Nicotine replacement therapy
Across 133 trials, every form of nicotine replacement raised long-term quit rates by about half against placebo or no NRT, and a patch plus a fast-acting form raised them further. Varenicline and nicotine e-cigarettes helped more people quit. Side effects were mostly local irritation, nausea and sleep changes. Serious and heart events did not clearly rise.
- Status
- In the US the nicotine patch, gum and lozenge are sold over the counter under FDA Drug Facts labels as stop smoking aids. The labels tell people under 18 to ask a doctor before use. The nicotine inhaler (Nicotrol Inhaler) and nicotine nasal spray (Nicotrol NS) are prescription drugs, labeled as aids to smoking cessation. In 2013 FDA concluded that label warnings on using OTC NRT with other nicotine products, or for longer than the labeled course, could be modified.
- Also called
- NRT, nicotine patch, NicoDerm CQ, Habitrol, nicotine gum, Nicorette gum, nicotine polacrilex, nicotine lozenge, Nicorette lozenge, Nicorette mini lozenge, nicotine inhaler, Nicotrol Inhaler, nicotine nasal spray, Nicotrol NS, combination NRT, quit smoking aids, stop smoking aid
- Taken for
- quitting smoking, cravings, nicotine withdrawal, cutting down before quitting, quitting in pregnancy, teens quitting, preventing weight gain after quitting, ulcerative colitis, Parkinson's disease, memory and focus
Strong several reviews agree · Moderate one review or consistent trials · Limited one or a few small studies · Untested no study in people, listed with what it rests on
Shown to help5
- StrongShown to raise long-term quit rates by about 55% against placebo or no NRT, about two to three extra quitters per 100, with every licensed form.
- ModerateShown to raise long-term quit rates about 27% more than one form of NRT alone, in trials of a patch plus gum, lozenge, inhaler or spray.
- ModerateShown that gum or lozenge gave quit rates similar to the patch. Higher-dose gum and 21 mg patches outperformed lower doses, and starting before quit day helped modestly.
- ModerateShown to keep its advantage over placebo for 2 to 8 years, though the extra share of ex-smokers fell from about 11 to about 7 per 100 through relapse.
- ModerateShown to raise remission of active ulcerative colitis against placebo over 4 to 6 weeks, 27% against 13%. It did not differ from prednisone or mesalamine.Very common
Reported risks10
- ModerateShown to raise mouth and throat soreness, mouth ulcers, hiccups and cough with oral forms. On the inhaler, 40% had mouth and throat irritation against 18% on placebo.Very common
- ModerateShown to raise nausea, vomiting and stomach complaints against control. On the inhaler, dyspepsia occurred in 18% against 9% on placebo.Very common
- ModerateShown to raise insomnia against control. In EAGLES, abnormal dreams were the most frequent side effect on the patch, at 12%.Very common
- LimitedThe label reports nasal irritation in 94% of spray users in the first 2 days and 81% after 3 weeks. A pepper-containing placebo also caused irritation.Very common
- LimitedThe spray label reports feelings of dependence in 32% of active users against 13% on placebo. FDA's 2013 review found no safety risks from NRT use beyond 12 weeks.Very common
- StrongShown to raise palpitations and chest pain about twofold against control, rare in both groups. Major cardiovascular events did not significantly rise.How often is not known
- ModerateShown to raise skin irritation about 2.8 times against control in patch trials. The label says to stop and ask a doctor if redness lasts over four days.How often is not known
- ModerateNot shown to change birth outcomes against control in trials. A large cohort found overall birth defects similar to smokers, with one signal for respiratory defects.How often is not known
- LimitedThe labels warn that even used patches hold enough nicotine to poison children and pets. They give no rate.How often is not known
- LimitedThe label says to ask a doctor or pharmacist before use with a prescription medicine for depression or asthma, because its dose may need adjusting.How often is not known
What people take it for, and what was found
Shown to help5
Quitting smoking
Shown to raise long-term quit rates by about 55% against placebo or no NRT, about two to three extra quitters per 100, with every licensed form.
Compared with placebo or no NRT [1][2]
The numbers and sources
- Effect
- Any NRT raised abstinence at 6 months or more against control (RR 1.55, 95% CI 1.49 to 1.61, 133 trials, 64,640 participants, high quality). By form: gum RR 1.49 (56 trials), patch 1.64 (51 trials), tablets or lozenges 1.52 (8 trials), inhaler 1.90 (4 trials) and nasal spray 2.02 (4 trials). The effect was largely independent of how much other support people received [1]. A network meta-analysis of 319 trials found the patch (OR 1.37) and fast-acting NRT (OR 1.41) raised quit rates against control, about two and three extra quitters per 100 [2].
