Cited by 277Fibromyalgia and Chronic Fatigue Syndrome ResearchPain Mechanisms and TreatmentsMusculoskeletal pain and rehabilitation

The DOI matches its Crossref record; 35 of the 38 references it cites were found in a registry or an index.

A 14-week, Randomized, Double-Blinded, Placebo-Controlled Monotherapy Trial of Pregabalin in Patients With Fibromyalgia

Open access

Arnold, Lesley M., Russell, I. Jon, Diri, E.W., Duan, W. Rachel, Young, James P., Sharma, Uma, Martin, Susan A., Barrett, Jeannette A., Haig, George·2008·The Journal of Pain

DOI 10.1016/j.jpain.2008.03.013

Open this paper in CoChat — free account

Abstract

Unlabelled The purpose of the study was to assess the efficacy and safety of pregabalin monotherapy in patients with fibromyalgia in a randomized, double-blinded, placebo-controlled trial. After 1 week of single-blinded administration of placebo, 750 patients meeting American College of Rheumatology criteria for fibromyalgia were randomly assigned to pregabalin (300 mg/d, 450 mg/d, 600 mg/d) or placebo, administered twice daily for 14 weeks. The primary outcome variable was comparison of end point mean pain scores, derived from daily diary ratings of pain intensity (0 to 10 scale), between each of the pregabalin groups and the placebo group. If positive, additional primary efficacy parameters included the Patient Global Impression of Change (PGIC) and the Fibromyalgia Impact Questionnaire (FIQ) total score. Compared with placebo-treated patients, mean changes in pain scores at the end point in pregabalin-treated patients were significantly greater (P < .001: 300 mg/d, -0.71; 450 mg/d, -0.98; 600 mg/d, -1.00). Compared with placebo, significantly more pregabalin-treated patients reported improvement on PGIC (P < .01 for all 3 pregabalin doses) and significant improvements in total FIQ score for the 450 mg/d (P = .004) and the 600 mg/d (P = .003) doses. Compared with placebo, all 3 doses of pregabalin were associated with significant improvement in sleep. The most commonly reported pregabalin-related adverse events were dizziness and somnolence, which tended to be dose-related.Perspective This randomized, placebo-controlled trial of 300, 450, and 600 mg/d of pregabalin monotherapy demonstrated that all 3 doses were efficacious for up to 14 weeks for the treatment of fibromyalgia and were well tolerated by most patients. These results provide evidence that pregabalin is an important treatment option for patients with fibromyalgia.

Integrity signals

Registry

Crossref · 10.1016/j.jpain.2008.03.013

Cites

35 of 35 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

We couldn’t retrieve this paper’s full text, so its claims and self-check weren’t run. The registry and citation checks still apply.

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?

Diagnostic and Statistical Manual of Mental Disorders
Williams, J. B. W., & First, M. B. (2013) · Oxford University Press eBooks · doi:10.1093/acrefore/9780199975839.013.104 · Cited by 109,845
The Hospital Anxiety and Depression Scale
Zigmond, A. S., & Snaith, R. P. (1983) · Acta Psychiatrica Scandinavica · doi:10.1111/j.1600-0447.1983.tb09716.x · Cited by 47,139
SAS System for Mixed Models
Littell, R. C. (1996) · Medical Entomology and Zoology · Cited by 10,345
The american college of rheumatology 1990 criteria for the classification of fibromyalgia
Wolfe, F., Smythe, H. A., Yunus, M. B., Bennett, R. M., Bombardier, C., Goldenberg, D. L., Tugwell, P., Campbell, S. M., Abeles, M., Clark, P., et al. (1990) · Arthritis & Rheumatism · doi:10.1002/art.1780330203 · Cited by 9,563
Self-citation
Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale
Farrar, J. T., Young, J. P., LaMoreaux, L., Werth, J. L., & Poole, M. R. (2001) · Pain · doi:10.1016/s0304-3959(01)00349-9 · Cited by 5,808
Self-citation
A sharper Bonferroni procedure for multiple tests of significance
HOCHBERG, Y. (1988) · Biometrika · doi:10.1093/biomet/75.4.800 · Cited by 4,829
The prevalence and characteristics of fibromyalgia in the general population
Wolfe, F., Ross, K., Anderson, J., Russell, I. J., & Hebert, L. E. (1995) · Arthritis & Rheumatism · doi:10.1002/art.1780380104 · Cited by 2,425
Self-citation
Advances in Pain Research and Therapy
Wang, J. K. (1980) · Anesthesia & Analgesia · doi:10.1213/00000539-198002000-00022 · Cited by 2,263
Handbook of pain assessment
Benjamin, S. (1994) · Journal of Psychosomatic Research · doi:10.1016/0022-3999(94)90012-4 · Cited by 2,001
Untitled work
(1991) · PubMed · Cited by 1,837

