TY - JOUR
T1 - The clinical effect of clomipramine in chronic idiopathic pain disorder revisited using the Spielberger State Anxiety Symptom Scale (SSASS) as outcome scale
AU - Bech, Per
AU - Gormsen, Lise
AU - Loldrup, Dorte
AU - Lunde, Marianne
N1 - Keywords: Adolescent; Adult; Aged; Antidepressive Agents, Tricyclic; Anxiety; Clomipramine; Double-Blind Method; Female; Humans; Male; Middle Aged; Pain; Personality Inventory; Psychiatric Status Rating Scales; Treatment Outcome; Young Adult
PY - 2009
Y1 - 2009
N2 - BACKGROUND: We have re-analysed our previous double-blind, placebo-controlled clomipramine study, changing the focus from depression to anxiety both in the response analysis and in the classification of minor affective states. METHODS: The Spielberger State Anxiety Symptom Scale (SSASS) including only the negatively phrased items was used to measure the pure anxiolytic effect. The analgesic effect was measured by the Visual Analogue Scale (VAS) for bodily pain. The General Health Questionnaire (GHQ-12) was used to identify minor affective states. RESULTS: In total 171 patients with chronic non-malignant pain were included (87 patients received placebo and 84 clomipramine). On the SSASS, clomipramine's (mean dose 125 mg daily) advantage over placebo in the planned 6-weeks' treatment period for all patients (intention-to-treat analysis) showed an effect size of 0.37. For completers only, the effect size was 0.45. In total 76 patients were GHQ-12 positive, and the effect size in favour of clomipramine was 0.50 (intention-to-treat approach) and 0.66 for completers. In general, the effect on the Bodily Pain VAS, i.e. the analgesic outcome, was low. Thus, even in completers who were GHQ-12 positive, the effect size was below 0.40. LIMITATIONS: No attempt has been made to measure the degree of pure neuropathic pain in the patients. CONCLUSIONS: In patients with chronic non-malignant pain, clomipramine is superior to placebo as regards anxiolytic effect measured by Spielberger State Anxiety Symptom Scale (SSASS). No pure analgesic effect was demonstrated.
AB - BACKGROUND: We have re-analysed our previous double-blind, placebo-controlled clomipramine study, changing the focus from depression to anxiety both in the response analysis and in the classification of minor affective states. METHODS: The Spielberger State Anxiety Symptom Scale (SSASS) including only the negatively phrased items was used to measure the pure anxiolytic effect. The analgesic effect was measured by the Visual Analogue Scale (VAS) for bodily pain. The General Health Questionnaire (GHQ-12) was used to identify minor affective states. RESULTS: In total 171 patients with chronic non-malignant pain were included (87 patients received placebo and 84 clomipramine). On the SSASS, clomipramine's (mean dose 125 mg daily) advantage over placebo in the planned 6-weeks' treatment period for all patients (intention-to-treat analysis) showed an effect size of 0.37. For completers only, the effect size was 0.45. In total 76 patients were GHQ-12 positive, and the effect size in favour of clomipramine was 0.50 (intention-to-treat approach) and 0.66 for completers. In general, the effect on the Bodily Pain VAS, i.e. the analgesic outcome, was low. Thus, even in completers who were GHQ-12 positive, the effect size was below 0.40. LIMITATIONS: No attempt has been made to measure the degree of pure neuropathic pain in the patients. CONCLUSIONS: In patients with chronic non-malignant pain, clomipramine is superior to placebo as regards anxiolytic effect measured by Spielberger State Anxiety Symptom Scale (SSASS). No pure analgesic effect was demonstrated.
U2 - 10.1016/j.jad.2009.03.007
DO - 10.1016/j.jad.2009.03.007
M3 - Journal article
C2 - 19349078
SN - 0165-0327
VL - 119
SP - 43
EP - 51
JO - Journal of Affective Disorders
JF - Journal of Affective Disorders
IS - 1-3
ER -