Gabapentin for chronic neuropathic pain in adults

Philip J Wiffen, Sheena Derry, Rae F Bell, Andrew Sc Rice, Thomas Rudolf Tölle, Tudor Phillips, R Andrew Moore, Philip J Wiffen, Sheena Derry, Rae F Bell, Andrew Sc Rice, Thomas Rudolf Tölle, Tudor Phillips, R Andrew Moore

Abstract

Background: Gabapentin is commonly used to treat neuropathic pain (pain due to nerve damage). This review updates a review published in 2014, and previous reviews published in 2011, 2005 and 2000.

Objectives: To assess the analgesic efficacy and adverse effects of gabapentin in chronic neuropathic pain in adults.

Search methods: For this update we searched CENTRAL), MEDLINE, and Embase for randomised controlled trials from January 2014 to January 2017. We also searched the reference lists of retrieved studies and reviews, and online clinical trials registries.

Selection criteria: We included randomised, double-blind trials of two weeks' duration or longer, comparing gabapentin (any route of administration) with placebo or another active treatment for neuropathic pain, with participant-reported pain assessment.

Data collection and analysis: Two review authors independently extracted data and assessed trial quality and potential bias. Primary outcomes were participants with substantial pain relief (at least 50% pain relief over baseline or very much improved on Patient Global Impression of Change scale (PGIC)), or moderate pain relief (at least 30% pain relief over baseline or much or very much improved on PGIC). We performed a pooled analysis for any substantial or moderate benefit. Where pooled analysis was possible, we used dichotomous data to calculate risk ratio (RR) and number needed to treat for an additional beneficial outcome (NNT) or harmful outcome (NNH). We assessed the quality of the evidence using GRADE and created 'Summary of findings' tables.

Main results: We included four new studies (530 participants), and excluded three previously included studies (126 participants). In all, 37 studies provided information on 5914 participants. Most studies used oral gabapentin or gabapentin encarbil at doses of 1200 mg or more daily in different neuropathic pain conditions, predominantly postherpetic neuralgia and painful diabetic neuropathy. Study duration was typically four to 12 weeks. Not all studies reported important outcomes of interest. High risk of bias occurred mainly due to small size (especially in cross-over studies), and handling of data after study withdrawal.In postherpetic neuralgia, more participants (32%) had substantial benefit (at least 50% pain relief or PGIC very much improved) with gabapentin at 1200 mg daily or greater than with placebo (17%) (RR 1.8 (95% CI 1.5 to 2.1); NNT 6.7 (5.4 to 8.7); 8 studies, 2260 participants, moderate-quality evidence). More participants (46%) had moderate benefit (at least 30% pain relief or PGIC much or very much improved) with gabapentin at 1200 mg daily or greater than with placebo (25%) (RR 1.8 (95% CI 1.6 to 2.0); NNT 4.8 (4.1 to 6.0); 8 studies, 2260 participants, moderate-quality evidence).In painful diabetic neuropathy, more participants (38%) had substantial benefit (at least 50% pain relief or PGIC very much improved) with gabapentin at 1200 mg daily or greater than with placebo (21%) (RR 1.9 (95% CI 1.5 to 2.3); NNT 5.9 (4.6 to 8.3); 6 studies, 1277 participants, moderate-quality evidence). More participants (52%) had moderate benefit (at least 30% pain relief or PGIC much or very much improved) with gabapentin at 1200 mg daily or greater than with placebo (37%) (RR 1.4 (95% CI 1.3 to 1.6); NNT 6.6 (4.9 to 9.9); 7 studies, 1439 participants, moderate-quality evidence).For all conditions combined, adverse event withdrawals were more common with gabapentin (11%) than with placebo (8.2%) (RR 1.4 (95% CI 1.1 to 1.7); NNH 30 (20 to 65); 22 studies, 4346 participants, high-quality evidence). Serious adverse events were no more common with gabapentin (3.2%) than with placebo (2.8%) (RR 1.2 (95% CI 0.8 to 1.7); 19 studies, 3948 participants, moderate-quality evidence); there were eight deaths (very low-quality evidence). Participants experiencing at least one adverse event were more common with gabapentin (63%) than with placebo (49%) (RR 1.3 (95% CI 1.2 to 1.4); NNH 7.5 (6.1 to 9.6); 18 studies, 4279 participants, moderate-quality evidence). Individual adverse events occurred significantly more often with gabapentin. Participants taking gabapentin experienced dizziness (19%), somnolence (14%), peripheral oedema (7%), and gait disturbance (14%).

