Saudi Journal of Gastroenterology
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Year : 1996  |  Volume : 2  |  Issue : 2  |  Page : 63-68
The effect of different types of intragastric balloons with and without a behavior modification program in morbid obesity


Department of Medicine and Clinical Psychology-Psychiatry, Erfan General Hospital, Jeddah, Saudi Arabia

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   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 Aug 11];2:63-8. Available from: http://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 [1] . Diet and exercise programs often fail to achieve a significant and persistent weight reduction [2] and various surgical procedures have several complications [3] .

Based on the clinical observation of patients with pathologic intragastric bezoars who experience a remarkable weight reduction due to appetite loss [4] , 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) [15],[16],[17],[18],[19],[20],[21],[22],[23],[24],[25] . 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 Top


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 Selection:

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.

Balloon

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 Top


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 Top


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 [1] . 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" [2] . 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 [3] 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 [4] . 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 [5] . 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 [5] . 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 [6],[7],[8] . 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 [5],[6],[7],[8],[9],[10],[11],[12],[13] . 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 [6],[7],[8] . 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 [13],[14],[15] and to removing the balloon after three months of implantation [12],[13],[15],[17] . Since there had been growing evidence in the literature [9],[10],[11],[12],[13],[14],[15],[16],[17] 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 [15],[16],[17] , 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 [19],[10],[22] . 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 [19],[20],[26] . 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 [14] . In contrast Barkin et al [14] 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 [22] 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 [21] 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 [23] 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 [24] and in the USA [25] 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 [18] 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 [13],[27].

