| Abstract|| |
Two consecutive and matched groups of morbidly obese patients, i.e. group (1) and (2) were selected to be treated with Garren-Edward Bubble (18 patients) and the Danish-Ballobe (10 patients), respectively, and according to the American FDA criteria. All patients were put on 1000-1200 K. cal diet and given the choice to enrol in the behavior modification program (BMP) or not; (15) patients enrolled in it (group A) and (13) patients refused (group B).
At the end of the treatment period (i.e. 3 months group 1; 4 months group 2) the mean loss in the body mass index (BMI) for group (1) and (2) were 5.46 ± 4.6 kg/m 2 , and 3.98 ± 5.5 kg/m 2 respectively. With insignificant statistical difference (P>1.0). While the mean loss in the BMI was 7.17 ± 4.54 kg/m 2 and 1.85 ± 0.92 kg/m 2 for group A & B respectively. With a very significant statistical difference (P<0.01). No major complication was noticed except that in two patients (group 1) and four patients (group 2), the ballon had to be removed within the first week of insertion due to intolerance. In conclusion, although both balloons are safe, they are weakly effective and the main effect could be attributed to the BMP.
|How to cite this article:|
Subei IM, Abdelazim A, Bayoumi A, Wahab MA, El Deriny S. The effect of different types of intragastric balloons with and without a behavior modification program in morbid obesity. Saudi J Gastroenterol 1996;2:63-8
|How to cite this URL:|
Subei IM, Abdelazim A, Bayoumi A, Wahab MA, El Deriny S. The effect of different types of intragastric balloons with and without a behavior modification program in morbid obesity. Saudi J Gastroenterol [serial online] 1996 [cited 2020 Nov 25];2:63-8. Available from: https://www.saudijgastro.com/text.asp?1996/2/2/63/34028
Morbid obesity is a major health problem which affects 5-10% of the population. It is complicated by many serious diseases e.g. arteriosclerotic cardiovascular diseases, hypertension, type II diabetes mellitus, hyperlipidemia and chronic respiratory insufficiency, all of which decrease the survival rate of their victims  . Diet and exercise programs often fail to achieve a significant and persistent weight reduction  and various surgical procedures have several complications  .
Based on the clinical observation of patients with pathologic intragastric bezoars who experience a remarkable weight reduction due to appetite loss  , several investigators around the world tried to implant an artificial bezoar i.e. different types of intragastric balloons, hoping to achieve a significant weight reduction in their patients. Most of the clinical trials were done on the "Garren-Edward Bubble" GEB (American Edward Lab., Inc., Santa Ana, Ca) and the "Danish Ballobes" DB (DOT APS, Rodovre, Denmark) ,,,,,,,,,, . However, to our knowledge, there has not been any study comparing the two types of intragastric balloons.
We present our trial, in which we studied the effect of the two different intragastric balloons, the GEB and the DB on two consecutive groups of patients. The same protocol was applied on the two groups except that the duration of balloon treatment, which was four months in the DB, and three months in the GEB group of patients.
| Patients and methods|| |
Over 40 months, 41 morbidly obese patients were referred by general medical and gastroenterology outpatient clinics for treatment with the balloon system. They were treated with two different types of gastric balloons, in addition to a balanced calorie-restricted diet of 1000 K. cal (females) and 1200 K. cal (males) and an optimal regular BMP.
Patients were selected according to the protocol set by the American-Edward Company, and which was approved by the FDA in 1985. However, we decreased the treatment period for GEB to three months and we excluded from the balloon treatment all patients with previous abdominal surgery.
Twenty-five patients were selected for the treatment with the GEB over a year's time, while sixteen patients were selected for the DB over two year's time. The two groups were matched for age, sex, baseline body weight, baseline body mass index, and the treatment period as shown in [Table - 1].
Upon selecting the candidate patients, and after completing all the investigations, they underwent one or more sessions of nutritional and psychological counselling. All patients signed an informed consent which detailed the exact role of the intragastric balloon, its limitations, potential complications and the pros and cons of other alternatives.
