https://doi.org/10.1002/14651858.CD010216.pub11
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|
Study ID |
Intervention/ comparator |
Time point |
Data |
Between-group difference[1] (↑ more AEs in EC/higher dose EC arm; ↔ equivocal; ↓ fewer AEs in EC/higher dose arm) |
|
Avila 2024 |
Nicotine EC v ONP |
4 weeks |
“Participants in the nicotine pouch group were more likely to report having a cough throughout the day and shortness of breath when exercising or walking up the stairs every day in the first week of the intervention period (N = 5 for cough and N = 6 for shortness of breath) than those in the EC group (N = 3 for cough and N = 1 for shortness of breath). The frequency of cough and shortness of breath decreased and became similar across groups by week 4.” |
↓ |
|
Baldassarri 2018 |
Nicotine EC + NRT v non-nicotine EC + NRT |
NS |
AEs only reported narratively, across whole sample. The most commonly reported side effects among all participants were cough (30%), sore throat (22.5%), increased appetite (17.5%), and vivid dreams (17.5%) (no significant differences by treatment group). |
↔ |
|
Begh 2021 |
Nicotine EC versus usual care |
2 months, n = 157 per group |
AEs by type. n reporting any AE in past 24 hr 90.4% control, 92.1% EC
|
↑ throat irritation ↓ cough ↓ headache ↑ palpitations ↓ nausea ↓ dry mouth ↑ dizziness ↓ shortness of breath ↓ stomach pain
|
|
Bonafont Reyes 2022 |
Nicotine EC v NRT |
12 weeks |
“There was a trend towards decreased dyspnea and COPD symptoms… in the EC arm compared to the NRT arm” |
↓ |
|
Caponnetto 2013* |
Nicotine EC v non-nicotine EC |
3 and 12 months |
No difference in frequency of AEs between groups. 5 most frequently reported at baseline: cough (26%), dry mouth (22%), shortness of breath (20%), throat irritation (17%), and headache (17%). In all groups the frequency of AEs decreased significantly over time, with the exception of throat irritation. |
↔ |
|
Edmiston 2022* |
Nicotine EC (comparison of flavours) v behavioural support only |
12 weeks |
“33 total AEs were reported by 13 test 1 subjects; 3 subjects in test 1… experienced an AE definitely related to study product” (no breakdown by group)
|
NE |
|
Felicione 2019 |
Nicotine EC v non-nicotine EC |
4 weeks |
Total n = 25. Number of participants reporting: headaches (n = 8), throat irritation (n = 6), nausea (n = 4), dry mouth (n = 3), coughing (n = 3), dizziness (n = 2), shortness of breath (n = 2). 52% of participants reported one of these effects during intervention period. Compared frequency between groups: “items with the largest effect sizes included throat irritation (p=.12, OR = 5.6) and headache P = .10; OR = 4.5). Other side effect items revealed small effect sizes, with ORs ranging from 0.04 to 1.7 (Ps = 0.10 to 0.86).” |
↑ throat irritation ↑ headache |
|
Hajek 2019 |
Nicotine EC v NRT |
Weeks 1 to 6 |
Only prespecified outcomes collected. Shortness of breath: 21% EC; 22.9% NRT. Wheezing 23.5% EC; 21.1% NRT. Cough 30.8% EC; 39.8% NRT. Phlegm 25.1% EC; 36.9% NRT. Nausea: 31% EC; 38% NRT. Throat/mouth irritation: 65% EC; 51% NRT. Sleep disturbances 64% EC; 68% NRT. Of these SEVERE: nausea 6.6% EC; 6.5% NRT. Throat/mouth irritation 5.9% EC, 3.8% NRT. Sleep disturbances 13% in both arms. |
Shortness of breath ↓ Wheezing ↑ Cough ↓ Phlegm ↓ Nausea↓ Throat/mouth irritation ↑ Sleep disturbances ↓ |
|
Kimber 2021 |
Nicotine EC (comparisons by nicotine level and device type) |
2 weeks |
“There was no main effect of time on the overall adverse effects reported following EC use in the lab sessions, F(1.51, 70.92) = 0.875, p = .394, ƞ2p = .018, no main effect of condition F(2, 47) = 0.864, p = .428, ƞ2p = .035, no significant time X condition interaction F(3.02, 70.92) = 0.636, p = .595, ƞ2p = .026…For the overall adverse effects, there were no changes over time or differences between conditions.”
