| Literature DB >> 30666002 |
Suzanne Tanya Nethan1, Dhirendra Narain Sinha2, Kumar Chandan3, Ravi Mehrotra3.
Abstract
BACKGROUND &Entities:
Keywords: Behavioural; intervention; nicotine replacement therapy; smokeless tobacco; tobacco dependence; tobacco use cessation
Mesh:
Substances:
Year: 2018 PMID: 30666002 PMCID: PMC6362721 DOI: 10.4103/ijmr.IJMR_1983_17
Source DB: PubMed Journal: Indian J Med Res ISSN: 0971-5916 Impact factor: 2.375
FigureFlow chart showing search strategy. *These were the number of articles which were chosen for screening of their abstracts after excluding other articles deemed irrelevant based on their titles.
Details of the smokeless tobacco (SLT) cessation intervention randomized controlled trials (RCT) and cohort studies
| Authors | Year | Country | Study type | Subject characteristics | Intervention period/method | Follow up period | Risk ratio and CI | |||
|---|---|---|---|---|---|---|---|---|---|---|
| Total | Case (n) | Control (n) | Age (yr) | |||||||
| NRT with behavioural interventions | ||||||||||
| Boyle | 1992 | USA | RCT | 100 | 50 | 50 | Average age 32 | 6 wk | 1, 6 and 12 months | 1.00 (0.52-1.94) |
| Hatsukami | 1996 | USA | RCT | 210 males | 106 | 104 | Average age 31 | Pharmacotherapy - 8 wk, | 12 months | 0.98 (0.63-1.54) |
| Behaviour therapy - 10 wk | ||||||||||
| Howard-Pitney | 1999 | USA | RCT | 410 males | 206 | 204 | Average age 36 | 6 months | 1.12 (0.86-1.45) | |
| Hatsukami | 2000 | USA | RCT | 402 | 201 | 201 | Average age 31 | 10 wk | Up to 62 wk | 1.27 (0.92-1.74) |
| Stotts | 2003 | USA | RCT | 303 males | 198 | 105 | 14-19 | 6 wk | 12 months | 1.26 (0.57-2.78) |
| Croucher | 2003 | UK | Pilot study | 130 UK-resident Bangladeshi women | 65 | 65 | Average age 42.5 | 4 wk | 1.25 (0.58-2.68) | |
| Ebbert | 2007 | USA | RCT | 42 males | 10 | 11 | Average age 34-38 (20-56) | 8 wks | 6 months | 1.10 (0.19-6.41) |
| Ebbert | 2009 | USA | RCT | 270 (264 males and 6 females) | 136 | 134 | 18 and above (average age 37) | 12 wk | 6 months | 1.40 (0.88-2.22) |
| Ebbert | 2010 | USA | RCT | 60 males | 30 | 30 | 18 yr and above (average age: randomized group 43.6±16.0, control group 42.4±11.7) | 12 wk | 6 months | 0.73 (0.34-1.55) |
| Croucher | 2012 | UK | Cohort | 239 South Asians | 219 | 20 | Average age 45 | 4 wk | 1 yr | 1.62 (0.94-2.80) |
| Croucher | 2012 | UK | Cohort | 419 UK resident Bangladeshi women | 330 | 89 | Average age 48.9 | 4 wk | 4.93 (2.02-12.00) | |
| Ebbert | 2013 | USA | RCT | 52 | 25 | 27 | Average age 41 (18-55) | 8 wk | 6 months | 1.73 (0.65-4.59) |
| Ebbert | 2013 | USA | Pilot study | 130 (125 males and 5 females) | 40 | 41 | 18 yr and above (average age 38) | 12 wk | 6 months | 1.03 (0.32-3.27) |
| Danaher | 2015 | USA | RCT | 407 (397 males and 10 females) | 205 | 202 | Average age 35 | 12 wk | 3 and 6 months | 1.53 (1.12-2.09) |
| Severson | 2015 | USA | RCT | 1067 males | 357 | 354 | Average age 36 | 12 wk | 3 and 6 months | 1.36 (1.12-1.66), 1.43 (1.20-1.71) |
| Behavioural interventions only | ||||||||||
| Gupta | 1992 | India | Cohort study | 7033 males and females SLT users | 4619 | 2414 | 15 yr and above | Intervention group: Concentrated programme of education against tobacco use. Control group: minimal advice against tobacco use | 10 yr | 2.79 (2.36, 3.29) |
| Cummings | 1995 | USA | RCT | 733 males | 316 | 417 | Average age 36 | 2 yr | 2 yr | 0.98 (0.76-1.27) |
| Stevens | 1995 | USA | RCT | 518 males | 245 | 273 | 15 yr and above | 18 months | 3 and 12 months | 1.47 (0.83-2.60) |