Show all 38 references

Sorted by citations

Pregabalin for acute and chronic pain in adults
Moore, R. A., Straube, S., Wiffen, P. J., Derry, S., & McQuay, H. J. (2009) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007076.pub2 · Cited by 786
Central sensitisation in chronic pain conditions: latest discoveries and their potential for precision medicine
Nijs, J., George, S. Z., Clauw, D. J., Fernández‐de‐las‐Peñas, C., Kosek, E., Ickmans, K., Fernández‐Carnero, J., Polli, A., Kapreli, E., Huysmans, E., et al. (2021) · The Lancet Rheumatology · doi:10.1016/s2665-9913(21)00032-1 · Cited by 592
Responsible, Safe, and Effective Prescription of Opioids for Chronic Non-Cancer Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines
Manchikanti, L. (2017) · Pain Physician · doi:10.36076/ppj.2017.s92 · Cited by 429
Minimal Clinically Important Difference in the Fibromyalgia Impact Questionnaire
BENNETT, R. M., BUSHMAKIN, A. G., CAPPELLERI, J. C., ZLATEVA, G., & SADOSKY, A. B. (2009) · The Journal of Rheumatology · doi:10.3899/jrheum.081090 · Cited by 407
Fibromyalgia: an overview
Clauw, D. J. (2009) · The American Journal of Medicine · doi:10.1016/j.amjmed.2009.09.006 · Cited by 350
The Opioid Epidemic: Crisis and Solutions
Skolnick, P. (2018) · Annual Review of Pharmacology and Toxicology · doi:10.1146/annurev-pharmtox-010617-052534 · Cited by 307
Use and misuse of opioids in chronic pain
Volkow, N., Benveniste, H., & McLellan, A. T. (2018) · Annual Review of Medicine · doi:10.1146/annurev-med-011817-044739 · Cited by 279
Fibromyalgia Syndrome Module at OMERACT 9: Domain Construct
MEASE, P., ARNOLD, L. M., CHOY, E. H., CLAUW, D. J., CROFFORD, L. J., GLASS, J. M., MARTIN, S. A., MOREA, J., SIMON, L., STRAND, C. V., et al. (2009) · The Journal of Rheumatology · doi:10.3899/jrheum.090367 · Cited by 256
Self-citation
Understanding fibromyalgia: lessons from the broader pain research community.
Williams, D. A., & Clauw, D. J. (2009) · The Journal of Pain · doi:10.1016/j.jpain.2009.06.001 · Cited by 250
The Efficacy and Safety of Milnacipran for Treatment of Fibromyalgia. A Randomized, Double-blind, Placebo-controlled Trial
Mease, P. J., Clauw, D. J., Gendreau, R. M., Rao, S. G., Kranzler, J., CHEN, W., & Palmer, R. H. (2009) · The Journal of Rheumatology · doi:10.3899/jrheum.080734 · Cited by 248
Treatment of fibromyalgia syndrome with gabapentin and pregabalin – A meta-analysis of randomized controlled trials
Häuser, W., Bernardy, K., Üçeyler, N., & Sommer, C. (2009) · Pain · doi:10.1016/j.pain.2009.05.014 · Cited by 243
Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia
Dailey, D. L., Rakel, B. A., Vance, C. G. T., Liebano, R. E., Amrit, A. S., Bush, H., Lee, K. S., Lee, J. E., & Sluka, K. A. (2013) · Pain · doi:10.1016/j.pain.2013.07.043 · Cited by 242
A Clinical Overview of Off-label Use of Gabapentinoid Drugs
Goodman, C. W., & Brett, A. S. (2019) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2019.0086 · Cited by 232
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
The adverse event profile of pregabalin: A systematic review and meta‐analysis of randomized controlled trials
Zaccara, G., Gangemi, P. F., Perucca, P., & Specchio, L. M. (2011) · Epilepsia · doi:10.1111/j.1528-1167.2010.02966.x · Cited by 216
Cognitive behavioral therapy for insomnia in patients with chronic pain-A systematic review and meta-analysis of randomized controlled trials
Selvanathan, J., Pham, C., Nagappa, M., Peng, P. W. H., Englesakis, M., Espie, C. A., Morin, C. M., & Chung, F. (2021) · Sleep Medicine Reviews · doi:10.1016/j.smrv.2021.101460 · Cited by 206
Fibromyalgia: Moderate and substantial pain intensity reduction predicts improvement in other outcomes and substantial quality of life gain
Moore, A. R., Straube, S., Paine, J., Phillips, C. J., Derry, S., & McQuay, H. J. (2010) · Pain · doi:10.1016/j.pain.2010.02.039 · Cited by 200