The Garren-Edward Bubble is a cylindrical 200 cm device made from polyurethane. The Danish Ballobes is a larger balloon which takes 500 ccm of air with an oval shape and with a very thin but durable silicon wall. The valve of the ballobes is radioopaque which negates the need to inject a contrast in the ballobes. After an endoscopy has been done to rule out any anatomical contraindication (e.g. hiatus hernia, peptic ulcer) and to have a proper assessment of the location of the gastroesophageal junction; the balloon was inflated with air, according to its size. Also, 10 ml of gastrografin was injected into the bubble to make it radioopaque. Plain film of abdomen was then taken to assure the proper location of the balloon in the stomach.
Post insertion management:
During the first week after the balloon insertion, the patients were placed on 500 K. cal liquid diet plus multivitamins and mineral supplement. Antiemetics and antispasmodics were given when needed, and all patients were put on prophylactic Ranitidine 300 mg daily. After the first week, patients were put on bulk-forming well-balanced diet of 1000 K. cal for females and 1200 K. cal for males. Vitamins, minerals and H2 antagonists were continued. Patients were offered to attend a behavior modification program with dietary counselling (DC) weekly. They were seen also by the internist monthly or whenever necessary.
| Results|| |
Out of the 25 patients who were treated with GEB (Group One) five patients moved out of town and were not available, at the end of treatment to have their results analyzed.
Similarly, two out of the sixteen patients who were treated with DB (second group) were withdrawn from the study for the same reason. Two patients from (group one) and four from (group two) could not tolerate the balloon due to intractable pain and/or vomiting, and the balloons had to be removed within the first week. At the end of the treatment period, 18 and 10 patients from groups 1 and 2 respectively, were available for the analysis of the results.
The mean loss in the body weight and body mass index were 15.2 ± 14.9 kg and 5.46 ± 4.6 kg/m 2 and; 8.8 ± 8.7 kg and 3.98 ± 5.5 kg/m 2 for groups 1 and 2, respectively. The difference between the results of the two groups was not significant as shown from [Figure - 1] (P 0.1).
Fifteen patients (twelve from group one, and three from group two) complied with the weekly BMP and DC (subgroup A) and thirteen patients (six from group one; seven from group two) did not comply with BMP and DC (subgroup B). The two subgroups almost matched in their baseline mean body weight and body mass index (P 0.1). However, at the end of the treatment period, the difference became statistically significant (P 0.01). [Table - 2] compares the two subgroups before and after the treatment.
We have not encountered serious complications in any of our patients except for a transient nausea and vomiting which affected almost all patients but were intolerable in six, the balloons were removed and these patients were found to have a moderate degree of acute gastric erosions in the fundus of the stomach.
| Discussion|| |
Obesity is a major health problem which affects more than 20% of the society. Five to ten percent have morbid obesity, which is found to be complicated by many hazardous diseases like hypertension, type II diabetes mellitus, hypercholesterolemia, arteriosclerotic cardiovascular disease and respiratory insufficiency  . The achievement of a significant weight reduction by diet and exercise is very difficult, and even when it happens, it rarely persists without a rebound weight gain, the so called "yo-yo syndrome"  . Due to this failure, surgeons have tried to create a malabsorption by performing jejuno-ileal bypass or to reduce the gastric capacity by performing gastric partition. However, many serious complications have been reported  and have encouraged clinicians to find a less invasive way to achieve weight reduction.
It has been noticed that patients who had intragastric bezoars caused by different medical problems continued to lose weight without developing any serious complication or showing evidence of intolerance  . Due to this observation, the idea of implanting an intragastric balloon to work as an artificial bezoar has been considered, and different devices have been utilized for this purpose  . In 1985, the FDA approved the use of a 200 ccm cylindrical plastic bubble, i.e. the "Garren-Edward Gastric Bubble" for clinical use in morbidly obese patients, as an adjunct to the dietary and behavior modification therapy  . Several nonrandomized prospective trials evaluated the use of GarrenEdward Bubble in morbidly obese patients have achieved a mean weight loss between 25-40 lbs. within six months of implantation ,, . However, several complications have been reported including gastric ulcer in 2.5%, bubble intolerance in 5%, troubles in inflating and deflating the device in up to 28.7%, spontaneous deflation of the bubble leading to intestinal obstruction which needed surgical intervention on 79 cases ,,,,,,,, . Over a year's time, we treated twenty-five morbidly obese patients with GEB combined with balanced restricted calorie diet and a behavior modification program. At the end of the treatment period, the mean weight loss and BMI loss was 12.54% and 13.55 %, respectively, of the baseline body weight and BMivalues compatible with what have been reported by others ,, . Almost all patients developed transient crampy abdominal pain with nausea and vomiting; but in two patients the symptoms were too severe to be tolerated, so the balloon had to be removed. Neither gastric ulcer, nor spontaneous deflation did occur in any of our patients which could be attributed to a prophylactic use of ranitidine ,, and to removing the balloon after three months of implantation ,,, . Since there had been growing evidence in the literature ,,,,,,,, of a relatively high complications rate related to the bubble, and as several randomized controlled studies failed to show a significant advantage of GEB over the sham procedure ,, , we decided not to use the bubble any more.
