BioEnterics Intragastric Balloon (BIB): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients.

BACKGROUND: The BioEnterics Intragastric Balloon (BIB) System in association with restricted diet has been used for the short-term treatment of morbid obesity. Aim of this study was to evaluate the real, short term, efficacy of the BIB for weight reduction in morbidly obese patients by using a prospective, double-blind, randomised, sham-controlled, crossover study. METHODS: Patients were recruited from January 2003 to December 2003. After selection, they were randomly allocated into two groups: BIB followed by sham procedure after 3 months (Group A), and sham procedure followed by BIB after 3 months (Group B). All endoscopic procedures were performed under unconscious intravenous sedation. The BioEnterics Intragastric Balloon (Inamed Health; Santa Barbara, CA, USA) was filled by using saline (500 ml) and methylene blue (10 ml). Patients were discharged with omeprazole therapy and diet (1000 kcal). Patients were followed up weekly by a physician blinded to randomisation. In both groups mortality, complications, BMI, BMI reduction and %EWL were considered. Data were expressed as mean +/- s.d., except as otherwise indicated. Statistical analysis was performed by means of Student's t-test, Fisher's exact test or chi (2) with Yates correction; P < 0.05 was considered significant. RESULTS: A total of 32 patients were selected and entered the study (8M/24F; mean age: 36.2 +/- 5.6 years, range 25-50 years; mean BMI 43.7+/-1.5 kg/m(2), range 40-45 kg/m(2); mean %EW: 43.1 +/- 13.1, range: 35-65). All patients completed the study. Mortality was absent. Complications related to endoscopy, balloon placement and removal were absent. Mean time of BIB positioning was 15 +/- 2 min, range 10-20 min. After the first 3 months of the study, in Group A patients the mean BMI significantly (P < 0.001) lowered from 43.5 +/- 1.1 to 38.0 +/- 2.6 kg/m(2), while in Group B patients the decrease was not significant (from 43.6 +/- 1.8 to 43.1 +/- 2.8 kg/m(2)). The mean %EWL was significantly higher in Group A than in Group B (34.0 +/- 4.8 vs 2.1 +/- 1%; P < 0.001). After crossover, at the end of the following 3 months, the BMI lowered from 38.0 +/- 2.6 to 37.1 +/- 3.4 kg/m(2) and from 43.1 +/- 2.8 to 38.8 +/- 3.1 kg/m(2) in Groups A and B, respectively. CONCLUSIONS: The results of this study show that treatment of obese patients with BioEnterics Intragastric Balloon is a safe and effective procedure. In association with appropriate diet it is significantly effective in weight reduction when compared to sham procedure plus diet. The BIB procedure can play a role in weight reduction in morbidly obese patients or in the preoperative treatment of bariatric patients.

Laparoscopic adjustable silicone gastric banding: prospective evaluation of intragastric migration of the lap-band.

Intragastric prosthesis (Lap-Band, BioEnterics Co., Carpinteria, CA, U.S.A.) migration is one of the major long-term complications of laparoscopic adjustable silicone gastric banding. The causes, clinical signs, timing, and overall incidence of band entrapment have not been prospectively investigated in a large series. The purpose of this study was to assess prospectively the incidence of Lap-Band intragastric migration and to establish the safety and effectiveness of minimally invasive band removal. Between January 1996 and June 2000, 148 consecutive patients enrolled in a multidisciplinary bariatric program underwent laparoscopic adjustable silicone gastric banding. In the follow-up treatment, gastrointestinal endoscopy was performed routinely. One hundred twenty-three patients with a minimum follow-up period of 12 months were entered into the study group. Eleven (9.2%) patients had long-term major complications. Intragastric band migration was observed in nine (7.5%) patients. The diagnosis was established by routine endoscopy between 10 and 41 months after surgery. Five erosions occurred in the first 30 cases (learning curve period). In six patients, the band was removed by an intragastric endoscopic-assisted approach avoiding laparotomy. The remaining three patients are under endoscopic surveillance. The results of this study show that routine upper gastrointestinal endoscopy can discover asymptomatic band migrations early. Band erosion did not require emergency treatment and can be removed safely by a minimally invasive approach.

Long-term changes in nodular goiter: a 5-year prospective randomized trial of levothyroxine suppressive therapy for benign cold thyroid nodules.

We studied for 5 yr a homogeneous group of 83 patients randomly assigned to a levothyroxine (L-T4) suppressive therapy or to a control group to evaluate changes in nodule or thyroid size, appearance of new nodules, and correlations with clinical parameters. In the control group, mean nodule volume increased significantly after 5 yr (2.12 +/- 1.46 vs. 1.46 +/- 0.77 mL), whereas in the treatment group it decreased, although not significantly (1.45 +/- 1.17 mL vs. 1.53 +/- 0.61 mL). Baseline nodule volume was not different in the two groups, but a significant difference was observed at 5 yr. After 5 yr, sonograms detected 12 new nodules in the control group (28.5%) and 3 (7.5%) in the treatment group. Nodule shrinkage was more frequent in patients with complete TSH suppression, but no correlation was found with other parameters. A significant increase in thyroid size was observed in the control group. In conclusion, long term TSH suppression induced volume reduction in only a subgroup of thyroid nodules, but effectively prevented the appearance of new lesions and increases in nodule and thyroid volume. As the changes in the natural history of nodular goiter are related to prolonged TSH suppression, which can induce unfavorable side-effects, L-T4 suppressive therapy should be reserved for small nodules in younger patients.

A prospective randomized trial of levothyroxine suppressive therapy for solitary thyroid nodules.