| Severson | 1998 | USA | RCT | 633 | 394 | 239 | 15 yr and above | 3 and 12 months | 3 and 12 months | 3.03 (1.44-6.37) |
| Walsh | 1999 | USA | RCT | 360 | 171 | 189 | Intervention group: Oral exam (3-5 min) with feedback, photos of ST effects, advice to quit, self-help manual, optional brief counselling (15-20 min) about quit date, triggers, tobacco withdrawal); optional nicotine gum (to mitigate withdrawal symptoms), optional phone counselling. Controls: Oral examination only | Up to 1 yr | 2.21 (1.5-3.25) | |
| Andrews | 1999 | USA | RCT | 633 (632 males and 1 female) | 394 | 239 | 15 yr and above (Average age 36.2) | Intervention: Determine tobacco use, identify oral disease, strong advice to quit, set quit date within two wk, motivation video, written material, call patient within two wk; Usual care | 3 and 12 months | 3.26 (1.49-7.17) |
| Cigrang | 2002 | USA | Pilot study | 60 males | 31 | 29 | Average age 31 (19-47) | Programme using motivational interviewing consisted of a treatment manual, video, and two supportive phone calls (about 10 min each) from a cessation counsellor | 3 and 6 months | 2.18 (0.62-7.65) |
| Walsh | 2003 | USA | RCT | 307 males | 141 | 166 | 14-18 | Peer-led component (50-60 min): Interactive, peer-led team directing education with videotape and brief discussion (10-15 min), slide show (20-30 min), and small-group discussion on tobacco industry advertising (10 min). Dental component with oral cancer screening examination by a dentist or hygienist. Included advice to quit, a self-help guide, tobacco cessation counselling in small groups (15 min), and a phone call on the quit date (5-10 min). Control group: No intervention | 1 and 12 months | 1.95 (1.22-3.10) |
| Boyle | 2004 | USA | RCT | 221 males | 109 | 112 | Average age 36 | Behavioural therapy 1. S-H materials (control) 2. S-H material + 4 proactive telephone counselling calls. Initial call four days after S-H material mailing. Subsequent calls were negotiated and placed emphasis on support, problem-solving, and use of cognitive-behavioural strategies including monitoring tobacco behaviour patterns, goal setting, finding alternative coping options and planning for high-risk situations or cues associated with tobacco use | 6 months | 1.61 (1.09-2.39) |
| Gansky | 2005 | USA | RCT | 637 | 285 | 352 | 17-20 | Intervention: 1. Three-hour video conference training for athletic trainers/dentists/hygienists; follow up newsletter for athletic trainers 2. Oral cancer screening by dentists/hygienists 3. Athletic trainer follow up and referral with follow up by trainer on quit date, plus 3 booster sessions one week apart 4. Peer-led component with education meeting (50-60 min). Control: anti-tobacco education | 1 yr | 0.98 (0.80-1.20) |
| Severson | 2007 | USA | RCT | 1069 males | 535 | 534 | Average age 39 (17-82) | Assisted self-help including: 1. Phone support (two calls, 10-15 min, with quit date setting and tobacco withdrawal management) 2. Self-help manual (60 pages) 3. Self-help videos (20 min). Controls received a self-help manual | 12 months | 1.32 (0.94-1.86) |
| Stigler | 2007 | India | Cohort study | 209 girls and boys | 100 | 109 | 10-16 | Four months | 2 yr (here, outcome of 1 yr) | 0.87 (0.7-1.09) |
