We randomly assigned 71 patients with active chronic Crohn's disease who were resistant to or intolerant of corticosteroids to treatment with oral cyclosporine (5 to 7.5 mg per kilogram of body weight per day) or placebo for three months. Disease activity was assessed on a clinical grading scale without knowledge of the treatment given. At the end of the treatment period, 22 of the 37 cyclosporine-treated patients (59 percent) had improvement, as compared with 11 of the 34 placebo-treated patients (32 percent) (P = 0.032). During cyclosporine treatment, there was significant improvement in plasma orosomucoid levels (P = 0.0025) and the Crohn's Disease Activity Index (P = 0.00012). The effect of treatment became evident after two weeks. In the subsequent three months, during which the patients were gradually withdrawn from treatment, the improvement continued in 14 of the 37 patients (38 percent) in the cyclosporine group and in 5 of the 34 (15 percent) in the placebo group (P = 0.034). No serious adverse events were observed. We conclude that cyclosporine has a beneficial therapeutic effect in patients with active chronic Crohn's disease and resistance to or intolerance of corticosteroids.
OBJECTIVE: To develop a reliable and valid measure of distress, related to extreme obesity. DESIGN: Items related to distress over obesity were selected from the literature, clinical experience and from input provided by a gastroplasty patient support group. The items were assessed in a longitudinal study, with the body mass index (BMI) and psychological assessment occurring 2 ± 6 months prior to, and 12 months following, gastroplasty surgery. SUBJECTS: 81 females and eight males (mean age 35.9 y) who had been accepted for gastroplasty surgery. All but two of the patients had BMIs b 40 (Mean 48.11, s.d. 6.84). MEASUREMENTS: BMIs were calculated using weight and height. Psychological characteristics were assessed using the Mental Health Inventory (MHI), the Sickness Impact Pro®le (SIP), and the Eating Inventory (EI). Demographic information was collected with a questionnaire. RESULTS: Attempts to factor analyse the 95 item questionnaire were unsuccessful. Alternatively, a shorter, 20 item questionnaire was developed. The questionnaire shows good test-retest reliability (r 0.867), good internal consistency (coef®cient alpha 0.719) , good face and construct validity, and is sensitive to pre-post surgical change. CONCLUSIONS: The Obesity Adjustment Survey (OAS) may be useful as a brief measure of distress in obese individuals. This measure can be used to index the psychological impact of gastroplasty surgery on psychological functioning, and can be used in future research as a disease-speci®c measure to predict success of surgery.
SUMMARY In order to determine some of the factors involved in the response of duodenal ulcers to placebo treatment, the following factors were studied prospectively during a double-blind, placebocontrolled trial: demographic data; duration of illness and effect of treatment; expectation of success or failure of the new drug; presence of psychiatric problems; and suggestibility. Healing (measured by endoscopy) occurred in 37 patients, 17 of whom were receiving placebo; relief of symptoms occurred in 35 patients, 16 of whom were receiving placebo. There was no significant difference between drug and placebo. Healing was significantly associated with relief of symptoms but with no other variable. Relief of symptoms was more common in male patients and in those from higher social classes, as well as in patients who expected a complete cure and those without evidence of psychiatric problems. The natural history of the disease may be different in these patients. Unexpectedly, suggestibility was not associated with healing or relief of symptoms in the patients receiving placebo.The 'placebo effect' (the increased healing of, for example, duodenal ulcers during treatment with placebo) is a well-recognised but little understood phenomenon which makes the interpretation of therapeutic trials extremely difficult. For any patient with any illness, response to treatment = natural healing+placebo effect+effects of drug (or other treatment). For example, during recent randomised double-blind studies of cimetidine in healing duodenal ulcers, the proportion of patients whose ulcers healed or whose symptoms were relieved during treatment with placebo tablets ranged from less than 20% to over 80%.1 The determinants of the placebo effect have been difficult to identify, as neither personality type nor therapeutic situation are specific for such effects. As expectations about the results of treatment influence the response to therapy,2 it has been found necessary to undertake therapeutic trials on the basis of 'double-blind' ignorance of the type of treatment (whether active or placebo) on the part of both investigator and
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