OBJECTIVE: We examined the effects of L-thyroxine therapy versus placebo over a 12-month period on volume of solitary thyroid nodules. DESIGN: Prospective randomized clinical trial; placebo and control groups followed for one year in three centres. PATIENTS: One hundred and one euthyroid patients with single palpable colloid thyroid nodules. MEASUREMENTS: Serum thyroid hormones, TSH, thyroglobulin, anti-thyroglobulin and anti-thyroid peroxidase antibodies measured at the first visit and after 2, 6 and 12 months; nodule volume and contralateral thyroid lobe thickness measured by ultrasound in double blind fashion; nodule diameter measured by palpation every 6 months. RESULTS: In the treatment group the nodule volume measured by ultrasound decreased progressively but not significantly; in the placebo group no changes were demonstrated. The number of nodules which decreased in size was however significantly larger in the treatment group. None of the initial parameters was predictive for the response. In the treatment group the nodule size assessed by palpation showed a significant decrease after 12 months when compared to baseline. CONCLUSIONS: In non-endemic areas TSH suppression induces nodule volume reduction measured by ultrasound which, although not significant, seems to be progressive and occurring only in a subgroup of patients. Significant palpatory nodule reduction is probably related to decreased thickness of the surrounding thyroid tissue still responsive to TSH.

Hürthle cell hyperplasia and sarcoidosis of the thyroid.

We report of a case of Hürthle cell hyperplasia of the thyroid that was correctly identified preoperatively by fine-needle aspiration cytology but was unexpectedly associated with sarcoid granulomas. To our knowledge, the association has not been previously reported. The rarely described thyroid involvement by sarcoidosis is briefly reviewed.

Electrocardiographic abnormalities in childhood spinal muscular atrophy.

Tremors of the isoelectric line in routine electrocardiograms have been described in patients with spinal muscular atrophy and have been interpreted as fasciculations of denervated muscles. In order to evaluate this phenomenon, 13 patients with spinal muscular atrophy have been studied (average age: 37.3 months). A first electrocardiogram was recorded routinely; a second tracing was then recorded with double sensitivity and double speed. In addition, all patients were evaluated clinically and had M-mode and cross-sectional echocardiography. Regular and constant spikes on the isoelectric electrocardiographic line were recorded in 12 patients (93.4%); their frequency ranged from 39 to 48 cycles/sec (average: 42.08 +/- 2.64). Contrary to previous reports, we found an "abnormal" electrocardiogram in all our patients with severe spinal muscular atrophy. The only patient with a normal electrocardiogram had a mild and clinically stable form of spinal muscular atrophy. We did not find any significant structural cardiac abnormality by clinical and echocardiographic evaluation. We conclude that continuous tremor on the isoelectric line of electrocardiogram represents a characteristic of spinal muscular atrophy in these patients. It is a result of muscle fasciculations and does not imply any abnormality of the heart.

Pulmonary cryptococcosis and Cushing's syndrome.

Pulmonary cryptococcosis occurred in two patients with Cushing's syndrome, both of whom were successfully treated with amphotericin B and flucytosine. Excessive endogenous production of corticosteroids may have predisposed these patients to the development of opportunistic infection. Persons with Cushing's syndrome and a pulmonary infiltrate should be examined for infection with Cryptococcus neoformans in addition to an examination for ectopic adrenocorticotropic hormone production.

The relationship between serum triiodothyronine and thyrotropin during systemic illness.

The reported failure of serum TSH to rise in response to the low serum T3 of severe systemic illness may be due to the known stress inhibition of TSH secretion. We therefore measured TSH and total and free thyroid hormones during the course of recovery from severe illness. During recovery, TSH increased at a time when T3 was rising but still below normal (mean TSH during recovery, 6.5 +/- 0.8 SEM microU/ml, n = 41 vs. normal, 2.5 +/- 0.2 SEM microU/ml; n = 31; P less than 0.001), TSH concentrations were negatively correlated with total and free T3 and less strongly correlated with total T4 but not with free T4. Average TSH concentrations were also significantly elevated in severely ill patients with hypothermia that was unrelated to cold exposure (mean TSH, 5.6 +/- 1.3 microU/ml; n = 11; P less than 0.005). The T3 concentrations in these sera were lower than those of other severely ill patients. Thus, during recovery from severe illness and during hypothermia not induced by cold, the relationship between serum T3 and TSH is qualitatively similar to that seen in primary hypothyroidism and may imply a pituitary response to a deficiency of thyroid hormone.

Pituitary-adrenocortical function in chronic renal failure: blunted suppression and early escape of plasma cortisol levels after intravenous dexamethasone.

The response to iv dexamehasone was studied in patients with chronic renal failure in whom resistance to suppression of plasma cortisol levels after oral steroid had been reported previously. One milligram of dexamethasone was given iv at 2300 h, and plasma cortisol levels were measured every 20 min between 0500-1000h in patients with renal failure, normal controls, and patients with pituitary-dependent Cushing's syndrome. Normal subjects showed a decrease in mean plasma cortisol levels to less than 3 micrograms/dl; patients with Cushing's syndrome showed no suppression of cortisol secretory activity during the sampling period. In renal failure patients, morning cortisol levels fell to values lower than those achieved when the 1-mg dose was given orally or when the steroid was not given, but did not suppress to the levels seen in normals. Early resumption of cortisol secretion occurred in four of five renal failure patients during the 6-11 h after dexamethasone administration. These studies show that iv dexamethasone is more effective than the oral steroid in suppressing pituitary-adrenocortical activity in renal failure patients. However, the incomplete suppression and early resumption of cortisol secretion which are present in chronic renal failure patients even after iv dexamethasone support the suggestion that they have disordered feedback control of the hypothalamic-pituitary-adrenocortical axis.