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Supplementary materials:

Legend: Supplementary Table 1. Summary of studies reporting continuous variables before and after.

Supplementary Table 2: Pooled mean differences (MD) for metabolic and weight loss outcomes in RCTs and observational studies.

Supplementary Table 3. Summary of weighted mean baseline and outcome values of primary outcomes and % decrease from baseline after IGB therapy.

Supplementary Figure 1. Meta-regression of baseline FBG on change in fasting glucose.

Supplementary Figure 2. Effect of IGB therapy on weight loss parameters.

Supplementary Figure 3 and 4. Funnel Plots and Eggers test

Supplementary Table 4 A and B: Quality Assessment of Studies

Supplementary Table 5 and 6. Adverse events summary and by study

Supplementary Figure 5: Forest plots for resolution of metabolic comorbidities.

Supplement 5: Comments on study characteristics

Supplementary Table 7: Search strategy

Main figures/tables:Table 1. Study characteristocsTable 2. Summary of meta-analyses for each outcome for RCTs with assessment of quality. Table 3. Baseline BMI and fasting glucose(FBG) had an impact on metabolic outcomes but did not affect weight loss. Sensitivity analysis for the main outcomes from observational studies. Table 4: Improvement or resolution in metabolic parameters

Figure legends:Figure 1. Study selection diagram.Figure 2. IGB treatment improved metabolic parameters. It decreased FBG to a greater extent than controls (A) in RCTs, in observational studies (B) and decreased HbA1C (D). In observational studies, greater decreases in HbA1C with IGB treatment are seen in studies with higher baseline HbA1C (C). Baseline HbA1C could explain 74% of the variability in A1C results.

First Author N analyzed BMI Waist Circumference Systolic BP Diastolic BPBefore After Δ Before After Δ Before After Before After

Al Kahtani, Khan [39] 140 46.7 (14.1) 43.1

(13.1)Albuquerque, Sarmento [46] NR 55.8±8.8 NR

Benamouzig, Uzzan [40] 67 36.6 (3.3) 32.2 (4)

Busetto, Enzi [47] 17 55.8 (9.9) 48.6

(11.2) 156.4 (17.6) 136.7 (18.4)

Chan, Chow [36]

6 cases12 controls

35.7 (NR)28 (NR)

33.6 (NR)28.1 (NR)

Crea, Pata [41] 138 36.2 (5.7) 29.6 (4.6)Donadio, Sburlati [48] 40 44.8 (8.9) 38.9 (6.8) 125.9 (18.7) 115.8 (17) 129.3 (14) 126.3

(10.4)82.2 (8.4) 82.8 (6.9)

Farina, Baratta [24]

30 cases20 controls

42.3±141±1.3

NRNR

125.8 (2.4)123.1 (3.2)

126.2 (2.1)123.2 (2.2)

80.8 (1.7)82.7 (1.9)

Forlano, Ippolito [49] 120 43 (8) 38 (8)

Folini[25] 13 cases16 controls

43.3(5.7)41.1(8.7)

38.5(4.9)40.1(10.6)

128(10.4)123(16.1)

117(9.3)124(21.4)

Fuller, Lau [26],x 31 cases35 controls

36 (2.7)36.7 (2.9)

5.1 (NR)1.7 (NR)

115.4 (10.9)115.2 (8.8)

13.1 (36)4.8 (36.7)

133.7 (10.1)129.6 (13.2)

86 (6.3)83 (7.3)

Konopko-Zubrzycka, Baniukiewicz [29]

21 cases15 controls

47.3 (5.7)47.1 (6.9)

133.3 (15.7)135.2 (14.9)

Lee, Low [30] 8 cases10 controls

30.3 (5.7)32.4 (9.1)

28.7 (8.1)31.6 (9.5)

Lorenzo, Boccia [50] 15 42.5 (5.3) 34.2 (4.9) 210 (60) 160 (40) 55 (15) 35 (10)

Mafort, Madeira [51] 40 39.1 (2.1) 34.5 (2.5) 113 (3.4) 105 (4.5) 137 (5.3) 126 (4.5) 78.5 (4) 74.5 (2.8)

Mariani 22 cases10 controls

41.8 (6.3)39.0 (6.9)

35.3 (7.2)35.5 (6.8)

129.6 (15.0)117.8 (6.3)

119 (13.5)112 (10.4)

Martinez-Brocca, Belda [31]

