scholarly journals Protocol for a randomised controlled trial of 90% kanuka honey versus 5% aciclovir for the treatment of herpes simplex labialis in the community setting

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e017766 ◽  
Author(s):  
Alex Semprini ◽  
Joseph Singer ◽  
Nicholas Shortt ◽  
Irene Braithwaite ◽  
Richard Beasley
Keyword(s):  
New Zealand ◽  
Herpes Simplex ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Healing Time ◽  
Research Network ◽  
Cold Sore ◽  
Cold Sores ◽  
Randomised Controlled ◽  
Medical Grade

IntroductionWorldwide, about 90% of people are infected with the herpes simplex virus, 30% of whom will experience recurrent herpes simplex labialis, commonly referred to as ‘cold sores’, which can last up to 10 days. The most common treatment is aciclovir cream which reduces healing time by just half a day compared with no specific treatment. This is a protocol for a randomised controlled trial (RCT) to determine the efficacy of medical grade kanuka honey-based topical treatment (Honevo) in reducing the healing time and pain of cold sores, compared with topical aciclovir treatment (Viraban).Methods and analysisThis open-label, parallel-group, active comparator superiority RCT will compare the efficacy of medical grade kanuka honey with 5% aciclovir cream in the treatment of cold sores in the setting of a pharmacy research network of 60 sites throughout New Zealand. Adults presenting with a cold sore (N=950) will be randomised by pharmacy-based investigators. The pharmacy-based investigators will dispense the investigational product to randomised participants and both study groups apply the treatment five times daily until their skin returns to normal or for 14 days, whichever occurs first. In response to a daily SMS message, participants complete an assessment of their cold sore healing, with reference to a visual guide, and transmit it to the investigators by a smartphone eDiary in real time. The primary outcome variable is time (in days) from randomisation to return to normal skin. Secondary endpoints include total healing time stratified by stage of the lesion at onset of treatment, highest pain severity and time to pain resolution.Ethics and disseminationNew Zealand Ethics Registration 15/NTB/93. Results will be published in a peer-reviewed medical journal, presented at academic meetings and reported to participants.Trial registration numberAustralia New Zealand Clinical Trials Registry: ACTRN12615000648527, pre-results.SCOTT Registration: 15/SCOTT/14Protocol version4.0 (12 June 2017)

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

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e026201 ◽  
Author(s):  
Alex Semprini ◽  
Joseph Singer ◽  
Irene Braithwaite ◽  
Nick Shortt ◽  
Darmiga Thayabaran ◽  
...  
Keyword(s):  
New Zealand ◽  
Herpes Simplex ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Normal Skin ◽  
Secondary Outcome ◽  
Outcome Variable ◽  
Stage 4 ◽  
Randomised Controlled ◽  
Medical Grade

ObjectiveTo compare New Zealand medical grade kanuka honey with topical aciclovir for the treatment of herpes simplex labialis.DesignProspective parallel randomised controlled open-label superiority trial.Setting76 community pharmacies across New Zealand between 10 September 2015 and 13 December 2017.Participants952 adults randomised within the first 72 hours of a herpes simplex labialis episode.InterventionsRandom assignment 1:1 to either 5% aciclovir cream or medical grade kanuka honey (90%)/glycerine (10%) cream, both applied five times daily.Outcome measuresThe 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.ResultsPrimary 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.ConclusionThere 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 numberACTRN12615000648527;Post-results

scholarly journals Indigenous health worker support for patients with poorly controlled type 2 diabetes: study protocol for a cluster randomised controlled trial of the Mana Tū programme

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e019572
Author(s):  
Vanessa Selak ◽  
Tereki Stewart ◽  
Yannan Jiang ◽  
Jennifer Reid ◽  
Taria Tane ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
New Zealand ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Determinants Of Health ◽  
Pacific People ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionType 2 diabetes mellitus (T2DM) and its complications are more common among Māori and Pacific people compared with other ethnic groups in New Zealand. Comprehensive and sustained approaches that address social determinants of health are required to address this condition, including culturally specific interventions. Currently, New Zealand has no comprehensive T2DM management programme for Māori or Pacific people.Methods and analysisThe Mana Tū programme was developed by a Māori-led collaborative of primary healthcare workers and researchers, and codesigned with whānau (patients and their families) in order to address this gap. The programme is based in primary care and has three major components: a Network hub, Kai Manaaki (skilled case managers who work with whānau with poorly controlled diabetes) and a cross-sector network of services to whom whānau can be referred to address the wider determinants of health. The Network hub supports the delivery of the intervention through training of Kai Manaaki, referrals management, cross-sector network development and quality improvement of the programme. A two-arm cluster randomised controlled trial will be conducted to evaluate the effectiveness of the Mana Tū programme among Māori, Pacific people or those living in areas of high socioeconomic deprivation who also have poorly controlled diabetes (glycated haemoglobin, HbA1c, >65 mmol/mol (8%)), compared with being on a wait list for the programme. A total of 400 participants will be included from 10 general practices (5 practices per group, 40 participants per practice). The primary outcome is HbA1c at 12 months. Secondary outcomes include blood pressure, lipid levels, body mass index and smoking status at 12 months. This protocol outlines the proposed study design and analysis methods.Ethics and disseminationEthical approval for the trial has been obtained from the New Zealand Health and Disability Ethics Committee (17/NTB/249). Findings will be presented to practices and their patients at appropriate fora, and disseminated widely through peer-reviewed publications and conference presentations.Trial registration numberACTRN12617001276347; Pre-result.

