Eye movement desensitization and reprocessing (EMDR) therapy compared to usual treatment for posttraumatic stress disorder in adults with psychosis in forensic settings: Randomized controlled trial.

OBJECTIVE: Little direct evidence supports any particular treatment for posttraumatic stress disorder (PTSD) in people with schizophrenia, forensic histories, and/or multiple comorbidities. This trial assesses the efficacy and risks of eye movement desensitization and reprocessing (EMDR) for people with PTSD and psychotic disorders receiving forensic care, including inpatients and prisoners. METHOD: Single-blind randomized controlled trial comparing EMDR therapy to wait-list (routine care) in forensic-treated adults with psychotic disorders and PTSD. The primary outcome was clinician-rated PTSD symptoms. Secondary outcomes included participant-rated PTSD symptoms, psychotic symptoms, social functioning, disability level, self-esteem, depressive symptoms, posttraumatic cognitions, complex posttraumatic difficulties, and adverse events. Blinded investigators assessed outcomes at baseline, and after 10 weeks and 6 months. Analysis of the primary outcome was by a mixed linear model. Twenty-four participants were randomized, recruitment being hindered by COVID-19 restrictions. RESULTS: Clinician Administered PTSD Scale mean (SD) scores after 6 months were lower (better) in the EMDR group, 21.3 (13.3), compared with the control group, 31.5 (20.7). The point estimate [95% CI] difference, averaged over two measurement times, was 11.4 [1.3, 21.4], p = .028, favoring EMDR. Self-esteem increased in the EMDR group and depressive symptoms and disability reduced. There were no statistically significant differences in psychotic symptoms or adverse events, although point estimates favored EMDR. CONCLUSIONS: This is the first EMDR trial in mental health inpatient, forensic, or custodial settings, where PTSD is common. There were improvements in PTSD and other symptomatology consistent with EMDR being a safe and effective treatment for PTSD in these settings. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Clinical Outcome Data of Children Treated with Cannabis-Based Medicinal Products for Treatment Resistant Epilepsy-Analysis from the UK Medical Cannabis Registry.

BACKGROUND: There is a paucity of high-quality evidence of the efficacy and safety of cannabis-based medicinal products in treatment of treatment-resistant epilepsy (TRE) in children. METHODS: A case series of children (<18 years old) with TRE from the UK Medical Cannabis Registry was analyzed. Primary outcomes were ≥50% reduction in seizure frequency, changes in the Impact of Pediatric Epilepsy Score (IPES), and incidence of adverse events. RESULTS: Thirty-five patients were included in the analysis. Patients were prescribed during their treatment with the following: CBD isolate oils (n = 19), CBD broad-spectrum oils (n = 17), and CBD/Δ9-THC combination therapy (n = 17). Twenty-three (65.7%) patients achieved a ≥50% reduction in seizure frequency. 94.1% (n = 16) of patients treated with CBD and Δ9-THC observed a ≥50% reduction in seizure frequency compared to 31.6% (n = 6) and 17.6% (n = 3) of patients treated with CBD isolates and broad-spectrum CBD products, respectively (p< 0.001). Twenty-six (74.3%) adverse events were reported by 16 patients (45.7%). The majority of these were mild (n = 12; 34.2%) and moderate (n = 10; 28.6%). CONCLUSION: The results of this study demonstrate a positive signal of improved seizure frequency in children treated with Cannabis-based medicinal products (CBMPs) for TRE. Moreover, the results suggest that CBMPs are well-tolerated in the short term. The limitations mean causation cannot be determined in this open-label, case series.

Eye movement desensitization and reprocessing (EMDR) therapy for posttraumatic stress disorder in adults with serious mental illness within forensic and rehabilitation services: a study protocol for a randomized controlled trial.

