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We compared the weight-reducing effect of diet and gastroplasty with that of diet alone in a randomized trial in 60 morbidly obese patients followed for two years. Initial median body weight was 120 kg in patients randomly assigned to gastroplasty plus diet and 115 kg in those assigned to diet alone. Maximum weight losses did not differ significantly between the groups (26.1 kg in the gastroplasty group and 22.0 kg in the group treated with diet alone, P greater than 0.05). The risk of a Type II error with a true difference larger than 9.5 kg was less than 5 per cent. However, the group treated with diet alone regained significantly more weight after maximum weight loss had been achieved, so that the gastroplasty group had a more favorable net outcome at two years (P less than 0.05).

Serum concentrations of total triiodothyronine (T3) and thyroxine (T4) were determined in 28 obese out-patients before and after 12 weeks of treatment with a conventional slimming diet of 5.2 MJ (1245 kcal). Twenty-one of the patients were also given central stimulating anorectics (diethylpropion and 'Elsinore-pill' containing ephedrine). The median weight loss was 8.1 kg (range 0.4-19.1 kg). After the treatment a small, but significant (P less than 0.02), fall in serum T3 could be demonstrated whilst serum T4 was unaffected. The median fall in T3 in percentage of pretreatment value was 9 per cent (96 per cent confidence limits: 4-16 per cent). Neither serum T3 nor serum T4 correlated with the initial body weight, overweight or energy intake. In the patients treated with anorectics serum T4 was not elevated after 12 weeks, indicating that a possible sympatomimetic effect of central stimulating anorectics upon the thyroid gland is only temporary.

Twenty-two consecutive obese patients were given very-low-calorie diet (VLCD) in the form of a casein and lactose preparation dissolved in orange juice containing 43.0 g protein, 30.4 g carbohydrate and 1.1 g lipid in a total of 317 kcal (1.3 MJ) daily. VLCD was given intermittently in eight-week periods alternating with three-week periods of conventional diet (900-1200 kcal, 3.8-5.0 MJ) to ensure recuperation of lean body mass and to establish a therapy which may facilitate indefinite patient compliance. In case of persisting hunger, diethyl-propion was given in small doses. The median observation time was nine weeks (range 1-37 weeks). The median weight loss was 15.5 kg (range 3.8-39.2 kg), and the median overweight decreased from 85.5 per cent (range 43-135 per cent) to 61.0 per cent (range 19-100 per cent). Blood glucose and cholesterol fell significantly (P < 0.01), and no major side-effects were observed.

Fifty-seven patients allocated at random to either diet supported by gastroplasty or very-low-calorie diet (VLCD) were followed for 5 years. One patient was lost to follow-up 1 year after surgery. Data were analyzed by survival statistics and success was liberally defined as a maintained weight loss of at least 10 kg. The cumulative success rate declined steadily in both groups, but it remained higher in the gastroplasty group (16 versus 3 percent, the 95 percent confidence limits being 11-21 percent and 1-5 percent, respectively; P less than 0.05). At 5 years, eight of 27 gastroplasty patients (30 percent, 95 percent confidence limits 14-50 percent) had not relapsed. Of 30 VLCD patients, relapse had not occurred in five (17 percent, 6-35 percent). The weight loss of patients without relapse did not differ significantly (medians of gastroplasty and VLCD patients 18 kg and 27 kg, respectively). Complications and side-effects were more numerous and serious among the gastroplasty patients. Although in this long-term study, the horizontal gastroplasty proved to be somewhat more effective than the diet alone, the surgical risks and the unsatisfactory maintenance of weight loss speak against the use of this operation.

Serum free triiodothyronine decreased significantly (P < 0.02) by 18 per cent (range from -8 to +47 per cent) in 13 grossly obese patients after 11 days (median) treatment (range 8-18 days) with a very-low-calorie diet consisting of 43.0 g protein, 30.4 g carbohydrate and 1.1 g lipid. Also a significant decrease was found in serum total triiodothyronine (P < 0.007), thyroxine-binding globulin (P < 0.008) and thyroxine-binding prealbumin (P < 0.005). No significant changes in serum free thyroxine, total thyroxine and TSH could be demonstrated.

Consecutive patients, between 18 and 54 years, suffering from morbid obesity (greater than or equal to 60 per cent overweight) are being randomized to either gastroplasty a.m. Gomez or to a very-low-calorie diet (341 kcal, 1.43 MJ) based on a high-value protein powder with an admixture of calcium, phosphate, sodium, chloride, and magnesium. Through a supplementary daily vitamin-mineral capsule and three tablets of potassium chloride the total regime complies with the 1980 RDA. After initial hospitalization, both groups are seen as out-patients. Twenty-eight patients have so far been studied and none has dropped out. Preliminary results show a substantial weight lose without significant differences between the groups.

Blood pressure (BP) and arm circumference were measured in 44 normotensive and borderline hypertensive obese patients during treatment with either a very low calorie diet or diet supported with gastroplasty. The patients had reductions in sodium, energy, and carbohydrate intake. BP was determined with both a normal cuff (12-by-35 cm bladder) and a large cuff (15-by-43 cm bladder), using a random-zero sphygmomanometer. Both systolic and diastolic BP declined (p less than 0.005) (from 133 to 124 +/- 4 mmHg and from 87 to 81 +/- 3 mmHg (mean +/- SED), respectively), but reached a plateau after an average weight loss of 11 kg. No further reduction in BP was seen despite a maximal weight loss of 40 kg. At the same time arm circumference decreased from 36.4 to 30.5 cm. Moreover, the study showed that reductions in systolic and diastolic BP were closely associated with the pretreatment BP but not with the weight loss. The normal cuff overestimated the systolic BP by 8 +/- 4 mmHg and the diastolic BP by 6 +/- 3 mmHg (mean +/- SED) in patients with arm circumference of 35 cm and more.