1. The use of Intragastric Balloon to reduce weight in the
management of Non-alcoholic Liver Disease and its
Effect on gastric ghrelin level
Shendy M. Shendy Sherif* and Nihal Al-Assaly** ,
Tropical, Hepatology and gastroenterology department*, Clinical biochemistry dep**,
Theodor Bilharz research Institute
Conference: 8th International Annual Congress of the Egyptian Society of Hepatology,
Gastroenterology and Infectious Diseases (ESHGID),in collaboration with Asian Pacific Association of
study of liver diseases (APASL) and the Egyptian Group of Colon and Rectal Surgeons. Helnan Palestine
Hotel, Alexandria, Egypt, Sept 13-15, 2006
Abstract:
Non-alcoholic liver disease is one of the components of the metabolic syndrome. Obesity and
insulin resistance are the most important etiological factors of accumulation of hepatocellular fat,
hepatic inflammation and fibrogenesis. The most important effective treatment of NAFLD is
weight reduction by all means, including diet and exercise. However, many patients do not respond
to these lines of treatment and ask for medical or surgical intervention to lose more weight. The
aim of this study is to evaluate the availability, the compliance, the efficacy and the safety of IGB
as a method of weight reduction in patients with NAFLD. The effects of weight reduction by this
manoeuvre on the liver affection, metabolic abnormalities and fasting ghrelin level are also
studied. Patients and methods: the study included 36 adult obese or morbid obese patients with
clinical evidences of steatohepatitis. All the patients are subjected to complete physical
examination, including weight, height, waist size, calculated BMI, waist hip ratio, and other vital
signs. Complete biochemical investigations, liver functions, abdominal ultrasound and H pylori
were done repeatedly before and after insertion of Intragastric balloon and for 6 months after
removal of the balloon. Results: The most common complaints of the patients after insertion were
nausea for 2-12 days (in 100%), vomiting for 3-7 days in 89% of patients and epigastric pain for
3–34 days in 67% of patients. Symptomatic reflux was reported by 31% of patients. The effects of
Intragastric balloon on all parameters of body weight, BMI, waist and waist/hip ratio, triceps skin
fold, fasting serum gherlin level serum cholesterol, triglycerides, uric acid, fasting blood sugar and
liver enzymes were highly significant (P <0.01). The mean weight loss was 20.98 ± 5.89 kg and
the mean reduction of BMI was 7.55 ± 2.03 after 6 months. All patients showed reduction of ALT
to below 1.5 the upper limit of normal. AST was normalized in all patients except two after 6
months. Normalization of liver enzyme ALT was found in 30/36 patients after 6 months and 32/36
patients 3-6 months after balloon removal. In all patients, AST was normalized after 3-6 months of
balloon removal. The grade of liver echogenicity was also significantly decreased towards normal
in all patients. The liver spans showed highly significant decrease after treatment (P <0.01).
Conclusion: It is concluded from this study that intragastric balloon is an available, effective,
acceptable as regards safety, and applicable method of weight reduction. It was also proved that
sustained weight loss by intragastric balloon, diet restriction and exercise; is one of the key
therapeutic interventions to limit the risks and comorbidities associated with the metabolic
syndrome including clinical manifestations of steatohepatitis such as elevated liver enzymes,
enlargement of the liver and increased echogenicity. The significant reduction in fasting ghrelin
level may be related to the decreased appetite and improved some metabolic parameters.
Introduction:

2. Non-alcoholic fatty liver disease (NAFLD) has been recently recognized as a leading cause of
chronic liver disease, with a prevalence estimated in some parts of the world of approximately
20%, far outweighing that of chronic hepatitis C virus (HCV) or alcoholic liver disease (Kim et al.,
2002; Clark et al., 2003 and Lonardo et al., 2004). The disease is becoming recognized as a
component of the metabolic syndrome and insulin resistance. Diagnosis of NAFLD can be made in
a patient who has mild elevation of transaminases, features of Syndrome X (obesity, diabetes, and
hyperlipidemia), insignificant alcohol consumption, no other liver disease, is not on potentially
steatogenic medications and has signs of steatosis on a liver ultrasound scan (Reaven 2001).
Typically, only a liver biopsy can confirm the diagnosis and determine the extent of disease. The
disease is progressive and carries a risk for progressive fibrosis, cirrhosis, end-stage liver disease
and even hepatocellular carcinoma (Tuma RS, 2005). The disease has a spectrum of histological
lesions. One end of the spectrum is bland steatosis, considered to be the most benign form of
NAFLD. On the other end of the spectrum is cirrhosis, which often may only be accompanied by
mild steatosis. Non-alcoholic steatohepatitis (NASH) is characterized by steatosis and varying
degrees of inflammation, hepatocellular damage and sinusoidal and portal fibrosis (PF) (Ludwig et
al., 1980 and Lee 1989).