Pregabalin: latest safety evidence and clinical implications for the management of neuropathic pain
Toth, C. C. (2013) · Therapeutic Advances in Drug Safety · doi:10.1177/2042098613505614 · Cited by 199
Fibromyalgia: An Afferent Processing Disorder Leading to a Complex Pain Generalized Syndrome
Smith, H. S. (2011) · Pain Physician · doi:10.36076/ppj.2011/14/e217 · Cited by 200
Psychometric properties of a single-item scale to assess sleep quality among individuals with fibromyalgia
Cappelleri, J. C., Bushmakin, A. G., McDermott, A. M., Sadosky, A. B., Petrie, C. D., & Martin, S. (2009) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-7-54 · Cited by 174
Self-citation
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
Self-citation
Adrenergic Dysregulation and Pain With and Without Acute Beta-Blockade in Women With Fibromyalgia and Temporomandibular Disorder
Light, K. C., Bragdon, E. E., Grewen, K., Brownley, K. A., Girdler, S. S., & Maixner, W. D. (2009) · Journal of Pain · doi:10.1016/j.jpain.2008.12.006 · Cited by 163
Abuse Potential of Pregabalin
Schjerning, O., Rosenzweig, M., Pottegård, A., Damkier, P., & Nielsen, J. (2016) · CNS Drugs · doi:10.1007/s40263-015-0303-6 · Cited by 166
A Framework for Fibromyalgia Management for Primary Care Providers
Arnold, L. M., Clauw, D. J., Dunegan, L. J., & Turk, D. C. (2012) · Mayo Clinic Proceedings · doi:10.1016/j.mayocp.2012.02.010 · Cited by 153
Self-citation
Update on Treatment Guideline in Fibromyalgia Syndrome with Focus on Pharmacology
Kia, S., & Choy, E. (2017) · Biomedicines · doi:10.3390/biomedicines5020020 · Cited by 166
Chronic Pain and Sleep Disturbances: A Pragmatic Review of Their Relationships, Comorbidities, and Treatments
HUSAK, A., & Bair, M. J. (2019) · Pain Medicine · doi:10.1093/pm/pnz343 · Cited by 144
Pregabalin for pain in fibromyalgia in adults
Derry, S., Cording, M., Wiffen, P. J., Law, S., Phillips, T., & Moore, A. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd011790.pub2 · Cited by 145
Measures of fibromyalgia: Fibromyalgia Impact Questionnaire (FIQ), Brief Pain Inventory (BPI), Multidimensional Fatigue Inventory (MFI‐20), Medical Outcomes Study (MOS) Sleep Scale, and Multiple Ability Self‐Report Questionnaire (MASQ)
Williams, D. A., & Arnold, L. M. (2011) · Arthritis Care & Research · doi:10.1002/acr.20531 · Cited by 149
Self-citation
Pregabalin in fibromyalgia - responder analysis from individual patient data
Straube, S., Derry, S., Moore, R. A., Paine, J., & McQuay, H. J. (2010) · BMC Musculoskeletal Disorders · doi:10.1186/1471-2474-11-150 · Cited by 126
Current and Emerging Pharmacotherapy for Fibromyalgia
Tzadok, R., & Ablin, J. N. (2020) · Pain Research and Management · doi:10.1155/2020/6541798 · Cited by 122
Pregabalin in fibromyalgia: meta-analysis of efficacy and safety from company clinical trial reports
Straube, S., Derry, S., Moore, R. A., & McQuay, H. J. (2010) · Rheumatology · doi:10.1093/rheumatology/kep432 · Cited by 122
An update on pharmacotherapy for the treatment of fibromyalgia
Calandre, E. P., Rico‐Villademoros, F., & Slim, M. (2015) · Expert Opinion on Pharmacotherapy · doi:10.1517/14656566.2015.1047343 · Cited by 119
Pregabalin, celecoxib, and their combination for treatment of chronic low-back pain
Romanò, C. L., Romanò, D., Bonora, C., & Mineo, G. V. (2009) · Journal of Orthopaedics and Traumatology · doi:10.1007/s10195-009-0077-z · Cited by 114
Alternatives to Opioids in the Pharmacologic Management of Chronic Pain Syndromes: A Narrative Review of Randomized, Controlled, and Blinded Clinical Trials
Chadwick, A. L., Hurley, R. W., & Benzon, H. T. (2017) · Anesthesia & Analgesia · doi:10.1213/ane.0000000000002426 · Cited by 110
Gabapentin and pregabalin in the treatment of fibromyalgia: a systematic review and a meta-analysis
