Table 3 Outcomes

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

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

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)

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)