10 cases11 controls

50.2 (9.6)51.3 (6.1)

45.7 (9.7)48.2 (7.8) 135.1 (15.8)

133.1 (14.4)Mathus-Vliegen and Eichenberger [32]

7 cases12 controls

43 (5.5)43.2 (7.1)

38.5 (4.9)39.4 (7.2)

4.6 (1.9)3.7 (2)

Mathus-Vliegen and de Groot [33]

19 cases23 controls

43 (5.5)43.6 (7.6)

NRNR

Mathus-Vliegen and Tygat [34] 19 cases

23 controls43.0 (1.26)43.6 (1.58)

38.4 (1.12)

29.8 (1.52)

124.9 (2.69)125.8 (3.06)

113.7 (2.36)

116 (3.05)

Mion, Napoleon [52] 15 NR NR 3.1 (0.7)

Mirosevic, Nikolic [27]

20 obese23 morbidly

obese37.7 (NR)44.6 (NR)

33.1 (NR)39.7 (NR)

Mohammed, Anwar [35]

80 cases40 controls

47.87 (1.08)47.46 (1.85)

42.92 (4.2)

140.2 (5.32)138.1 (9.5)

120.98 (5.6)

46.25 (3.7)

135.1 (9.22)

Mui, Ng [42] 119 38.4 (8.0) 33.8 (7.9) 4.6 (2.7) 117.7 (17.6) 107 (18.4) 145.4 (19.7) 133.2 (20.9)

84.3 (12.6) 78.8 (15.4)

Nikolic, Mirosevic [53] 32 41.4 (7.4) 35.6 (5.2) 4.5 (NR) 122 (21) 110 (14.3)

Ponce 187 cases139 controls

35.3 (2.8)35.4 (2.6)

43.3 (4.4)43.2 (4.4)

40.4 (2.6)41.2 (3.7)

130.4 (13.9)133.2 (14.0)

122 (15.6)127 (13.6)

81.8 (10.1)82.8 (10.2)

77.5 (10.7)80.4 (10.1)

Ricci, Bersani [43] 93 42.1 (5.8) 37.8 (5.5)

Sekino, Imajo [54] 8 44* (4.3)Stimac, Majanovic [44] 165 41.6 (7.5) 35.8 (7.9) 5.8 (NR) 127.8 (16.7) 113.3

(18.9)130.9 (14.5) 124.2

(14.1)85.9 (9.5) 81.9 (10.5)

Succurro, Ruffo [55],x 10 NR NR

Tai, Lin [57] 28 32.4 (3.7) 28.5 (3.7) 101.9 (8.9) 90.6 (9.3) 136.8 (14.3) 125.9 (11.5)

84 (13.4) 76.1 (9.8)

Takihata, Nakamura [37] 8 cases

8 controls45.2 (5.9)

48.5 (10.4)

41 (6.2)42.2 (10) 129.2 (8.3)

121.5 (17.9)

123.8 (12.3)108.1 (16.9)

Tayyem, Obondo [45] 17 61.4 (8) 53 (8) 133.6 (15) 128 (8) 83.7 (7.9) 79 (4)

Zerrweck, Maunoury [38]

23 cases37 controls

65 (3.8)66.6 (6.7)

60.5 (4.3)66.3 (6.8)

146.4 (20.1)146.9 (22.6)

130 (16.2)?

72.9 (13.6)78 (11)

66.6 (9.6)?

First Author N analyzed Fasting Blood Glucose HA1C LDL TgBefore After Before After Before After Before After

Al Kahtani, Khan [39] 140 136.8 (73.8) 142.2 (100.8) 121.4

(34.8)109.8 (27.1)

Albuquerque, Sarmento [46] NRBenamouzig, Uzzan [40] 67 90.4 (8.3)

Busetto, Enzi [47] 17Chan, Chow [36]

6 cases12 controls

8.6 (NR)9 (NR)

7.3 (NR)9 (NR)

Crea, Pata [41] 138 7.5 (2.1) 5.7 (1.9)Donadio, Sburlati [48] 40 93.6 (12.7) 88.9 (10.4) 5.4 (0.5) 5.3 (0.4) 134.1 (67.8) 118.8 (66.5)


30 cases20 controls

100.4(41.4)93.9(36)

131.7 (12)110 (12.3)

Follini 13 cases16 controls

93.8(18.6) 90.2(9.6) 6.6(1.2)6.7(1.4)

