Discomfort or disability in patients with chronic pain syndrome.

In the present study of 253 patients with chronic pain syndrome we have made a multidimensional approach. All patients have been included in the study independent of coexisting states of anxiety or depression. We included criteria for diagnosis, duration, generability and intensity of pain, anxiety and depression, psychosocial stressors and social functioning. Using this system we have evaluated the antipain effectiveness of clomipramine and mianserin in a double-blind, placebo-controlled trial. By use of the Melancholia Scale 16 patients (6%) had a major depression, and by use of the Hamilton Anxiety Scale, 72 patients (28%) had a generalized anxiety disorder. The results showed no statistically significant difference between the three treatments, when using a visual analogue scale (VAS 10 cm with cut-off score 2 cm) for severity of pains as outcome criteria or the results of VAS and Global Clinical Impression Scale using the criteria of reduction of 50% or more between the pretreatment and posttreatment scores. By use of all the assessments it is possible to make an improvement curve for each patient expressed by the area under the curve, and not even there we found a difference between the three treatments. Clomipramine and mianserin were significantly superior to placebo in the topographical pain subgroup with headache using area under the improvement curves as criteria (p less than 0.05). When the 60-item General Health Questionnaire was used to identify minor psychiatric morbidity 44% was found. We can use this as a measure of quality of life. Our results have indicated that placebo-controlled studies are still needed in this field of research.

RCT Entities:   Population Interventions Outcomes