The safety, effectiveness and cost‐effectiveness of cytisine in achieving six‐month continuous smoking abstinence in tuberculosis patients—protocol for a double‐blind, placebo‐controlled randomized trial

Dogar, Omara; Barua, Deepa; Boeckmann, Melanie; Elsey, Helen; Fatima, Razia; Gabe, Rhian; Huque, Rumana; Keding, Ada; Khan, Amina; Kotz, Daniel; Králíková, Eva; Newell, James; Nohavová, Iveta; Parrott, Steve; Readshaw, Anne; Renwick, Lottie; Sheikh, Aziz; Siddiqi, Kamran

doi:10.1111/add.14242

Cited by 19 publications

(22 citation statements)

References 31 publications

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“…One of the possible less expensive pharmacotherapy options is cytisine, whose efficacy compares to that of currently licensed products. A study from Bangladesh 8 may bring interesting findings; two face-to-face behavioural support sessions will be delivered and cytisine (active arm) or matching placebo (control arm) will be administered in a 25-day course. The success rate may depend on pharmacotherapy duration (at least 3 months) as well as on the type of intervention provided.…”

Section: Discussionmentioning

confidence: 99%

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A narrative review of facilitators and barriers to smoking cessation and tobacco-dependence treatment in patients with tuberculosis in low- and middle-income countries

Zvolská¹,

Pánková²,

Nohavová³

et al. 2020

Tob. Induc. Dis.

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INTRODUCTION Smoking is a substantial cause of premature death in patients with tuberculosis (TB), particularly in low-and middle-income countries (LMICs) with high TB prevalence. The importance of incorporating smoking cessation and tobacco-dependence treatment (TDT) into TB care is highlighted in the most recent TB care guidelines. Our objective is to identify the likely key facilitators of and barriers to smoking cessation for patients with TB in LMICs. METHODS A systematic search of studies with English-language abstracts published between January 2000 and May 2019 was undertaken in the EMBASE, MEDLINE, EBSCO, ProQuest, Cochrane and Web of Science databases. Data extraction was followed by study-quality assessment and a descriptive and narrative synthesis of findings. RESULTS Out of 267 potentially eligible articles, 36 satisfied the inclusion criteria. Methodological quality of non-randomized studies was variable; low risk of bias was assessed in most randomized controlled studies. Identified facilitators included brief, repeated interventions, personalized behavioural counselling, offer of pharmacotherapy, smoke-free homes and a reasonable awareness of smoking-associated risks. Barriers included craving for a cigarette, low level of education, unemployment, easy access to tobacco in the hospital setting, lack of knowledge about quit strategies, and limited space and privacy at the clinics. Findings show that the risk of smoking relapse could be reduced through consistent follow-up upon completion of TB therapy and receiving a disease-specific smoking cessation message. CONCLUSIONS Raising awareness of smoking-related health risks in patients with TB and implementing guideline-recommended standardized TDT within national TB programmes could increase smoking cessation rates in this high-risk population.

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Section: Discussionmentioning

confidence: 99%

“…Although in general populations, behavioural support combined with pharmacotherapy is the most effective strategy in helping people to quit, there is no evidence for the effectiveness of this strategy in TB patients who smoke. While medications are widely recommended, their costs prohibit their use in LMICs 8 .…”

Section: Introductionmentioning

confidence: 99%

A narrative review of facilitators and barriers to smoking cessation and tobacco-dependence treatment in patients with tuberculosis in low- and middle-income countries

Zvolská¹,

Pánková²,

Nohavová³

et al. 2020

Tob. Induc. Dis.

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“…A cross-sectional survey was conducted among TB patients to assess their eligibility and recruit them to a smoking cessation randomized controlled trial 21 . The trial assessed the effectiveness and cost-effectiveness of cytisine plus behavioural support compared with placebo plus behavioural support.…”

Section: Designmentioning

confidence: 99%

Smoking prevalence among tuberculosis patients: A cross-sectional study in Bangladesh and Pakistan

Marshall¹,

Barua²,

Mitchell³

et al. 2020

Tob. Induc. Dis.