- Population
- Adults motivated to quit, typically smoking 15 or more cigarettes a day, in 133 randomized trials [1]; 157,179 adults in 319 randomized trials, pregnant people excluded [2].
- Sources
- [1], [2]
- Caveats
- Most trials were at high or unclear risk of bias, though restricting to low-risk trials did not change the result [1]. 118 trials in [2] reported pharmaceutical or tobacco industry funding.
Using a patch and a fast-acting form together
Shown to raise long-term quit rates about 27% more than one form of NRT alone, in trials of a patch plus gum, lozenge, inhaler or spray.
Compared with a single form of NRT [3]; control, by an additive network estimate [2]
The numbers and sources
- Effect
- Combination NRT (a patch plus a fast-acting form) raised long-term abstinence against a single form (RR 1.27, 95% CI 1.17 to 1.37, I2 12%, 16 studies, 12,169 participants, high certainty) [3]. A calculated additive estimate against control was OR 1.93 (95% CrI 1.61 to 2.34) [2].
- Population
- 12,169 adults in 16 randomized trials [3]; 319 randomized trials in adults [2].
- Sources
- [3], [2]
- Caveats
- The network estimate for combination NRT was calculated from its parts, not measured directly, and its certainty was not rated [2].
Which form, which dose, and starting before quit day
Shown that gum or lozenge gave quit rates similar to the patch. Higher-dose gum and 21 mg patches outperformed lower doses, and starting before quit day helped modestly.
Compared with another form of NRT, a lower dose, or starting on quit day [3]
The numbers and sources
- Effect
- A fast-acting form and the patch gave similar long-term quit rates (RR 0.90, 95% CI 0.77 to 1.05, 8 studies, 3,319 participants, high certainty). 21 mg patches outperformed 14 mg (RR 1.48, 1 study), and 42 or 44 mg patches did not differ from 21 or 22 mg (RR 1.09). The authors report high-certainty evidence for 4 mg over 2 mg gum. Starting NRT before quit day while still smoking raised abstinence (RR 1.25, 95% CI 1.08 to 1.44, 9 studies, 4,395 participants, moderate certainty). No clear effect of patch duration was found [3].
- Population
- 43,327 participants in 68 randomized trials comparing one way of using NRT with another [3].
- Sources
- [3]
- Caveats
- 28 of 68 trials were at high risk of bias, and the preloading result weakened when they were removed [3]. The abstract does not give the gum dose estimate.
Staying quit for years
Shown to keep its advantage over placebo for 2 to 8 years, though the extra share of ex-smokers fell from about 11 to about 7 per 100 through relapse.
Compared with placebo [4]
The numbers and sources
- Effect
- At final follow-up of 2 to 8 years, abstinence favored NRT over placebo (OR 1.99, 95% CI 1.50 to 2.64). Relapse between 12 months and final follow-up was 30.0% and did not differ between NRT and placebo groups. The extra ex-smokers attributable to NRT fell from 10.7 per 100 at one year to 7.2 per 100 at an average 4.3 years [4].
- Population
- 4,792 participants in 12 placebo-controlled trials with follow-up beyond one year [4].
- Sources
- [4]
- Caveats
- One review, published in 2006 [4].
Ulcerative colitis
Shown to raise remission of active ulcerative colitis against placebo over 4 to 6 weeks, 27% against 13%. It did not differ from prednisone or mesalamine.
Compared with placebo [12]; prednisone or mesalamine [12]
The numbers and sources
- How common
- Very common: more than 1 in 10 people.
- Effect
- After 4 to 6 weeks, 19 of 71 people on a nicotine patch and 9 of 70 on placebo were in clinical remission (OR 2.56, 95% CI 1.02 to 6.45). Against prednisone or mesalamine, remission was 33 of 66 on nicotine and 34 of 63 on standard therapy (OR 0.77, 95% CI 0.37 to 1.60). People on nicotine were more likely to stop for adverse events (OR 5.82) [12].
- Population
- People with active mild to moderate ulcerative colitis in 5 randomized trials, 137 on nicotine 15 to 25 mg a day [12].
