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Table 3 Outcomes

From: Smoking cessation in severe mental ill health: what works? an updated systematic review and meta-analysis

  Change in BMI Change in psychiatric symptoms Adverse events Quit rate (%) intervention (I) control (C)
Complex interventions
Baker 2006 [18, 38] (including data from Baker 2010) Not reported Time-points: 4 months, 7 months, 13 months
CDI: significantly lower score for intervention group p < 0.001 at all time-points
BPRS: not significant at any time point
SF-12 (mental): significantly lower score for intervention group p < 0.001 at all time-points
STAI: significantly lower for intervention group p < 0.001 at 7 months
Not reported 4 months
I: 22/147 (15.0) C: 9/151 (6.0)
7 months
I: 14/147 (9.5) C: 6/151 (4.0)
13 months
I: 16/147 (10.9) C: 10/151 (6.6)
4 years
I: 13/147 (8.8) C: 17/151 (11.3)
Baker 2015 [32] Not reported Time point 3.75, 12 months
BPRS, BDI, GAF, SF-12 not significant
Not reported 3 months
I: 13/122(10.7) C: 13/113 (11.5)
12 months
I: 8/122 (6.6) C: 7/113 (6.2)
George 2000 [12] Not reported Time-points: 3 months, 8.5 months
AIMS, BDI, PANSS, WEPS: not significant
Not reported 3 months
I: 10/28 (35.7) C: 6/17 (35.3)
8.5 months
I: 3/28 (10.7) C: 3/17 (17.6)
Gilbody 2015 [33] Change in BMI not reported. Mean BMI at baseline and 12 month reported. Time points 1,6,12 months
PHQ-9, EQ-5D, SF-12 mental reported but not tested for significance
21 events of which 12 SAEs, 10 in intervention 2 in usual care 12 months
I: 12/33 (36.3) C: 8/35 (22.9)
Smith 2015 [34] Not reported Time point after final session
PANSS and PYCHRATS no significant differences
15 AEs in active treatment arm and 16 in sham treatment arm Abstinence not reported
Steinberg 2003 [15] Not reported Not reported Not reported Abstinence not reported
Steinberg 2016 [36] Not reported Not reported Not reported 1 month
I: 8/49 (16.3) C: 5/49 (10.2)
Williams 2010 [23] Not reported Time-point 3 months
BDI and PANSS positive and negative not significant
Not reported 3 months
I: 7/45 (15.6) C: 11/42 (26.2)
6 months
I: 7/45 (15.6) C: 8/43 (18.6)
12 months
I: 6/45 (13.3) C: 6/43 (14.0)
Wing 2012 [28] Not reported No detail on secondary outcomes given Not reported Abstinence not reported
Bupropion studies
Evins 2001 [13, 16] (including data from Evins 2004)   Time-points 3 months, 6 months
AIMS, SANS, SAS: not significant
BPRS (total): significant decrease intervention group 0–3 months (p = 0.03) and 3–6 months (p = 0.02)
BPRS (+ve symptoms): significant decrease intervention group 0–3 months (p = 0.03). Not significant 3-6 m.
HAM-D: significant increase for placebo group 0–3 months (p < 0.01). Not significant 3-6 m.