BACKGROUND: Eye movement desensitization and reprocessing (EMDR) is an evidenced-based treatment for posttraumatic stress disorder (PTSD). Forensic mental health services provide assessment and treatment of people with mental illness and a history of criminal offending, or those who are at risk of offending. Forensic mental health services include high, medium, and low-security inpatient settings as well as prison in-reach and community outpatient services. There is a high prevalence of PTSD in forensic settings and posttraumatic experiences can arise in people who violently offend in the context of serious mental illness (SMI). Successful treatment of PTSD may reduce the risk of relapse and improve clinical outcomes for this population. This study aims to assess the efficacy, risk of harm, and acceptability of EMDR within forensic and rehabilitation mental health services, as compared to treatment as usual (routine care). METHODS: This is a single-blind, randomized controlled trial comparing EMDR therapy to the waiting list (routine care). Adult forensic mental health service users (n = 46) with SMI and meeting the criteria for PTSD will be included in the study. Participants will be randomized after baseline assessment to either treatment as usual plus waiting list for EMDR or to treatment as usual plus EMDR. The EMDR condition comprises nine sessions, around 60 min in length delivered weekly, the first of which is a case conceptualization session. The primary outcomes are clinician and participant-rated symptoms of PTSD, and adverse events. Secondary outcomes include psychotic symptoms, social functioning, level of disability, self-esteem, depressive symptoms, post-trauma cognitions, and broad domains of complex posttraumatic difficulties. A trained assessor blinded to the treatment condition will assess outcomes at baseline, 10 weeks, and 6 months. Additionally, grounded theory qualitative methods will be used to explore participant experience of EMDR for a subset of participants. DISCUSSION: This study will contribute to the currently limited evidence base for EMDR for PTSD in forensic settings. It is the first randomized clinical trial to assess the efficacy, risk of harm, and acceptability of EMDR for PTSD in people with SMI in either forensic, mental health inpatient, or custodial settings. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Network, ACTRN12618000683235. Registered prospectively on 24 April 2018.

Percutaneous electrical nerve stimulation (PENS) therapy for refractory primary headache disorders: a pilot study.

Purpose: Primary headache disorders are common, but many patients are refractory to medical treatment. Percutaneous electrical nerve stimulation (PENS) therapy involves the stimulation of one or more individual nerves or dermatomes using needle probes. We assessed whether a 'single shot with single probe' strategy would benefit patients with refractory headache disorders, including chronic migraine (CM), and chronic cluster headache (CCH).Materials and methods: Service evaluation of 36 patients treated with PENS therapy between September 2012 and June 2016. Follow-up data were available for 33 patients, of whom 16 had CM, nine had CCH, and six had secondary headache disorders. PENS was given using Algotec® disposable 21 gauge PENS therapy probes (8 cm) to the occipital nerve ipsilateral to the pain (or bilaterally in cases of bilateral pain). Stimulation was delivered at 2 Hz/100 Hz, at 3 cycles/s, between 1.2 and 2.5 V depending on patient tolerability, for 25-28 min.Results: Six of nine patients with CCH improved significantly after the first session. In all patients with CCH, PENS therapy was well tolerated, with no significant adverse events reported. One patient with CCH reverted to episodic cluster. Only four patients with CM experienced any benefit.Conclusion: PENS therapy shows potential as a relatively non-invasive, low-risk, and inexpensive component of the treatment options for refractory primary headache disorders, particularly CCH.

Protocol for a randomised, single-blind, two-arm, parallel-group controlled trial of the efficacy of rhinothermy delivered by nasal high flow therapy in the treatment of the common cold.

INTRODUCTION: The common cold is the most common infectious disease affecting humans. It is usually a self-limiting disease; however, the common cold can cause significant morbidity and has a substantial economic impact on society. Human rhinoviruses (HRVs), which cause up to two-thirds of colds, have temperature-dependent replication and most HRV strains replicate optimally at 33°C. Delivery of heated, humidified air to the upper airways has the potential to reduce viral replication, but evidence of the effectiveness of this treatment of the common cold is inconclusive. We plan to test the hypothesis that delivery of humidified air heated to 41°C at high flow, nasal high flow rhinothermy (rNHF), for 2 hours daily for five days is more effective in reducing common cold symptom severity and duration than five days of 'sham' rhinothermy. METHODS AND ANALYSIS: This is a randomised, single-blind, parallel-group trial comparing rNHF to 'sham' rhinothermy in the treatment of common cold. We plan to recruit 170 participants within 48 hours of the onset of symptoms of common cold and randomise them 1:1 to receive one of the two treatments for five days. The study duration is 14 days, which includes clinic visits on the first day of randomisation and four days post-randomisation, and a phone call on the 14th day. Participants will complete daily symptom diaries which include a symptom score, the Modified Jackson Score (MJS). The primary outcome is the MJS after four days. ETHICS AND DISSEMINATION: New Zealand Ethics Registration: 17/STH/174. Results will be published in a peer-reviewed medical journal, presented at academic meetings, and reported to participants. TRIAL REGISTRATION NUMBER: U1111-1194-4345 and ACTRN12617001340325; Pre-results.