Tzellos, T., Toulis, K. A., Goulis, D. G., Papazisis, G., Zampeli, V., Vakfari, A., & Kouvelas, D. (2010) · Journal of Clinical Pharmacy and Therapeutics · doi:10.1111/j.1365-2710.2009.01144.x · Cited by 107
More ubiquitous effects from non‐pharmacologic than from pharmacologic treatments for fibromyalgia syndrome: A meta‐analysis examining six core symptoms
Perrot, S., & Russell, I. J. (2014) · European Journal of Pain · doi:10.1002/ejp.564 · Cited by 114
Self-citation
The effects of pregabalin on sleep disturbance symptoms among individuals with fibromyalgia syndrome
Russell, I. J., Crofford, L. J., León, T., Cappelleri, J. C., Bushmakin, A. G., Whalen, E., Barrett, J. A., & Sadosky, A. (2009) · Sleep Medicine · doi:10.1016/j.sleep.2009.01.009 · Cited by 101
Self-citation
Targeting Voltage-Gated Calcium Channels for Neuropathic Pain Management
Perret, D. M., & Luo, Z. D. (2009) · Neurotherapeutics · doi:10.1016/j.nurt.2009.07.006 · Cited by 95
Neurophysiopathogenesis of Fibromyalgia Syndrome: A Unified Hypothesis
Russell, I. J., & Larson, A. A. (2009) · Rheumatic Disease Clinics of North America · doi:10.1016/j.rdc.2009.06.005 · Cited by 94
Self-citation
Sleep Disorders and Fibromyalgia
Roizenblatt, S., Neto, N. S. R., & Tufik, S. (2011) · Current Pain and Headache Reports · doi:10.1007/s11916-011-0213-3 · Cited by 100
Comparison of Amitriptyline and US Food and Drug Administration–Approved Treatments for Fibromyalgia
Farag, H., Yunusa, I. U., Goswami, H. H., Sultan, I., Doucette, J. A., & Eguale, T. (2022) · JAMA Network Open · doi:10.1001/jamanetworkopen.2022.12939 · Cited by 94
An International, Randomized, Double-blind, Placebo-controlled, Phase III Trial of Pregabalin Monotherapy in Treatment of Patients with Fibromyalgia
Pauer, L., Winkelmann, A., Arsenault, P., Jespersen, A., Whelan, L., Atkinson, G., León, T., & Zeiher, B. G. (2011) · The Journal of Rheumatology · doi:10.3899/jrheum.110569 · Cited by 89
Fibromyalgia: an afferent processing disorder leading to a complex pain generalized syndrome.
Smith, H. S., Harris, R. E., & Clauw, D. J. (2011) · PubMed · Cited by 88
Anticonvulsants for fibromyalgia
Üçeyler, N., Sommer, C., Walitt, B. T., & Häuser, W. (2013) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd010782 · Cited by 89
Retracted
Fibromyalgia
(2014) · Handbook of Clinical Neurology · doi:10.1016/b978-0-7020-4086-3.00033-3 · Cited by 86
Fibromyalgia Syndrome in Need of Effective Treatments
Theoharides, T. C., Tsilioni, I., Arbetman, L., Panagiotidou, S., Stewart, J. M., Gleason, R. M., & Russell, I. J. (2015) · Journal of Pharmacology and Experimental Therapeutics · doi:10.1124/jpet.115.227298 · Cited by 95
Self-citation
Role of the primary motor cortex in the maintenance and treatment of pain in fibromyalgia
Saavedra, L. C., de Mendonça, M. E., & Fregni, F. (2014) · Medical Hypotheses · doi:10.1016/j.mehy.2014.06.007 · Cited by 82
Listening to Lyrica: contested illnesses and pharmaceutical determinism
Barker, K. K. (2011) · Social Science & Medicine · doi:10.1016/j.socscimed.2011.05.055 · Cited by 84
A randomized, double-blind, multicenter, placebo-controlled phase III trial to evaluate the efficacy and safety of pregabalin in Japanese patients with fibromyalgia
Ohta, H., Oka, H., Usui, C., Ohkura, M., Suzuki, M., & Nishioka, K. (2012) · Arthritis Research & Therapy · doi:10.1186/ar4056 · Cited by 87
Evaluation of the impact of fibromyalgia on patients' sleep and the content validity of two sleep scales
Martin, S. A., Chandran, A., Zografos, L. J., & Zlateva, G. (2009) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-7-64 · Cited by 77
Self-citation
Advances in the Assessment of Fibromyalgia
Williams, D. A., & Schilling, S. G. (2009) · Rheumatic Disease Clinics of North America · doi:10.1016/j.rdc.2009.05.007 · Cited by 79
Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: A randomized, placebo‐controlled, 2‐way crossover polysomnography study
