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Background: Osteoarthritis (OA) is a common cause of pain and disability. Currently available analgesics are often insufficiently effective or have unacceptable adverse effects. Tricyclic antidepressants may offer a useful centrally-acting analgesic. Nortriptyline is a readily-available, cheap and comparatively well-tolerated tricyclic antidepressant.Methods/design: We will conduct a parallel group, two-arm, participant and investigator-blinded, randomised controlled superiority trial comparing nortriptyline with placebo. Two hundred participants with primary knee OA will be enrolled. Participants will take study medication for 14 weeks. The primary outcome is difference between treatment arms in mean pain score measured on the Western Ontario and McMaster Universities (WOMAC) pain scale at 14 weeks.Discussion: This protocol describes the first randomised controlled trial of a tricyclic antidepressant in the treatment of OA. The results of the study may have significant implications for the management of this common and painful condition.Trial Registration: The trial was registered with the Australian New Zealand Clinical Trials Registry on 27 June 2014. The trial registration number is: ACTRN12614000683639 . [ABSTRACT FROM AUTHOR]

Background: Electronic cigarettes (e-cigarettes or electronic nicotine delivery systems [ENDS]) are electrically powered devices generally similar in appearance to a cigarette that deliver a propylene glycol and/or glycerol mist to the airway of users when drawing on the mouthpiece. Nicotine and other substances such as flavourings may be included in the fluid vaporised by the device. People report using e-cigarettes to help quit smoking and studies of their effects on tobacco withdrawal and craving suggest good potential as smoking cessation aids. However, to date there have been no adequately powered randomised trials investigating their cessation efficacy or safety. This paper outlines the protocol for this study. Methods/design: Design: Parallel group, 3-arm, randomised controlled trial. Participants: People aged =18 years resident in Auckland, New Zealand (NZ) who want to quit smoking. Intervention: Stratified blocked randomisation to allocate participants to either Elusion™ e-cigarettes with nicotine cartridges (16 mg) or with placebo cartridges (i.e. no nicotine), or to nicotine patch (21 mg) alone. Participants randomised to the e-cigarette groups will be told to use them ad libitum for one week before and 12 weeks after quit day, while participants randomised to patches will be told to use them daily for the same period. All participants will be offered behavioural support to quit from the NZ Quitline. Primary outcome: Biochemically verified (exhaled carbon monoxide) continuous abstinence at six months after quit day. Sample size: 657 people (292 in both the nicotine e-cigarette and nicotine patch groups and 73 in the placebo e-cigarettes group) will provide 80% power at p = 0.05 to detect an absolute difference of 10% in abstinence between the nicotine e-cigarette and nicotine patch groups, and 15% between the nicotine and placebo e-cigarette groups. Discussion: This trial will inform international debate and policy on the regulation and availability of e-cigarettes. If shown to be efficacious and safe, these devices could help many smokers as an alternative smoking cessation aid to standard nicotine products. [ABSTRACT FROM AUTHOR]

Background: Acute gastroenteritis is a substantial cause of hospitalization in children. Shigella, Salmonella, Campylobacter, Yersinia, enterotoxigenic Escherichia coli (ETEC), Giardia and Cryptosporidium are gastrointestinal pathogens that are notifiable in New Zealand (NZ). The impact of these infections in the pediatric population has not yet been analyzed. The aim of this study was to describe the epidemiological trends in disease notifications and hospital admissions due to non-viral gastroenteritis in NZ children.Methods: In this population-based descriptive study, age-specific and age-standardized notification and hospital admission rates were analyzed from 1997-to-2015 for Shigella, Salmonella, Campylobacter, Yersinia, ETEC, Giardia and Cryptosporidium infections in children < 15 years of age. Variations in disease by gender, age, ethnicity and geography were described.Results: From 1997-to-2015 there were 74,454 notifications (57.6% male) and 3192 hospitalizations (56.4% male) due to non-viral gastroenteritis in NZ children aged < 15 years. There was an overall trend towards a reduction in disease notifications and hospitalizations, however each disease showed a unique pattern of change over time. Campylobacter was the pathogen most frequently notified, accounting for 51.7% of notifications and 43.4% of hospitalizations. The hospitalization-to-notification ratios were, from highest to lowest, Salmonella typhi (1:1.09), Shigella (1:4.0), ETEC (1:7.81), nontyphoidal Salmonella (1:13.1), Campylobacter (1:27.8), Yersinia (1:29.2), Cryptosporidium (1,33.4), and Giardia (1,72.5). Compared to females, male notification rates were approximately 40% higher for Campylobacter, 25% higher for Giardia and Yersinia, and 15% higher for Cryptosporidium and nontyphoidal Salmonella (p < 0.001). Notification rates were highest in children 1-4 years, with the exceptions of nontyphoidal Salmonella, Salmonella typhi and Yersinia. Notification rates for nontyphoidal Salmonella and Yersinia were highest in children < 1 year, and for Salmonella typhi those aged 5-9 years. Children < 1 year were most likely to be hospitalized.Conclusions: The incidence of non-viral gastroenteritis in NZ children reduced during the 19-year period considered. The burden of disease was highest in the community, with only a small percentage of cases requiring hospitalization. This study provides important insight into the non-viral causes of gastroenteritis in NZ children and how environmental influences and changes in food safety practices may have helped to reduce the burden of these diseases in children. [ABSTRACT FROM AUTHOR]

Background: Smokers need effective support to maximise the chances of successful quit attempts. Current smoking cessation medications, such as nicotine replacement therapy (NRT), bupropion, nortriptyline or varenicline, have been shown to be effective in clinical trials but are underused by smokers attempting to quit due to adverse effects, contraindications, low acceptability and/or high cost. Cytisine is a low-cost, plant-based alkaloid that has been sold as a smoking cessation aid in Eastern Europe for 50 years. A systematic review of trial evidence suggests that cytisine has a positive impact on both short- and long-term abstinence rates compared to placebo. However, the quality of the evidence is poor and insufficient for licensing purposes in many Western countries. A large, well-conducted placebo-controlled trial (n = 740) of cytisine for smoking cessation has recently been published and confirms the findings of earlier studies, with 12-month continuous abstinence rates of 8.4% in the cytisine group compared to 2.4% in the placebo group (Relative risk = 3.4, 95% confidence intervals 1.7-7.1). No research has yet been undertaken to determine the effectiveness of cytisine relative to that of NRT., Methods/design: A single-blind, randomised controlled, non-inferiority trial has been designed to determine whether cytisine is at least as effective as NRT in assisting smokers to remain abstinent for at least one month. Participants (n = 1,310) will be recruited through the national telephone-based Quitline service in New Zealand and randomised to receive a standard 25-day course of cytisine tablets (Tabex®) or usual care (eight weeks of NRT patch and/or gum or lozenge). Participants in both study arms will also receive a behavioural support programme comprising an average of three follow-up telephone calls delivered over an eight-week period by Quitline. The primary outcome is continuous abstinence from smoking at one month, defined as not smoking more than five cigarettes since quit date. Outcome data will also be collected at one week, two months and six months post-quit date., Discussion: Cytisine appears to be effective compared with placebo, and given its (current) relative low cost may be an acceptable smoking cessation treatment for smokers, particularly those in low- and middle-income countries. Cytisine's 'natural' product status may also increase its acceptability and use among certain groups of smokers, such as indigenous people, smokers in countries where the use of natural medicines is widespread (e.g. China, India), and in those people who do not want to use NRT or anti-depressants to help them quit smoking. However it is important to ascertain the effectiveness of cytisine compared with that of existing cessation treatments., Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN12610000590066).