Kanuka honey versus aciclovir for the topical treatment of herpes simplex labialis: a randomised controlled trial.

OBJECTIVE: To compare New Zealand medical grade kanuka honey with topical aciclovir for the treatment of herpes simplex labialis. DESIGN: Prospective parallel randomised controlled open-label superiority trial. SETTING: 76 community pharmacies across New Zealand between 10 September 2015 and 13 December 2017. PARTICIPANTS: 952 adults randomised within the first 72 hours of a herpes simplex labialis episode. INTERVENTIONS: Random assignment 1:1 to either 5% aciclovir cream or medical grade kanuka honey (90%)/glycerine (10%) cream, both applied five times daily. OUTCOME MEASURES: The primary outcome was time from randomisation to return to normal skin (stage 7). Secondary outcomes included time from randomisation to stage 4 (open wound), time from stage 4 to 7, maximal pain, time to pain resolution and treatment acceptability. RESULTS: Primary outcome variable: Kaplan-Meier-based estimates (95% CI) for the median time in days for return to normal skin were 8 (8 to 9) days for aciclovir and 9 (8 to 9) for honey; HR (95% CI) 1.06 (0.92 to 1.22), p=0.56. There were no statistically significant differences between treatments for all secondary outcome variables. No related serious adverse events were reported. CONCLUSION: There was no evidence of a difference in efficacy between topical medical grade kanuka honey and 5% aciclovir in the pharmacy-based treatment of herpes simplex labialis. TRIAL REGISTRATION NUMBER: ACTRN12615000648527;Post-results.

RCT of the effect of berryfruit polyphenolic cultivar extract in mild steroid-naive asthma: a cross-over, placebo-controlled study.

OBJECTIVE: There is preclinical evidence that consumption of berryfruit extract may reduce chronic airways inflammation and modify airway remodelling in allergen-induced models of lung inflammation. We investigated the effect of berryfruit extract on the fractional expired nitric oxide (FeNO), a biomarker of eosinophilic airways inflammation, in adults with steroid-naïve asthma. DESIGN: Randomised placebo-controlled cross-over double-blind trial. SETTING: Single-centre community-based trial. PARTICIPANTS: 28 steroid-naïve mild asthmatics with Feno >40 ppb, of whom 25 completed both study interventions. INTERVENTIONS: Participants were randomised to receive, according to the cross-over design, 100 mg berryfruit polyphenolic extract (BFPE) or placebo for 4 weeks, with a 4-week washout period between the interventions. PRIMARY OUTCOME MEASURE: The primary outcome variable was FeNO at 4 weeks, analysed by a mixed linear model, with a random effect for participant and baseline FeNo as a covariate. RESULTS: The mean (SD) natural logarithm transformed (ln) FeNO after 4 weeks of treatment for the BFPE and placebo groups was 4.28 (0.47) and 4.22 (0.47), respectively. The paired change from baseline mean (SD) BFPE minus placebo ln FeNO was -0.03 (0.39), N=25. The mixed linear model estimate, with baseline covariate adjustment, difference in ln FeNO, was -0.002 (95% CI -0.15 to 0.14), p=0.98. This is equivalent to a ratio of geometric mean FeNO of 1.0 (95% CI 0.86 to 1.15). CONCLUSIONS: In steroid-naïve participants with mild asthma and elevated FeNO, there was no effect of BFPE on FeNO, a biomarker of eosinophilic airways inflammation. Caution is required in the extrapolation of apparent benefit in murine models of lung eosinophilia to clinical efficacy in patients with asthma. TRIAL REGISTRATION NUMBER: ANZCTR: 12613000451707; Results.

Sublingual vitamin B12 compared to intramuscular injection in patients with type 2 diabetes treated with metformin: a randomised trial.