Authors' conclusions: Gabapentin at doses of 1800 mg to 3600 mg daily (1200 mg to 3600 mg gabapentin encarbil) can provide good levels of pain relief to some people with postherpetic neuralgia and peripheral diabetic neuropathy. Evidence for other types of neuropathic pain is very limited. The outcome of at least 50% pain intensity reduction is regarded as a useful outcome of treatment by patients, and the achievement of this degree of pain relief is associated with important beneficial effects on sleep interference, fatigue, and depression, as well as quality of life, function, and work. Around 3 or 4 out of 10 participants achieved this degree of pain relief with gabapentin, compared with 1 or 2 out of 10 for placebo. Over half of those treated with gabapentin will not have worthwhile pain relief but may experience adverse events. Conclusions have not changed since the previous update of this review.

Conflict of interest statement

PW: none known

SD: none known

RFB: none known. RFB is a retired specialist pain physician who has managed patients with neuropathic pain.

ASCR: undertakes consultancy and advisory board work for Imperial College Consultants ‐ since June 2013 this has included remunerated work for: Spinifex, Abide, Astellas, Neusentis, Merck, Medivir, Mitsubishi, Aquilas, Asahi Kasei, Relmada, Novartis, and Orion. All consultancy activity relates to consultancy advice on the preclinical/clinical development of drugs for neuropathic pain. Neusentis was a subsidiary of Pfizer. He owned share options in Spinifex Pharmaceuticals which was acquired by Novartis in July 2015. ASCR was a Principal Investigator in the EuroPain consortium. EuroPain has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement number 115007, resources for which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/20072013) and European Federation of Pharmaceutical Industries and Associations (EFPIA) companies (www.imieuropain.org). Specifically, research funding for ASCR's laboratory has been received by Imperial College from Pfizer (manufacturer of gabapentin) and Astellas ‐ both these grants were for projects related to improving the validity of animal models of neuropathic pain. ASCR is a site investigator for the Neuropain project, funded by Pfizer via Kiel University ‐ Chief Investigator Prof Ralf Baron. He is Vice‐Chair of the International Association for the Study of Pain (IASP) Special Interest Group on Neuropathic Pain (www.neupsig.org) and serves on the Executive Committee of ACTTION (Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks; www.acttion.org).

TRT is a site investigator for the Neuropain project, funded by Pfizer. Since 2014 TRT has consulted with or received lecture fees from pharmaceutical companies related to chronic pain and analgesics: Astellas, Eli Lilly, Grünenthal, Pfizer, and Mundipharma.

TP: none known. TP is a specialist pain physician who has managed patients with neuropathic pain.

RAM has received grant support from Grünenthal relating to individual participant‐level analyses of trial data regarding tapentadol in osteoarthritis and back pain (2015) and from Novartis for network meta‐analyses in acute pain. He has received honoraria for attending boards with Menarini concerning methods of analgesic trial design (2014), with Novartis (2014) about the design of network meta‐analyses, and RB on understanding pharmacokinetics of drug uptake (2015). He has received honoraria from Omega Pharma (2016) and Futura Pharma (2016) for providing advice on trial and data analysis methods.

This review was identified in a 2019 audit as not meeting the current definition of the Cochrane Commercial Sponsorship policy. At the time of its publication it was compliant with the interpretation of the existing policy. As with all reviews, new and updated, at update this review will be revised according to 2020 policy update.