- Sources
- [12]
- Caveats
- The placebo comparison rests on 2 small trials. The review dates from 2004 [12]. Nicotine is not FDA approved for this use.
Mixed results4
Against varenicline, bupropion and e-cigarettes
Mixed results: varenicline and nicotine e-cigarettes helped more people quit than single-form NRT. Combination NRT and varenicline did not clearly differ, and the patch matched bupropion.
Compared with varenicline [5][6][2]; bupropion [5][2]; nicotine e-cigarettes [7][2]
The numbers and sources
- Effect
- Varenicline helped more people quit than a single form of NRT (RR 1.25, 95% CI 1.14 to 1.37, 11 studies, 7,572 participants), and did not clearly differ from dual-form NRT (RR 1.02, 95% CI 0.87 to 1.20, 5 studies) [6]. In the EAGLES trial, varenicline beat the 21 mg patch (OR 1.68, 95% CI 1.46 to 1.93), while the patch (OR 2.15) and bupropion (OR 2.07) each beat placebo by similar margins [5]. Nicotine e-cigarettes raised quit rates against NRT (RR 1.61, 95% CI 1.23 to 2.12, 11 studies, 4,114 participants, high certainty), about four more quitters per 100 [7]. The network meta-analysis placed e-cigarettes (OR 2.37), varenicline (OR 2.33) and cytisine above the patch (OR 1.37) and fast-acting NRT (OR 1.41) [2].
- Population
- 45,049 people in 75 trials [6]; 8,144 smokers with and without psychiatric disorders in 16 countries [5]; 29,861 participants in 80 trials [7]; 319 trials in adults [2].
- Sources
- [6], [5], [7], [2]
- Caveats
- EAGLES was funded by Pfizer and GlaxoSmithKline [5]. Heterogeneity for the e-cigarette comparison was 55% [7].
Quitting during pregnancy
Mixed results: NRT raised quitting in later pregnancy across all trials, but in placebo-controlled trials alone the effect was not significant.
Compared with placebo [8]; behavioral support only [8]
The numbers and sources
- Effect
- Across 9 trials, NRT raised abstinence in later pregnancy (RR 1.37, 95% CI 1.08 to 1.74, 2,336 women, low certainty). In the 6 placebo-controlled trials the effect was RR 1.21 (95% CI 0.95 to 1.55), and in 3 non-placebo trials RR 8.55. Adherence to NRT was generally low [8].
- Population
- 2,336 pregnant women who smoked, in 9 randomized trials of NRT with matched behavioral support [8].
- Sources
- [8]
- Caveats
- Low-certainty evidence. The authors note the effect was not evident once potentially biased non-placebo trials were set aside [8].
Weight gain after quitting
Shown to cut weight gain slightly, about half a kilogram, by the end of treatment in people who quit. At 12 months the difference was not significant.
Compared with placebo or no NRT [11]
The numbers and sources
- Effect
- Among people abstinent from smoking, NRT lowered weight gain at the end of treatment (MD -0.52 kg, 95% CI -0.99 to -0.05, 21 studies, 2,784 participants, I2 81%, moderate certainty). At 12 months the difference was -0.37 kg (95% CI -0.86 to 0.11, 17 studies, 1,463 participants) [11].
- Population
- People who stopped smoking in NRT trials reporting weight [11].
- Sources
- [11]
- Caveats
- Weight was measured only in people who stayed abstinent. The authors found no intervention with moderate certainty of a useful long-term effect on weight [11].
Memory and attention in mild cognitive impairment
One small trial found a 15 mg nicotine patch improved attention and memory tests over 6 months in nonsmokers with mild cognitive impairment, but not clinician-rated global change.
Compared with placebo patch [13]
The numbers and sources
- Effect
- The primary attention test (Connors Continuous Performance Test) improved on nicotine against placebo, as did secondary measures of attention, memory and psychomotor speed. Clinician-rated global improvement did not differ [13].
- Population
- 74 nonsmokers with amnestic mild cognitive impairment, 67 completing [13].
- Sources
- [13]
- Caveats
- A pilot trial. The authors say larger studies are needed to know if the changes matter clinically [13].
Not shown to help2
Quitting in teenagers and young people
Not shown to raise long-term quitting in smokers under 20. One review found a short-term gain at 4 weeks that did not last.
