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Table 1 Characteristics of included studies

From: Efficacy, acceptability, and safety of antidepressants for low back pain: a systematic review and meta-analysis

Study Patient sample Setting Number of trial arms Intervention, number assigned Comparator, number assigned Duration of treatment Outcome measures applicable to this review
Label, citation Study level data unless reported otherwise; mean (SD) (mg/day unless indicated) (mg/day unless indicated)
Alcoff et al. [51] 50 participants with subacute and chronic LBP; mean age imipramine group 29.2 years, placebo group 33.8 yearsb; n = 24 (48%) female USA; 2 sites 2 Oral imipramine 75 for 3 days, 150 thereafter, n = 28 Placebo, n = 22 8 weeks SBPQ, BDI
Atkinson et al. [52] 121 participants with chronic LBP; mean age 46.4 (10.2) years; n = 47 (38.8%) female USA 7 Oral desipramine target concentrations of 50 ng/mL n = 17, or 110 ng/mL n = 17, or 150 ng/mL n = 18, or fluoxetine target concentrations of 50 ng/mL n = 14, or 100 ng/mL n = 14, or 150 ng/mL n = 15 Active placebo (benztropine mesylate) n = 26 12 weeks DDS, BDI, RMDQ
Atkinson et al. [62] 103 participants with chronic LBP; mean age 49.2 (9.4) years; n = 38 (37%) female USA 3 Oral maprotiline 150, n = 33, or paroxetine 30, n = 34 Active placebo (diphenhydramine) 37.5, n = 36 8 weeks DDS, BDI
Atkinson et al. [63] 78 participants with chronic LBP; mean age nortriptyline group 45.79 (10.59) years, placebo group 47.13 (10.65) years; n = 0 (0%) female USA 2 Oral nortriptyline 25 for 3 days, 50 for 4 days, 75 for 3 days, 100 for 4 days to reach target concentration of 50–150 ng/ml, n = 38 Placebo, n = 40 8 weeks DDS, BDI
Dickens et al. [64] 92 participants with chronic LBP. Mean age 45 yearsb; n = 50 (54%) female UK 2 Oral paroxetine 20, n = 44 Placebo, n = 48 8 weeks 100 mm VAS, MADRS
Goodkin et al. [65] 42 participants with chronic LBP; mean age 53.6 (12.9) years; n = 16 (38%) female USA 2 Oral trazodone 50, increasing to 600, n = 22 Placebo, n = 22 6 weeks 100 mm VAS, BDI
Gould et al. [66] 142 participants with chronic LBP; mean age 55.8 (11.7) years; n = 15 (11 %) female USA 4 Oral desipramine hydrochloride to reach target concentration of 5–60 ng/ml, n = 37, or desipramine hydrochloride to reach target concentration of 5–60 ng/ml and cognitive behavioral therapy, n = 37 Active placebo (benztropine mesylate) 0.125 and cognitive behavioral therapy, n = 33, or active placebo (benztropine mesylate) 0.125, n = 32 12 weeks DDS, RMDQ
Jenkins et al. [67] 59 participants with acute and chronic LBP; mean age imipramine group 26 years, placebo group 26.7 yearsb; n = 3 (5%) female UK 2 Oral imipramine 75, n = 30 Placebo, n = 29 4 weeks 10 cm VAS, BDI
Johnson et al. [68] (crossover) 14 participants with chronic LBP; mean age 36.93 (13.05) years; n = 0 (0%) female USA 2 Oral duloxetine, 30 for 1 week, titration to 60 for 2 weeks, then maintenance for 4 weeks, 30 for final week, n = 7 a Placebo, n = 7a 8 weeks/phase with 1-week washout BPI
Katz et al. [69] (crossover) 54 participants with chronic LBP; mean age 50.6 (10.7) years; n = 21 (48%) femalec USA 2 Oral bupropion 150 for 3 days, 300 until end week 5, 150 until week 7, n = 21a Placebo, n = 23a 7 weeks/phase with 2-week washout 11-point NRS, BDI, RMDQ
Konno et al. [53] 458 participants with chronic LBP; mean age 58.9 (13.4) years; n = 237 (52%) female Japan; 58 sites 2 Oral duloxetine 20 first week, 40 second week, 60 weeks 3–14, n = 232 Placebo, n = 226 14 weeks 11-point NRS, RMDQ
NCT00227292 (withdrawn) Chronic LBP Germany 2 Oral escitalopram 10 for 1 week, 20 for 3 weeks Placebo 4 weeks VAS, HDRS
NCT01225068 40 participants with chronic neuropathic LBP; mean age 47.7 (10.3) years; n = 21 (52%) female USA 2 Oral milnacipran 100, option to increase to 200 after 2 weeks, n = 20. Drug escalated in week 1 and discontinued after week 6 Placebo, n = 20 6 weeks 100 mm VAS
