Introduction
Methods
Eligibility criteria
Search strategy
Study selection
Data collection
Data analysis
Results
Study inclusion and methods reporting (Figure 1)
Author | Country | Participants | Cigarettes per day *(mean, median) | Years Smoking *(mean, median) | Intervention | Dosage (mg) | Number treated | co-intervention | Duration of treatment |
---|---|---|---|---|---|---|---|---|---|
Hilleman, 1994 | USA | Healthy | 26* | ≥ 3 | Patch (fixed dosage) | 21 | 69 | Education session | 12 weeks |
Patch (tapered dose) | 7,14,21 | 71 | |||||||
Orleans, 1994 | USA | Older adults | 17* | 50* | Patch | 7,14,21 | 871 | Counseling | 12 weeks |
Fredrickson, 1995 | USA | Healthy | >20 | 28* | Patch | 22,44 | 40 | Counseling | 8 weeks |
Herrera, 1995 | Sweden | Healthy | ≥ 10 | NA | Gum | 2,4 | 167 | Behavioural modification program | 3 months |
Jorenby, 1995 | USA | Healthy | 27* | 1 | Patch | 22,44 | 504 | Counseling | 8 weeks |
Martin, 1995 | New Zealand | Healthy and unhealthy | 26* | 10* | Patch | 7,14,21 | 80 | Counseling | 12 weeks |
Smith, 1995 | USA | Healthy and unhealthy | 26* | 20* | Patch | 7,14,21 | 110 | Counseling | 12 weeks |
Smith, 1996 | USA | Adolescent | 23* | 2.6* | Patch | 11,22 | 22 | Counseling | 8 weeks |
Hurt, 1998 | USA | Healthy | 28* | 22* | Nasal spray | 1-2 mg/h | 50 | Counseling | 8 weeks |
Gourlay, 1999 | Australia | Healthy | ≥ 15 | ≥ 3 | Patch | 21 | 1481 | Counseling | 12 weeks |
Hays, 1999 | USA | Healthy | ≥ 15 | ≥ 1 | Patch | 22 | 315 | None | 6 weeks |
Killen, 1999 | USA | Healthy | 35* | NA | Patch | 15 or 25 | 408 | Self-treatment booklet | 6 weeks |
Hurt, 2000 | USA | Adolescent | 20* | >1 | Patch | 15 | 101 | Counseling | 6 weeks |
Shiffman, 2002 | USA | Healthy | 27* | 24* | Patch | 7,14,21 | 2367 | None | 12 weeks |
27* | 23* | Gum | 2,4 | 2981 | None | 12 weeks | |||
Croghan, 2003 | USA | Healthy | ≥ 15 | ≥ 1 | Patch, Nasal spray, Patch + Nasal spray | 15 mg/patch, 0.5 mg/spray | 1384 | Behavioural counseling | 6 weeks |
Hasford, 2003 | Germany | Healthy and unhealthy | NA | 19* | Patch | 7,14,21 | 633 | None | 12 weeks |
Carpenter, 2004 | USA | Healthy | ≥ 10 | NA | Patch | 7,14,21 | 300 | Reduction counseling | 6 weeks |
Fiore, 2004 | USA | Healthy | ≥ 10 | NA | Patch | 7,14, 21 | 1869 | With or without education program | 10 weeks |
Lerman, 2004 | USA | Healthy | ≥ 10 | 1 | Patch, Nasal spray | 0.5, 7-21 | 350 | Counseling | 8 weeks |
Schuurmans, 2004 | South Africa | Healthy | ≥ 15 | ≥ 3 | Patch | NA | 184 | None | 10 weeks |
Hughes, 2005 | USA | Healthy and unhealthy | 25* | 27* | Nasal spray | NA | 535 | None | 4 weeks |
Marsh, 2005 | Czech Republic | Medical illness | 25* | ≥ 1 | Gum, Lozenge | 4 | 901 | None | 12 weeks |
Bolliger, 2007 | South Africa | Healthy | 23* | 23* | Gum, Patch, Nasal spray | NA | 100 | Behavioural counseling | 3 months |
Aubin, 2008 | USA | Healthy | 23* | 25* | Patch | 7,14,21 | 370 | Counseling | 10 weeks |
Stapleton, 2008 | UK | Healthy and unhealthy | 21* | NA | NRT | NA | 204 | Education session | 12 weeks |