Compared with placebo or no medication [9][10]
The numbers and sources
- Effect
- In 3 trials of NRT in young people, quitting did not clearly differ from control (RR 1.11, 95% CI 0.48 to 2.58) [9]. Pooling 9 trials of quit-smoking medicines in adolescents, abstinence rose overall (RR 1.62, 95% CI 1.08 to 2.44) and at 4 weeks (RR 1.87), but not significantly at 8 to 52 weeks [10].
- Population
- Regular smokers under 20 in randomized trials [9]; 1,188 smokers aged 12 to 20 in 9 trials [10].
- Sources
- [9], [10]
- Caveats
- Few small trials and wide confidence intervals [9]. [10] pooled NRT with other medicines.
Parkinson's disease
Not shown to improve movement symptoms, daily functioning, cognition or quality of life in Parkinson's disease, short term or over 6 months or more.
Compared with placebo [14]
The numbers and sources
- Effect
- Motor outcomes did not differ from control in the short term (SMD -0.45, 95% CI -1.61 to 0.71) or at 6 months or more (SMD 0.17, 95% CI -0.44 to 0.79). Short-term daily functioning, cognition and quality of life also did not improve [14].
- Population
- 346 people with Parkinson's disease in 5 randomized trials [14].
- Sources
- [14]
- Caveats
- Heterogeneity between trials was considerable [14].
Doses studied
The over-the-counter patch label directs 21 mg a day for weeks 1 to 6, 14 mg for weeks 7 to 8 and 7 mg for weeks 9 to 10 for people smoking more than 10 cigarettes a day, and starting at 14 mg for 10 or fewer [15]. The gum label uses 4 mg for people whose first cigarette comes within 30 minutes of waking and 2 mg otherwise, one piece every 1 to 2 hours in weeks 1 to 6, tapering over 12 weeks, at most 24 pieces a day [16]. The lozenge label uses the same 2 or 4 mg split, at least 9 a day for the first 6 weeks, at most 20 a day, over 12 weeks [17]. The prescription nasal spray delivers 1 mg per dose (2 sprays), starting at 1 or 2 doses an hour, up to 40 mg a day [18]. Inhaler trials used 4 to 20 cartridges a day, each delivering about 4 mg [19]. EAGLES used a 21 mg patch with taper for 12 weeks [5]. The ulcerative colitis trials used 15 to 25 mg a day [12], and the cognitive impairment trial 15 mg a day [13].
Risks
Reported risks9
Mouth and throat irritation, hiccups and cough with gum, lozenge and inhaler
Shown to raise mouth and throat soreness, mouth ulcers, hiccups and cough with oral forms. On the inhaler, 40% had mouth and throat irritation against 18% on placebo.
The numbers and sources
- How common
- Very common: more than 1 in 10 people.
- Effect
- Oral NRT raised mouth and throat soreness (OR 1.87, 95% CI 1.36 to 2.57), mouth ulcers (OR 1.49), hiccups (OR 7.68) and coughing (OR 2.89) against control [20]. In the inhaler trials, local mouth and throat irritation occurred in 40% on the inhaler and 18% on placebo [19].
- Population
- Randomized trials of oral NRT [20]; inhaler label trials [19].
- Sources
- [20], [19]
- Caveats
- The inhaler label available is a 2011 repackager copy [19].
Nasal irritation with the nasal spray
The label reports nasal irritation in 94% of spray users in the first 2 days and 81% after 3 weeks. A pepper-containing placebo also caused irritation.
The numbers and sources
- How common
- Very common: more than 1 in 10 people.
- Effect
- Nasal irritation was reported by 94% in the first 2 days, mostly moderate or severe, and by 81% after 3 weeks, mostly moderate or mild. Runny nose, throat irritation, watering eyes, sneezing and cough were common on both active and placebo sprays. Nasal congestion, transient nosebleeds, eye irritation and changes in smell were somewhat more common on active spray [18].
- Population
- Participants in the nasal spray label trials, 730 smokers in 3 studies [18].
- Sources
- [18]
- Caveats
- The label does not give the placebo share for nasal irritation [18].
Nausea and stomach upset
Shown to raise nausea, vomiting and stomach complaints against control. On the inhaler, dyspepsia occurred in 18% against 9% on placebo.
The numbers and sources
- How common
- Very common: more than 1 in 10 people.
