Efficacy of intragastric balloon on weight reduction: Saudi perspective

Table 1 Baseline characteristics of the subjects (n = 301) included for intragastric balloon therapy

Characteristics	Average (mean ± SD)1	Range
Age (yr)	34.34 ± 10.38	14-65
Female (%)	67
Body weight (kg)	94.73 ± 16.38	67-203
Height (cm)	161.52 ± 6.11	150-179
BMI (kg/m2)	36.24 ± 5.24	27.10-70.24
Excess body weight (ideal BMI 25)	29.42 ± 14.61	5.6-130.8
Fasting blood glucose (mg/dL)	100.15 ± 29.26	69-240

¹Applicable to all the values except % females. BMI: Body mass index.

Table 2 Reasons for removal of the intragastric balloon

Reason for removal	No.	Reason for removal	No.
TDC	221	Intolerance	4
Abdominal pain	1	Vomition	1
Miscellaneous	2	TDC and intolerance	1
TDC and abdominal pain	19	TDC and vomition	10
TDC and discomfort	24	TDC and other reasons	2
Intolerance and abdominal pain	4	Intolerance and vomition	2
Intolerance and other reason	1	Abdominal pain and vomition	3
Abdominal pain and other reason	1	Discomfort and other reason	1
TDC, abdominal pain and vomition	1	Intolerance, abdominal pain and vomition	2
TDC, abdominal pain and discomfort	1

Abdominal discomfort was a state of tolerable uneasiness without pain; Abdominal pain involved a state of colic; Vomition was a state of uncontrolled expulsion of gastric contents; Intolerance was a state wherein subjects experienced a mix of side effects and were unable to tolerate. Other reasons were a variety of situations that did not show a consistent pattern. TDC: Treatment duration complete.

Table 3 Weight related measurements at intragastric balloon removal and after 6 mo of removal

Characteristics	At removal (mean ± SD)a	After 6 mo of removal
Body weight (kg) (Min-Max)	82.25 ± 14.73b (55-181)	81.06 ± 14.84b (53-181)
BWL (kg) (Min-Max)	12.48 ± 5.16 (0-30)	13.67 ± 6.65b (-1-42)
BWL (%) (Min-Max)	13.08 ± 4.81 (0-35.29)	14.30 ± 6.12b (-0.85-32.14)
No. of patients with BWL% > 10	224	226
Excess body weight (ideal BMI 25) (Min-Max)	16.93 ± 13.44b (-10.61-108.75)	15.74 ± 13.73b (-12.72-107.04)
BMI (kg/m2) (Min-Max)	31.49 ± 4.88b (20.96-62.63)	31.04 ± 5.01b (20.44-63.14)
BMI loss (kg/m2) (Min-Max)	4.75 ± 1.87 (0-11.43)	5.20 ± 2.40b (-0.36-15.43)
EBMIL% (Min-Max)	46.67 ± 22.88 (0-161.09)	51.07 ± 27.66b (-2.12-195.53)
Fasting blood glucose (mg/dL) (Min-Max)	98.67 ± 20.28 (71-187)	--

^aP < 0.05 vs

^bP < 0.001. BWL: Body weight loss; BMI: Body mass index; EBMIL: Excess BMI loss.

Table 4 Association of gender and exercise on end of treatment success and long term success

Characteristics	At removal (mean ± SD)a				After 6 mo of removal
	Gender		Exercise		Gender
	Male (n = 72)	Female (n = 229)	Yes (n = 131)	No (n = 170)	Male (n = 72)	Female (n = 229)
BWL (%)	14.99 ± 4.72	12.48 ± 4.68b	15.22 ± 4.81	11.43 ± 4.11b	16.71 ± 6.72	13.53 ± 5.72b
Number of patients with BWL% > 10	8	160b	113	111b	9	163b
Body mass index loss (kg/m2)	5.56 ± 1.92	4.49 ± 1.78b	5.47 ± 1.85	4.19 ± 1.68b	6.19 ± 2.72	4.89 ± 2.20b
EBMIL%	51.61 ± 24.75	45.12 ± 22.09a	55.66 ± 25.12	39.74 ± 18.24b	57.48 ± 30.27	49.06 ± 26.53a
Fasting blood glucose reduction (%)	-0.59 ± 13.29	-0.92 ± 13.14	-0.37 ± 13.10	-1.25 ± 13.22	--	--

^aP < 0.05 vs

^bP < 0.001. ETS: End of treatment success; LTS: Long term success; BWL: Body weight loss; EBMIL: Excess body mass index loss.

Table 5 Correlation of age and initial body mass index with weight-linked parameters

	Age	InitialBMI	BMIat removal	EBMIL%at removal	BMIafter 6 mo of removal	EBMIL%after 6 mo of removal
Age	1	0.074	0.082	-0.108	0.082	-0.108
Initial BMI	0.074	1	0.934b	-0.413 b	0.891b	-0.376b

Values are Pearson Correlation Coefficient (r);

^bP < 0.01. BMI: Body mass index; EBMIL: Excess BMI loss.

Table 6 Studies reporting outcomes in body composition after placement of intragastric balloon

Study	Weight loss at removal (duration of placement in months)	Weight loss at follow-up (duration of follow-up in months)
Mathus-Vliegen et al[26], 2005	21.3 (12)	12.6 (12)
Herve et al[27], 2005	12.0 (6)	8.6 (12)
Doldi et al[28], 2004	15.5 (6)	-1.3 (14)
Melissas et al[29], 2006	41.6% EWL (6)	23.9% EWL (6-30)
Angrisani et al[30], 2006	32.9% EWL (6)	27.1% EWL
Ganesh et al[31], 2007	4.4 (6)	1.5 (6-12)
Ohta et al[32], 2009	12 (6)	6.4 (12)
Gümürdülü et al[33], 2013	12.4 (6)	9.7 (6)
Bužga et al[20], 2014	18.4 (6)	-
Present study	13.08 (6)	14.30 (6)

Weight in kilograms; EWL: Excess weight loss.

Table 7 Comparison of weight-loss with other types of intragastric balloons

Balloon	Type (volume)	Material	Weight loss (EOT in months)	Ref.
Medsil BIB	Fluid-supplied (400-700 mL saline)	Silicone	12.48 ± 5.16 kg (6 mo)	This study
Orbera (Apollo Endosurgery)	Fluid-supplied (400-700 mL saline)	Silicone	16.9 ± 0.9 kg (6 mo)	Gaur et al[34], 2015
The Elipse™ (Allurion Technologies)	Fluid-supplied (450-550 mL filling fluid)	NA	2.4 kg (6 wk)	Machytka et al[35], 2016
ReShape Duo® Integrated DualBalloon System (ReShape medical)	Fluid-supplied (900 mL; 450 mLX2 saline)	Silicone	25.1 ± 1.6% EWL (6 mo)	Ponce et al[36], 2015
Spatz Adjustable Balloon system (Spatz FGIA)	Fluid-supplied (400-600 mL saline)	Silicone	24 kg (at 12 mo)	Brooks et al[37], 2014
Heliosphere BAG® (Helioscopie)	Air-supplied (950 mL air)	Polyurethane and silicone	16 ± 7 kg (6 mo)	Giardiello et al[38], 2012
Obalon® Gastric Balloon (Obalon Therapeutics)	Air-supplied (250 mL air, nitrogen)	NA	5 kg (12 wk)	Mion et al[39], 2013

EOT: End of treatment; EWL: Excess weight loss; NA: Not available; BIB: Bioenetric intragastric balloon.