Gunnell, 2009 | Europe | Healthy and unhealthy | NA | NA | NRT | NA | 63265 | None | 12-26 weeks |
Ossip, 2009 | USA | Healthy and unhealthy | NA | NA | Gum, Patch, Lozenge | 2,7-21,2 | 65599 | None | 2 weeks |
Steinberg, 2009 | USA | Medical illnesses | >10 | >20 | Patch | 7,14,21 | 64 | None | 10 weeks |
Adverse events
RCTs (See Figure 2)
Adverse event | RCTs | References | n treatment having event | Total n in treatment | n control having event | Total n in control | OR | 95% CI | P-value | I2 |
---|---|---|---|---|---|---|---|---|---|---|
Headache | 32 | 938 | 9227 | 664 | 5988 | 0.99 | 0.84-1.17 | 0.95 | 43% | |
Dizziness | 24 | 414 | 4701 | 275 | 3518 | 1.05 | 0.86-1.29 | 0.59 | 18% | |
Heart palpitations and chest pains | 12 | 189 | 6249 | 64 | 3985 | 2.06 | 1.51-2.82 | <0.001 | 0% | |
Nausea or vomiting | 31 | 747 | 7249 | 388 | 6061 | 1.67 | 1.37-2.04 | <0.001 | 62% | |
Indigestion Gastrointestinal complaints | 26 | 930 | 8575 | 489 | 5882 | 1.54 | 1.25-1.89 | <0.001 | 35% | |
Skin irritation | 32 | 1550 | 8646 | 511 | 5497 | 2.80 | 2.28-3.44 | <0.001 | 0% | |
Arthralgia | 5 | 50 | 756 | 34 | 686 | 1.51 | 0.87-2.63 | 0.13 | 0% | |
Hiccoughs | 14 | 934 | 3858 | 573 | 3424 | 7.68 | 4.59-12.85 | <0.001 | 0% | |
Mouth and throat soreness | 23 | 935 | 3858 | 573 | 3424 | 1.87 | 1.36-2.57 | <0.001 | 66% | |
Mouth ulcers | 6 | 123 | 61 | 766 | 610 | 1.49 | 1.05-2.20 | 0.02 | 43% | |
Urticaria | 3 | 80 | 801 | 66 | 595 | 1.13 | 0.77-1.65 | 0.52 | 0% | |
Coughing | 12 | 583 | 3989 | 309 | 3893 | 2.89 | 1.92-4.33 | <0.001 | 72% | |
Insomnia | 19 | 636 | 5805 | 349 | 3504 | 1.42 | 1.21-1.66 | <0.001 | 65% | |
Sweating | 3 | 56 | 355 | 63 | 337 | 1.29 | 0.51-3.21 | 0.58 | 76% | |
Anxiety | 6 | 25 | 367 | 21 | 362 | 1.24 | 0.73-2.10 | 0.42 | 0% | |
Depression | 9 | 56 | 937 | 59 | 897 | 0.82 | 0.53-1.26 | 0.37 | 8% | |
Mortality | 8 | 11 | 1387 | 16 | 1378 | 0.74 | 0.33-1.67 | 0.47 | 0% |
Cardiovascular and respiratory
Gastrointestinal
Oral
Neurological
Dermatological
Psychological
Serious Adverse Events
Explanations of heterogeneity
Observational studies (See Figure 3)
Adverse event | Number of studies | References | N of events | Pooled n | Proportion | 95% CI |
τ
2
|
---|---|---|---|---|---|---|---|
Headache | 17 | 1472 | 75764 | 9.7 | 4.6-19.5 | 2.97 | |
Nausea or vomiting | 14 | 1902 | 74449 | 8.5 | 4.6-15.3 | 1.39 | |
Gastrointestinal complaints | 11 | 593 | 74256 | 3.9 | 1.4-10.4 | 3.02 | |
Heart palpitations | 7 | 72 | 2446 | 3.6 | 1.4-9.0 | 1.49 | |
Mouth and throat soreness | 6 | 406 | 72533 | 5.4 | 0.9-25.6 | 5.00 | |
Skin irritation | 16 | 1337 | 10356 | 19.5 | 11.5-31.1 | 1.56 | |
Hiccoughs | 4 | 375 | 71948 | 2.5 | 0.3-16.5 | 4.63 | |
Coughing | 5 | 125 | 1672 | 8.1 | 2.1-26 | 2.29 | |
Depression | 6 | 69 | 66344 | 2.6 | 0.2-27 | 10.57 | |
Anxiety | 5 | 104 | 5841 | 2.9 | 0.8-9.8 | 1.70 | |
Insomnia | 18 | 2262 | 76169 | 11.4 | 4.8-24.6 | 4.05 | |
Dizziness | 8 | 299 | 7338 | 7.3 | 3.7-13.9 | 0.94 | |
Self-harm | 1 | 141 | 63265 | 0.2 | 0-8.4 | NA |