- Effect
- NRT raised nausea and vomiting (OR 1.67, 95% CI 1.37 to 2.04) and gastrointestinal complaints (OR 1.54, 95% CI 1.25 to 1.89) against control [20]. Dyspepsia occurred in 18% on the inhaler and 9% on placebo [19]. The patch label lists nausea, vomiting, dizziness, weakness and rapid heartbeat as signs of nicotine overdose [15].
- Population
- Randomized trials against inert control [20]; inhaler label trials [19].
- Sources
- [20], [19], [15]
- Caveats
- Rates differ by form.
Insomnia and vivid dreams
Shown to raise insomnia against control. In EAGLES, abnormal dreams were the most frequent side effect on the patch, at 12%.
The numbers and sources
- How common
- Very common: more than 1 in 10 people.
- Effect
- NRT raised insomnia against control (OR 1.42, 95% CI 1.21 to 1.66) [20]. Abnormal dreams were the most frequent adverse event on the nicotine patch, in 251 of 2,022 people (12%) [5]. The patch label says to remove the patch at bedtime if vivid dreams or other sleep problems occur [15].
- Population
- Randomized trials against inert control [20]; 2,022 people on the 21 mg patch [5].
- Sources
- [20], [5], [15]
- Caveats
- The EAGLES abstract does not give the placebo rate of abnormal dreams [5].
Dependence and long-term use
The spray label reports feelings of dependence in 32% of active users against 13% on placebo. FDA's 2013 review found no safety risks from NRT use beyond 12 weeks.
The numbers and sources
- How common
- Very common: more than 1 in 10 people.
- Effect
- Feelings of dependency were reported by 32% of nasal spray users and 13% of placebo spray users. 15% to 20% used the spray longer than the label directs and 5% at higher doses, and of 64 people abstinent at a year, 23 were still using it. The label states the spray's dependence potential lies between other NRT and cigarettes [18]. FDA reviewed published studies of NRT use over periods longer than 12 weeks and stated it had not identified safety risks, citing the Lung Health Study, where over 1,000 people still used nicotine gum after a year [22].
- Population
- Nasal spray label trials [18]; studies reviewed by FDA [22].
- Sources
- [18], [22]
- Caveats
- The dependence rate is for the nasal spray. The labels give no rate for the patch, gum or lozenge.
Skin irritation from the patch
Shown to raise skin irritation about 2.8 times against control in patch trials. The label says to stop and ask a doctor if redness lasts over four days.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- Pooled trial evidence for the patch found more skin irritation than control (OR 2.80, 95% CI 2.28 to 3.24) [20]. The Cochrane review lists skin irritation from patches among product-related adverse events [1]. The label says to ask a doctor before use with an adhesive allergy or skin problems [15].
- Population
- 32,185 participants in 92 randomized trials against inert control [20].
- Sources
- [20], [1], [15]
- Caveats
- The abstracts give odds ratios, not the share of people affected [20].
Palpitations, chest pain and heart events
Shown to raise palpitations and chest pain about twofold against control, rare in both groups. Major cardiovascular events did not significantly rise.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- Chest pain or palpitations were more common on NRT than control (OR 1.88, 95% CI 1.37 to 2.57, 15 trials, 11,074 participants), and rare in both groups [1]. A second review found OR 2.06 (95% CI 1.51 to 2.82) [20]. In a network meta-analysis of 21 NRT trials, all cardiovascular events rose (RR 2.29, 95% CI 1.39 to 3.82), driven mostly by less serious events, while major adverse cardiovascular events did not significantly differ (RR 1.95, 95% CI 0.26 to 4.30) [21]. The patch label says to ask a doctor first with heart disease, recent heart attack, irregular heartbeat or uncontrolled high blood pressure [15].
- Population
- 11,074 participants in 15 trials [1]; 92 randomized trials [20]; 63 randomized trials of quit-smoking drugs [21].
- Sources
- [1], [20], [21], [15]
- Caveats
- The confidence interval for major events was wide [21].
Poisoning in children and pets
The labels warn that even used patches hold enough nicotine to poison children and pets. They give no rate.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- The patch label states used patches have enough nicotine to poison children and pets, and to get medical help or call a Poison Control Center if one is swallowed [15]. The inhaler label states amounts tolerated by adult smokers can cause poisoning and could be fatal in children [19].
- Population
- Labeling statements [15][19].
- Sources
- [15], [19]
- Caveats
- No case counts are given in these labels.