|
↔ |
|
Kumral 2016 |
Nicotine EC v behavioural support only |
3 months |
Only measured sinonasal symptoms. SNOT 22 (lower = better) Significant declines in both groups between baseline and 3 months with significantly lower scores in non-EC group at 3m (P = 0.0001) |
Sinonasal symptoms ↑ |
|
Lucchiari 2022 |
Nicotine EC v non-nicotine EC[2] |
6 months |
6 months; N = 52 nicotine; 51 non-nicotine. Burning throat: 15.9% nicotine; 5.6% non-nicotine. Cough 5.8% nicotine, 2.8% non-nicotine. Nausea 5.8% nicotine, 7% non-nicotine. Headache 0% nicotine; 1.4% non-nicotine. Insomnia 1.4% nicotine; 0 non-nicotine. Stomach ache 4.3% nicotine; 4.2% non-nicotine. Confusion 1.4% nicotine; 0 non-nicotine.
12 months: denominators unclear. Burning throat: 7.8% nicotine; 1.2% non-nicotine. Cough 3.8% nicotine, 0% non-nicotine. Nausea 4.1% nicotine, 5% non-nicotine. Stomach ache 4.3% nicotine; 4.5% non-nicotine. |
Burning throat 6m ↑; 12m ↑ Cough 6m ↑; 12m ↑ Nausea 6m ↓; 12m ↔ Headache 6m ↓ Insomnia 6m ↑ Stomach ache 6m ↔; 12m ↔ Confusion 6m ↑ |
|
Ozga-Hess 2019 |
Nicotine EC v combustible cigarettes |
4 weeks |
Participants were asked to rate throat irritation, cough, dry mouth, nausea, and dizziness on scale of 0 - 100 (high score = more serious). Throat irritation: 37.4 (32.2) EC, 30.87 (28.8) TC. Cough 44.7 (32.2) EC, 40.2 (32.2) TC. Dry mouth: 46.9 (30.3) EC, 41.8 (31.3) TC. Comparison not provided for nausea and dizziness, but authors state: “The effects of nausea (56.2% vs. 65.8-75.3%, respectively) and dizziness (56.9% vs. 63.6-74.7%, respectively) were reported on slightly fewer days for ECIG+OB participants who made the choice to quit, relative to other subgroups (p’s < .05).” |
Throat irritation ↑ Cough ↑ Dry mouth ↑ |
|
Pratt 2022 |
Nicotine EC v behavioural support only |
26 weeks |
Average number of symptoms 1.9 (SD 2.2) in EC group and 2.1 (SD 2.0) in control. No statistically significant between group difference. |
↔ |
|
Pope 2024 |
Nicotine EC v behavioural support only |
26 weeks |
In the EC arm 136 of 310 participants (43.9%) experienced dry cough, and 104 of 310 participants (33.5%) experienced throat & mouth irritation. In the referral information arm 138 of 292 (47.2%) participants experienced dry cough, and 117 of 293 participants (33.5%) experienced throat & mouth irritation |
Dry cough ↔ Throat & mouth irritation ↔ |
|
Pulvers 2020 |
Nicotine EC v combustible cigarettes |
2, 6 weeks |
Respiratory symptoms as measured with the American Thoracic Society Questionnaire “The e-cigarette group had significantly greater reductions in …respiratory symptoms (RR, 0.63 [95%CI, 0.47-0.85]; P = .002) …than the cigarettes as usual group.” |
↓ |
|
Tseng 2016 |
Nicotine EC v non-nicotine EC |
1 and 3 weeks |
“Reported side effects”: 34.1% for intervention and 17.5% for placebo group at week 1 (P = .09); 22.5% for intervention and 10.3% for placebo group at week 3 (P = .14). “Common side effects included mouth or throat irritation, cough, insomnia or difficulty sleeping, abnormal dreams, headache and fatigue.” |
↑ |
|
Tuisku 2024 |
Nicotine EC v varenicline v placebo |
52 weeks |
AEs leading to discontinuation of a study treatment: EC 15 (9.9%), Varenicline 27 (17.6%), placebo 14 (9.2%). |
Vs varenicline ↓ Vs placebo ↔ |
|
Yingst 2020 |
Nicotine EC (36 mg/ml; refillable) versus nicotine EC (24 mg/ml; cig-a-like) |
3 weeks |
N = 17. Score range 0 (not at all) to 10 (extremely) Dizziness: 0.9 (1.4) refillable; 0.7 (1.0) cig-a-like Nausea 0.5 (1.1) refillable; 0.5 (1.1) cig-a-like |
Dizziness ↑ Nausea ↔ |
[1] Where specified; NE = non estimable
[2] Third non EC arm did not have AE data collected