Venlafaxine extended release in the short-term treatment of depressed and anxious primary care patients with multisomatoform disorder.
OBJECTIVE
This pilot study explored the efficacy and tolerability of extended-release venlafaxine (venlafaxine ER) in anxious and/or depressed patients with multisomatoform disorder (MSD).


METHODS
This 12-week, multicenter, randomized, double-blind study evaluated adult primary care outpatients with MSD and comorbid major depressive disorder, generalized anxiety disorder, or social anxiety disorder (DSM-IV criteria). The intent-to-treat population included 112 patients (venlafaxine ER, N = 55; placebo, N = 57). The primary efficacy variable was the change in the 15-item Patient Health Questionnaire (PHQ-15) somatic symptom severity score. Secondary outcomes included the Hamilton Rating Scale for Depression (HAM-D-17) and for Anxiety (HAM-A), Clinical Global Impressions-Severity of Illness (CGI-S) and -Improvement (CGI-I) scales, McGill Quality of Life Questionnaire Physical Symptoms Scale (MQOL-PS), and Medical Outcomes Study Short-Form 36-Item questionnaire (MOS SF-36). Data were collected from April 2003 to December 2003.


RESULTS
The decline by week 12 in PHQ-15 scores was significant (p < .0001) in both groups; however, the difference between the venlafaxine ER and placebo groups (-8.3 vs. -6.6, respectively) was not (p = .097). Improvement was greater with venlafaxine ER than placebo on the PHQ-15 pain subscale (p = .03), SF-36 bodily pain scale (26.1 vs. 14.5, p = .03), MQOL-PS (-11.7 vs. -6.0, p = .02), HAM-A psychic anxiety subscale (p = .02), SF-36 mental component summary (p = .03), time to response (54 vs. 71 days, p = .01), and CGI-I scale (p = .009). Venlafaxine ER was generally well tolerated.


CONCLUSIONS
These results suggest that venlafaxine ER may be effective in relieving some types of somatic physical symptoms, particularly pain, in patients with depression and/or anxiety disorders.
Kroenke
Kurt
K
Indiana University School of Medicine, Indianapolis, IN, USA. kkroenke@regenstrief.org
Messina
Nicholas
N
Benattia
Isma
I
Graepel
Jay
J
Musgnung
Jeff
J
D000553:Ambulatory Care; D001008:Anxiety Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D015897:Comorbidity; D003511:Cyclohexanols / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D004311:Double-Blind Method; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010865:Pilot Projects; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D013001:Somatoform Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D000069470:Venlafaxine Hydrochloride
D003511:Cyclohexanols; D003692:Delayed-Action Preparations; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors; D000069470:Venlafaxine Hydrochloride