Methods

Design:
Double/multi center (Virginia & Washington D.C.)
Follow‐up:
24 weeks

Participants

Country:
U.S.A.
Number:
Total 90
Weight (mean):
30 % above ideal body weight

Interventions

12 weeks:
Group 1: Balloon X Sham
Group 2: Sham X Balloon
Group 3: Balloon X Balloon
12 wks Balloon sham Balloon
12 wks sham Balloon Balloon

Outcomes

Weight change (%of loss or kg):
First 12 weeks:
B + S = ‐ 8.6 kg
S + B = ‐ 5.4 kg
B + B = ‐ 3.6 kg
Last 12 weeks:
B + S = ‐ 10.4 kg
S + B = ‐ 7.2 kg
B + B = ‐ 8.6 kg

Weight change (BMI):
First 12 weeks:
B + S = ‐ 3.1 kg/m²
S + B = ‐ 2.3 kg/m²
B + B = ‐ 2.9 kg/m²

B+S x S+B P = 0.3
B+S x B+B P = 0.6
S+B x B+B P = 0.6

Last 12 weeks:
B + S = ‐ 0.0 kg/m²
S + B = ‐ 0.7 kg/m² B + B = ‐ 0.4 kg/m²

B+S x S+B P = 0.3
B+S x B+B P = 0.5
S+B x B+B P = 0.6

Losses:
29 exclusions
1 inability to tolerate crossover endoscopy
8 lost to follow‐up

Complications:
Small bowel obstruction (2%), Mallory‐Weiss tears (11%), Oesophageal laceration (1%)

Notes

In 24 weeks of study:
There was no significant difference between any of these groups at 12 or 24 wks with respect to weight loss or change in BMI;
Major part of weight loss during this study occurred during the first 12 weeks period, irrespective of therapy (bubble or sham).
The use of GEGB did not result in significantly more weight loss than diet and behavioural modification alone.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Design:
Single center
Follow‐up:
3 months

Participants

Country:
U.S.A.
Number:
Total 86
Sex:
16 males, 70 females
Obese individuals with BMI > 40

Interventions

4 groups
Group 1: Balloon only
Group 2: Balloon + diet 1000 kcal/day
Group 3: Diet only
Group 4: No treatment

Outcomes

Weight change (%of loss or kg):
Group 1 (balloon only):
‐3.2 kg (+‐ 0.9)
Group 2 (balloon + diet):
‐5.1 kg (+‐ 1.0)
Group 3 (diet only):
‐6.9 kg (+‐ 1.4)
Group 4 (No treatment): +0.6 kg (+‐ 0.5)

Losses: 16
Group A: 3,
Group B: 3,
Group C: 1,
Group D: 9.
Side‐effects: gastric spasms, nausea, ulcers and superficial erosions.

Notes

First months:
B produced the larger weight loss. The differences between A, B and C groups were not significant;
Second month:
The effect of balloon only (A) diminished relative to the other treatment groups (B and C) so that at the end of the intervention period, it was significantly less effective than the diet only group (C).
Third month and later:
All the interventions (A, B, C) produced significantly more weight loss than the control group (D).
The differences between the balloon only group (A) and the diet only group (C) were no longer significant.
The body weight of the patients in the treatments groups (A, B, C) remained significantly lower than the control group (D).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Design:
Single center
Follow‐up: 12 months

Participants

Country:
U.S.A.
Number:
Total 59
Age (median);
Balloon 6 male and 28 female
(33.8 y)
Sham 5 male and 20 female (36.8 y)

Obese indivuduals above ideal weight

Interventions

3 months with balloon + 9 months of follow‐up

Outcomes

56 patients completed the first 3 months: 22 sham + 34 balloon

Weight change (%of loss or kg): Balloon = ‐ 7.2%
Sham= ‐ 8.3%

Weight change (BMI):
Balloon = ‐ 3.0 kg/m²
Sham= ‐ 3.5 kg/m²

Normal balloons or over 70% full:
25 (73%)
Half empty balloons:
9 (27%)
Completely deflated balloons:
4 (10%)
Over 50% deflated balloons:
4 (12%)

Losses:
1 died (IAM)
2 moved away
1 invalid initial weight
2 realized wasn't using the balloon

Side‐effects:
Dyspepsia, gastric antral ulcers (2 patients), erosions in mucosa (2 patients), erosions in gastric‐oesophageal junction (4 patients).

