A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder
Abstract
This was a 12-week, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of duloxetine, a selective serotonin and norepinephrine reuptake inhibitor, in 354 female patients with primary fibromyalgia, with or without current major depressive disorder. Patients (90% Caucasian; mean age, 49.6 years; 26% with current major depressive disorder) received duloxetine 60 mg once daily (QD) (N=118), duloxetine 60 mg twice daily (BID) (N=116), or placebo (N=120). The primary outcome was the Brief Pain Inventory average pain severity score. Response to treatment was defined as >or=30% reduction in this score. Compared with placebo, both duloxetine-treated groups improved significantly more (P or=30% in this score (duloxetine 60 mg QD (55%; P<0.001); duloxetine 60 mg BID (54%; P=0.002); placebo (33%)). The treatment effect of duloxetine on pain reduction was independent of the effect on mood and the presence of major depressive disorder. Compared with patients on placebo, patients treated with duloxetine 60 mg QD or duloxetine 60 mg BID had significantly greater improvement in remaining Brief Pain Inventory pain severity and interference scores, Fibromyalgia Impact Questionnaire, Clinical Global Impression of Severity, Patient Global Impression of Improvement, and several quality-of-life measures. Both doses of duloxetine were safely administered and well tolerated. In conclusion, both duloxetine 60 mg QD and duloxetine 60 mg BID were effective and safe in t…
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The DLX studies demonstrated that the effects of DLX on pain did not differ between patients with and without major depression.
“The DLX studies demonstrated that the effects of DLX on pain did not differ between patients with and without major depression.”
From Comparative Efficacy and Harms of Duloxetine, Milnacipran, and Pregabalin in Fibromyalgia Syndrome (2010) · cites this paper as [3]
Cites
Hamilton, M. (1960) · Journal of Neurology, Neurosurgery & Psychiatry · doi:10.1136/jnnp.23.1.56 · Cited by 32,817 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
EULAR evidence-based recommendations for the management of fibromyalgia syndrome
Carville, S. F., Arendt-Nielsen, S., Bliddal, H., Blotman, F., Branco, J. C., Buskila, D., Da Silva, J. A. P., Danneskiold-Samsøe, B., Dincer, F., Henriksson, C., et al. (2008) · Annals of the Rheumatic Diseases · doi:10.1136/ard.2007.071522 · Cited by 752 · see citing works
Duloxetine for treating painful neuropathy, chronic pain or fibromyalgia
Lunn, M. P., Hughes, R. A., & Wiffen, P. J. (2014) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007115.pub3 · Cited by 565 · see citing works
Lee, Y. C., Nassikas, N. J., & Clauw, D. J. (2011) · Arthritis Research & Therapy · doi:10.1186/ar3306 · Cited by 377 · see citing works
Clauw, D. J. (2009) · The American Journal of Medicine · doi:10.1016/j.amjmed.2009.09.006 · Cited by 350 · see citing works
Treatment of Fibromyalgia Syndrome With Antidepressants: A Meta-analysis
Häuser, W., Bernardy, K., Üçeyler, N., & Sommer, C. (2009) · JAMA · doi:10.1001/jama.2008.944 · Cited by 338 · see citing works
Schmidt, S., Grossman, P., Schwarzer, B., Jena, S., Naumann, J., & Walach, H. (2011) · PAIN · doi:10.1016/j.pain.2010.10.043 · Cited by 297 · see citing works
Acceptance and commitment therapy for fibromyalgia: A randomized controlled trial.
Wicksell, R. K., Kemani, M., Jensen, K., Kosek, E., Kadetoff, D., Sorjonen, K., Ingvar, M., & Olsson, G. L. (2013) · European Journal of Pain · doi:10.1002/j.1532-2149.2012.00224.x · Cited by 244 · see citing works
Jensen, K. B., Kosek, E., Wicksell, R., Kemani, M., Olsson, G., Merle, J. V., Kadetoff, D., & Ingvar, M. (2012) · PAIN · doi:10.1016/j.pain.2012.04.010 · Cited by 230 · see citing works
Comparative Efficacy and Harms of Duloxetine, Milnacipran, and Pregabalin in Fibromyalgia Syndrome
Häuser, W., Petzke, F., & Sommer, C. (2010) · The Journal of Pain · doi:10.1016/j.jpain.2010.01.002 · Cited by 216 · see citing works
Estimation of minimum clinically important difference for pain in fibromyalgia
Mease, P. J., Spaeth, M., Clauw, D. J., Arnold, L. M., Bradley, L. A., Russell, I. J., Kajdasz, D. K., Walker, D. J., & Chappell, A. S. (2011) · Arthritis Care & Research · doi:10.1002/acr.20449 · Cited by 171 · see citing works
Self-citationBiology and therapy of fibromyalgia. New therapies in fibromyalgia.