scholarly journals Postcard intervention for repeat self-harm: randomised controlled trial

2010 ◽  
Vol 197 (1) ◽  
pp. 55-60 ◽  
Author(s):  
Annette L. Beautrais ◽  
Sheree J. Gibb ◽  
Alan Faulkner ◽  
David M. Fergusson ◽  
Roger T. Mulder
Keyword(s):  
Emergency Department ◽  
New Zealand ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Suicidal Behaviour ◽  
Controlled Trial ◽  
Elevated Risk ◽  
Emergency Department Presentation ◽  
Self Harm ◽  
Randomised Controlled

BackgroundSelf-harm and suicidal behaviour are common reasons for emergency department presentation. Those who present with self-harm have an elevated risk of further suicidal behaviour and death.AimsTo examine whether a postcard intervention reduces self-harm re-presentations in individuals presenting to the emergency department.MethodRandomised controlled trial conducted in Christchurch, New Zealand. The intervention consisted of six postcards mailed during the 12 months following an index emergency department attendance for self-harm. Outcome measures were the proportion of participants re-presenting with self-harm and the number of re-presentations for self-harm in the 12 months following the initial presentation.ResultsAfter adjustment for prior self-harm, there were no significant differences between the control and intervention groups in the proportion of participants re-presenting with self-harm or in the total number of re-presentations for self-harm.ConclusionsThe postcard intervention did not reduce further self-harm. Together with previous results this finding suggests that the postcard intervention may be effective only for selected subgroups.

scholarly journals A targeted promotional DVD fails to improve Māori and Pacific participation rates in the New Zealand bowel screening pilot: results from a pseudo-randomised controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Karen Bartholomew ◽  
Lifeng Zhou ◽  
Sue Crengle ◽  
Elizabeth Buswell ◽  
Anne Buckley ◽  
...  
Keyword(s):  
New Zealand ◽  
Randomised Controlled Trial ◽  
Positive Impact ◽  
Controlled Trial ◽  
Trial Registration ◽  
Reminder Letter ◽  
Pacific People ◽  
Screening Participation ◽  
Test Kit ◽  
Randomised Controlled

Abstract Background New Zealand’s Bowel Screening Pilot (BSP) used a mailed invitation to return a faecal immunochemical test. As a pilot it offered opportunities to test interventions for reducing ethnic inequities in colorectal cancer screening prior to nationwide programme introduction. Small media interventions (e.g. educational material and DVDs) have been used at both community and participant level to improve uptake. We tested whether a DVD originally produced to raise community awareness among the Māori population would have a positive impact on participation and reduce the proportion of incorrectly performed tests (spoiled kits) if mailed out with the usual reminder letter. Methods The study was a parallel groups pseudo-randomised controlled trial. Over 12 months, all Māori and Pacific ethnicity non-responders four weeks after being mailed the test kit were allocated on alternate weeks to be sent, or not, the DVD intervention with the usual reminder letter. The objective was to determine changes in participation and spoiled kit rates in each ethnic group, determined three months from the date the reminder letter was sent. Participants and those recording the outcomes (receipt of a spoiled or non-spoiled test kit) were blinded to group assignment. Results 2333 Māori and 2938 Pacific people participated (11 withdrew). Those who were sent the DVD (1029 Māori and 1359 Pacific) were less likely to participate in screening than those who were not (1304 Māori and 1579 Pacific). Screening participation was reduced by 12.3% (95% CI 9.1–15.5%) in Māori (13.6% versus 25.9%) and 8.3% (95% CI 5.8–10.8%) in Pacific (10.1% versus 18.4%). However, spoiled kit rates (first return) were significantly higher among those not sent the DVD (33.1% versus 12.4% in Māori and 42.1% versus 21.9% in Pacific). Conclusion The DVD sent with the reminder letter to BSP non-responders reduced screening participation to an extent that more than offset the lower rate of spoiled kits. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12612001259831. Registered 30 November 2013.

scholarly journals Promoting independence in frail older people: a randomised controlled trial of a restorative care service in New Zealand

2014 ◽  
Vol 43 (3) ◽  
pp. 418-424 ◽  
Author(s):  
H. E. J. Senior ◽  
M. Parsons ◽  
N. Kerse ◽  
M.-H. Chen ◽  
S. Jacobs ◽  
...  
Keyword(s):  
New Zealand ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Care Service ◽  
Controlled Trial ◽  
Frail Older People ◽  
Randomised Controlled

scholarly journals Effectiveness of recruitment to a smartphone-delivered nutrition intervention in New Zealand: analysis of a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (6) ◽  
pp. e016198 ◽  
Author(s):  
Ekaterina Volkova ◽  
Jo Michie ◽  
Callie Corrigan ◽  
Gerhard Sundborn ◽  
Helen Eyles ◽  
...  
Keyword(s):  
New Zealand ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Nutrition Intervention ◽  
Randomised Controlled

scholarly journals WELCOME-GP: A randomised controlled trial of the effectiveness of a targeted postal cancer awareness intervention for increasing attendance at general practice