UNLABELLED: MAIM: To compare a single 1mg intramuscular hydroxocobalamin injection with a 3-month course of 1mg/day sublingual methylcobalamin supplements on serum vitamin B12 concentrations in participants withtype 2 diabetes treated with metformin. METHOD: Participants on metformin treatment with vitamin B12 concentrations below 220pmol/L were recruited through hospital diabetes clinics and primary care practices. They were randomised to receive either the injection or sublingual treatment. The primary outcome was serum vitamin B12 level after 3 months adjusted for baseline assessed by analysis of covariance (ANCOVA). The trial was registered on the Australia New Zealand Clinical Trial registry (ACTRN12612001108808). RESULTS: A total of 34 participants were randomised; 19 to the tablet, and 15 to the injection. The mean (SD) age, duration of diabetes, and duration of metformin use were, 64.2 (7.3) years, 13.7 (6.4) years, and 11.6 (5.0) years, respectively. After 3 months, the mean (SD) vitamin B12 was 372.1 (103.3) pmol/L in the tablet group (n=19) compared to 251.7 (106.8) pmol/L in the injection group (n=15), ANCOVA estimated difference -119.4 (95% CI -191.2 to -47.6), p=0.002. After 6 months, the mean (SD) serum B12 was 258.8 (58.7) pmol/L in the tablet group (n=17) and 241.9 (40.1) pmol/L in the injection group (n=15); ANCOVA estimated difference -15.2 (95% CI -50.3 to 19.8), p=0.38. Higher metformin dose was associated with lower serum B12 at 3 months, but not at baseline or 6 months. CONCLUSION: Decreased serum vitamin B12 level in patients with type 2 diabetes who are treated with metformin can be corrected through treatment with either hydroxocobalamin injections or methylcobalamin sublingual supplements.

Randomised controlled trial of topical kanuka honey for the treatment of acne.

OBJECTIVE: To investigate the efficacy of Honevo, a topical 90% medical-grade kanuka honey, and 10% glycerine (honey product) as a treatment for facial acne. DESIGN: Randomised controlled trial with single blind assessment of primary outcome variable. SETTING: Outpatient primary care from 3 New Zealand localities. PARTICIPANTS: Of 136 participants aged between 16 and 40 years with a diagnosis of acne and baseline Investigator's Global Assessment (IGA) for acne score of ≥ 2.68, participants were randomised to each treatment arm. INTERVENTIONS: All participants applied Protex, a triclocarban-based antibacterial soap twice daily for 12 weeks. Participants randomised to the honey product treatment arm applied this directly after washing off the antibacterial soap, twice daily for 12 weeks. OUTCOME MEASURES: The primary outcome was ≥ 2 point decrease in IGA score from baseline at 12 weeks. Secondary outcomes included mean lesion counts and changes in subject-rated acne improvement and severity at weeks 4 and 12, and withdrawals for worsening acne. RESULTS: 4/53 (7.6%) participants in the honey product group and 1/53 (1.9%) of participants in the control group had a ≥ 2 improvement in IGA score at week 12, compared with baseline, OR (95% CI) for improvement 4.2 (0.5 to 39.3), p=0.17. There were 15 and 14 participants who withdrew from the honey product group and control group, respectively. CONCLUSIONS: This randomised controlled trial did not find evidence that addition of medical-grade kanuka honey in combination with 10% glycerine to standard antibacterial soap treatment is more effective than the use of antibacterial soap alone in the treatment of acne. TRIAL REGISTRATION NUMBER: ACTRN12614000003673; Results.

The effect of a cinnamon-, chromium- and magnesium-formulated honey on glycaemic control, weight loss and lipid parameters in type 2 diabetes: an open-label cross-over randomised controlled trial.