Mechanisms responsible for the progression of fatty liver to NASH and cirrhosis are still not
clearly understood. Insulin resistance appears to be the common underlying metabolic abnormality
associated with NAFLD (Clark et al., 2002). It is assumed that obesity and insulin resistance are
the key correlates of hepatic inflammation and fibrogenesis; and insulin resistance is an antecedent
in the accumulation of hepatocellular fat. Also, excess intracellular fatty acids, oxidative stress,
energy depletion, and mitochondrial dysfunction cause cellular injury in the steatotic liver. High
serum free fatty acid concentrations allow greater hepatic fatty acid uptake. Increased fatty acid
delivery to the liver affects hepatocytes, interfering with insulin function and mitochondrial beta-oxidation.
Thus, obesity is the single most significant risk factor for the development of NASH
(Kitade et al 2005, Kakajima et al., 2005 and Bailey et al., 2005).
At present, there is no effective treatment for NAFLD other than weight loss by diet and
exercise, which would be advised regardless of the degree of liver disease in a patient who is
overweight and/or diabetic (Mendeler et al., 2005). However, many patients do not respond to
these lines of treatment and ask for medical or surgical intervention to lose more weight. Bariatric
operations can be technically challenging in massively obese patients. In selected patients
intragastric balloon can be used as effective and safe approach and could be a great help to induce
weight loss and to prepare for surgery. In one study, placement of an intragastric balloon can
reduce the excess weight by 10% within 3 months (Alfalah et al., 2006). It was also found a safe
and effective device that achieved moderate weight loss in a Chinese study (Lik-Man et al., 2006).
In the obese ethnic Chinese patients, median BW and BMI loss were 15.3 (range 5.3-30.9) kg and
5.6 (range 1.9-12.5) kg/m2 after IGB. The median waist circumference (WC) loss was 9 (range 4-
23) cm, and 66.7% of patients were highly satisfied with the treatment.
The gastric hormone ghrelin has recently been identified as an important modulator of energy
homeostasis. It is a 28-residue peptide hormone, secreted from the stomach. It is an endogenous
growth hormone secretagogue (GHS). It has orexigenic and anabolic actions, which are
independent from its ability to stimulate growth hormone (GH) secretion from the pituitary
(Kojima et al., 1999). Ghrelin induces adiposity in rodents by increasing food intake and
decreasing fat use (Tschop et al., 2000). More recently, ghrelin has also been shown to induce
appetite and increase food intake in humans, thus responsible for long-term regulation of body
weight (Wren et al., 2001) .Ghrelin regulation of energy balance is believed to be mediated by the
hypothalamus (Horvath et al., 2001). Physiologically, ghrelin levels rise shortly before a meal and

3. drop rapidly after a meal. Ingestion of glucose but not water or protein reduces circulating ghrelin
by 30–50%. Ghrelin concentrations have been reported to be indirectly correlated to BMI with
reduced level in obesity that increases in response to weight loss (Wren et al., 2001, Cummings et
al., 2001 and 2002, Caixas et al. 2002 and Shiiya et al. 2002). Short-term ghrelin application in
man directly stimulates appetite for several hours and reduces postprandial satiety (Wren et al.,
2001). Long-term infusion of ghrelin in animal models via centrally stimulating food intake
increases body fat accumulation and causes adiposity (Wren et al., 2001, Tschop et al., 2000 and
2002). In humans in states of chronic malnutrition such as anorexia nervosa, serum ghrelin levels
are increased whereas obesity is associated with decreased ghrelin concentrations that increase
after weight loss (Otto et al. 2001, Tschop et al., 2001 and Hanssen et al., 2002).
In polycystic ovary syndrome; which is one of the features of metabolic syndrome associated
with insulin resistance; the serum ghrelin level was found significantly lower compared with
healthy controls, and this was strongly related to the degree of insulin resistance (Schofl et al.,
2002). The plasma ghrelin level was found to increase with diet-induced weight loss while gastric
bypass and intragastric balloons were associated with significantly suppressed ghrelin levels,
possibly contributing to the weight-reducing effect of these procedures (Cummings et al., 2002 and
Mion et al., 2005).
The role of intragastric balloon (IGB) in metabolic syndrome associated with steatohepatitis
was not explored before. The simplicity, availability and lower cost of such measure in comparison
to surgical intervention help to explore these effects in addition to reduction of body weight and
BMI. Also the effect of weight reduction using this balloon on ghrelin level was not extensively
studied and needs to be re-evaluated as a possible etiological factor and as a therapeutic target in
weight control.