| Severson | 2008 | USA | RCT | 2523 males | 1260 | 1263 | Average age 36.8 | Intervention (enhanced website): a guided interactive programme for quitting tobacco, useful resources and other weblinks, web forums namely ‘Talk with Others’ and ‘Ask an Expert’, planning to quit and staying quit modules Controls (basic website): a static website having a pocket guide titled “Enough Snuff ”and a section with useful materials and links | 3 & 6 months | 1.59 [1.26, 2.02] |
| Boyle | 2008 | USA | RCT | 406 (399 males and 7 females) | 201 | 205 | Average age 40 | A self-help manual plus proactive phone-based cessation counselling. Phone-based treatment included up to 4 calls in support of quitting and personalized cognitive and behavioural tobacco treatment strategies ( | 3 and 6 months | 3.16 (1.99-5.03) |
| Severson | 2009 | USA | RCT | 785 males | 392 | 393 | Average age 30 | Telephone counselling by a trained cessation counsellor who offered assistance in quitting ST use (3 calls: First call one week after dental examination, second call three weeks after quitting materials were mailed, third call a few days after participant’s quit date or two weeks after the second call); a mailed videotape and self-help guide tailored for the military. Controls received usual care | 6 months | 3.84 (2.33-6.33) |
| Walsh | 2010 | USA | RCT | 4731 males | 123 | 123 | 14-18 | Peer-led educational session (45 min), oral exam with feedback, and three nurse-led group cessation counselling sessions (one hour each, optional). Peer-led sessions included video/slide presentation and discussion about the presentations and how the tobacco industry targets young males. Oral examination included feedback about any tobacco-related lesions, advice to quit using ST, assessing of readiness to quit. The first nurse-led session focused on assessment, education, preparation to get ready to quit, and the importance of social support; the second session focused on setting a quit date and skills to cope with cravings and temptation to use; the third session reviewed progress and focused on relapse prevention. Controls received no intervention | 1 yr | 1.08 (0.84-1.39) |
| Danaher | 2013 | USA | RCT | 1716 (1656 males and 60 females) | 857 | 859 | Average age 21 (14-25) | Behavioural therapy 1. Basic condition (control): Static website content including an ‘Enough Snuff’ pocket guide, a resource section with informational materials and links to websites offering content for ST cessation and relaxation strategies 2. Enhanced condition: Interactive and multimedia features with functionality to create online lists, watch videos, and a Web blog moderated by research staff. Automated email reminders encouraged website use and provided supportive measures | 3 and 6 months | 1.07 (0.87-1.31) |
| Danaher | 2015 | USA | RCT | 1683 (1641 males and 42 females) | 1259 | 424 | Average age 38 | Behavioural therapy: 1. Web only: Automated, tailored and interactive intervention delivered as text, activities, and videos 2. Quitline only: Proactive telephone counselling through the California Tobacco Chewers’ Helpline 3. Web + Quitline: Received the Web and Quitline Interventions 4. Control: Self-help printed guide | 3 and 6 months | 1.33 (1.09-1.63) |
| Virtanen | 2015 | Scandinavia (Sweden) | RCT | 241 males and females | 94 | 100 | 18-75 | Behavioural therapy: 1. Structured tobacco use intervention based upon the 5 A’s specifically referring to oral health with reference to pharmacotherapy, more intensive counselling in the primary care clinic and the telephone quitline. Hand-outs supplied 2. Usual care | 6 months | 3.72 (0.79-17.47) |
| Jhanjee | 2017 | India | Pilot study | 100 women | 50 | 50 | Average age 43 | 3 months | 1.80 [0.77, 4.25] | |
