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Table 2 Adverse events reported in RCTs

From: Adverse events associated with nicotine replacement therapy (NRT) for smoking cessation. A systematic review and meta-analysis of one hundred and twenty studies involving 177,390 individuals

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

[27, 33–35, 41, 43–45, 48, 50, 51, 55, 57, 58, 61, 64, 68, 71, 74–76, 85, 90, 94, 95, 103, 115, 117]

938

9227

664

5988

0.99

0.84-1.17

0.95

43%

Dizziness

24

[37–39, 41, 45–48, 51, 53, 58, 60, 64, 72, 73, 78, 92, 96, 117, 119]

414

4701

275

3518

1.05

0.86-1.29

0.59

18%

Heart palpitations and chest pains

12

[32, 44, 45, 50, 57, 61, 68, 71, 74, 75, 102, 116]

189

6249

64

3985

2.06

1.51-2.82

<0.001

0%

Nausea or vomiting

31

[24, 27, 31, 37–39, 45–48, 51, 53, 56, 58, 59, 62, 68, 71, 74–76, 85, 90, 94, 95, 103, 115]

747

7249

388

6061

1.67

1.37-2.04

<0.001

62%

Indigestion Gastrointestinal complaints

26

[27, 28, 32, 35, 37, 42, 43, 45, 51, 58, 63, 68, 70, 71, 80, 84, 85, 90, 94, 95, 105, 116, 117]

930

8575

489

5882

1.54

1.25-1.89

<0.001

35%

Skin irritation

32

[39–41, 43, 45, 47, 48, 51, 53–55, 58, 59, 61, 64, 66, 68–72, 74–77, 87, 90, 93, 94, 102, 105, 117]

1550

8646

511

5497

2.80

2.28-3.44

<0.001

0%

Arthralgia

5

[43, 45, 61, 70, 90]

50

756

34

686

1.51

0.87-2.63

0.13

0%

Hiccoughs

14

[27, 32, 34, 35, 37, 38, 63, 80, 83, 84, 94, 95, 117]

934

3858

573

3424

7.68

4.59-12.85

<0.001

0%

Mouth and throat soreness

23

[27, 31–35, 37, 42, 44, 46, 50, 57, 63, 67, 78, 80, 84, 85, 94–96, 117]

935

3858

573

3424

1.87

1.36-2.57

<0.001

66%

Mouth ulcers

6

[27, 33–35, 63, 84]

123

61

766

610

1.49

1.05-2.20

0.02

43%

Urticaria

3

[48, 70, 90]

80

801

66

595

1.13

0.77-1.65

0.52

0%

Coughing

12

[44, 50, 57, 63, 67, 78, 79, 83, 84, 94, 116]

583

3989

309

3893

2.89

1.92-4.33

<0.001

72%

Insomnia

19

[27, 28, 32, 35, 37, 42, 43, 45, 51, 58, 63, 68, 70, 71, 80, 84, 85, 90, 94, 95, 105, 116, 117]

636

5805

349

3504

1.42

1.21-1.66

<0.001

65%

Sweating

3

[44, 50, 57]

56

355

63

337

1.29

0.51-3.21

0.58

76%

Anxiety

6

[71, 76, 94, 103, 115]

25

367

21

362

1.24

0.73-2.10

0.42

0%

Depression

9

[43, 45, 58, 64, 71, 94, 102, 103, 115]

56

937

59

897

0.82

0.53-1.26

0.37

8%

Mortality

8

[73, 82, 85, 93, 97, 105, 113, 115]

11

1387

16

1378

0.74

0.33-1.67

0.47

0%