Cognitive behavioural therapy added to standard care for first-episode and recent-onset psychosis.

BACKGROUND: Cognitive behavioural therapy (CBT) can be effective in the general population of people with schizophrenia. It is still unclear whether CBT can be effectively used in the population of people with a first-episode or recent-onset psychosis. OBJECTIVES: To assess the effects of adding cognitive behavioural therapy to standard care for people with a first-episode or recent-onset psychosis. SEARCH METHODS: We conducted a systematic search on 6 March 2022 in the Cochrane Schizophrenia Group's Study-Based Register of Trials, which is based on CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, PubMed, ClinicalTrials.gov, ISRCTN, and WHO ICTRP. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing CBT added to standard care vs standard care in first-episode or recent-onset psychosis, in patients of any age. DATA COLLECTION AND ANALYSIS: Two review authors (amongst SFM, CC, LK and IB) independently screened references for inclusion, extracted data from eligible studies and assessed the risk of bias using RoB2. Study authors were contacted for missing data and additional information. Our primary outcome was general mental state measured on a validated rating scale. Secondary outcomes included other specific measures of mental state, global state, relapse, admission to hospital, functioning, leaving the study early, cognition, quality of life, satisfaction with care, self-injurious or aggressive behaviour, adverse events, and mortality. MAIN RESULTS: We included 28 studies, of which 26 provided data on 2407 participants (average age 24 years). The mean sample size in the included studies was 92 participants (ranging from 19 to 444) and duration ranged between 26 and 52 weeks. When looking at the results at combined time points (mainly up to one year after start of the intervention), CBT added to standard care was associated with a greater reduction in overall symptoms of schizophrenia (standardised mean difference (SMD) -0.27, 95% confidence interval (CI) -0.47 to -0.08, 20 RCTs, n = 1508, I2 = 68%, substantial heterogeneity, low certainty of the evidence), and also with a greater reduction in positive (SMD -0.22, 95% CI -0.38 to -0.06, 22 RCTs, n = 1565, I² = 52%, moderate heterogeneity), negative (SMD -0.20, 95% CI -0.30 to -0.11, 22 RCTs, n = 1651, I² = 0%) and depressive symptoms (SMD -0.13, 95% CI -0.24 to -0.01, 18 RCTs, n = 1182, I² = 0%) than control. CBT added to standard care was also associated with a greater improvement in the global state (SMD -0.34, 95% CI -0.67 to -0.01, 4 RCTs, n = 329, I² = 47%, moderate heterogeneity) and in functioning (SMD -0.23, 95% CI -0.42 to -0.05, 18 RCTs, n = 1241, I² = 53%, moderate heterogeneity, moderate certainty of the evidence) than control. We did not find a difference between CBT added to standard care and control in terms of number of participants with relapse (relative risk (RR) 0.82, 95% CI 0.57 to 1.18, 7 RCTs, n = 693, I² = 48%, low certainty of the evidence), leaving the study early for any reason (RR 0.87, 95% CI 0.72 to 1.05, 25 RCTs, n = 2242, I² = 12%, moderate certainty of the evidence), adverse events (RR 1.29, 95% CI 0.85 to 1.97, 1 RCT, n = 43, very low certainty of the evidence) and the other investigated outcomes. AUTHORS' CONCLUSIONS: This review synthesised the latest evidence on CBT added to standard care for people with a first-episode or recent-onset psychosis. The evidence identified by this review suggests that people with a first-episode or recent-onset psychosis may benefit from CBT additionally to standard care for multiple outcomes (overall, positive, negative and depressive symptoms of schizophrenia, global state and functioning). Future studies should better define this population, for which often heterogeneous definitions are used.

Efficacy of an experimental toothpaste containing 5% calcium sodium phosphosilicate in the relief of dentin hypersensitivity: An 8-week randomized study (Study 1).