The aim of the work:
The aim of this study is to evaluate the availability, the compliance, the efficacy and the safety
of IGB as a method of weight reduction in patients with NAFLD. The effects of weight reduction
by this manoeuvre on the liver affection, metabolic abnormalities and fasting ghrelin level are also
studied.
Materials and methods:
This study is conducted in Elite Medical and Surgical centre; Riyadh, Saudi Arabia. It
included 36 adult patients with the following criteria:
1- Body mass index (BMI) between 29-46
2- Elevated liver enzymes for at least 3 months
3- Hepatic steatosis on abdominal ultrasound
4- Negative hepatitis markers for hepatitis viruses; HBV, HCV, HAV and HEV.
5- No history of alcohol intake
6- No major medical illness; such as cardiac, renal, hepatic, endocrinological (except DM), or
psychological diseases.
7- No recent history of medications that may increase body weight or affect liver function.
8- Written and informed consent given by the patient
9- Complete acceptance and expectation to the procedure and its side effects
10-No reflux oesophagitis, active peptic ulcer, gastritis or H pylori infection on endoscopic
examination
All the patients were given complete data about the procedure, side effects and expected effect
on the body weight and metabolic abnormalities. Written consent must be given by the patient.

4. Patients are followed for a period of 6 months when the balloon is removed and for more 6 months
after removal of the balloon.
All patients are subjected to the following:
1- History and complete physical examination including blood pressure, pulse, weight, height,
hip and waist sizes, waist/hip ratio, Calculation of BMI, and systemic examination
including ECG.
2- H pylori serology, lipid profile, uric acid, fasting blood sugar and CBC.
3- Liver function tests including ALT, AST, bilirubin, s albumin and prothrombin time
4- HBs Ag, HCV Ab, HAV Ab and HEV Ab.
5- Abdominal ultrasonography to evaluate size and echo-pattern of the liver, gall bladder and
other pathology. The echogenicity of the liver is graded roughly into normal, mildly
increased, moderately increased and markedly increased grades (1,2,3, and 4 respectively).
6- Upper gastrointestinal endoscopy just before insertion of intragastric balloon to examine
the oesophagus, cardia, stomach and duodenum in addition to taking antral biopsy for rapid
urease test of H pylori and general evaluation for the proposed volume of the fluid in the
balloon
7- Insertion of The BioEnterics Intragastric Balloon System (BIB, INAMED Corporation,
Santa Barbara, CA, USA) which is a smooth, spherical, silicone elastomer balloon and its
inflation with methylene blue-colored saline solution of 400-650 ml under direct vision.
Mild sedation using midazolam (2-5 mg) with or without fentanyl 100 mg intravenously.
Also, pulse, blood pressure and oxygen saturation were monitored all the time during
procedure.
8- After the procedure, patient can return home within 30 minutes and given instructions for
diet and possible medical treatment. Patients were given a balanced diet of 1000-1500
kcal/day starting with liquid diet for first 2 weeks followed by gradual return to usual diet
elements. Patients are encouraged to stick to regular exercise of at least one hour daily for
at least 5 days per week to increase their energy expenditure.
9- Follow up for one year with periodic examination, investigations of liver function,
ultrasound and metabolic profile.
10- Serum Ghrelin level is measured by the Desacyl-Ghrelin ELISA which is an enzymatically
amplified "two-step" sandwich-type immunoassay. In the assay, standards, controls and
unknown plasma samples are incubated in microtitration wells which have been coated
with anti-desacyl ghrelin monoclonal antibody. After incubation and washing, the wells are
treated with another anti-ghrelin detection antibody labeled with the enzyme horseradish
peroxidase (HRP). After a second incubation and washing step, the wells are incubated
with the substrate tetramethylbenzidine (TMB). An acidic stopping solution is then added
and the degree of enzymatic turnover of the substrate is determined by absorbance
measurement at 450 nm. The absorbance measured is directly proportional to the
concentration of desacyl ghrelin present. A set of desacyl ghrelin standards is used to plot a
standard curve of absorbance versus desacyl ghrelin concentration from which the desacyl
ghrelin concentrations in the unknowns can be calculated (Hosoda, H. et al. 2000 and
Matsumoto, M. et al.2001)
Statistical Analysis
Results are expressed as absolute values and mean ± SD. Statistical analysis of the data was carried out
using the ANOVA test. For correlation studies, the Pearson correlation coefficient was used. A p -value of <
0.05 was considered significant. Statistical analysis was performed using the SPSS 12 for window statistical
Package.