Arnold (2006) · Arthritis Research & Therapy · doi:10.1186/ar1971 · Cited by 145 · see citing works
McCleane, G. (2008) · CNS Drugs · doi:10.2165/00023210-200822020-00005 · Cited by 109 · see citing works
Developments in the scientific and clinical understanding of fibromyalgia
Buskila, D. (2009) · Arthritis Research & Therapy · doi:10.1186/ar2720 · Cited by 81 · see citing works
A meta-analysis of the efficacy of fibromyalgia treatment according to level of care
Garcia-Campayo, J., Magdalena, J., Magallón, R., Fernández-García, E., Salas, M., & Andrés, E. (2008) · Arthritis Research & Therapy · doi:10.1186/ar2455 · Cited by 76 · see citing works
Marangell, L. B., Clauw, D. J., Choy, E., Wang, F., Shoemaker, S., Bradley, L., Mease, P., & Wohlreich, M. M. (2011) · Pain · doi:10.1016/j.pain.2010.05.029 · Cited by 70 · see citing works
Clinical evidence for serotonin and norepinephrine reuptake inhibition of duloxetine
Trivedi, M. H., Desaiah, D., Ossanna, M. J., Pritchett, Y. L., Brannan, S. K., & Detke, M. J. (2008) · International Clinical Psychopharmacology · doi:10.1097/yic.0b013e3282f41d7e · Cited by 59 · see citing works
Self-citationLong-Term Safety, Tolerability, and Efficacy of Duloxetine in the Treatment of Fibromyalgia
Mease, P. J., Russell, I. J., Kajdasz, D. K., Wiltse, C. G., Detke, M. J., Wohlreich, M. M., Walker, D. J., & Chappell, A. S. (2010) · Seminars in Arthritis and Rheumatism · doi:10.1016/j.semarthrit.2008.11.001 · Cited by 54 · see citing works
Murakami, M., Osada, K., Mizuno, H., Ochiai, T., Alev, L., & Nishioka, K. (2015) · Arthritis Research & Therapy · doi:10.1186/s13075-015-0718-y · Cited by 46 · see citing works
Duloxetine for the treatment of fibromyalgia
Wright, C. L., Mist, S. D., Ross, R. L., & Jones, K. D. (2010) · Expert Review of Clinical Immunology · doi:10.1586/eci.10.64 · Cited by 43 · see citing works
Berger, A., Sadosky, A., Dukes, E., Martin, S., Edelsberg, J., & Oster, G. (2008) · Current Medical Research and Opinion · doi:10.1185/03007990802316550 · Cited by 40 · see citing works
Duloxetine for fibromyalgia syndrome: a systematic review and meta-analysis
Migliorini, F., Maffulli, N., Eschweiler, J., Baroncini, A., Bell, A., & Colarossi, G. (2023) · Journal of Orthopaedic Surgery and Research · doi:10.1186/s13018-023-03995-z · Cited by 40 · see citing works
Novel pharmacotherapy for fibromyalgia
Wood, P. B., Holman, A. J., & Jones, K. D. (2007) · Expert Opinion on Investigational Drugs · doi:10.1517/13543784.16.6.829 · Cited by 30 · see citing works
Assessment of Patients with Fibromyalgia Syndrome
Mease, P. J. (2008) · Journal of Musculoskeletal Pain · doi:10.1080/10582450801960347 · Cited by 20 · see citing works
Simm, R., Iddon, J., & Barker, C. (2014) · British Journal of Pain · doi:10.1177/2049463713507910 · Cited by 17 · see citing works
(2014) · Handbook of Clinical Neurology · doi:10.1016/b978-0-7020-4086-3.00033-3 · Cited by 86 · see citing works
- Authors
- Arnold, L. M., Rosen, A., Pritchett, Y. L., D'Souza, D. N., Goldstein, D. J., Iyengar, S., & Wernicke, J. F.
- Affiliations
- Eli Lilly (United States) (US)
- Venue
- Pain
- Published
- 2005-12
- Volume
- 119
- Issue
- 1-3
- Pages
- 5-15
- ISSN
- 0304-3959 (ISSN-L)
- OpenAlex
- W1990079987
- Cited by
- 471
- References
- 1
- Citations by year
- 2026: 6 · 2025: 6 · 2024: 9 · 2023: 8 · 2022: 6 · 2021: 7 · 2020: 8 · 2019: 8 · 2018: 6 · 2017: 14 · 2016: 15 · 2015: 14 · 2014: 25 · 2013: 26 · 2012: 31
- FWCI
- 21.96
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Pain (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
- Health Sciences › Medicine › Physiology › Pain Mechanisms and Treatments
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Keywords
- duloxetine, fibromyalgia, major depressive disorder, women, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, pain intensity, pain interference, quality of life, dose comparison, drug safety and tolerability
- MeSH terms
- Duloxetine Hydrochloride, Adolescent, Adult, Aged, Aged, 80 and over, Analgesics, Antidepressive Agents, Depressive Disorder, Major, Major Depressive Disorder, Double-Blind Method, Female, Fibromyalgia, Humans, Middle Aged, Pain Measurement, Quality of Life, Thiophenes, United States, Comorbidity, Placebo Effect, Women's Health, Treatment Outcome
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