PURPOSE: This randomised controlled trial assessed the acute and long-term effects of daily supplementation of kanuka honey, formulated with cinnamon, chromium and magnesium on glucose metabolism, weight and lipid parameters in individuals with type 2 diabetes. METHODS: Twelve individuals with type 2 diabetes received 53.5 g of a formulated honey and a control (non-formulated) kanuka honey in a random order for 40 days, using cross-over design. Fasting glucose, insulin, HbA1c, lipids and anthropometric measures were measured at baseline and end of treatment. A meal tolerance test was performed at baseline to assess acute metabolic response. RESULTS: There was no statistically significant difference in acute glucose metabolism between treatment groups, as measured by the Matsuda index and AUC for glucose and insulin. After the 40-day intervention with honey, fasting glucose did not differ significantly between the two treatments (95 % CI -2.6 to 0.07). There was no statistically significant change in HbA1c or fasting insulin. There was a statistically significant reduction in total cholesterol by -0.29 mmol/L (95 % CI -0.57 to -0.23), LDL cholesterol by -0.29 mmol/L (95 % CI -0.57 to -0.23) and weight by -2.2 kg (95 % CI -4.2 to -0.1). There was a trend towards increased HDL and reduced systolic blood pressure in the intervention treatment. CONCLUSION: The addition of cinnamon, chromium and magnesium supplementation to kanuka honey was not associated with a significant improvement in glucose metabolism or glycaemic control in individuals with type 2 diabetes. Use of the formulated honey was associated with a reduction in weight and improvements in lipid parameters, and should be investigated further.

Randomised controlled trial of topical kanuka honey for the treatment of rosacea.

OBJECTIVE: To investigate the efficacy of topical 90% medical-grade kanuka honey and 10% glycerine (Honevo) as a treatment for rosacea. DESIGN: Randomised controlled trial with blinded assessment of primary outcome variable. SETTING: Outpatient primary healthcare population from 5 New Zealand sites. PARTICIPANTS: 138 adults aged ≥ 16, with a diagnosis of rosacea, and a baseline blinded Investigator Global Assessment of Rosacea Severity Score (IGA-RSS) of ≥ 2. 69 participants were randomised to each treatment arm. 1 participant was excluded from the Honevo group, and 7 and 15 participants withdrew from the Honevo and control groups, respectively. INTERVENTIONS: Participants were randomly allocated 1:1 to Honevo or control cream (Cetomacrogol), applied twice daily for 8 weeks. MAIN OUTCOME MEASURES: The primary outcome measure was the proportion of participants who had a ≥ 2 improvement in the 7-point IGA-RSS at week 8 compared to baseline. Secondary outcomes included change in IGA-RSS and subject-rated visual analogue score of change in severity (VAS-CS) on a 100 mm scale (0 mm 'much worse', 100 mm 'much improved') at weeks 2 and 8. RESULTS: 24/68 (34.3%) in the Honevo group and 12/69 (17.4%) in the control group had a ≥ 2 improvement in IGA-RSS at week 8 compared to baseline (relative risk 2.03; 95% CI 1.11 to 3.72, p=0.020). The change in IGA-RSS for Honevo compared to control at week 2 minus baseline was -1 (Hodges-Lehman estimate, 95% CI -1 to 0, p=0.03), and at week 8 minus baseline was -1 (Hodges-Lehman estimate, 95% CI -1 to 0, p=0.005). The VAS-CS at week 2 was 9.1 (95% CI 3.5 to 14.7), p=0.002, and at week 8 was 12.3 (95% CI 5.7 to 18.9)¸ p<0.001 for Honevo compared to control. CONCLUSIONS: Honevo is an effective treatment for rosacea. TRIAL REGISTRATION NUMBER: This trial was registered in the Australian and New Zealand Clinical Trials Registry ACTRN12614000004662.

Efficacy of regular sauna bathing for chronic tension-type headache: a randomized controlled study.

OBJECTIVE: Chronic tension-type headache (CTTH) is a chronic syndrome characterized by frequent headache occurring more than 15 days per month. The intensity and duration of headache pain can be very distressing and disabling on an individuals' well-being. The purpose of this study was to examine the applicability of sauna bathing as a new method of treatment for reducing pain in patients with CTTH. METHODS: Thirty-seven people who fulfilled the International Headache Society criteria for CTTH were randomly assigned into two groups. The control group (n=20) received advice and education while the intervention group (n=17) received the same advice and attended a sauna regularly for 8 weeks. Reductions in subjective pain were determined using the numerical pain rating scale (NPRS). Disturbance in sleep, depression as assessed by Beckman Disability Index (BDI), and Headache Disability Index (HDI) were measured. RESULTS: Mean change in headache intensity significantly differed between the sauna and control group by 1.27 (95% confidence interval, 0.48-2.07; F=10.17; df=1, 117; p=0.002). There was no statistically significant change in duration of headache or improvement in sleep, depression, or HDI between the sauna and control groups. CONCLUSION: Regular sauna bathing is a simple, self-directed treatment that is effective for reducing headache pain intensity in CTTH.