5. Results:
This study included 39 patients; 22 males and 17 females. Three female patients were excluded
from the study due to removal of balloon prematurely after 3, 5, and 47 days; mostly due to
intolerance to the abdominal pain and vomiting. The mean age of those who completed the study
protocol (36 patients) was 33.25 ± 11.21 years. Other basal data including height, weight, body
mass index (BMI) and waist circumference are shown in table 1. Biochemical data such as ALT,
AST, cholesterol, triglyceride, uric acid, and fasting blood sugar are shown in table 2. Bilirubin
and prothrombin time were found normal in all cases. Alkaline phosphatase was not done in these
patients. H pylori antibody positivity was detected in 21/36 patients (58.35%) in addition to 6
patients found to have positive rapid urease test on gastric biopsies with negative antibody test .
All positive patients (27 patients; 75%) were given eradication therapy for 2 weeks before the
balloon insertion. Mean procedure time was 21 ± 2.63 minutes (range 16-26) and mean amount of
fluids used for balloon inflation was 511.94 ± 38.48 ml of saline (range 450-600 ml) days. No
serious complications related to IGB insertion were encountered. The most common complaints of
the patients after insertion were nausea for 2-12 days (in 100%), vomiting for 3-7 days in 89% of
patients and epigastric pain for 3–34 days in 67% of patients. Symptomatic reflux was reported by
31% of patients. Endoscopic evaluation for severe symptoms was performed only in 2 patients
after 7 and 32 days. The first one of them was found to have severe reflux oesophagitis grade 2,
and the other to have erosive gastritis with H pylori positive rapid urease test. All these side effects
were managed by proton pump inhibitors in addition to anti-emetic medications (mainly
ondansetron; Zofran 4mg every 12 hours) followed by triple therapy for H pylori positive case.
Except for the three females in whom the balloon was removed, all were responding and continued
for the recommended period. No spontaneous deflation or migration was detected. All balloons
were deflated and removed after about 6 months of follow up. The mean time for removal was
25.64 ± 3.20 minutes (range 12-35 minutes).
The mean weight loss was 20.98 ± 5.89 kg and the mean reduction of BMI was 7.55 ± 2.03
after 6 months. The effects of Intragastric balloon on all parameters of body weight, BMI, waist
and waist/hip ratio, triceps skin fold, fasting serum gherlin level serum cholesterol, triglycerides,
uric acid, fasting blood sugar and liver enzymes were highly significant (P <0.01). Normalization
of liver enzyme ALT was found in 30/36 patients after 6 months and 32/36 patients 3-6 months
after balloon removal. All patients showed reduction of ALT to below 1.5 the upper limit of
normal. AST was normalized in all patients except two after 6 months. In all patients, AST was
normalized after 3-6 months of balloon removal. The grade of liver echogenicity was also
significantly decreased towards normal in all patients. The liver spans showed highly significant
decrease after treatment (P <0.01).
Table 1: mean and SD of age, height, weight, body mass index (BMI) and waist circumference in
patients studied.
Age (years) Height (cm) weight before ttt (kg) BMI before ttt Waist before ttt (cm)
Mean 33.25 165.33 94.12 34.52 104.64
Std D. 11.21 7.05 10.41 4.15 7.39
Table 2: mean and SD of ALT, AST, cholesterol, triglyceride, uric acid, and fasting blood sugar in
patients studied.
ALT
before
treatment
(μ/dl)
AST
before
treatment
(μ/dl)
Cholesterol
before
treatment
(mg/dl)
Triglyceride
before
treatment
(mg/dl)
Uric acid
before
treatment
(mg/dl)
Fasting blood
sugar before
treatment
(mg/dl)
Mean 70.25 64.89 221.72 217.42 6.98 120.22
Std D. 17.47 23.05 32.99 54.48 1.50 33.80

6. Table 3: the effect of Intragastric Balloon on the body weight and body mass index (BMI).
weight
before
treatment
weight
after 6
months
weight 3-6 months
after removal of
balloon
BMI
before
treatment
BMI after
6 months
BMI 3-6 months after
removal of balloon
Mean 94.12 73.22 73.47 34.52 26.88 26.98
Std Deviation 10.41 6.55 5.83 4.15 3.09 3.17
Table 4: the degree of loss and reduction of BMI after 6 month of Intragastric Balloon.
Weight loss after 6 months Reduction of BMI after 6 months
Mean 20.98 7.55
Std Deviation 5.89 2.03
Table 5: the effect of Intragastric Balloon on the waist circumference (cm) and waist/hip ratio.