HAS: not significant
No adverse events 1 months I: 3/9 (33.3) C: 1/9 (11.1)
3 months
I: 1/9 (11.1) C: (0/9) (0.0)
6 months
I: 1/9 (11.1) C: 0/9 (0.0)
24 months
I: 2/9 (22.2) C: 2/9 (22.2)
Evins 2005 [17] Not reported Time-points 3 months
Barnes Akathisia Scale: not significant
HAM-A, HAM-D, SANS, SAS, WEPS, PANSS (total): not significant
PANSS (subscale); significant increase in excitement score placebo versus intervention group (P = 0.017)
Significant decrease cognitive score intervention versus placebo (P = 0.029)
Other subscales not significant
3 events requiring withdrawal, 1 in the intervention, 2 group unknown 1 months
I: 9/25 (36.0) C: 2/28 (7.0)
3 months
4/25 (16.0) c: 2/28 (0.0)
3.5 months
I: 2/25 (8.0) C: 1/28 (3.6)
6 months
I: 1/25 (4.0) C: 1/28 (3.6)
Evins 2007 [19] Not reported Time-points: 3 months
AIMS, BDI, SANS, STAI, HAM-D, PANSS: not significant
Barnes Akathisia Scale: significantly lower in intervention group (P = 0.005)
SAS: significantly lower score in the intervention group (P = 0.016)
No SAEs 2 months*
I: 13/25 (52.0) C:5/26 (19.2)
3 months*
I: 9/25 (36.0) C: 5/26 (19.2)
6 months*
I: 5/25 (20.0) C: 2/26 (7.7)
15 months*
I: 3/25 (12.0) C: 2/26 (7.7)
Fatemi 2013 [30] Not reported Time point: 3 months
Significant positive correlation between serum cotinine levels and BPRS total score (p = 0.014), BPRS +ve subscale score (p = 0.002), SAPS total composite score (p = 0.02) and SAPS delusion subscale score (p = 0.013)
Not fully reported Abstinence not reported
George 2002 [14] Not reported Time-points 2.5 months, 8.5 months
AIMS, BDI, WEPS: not significant
PANSS: significant decrease in intervention group for negative symptoms (P < 0.05; general positive subscales not significant
Not reported 2.5 months
I: 8/16 (50.0) C: 2/16 (12.5)
8.5 months
I: 3/16 (18.8) C: 1/16 (6.3)
George 2008 [21] Not reported Time-points: 2.5 months, 6.75 months
BDI, PANSS: not significant
No SAEs 2.5 months
I: 10/29 (34.5) C: 3/29 (10.3)
6.75 months
I: 4/29 (13.8) C: 0/29 (0.0)
Weinberger 2008 [22] Not reported No details given on secondary outcomes Not fully reported 2.5 months
I: 1 /2 (50.0) C: 0/3 (0.0)
Weiner 2012 [26] Not reported Time-points: 2 weeks, 1 month, 2 months and 3.5 months
BPRS, SANS: not significant
5 SAEs in the intervention group and 2 in the placebo group 3.5 months
I: 8/24 (33.3) C: 3/22 (13.6)
Tidey 2011 [24] Not reported Time-points 1,2, 3, 4 weeks
PANSS, UPDRC ad AIMS not significant
Not fully reported incidence of specific AEs reported but not all Abstinence not reported
Varenicline studies
Chengappa 2014 [31] Mean weight gain Time-points 3, 6 months
Scores for MADRS, YMRS, HARS and CGI reported but not tested for significance.
6 SAEs in the intervention group and 4 in the placebo group 3 months
I: 15/31 (48.4) C: 3/29 (10.3)
6 months
I: 6/31(19.4) C: 2/29 (6.9)
Smith 2016 [35] Not reported Time-point 8 weeks
Scores for PANSS, and SANS not significant when corrected for multiple comparisons.
Comparisons made between number of AEs in both groups. Concluded that no AE involving emergent psychiatric symptoms could be attributed to varenicline. 8 weeks
I:7/42 (16.7) C: 4/45 (8.9)
Weiner 2011 [25] Not reported Time-points 3 months
BPRS +ve items, anxiety/depression not significant
8 side effects in the intervention group 2 in the placebo group 4 months
I: 3 /4 (0.75) C: 0/4 (0.0)
Williams 2012 [27] Not reported Time-points: 3, 6 months
PANSS not significant
9 SAEs in the intervention group and 4 in the placebo group 3 months
I: 16/84 (19.0) C: 2/43 (4.7)
6 months
I: 10/84 (11.9) C: 1/43 (2.3)
Wu 2012 [37] Not reported Time-points 2.5 months
Psychiatric symptoms not significantly changed
Not fully reported 2.5 months
I: 1/3 (33.3) C: 0/2 (0.0)
6 months
I: 0/3 (0.0) C: 0/2 (0.0)
NRT studies
Chen 2013 [29] Not reported Time-points: 2 months
PANSS, SAS not significant
Not reported 2 months
I: 1/92 (1.1) C: 4/92 (4.3)
I = high dose C = low dose
Dalak 1999 [11] Not reported Time-points: day 2
AIMS: significantly increased score intervention group day 2 (p < 0.05)
BPRS, HAM-D, SANS, SAS: not significant
Assessment for signs of nicotine toxicity none reported Abstinence not reported
Gallagher 2007 [20] Not reported Time points 5, 9 months
BSI not significant
Not reported 5 months
Ia**: 23/60 (38.3) Ib***: 25/60 (41.7) C: 3/60 (5.0)
8.5 months
Ia: 22/60 (36.7) Ib: 26/60 (43.3) C: 5/60 (8.3)
  1. **Ia = contingent reinforcement *** Ib = Contingent reinforcement plus NRT