Roth, T. G., Lankford, D. A., Bhadra, P., Whalen, E., & Resnick, E. M. (2012) · Arthritis Care & Research · doi:10.1002/acr.21595 · Cited by 74
Medikamentöse Therapie des Fibromyalgiesyndroms
Sommer, C., Häuser, W., Alten, R., Petzke, F. W., Späth, M., Tölle, T. R., Üçeyler, N., Winkelmann, A., Winter, E., & Bär, K. (2012) · Der Schmerz · doi:10.1007/s00482-012-1172-2 · Cited by 79
The pathophysiology, diagnosis and treatment of fibromyalgia.
Arnold, L. (2010) · Psychiatric Clinics of North America · doi:10.1016/j.psc.2010.01.001 · Cited by 73
Self-citation
Central Sensitization and CaVα2δ Ligands in Chronic Pain Syndromes: Pathologic Processes and Pharmacologic Effect
Tuchman, M. M., Barrett, J. A., Donevan, S. D., Hedberg, T. G., & Taylor, C. P. (2010) · Journal of Pain · doi:10.1016/j.jpain.2010.02.024 · Cited by 73
Self-citation
A four arm, double blind, randomized and placebo controlled study of pregabalin in the management of post-burn pruritus
Ahuja, R. B., & Gupta, G. K. (2012) · Burns · doi:10.1016/j.burns.2012.09.016 · Cited by 73
Anticonvulsants for fibromyalgia
Üçeyler, N., Sommer, C., Walitt, B. T., & Häuser, W. (2017) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd010782.pub2 · Cited by 73
Retracted
Pharmacotherapy of fibromyalgia
Mease, P. J., Dundon, K. M. W., & Sarzi‐Puttini, P. (2011) · Best Practice & Research Clinical Rheumatology · doi:10.1016/j.berh.2011.01.015 · Cited by 75
Does Sleep Differ Among Patients with Common Musculoskeletal Pain Disorders?
Lavigne, G. J., Nashed, A., Manzini, C., & Carra, M. C. (2011) · Current Rheumatology Reports · doi:10.1007/s11926-011-0209-3 · Cited by 71
Sodium oxybate therapy provides multidimensional improvement in fibromyalgia: results of an international phase 3 trial
Spaeth, M., Bennett, R. M., Benson, B. A., Wang, Y. G., Lai, C., & Choy, E. (2012) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2011-200418 · Cited by 70
Fatigue in fibromyalgia: a conceptual model informed by patient interviews
Humphrey, L., Arbuckle, R., Mease, P., Williams, D. A., Samsoe, B. D., & Gilbert, C. (2010) · BMC Musculoskeletal Disorders · doi:10.1186/1471-2474-11-216 · Cited by 68
Effect of Transcutaneous Electrical Nerve Stimulation on Pain, Function, and Quality of Life in Fibromyalgia: A Double-Blind Randomized Clinical Trial
Noehren, B. W., Dailey, D. L., Rakel, B. A., Vance, C. G. T., Zimmerman, M. B., Crofford, L. J., & Sluka, K. A. (2014) · Physical Therapy · doi:10.2522/ptj.20140218 · Cited by 72
Durability of Therapeutic Response to Milnacipran Treatment for Fibromyalgia. Results of a Randomized, Double-Blind, Monotherapy 6-Month Extension Study
Goldenberg, D. L., Clauw, D. J., Palmer, R. H., Mease, P. J., Chen, W., & Gendreau, R. M. (2009) · Pain Medicine · doi:10.1111/j.1526-4637.2009.00755.x · Cited by 65
OMERACT-based fibromyalgia symptom subgroups: an exploratory cluster analysis
Vincent, A., Hoskin, T. L., Whipple, M. O., Clauw, D. J., Barton, D. L., Benzo, R. P., & Williams, D. A. (2014) · Arthritis Research & Therapy · doi:10.1186/s13075-014-0463-7 · Cited by 71
Toward Development of a Fibromyalgia Responder Index and Disease Activity Score: OMERACT Module Update
Mease, P. J., Clauw, D. J., Christensen, R., Crofford, L. J., Gendreau, R. M., Martin, S. A., Simon, L. S., Strand, V., Williams, D. A., Arnold, L. M., et al. (2011) · The Journal of Rheumatology · doi:10.3899/jrheum.110277 · Cited by 70
Self-citation
A Systematic Review and Mixed Treatment Comparison of the Efficacy of Pharmacological Treatments for Fibromyalgia
Choy, E., Marshall, D. A. S., Gabriel, Z., Mitchell, S., Gylee, E., & Dakin, H. (2011) · Seminars in Arthritis and Rheumatism · doi:10.1016/j.semarthrit.2011.06.003 · Cited by 66
Management of Fibromyalgia Syndrome in 2016
Okifuji, A., Gao, J., Bokat, C. E., & Hare, B. D. (2016) · Pain Management · doi:10.2217/pmt-2016-0006 · Cited by 66