Use of nebulised magnesium sulphate as an adjuvant in the treatment of acute exacerbations of COPD in adults: a randomised double-blind placebo-controlled trial.

BACKGROUND: Intravenous magnesium has been shown to cause bronchodilation in acute severe asthma and in small trials in acute exacerbations of chronic obstructive pulmonary disease (AECOPD). There is also some evidence of benefit from nebulised magnesium in acute severe asthma. Our hypothesis was that adjuvant magnesium treatment administered via repeated nebulisation was effective in the management of AECOPD. METHODS: In this randomised double-blind placebo-controlled trial, we approached 161 patients with AECOPD presenting to the emergency departments at two New Zealand hospitals with a forced expiratory volume in 1 s (FEV1) <50% predicted 20 min after initial administration of salbutamol 2.5 mg and ipratropium 500 µg via nebulisation. Patients received 2.5 mg salbutamol mixed with either 2.5 ml isotonic magnesium sulphate (151 mg per dose) or 2.5 ml isotonic saline (placebo) on three occasions at 30 min intervals via nebuliser. The primary outcome measure was FEV1 at 90 min. RESULTS: 116 patients were randomised, 52 of whom were randomly allocated to the magnesium adjuvant group. At 90 min the mean (SD) FEV1 in the magnesium group (N=47) was 0.78 (0.33) l compared with 0.81 (0.30) l in the saline group (N=61) (difference -0.026 l (95% CI -0.15 to 0.095, p=0.67). No patients required non-invasive ventilation. There were 43/48 admissions to hospital in the magnesium group and 56/61 in the saline group (RR 0.98, 95% CI 0.86 to 1.10, p=0.69). CONCLUSIONS: Nebulised magnesium as an adjuvant to salbutamol treatment in the setting of AECOPD has no effect on FEV1. Australian New Zealand Clinical Trials Registry ACTRN12608000167369.

An assessment of the Hua Oranga outcome instrument and comparison to other outcome measures in an intervention study with Maori and Pacific people following stroke.

AIM: Health outcomes research for Maori has been hampered by the lack of adequately validated instruments that directly address outcomes of importance to Maori, framed by a Maori perspective of health. Hua Oranga is an outcome instrument developed for Maori with mental illness that uses a holistic view of Maori health to determine improvements in physical, mental, spiritual and family domains of health. Basic psychometric work for Hua Oranga is lacking. We sought to explore the psychometric properties of the instrument and compare its responsiveness alongside other, more established tools in an intervention study involving Maori and Pacific people following acute stroke. METHODS: Randomised 2x2 controlled trial of Maori and Pacific people following acute stroke with two interventions aimed at facilitating self-directed rehabilitation, and with follow-up at 12 months after randomisation. Primary outcome measures were the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Short Form 36 (SF36) at 12 months. Hua Oranga was used as a secondary outcome measure for participants at 12 months and for carers and whanau (extended family). Psychometric properties of Hua Oranga were explored using plots and correlation coefficients, principal factors analysis and scree plots. RESULTS: 172 participants were randomised, of whom 139 (80.8%) completed follow-up. Of these, 135 (97%) completed the Hua Oranga and 117 (84.2%) completed the PCS and MCS of the SF36. Eighty-nine carers completed the Hua Oranga. Total Hua Oranga scores and PCS improved significantly for one intervention group but not the other. Total Hua Oranga scores for carers improved significantly for both interventions. Total Hua Oranga score correlated moderately with the PCS (correlation coefficient 0.55, p<0.001). Factor analysis suggested that Hua Oranga measures two and not four factors; one 'physical-mental' and one 'spiritual-family'. CONCLUSION: The Hua Oranga instrument, developed for Maori people with mental illness, showed good responsiveness and adequate psychometric properties in Maori and Pacific people after stroke. Its simplicity, relative brevity, minimal cost and adequate psychometric properties should favour its use in future studies with both Maori and Pacific people. Suggestions are made for refinements to the measure. These should be tested in a new population before Hua Oranga is recommended for general use in a clinical setting.

