval (CI) 0.65-0.97. The E-rate correlated strongly at baseline with the maximum level of synovial enhancement (E-max) (r = 0.88, P < 0.0001) and the static MRI synovitis score (r = 0.52, P = 0.0004). There was also a weaker but significant correlation between E-rate and the pain score (r = 0.29, P = 0.04). The E-rate fell from baseline to 1 yr (P = 0.02) concordant with clinical improvement after treatment with standard therapies. E-rate scores were higher in SE+ than SE - patients (F(1,25) = 5.19, P = 0.03) and were predictive of MRI erosions at 1 yr [chi-square = 5.0 (1 d.f.), P = 0.03]. The baseline C-reactive protein (CRP) was also predictive of MRI erosions at 1 yr to a similar degree [chi-square = 4.7 (1 d.f. ), P = 0.03] but the mean static synovitis score at baseline was the strongest predictor [chi-square = 9.2 (1 d.f.), P = 0.003]. CONCLUSIONS: These results show that dynamic MRI can be used to score synovitis objectively in early RA patients. Synovitis was greater in SE+ patients, suggesting an early genetic influence on joint inflammation, and was predictive for the development of erosions at 1 yr.     

Effect of Antidepressant Choice on the Incidence and Economic Intensity of Hospitalization Among Depressed Individuals

This study identified differences in hospital utilization for mental health problems among depressed patients initially treated with selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants (TCAs). A retrospective sample of 2,557 patients was obtained from a private insurance claims database. Quasi-experimental, two-stage multivariate regression modeling was used to estimate the likelihood of hospitalization and subsequent inpatient expenditures. Only 2% of the sample were hospitalized, and the average expenditures per admitted patient was about $8,000. Patients initially prescribed sertraline had the same likelihood of hospitalization for a mental health problem as patients prescribed TCAs. Patients initially prescribed fluoxetine were half as likely to be hospitalized as patients initially prescribed TCAs. Once hospitalized, no differential effects of a specific antidepressant on inpatient expenditures were found.     

Racial variation in antidepressant treatment in a Medicaid population

BACKGROUND: Many studies have found racial and socioeconomic variation in medical care for a variety of conditions. Undertreatment of depression for individuals of all races is a concern, but especially may affect vulnerable populations such as Medicaid recipients and minorities. With this study, we examine racial differences in the antidepressant usage in a Medicaid population. METHOD: Treatment of 13,065 depressed patients (ICD-9-CM criteria) was examined in a state Medicaid database covering the years 1989 through 1994. Treatment differences were assessed in terms of whether an antidepressant was received at the time of the initial depression diagnosis and the type of antidepressant prescribed (tricyclic antidepressants [TCAs] vs. selective serotonin reuptake inhibitors [SSRIs]), using logistic regression techniques. RESULTS: African Americans were less likely than whites to receive an antidepressant at the time of their initial depression diagnosis (27.2% vs. 44.0%, p < .001). Of those receiving an antidepressant, whites were more likely than African Americans to receive SSRIs versus TCAs. These findings remained even after adjusting for other covariates. CONCLUSION: Despite the easy availability of effective treatments, we found that only a small portion of depressed Medicaid recipients receive adequate usage of antidepressants. Within this Medicaid population, limited access to treatment was especially pronounced among African Americans. Racial differences existed in terms of whether an antidepressant was received and the type of medication used.