Waist
before
treatment
Waist after
6 months
Waist 3-6 months
after removal of
balloon
Waist/hip
R before
treatment
Waist/hip R
after 6 months
Waist/hip R after 3-6
months of removal
of Balloon
Mean 104.64 97.47 96.94 1.14 1.06 1.06
Std Deviation 7.39 6.80 5.88 .06 .06 .05
Table 6: the effect of Intragastric Balloon on the Alanine aminotransferase (μ/dl).
ALT before
treatment
ALT after 1
month
ALT after 3
month
ALT after 6
month
ALT 3-6 month after
removal of balloon
Mean 70.25 62.39 46.25 33.22 30.47
Std Deviation 17.47 14.19 11.73 8.74 7.14
Table 7: the effect of Intragastric Balloon on the Alanine aminotransferase (μ/dl).
AST before
treatment
AST after 1
month
AST after 3
month
AST after 6 month AST after 9-12 month
Mean 64.89 52.03 41.39 30.22 27.22
Std Deviation 23.05 15.31 11.18 7.14 4.88
Table 8: the effect of Intragastric Balloon on the S. cholesterol, triglycerides, and uric acids (mg/dL).
Cholesterol
before
treatment
Cholesterol
after
treatment
Triglyceride
before
treatment
Triglyceride
after
treatment
Uric acid
before
treatment
Uric acid
after
treatment
Mean 221.72 190.64 217.42 179.58 6.98 6.41
Std Deviation 32.99 25.32 54.48 25.90 1.50 1.05
Table 9: the effect of Intragastric Balloon on the fasting blood sugar (mg/dl), F. gherlin level
(pmol/L) and triceps skin fold (cm).
Fasting blood
sugar before
treatment
Fasting blood
sugar after
treatment
Fasting Gherlin
level before
treatment
Fastin g
Gherlin level
after treatment
Triceps skin
fold before
treatment
Triceps skin
fold after
treatment
Mean 120.22 109.94 293.17 237.03 2.62 2.22
Std D. 33.80 27.59 73.44 56.82 .54 .44
Table 10: the effect of Intragastric Balloon on liver spans (cm) and echogenicity.

7. Liver span in
MCL before
treatment
Liver span in
MCL after
treament
Liver span in
ML before
treatment
Liver span in
ML after
treatment
Liver
echogenicity
before treatment
Liver
echogenicity
after treatment
Mean 15.24 13.69 13.67 12.18 2.94 1.889
Std D 1.36 .93 .95 .99 .75 .747
Discussion
Based on autopsy studies, estimates suggest that 20% to 30% of adults have excess fat
accumulation in the liver and 2% to 3% of adults meet diagnostic criteria for NASH
(Neuschwander-Tetri and Caldwell, 2003). In a prospective study of 241 consecutive patients in
a primary care clinic, the prevalence of fatty liver was 37% (Dasarathy et al., 2005). Patients
with NAFLD were more likely to be obese and have diabetes (54% vs. 4%), hypertension (41%
vs 10%), and insulin resistance (54% vs. 20%). Obesity and insulin resistance are key factors in
exacerbating hepatic inflammation and fibrogenesis in NASH. Weight loss was found the most
effective measure in the management of this disease (Mendeler et al., 2005).
Intragastric balloons are a temporary non-surgical obesity treatment that induces short-term
weight loss by partially filling the stomach to achieve satiety and reduce food intake. The time
required for balloon insertion or removal was comparable to and even lower than the previous
studies. In this study, the time required for insertion was 21 ± 2.63 minutes and for removal was
25.64 ± 3.20 minutes. In one previous study, the time of insertion was 25 minutes with hospital
stay of average of 2 days (Lik-Man, et al., 2006). No patients were admitted in this series. Thus,
this method can be applicable in the management of obesity associated with other comorbidity.
A new strategy was followed for the first time in this work in which serological H pylori
testing was performed pre-operatively for all patients. The objective is to treat this infection to
avoid its activation in the presence of balloon leading to gastric inflammation or ulceration.
These can add to the complaints of the patients particularly abdominal pain. Positive cases were
given eradication therapy. Negative cases were again tested during endoscopy by rapid urease
test and, if positive, eradication therapy was given before balloon implantation. Twenty one
patients were positive by antibody testing while 6 patients were only positive by rapid urease test
of antral biopsy. Therefore, it is recommended to do tissue-dependent tests for all patients; either
rapid urease or breath test to avoid the false negative serology not uncommonly seen in these
asymptomatic patients. Also, the prevalence of H pylori infection in these random of
asymptomatic patients was 75 % which can be considered a reflection of the prevalence in the
community.