Notes

The loss of weight in the follow‐up was difficult to evaluate due to the high rate of drop‐outs after removing the balloon; the patients in the final meeting (28 balloon, 16 sham) showed a continuous tendency of weight loss in the control group and of weight gain in the balloon treated group;
In the 2 weeks after placement of the balloon there was a high incidence of nausea and burning pain in the abdomen when compared to the control group;
After the end of 3 months there was no significant difference of these symptoms between the 2 groups;
There was a loss of appetite in the first 3 months in the majority of the patients (for both groups);
There was no increased early satiation in the patients using the balloon (87%) when compared with the control group (39%).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Design:
Single center (Mayo Clinic)
Follow‐up:
15 months (4 months of observation and pre‐selection + 3 months of treatment + 8 months of diet only)

Participants

Country:
U.S.A.
Number:
Total 22
Age:
25‐51 years
Sex:
20 female and 2 male

21%‐77% above ideal body weight:

Interventions

11 underwent insertion of intragastric balloon and 11 underwent sham procedures.
Results in weight change (% of loss or kg):
B = ‐5.8 (+‐ 5.9 kg)
Sham = ‐2.8 (+‐ 3.9 kg)
P > 0.15
95 confidence interval: ‐1.5 to 7.7 kg

Outcomes

8 in 10 balloons were found deflated.

Baloon group: 1 patient showed migration of a deflated balloon through all the intestinal tract; 1 patient had abdominal pain, withdrawing only 3 days after balloon insertion.

Sham group: 2 patients with gastric erosions associated with the use of aspirin.

Notes

There was no important difference in weight loss between these 2 groups.

Costs: The balloon and introducer costs were approximately $400 and the endoscopic charges for insertion and removal of each balloon cost $1200 to $1600 in addition.
In a 3 months study, these translate into an additional $600 for each kg of weight lost after the balloon procedure.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Design:
Single center
Follow‐up:
35 weeks

Participants

Country:
Netherlands
Number:
Total 28
Age (median):
male 33.9 (24‐51 y) and female 32.7 (23‐53 y)
Sex:
15 male, 13 female
BMI (median):
male 51.9 kg/m² (43‐66) and female 57.1 kg/m² (51‐88)
Weight (mean):
male 176.5 kg (152.4‐220.3) and female 165.6 kg (127.7‐191.2)

Interventions

4 Groups
Group A:
Balloon (for 17 weeks) + sham (17‐35 week)
Group B:
Sham (for 17 weeks) + balloon (17‐35 week)
Group C:
Balloon (for 17 weeks) + balloon (17‐35 week)
Group D:
Sham (for 17 weeks) + sham (17‐35 week)

Outcomes

Weight change (%of loss or kg) of all patients:
Week 0 (mean):
172 kg
Week 17:
134.1 kg (‐ 37.9 kg)
Week 0‐35:
‐ 49.8 kg
Week 35:
122.2 kg (‐ 11.9 kg)

BMI change of all patients:
Week 0 (mean):
54.6 kg/m²
Week 17:
42.7 kg/m² ( ‐ 11.9)
Week 35:
38.8 kg/m² ( ‐ 3.9)

Side‐effects in balloon patients: Hiccups and gastric fullness.
61% were sure to have no balloon.
After the second period 2 patients had erosions in antrum and 1 had reflux oesophagitis.
A footnote added to the questionnaires: "…lying on right side relieve the complaints"
2 patients with ulcers.

Side‐effects in sham‐treated patients: nausea, heartburn and belching; 36% were sure that they felt a balloon after the sham
procedure.1 patient with ulcer.

Losses:
1 patient had the balloon removed after gastric complaints (Group A); 1 did not attend the visits to the clinic for legitimate reasons (Group A);
1 showed incooperative behaviour at the time of balloon insertion after 17 weeks ‐ initially compliant work‐up (Group B)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Design:
Single center
Follow‐up:
2 years(4 periods of 3 months)

Participants

Country:
Netherlands
Number:
Total 43
Age (median):
41.4 (22‐64 y)
Sex:
23 in group 1 (3 male, 20 female) & 20 in group 2 (4 male, 16 female)
BMI (median):
43.3 kg/m² (33,9‐61,3)
Weight (mean):
125 kg (93.2‐187.7)

Interventions

3m group 1: Sham
Group 2: Balloon

3‐6m group 1: Balloon
Group 2: Balloon

After 6months until year one: removal of all balloons and observation of weight maintenance

Outcomes

10 excluded patients:
3 losses, deflated ballon: 1.6% (2/128) and 2.3% (3/128)

Weight change (%of loss or kg):
0‐3 months:
Sham ‐11.2 kg (9%)
Balloon ‐12.9 kg (10.4%)

3‐6 months:
Balloon ‐8.8 kg (7.9%)
patients who had sham therapy in months 0‐3
Balloon ‐3.9 kg (3.5%)
patients with second
balloon treatment period

After 6 months, the overall weight loss was:
Sham/balloon ‐20 kg (16.1%)
Balloon/balloon ‐16.7 kg (13.4%)

Weight loss in 33 patients who had completed the study per protocol:
‐20.5% (‐25.6 kg) after 1 year, and ‐11.4% (‐14.6 kg) after 2 years.

47% of all patients sustained a greater than 10% weight loss, with considerably reduced comorbidity.

Complications: Gastric erosions, gastric ulcers, minor gastric bleeding, Mallory‐Weiss tears, oesophageal lacerations

Notes

55% of patients maintained a weight loss greater than 10%.