 
   References Top

1.Health Implications of Obesity. National Institute of Health Consensus Development Conference (Statement). Ann of Inter Med 1985;103:147-51.  Back to cited text no. 1    
2.Wadden TA, Stunkard AJ, Brownell KD, Day SC. Treatment of Obesity by behavior therapy and very low calorie diet. J Consult Clin Psychol 1984;52:692-4.  Back to cited text no. 2  [PUBMED]  
3.Martin et al: Complications of gastric restrictive operations in morbidly obese patients. Surg Clin of North Am 1983;63:1181-92.  Back to cited text no. 3    
4.Debakey M, Ochmer A. Bezoars and concretions: a comprehensive review of the literature with an analysis of 303 collected cases and a presentation of additional cases. Surgery 1938;4:934-63.  Back to cited text no. 4    
5.Schapiro M. Has Bubble Therapy for obesity been deflated ? Gastroenterology 1988;95:834-6.   Back to cited text no. 5  [PUBMED]  
6.Garren LR and Garren ML. The Garren Gastric Bubble: an aid to treatment of obesity. Gastrointest Endoscopy 1985;31;162 (Abstract).  Back to cited text no. 6    
7.Garren LR, Garren ML. Garren RB, Giordano F. Gastric Balloon Implantation for weight loss in the morbidly obese. Am J Gastroenterol 1985;80:860(Abstract).  Back to cited text no. 7    
8.Kirby DF, Mills PR, Wade JB, Zfass Am et al. A prospective study of the Garren Gastric Bubble in the treatment of morbid obesity. Gastroenterology 1987;92:1467(A).  Back to cited text no. 8    
9.Boyle TM, Agus SG and Bauer JJ. Small Intestinal Obstruction Secondary to obturation by a Garren Gastric Bubble. Am J Gastroenterology 1987;82:51-3.  Back to cited text no. 9    
10.Kirby DF, Mills PB, Kellum JM et al. Incomplete Small Bowel Obstruction by the Garren-Edwards Gastric Bubble necessitating surgical intervention. Am J Gastroenterol 1987;82:251-3.  Back to cited text no. 10    
11.Fedotin MS and Ginsberg BW. Partial deployment of the Garren Gastric Bubble: A new complication. AM J Gastroenterology 1987;82:471-1.  Back to cited text no. 11    
12.Benjamin SB. Small bowel obstruction and the Garren Edward Bubble: Lessons to be learned ? Gastrointestinal Endoscopy 1987;33:836(A).  Back to cited text no. 12    
13.Schapiro M, Benjamin S, Blackburn G et al. Obesity and the gastric balloon. A comprehensive workshop, Tarpon Springs, Florida. March 19-21, 1987. Gastrointestinal Endoscopy 1987;33:323-27.  Back to cited text no. 13    
14.Levine GM, Goldstein M, Lowe M et al. The Gastric Buble­Fad or Fantastic? Gastroenterology 1987;92:1505(A).  Back to cited text no. 14    
15.Benjamin SB, Maher KA, Cattau El et al. Double-blind controlled trial of the Garren Edwards Gastric Bubble: an adjunctive treatment for exogenous obesity. Gastroenterology 1988;95:581-8.  Back to cited text no. 15    
16.Meshkinpour H, HSU D, Farivar S. Effect of Gastric Bubble as a weight reduction device: a controlled, cross-over study. Gastroenterology 1988;95:589-92.  Back to cited text no. 16  [PUBMED]  
17.Hogan RB, Johnston JH, Long BW et al. A double-blind, randomized sham-controlled trial of the gastric bubble for obesity. Gastrointest Endoscopy 1989;35:381-5.  Back to cited text no. 17    
18.Kral JG, Gastric Balloons: a plea for sanity in the midst of balloonacy. Gastroenterology 1988;95:213-5.  Back to cited text no. 18    
19.Nieben O, Harboe H, Ballobes Intragastric Balloon in a multicentre trial-II. 5th Annual Symposium on Surgical Treatment of Obesity, Los Angeles, U.S.A. February 11-14, 1987.  Back to cited text no. 19    
20.Durano D, Taylor TV. Comparison of weight loss with short-term dietary and intragastric balloon treatment. Gut 1989;30:565-8.  Back to cited text no. 20    
21.Barkin JS, Reiner DK, Goldberg RI et al. Effects of Gastric Bubble implant on weight change with and without compliance with a behavior modification program. Am J Gastroenterology 1988;930-4.  Back to cited text no. 21    
22.Mathus-Vliegen EMH, Tytgat GNJ, Veldhuyzen-Offermans. Intragasric Balloon in the treatment of Super-Morbid obesity: Double-Blind, Sham-Controlled, Crossover Evaluation of 500 ml balloon. Gastroenterology 1990;99: 362-9.  Back to cited text no. 22    
23.Kramer FM, Stunkard AJ, Spiegel TA et al. Limited weight loss with gastric balloon. Arch Intern Med 1989;149:411-3.  Back to cited text no. 23    
24.McFarland RJ, Grundy A, Gazet JC et al. The intragastric balloon: a novel idea proved ineffective. Brit J Surg 1987;137-9.  Back to cited text no. 24    
25.Marshal JB, Schreiber H, Kolozsi W et al. A prospective, multicenter clinical trial of the Taylor Intragastric Balloon for the treatment of morbid obesity. Am J Gastroenterology 1990;85:833-7.  Back to cited text no. 25    
26.Perez-Cuadrado, Martinez E. Silva, Dourada R. Lama, Robles Reyes A. Complications of the intragasric balloon prosthesis. Rev Esp Enferm Diag 1993;84:291-5.  Back to cited text no. 26    
27.Kirby DF, Wade JB, Mills PR, Sugerman HJ, Keller JM, Zfars AM, Starkey JV: A Prospective assessment of Garren-Edwards Gastric Bubble and bariaric surgery in the treatment of morbid obesity. Am J Surg 1990;56:575-80.  Back to cited text no. 27    

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Correspondence Address:
Iyad M Subei
Division of Gastroenterology, Erfan General Hospital P.O. Box 6519 Jeddah 21452
Saudi Arabia
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Source of Support: None, Conflict of Interest: None


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