Figures

1
1
Study flow diagram
2
2
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
3
3
Forest plot of comparison: 1 All placebo‐controlled studies, outcome: 1.1 At least 50% pain reduction over baseline.
4
4
Forest plot of comparison: 1 All placebo‐controlled studies, outcome: 1.2 Very much improved.
5
5
Forest plot of comparison: 1 All placebo‐controlled studies, outcome: 1.3 Much or very much improved.
6
6
Forest plot of comparison: 1 All placebo‐controlled studies, outcome: 1.4 IMMPACT outcome of substantial improvement.
7
7
Forest plot of comparison: 1 All placebo‐controlled studies, outcome: 1.5 IMMPACT outcome of at least moderate improvement.
8
8
Postherpetic neuralgia: percentage of participants achieving at least 50% pain intensity reduction (PIR) over baseline with gabapentin 1200 mg‐3600 mg daily, or placebo
9
9
Painful diabetic neuropathy: percentage of participants achieving at least 50% pain intensity reduction (PIR) over baseline with gabapentin 1200‐3600 mg daily, or placebo
1.1. Analysis
1.1. Analysis
Comparison 1 Efficacy ‐ placebo‐controlled studies, Outcome 1 At least 50% pain reduction over baseline.
1.2. Analysis
1.2. Analysis
Comparison 1 Efficacy ‐ placebo‐controlled studies, Outcome 2 Very much improved.
1.3. Analysis
1.3. Analysis
Comparison 1 Efficacy ‐ placebo‐controlled studies, Outcome 3 Much or very much improved.
1.4. Analysis
1.4. Analysis
Comparison 1 Efficacy ‐ placebo‐controlled studies, Outcome 4 IMMPACT outcome of substantial improvement.
1.5. Analysis
1.5. Analysis
Comparison 1 Efficacy ‐ placebo‐controlled studies, Outcome 5 IMMPACT outcome of at least moderate improvement.
2.1. Analysis
2.1. Analysis
Comparison 2 Withdrawals ‐ placebo‐controlled studies, Outcome 1 All‐cause withdrawal.
2.2. Analysis
2.2. Analysis
Comparison 2 Withdrawals ‐ placebo‐controlled studies, Outcome 2 Adverse event withdrawal.
2.3. Analysis
2.3. Analysis
Comparison 2 Withdrawals ‐ placebo‐controlled studies, Outcome 3 Lack of efficacy withdrawal.
3.1. Analysis
3.1. Analysis
Comparison 3 Adverse events, Outcome 1 At least one adverse event.
3.2. Analysis
3.2. Analysis
Comparison 3 Adverse events, Outcome 2 Serious adverse events.
3.3. Analysis
3.3. Analysis
Comparison 3 Adverse events, Outcome 3 Somnolence.
3.4. Analysis
3.4. Analysis
Comparison 3 Adverse events, Outcome 4 Dizziness.
3.5. Analysis
3.5. Analysis
Comparison 3 Adverse events, Outcome 5 Peripheral oedema.
3.6. Analysis
3.6. Analysis
Comparison 3 Adverse events, Outcome 6 Ataxia or gait disturbance.