Efficacy and safety of a TIA/stroke electronic support tool (FASTEST) trial: study protocol.

BACKGROUND: Strokes are a common cause of adult disability and mortality worldwide. Transient ischaemic attacks (TIA) are associated with a high risk of subsequent stroke, and rapid intervention has the potential to reduce stroke burden. This study will assess a novel electronic decision support (EDS) tool to allow general practitioners (GPs) to implement evidence-based care rapidly without full reliance on specialists. METHODS/DESIGN: This is a cluster randomized controlled trial comparing TIA/stroke management of GPs with access to the EDS tool versus usual care. The intervention period is 12 months with a 3-month follow-up period for individual patients. Primary outcomes consist of stroke within 90 days of presenting event and adherence to the New Zealand national TIA guideline. DISCUSSION: A positive study will provide strong evidence for widespread implementation of this tool in practice and has the potential to improve key outcomes for patients and reduce the burden of stroke. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry ACTRN12611000792921.

A cross-over study of the acute effects of espresso coffee on glucose tolerance and insulin sensitivity in people with type 2 diabetes mellitus.

The objective was to determine the effect of a single dose of espresso caffeinated coffee, decaffeinated coffee, or water on glucose tolerance and insulin sensitivity in people with type 2 diabetes mellitus. Eighteen participants who were habitual coffee drinkers, were studied using a random-order cross-over design. After a fasting blood sample participants consumed either a double-shot black espresso coffee, decaffeinated coffee, or hot water. The main outcomes were area under the curve (AUC) glucose and insulin, and insulin sensitivity (Matsuda index) during a 75 g oral glucose tolerance test (OGTT) performed one hour later. Other outcomes were change in glucose and insulin and also the insulinogenic index (IGI) and disposition index (DI). AUC glucose was marginally different between beverages (P=.06) being greater following caffeinated coffee than water, mean difference 104 mmol/L/180 min (95% CI 0.1 to 198.1, P=.031), or decaffeinated coffee, mean difference 92.1 mmol/L/180 min (95% CI -1.9 to 186.1, P=.055). There was no difference in AUC insulin (P=.87) or insulin sensitivity (P=.47), nor in change in glucose or insulin over the hour following beverage consumption. There was a marginal difference in IGI between beverages (P=.097) with coffee having a lower incremental increase in insulin/glucose than water (P=.037) though no difference between coffee and decaffeinated coffee (P=.54) and no difference in DI (P=.23). Black espresso coffee in people with type 2 diabetes mellitus results in a marginally greater excursion of glucose during a following OGTT compared with water or decaffeinated coffee. This effect does not appear to be mediated by changes in insulin sensitivity.

What risks do women face when seeking advice during pregnancy from pharmacies and natural health retailers?

AIM: Potential risks to mother and foetus exist with the incorrect use of complementary and alternative medicine (CAM) products during pregnancy. This study aimed to identify the risks that a woman may face when seeking advice during pregnancy from pharmacies and health food stores (HFS) in Greater Wellington (New Zealand). METHODS: 21 HFS and 21 geographically-matched pharmacies were visited by a researcher who sought advice regarding vitamin supplementation and nausea in early pregnancy using a standardised scenario. Any advice given, including details of recommended products, was documented immediately upon leaving the premises. Proportions were obtained and paired contingency table analysis was used to examine the agreement between the matched pairs. RESULTS: A minority of pharmacies (5/21, 23.8%) and HFS (1/21, 4.8%) made primary recommendations for nausea which were supported by Ministry of Health (MOH) guidelines, and both pharmacies (14/21, 66.7%) and HFS (7/21, 33.3%) recommended products contrary to these guidelines. A greater proportion of pharmacies gave advice consistent with MOH recommended dosage of folic acid supplementation than HFS (20/21, 95.2% vs 10/21, 47.6%). 2/21 (9.5%) of pharmacies and 4/21 (19%) of HFS gave advice with a potential risk of vitamin A overdose. CONCLUSIONS: Pharmacies and HFS in Greater Wellington provided potentially hazardous advice, recommending products, often branded for pregnancy, which contradicted NZ MOH guidelines. Regulatory reform of CAM products and those who sell them is called for in New Zealand.