Nausea, vomiting and abdominal pain are the most common complaints in these patients
(100%, 89%, 67% respectively). These occurred predominantly in the first few days up to one
week in most cases, rarely lasted longer, after balloon implantation. They were managed easily
by common medications. Severe complications were rare in this study and endoscopy was rarely
required to re-evaluate such severity, added to the early removal of balloons in 3 patients. The
reflux symptoms and vomiting were most annoying to the patients but can be managed in all
cases. It was known that chronic distension by an intragastric balloon increased reflux up to 10
week after placement because of an increase in the percentage of lower oesophageal sphincter
relaxation time (TLESRs) accompanied by a reflux episode. In addition, prolonged balloon
distension increased the rate of TLESRs and created a postprandial state even 10 wk after
balloon placement. After 20 wk these effects largely resolved, illustrating adaptation to this
artificial situation (Hirsch et al., 2003). Also, delayed gastric emptying may add to the severity of

8. reflux as shown in one study in which it was found that gastric emptying rates were significantly
decreased with the balloon in place, and returned to pre-implantation values after balloon
removal (Mion et al., 2005). In one study, nausea and vomiting in the first week occurred in
77.2%, abdominal pain in 15.9 % and gastroesophageal reflux in 6.8%. Hypokalemia also
occurred in 6.8%, functional renal insufficiency in 4.5 % in addition to one gastric perforation
that was treated laparoscopically after removal of the balloon, one gastric ulcer and 4 cases of
intolerance (Al-Momen and El-Mogy, 2005). In another earlier study, 76.8% of the patients
(41/69) complained of severe nausea and vomiting lasting an average of 1 week (1 day-6
months), resulting in 3 patients in early removal of the balloon (at 1 day, 1 week, 1 month after
placement respectively). 2 patients suffered gastric perforation presenting as acute peritonitis 3
and 4 months after placement and were operated. Extraction of the balloon was performed in 3
patients after 3 months and in 66 patients after 6 months. In 11 patients (22%), esophagitis was
present (8 grade 1, 2 grade II, 1 grade III), and one patient showed diffuse gastric erosion. One
patient required removal of the balloon by rigid esphagoscopy following technical failure of the
endoscopic extraction device (Totté et al., 2001).
In a big Italian experience of 2,515 patients, positioning of the Bioenteric Intragastric
Balloon (BIB) was uncomplicated in all but two cases (0.08%), with acute gastric dilation treated
conservatively. Overall complication rate was 70/2,515 (2.8%). Gastric perforation occurred in 5
patients (0.19%), 4 of whom had undergone previous gastric surgery: 2 died and 2 were
successfully treated by laparoscopic repair after balloon removal. 19 gastric obstructions (0.76%)
presented in the first week after positioning and were successfully treated by balloon removal.
Balloon rupture (n=9; 0.36%) was not prevalent within any particular period of BIB treatment,
and was also treated by BIB removal. Esophagitis (n=32; 1.27%) and gastric ulcer (n=5; 0.2%)
presented in patients without a history of peptic disease and were treated conservatively by
drugs. Preoperative co-morbidities were diagnosed in 1,394/2,471 patients (56.4%); these
resolved in 617/1,394 (44.3%), improved (less pharmacological dosage or shift to other
therapies) in 625/1,394 (44.8%), and were unchanged in 152/1,394 (10.9%) (Genco et al., 2005).
On the other hand, there are more complications after barietric surgery. In one study over a
20-year period of 32 adolescents, 3 had gastroplasty, 16 had gastric bypass, 3 had distal gastric
bypass, and 10 had long-limb gastric bypass. Despite there were no postoperative deaths or
leaks, early complications included 1 pulmonary embolus, 1 major wound infection, 4 minor
wound problems, 3 stomal stenoses that were dilated endoscopically, and 4 marginal ulcers
treated with acid suppression. Late complications included 1 bowel obstruction, 4 incisional
hernias, and 1 sudden death 6 years after surgery. Two patients needed revisional surgery, 1 for
malnutrition and 1 for inadequate weight loss (Vogin, 2002).
Most of the patients in this study were in the 4th decade of life with their BMI in the range of
obesity or morbid obesity (39-46) and increased waist circumference. They had higher
cholesterol and triglyceride levels than normal. Uric acid level was in the high normal range in
most patients. Many cases are diabetic or having fasting hyperglycaemia. All these parameters,
which are components of metabolic syndrome, showed highly significant improvement with
reduction of body weight during early follow up period of the study and continued to improve
after removal of balloon. Thus, reduction of body weight helps to correct many metabolic
changes related to obesity and intragastric balloon showed a highly effect method in this
situation.