References

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Backonja 1998 {published data only}
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Gorson 1999 {published data only}
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Hahn 2004 {published data only}
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Harden 2013 {published data only}
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Irving 2009 {published data only}
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Mishra 2012 {published data only}
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Morello 1999 {published data only}
    1. Morello CM, Leckband SG, Stoner CP, Moorhouse DF, Sahagian GA. Randomized double‐blind study comparing the efficacy of gabapentin with amitriptyline on diabetic peripheral neuropathy pain. Archives of Internal Medicine 1999;159(16):1931‐7. [PUBMED: 10493324]
NCT00475904 {published data only}
    1. A Phase II, double‐blind, randomized, placebo‐controlled non‐inferiority trial of EpiCept™ NP‐1 topical cream (2% ketamine/4% amitriptyline) vs. oral gabapentin in postherpetic neuralgia (PHN). (accessed 13 February 2017). [CTG: NCT00475904]
NCT00904202 {published data only}
    1. A study of lidocaine patch 5% alone, gabapentin alone, and lidocaine patch 5% and gabapentin in combination for the relief of pain in patients with diverse peripheral neuropathic pain conditions. (accessed 13 February 2017). [CTG: NCT00904202]
    1. Clinical trial results summary: a multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group study of lidocaine patch 5% alone, gabapentin alone, and lidocaine patch 5% and gabapentin in combination for the relief of pain in patients with diverse peripheral neuropathic pain conditions. (accessed 13 February 2017).
Perez 2000 {published data only}
    1. Perez HET, Sanchez GF. Gabapentin therapy for diabetic neuropathic pain. Journal of Medicine 2000;108:689. [DOI: 10.1016/S0002-9343(00)00398-3]
Rao 2007 {published data only}
    1. Rao RD, Michalak JC, Sloan JA, Loprinzi CL, Soori GS, Nikcevich DA, et al. North Central Cancer Treatment Group. Efficacy of gabapentin in the management of chemotherapy‐induced peripheral neuropathy: a phase 3 randomized, double‐blind, placebo‐controlled, crossover trial (N00C3). Cancer 2007;110(9):2110‐8. [CTG: NCT00027963; DOI: 10.1002/cncr.23008]
Rauck 2013a {published data only}
    1. Rauck R, Makumi CW, Schwartz S, Graff O, Meno‐Tetang G, Bell CF, et al. A randomized, controlled trial of gabapentin enacarbil in subjects with neuropathic pain associated with diabetic peripheral neuropathy. Pain Practice 2013;13(6):485‐96. [CTG: NCT02074267; DOI: 10.1111/papr.12014]
Rauck 2013b {published data only}
    1. Rauck R, Coffey RJ, Schultz DM, Wallace MS, Webster LR, McCarville SE, et al. Intrathecal gabapentin to treat chronic intractable noncancer pain. Anesthesiology 2013;119(3):675‐86. [CTG: NCT00414466; DOI: 10.1097/ALN.0b013e3182a10fbf]
Rice 2001 {published data only}
    1. Study detail and analysis, Parke‐Davis 945‐295. Unpublished Report No. RR‐430‐00124 2000.
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Rintala 2007 {published data only}
    1. Rintala DH, Holmes SA, Courtade D, Fiess RN, Tastard LV, Loubser PG. Comparison of the effectiveness of amitriptyline and gabapentin on chronic neuropathic pain in persons with spinal cord injury. Archives of Physical Medicine and Rehabilitation 2007;88(12):1547‐60. [DOI: 10.1016/j.apmr.2007.07.038]
Rowbotham 1998 {published data only}
    1. Detailed summary, study No.4, Parke‐Davis 945‐211. Unpublished Report No. RR‐995‐00070 1998.
    1. Rowbotham M, Harden N, Stacey B, Bernstein P, Magnus‐Miller L. Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial. JAMA 1998;280(21):1837‐42. [DOI: 10.1001/jama.280.21.1837]
Sandercock 2012 {published data only}
    1. Sandercock D, Cramer M, Biton V, Cowles VE. A gastroretentive gabapentin formulation for the treatment of painful diabetic peripheral neuropathy: efficacy and tolerability in a double‐blind, randomized, controlled clinical trial. Diabetes Research and Clinical Practice 2012;97(3):438‐45. [DOI: 10.1016/j.diabres.2012.03.010]
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Sang 2013 {published data only}
    1. Freeman R, Wallace MS, Sweeney M, Backonja MM. Relationships among pain quality, pain impact, and overall improvement in patients with postherpetic neuralgia treated with gastroretentive gabapentin. Pain Medicine (Malden, Mass.) 2015;16(10):2000‐11. [DOI: 10.1111/pme.12791]
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Serpell 2002 {published data only}
    1. Parke Davis/Pfizer. 945‐430‐306. Unpublished 2000.
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Simpson 2001 {published data only}
    1. Simpson DA. Gabapentin and venlafaxine for the treatment of painful diabetic neuropathy. Journal of Clinical Neuromuscular Disease 2001;3(2):53‐62. [PUBMED: 19078655]
Smith 2005 {published data only}
    1. Smith DG, Ehde DM, Hanley MA, Campbell KM, Jensen MP, Hoffman AJ, et al. Efficacy of gabapentin in treating chronic phantom limb and residual limb pain. Journal of Rehabilitation Research and Development 2005;42(5):645‐54. [DOI: 10.1682/JRRD.2005.05.0082]
Tai 2002 {published data only}
    1. Tai Q, Kirshblum S, Chen B, Millis S, Johnston M, DeLisa JA. Gabapentin in the treatment of neuropathic pain after spinal cord injury: a prospective, randomized, double‐blind, crossover trial. Journal of Spinal Cord Medicine 2002;25(2):100‐5. [PUBMED: 12137213]
Wallace 2010 {published data only}
    1. Freeman R, Wallace MS, Sweeney M, Backonja MM. Relationships among pain quality, pain impact, and overall improvement in patients with postherpetic neuralgia treated with gastroretentive gabapentin. Pain Medicine 2015;16(10):2000‐11. [DOI: 10.1111/pme.12791]
    1. Mehta N, Bucior I, Bujanover S, Shah R, Gulati A. Relationship between pain relief, reduction in pain‐associated sleep interference, and overall impression of improvement in patients with postherpetic neuralgia treated with extended‐release gabapentin. Health and Quality of Life Outcomes 2016;14:54. [DOI: 10.1186/s12955-016-0456-0]
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Zhang 2013 {published data only}
    1. Calkins AM, Gudin J, Gidal B, Jaros MJ, Kim R, Shang G. Impact of data imputation methodology on pain assessment over 24 hours in a randomized, placebo‐controlled study of gabapentin enacarbil in patients with neuropathic pain associated with postherpetic neuralgia. Pain Medicine 2016;17(4):728‐36. [DOI: 10.1093/pm/pnv072]
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References to studies excluded from this review Arai 2010 {published data only}
    1. Arai YC, Matsubara T, Shimo K, Suetomi K, Nishihara M, Ushida T, et al. Low‐dose gabapentin as useful adjuvant to opioids for neuropathic cancer pain when combined with low‐dose imipramine. Journal of Anesthesia 2010;24(3):407‐10. [DOI: 10.1007/s00540-010-0913-6]
Berry 2005 {published data only}
    1. Berry JD, Petersen KL. A single dose of gabapentin reduces acute pain and allodynia in patients with herpes zoster. Neurology 2005;65(3):444‐7. [DOI: 10.1212/01.wnl.0000168259.94991.8a]
Dallocchio 2000 {published data only}
    1. Dallocchio C, Buffa C, Mazzarello P, Chiroli S. Gabapentin vs. amitriptyline in painful diabetic neuropathy: an open‐label pilot study. Journal of Pain and Symptom Management 2000;20(4):280‐5. [DOI: 10.1016/S0885-3924(00)00181-0]
Ding 2014 {published data only}
    1. Ding Y, Yao P, Lan P, Ma J, Wang Z, Hong T, et al. Assessment of transdermal fentanyl combined with gabapentin for malignant neuropathic pain treatment. Chinese Journal of Clinical Oncology 2014;41(20):1307‐11. [DOI: 10.3969/j.issn.1000-8179.20141212]
Dworkin 2009 {published data only}
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Ho 2009 {published data only}
    1. Ho TW, Backonja M, Ma J, Leibensperger H, Froman S, Polydefkis M. Efficient assessment of neuropathic pain drugs in patients with small fiber sensory neuropathies. Pain 2009;14(1‐2):19‐24. [DOI: 10.1016/j.pain.2008.07.013]
Jean 2005 {published data only}
    1. Jean WH, Wu CC, Mok MS, Sun WZ. Starting dose of gabapentin for patients with post‐herpetic neuralgia‐‐a dose‐response study. Acta Anaesthesiologica Taiwan 2005;43(2):73‐7. [PUBMED: 16060401]
Kasimcan 2010 {published data only}
    1. Kasimcan O, Kaptan H. Efficacy of gabapentin for radiculopathy caused by lumbar spinal stenosis and lumbar disk hernia. Neurologia Medico Chirurgica (Tokyo) 2010;50(12):1070‐3. [DOI: 10.2176/nmc.50.1070]
Keskinbora 2007 {published data only}
    1. Keskinbora K, Pekel AF, Aydinli I. Gabapentin and an opioid combination versus opioid alone for the management of neuropathic cancer pain: a randomized open trial. Journal of Pain Symptom Management 2007;34(2):183‐9. [10.1016/j.jpainsymman.2006.11.013]
Kimos 2007 {published data only}
    1. Kimos P, Biggs C, Mah J, Heo G, Rashiq S, Thie NM, et al. Analgesic action of gabapentin on chronic pain in the masticatory muscles: a randomized controlled trial. Pain 2007;127(1‐2):151‐60. [DOI: 10.1016/j.pain.2006.08.028]
Ko 2010 {published data only}
    1. Ko SH, Kwon HS, Yu JM, Baik SH, Park IB, Lee JH, et al. Comparison of the efficacy and safety of tramadol/acetaminophen combination therapy and gabapentin in the treatment of painful diabetic neuropathy. Diabetes Medicine 2010;27(9):1033‐40. [DOI: 10.1111/j.1464-5491.2010.03054.x]
McCleane 2001 {published data only}
    1. McCleane GJ. Does gabapentin have an analgesic effect on background, movement and referred pain? A randomised, double‐blind, placebo controlled study. The Pain Clinic 2001;13:103.
NCT00634543 {published data only}
    1. A study to compare safety and efficacy of tramadol hydrochloride/acetaminophen with gabapentin in participants with diabetic neuropathy. (accessed 13 February 2017). [CTG: NCT00634543]
NCT01263132 {published data only}
    1. Neuropathic pain treatment using F0434 vs. gabapentin in patients with chronic distal diabetic polyneuropathy: a randomized, controlled, double‐blind study. (accessed 13 February 2017). [CTG: NCT01263132]
NCT01623271 {published data only}
    1. Treatment of complex regional pain syndrome with once daily gastric‐retentive gabapentin (Gralise). (accessed 13 February 2017). [CTG: NCT01623271]
Nikolajsen 2006 {published data only}
    1. Nikolajsen L, Finnerup NB, Kramp S, Vimtrup AS, Keller J, Jensen TS. A randomized study of the effects of gabapentin on postamputation pain. Anesthesiology 2006;105(5):1008‐15. [PUBMED: 17065896]
Pandey 2002 {published data only}
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Pandey 2005 {published data only}
    1. Pandey CK, Raza M, Tripathi M, Navkar DV, Kumar A, Singh UK. The comparative evaluation of gabapentin and carbamazepine for pain management in Guillain‐Barre syndrome patients in the intensive care unit. Anesthesia and Analgesia 2005;101(1):220‐5. [DOI: 10.1213/01.ANE.0000152186.89020.36]
Salvaggio 2008 {published data only}
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Sator‐Katzenschlager 2005 {published data only}
    1. Sator‐Katzenschlager SM, Scharbert G, Kress HG, Frickey N, Ellend A, Gleiss A, et al. Chronic pelvic pain treated with gabapentin and amitriptyline: a randomized controlled pilot study. Wiener Klinische Wochenschrift 2005;117(21‐22):761‐8. [DOI: 10.1007/s00508-005-0464-2]
Tanenberg 2011 {published data only}
    1. Tanenberg RJ, Irving GA, Risser RC, Ahl J, Robinson MJ, Skljarevski V, et al. Duloxetine, pregabalin, and duloxetine plus gabapentin for diabetic peripheral neuropathic pain management in patients with inadequate pain response to gabapentin: an open‐label, randomized, noninferiority comparison. Mayo Clinic proceedings 2011;86(7):615‐26. [CTG: NCT00385671; DOI: 10.4065/mcp.2010.0681]
Van de Vusse 2004 {published data only}
    1. Vusse AC, Stomp‐van den Berg SG, Kessels AH, Weber WE. Randomised controlled trial of gabapentin in Complex Regional Pain Syndrome type 1 [ISRCTN84121379]. BMC Neurology 2004;4:13. [DOI: 10.1186/1471-2377-4-13]
Yaksi 2007 {published data only}
    1. Yaksi A, Ozgonenel L, Ozgonenel B. The efficiency of gabapentin therapy in patients with lumbar spinal stenosis. Spine 2007;32(9):939‐42. [DOI: 10.1097/01.brs.0000261029.29170.e6]
Yelland 2009 {published data only}
    1. Yelland MJ, Poulos CJ, Pillans PI, Bashford GM, Nikles CJ, Sturtevant JM, et al. N‐of‐1 randomized trials to assess the efficacy of gabapentin for chronic neuropathic pain. Pain Medicine 2009;10(4):754‐61. [DOI: 10.1111/j.1526-4637.2009.00615.x]
Yildrim 2003 {published data only}
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References to ongoing studies Fleckstein 2009 {published data only}
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IRCT201212019014N14 {published data only}
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NCT00674687 {published data only}
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Moore 2010a
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Moore 2010e
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