A double-blind trial of mazindol using a very low calorie formula diet.

Thirty-eight obese patients, resistant to conventional diet therapy, agreed to consume a 1.09 MJ (260 kcal)/day semi-synthetic diet consisting of 25 g egg albumin, 40 g oligosaccharides, vitamins and minerals, and were seen weekly as outpatients for eight weeks. At the beginning, the semi-synthetic diet was given with either the anorectic drug, mazindol (2 mg/day) or a placebo for four weeks and then changed over for the remaining four weeks; the study being conducted on a double-blind basis. The final treatment was a 4.2 MJ (1000 KCAL) conventional diet for a further four weeks without drug or placebo. Twenty-five patients completed the first eight weeks and 21 patients the final four weeks of the trial. The total mean weight losses were as follows: week 4, 9.3 kg; week 8, 13.7 kg; week 12, 12.2 kg. There was no significant difference in weight loss between mazindol treatment and placebo but the former group reported feeling less hungry. The chief side-effects observed were dizziness, nausea, dry mouth, insomnia and depression which were more frequent with mazindol. Six patients had to stop mazindol because of side-effects, but were able to continue the diet alone. It is concluded that a semi-synthetic diet containing 1.09 MJ (260 kcal) daily can be successfully employed in the treatment of obese outpatients, and is a practical therapeutic alternative to admission to hospital. There is no clinical advantage to be gained by the additional use of the anorectic drug, mazindol.