Psychiatric problems in fibromyalgia: clinical and neurobiological links between mood disorders and fibromyalgia
Alciati, A., Sgiarovello, P., Atzeni, F., & Sarzi‐Puttini, P. (2012) · Reumatismo · doi:10.4081/reumatismo.2012.268 · Cited by 63
A review of the effects of pregabalin on sleep disturbance across multiple clinical conditions
Roth, T. G., Arnold, L. M., Garcı́a-Borreguero, D., Resnick, M., & Clair, A. G. (2013) · Sleep Medicine Reviews · doi:10.1016/j.smrv.2013.07.005 · Cited by 59
Self-citation
Interference with work in fibromyalgia - effect of treatment with pregabalin and relation to pain response
Straube, S., Moore, R. A., Paine, J., Derry, S., Phillips, C. J., Hallier, E., & McQuay, H. J. (2011) · BMC Musculoskeletal Disorders · doi:10.1186/1471-2474-12-125 · Cited by 60
Re-energizing the Development of Pain Therapeutics in Light of the Opioid Epidemic
Skolnick, P., & Volkow, N. D. (2016) · Neuron · doi:10.1016/j.neuron.2016.09.051 · Cited by 63
Fibromyalgia: Presentation and Management with a Focus on Pharmacological Treatment
Sumpton, J. E., & Moulin, D. E. (2008) · Pain Research and Management · doi:10.1155/2008/959036 · Cited by 60
Fibromyalgia Syndrome: A Discussion of the Syndrome and Pharmacotherapy
Smith, H. S., & Barkin, R. L. (2010) · American Journal of Therapeutics · doi:10.1097/mjt.0b013e3181df8e1b · Cited by 55
Strategies for Managing Fibromyalgia
Arnold, L. M. (2009) · The American Journal of Medicine · doi:10.1016/j.amjmed.2009.09.009 · Cited by 54
Self-citation
Pregabalin for the Management of Neuropathic Pain in Adults with Cancer: A Systematic Review of the Literature
Bennett, M., Laird, B. J. A., van Litsenburg, C., & Nimour, M. (2013) · Pain Medicine · doi:10.1111/pme.12212 · Cited by 54
What Is the Role of Sedating Antidepressants, Antipsychotics, and Anticonvulsants in the Management of Insomnia?
McCall, C., & McCall, W. V. (2012) · Current Psychiatry Reports · doi:10.1007/s11920-012-0302-y · Cited by 50
Management of Fibromyalgia Syndrome: Review of Evidence
Okifuji, A., & Hare, B. D. (2013) · Pain and Therapy · doi:10.1007/s40122-013-0016-9 · Cited by 49
Comparative efficacy and tolerability of duloxetine, pregabalin, and milnacipran for the treatment of fibromyalgia: a Bayesian network meta-analysis of randomized controlled trials
Lee, Y. H., & Song, G. G. (2016) · Rheumatology International · doi:10.1007/s00296-016-3468-5 · Cited by 49
Resistance Training Improves Quality of Life and Associated Factors in Patients With Fibromyalgia Syndrome
Andrade, A., Sieczkowska, S. M., & Vilarino, G. T. (2018) · PM&R · doi:10.1016/j.pmrj.2018.09.032 · Cited by 52
A Meta‐Analysis of Pain Response in the Treatment of Fibromyalgia
Roskell, N., Beard, S. M., Zhao, Y., & Le, T. K. (2010) · Pain Practice · doi:10.1111/j.1533-2500.2010.00441.x · Cited by 47
Comparative efficacy of amitriptyline, duloxetine and pregabalin for treating fibromyalgia in adults: an overview with network meta-analysis
Alberti, F. F., Becker, M. W., Blatt, C. R., Ziegelmann, P. K., Pizzol, T. D. S. D., & Pilger, D. A. (2022) · Clinical Rheumatology · doi:10.1007/s10067-022-06129-8 · Cited by 50
Efficacy and Safety of Pregabalin in Patients with Fibromyalgia and Comorbid Depression Taking Concurrent Antidepressant Medication: A Randomized, Placebo-controlled Study
Arnold, L. M., Sarzi‐Puttini, P., Arsenault, P., Khan, T. M., Brown, P. B., Clair, A. G., Scavone, J. M., Driscoll, J., Landen, J. W., & Pauer, L. (2015) · The Journal of Rheumatology · doi:10.3899/jrheum.141196 · Cited by 48
Self-citation
Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study
on behalf of the Pregabalin Adolescent Fibromyalgia Study Group, Arnold, L. M., Schikler, K. N., Bateman, L., Khan, T. M., Pauer, L., Brown, P. B., Clair, A. G., Chew, M. L., & Scavone, J. M. (2016) · Pediatric Rheumatology · doi:10.1186/s12969-016-0106-4 · Cited by 46
Self-citation