| Non-nicotine therapy (with behavioural interventions): Bupropion | ||||||||||
| Glover | 2002 | USA | Double-blind RCT | 70 males | 35 | 35 | 18 & above | 7 wk | 5 wk | 2.73 [1.07, 7.72] (at 7 wk), 1.93 [0.71, 5.47] (at follow up) |
| Dale | 2002 | USA | RCT | 68 (67 males, 1 female) | 34 | 34 | Average age 37 | 12 wk | 24 wk | 1 [0.27, 3.68] |
| Dale | 2007 | USA | RCT | 225 males | 113 | 112 | Average age 38 (19-72) | 12 wk | 24 & 52 wk | 0.87 [0.51, 1.46] |
| Non-nicotine therapy (with behavioural interventions): Varenicline | ||||||||||
| Fagerstrom | 2010 | Scandinavia (Sweden & Norway) | RCT | 431 (385 males & 46 females) | 213 | 218 | Average age 43.9 | 12 wk | 6 months | 1.33 [1.05, 1.69] |
| Ebbert | 2011 | USA | RCT | 76 males | 38 | 38 | Average age 41 | 12 wk | 3 & 6 months | 1.42 [0.79, 2.55] |
| Jain | 2014 | India | Double-blind RCT | 237 (mostly males) | 119 | 118 | Average age 34.2 | 12 wk | 2.60 [1.20, 4.20] | |
SLT, smokeless tobacco; RCT, randomized controlled trials
Details of smokeless tobacco cessation intervention non case-control studies
| Authors | Country | Year | Study type | Subject characteristics | Intervention period | Follow up period | Quit rate (%) | |
|---|---|---|---|---|---|---|---|---|
| n | Age (yr) | |||||||
| Behavioural interventions only | ||||||||
| Eakin | USA | 1989 | Pilot study | 25 males | 3 months | 16 | ||
| Masouredis | USA | 1997 | RCT | 1208 males | 3 months | 24 | ||
| Walsh | USA | 1998 | Pilot study | 304 males | Minor and major league players | 6 months | 9 | |
| Boyle | USA | 1999 | Media campaign | 205 males | 21-79 Average age=37.5 | 1 yr | 11.5 | |
| Fisher | USA | 2001 | Cohort study | 50 (49 males, 1 female) | 18 and above | 6 wk | 58 | |
| Lichtenstein | USA | 2002 | 363 female romantic partners of male smokeless tobacco users | Average age=40 | 6 months | 32 | ||
| Gala | USA | 2008 | Cohort study | 18 males | 18 and above | 1 month | 8 | |
| Mishra | India | 2009 | Cohort study | 104 males | 1 yr | 51.5 | ||
| Meier | USA | 2013 | Institutional intervention | 2293 males | 18-56 (average age =20.6) | 4 yr | 16.4 | |
| Mishra | India | 2014 | Community-based intervention | 304 women | 1 yr | 33.5 | ||
| Siddiqi | UK, Pakistan | 2016 | Pilot study | 32 (16 males and 16 females) | 18 and above | 6 months | 12.5 | |
| Gupta | India | 2016 | Quitline | 1105 | Majority between 16-25 | 1 call session | 1 wk, 1 month, 3 months, 6 months, 1 yr | 20.0 (at 18 months) |
| NRT with behavioural interventions | ||||||||
| Sinusas | USA | 1993 | Preliminary trial | 14 males | 2-4 months | Up to 12 months | 21 (at the end of treatment), 7 (at follow up) | |
| Hatsukami | USA | 2003 | Pilot study | 40 males | Average age=31.9 | 12 wk | At 26 wk | 25 (at end of treatment) 15 (at follow up) |
| Ebbert | USA | 2007 | Open-label, one-arm, phase II clinical trial | 30 (29 males, 1 female) | Average age=35.4 | 12 wk | 6 months | 53 (at end of treatment), 47 (at follow up) |
| Wallstrom | Sweden | 2010 | Prospective, open, non-randomized intervention trial | 50 males | Average age=42.2 | Six wk | 3, 6, 12 months | 30 (at 12 months) |
| Mushtaq | USA | 2015 | Cohort study | 374 males | Average age=41.3 | 7 months | 43 | |
| Non-Nicotine therapy with behavioural interventions: Varenicline | ||||||||
| Ebbert | USA | 2010 | Pilot study | 20 males | Average age=42.8 | 12 wk | 6 months | 15 (at 12 wk) 10 (at 6 months) |
NRT, Nicotine replacement therapy