PURPOSE: To evaluate the efficacy of an experimental toothpaste containing 5% (w/w) calcium sodium phosphosilicate (CSPS) in relieving dentin hypersensitivity (DH) compared with control toothpastes containing no known anti-sensitivity ingredients. METHODS: This was the first of two exploratory, randomized, four-treatment, examiner-blind, parallel-design, single-site, 8-week studies in healthy subjects with self-reported and clinically diagnosed DH. The experimental toothpaste contained 5% CSPS with a modified surfactant system, developed to enhance its organoleptic properties. Efficacy was evaluated against an abrasivity-matched placebo formulation (0% CSPS) with additional abrasive silica replacing the CSPS, and two commercially available fluoride toothpastes as controls. After an initial lead-in period, subjects were randomized to one of the four study treatments and instructed to brush twice daily for the next 8 weeks. DH was assessed at baseline and following 4 and 8 weeks of treatment by response to tactile and evaporative (air) stimuli, and using a Dentine Hypersensitivity Experience Questionnaire (DHEQ; a validated quality-of-life measure for DH). RESULTS: A total of 134 subjects were randomized and completed the study. All treatments demonstrated statistically significant reductions in sensitivity from baseline at Week 4 and Week 8 for each clinical measure of sensitivity (all P ≤ 0.001). The 0% CSPS toothpaste demonstrated small but statistically significant reductions in Schiff sensitivity score compared with the other study toothpastes at Week 8 (all P< 0.05), whereas the experimental 5% CSPS toothpaste significantly improved the tactile threshold at Week 4 compared with the 0% CSPS toothpaste (P = 0.0467). The DHEQ responses did not reveal any consistent statistically significant within-treatment changes from baseline or between-treatment differences. Correlation analysis showed weak-to-moderate associations between the DHEQ outcomes and clinical endpoints. Study treatments were well tolerated. The treatment differences observed in this exploratory study were small and inconsistent between measures. The reasons for the inconsistencies are not clear but may be related to the properties of the abrasivity-matched 0% CSPS formulation, with the increased level of dental silica conferring an advantage in terms of reducing DH. The ability of dental silicas to occlude exposed dentin tubules and thereby reduce DH has been demonstrated in previous studies, and may warrant further clinical investigation.

The efficacy of an experimental dentifrice containing 0.454% w/w stannous fluoride in providing relief from the pain of dentin hypersensitivity: an 8-week clinical study.

PURPOSE: To compare the efficacy of a 0.454% w/w stannous fluoride containing anhydrous dentifrice and a negative control dentifrice containing 1,000 ppm fluoride (as sodium monofluorophosphate) at reducing dentin hypersensitivity over an 8-week period, following twice daily brushing. METHODS: This was a randomized, examiner blind, two-treatment arm, stratified (by maximum baseline Schiff sensitivity score), parallel design, single-site study in 118 subjects, who had at least two sensitive teeth, and met all the criteria at the screening and baseline visit. The study was conducted in Las Vegas, NV, USA. Tactile threshold (Yeaple Probe) and evaporative (air-blast) sensitivity (with Schiff sensitivity scale) were employed as clinical measures to compare the efficacy of the test dentifrice containing 0.454% w/w stannous fluoride to the negative control (Colgate Cavity Protection) at reducing sensitivity at Weeks 4 and 8. RESULTS: 117 subjects completed the clinical study. At the 4- and 8-week time points, between treatment analyses demonstrated the test dentifrice to be significantly better at relieving subjects' sensitivity, for both validated clinical measures, compared to the negative control (at 4 weeks Schiff P < 0.0001 tactile threshold P < 0.0001; at 8 weeks Schiff P < 0.0001; tactile threshold P < 0.0001).

A randomized clinical study investigating the staining profile of an experimental stannous fluoride dentifrice.