NCT03249558 (ongoing) Chronic LBP or chronic neck pain USA 3 Oral morphine 60 plus duloxetine, or morphine plus placebo duloxetine, or placebo morphine plus duloxetine 60 Placebo 10 weeks VAS
NCT03364075 (crossover; terminated) Chronic LBP NR 3 Oral duloxetine 30 for 1 week then 60 for 1 week plus placebo, or propranolol 40 for 1 week then 60 for 1 week plus placebo, or duloxetine 30 for 1 week then 60 for 1 week plus propranolol 40 for 1 week then 60 for 1 week Placebo 2 weeks/phase with 1-week washout Pain index
Pheasant et al. [54] (crossover) 16 participants with chronic LBP; mean age 47.2 yearsb; n = 16 (75%) female USA 2 Oral amitriptyline 50, n = 6a Active placebo (atropine) 0.2, n = 10a 6 weeks/phase with 2-week washout Functional evaluation rating
Schliessbach et al. [55] (crossover) 50 participants with chronic LBP; mean age 54.4 (17.3) years; n = 32 (64%) female Switzerland 2 Oral imipramine 75  single dose, n = 50 Active placebo (tolderodine) 1.0, single dose, n = 50 2 h/phase with 1-week washout 11-point NRS
Schukro et al. [56] (crossover) 41 participants with chronic LBP and leg pain; mean age 57.9 years (13.4); n = 21 (51%) female Austria 2 Oral duloxetine 30 to 60 first week; 60 to 120 second week; 120 for 2 weeks, n = 16a Placebo, n = 18a 4 weeks/phase with 2-week washout 10 cm VAS, BDI, RMDQ
Skljarevski et al. [57] 236 participants with chronic LBP, mean age duloxetine groups 51.8 (14.9) years; placebo group 51.2 (13.5) years; n = 144 (61%) female 18 clinical sites in Brazil, France, Germany, Mexico, and Netherlands 2 Oral duloxetine 30 for 1 week, 60 for 6 weeks, non-responders increased to 120/day for remainder of study, n = 115 Placebo, n = 121 13 weeks 11-point NRS, BDI-II, RMDQ
Skljarevski et al. [58] 404 participants with chronic LBP; mean age duloxetine 20 mg group 52.9 (12.8) years, duloxetine 60 mg group 53.3 (14.7) years, duloxetine 120 mg group 54.9 (14.8) years, placebo group 54 (13.5) years; n = 232 (57%) female NR 4 Oral duloxetine 20, n = 59, or 60, n = 116, or 120, n = 112 Placebo, n = 117 13 weeks 11-point NRS, BDI-II, RMDQ
Skljarevski et al. [59] 401 participants with chronic LBP, mean age duloxetine group 54.9 (13.7) years; placebo group 53.4 (14.2) years; n = 246 (61%) female 27 sites in Germany, Netherlands, Poland, Russia, Spain, and USA 2 Oral duloxetine 60, n = 198 Placebo, n = 203 12 weeks 11-point NRS, BDI-II, RMDQ
Treves et al. [60] 68 participants with chronic LBP, LBP with leg pain, and sciatica; mean age 45.6b years; n = 35 (51%) female France 3 IV clomipramine, progressive doses in the morning until maximum dose of 75 reached (3rd day) and maintained for the next 7 days with placebo in evening, n = 25, or IV clomipramine progressive doses in the evening until maximum dose of 75 reached (3rd day) and maintained for the next 7 days with placebo in morning, n = 27 IV placebo (isotonic glucose), n = 16 10 days 10 cm VAS
Urquhart et al. [61] 146 participants with chronic LBP; mean age amitriptyline group 53.5 (14.2) years, placebo group 56.0 (13.2) years; n = 56 (38.%) female Australia 2 Oral amitriptyline 25, n = 72 Active placebo (benztropine mesylate) 1.0, n = 74 6 months 100 mm VAS, BDI, RMDQ
  1. NR not reported, LBP low back pain, SBPQ Short Back Pain Questionnaire, BDI Beck Depression Inventory, BDI-II Beck Depression Inventory II, DDS Descriptor Differential Scale, RMDQ Roland Morris Disability Questionnaire, VAS visual analog scale, MADRS Montgomery Asberg Depression Rating Scale, NRS numerical rating scale, BPI Brief Pain Inventory, HDRS Hamilton Depression Rating Scale
  2. aNumber of participants randomized in the first phase of crossover trial
  3. bNo measure of central tendency reported
  4. cAge and sex data presented for intention-to-treat sample
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Systematic Reviews

ISSN: 2046-4053