Although an independent benefit of balloon treatment beyond diet, exercise, and behavioural therapy could not be demonstrated in the first 3 months, balloon treatment for 1 year resulted in a substantial weigh loss, the greater part of which was maintained during the balloon‐free second year.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Design:
Single center
Follow‐up:
24 weeks

Participants

Country:
U.S.A.
Number:
Total 23
Age (median):
37.4 y (21‐53 y)
Sex:
2 male, 21 female
BMI (median):
38.3 kg/m² (29.7‐50.2)
Weight (mean):
25 ‐ 111 % above ideal body weight

Interventions

12 weeks balloon + 12 weeks sham

12 weeks sham + 12 weeks balloon

Outcomes

Weight change (%of loss or kg): sham +‐ 0.8 kg (14 patients)
bubble +‐1.7 kg (18 patients)

BMI change:
sham ‐ 4.9%
bubble ‐ 5.3%

Losses:
1 patient passed the bubble *
1 patient had a deflated device

*1 migration of deflated balloon through abdominal tract

Side‐effects:
Gastric ulcers ‐ 2 patients
Abdominal cramps ‐ 17 patients
Nausea
Vomiting

Notes

Neither mean cumulative weight reduction nor BMI in the 2 evaluation periods (12 wks each) differed significantly;
the data reveal that with the gastric bubble, weight loss was more significant during the first & second 2 weeks evaluation periods (p<0.005 and p<0.025, respectively). This trend, however, disappeared after the initial 4 weeks of treatment.
Overweight patients lose weight slowly during both sham procedure and gastric bubble implantation periods;
the mean cumulative weight loss is not significantly different between the two periods;
According to the authors, the Garren‐Edwards Gastric Bubble tested (GEGB) is of no value as an adjuvant device in weight reduction.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Design:
Single center
Follow‐up:
6 months

Participants

Country:
England
Number:
Total 24
Sex:
100% females
Obese participants with a BMI > 30 Mean BMI: 41 kg/m²
Mean weight: 110 kg

Interventions

Balloon in 12 patients
Sham in 12 patients
Associated with dietary advice (800 kcal/day)

Outcomes

Weight change (%of loss or kg): Balloon ‐7.33 kg
Sham ‐3.33 kg
(in first 3 months)
Balloon ‐9.37 kg
Sham ‐4.41 kg
(in next 6 months)
p < 0.05

8 losses: 5 put on weight, 2 did not lose weight, did not attend follow‐ up

Side‐effects:
Abdominal discomfort:
7 balloon + 0 sham
Abdominal cramps:
8 balloon + 0 sham
Abdominal fullness: 6 balloon + 0 sham
Vomiting:
5 balloon + 1 sham
Nausea:
10 balloon + 4 sham
Flatulence:
6 balloon + 4 sham

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Design:
Single center
Follow‐up:
16 weeks

Participants

Country:
France
Number:
Total 20
Age (median):
Balloon 41.8 (+‐ 3.1)
Sham 42.1 (+‐ 3.3)
Sex:
8 males, 12 females
Obese participants with BMI > 40

Interventions

11 received air‐filled balloons,
9 had a sham procedure.
All participants had dietary counselling to help them follow a relatively low energy diet (60 % of individual spontaneous intake).

Outcomes

Weight change (%of loss or kg): Balloon ‐8.6 kg
Sham ‐9.1 kg
First month:
P < 0.001
2nd, 3rd, 4th months:
P < 0.05

Weight change (BMI):
Balloon ‐45,4 (+‐ 3.3 kg/m²) to ‐42.2 (+‐ 3.3 kg/m²)
Sham ‐42.8 (+‐ 3.3 kg/m²) to ‐39.5 (+‐ 2.6 kg/m²)
P < 0.05

Side‐Effects "sensation of balloon presence", "gastric distension", "hunger sensation".

There was a considerable correlation between the distension and the presence / sensation of the balloon (r=0.901, p<0.001) and a negative correlation between the hunger and the sensation of distension (r=0.8, p<0.0001)

Notes

The cumulative loss was not significantly different between two groups.
Most of the weight was lost during the first 4 weeks (P<0.001) in both groups.
The rate of weight loss decreased significantly, P<0.05 for the 2nd, 3rd and 4th month relative to the 1st month.
The weight loss between the 2nd and 3rd month was significantly different P<0.05.
The lowest weight was achieved in both groups 3 months post manipulation.
The amount of weight lost per month was similar between men and women in both groups, except during the 3rd month when sham balloon men lost significantly (P<0.05) more weight than women.
The mean energy intake was significantly lower during the first 2 months (P<0.003).
After 2 months, the balloon group increased progressively the energy intake to initial value, each month being higher from the previous one, and at week 16 there was no difference as compared to week 0.
The sham balloon group maintained reduced energy intake throughout the 4 months, and at week 16 was 20% lower then at week 0 (P<0.05).
The monthly energy intake was not significantly different between the two groups.
Women consumed less energy than men in both groups at all time points (men vs women, months 1 or 2 or 3, balloon group P< 0.05 and sham balloon group P<0.001).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear