Duloxetine for treating painful neuropathy or chronic pain

(Review)

Lunn MPT, Hughes RAC, Wiffen PJ

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library2010, Issue 3

http://www.thecochranelibrary.com

Duloxetine for treating painful neuropathy or chronic pain (Review)

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

http://www.thecochranelibrary.com

T A B L E O F C O N T E N T S

1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . . . . . . . . . . . . . . . . . . .5BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Figure 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Figure 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Figure 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Figure 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Figure 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Figure 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

18DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Analysis 1.1. Comparison 1 Duloxetine versus placebo in the treatment of painful neuropathy, Outcome 1 Number ofpatients with >50% improvement of pain at 12 weeks or less. . . . . . . . . . . . . . . . . . 46

Analysis 1.2. Comparison 1 Duloxetine versus placebo in the treatment of painful neuropathy, Outcome 2 Meanimprovement in pain at 12 weeks or less. . . . . . . . . . . . . . . . . . . . . . . . . 47

Analysis 1.3. Comparison 1 Duloxetine versus placebo in the treatment of painful neuropathy, Outcome 3 Number ofpatients with >30% improvement in pain at 12 weeks or less. . . . . . . . . . . . . . . . . . 48

Analysis 1.4. Comparison 1 Duloxetine versus placebo in the treatment of painful neuropathy, Outcome 4 Meanimprovement in SF-36 Physical subscore at 12 weeks or less. . . . . . . . . . . . . . . . . . . 49

Analysis 1.5. Comparison 1 Duloxetine versus placebo in the treatment of painful neuropathy, Outcome 5 Meanimprovement in SF-36 Mental Subscore at 12 weeks or less. . . . . . . . . . . . . . . . . . . 50

Analysis 1.6. Comparison 1 Duloxetine versus placebo in the treatment of painful neuropathy, Outcome 6 Meanimprovement in SF-36 Bodily Pain Subscore at 12 weeks or less. . . . . . . . . . . . . . . . . 51

Analysis 1.7. Comparison 1 Duloxetine versus placebo in the treatment of painful neuropathy, Outcome 7 Meanimprovement in Patient Reported Global Impression of Change at 12 weeks or less. . . . . . . . . . . 52

Analysis 1.8. Comparison 1 Duloxetine versus placebo in the treatment of painful neuropathy, Outcome 8 Meanimprovement in BPI severity - average pain at 12 weeks or less. . . . . . . . . . . . . . . . . . 53

Analysis 1.9. Comparison 1 Duloxetine versus placebo in the treatment of painful neuropathy, Outcome 9 Meanimprovement in pain at rest (night pain) at 12 weeks or less. . . . . . . . . . . . . . . . . . . 54

Analysis 2.1. Comparison 2 Duloxetine versus placebo in the treatment of fibromyalgia, Outcome 1 Number of patientswith = or >50% improvement of pain at = or 50% improvement of pain at >12 weeks. . . . . . . . . . . . . . . . . . . . . 56

Analysis 2.3. Comparison 2 Duloxetine versus placebo in the treatment of fibromyalgia, Outcome 3 Number of patientswith = or >30% improvement of pain at = or

Analysis 2.6. Comparison 2 Duloxetine versus placebo in the treatment of fibromyalgia, Outcome 6 Mean improvement inthe SF36 Bodily Pain subscore. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Analysis 2.7. Comparison 2 Duloxetine versus placebo in the treatment of fibromyalgia, Outcome 7 Mean improvement inthe patient reported global impression of change at 12 weeks or less. . . . . . . . . . . . . . . . 61

Analysis 3.1. Comparison 3 Duloxetine versus placebo: adverse events during first 12 weeks of treatment for painfulneuropathy or fibromyalgia, Outcome 1 Proportion of patients with any adverse event. . . . . . . . . 62

Analysis 3.2. Comparison 3 Duloxetine versus placebo: adverse events during first 12 weeks of treatment for painfulneuropathy or fibromyalgia, Outcome 2 Nausea. . . . . . . . . . . . . . . . . . . . . . . 63

Analysis 3.3. Comparison 3 Duloxetine versus placebo: adverse events during first 12 weeks of treatment for painfulneuropathy or fibromyalgia, Outcome 3 Somnolence. . . . . . . . . . . . . . . . . . . . . 64

Analysis 3.4. Comparison 3 Duloxetine versus placebo: adverse events during first 12 weeks of treatment for painfulneuropathy or fibromyalgia, Outcome 4 Dry mouth. . . . . . . . . . . . . . . . . . . . . 65

Analysis 3.5. Comparison 3 Duloxetine versus placebo: adverse events during first 12 weeks of treatment for painfulneuropathy or fibromyalgia, Outcome 5 Dizziness. . . . . . . . . . . . . . . . . . . . . . 66

Analysis 3.6. Comparison 3 Duloxetine versus placebo: adverse events during first 12 weeks of treatment for painfulneuropathy or fibromyalgia, Outcome 6 Adverse event leading to cessation. . . . . . . . . . . . . 67

Analysis 3.7. Comparison 3 Duloxetine versus placebo: adverse events during first 12 weeks of treatment for painfulneuropathy or fibromyalgia, Outcome 7 Serious adverse event. . . . . . . . . . . . . . . . . . 68

69APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72FEEDBACK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .75INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iiDuloxetine for treating painful neuropathy or chronic pain (Review)

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

[Intervention Review]

Duloxetine for treating painful neuropathy or chronic pain

Michael PT Lunn1 , Richard AC Hughes2, Philip J Wiffen3

1Department of Neurology, National Hospital for Neurology and Neurosurgery, London, UK. 2MRC Centre for NeuromuscularDisease, National Hospital for Neurology and Neurosurgery, London, UK. 3UK Cochrane Centre, Oxford, UK

Contact address: Michael PT Lunn, Department of Neurology, National Hospital for Neurology and Neurosurgery, Queen Square,London, WC1N 3BG, UK. michael.lunn@uclh.nhs.uk.

Editorial group: Cochrane Neuromuscular Disease Group.Publication status and date: Edited (no change to conclusions), comment added to review, published in Issue 3, 2010.Review content assessed as up-to-date: 1 March 2009.

Citation: Lunn MPT, Hughes RAC, Wiffen PJ. Duloxetine for treating painful neuropathy or chronic pain. Cochrane Database ofSystematic Reviews 2009, Issue 4. Art. No.: CD007115. DOI: 10.1002/14651858.CD007115.pub2.

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

A B S T R A C T

Background

Duloxetine is a balanced serotonin and noradrenaline reuptake inhibitor licensed for the treatment of major depressive disorders, urinarystress incontinence and the management of neuropathic pain associated with diabetic peripheral neuropathy. A number of trials havebeen conducted to investigate the use of duloxetine in neuropathic and nociceptive painful conditions.

Objectives

To assess the benefits and harms of duloxetine for treating painful neuropathy and different types of chronic pain.

Search strategy

We searched The Cochrane Neuromuscular Group Specialized Register (10 March 2009), The Cochrane Central Register of ControlledTrials (The Cochrane Library Issue 3, 2009), MEDLINE (January 1966 to March 2009), EMBASE (January 1980 to March 2009),and www.clinicaltrials.gov to March 2009 and the reference lists of identified publications for trials of duloxetine used for the treatmentof painful peripheral neuropathy or chronic pain.

Selection criteria

We selected all randomised or quasi-randomised trials of a