Satisfactory weight loss was achieved in most patients of this study during the treatment
period and even during follow up after removal of balloon. The mean loss of body weight after 6

9. months was 20.98 ± 5.89 kg and mean reduction of BMI was 7.55 ± 2.03. These effects are more
than expected from previous studies. Another important finding in this study is the maintenance
of reduction of body weight and BMI without significant increase for about 6 months after
removal. This stationary phase is very important to stabilize the patients and prevent rapid
rebound of their initial measures and metabolic abnormalities. The strict follow up and
encouraging of patients to continue on diet restriction and exercise programs were the main
factors behind this success. All the previous studies using this manoeuvre showed also
significant reduction in body weight. The loss of excess weight ranged from 33.9 to 50.8%, the
BMI was reduced by 4.8- 9 kg/m2 and the mean weight loss was 13.0- 33 kg. Weight loss was
accompanied by an improvement of the diseases associated with obesity, in particular diabetes.
The BIB system was found a safe and efficient measure of reducing weight in patients with mild
or moderate obesity and as preoperative treatment for super-obese patients to reduce the surgical
risk before LAGB ( laparoscopic gastric banding). In these studies, it was concluded that BIB is
an effective procedure with satisfactory weight loss and improvement in co-morbidities after 6
months (Totté et al. (2001, Doldi et al., 2002, Al-Momen and El-Mogy, 2005 and Genco et al.,
2005).
It was known that the level of Ghrelin rise in the fasting state immediately before the time of
the meal then decreases in the postprandial period to the original level. In this study and in a
previous study (Mion et al., 2005), the fasting level was found to decrease after reducing the
weight by the intragastric balloon. As ghrelin has been shown to induce appetite and increase food
intake in humans, it may be responsible for long-term regulation of body weight (Wren et al.,
2001). The decrease in gastric emptying rates and gastric distension by the presence of the balloon
may be the factors responsible for such effect. Ghrelin inhibition may explain part of the effect of
the balloon on satiety. (Mion et al., 2005). However, it is unclear whether the decrease of ghrelin
after balloon-induced weight reduction is an incidental finding or has a role in the whole process
with improvement in many metabolic abnormalities such as insulin resistance, fasting blood sugar
and lipid profile.
In vivo and in vitro data suggest a stimulatory action of ghrelin on insulin release (Broglio et
al., 2001, Egido et al., 2002, Lee et al., 2002 and Date et al.,2002). On the other hand, insulin
stimulates up-regulation of ghrelin mRNA in the stomach in vitro, but in vivo iv insulin has no
impact on circulating ghrelin levels in humans, demonstrating a complex interplay between both
hormones (Caixas et al., 2002, Toshinai et al., 2001). Thus, apart from its role in the control of
appetite and body weight, ghrelin could be linked to insulin resistance in these patients.
In this study, it was found that ALT and to a less extent AST were elevated before weight
reduction. They showed highly significant reduction and mostly normalized in most patients after
6 months of maintained weight reduction by the BIB system. Non-alcoholic fatty liver disease is
becoming recognized as a component of the metabolic syndrome and insulin resistance. Elevations
of ALT, AST, and ALK are common in individuals with type 2 diabetes as well as the metabolic
syndrome. ALT was found to be the most specific marker of liver pathology and appears to be the
best marker for liver fat accumulation in patients with NAFLD (Tiikkainen et al., 2003). In another
study, ALT, but not aspartate aminotransferase levels were found to increase progressively with
the increasing number of metabolic syndrome abnormalities and the levels of ALT and ALK were
correlated with the number of metabolic disorders (Naveed Sattar et al., 2004).
It is concluded from this study that intragastric balloon is an available, effective, acceptable as
regards safety, and applicable method of weight reduction. Also, close follow up and compliance
of patients after balloon removal help to maintain weight loss beyond the recommended period of

10. the balloon. It was also proved that sustained weight loss by intragastric balloon, diet restriction
and exercise; is one of the key therapeutic interventions to limit the risks and comorbidities
associated with the metabolic syndrome including clinical manifestations of steatohepatitis such as
elevated liver enzymes, enlargement of the liver and increased echogenicity. The significant
reduction in fasting ghrelin level may be related to the decreased appetite and improved some
metabolic parameters.