PURPOSE: The primary objective of this study was to investigate the staining profile of an experimental test dentifrice containing 0.454% w/w stannous fluoride compared to that of a marketed control dentifrice containing 0.76% w/w sodium monofluorophosphate (Colgate Cavity Protection) following regular and repeat use, with twice daily brushing over 8 weeks. As an exploratory objective, the staining profile of the test dentifrice was compared to that of a marketed comparator dentifrice containing 0.454% w/w stannous fluoride (Crest Pro-Health - Clean Mint). METHODS: This was a single-center, examiner-blind, randomized, three arm, parallel group study, stratified by pre-baseline stain score [total Lobene Stain Index (LSI) (area x intensity) score < 31, > or = 31] and smoking status. Following initial screening, 137 healthy subjects, aged 18 years and above, with 12 gradable anterior teeth returned for baseline assessments. At the baseline visit, subjects received an oral soft tissue (OST) examination and an assessment of extrinsic dental stain using the LSI on the facial and lingual surfaces of the 12 anterior teeth, LSI area, LSI intensity and LSI area x intensity (the LSI area x intensity score was termed the pre-baseline LSI score). Subjects who met study requirements received a dental prophylaxis of the anterior teeth to remove all visible stain from their tooth surfaces such that an LSI (area x intensity) score of 0 was achieved. Randomized subjects brushed with their assigned dentifrice at home twice daily for 1 timed minute and returned after 4 and 8 weeks for an OST examination and dental stain assessment of the anterior teeth using LSI. RESULTS: There were no statistically significant differences in dental stain build-up between the test dentifrice containing 0.454% w/w stannous fluoride and a marketed control dentifrice (Colgate Cavity Protection), after 4 and 8 weeks of twice daily brushing, in terms of LSI area x intensity, LSI area or LSI intensity scores. Exploratory analysis indicated that the marketed stannous fluoride dentifrice (Crest Pro-Health) exhibited more dental stain build-up at 4 and/or 8 weeks compared to the other two study dentifrices. However, post-hoc analysis revealed an imbalance in LSI baseline stain levels between the treatment groups, with higher stain levels in the marketed comparator group, which made it difficult to draw robust conclusions from the exploratory data. This imbalance was not considered to impact the other study analyses. Study treatments were well tolerated.

Strangers in a strange land: coping with imprisonment as a racial or ethnic foreign national inmate.

A wide range of scholarship examining the global effects of neo-liberalism draws attention to the precarious position of individuals who are not seen as part of the social body. While immigrants, racial minorities, and common criminals are central to this discourse, relatively little research has examined how the experiences of these individuals may vary based on statuses other than citizenship when they are imprisoned. Our research focuses on the interactions (between prisoners and between prisoners and correctional staff) of a racially diverse group of Dutch foreign national prisoners incarcerated in England. Although all of these prisoners clearly saw themselves as 'outsiders,' visible minorities faced a unique set of challenges relative to their White counterparts. We consider both the practical and theoretical import of these findings.

Psychosocial impact of being diagnosed with mild cognitive impairment: patient and carer perspective.

BACKGROUND: Mild cognitive impairment (MCI) may represent an intermediate, prodromal phase of dementia. Although persons with MCI (PwMCI) are able to function independently, they often experience reduced ability to carry out their usual activities. This can result in social, emotional and functional challenges. AIMS: To explore the understanding and psychosocial impact of receiving a diagnosis of MCI on patients and carers. METHOD: A cross-sectional cohort study was conducted at St James's Hospital Memory Clinic involving patients who attended the clinic for assessment from 1 January 2020 to 30 April 2021 and received a diagnosis of MCI. We completed questionnaires with patients and a nominated family member or friend of each patient (FwMCI). RESULTS: Forty-seven PwMCI participated in the study, and 36 nominated family members and/or friends completed the FwMCI questionnaire. In our cohort of PwMCI, most of the participants were not aware of their diagnosis; only 21% used the term MCI, and only 25% attributed their problems to a pathological cause. The majority of participants had no recollection of any discussion around the likelihood of progression. One-third of participants expressed relief that they did not have dementia. Most PwMCI reported positive psychological well-being and did not endorse symptoms of depression or anxiety. There was slight discordance of illness perception among the PwMCI-FwMCI dyads. Forty-seven per cent of FwMCI reported at least a mild degree of carer burden on the Zarit Burden Scale. CONCLUSIONS: Patients' awareness of being diagnosed with MCI is relatively limited. Public education campaigns raising awareness about MCI can help influence the 'illness representation' for MCI and enable people to seek timely advice and support.