The European "Danish Ballobes" seemed theoretically to have several advantages over GEB. The size is 500 ccm instead of 200 ccm; the shape is oval which is more physiologic. The balloon does not have sharp edges to cause pressure necrotic ulcer, and spontaneous deflation has been found to rarely occur and even if it happens, the very thin wall of the DB allows its easy passage through the intestines. Furthermore its valve is radio opaque, so the balloon could be traced by X-ray ,, . The above-mentioned advantages, in addition to the results of the prospective trials which proved the DB to be very safe and relatively effective, stimulated many gastroenterologists to use it for their obese patients, but most of them did not have an adjunctive BMP ,, . We decided to prospectively evaluate the DB in comparison with our previous results with the GEB using the same selection criteria, diet restriction, BMP and DC program. At the end of the treatment, the difference between the efficiency of GEB and DB was non-significant for both the body weight and the body mass index (P 0.1) as shown in [Figure - 1]. This means that the increase in the treatment period did not offer any further advantage, and supports the finding of Levine et al  . In contrast Barkin et al  found a more significant weight loss in cases treated for four months compared to three months. Four patients could not tolerate the DB, so we had to remove it within the first week, as compared to two cases in GEB. Although statistically, the difference was not significant, it seemed that there is a trend showing that DB is probably less well tolerated than GEB and the lack of noticing a significant statistical difference could be attributed to the relatively low number of cases (Type II error). Similarly in this group, we have not encountered any complication, otherwise.
Recently, Mathus-Vliegen et al  prospectively studied the efficacy of DB on super-morbid obese patients in a double-blind, sham-controlled and cross over trials. They confirmed the safety of DB, but there was no significant difference between the balloon and the sham regarding the achieved weight loss, although the achieved weight loss was very impressive in both.
We reanalyzed the data according to the compliance of the patients with our BMP and DC. The fifteen patients who complied with the BMP lost (15.95%) and (17.23%) of their BMI and body weight i.e. a mean value of 7.17 ± 4.54 kg/m 2 and 19.71 ± 15.02 kg, respectively. While the noncompliant thirteen patients lost only 4.7% and 4.79% of their BMI and body weight respectively.
The difference was significant (P 0.01) [Figure - 2]. These findings showed that both the two types of the intragastric balloons themselves had no significant effect on weight reduction and, indeed, the main effect is to be attributed to BMP. Barkin et al  studied this matter elegantly on the Garren-Edward Bubble and also found a significant difference in both the loss of weight and body mass index between the compliant and non-compliant groups of their patients. Kramer et al  decided to use GEB without any adjunct therapy and found after 12 weeks of treatment, that the mean weight loss was only 2.5 kg, which is similar to the results in our non-compliant patients. However, to our knowledge, our study is the first one to include the Danish Ballobes which were theoretically thought to be superior to GEB.
Two different types of intragastric balloons have also been tried both in Europe  and in the USA  without much impressive results. Other types of balloons have also been tried without significant results. Indeed, strict diet control proved to be superior to balloon in achieving weight reduction.
In conclusion, although the use of the two types of intragastric balloons was not associated with serious complications in our trial, none of them seems to be really effective, if used without the BMP.
We agree with Kral  to question whether the intragastric balloon idea is indeed "investigational", but definitely, at least, it should be abandoned in noninvestigational clinical use all over the world in agreement with the recommendations of Schapiro et al ,.
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Iyad M Subei
Division of Gastroenterology, Erfan General Hospital P.O. Box 6519 Jeddah 21452
Source of Support: None, Conflict of Interest: None
[Figure - 1], [Figure - 2]
[Table - 1], [Table - 2]