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استخدام بالون المعدة لنققاص الوزن كوسيلة لعلج مرض التشمع الكبدى
.الغير كحولى وتأثيرها على مستوى الغرلين المعدي بالدم
شندى محمد شندى شريف. قسم المراض المتوطنة معهد تيودور بلهارس للبحاث
نقهال العسالى قسم الكيمياء الكلينيكية معهد تيودور بلهارس للبحاث
يعتبر مرض التشمع الكبدى الغير كحولى أحد مكونقات متلزمة التمثيل الغذائى وان السمنة وعدم الستجابة للنقسولين هههى
أهم العوامل المسببة لتراكم الدهون قى خليا الكبد ومن ثم التهابه وتليفه. ومههن ثهم فهٳن إنققهاص الهوزن باسهتخدام الحميهة
الغذائية وممارسة الرياضة يعتبر أهم الوسائل الفعالة على الطلق لعلج هذا المرض. ولكن الكثير من هههؤلء المرضههى ل
يستجيبون لذه الوسائل وعادة ما يبحثون عن تدخل دوائي أو جراحى للمساعدة فى انققاص أكثر للوزن. وقد كان الهدف من
هذا البحث هو تقييم كفاءة واستعمال وأمان وتأقلم المرضهى مهع هههذه الوسهيلة فهى مرضهى التشهمع الكبههدى الغيههر كحهولى
وتأثيرها فى انققاص الوزن على حالة الكبد و خلل التمثيل الغذائى و مستوى الغرلين المعدي بالدم. وقد شملت الدراسههة ٣٦
مريضا بالغا يعانقون من السمنة أو السمنة المفرطة مع وجود دلئهل اللتههاب الكبههدى التشهمعى. وقههد تهم فحصهههم اكلينيكهها
لمعرفة الوزن والطول و محيط الخاصر و معدل كتلة الجسم الحسابى ونقسبة المحيط عند مفصل الحوض الههى المحيههط عنههد
الخاصر والعلمهات الحيويهة الخهري، ههذا بالضهافة الهى الفحهوص الكيميائيهة ووظهائف الكبهد والموجهات الفهوق صهوتية
والبكتريا الحلزونقية البوابية وذلك قبل و أثنهاء وجهود وبعهد إزالهة البهالون لمههدة ٦ أشههر. وقههد لهوحظ فهى ههذا البحههث أن
الشعور بالغثيان والقئ وألم المعدة كانقت أكثر العراض التى اشتكى منها المرضى بعد تركيههب البههالون وقههد حههدثت حسههب
٣٤ يوما. وحههدثت ־ ٧ و ٣ ־ ١٢ و ٣ ־ الترتيب فى ١٠٠ ٪ و ٨٩ ٪ و ٦٧ ٪ وذلك فى مدة تتراوح حسب الترتيب أيضا من ٢
شكوى من الرتداد المعدي المرئ فى ٣١ ٪. وكان التأثير اليجابى لبالون المعدة ذو دللة إحصائية علهى كهل مههن الههوزن و
محيط الخاصر و معدل كتلة الجسم الحسابى ونقسبة المحيط عند مفصل الحوض الى المحيههط عنههد الخاصههر وسههمك الجلههد و
مستوى الغرلين المعدي بالدم والكولسترول و الدهون الثلثية وحمض البوليك والسكر وإنقزيمات الكبههد حيههث كهان متوسهط
٢٫٠٣ بعد ٦ أشهر وقههد انقخفضههت إنقزيمههات الكبههد إلههى ± ٥٫٨٩ كجم وفى معدل كتلة الجسم ٧٫٥٥ ± نققص الوزن ٢٠٫٩٨
إلههى الطهبيعى فهى ٣٠ مريضهها بعههد ٦ ALT)) أقل من ١٫٥ المعدل الطبيعى فى جميع المرضى. وانقخفضت إنقزيمههات الكبههد
إلهى الطهبيعى فهى جميهع المرضهى AST)) ٦ أشهر من بعد إزالة البالون. وانقخفضت إنقزيمات الكبهد ־ أشهر وفى ٣٢ بعد ٣
٦ أشهر من بعد إزالة البالون. وقههد تحسههن النمهط الصهوتى للكبههد وحجمهه تحسهنا ذو ־ فقط بعد ٦ أشهر ماعدا اثنين بعد ٣
دللة إحصائية فى التجاه الطبيعى فى كل المرضى. يستنتج من هذا البحث أن بالون المعدة وسيلة متاحههة وفعالههة ومقبولههة
حيث أنقها آمنة ويمكن استخدامها لنققاص الوزن كما ثبهت أن اسهتمرار إنققهاص الهوزن بواسهطة بهالون المعهدة مهع الحميهة
الغذائية وممارسة الرياضة تعتبر المدخل الرئيسى للحد من الخاطر والمراض المصاحبة لمتلزمة التمثيل الغذائى بمهها فههى
ذلههك أعههراض وعلمههات اللتهههاب الكبههدى التشهمعى مثههل ارتفههاع إنقزيمههات الكبههد و تضهخمه وزيههادة النمههط الصههوتى. وان
النقخفاض ذو الدللة فى مستوى الغرلين المعدي بالدم قد يكون لهه علقهة بتقليهل الشههية و تحسهن بعهض عوامهل التمثيهل
الغذائى.