6.0(0.7)

Forlano, Ippolito [49] 120 99.3 (22.9) 89.6 (18.6) 154.1 (70.5) 126.2 (52.8)

Fuller, Lau [26],x

31 cases35 controls

100.8 (18)111.6 (37.8)

131.5 (38.7)119.9 (38.7)

194.9 (106)168.3 (89)


21 cases15 controls

109.7 (27.3)93.7 (10.7)

92.2 (10.6)98.5 (11.3)

Lee, Low [30]8 cases

10 controls

144.2 (59.6)109.1 (15.5)

119.6 (61.1)137.3

(145.3)

Lorenzo, Boccia [50] 15Mafort, Madeira [51] 40 98.5 (4.4) 90 (2.8) 141 (28.8) 101 (16)

Mariani 22 cases10 controls

95.9 (16.5)93.5 (12.1)

89.4 (8.9)91.4 (13.6)

5.6 (0.3)5.6 (0.4)

5.4 (0.3)5.2 (0.3)

120 (26.9)110.6(23.2)

129.8(39.4)109.2(26.1)

140.7(112)112.6(40.8)

106.5(60)111.1(36.8)


10 cases11 controls

Mathus-Vliegen and Eichenberger [32]

7 cases12 controls

115.56 (49.32)111.42 (21.06)

160.3 (93.0)134.6 (73.5)

160.3 (93.0)134.6 (73.5)


19 cases23 controls

115.56 (49.32)110.16 (20.52)

110.7 (15.84)104.8

(15.842)Mathus-Vliegen and Tygat [34]

19 cases23 controls

Mion, Napoleon [52] 15Mirosevic, Nikolic [27]

20 obese23 morbidly

99 (NR)?

90 (NR)?

4.9 (NR)?

4.6 (NR)?

137.28 (NR)

97.43 (NR) 137.3 (NR) 97.4 (NR)

obeseMohammed, Anwar [35]

80 cases40 controls

160.2 (14.2)161.4 (12.3)

125.4 (12.3)162.4 (18.4)

70.8 (10.8)68.2 (10.9)

Mui, Ng [42] 119 109.8 (36) 95.4 (30.6) 7.4 (1.6) 5.8 (0.7) 150.6 (88.6) 115.1 (62.0)Nikolic, Mirosevic [53] 32 95.4 (14.4) 90 (10.8) 4.7 (0.5) 4.6 (0.5) 127.6

(34.8)116.0 (34.8) 124.0 (88.6) 124.0

(115.1)Ponce 187 cases

139 controls93.15 (23.3)99.37 (24.6)

92.83 (16.12)95.91 (24.64)

5.7 (0.7)5.7 (0.9)

5.44 (0.5)5.52 (0.6)

141 (87)137 (88)

135 (61)134 (72)

Ricci, Bersani [43] 93Sekino, Imajo [54] 8 112 (47) 99.5 (41.5) 5.7 (1.25) 5.45 (1.1) 101 (24.75) 109.5 (16.5) 132.5

(146.3)155.5 (53.8)

Stimac, Majanovic [44] 165 93.6 (19.8) 82.8 (14.4) 115.6

(30.9)116.0 (30.9) 118.7 (87.7) 81.5 (66.4)

Succurro, Ruffo [55],x 10 118 (31) 91 (4)

Tai, Lin [57] 28 93.5 (31.5) 91 (10.3) 149* (49) 88.5* (39.75)

149* (49) 88.5* (39.8)

Takihata, Nakamura [37] 8 cases

8 controls

150 (70.92)145 (81)

125.82 (54.9)123.84 (72.9)

6.7 (1.43)6.76

(1.46)

6.38 (1.49)

6.2 (1.45)

124.9 (27.8)104.0 (30.2)

124.1 (17.0)100.9 (22.8)

186 (159)221.4 (197)

133.7 (52.3)150.6 (80.6)

Tayyem, Obondo [45] 17 113.4 (18) 93.6 (18) 6.1 (1) 5.3 (0.8) 108.3

(27.1)81.2 (27.1) 248.0

(150.6)141.7 (26.6)


23 cases37 controls

115.2 (32.4)115.2 (39.6)

122.4 (50.4)?

6.6 (1.3)6.6 (1.1)

6.3 (1)

First Author N analyzed ALT CRPBefore After Before After

Al Kahtani, Khan [39] 140Albuquerque, Sarmento [46] NR 16.5 (12.1) 11.8 (10.1)

Benamouzig, Uzzan [40] 67Busetto, Enzi [47] 17Chan, Chow [36]

6 cases12 controls

Crea, Pata [41] 138Donadio, Sburlati [48] 40 30.7 (14) 23.4 (9.3)


30 cases20 controls

Follini 13 cases16 controls

26(11.6)44.5(30.3)

17.4(6.8)42.2(54.9)

Forlano, Ippolito [49] 120 39.3 (25.6) 24.4 (10)

Fuller, Lau [26],x 31 cases35 controls

Konopko- 21 cases

Zubrzycka, Baniukiewicz [29]

15 controls

Lee, Low [30] 8 cases10 controls

97 (34)83.5 (54)

Lorenzo, Boccia [50] 15Mafort, Madeira [51] 40Martinez-Brocca, Belda [31]

10 cases11 controls


7 cases12 controls


19 cases23 controls

Mathus-Vliegen and Tygat [34]

19 cases23 controls

Mion, Napoleon [52] 15Mirosevic, Nikolic [27]

20 obese23 morbidly

obeseMohammed, Anwar [35]

80 cases40 controls

Mui, Ng [42] 119 6.9 (6.5) 5.1 (6.5)Nikolic, Mirosevic [53] 32Ricci, Bersani [43]

65 Fatty Liver28 non FL

31.5 (29)21 (16.25)

24 (16)16.5 (13)

Sekino, Imajo [54] 8 52.5 (43) 25 (36.5)

Stimac, Majanovic [44] 165 30 (23.3) 27 (17)

Succurro, Ruffo [55],x 10Tai, Lin [57] 28 49* (45.3) 22* (23.3)Takihata, Nakamura [37]

8 cases8 controls

32 (26.7)57.1 (55.6)

18 (11.3)43.1 (48.8)

Tayyem, Obondo [45] 17 13.9 (6.8) 9.9 (3.4)


23 cases37 controls

43.8 (31.9)35.4 (43.9)

29.1 (13.5)?

Supplementary Table 1. Main outcomes summary by study.

Comparison Mean Differen

ce

95% CI No. of studies

(subjects)

I2 Tau2 Q P

Metabolic Outcomes, RCTFBG, mg/dL -12.7 - 21.5, -4 5(555) 94% 77 85 <0.001HbA1c, % -1.1 -1.6, -0.6 3 (63) 3% 0.007 2 <0.001TG, mg/dL -19 -41.6, 3.5 2(361) 88% 312 16 0.1SBP, mm Hg -3.4 -8.5, 1.7 2(361) 94% 19 36.6 0.2DBP, mmHg -2.9 -4.1, -1.8 2(361) 0% 0 1.9 0.001Waist Circ, cm -4.1 -6.9, -1.4 8(679) 91% 11 90 0.003Metabolic Outcomes, Observational studiesFBG, mg/dL -8 -11, -5 18(768) 71% 24 59 <0.001HbA1C, % -0.6 -1.0, -0.3 12(470) 95% 0.3 210 <0.001LDL, mg/dL -7 -14, 0.01 8(330) 67% 64 22 0.05TG, mg/dL -33.4 -42, -25 12 (660) 59% 105 27 <0.001SBP, mmHg -9.1 -12, -6.5 10(484) 78% 11 40 <0.001DBP, mmHg -4.6 -6, -3 9(467) 67% 3 25 <0.001ALT, U/L -9 -12, -5.2 10(531) 71% 21 34 <0.001AST, U/L -3 -6, -0.1 7(305) 74% 7.5 23 0.04Waist Circ, cm -11.0 -13, -9 11(435) 65% 6 28 <0.001CRP -3.4 -5, -2 4(216) 55% 1.5 6.8 <0.001Weight Loss Outcomes, RCTBMI, Kg/m2 -2.7 -3.7, -4.2 9(590) 86% 1.5 58 <0.001%EWL 22.3 8.9, 35.8 3(481) 96% 132 50 <0.001%TBWL 5.9 3.7, 8.1 8(647) 99% 8.7 722 <0.001Weight Loss Outcomes, Observational studiesBMI, Kg/m2 -5.2 -5.7, -4.7 20 (1157) 50% 0.6 38 <0.001% EWL 31.8 27.3, 36.2 11(777) 92% 45 119 <0.001%TBWL 11% 9.5, 12.7 16(992) 99% 11 1609 <0.00112 months follow-up( 6 months after IGB removal)BMI, Kg/m2 -4.8 -6.3, -3.3 5(361) 94% 3.1 80 <0.001Kg lost -13.5 -18.6, -8.4 4(223) 96% 29 99 <0.001%EWL 28% 23.5, 32 5(403) 92% 18 52 <0.001

Supplementary Table 2: Pooled mean differences (MD) for metabolic and weight loss outcomes

in RCTs and observational studies.

Abbreviations: FBG, fasting blood glucose; LDL, low-density lipoprotein; TG, triglyceride; SBP, systolic

blood pressure; DBP, diastolic blood pressure; ALT, alanine aminotransferase; AST, aspartate

aminotransferase; %EWL, % excess weight loss; TBWL, total body weight loss; waist circ, waist

circumference; CRP, C-reactive protein; cm, centimeters.

Variable Mean baseline

95% CI Meanoutcome

95%CI % Decrease from

baselineAll studies, FPG, mg/dL

101.4 97, 105 91.4 89, 94 10

Studies with FPG>100mg/dL

117.9 111, 125 100.9 94, 108 15

All studies, HbA1C, %

6.1 5.5, 6.6 5.5 5.1, 5.8 9

Studies with HbA1C>6.5%

7.2 6.8, 7.6 6 5.7, 6.3 17

All studies. LDL, mg/dL

117.4 111, 124 109 102, 117 7

All studies, TG, mg/d

142.5 133, 152 112 101, 123 22

All studies, SBP, mm Hg

138.5 134, 143 127.8 125, 130 8

All studies, DBP, mm Hg

81.9 79, 85 77.3 74, 81 6

All studies, ALT, U/L

33.2 29.6, 36.9 23.6 21.2, 26 29

All studies, Waist, cm

125.5 118, 133 113 108, 118 10

All studies, BMI, kg/m2

43.4 41, 46.4 38.3 35.5,41 12

Supplementary Table 3. Summary of weighted mean baseline and outcome values of primary

outcomes and % decrease from baseline after IGB therapy. Also shown is subgroup analysis for

variables with significant variations in outcomes depending on baseline values.

Supplementary Figure 1. Meta-regression of baseline FBG on change in fasting glucose with IGB

therapy in observational studies. R2 = 0.37.

Regression of Difference in means on Baseline FBG

Baseline FBG

70.0 80.0 90.0 100.0 110.0 120.0 130.0 140.0 150.0 160.0 170.0

Diffe

renc

e in

mea

ns

30.00

20.00

10.00

0.00

-10.00

-20.00

-30.00

-40.00

-50.00

-60.00

-70.00

Supplementary Figure 2. IGB use led to more excess weight loss(A) and total body weight loss(C)

than diet/controls. In observational studies, excess weight loss was 31.8% at the end of treatment

with IGB(B), and total body weight loss, 11.1 %(D).

Supplementary Figure 3. Funnel Plots of Standard Error by Mean Differences before and after 6

months of IGB therapy and significance value for Eggers test for : (A) LDL, P= 0.2; (B) TGs; P=0.8; (C)

FBG, P=0.9; (D)HbA1c, P=0.2.

Supplementary Figure 4. Funnel Plots of Standard Error by Mean Differences

before and after 6 months of IGB therapy and significance value for Eggers test for

(A) BMI, P=0.99; (B) %TBWL, P=0.12; (C) ALT, P=0.2; (D) SBP, P=0.5.

Supplementary Table 4. Quality Assessment of Included Trials. (A) Cochrane Risk-

of-Bias Tool for RCTs. (B) Newcastle-Ottawa Scale for case-controls studies.

Ran

dom

seq

uenc

e ge

nera

tion

(sel

ectio

n bi

as)

Allo

catio

n co

ncea

lmen

t (se

lect

ion

bias

)

Blin

ding

of p

artic

ipan

ts a

nd p

erso

nnel

(p

erfo

rman

ce b

ias)

Blin

ding

of o

utco

me

asse

ssm

ent

(det

ectio

n bi

as)

Inco

mpl

ete

outc

ome

data

(attr

ition

bi

as)

Sele

ctiv

e re

port

ing

(rep

ortin

g bi

as)

Ove

rall

qual

ity

Ponce 2015 + + + + + + High

Farina, Baratta [24] 2012 + + - + + + High

Fuller, Lau [26],3 2013 + + - - + + Mod


2009 - - - - - + Low

Lee, Low [30] 2012 + + + - + + High

Martinez-Brocca, Belda [31] 2007 + + + + + + High


2014 - - + + + + Mod


2013 - - + + + + Mod


2002 - - + + + + Mod

Mohammed, Anwar [35] 2014 - - - - + + Low

(A)

Selection

Comparability

Outcome

Case definition adequate: validation, or record linkage

Representation of cases: consecutive or obvious

Selection of controls: community or hospital, consecutive

Definition of controls: Intervention not present at start

Cases and controls are comparable on the basis of obesity (BMI>30)

Exposure confirmed: records or interview

Follow-up Length for Outcome

Non-response rate: similar for both groups

Chan * * * * * * *Takihata

* * * * * * * *

Zerrweck

* * * * * *

Follini * * * * * * * *

Mariani * * * * * * *(B)

Supplementary Table 5. Summary of Adverse Events. Serious complications for

all studies were: 1 case of acute cholecystitis, 1 case of Mallory-Weiss tear, 4

gastric ulcers with GI bleeding, 1 case of hypokalemia, 5 cases of severe

nausea/vomiting; 5 cases of gastric perforation. Mortality included two deaths

from gastric perforation.

Early

Removal

Abdom

inal P

ain

Vomitin

g

Esoph

agitis

Seriou

s Com

plica

tions

Mortal

ity0

5

10

15

20

25

Chart Title

Supplementary Table 6. Adverse events by study

First Author Year N enrolled Com

plic

atio

ns

Rep

orte

dA

bdom

inal

pai

n

Deh

ydra

tion

Esop

hagi

tis

Vom

iting

Early

Rem

oval

Maj

or c

ompl

icat

ions

Not

es

Randomized Controlled TrialsFarina, Baratta [24]

2012 30 cases20 controls

0 8 – GERD and 2 required PPI

Fuller, Lau [26],3 2013 31 cases35 controls

243

80

243



57% 2 81% 0

Lee, Low [30] 2012 11 cases10 controls

3 3 3



1 1



NR



32



6 81

Mohammed, Anwar [35]


35.7% 33

3 Gastric ulcer, GI bleeding

Case ControlChan, Chow [36]


NR

Genco 2008 130 cases130

controls

65% 51% 0

Takihata, Nakamura [37]


1 4 0



NR 2 – perforation, leak4 – infection,

hematoma, 2 leaks (controls are LRYG)

Major complications were associated with LRYGB

Consecutive Case SeriesAl Kahtani, Khan [39]

2010 140 Pain by mo

14 (8.1%

)

28 at 2 weeks, 4

at 6mo, etc

33 3 went to ED, unclear why

n/v/abd pain etc broken down by weeks post

insertionBenamouzig, Uzzan [40]

2013 67 7 12 3 2 hospital stays Reflux 9 (14%)

Crea, Pata [41] 2009 138 5 2-persistent vomiting2 cases of balloon migration, 1 rupture

Genco 2010 50 0Lopez Nava 2009 714 0.9% 4.3%Mui, Ng [42] 2010 119 4 1-Hypokalemia, 1-

anemiaRicci, Bersani [43]

2008 93 NR

Stimac, Majanovic [44]

2011 165 (171) 3 6 Vomiting seen in everyone in first 3 days, resolved in all

but 3 prompting early removal

Tayyem, Obondo [45]

2011 17 4 (25%) 5 5 required replacement of balloon; n/v stopped with

anti-emeticsCase Series

Albuquerque, Sarmento [46]

2013 NRBusetto, Enzi 2005 17 1 0

[47]Genco 2005

251511

(0.4%)5 gastric perforations

2 died5 gastric ulcers

19 gastric obstructions

Genco 2009 80 NR NRGenco 2013 261 1 15

(0.7%)2 duodenal ulcers 28 leaks

Donadio, Sburlati [48]

2009 40 NR?

Forlano, Ippolito [49]

2010 120 2 60% 10 (8%)

n/v/abd pain 60% - mild; 2 severe n/v, 2 abd pain, 1

acute cholecystitis; 1 blowout of balloon

Lorenzo, Boccia [50]

2011 15 NR?

Mafort, Madeira [51]

2014 40 6 5 – gastric intolerance, 1 - rupture

Mion, Napoleon [52]

2005 15 2 15 1 1 Severe GI bleeding/anemia 2/2

gastric ulcersMirosevic, Nikolic [27]

2014 20 obese23 m. obese

NR

Nikolic, Mirosevic [53]

2011 32 (33?) 15 2 (mild)

21 1

Sekino, Imajo [54]

2011 8 1 4 0 n/v resolved, 0 hospital stays

Succurro, Ruffo [55],32

2014 10 NR

Tai, Lin [57] 2013 28 9 3 1 Panic attack, 1 intractable vomiting, 1

ulcer bleed

; 1 Mallory Weiss treated conservatively

Supplementary Figure 5. Forest Plots for resolution or improvement in metabolic conditions. Fixed effects meta-analysis was performed for most since I2 = 0% except resolution of dyslipidemia (I2 = 84%).

Supplement 5. Comments on individual studies.

Farina: After balloon removal, cases were subdivided into two groups: 15 on diet alone, 15 on sibutramine and were followed for a total of 12 mos. 20 controls continued with diet for a total of 12 months. We used the 12 months’ data on 15 cases IGB/diet ( 6 months with IGB and then followed for 6 more months),15 cases with IGB followed by sibutramine and 20 controls. All analyzed in intention-to-treat(ITT).Fuller: All analyzed in ITT, except 2 controls. 12 months’ data reported and included in analysis (6 months with IGB followed by 6 months without IGB). Lee: 3(14%) cases withdrew after IGB placement and had early removal; were not included in study analysis.Martinez-Broca: 1 withdrew after IGB placement and had early removal; not included in study analysis.Mathus-Vliegen 2002: 1 withdrew after IGB placement and had early removal; not included in study analysis. Mohammed: 3 cases withdrew after IGB placement and had early removal; 2 controls also withdrew; were not included in study analysis(4% total).Genco 2010: Used only data after 1st IGB placement( 6 months) for both groupsMui 2010: 8(6%) cases missed their follow-up, not included.Stimac: 6(3.5%) had early removal, not included in study analysis.

Genco 2009: case-control: 40 pts with laparoscopic sleeve gastrectomy compared to 80 IGB patients. Only IGB data used for this analysis.Forlano: 10(8%) had early removal, not included in study analysis. Mafort: 6 missed lung testing, 6 had early remova l(23% total).Mirosevic: 1 lost to follow-up.Tai: 5(15%) had early removal, not included in study analysis.In high quality RCTs, the authors’ names are underlined with a solid line, moderate quality RCTs are lined with a dotted line, low quality RCTs are not lined.

Supplementary Table 7

Search Strategy:

# ▲ Searches

1 balloon.mp. [mp=ti, ab, ot, nm, hw, kf, px, rx, ui, sh, tn, dm, mf, dv, kw]

2 limit 1 to english language

3 limit 2 to humans

4 limit 3 to "all adult (19 plus years)" [Limit not valid in Embase; records were retained]

5 limit 4 to human

6 gastric balloon.mp. [mp=ti, ab, ot, nm, hw, kf, px, rx, ui, sh, tn, dm, mf, dv, kw]

7 1 and 6

8 (intragastric balloon* and obesity).mp. [mp=ti, ab, ot, nm, hw, kf, px, rx, ui, sh, tn, dm, mf, dv, kw]

9 obesity.mp. [mp=ti, ab, ot, nm, hw, kf, px, rx, ui, sh, tn, dm, mf, dv, kw]

10 1 and 9

11 endoscopic.mp. [mp=ti, ab, ot, nm, hw, kf, px, rx, ui, sh, tn, dm, mf, dv, kw]

http://ovidsp.tx.ovid.com/sp-3.15.1b/ovidweb.cgi?&S=GFOMFPEOIKDDKOIENCKKMDJCGMECAA00&Sort+Sets=descending


13 limit 12 to humans

14 10 and 13

15 intragastric balloon*.mp. [mp=ti, ab, ot, nm, hw, kf, px, rx, ui, sh, tn, dm, mf, dv, kw]


17 limit 16 to human

18 bioenteric.mp. [mp=ti, ab, ot, nm, hw, kf, px, rx, ui, sh, tn, dm, mf, dv, kw]


20 17 or 18

21 remove duplicates from 20

22 5 and 13

23 9 and 22


25 1 and 10 and 11

26 15 or 18 or 24 or 25



29 limit 28 to humans


31 from 30 keep 22-23, 28, 30-32, 42, 45, 49-52...

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