Fibromyalgia: Diagnosis and treatment options
Marcus, D. A. (2009) · Gender Medicine · doi:10.1016/j.genm.2009.01.004 · Cited by 45
Narcotic Bowel Syndrome and Opioid-Induced Constipation
Szigethy, E., Schwartz, M., & Drossman, D. (2014) · Current Gastroenterology Reports · doi:10.1007/s11894-014-0410-4 · Cited by 42
Pregabalin for the management of fibromyalgia syndrome
Boomershine, C. S. (2010) · Journal of Pain Research · doi:10.2147/jpr.s7884 · Cited by 44
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
Permanent Relief from Intermittent Cold Stress-Induced Fibromyalgia-Like Abnormal Pain by Repeated Intrathecal Administration of Antidepressants
Nishiyori, M., Uchida, H., Nagai, J., Araki, K., Mukae, T., Kishioka, S., & Ueda, H. (2011) · Molecular Pain · doi:10.1186/1744-8069-7-69 · Cited by 43
Pregabalin: A Review of its Use in Fibromyalgia
Lyseng-Williamson, K. A., & Siddiqui, M. A. A. (2008) · Drugs · doi:10.2165/00003495-200868150-00009 · Cited by 50
Characterizing and understanding body weight patterns in patients treated with pregabalin
Cabrera, J., Emir, B., Dills, D. G., Murphy, T. K., Whalen, E., & Clair, A. G. (2012) · Current Medical Research and Opinion · doi:10.1185/03007995.2012.684044 · Cited by 42
Heterogeneity Within the Fibromyalgia Population: Theoretical Implications of Variable Tender Point Severity Ratings
Wilson, H., Starz, T. W., Robinson, J. P., & Turk, D. C. (2009) · The Journal of Rheumatology · doi:10.3899/jrheum.090432 · Cited by 42
Fibromyalgia: Understanding, Diagnosis and Modern Approaches to Treatment
Filipović, T., Filipović, A., Nikolić, D., Gimigliano, F., Stevanov, J., Hrković, M., & Bosanac, I. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm14030955 · Cited by 46
Intravenous Micronutrient Therapy (Myers' Cocktail) for Fibromyalgia: A Placebo-Controlled Pilot Study
Ali, A., Njike, V. Y., Northrup, V. S., Sabina, A. B., Williams, A.-L., Liberti, L. S., Perlman, A. I., Adelson, H., & Katz, D. L. (2009) · The Journal of Alternative and Complementary Medicine · doi:10.1089/acm.2008.0410 · Cited by 41
Systematic Review of the Comparative Effectiveness of Antiepileptic Drugs for Fibromyalgia
Siler, A. C., Gardner, H., Yanit, K., Cushman, T. E., & McDonagh, M. S. (2010) · Journal of Pain · doi:10.1016/j.jpain.2010.09.007 · Cited by 41
Identification of symptom and functional domains that fibromyalgia patients would like to see improved: a cluster analysis
Bennett, R. M., Russell, J. I., Cappelleri, J. C., Bushmakin, A. G., Zlateva, G., & Sadosky, A. (2010) · BMC Musculoskeletal Disorders · doi:10.1186/1471-2474-11-134 · Cited by 39
Pharmacotherapy of fibromyalgia
Traynor, L. M., Thiessen, C. N., & Traynor, A. P. (2011) · American Journal of Health-System Pharmacy · doi:10.2146/ajhp100322 · Cited by 39
Beyond the Pain: A Systematic Narrative Review of the Latest Advancements in Fibromyalgia Treatment
Ram, P. R., Jeyaraman, M., Jeyaraman, N., Nallakumarasamy, A., Khanna, M., Gupta, A., & Yadav, S. (2023) · Cureus · doi:10.7759/cureus.48032 · Cited by 38
Relationships Among Pain and Depressive and Anxiety Symptoms in Clinical Trials of Pregabalin in Fibromyalgia
Arnold, L. M., León, T., Whalen, E., & Barrett, J. A. (2010) · Psychosomatics · doi:10.1016/s0033-3182(10)70741-6 · Cited by 36
Self-citation
Reporting of Sample Size Calculations in Analgesic Clinical Trials: ACTTION Systematic Review
McKeown, A., Gewandter, J. S., McDermott, M., Pawlowski, J. R., Poli, J. J., Rothstein, D., Farrar, J. T., Gilron, I., Katz, N. P., Lin, A. H., et al. (2014) · Journal of Pain · doi:10.1016/j.jpain.2014.11.010 · Cited by 37
A Systematic Review of Studies Using the Multidimensional Assessment of Fatigue Scale
Belza, B., Miyawaki, C. E., Liu, M.-H., Aree-Ue, S., Fessel, M., Minott, K., & Zhang, X. (2018) · Journal of Nursing Measurement · doi:10.1891/1061-3749.26.1.36 · Cited by 32