A phase II randomized study of cisplatin-pemetrexed plus either enzastaurin or placebo in chemonaive patients with advanced non-small cell lung cancer.

OBJECTIVES: Enzastaurin is a serine/threonine kinase inhibitor that targets protein kinase C and AKT pathways. Enzastaurin and pemetrexed demonstrated synergy in preclinical studies. This trial was designed to evaluate the safety and efficacy of first-line enzastaurin plus cisplatin-pemetrexed in advanced non-small cell lung cancer (NSCLC). METHODS: A safety lead-in phase (n = 13) of enzastaurin 125 or 250 mg twice daily was added to cisplatin-pemetrexed. A subsequent randomized, placebo-controlled phase II study (n = 22) of the combination was conducted to evaluate efficacy. RESULTS: The combination was well tolerated and showed activity, with 7 (53.8%, 95% CI 26.7-80.9) confirmed partial responses and 2 stable diseases in 13 treated patients in the lead-in phase. However, the study was terminated early based on interim results from two phase II NSCLC studies of enzastaurin plus cytotoxic chemotherapy, which indicated no efficacy improvement. CONCLUSIONS: Enzastaurin and cisplatin-pemetrexed is tolerable with preliminary activity in patients with advanced NSCLC, but because of a lack of efficacy improvement in other phase II NSCLC studies, the study was terminated early.

An audit of the cervical screening programme in the National Drug Treatment Centre (NDTC).

BACKGROUND: Women diagnosed with substance use disorders (SUDs) have higher rates of major medical conditions compared to women without SUDs. Cervical cancer is the second leading cause of cancer death in women aged 20-39 years worldwide and women with SUDs have an increased risk of cervical cancer compared to women without SUD. The National Drug Treatment Centre (NDTC) cervical screening programme, derived from the national CervicalCheck programme, offers free cervical screening to patients attending for treatment of SUDs. AIMS: This study aimed to audit adherence to the NDTC Cervical Screening guidelines before and after the implementation of an awareness-raising educational intervention. METHODS: The electronic clinical records of women aged between 25 and 60 years attending the lead consultant's (M.S.) outpatient clinic were reviewed for documentary evidence indicating that information about the cervical screening programme had been discussed. This was completed before and one month after the implementation of an awareness-raising educational intervention. RESULTS: All women (n = 46, mean age 36.3 (SD = 6.5) years) had an opioid use disorder; 85% had a benzodiazepine use disorder, and 24% had an alcohol use disorder. Of these, 80% had at least one chronic medical condition, 76% had a psychiatric disorder, and 59% were homeless. Adherence to the NDTC cervical screening guideline, as indicated by documentary evidence in clinical records, was 33% (14/43) at baseline, and rose to 88% (36/41) (p < 0.0001) one month after the intervention. CONCLUSIONS: This completed audit cycle shows that an awareness-raising educational intervention can significantly improve adherence to a cervical screening programme in women with SUDs.

Pharmacological treatment and other predictors of treatment outcomes in previously untreated patients with schizophrenia: results from the European Schizophrenia Outpatient Health Outcomes (SOHO) study.

The present study aimed to compare health outcomes and tolerability according to antipsychotic medication (olanzapine, risperidone or an oral typical antipsychotic) after 6 months of treatment in a group of 919 schizophrenic patients who had never previously been treated with antipsychotics. Demographic and clinical predictors of outcome were also identified. Data were extracted from the Schizophrenia Outpatient Health Outcomes (SOHO) study, a prospective, observational study of schizophrenia treatment in 10 European countries. Patients who initiated olanzapine were more likely to have a clinical response than those in the risperidone cohort, and had a greater improvement in quality of life than patients in the risperidone or typical antipsychotic cohorts. High negative and depression symptom scores at baseline and the presence of extrapyramidal symptoms at baseline predicted a worse clinical response, whereas hostile behaviour, paid employment and substance abuse predicted a better clinical outcome. The olanzapine cohort gained more weight than patients in the risperidone cohort, but no significant difference in weight gain was observed between olanzapine and the oral typical antipsychotic cohort. The results should be interpreted conservatively due to the observational study design.