2020 ◽  
Author(s):  
Jean-Pierre Laake ◽  
Daniel Vulkan ◽  
Samantha L Quaife ◽  
William T Hamilton ◽  
Tanimola Martins ◽  
...  
Keyword(s):  
General Practice ◽  
General Practitioner ◽  
Randomised Controlled Trial ◽  
Health Research ◽  
Help Seeking ◽  
Controlled Trial ◽  
Policy Research ◽  
Research Network ◽  
Cancer Awareness ◽  
Randomised Controlled

ABSTRACTObjectiveTo assess the effectiveness of a targeted postal promotion for improving cancer symptom awareness and increasing help-seeking in general practice, on subsequent general practitioner (GP) consultation rates in a population which has made infrequent use of consultations at their local practice.Setting23 general practices in England.DesignRandomised controlled trial comparing a mailed leaflet providing information on six key cancer symptoms plus a covering letter signed by their general practitioner designed to reduce barriers to primary care help-seeking (intervention arm), with usual care (control arm).Participants1,513 adults aged 50-84 years (783 individually randomised to the intervention arm and 730 individually randomised to the control arm) who had not consulted their GP in the last 12 months and had at least two other risk factors for late presentation with cancer, identified by practice staff between November 2016 and May 2017. 749 individuals in the intervention arm and 705 in the control arm were included in the intention to treat analyses.Outcome measureThe primary outcome was number of GP consultations in the six months subsequent to mailing of the intervention.ResultsThere was a significantly higher rate of consultation in the intervention arm: 436 consultations compared to 335 in the control arm (RR = 1.40, 95% CI 1.11-1.77, p=0.004). However, there was no difference in the numbers of persons consulting their GP, with 165 in each group.ConclusionsTargeted interventions of this nature can change behaviour. This intervention stimulated a greater number of consultations but not a greater number of patients consulting. There is a need to develop interventions which can be more effective on the broader less engaged population.Trial registrationThe trial was registered prospectively on the International Standard Randomised Controlled Trial Number (ISRCTN) registry (ISRCTN95610478).FundingThis research is funded by the National Institute for Health Research (NIHR) Policy Research Programme, conducted through the Policy Research Unit in Cancer Awareness, Screening and Early Diagnosis, 106/0001. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Additional support, including NHS service support costs, were provided by the National Institute for Health Research Clinical Research Network (NIHR CRN) (UKCRN ID 31163).

scholarly journals Protocol for a pilot randomised controlled trial of metformin in pre-diabetes after kidney transplantation: the Transplantation and Diabetes (Transdiab) study

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e016813 ◽  
Author(s):  
Basil Alnasrallah ◽  
Helen Pilmore ◽  
Paul Manley
Keyword(s):  
Clinical Trials ◽  
Kidney Transplantation ◽  
Renal Transplantation ◽  
New Zealand ◽  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Significant Morbidity ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

IntroductionPost-transplant diabetes mellitus (PTDM) is a common complication of kidney transplantation and is associated with significant morbidity and mortality. In the general population, metformin has been used for diabetes prevention in high-risk individuals. Improving insulin sensitivity is one of many proven favourable effects of metformin. Despite the high incidence of PTDM in kidney transplant recipients, there is a lack of evidence for the role of metformin in the prevention of diabetes in this setting.Methods and analysisTransplantation andDiabetes (Transdiab)is a single-centre, unblinded, pilot randomised controlled trial assessing the feasibility, tolerability and efficacy of metformin after renal transplantation in patients with impaired glucose tolerance (IGT). Participants will undergo an oral glucose tolerance test in the 4–12 weeks post-transplantation; those with IGT will be randomised to standard care or standard care and metformin 500 mg twice daily, and followed up for 12 months. The primary outcomes of the study will be the feasibility of recruitment, the tolerability of metformin assessed using the Gastrointestinal Symptom Rating Scale at 3 and 12 months, and the efficacy of metformin assessed by morning glucose and glycated haemoglobin at 3, 6, 9 and 12 months.Ethics and disseminationDespite the significant morbidity and mortality of PTDM, there are currently no randomised clinical trials assessing pharmacological interventions for its prevention after kidney transplantation. The Transdiab trial will thus provide important data on the feasibility, safety, tolerability and efficacy of metformin after renal transplantation in patients with IGT; this will facilitate undertaking larger multicentre trials of interventions to reduce the incidence or severity of diabetes after kidney transplantation. This study has been approved by the Northern B Health and Disability Ethics Committee of the Ministry of Health in New Zealand. On study completion, results are expected to be published in a peer-reviewed journal.Trial registration numberAustralian New Zealand Clinical Trials Registry Number: ACTRN12614001171606.

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