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Relationships among pain, depressed mood, and global status in fibromyalgia patients: post hoc analyses of a randomized, placebo-controlled trial of milnacipran.
Psychosomatics 2012 Jul-Aug; 53(4):371-9P

Abstract

BACKGROUND

Patients with fibromyalgia often experience depressive symptoms in addition to chronic pain and other characteristic symptoms associated with this disorder.

OBJECTIVE

To examine the relationships among pain, depressive symptoms, and global status in a clinical trial of milnacipran for fibromyalgia.

METHODS

Data from a randomized, double-blind study (milnacipran 100 mg/d, n = 516; placebo, n = 509) were analyzed. Treatment outcomes included quantitative changes in pain and Beck depression inventory (BDI) scores, mean Patient Global Impression of Change (PGIC) scores, and three responder endpoints: patients with ≥30% pain improvement, PGIC score ≤2, and patients meeting both pain and PGIC responder criteria (2-measure composite responders). Correlations and path analyses were conducted to evaluate relationships among improvements in depressive symptoms, pain, and PGIC.

RESULTS

Patients receiving milnacipran had greater decreases in mean pain scores, lower mean PGIC endpoint scores, and higher responder rates regardless of baseline severity of depressive symptoms. The highest responder rates were found in patients with greater than four-point improvement in BDI scores (milnacipran vs. placebo: pain, 57.5% vs. 39.0%; PGIC, 60.1% vs. 38.2%; 2-measure composite, 49.0% vs. 27.9%; all p < 0.01), although significant differences between treatment groups were also found in patients with no improvement or worsening of depressive symptoms. Correlations between changes in BDI and changes in pain or PGIC were low (r ≤ 0.3). Path analyses indicated 87.2% of pain reduction to be a direct effect of milnacipran treatment.

CONCLUSION

Symptom improvements with milnacipran were only weakly associated with baseline depressive symptoms and were largely independent of improvements in depressive symptomatology.

Authors+Show Affiliations

Women's Health Research Program, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA. Lesley.Arnold@uc.eduNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22677218

Citation

Arnold, Lesley M., et al. "Relationships Among Pain, Depressed Mood, and Global Status in Fibromyalgia Patients: Post Hoc Analyses of a Randomized, Placebo-controlled Trial of Milnacipran." Psychosomatics, vol. 53, no. 4, 2012, pp. 371-9.
Arnold LM, Palmer RH, Gendreau RM, et al. Relationships among pain, depressed mood, and global status in fibromyalgia patients: post hoc analyses of a randomized, placebo-controlled trial of milnacipran. Psychosomatics. 2012;53(4):371-9.
Arnold, L. M., Palmer, R. H., Gendreau, R. M., & Chen, W. (2012). Relationships among pain, depressed mood, and global status in fibromyalgia patients: post hoc analyses of a randomized, placebo-controlled trial of milnacipran. Psychosomatics, 53(4), pp. 371-9. doi:10.1016/j.psym.2012.02.005.
Arnold LM, et al. Relationships Among Pain, Depressed Mood, and Global Status in Fibromyalgia Patients: Post Hoc Analyses of a Randomized, Placebo-controlled Trial of Milnacipran. Psychosomatics. 2012;53(4):371-9. PubMed PMID: 22677218.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Relationships among pain, depressed mood, and global status in fibromyalgia patients: post hoc analyses of a randomized, placebo-controlled trial of milnacipran. AU - Arnold,Lesley M, AU - Palmer,Robert H, AU - Gendreau,R Michael, AU - Chen,Wei, Y1 - 2012/06/06/ PY - 2011/12/15/received PY - 2012/02/09/revised PY - 2012/02/15/accepted PY - 2012/6/9/entrez PY - 2012/6/9/pubmed PY - 2012/11/1/medline SP - 371 EP - 9 JF - Psychosomatics JO - Psychosomatics VL - 53 IS - 4 N2 - BACKGROUND: Patients with fibromyalgia often experience depressive symptoms in addition to chronic pain and other characteristic symptoms associated with this disorder. OBJECTIVE: To examine the relationships among pain, depressive symptoms, and global status in a clinical trial of milnacipran for fibromyalgia. METHODS: Data from a randomized, double-blind study (milnacipran 100 mg/d, n = 516; placebo, n = 509) were analyzed. Treatment outcomes included quantitative changes in pain and Beck depression inventory (BDI) scores, mean Patient Global Impression of Change (PGIC) scores, and three responder endpoints: patients with ≥30% pain improvement, PGIC score ≤2, and patients meeting both pain and PGIC responder criteria (2-measure composite responders). Correlations and path analyses were conducted to evaluate relationships among improvements in depressive symptoms, pain, and PGIC. RESULTS: Patients receiving milnacipran had greater decreases in mean pain scores, lower mean PGIC endpoint scores, and higher responder rates regardless of baseline severity of depressive symptoms. The highest responder rates were found in patients with greater than four-point improvement in BDI scores (milnacipran vs. placebo: pain, 57.5% vs. 39.0%; PGIC, 60.1% vs. 38.2%; 2-measure composite, 49.0% vs. 27.9%; all p < 0.01), although significant differences between treatment groups were also found in patients with no improvement or worsening of depressive symptoms. Correlations between changes in BDI and changes in pain or PGIC were low (r ≤ 0.3). Path analyses indicated 87.2% of pain reduction to be a direct effect of milnacipran treatment. CONCLUSION: Symptom improvements with milnacipran were only weakly associated with baseline depressive symptoms and were largely independent of improvements in depressive symptomatology. SN - 1545-7206 UR - https://www.unboundmedicine.com/medline/citation/22677218/Relationships_among_pain_depressed_mood_and_global_status_in_fibromyalgia_patients:_post_hoc_analyses_of_a_randomized_placebo_controlled_trial_of_milnacipran_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0033-3182(12)00037-0 DB - PRIME DP - Unbound Medicine ER -