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extends to 64% of its population with a success rate of 93% 1. It is estimated that TB incidence in Bangladesh and Pakistan will cost the countries 22 and 14 billion US$, respectively, between 2015 and 2030 6. Approximately 1.3 billion people smoke tobacco worldwide, 80% of which reside in LMICs such as Bangladesh and Pakistan, where the burden of TB is also high 7. The prevalence of daily smoking (those who currently smoke tobacco on a daily basis) in the general population according to the most recent Global Adult Tobacco Survey (GATS) reports (GATS 2017 for Bangladesh and 2014 for Pakistan) is 16.4% (33.1% of males and 0.7% of females) and 11.5% (20.6% of males and 2% of females) in Bangladesh and Pakistan, respectively 8,9. Smoking has a negative impact on TB outcomes. ABSTRACT INTRODUCTION Smoking has a negative impact on TB outcomes. We estimated the proportion of TB patients who smoke and are willing to quit in two high TB burden countries, Bangladesh and Pakistan. METHODS A cross-sectional survey was conducted among TB patients to assess their eligibility and recruit them to a smoking cessation randomized controlled trial. Adults diagnosed with TB were recruited from 32 health facilities in Bangladesh and Pakistan. Data on smoking behaviour and willingness to quit were collected and analysed. RESULTS In total, 13934 TB patients completed the survey between June 2017 and April 2018. The prevalence of smoking in these TB patients was estimated to be 22.5% (95% CI: 21.8, 23.2). Moreover, the prevalence of smoking in TB patient population was 8% (RR=1.49; 95% CI: 7.1-8.9; p<0.01) and 8.3% (RR=1.24; 95% CI: 7.3-9.4; p<0.01) higher than smoking prevalence in the general population in Bangladesh and Pakistan, respectively. Among TB patients who smoke, 97.7% (95% CI: 97.2-98.2) were willing to quit. CONCLUSIONS The estimated prevalence of smoking was higher in TB patients than the general population; however, a vast majority of TB patients who smoke were willing to quit.

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“…We will also record contacts with health services for TB by patients in each trial arm, using the questionnaires adapted from those used in a previous trial of TB [44]. Applying unit costs of health care to quantities recorded in the service use questionnaire will produce a health care cost profile for each patient at baseline, three and six-month follow up.…”

Section: Economic Evaluationmentioning

confidence: 99%

ImPROving TB outcomes by modifying LIFE-style behaviours through a brief motivational intervention followed by short text messages (ProLife): study protocol for a randomised controlled trial

Moriarty

Louwagie

Dadirai

et al. 2019

Preprint

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Background South Africa is among the 7 highest tuberculosis (TB) burden countries. Harmful lifestyle behaviours, such as smoking and alcohol, and poor medication adherence can affect clinical outcomes. Modification of these behaviours is likely to improve TB treatment outcomes and has proven possible using motivational interviewing (MI) techniques or use of short message service (SMS) text messaging. There have been no studies assessing the effect of combined MI and SMS interventions on multiple lifestyle factors and TB treatment outcomes. Methods This is a prospective, multi-centre, two-arm individual randomised controlled trial looking at the effectiveness and cost-effectiveness of a complex behavioural intervention (the ProLife programme) on improving TB and lifestyle-related outcomes in 3 provinces of South Africa. The ProLife programme consists of an MI counselling strategy, delivered by lay health workers, augmented with subsequent SMS. We aim to recruit 696 adult participants (aged 18 years and over) with drug-sensitive pulmonary TB who are current smokers and/or report harmful or hazardous alcohol use. Patients will be consecutively enrolled at 27 clinics in 3 different health districts in South Africa. Participants randomised individually to the intervention arm will receive 3 MI counselling sessions 1 month apart. Each MI session will be followed by twice-weekly SMS messages targeting treatment adherence, alcohol use and tobacco smoking, as appropriate. We will assess the effect on TB treatment success, using standard World Health Organization (WHO) treatment outcome definitions (primary outcome), as well as on a range of secondary outcomes including smoking cessation, reduction in alcohol use and TB medication and anti-retroviral therapy adherence. Secondary outcomes will be measured at 3 and 6 months follow-up. Discussion This trial aligns with the WHO agenda of integrating TB care with the care for chronic diseases of life-style, such as provision of smoking cessation treatments, and with the use of digital technologies. If the ProLife programme is found to be effective and cost-effective, the programme could have significant implications for TB treatment globally and could be successfully implemented in a wide range of TB treatment settings.

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The safety, effectiveness and cost‐effectiveness of cytisine in achieving six‐month continuous smoking abstinence in tuberculosis patients—protocol for a double‐blind, placebo‐controlled randomized trial

Cited by 19 publications

References 31 publications

A narrative review of facilitators and barriers to smoking cessation and tobacco-dependence treatment in patients with tuberculosis in low- and middle-income countries

A narrative review of facilitators and barriers to smoking cessation and tobacco-dependence treatment in patients with tuberculosis in low- and middle-income countries

Smoking prevalence among tuberculosis patients: A cross-sectional study in Bangladesh and Pakistan

ImPROving TB outcomes by modifying LIFE-style behaviours through a brief motivational intervention followed by short text messages (ProLife): study protocol for a randomised controlled trial

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