| | Study | Design | Intervention (sample size and age) | Duration (week) | Primary endpoints | Secondary endpoints | Common AEs | Jadad score |
| | Irving 2009 [13] | Double-blind, randomized, placebo-controlled, parallel | 158 included in the ITT analysis: Gabapentin ER1800 mg, QD, PM (55) (71±10.3); BID, 600 mg AM, 1200 mg PM (52) (68±12.9) placebo (51) (69±11.5) | 5 | ADP scores | ⩾30% improvement, ⩾50% improvement, Sleep interference, SF-MPQ, NPS, PGIC/CGIC | Dizziness, Somnolence, Nausea, Dry mouth, Headache, Fatigue, Gait disturbance, Peripheral edema, Upper respiratory tract infection | 5 | | Wallace 2010 [22] | Double-blind, randomized, placebo-controlled, multicenter, parallel | 400 included in ITT analysis: Gabapentin ER 1800 mg, QD (134) (68±11.8); BID (135) (66±13.2) placebo (131) (66±12.6) | 11 | ADP scores | ⩾50% improvement, Sleep interference, SF-MPQ, NPS, BPI, PGIC/CGIC | Dizziness, Headache, Somnolence, Peripheral edema | 5 | | Backonja 2011 [23] | Double-blind, randomized, placebo-controlled, parallel | 101 included in ITT analysis: GEn1200 mg, BID (47) (65±12.32); placebo (54)(64±12.69) | 4 | ADP scores | ⩾30% improvement, ⩾50% improvement, Sleep interference, POMS, PGIC, SF-MPQ | Dizziness, Nausea, Headache, Diarrhea, Fatigue, PHN, Insomnia, Depression | 4 | | Zhang 2013 [14] | Double-blind, randomized, placebo-controlled, multicenter, parallel | 371 included in the ITT analysis: GEn 1200 mg, BID, (107) (61.7±12.58); GEn 2400 mg, BID, (82) (64.1±8.94); GEn 3600 mg, BID, (87) (61.3±15.41); Placebo (95) (61.7±12.77) | 14 | ADP scores | ⩾30% improvement, ⩾50% improvement, Pain intensity, Sleep interference, NPS, SF-MPQ, BPI, SF-36, Dynamic Allodynia, POMS-B, PGIC/CGIC, Use of Rescue Medication | Dizziness, Somnolence, Headache, Nausea, Constipation, Diarrhea, Fatigue, Nasopharyngitis, Edema peripheral, Arthralgia, Insomnia, Urinary tract infection, Back pain, Weight increase, Dry mouth, Hypertension, Nasal congestion, Vision blurred, Flatulence, Joint sprain, Tremor | 5 | | Rice 2001 [15] | Double-blind, randomized, placebo-controlled, multicenter, parallel | 334 included in ITT analysis: Gabapentin 1800 mg (115) (74.8, 22.5–88.6); 2400 mg (108) (76.3, 36.1–90.8); Placebo (111) (74.9, 28.9–94.8) | 7 | ADP scores | ⩾30% improvement, ⩾50% improvement, Sleep interference, SF-MPQ, PGIC/CGIC, SF-36 | Dizziness, Somnolence, Peripheral edema, Asthenia, Dry mouth, Diarrhea | 5 | | Sang 2013 [16] | Double-blind, randomized, placebo-controlled, multicenter, parallel | 450 included in the ITT analysis: gabapentin ER 1800 mg, QD (220) (65.3±13.3); Placebo (230) (65.9±11.1) | 10 | ADP scores | ⩾ 50% improvement, PGIC/CGIC, Sleep interference | Dizziness, Somnolence, Headache, Nausea, Peripheral edema, Nasopharyngitis | 4 | | Rowbotham 1998 [17] | Double-blind, randomized, placebo-controlled, multicenter, parallel | 229 included in the ITT analysis: Gabapentin 3600 mg, TID (113) (73,40–90); placebo (116)(74,39-89) | 8 | ADP scores | Sleep interference, SF-MPQ, PGIC/CGIC, SF-36, POMS | Somnolence, Dizziness, Ataxia, Peripheral edema, Infection | 5 | | Gong 2008 [18] | Double-blind, randomized, placebo-controlled, multicenter, parallel | 215 included in the ITT analysis: Gabapentin divided-doses 1800 mg (109) (67.49±11.55); Placebo (106) (65.25±12.11) | 6 | ADP scores | ⩾ 50% improvement, ADP,SF-MPQ,PGIC/CGIC | Dizziness, Somnolence, Amblyopia, Peripheral edema, Nausea, Vomiting, Nystaxis, Dysuria | 5 | | Jin 2006 [19] | Double-blind, randomized, placebo-controlled, parallel | 36 included in the ITT analysis: Gabapentin divided-does 2400 mg (18) (63±10.3); Placebo (18) (64.39±9.12) | 4 | ADP scores | ⩾ 50% improvement, ADP, PGIC/CGIC | Dizziness, Somnolence, Ataxia, Nausea, Vomiting | 5 | | Xie 2009 [20] | Double-blind, randomized, placebo-controlled, parallel | 50 included in the ITT analysis: Gabapentin divided-does 2400 mg (26); Placebo (24) | 4 | ADP scores | ⩾ 51% improvement, ADP, PGIC/CGIC | Dizziness, Somnolence, Anorexia, Insomnia | 4 | | He 2008 [21] | Double-blind, randomized, placebo-controlled, parallel | 32 included in the ITT analysis: Gabapentin divided-does 1200 mg (16) (74.1±12.2); Placebo (16) (72.69±11.7) | 4 | ADP scores | ⩾ 52% improvement, ADP, PGIC/CGIC,QS | Dizziness, Somnolence, Week, Ataxia, Anorexia, Insomnia, Vertigo | 4 |
|
|