Authors: Arnold, L. M., Russell, I. J., Diri, E. W., Duan, W. R., Young, J. P., Sharma, U., Martin, S. A., Barrett, J. A., & Haig, G.
Affiliations: University of Cincinnati (US)
The University of Texas at San Antonio Health Science Center (US)
Trinity Health (US)
Pfizer (United States) (US)
Corresponding author: Arnold, Lesley M.
ORCID: Arnold, Lesley M.
Diri, E.W.
Martin, Susan A.
Venue: The Journal of Pain
Publisher: Elsevier BV
Published: 2008-09
Volume: 9
Issue: 9
Pages: 792-805
ISSN: 1526-5900 (ISSN-L)
DOI: 10.1016/j.jpain.2008.03.013
OpenAlex: W2148029309
Cited by: 277
References: 38
Citations by year: 2026: 4 · 2025: 8 · 2024: 2 · 2023: 4 · 2022: 8 · 2021: 8 · 2020: 7 · 2019: 6 · 2018: 6 · 2017: 16 · 2016: 16 · 2015: 14 · 2014: 20 · 2013: 22 · 2012: 27
FWCI: 25.50
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 5488 d)
Locations: Journal of Pain (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
Health Sciences › Medicine › Physiology (medical) › Pain Mechanisms and Treatments
Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Musculoskeletal pain and rehabilitation
Keywords: pregabalin, fibromyalgia, monotherapy, pain intensity, sleep quality, Fibromyalgia Impact Questionnaire, Patient Global Impression of Change, adverse events, dizziness, sleepiness, dose comparison
MeSH terms: Pregabalin, Adult, Analgesics, Analysis of Variance, Dizziness, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Fibromyalgia, gamma-Aminobutyric Acid, Humans, Male, Middle Aged, Pain Measurement, Placebos, Severity of Illness Index, Single-Blind Method, 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

A 14-week, Randomized, Double-Blinded, Placebo-Controlled Monotherapy Trial of Pregabalin in Patients With Fibromyalgia

Abstract

Overview

Integrity signals

Verification

Claims the paper makes

Claims other papers make about this one

Citations

Cites

Cited by

Related

Metadata

Record

About these checks