Interactions with antidepressant and asthma medicines
The label says to ask a doctor or pharmacist before use with a prescription medicine for depression or asthma, because its dose may need adjusting.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- The patch label lists taking a prescription medicine for depression or asthma, and using a non-nicotine stop smoking drug, as reasons to ask a doctor or pharmacist first, and states the prescription dose may need to be adjusted [15].
- Population
- Labeling statement [15].
- Sources
- [15]
- Caveats
- The label names classes, not specific drugs, and gives no rate.
Mixed results1
Pregnancy
Not shown to change birth outcomes against control in trials. A large cohort found overall birth defects similar to smokers, with one signal for respiratory defects.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- In 9 trials, miscarriage, stillbirth, premature birth, birthweight, neonatal intensive care, cesarean section, congenital abnormalities and neonatal death did not differ between NRT and control. Headache, nausea and local reactions were reported [8]. In 192,498 UK children, the adjusted odds of major congenital anomalies were 1.12 (99% CI 0.84 to 1.48) after NRT against nonsmokers and 1.07 against smokers. Respiratory anomalies were higher (OR 4.65, 99% CI 1.76 to 12.25, 10 exposed cases), an absolute difference of 3 per 1,000 births [23]. The patch label says to use it in pregnancy only on a health care provider's advice, and that the risks to the child are not fully known [15].
- Population
- 2,336 pregnant women in 9 trials [8]; 192,498 children with linked mother-child records [23].
- Sources
- [8], [23], [15]
- Caveats
- Trial evidence was low certainty [8]. Women prescribed NRT had more illness, which may explain some differences [23].
Checked, no increase found3
Serious adverse events
Not shown to raise serious adverse events against placebo or no medication, with about 3% having one across treatments.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- Serious adverse events averaged 3% across treatments, and low-certainty evidence showed no clear difference between NRT and placebo or no medication [2]. Serious adverse events were extremely rare in the NRT trials [1].
- Population
- Adults in 319 randomized trials [2]; NRT trials [1].
- Sources
- [2], [1]
- Caveats
- Serious events were sparse and variably reported [2].
Depression, anxiety and other psychiatric effects
Not shown to raise moderate or severe psychiatric adverse events against placebo, in people with or without psychiatric disorders.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- In the non-psychiatric cohort, moderate and severe neuropsychiatric adverse events occurred in 2.5% on the patch and 2.4% on placebo. In the psychiatric cohort, they occurred in 5.2% on the patch and 4.9% on placebo [5]. Pooled trials found no significant rise in anxiety or depressive symptoms with NRT [20].
- Population
- 8,058 smokers in the EAGLES safety analysis [5]; randomized trials against inert control [20].
- Sources
- [5], [20]
- Caveats
- EAGLES was industry funded [5].
Using NRT while still smoking or with a second nicotine product
FDA concluded in 2013 that label warnings against using OTC NRT with cigarettes or other nicotine products were no longer needed in their old form.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- FDA reviewed the evidence and concluded that statements on concomitant use with other nicotine-containing products and on duration of use could be modified, stating they were "no longer believed to be necessary in their current form to ensure the safe and effective use" of OTC NRT. FDA took no position on whether such use is more effective [22]. Trials of starting NRT before quit day, while still smoking, found higher quit rates (RR 1.25) [3].
- Population
- Published studies reviewed by FDA [22]; 4,395 participants in 9 preloading trials [3].
- Sources
- [22], [3]
- Caveats
- This is a regulator's review of the literature, not a pooled safety analysis.
Claims tested and not found
- That a nicotine patch slows or eases Parkinson's disease. Across 5 randomized trials, motor symptoms, daily function, cognition and quality of life did not differ from control [14].
- That NRT keeps weight off a year after quitting. At 12 months, weight gain differed by -0.37 kg (95% CI -0.86 to 0.11), not significant [11].
- That NRT helps teenagers stay quit. In 3 trials in young people, quit rates did not differ from control (RR 1.11, 95% CI 0.48 to 2.58) [9].
- That the nicotine patch causes depression or anxiety. In EAGLES, moderate and severe psychiatric adverse events on the patch matched placebo, 2.5% against 2.4% in people without psychiatric disorders [5].
Related
Sources
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- Lindson N, Theodoulou A, Ordóñez-Mena JM, et al. Pharmacological and electronic cigarette interventions for smoking cessation in adults: component network meta-analyses. Cochrane Database of Systematic Reviews. 2023. https://doi.org/10.1002/14651858.cd015226.pub2
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