Effectiveness and Safety of Progabide for Refractory Epilepsy: A Meta-Analysis_Chinese Journal of Evidence-Based Medicine

Authors：

YUAN Tingting , WU Bo ,  ZOU Xiaoyi

Department of Neurology, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

ZOU Xiaoyi, Email: xiaoyizou@163.com

Keywords：

Progabide; Refractory epilepsy; Meta-analysis; Systematic review; Randomized controlled trial

DOI：

10.7507/1672-2531.20120124

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective 　To assess the effectiveness and safety of progabide (PGB) for refractory epilepsy.
Methods 　Randomized controlled trials (RCTs) on PGB treating refractory epilepsy were searched from the following databases as PubMed, EMbase, The Cochrane Library, CNKI, CBM and VIP from the date of their establishment to July 2011. The data of RCTs meeting the inclusive criteria were extracted according to Cochrane methods by two reviewers independently, and after the quality was evaluated and cross-checked, meta-analyses were conducted using RevMan 5.1 software.
Results 　A total of seven studies involving 231 patients were included. The results of Meta-analyses showed that based on the conventional therapy, PGB was ineffective in treating refractory partial epilepsy compared with the placebo (OR=1.76, 95%CI 0.40 to 7.65, P=0.45), but it was superior to the placebo in treating refractory partial and generalized epilepsy (OR=4.46, 95%CI 2.06 to 9.65, P=0.000 1). The main adverse events of PGB were somnolence, dizziness and headache, which were mild and transient, which could turn to normal after reducing the dose of PGB and only a few patients needed to stop taking PGB.
Conclusion 　Current studies shows that progabide may be effective in treating refractory partial and generalized epilepsy, but its effectiveness in treating refractory partial epilepsy is still unknown. The side effects of PGB are mostly mild. For the possibility of moderate selection bias existing in the quality of the included studies which may affect the authenticity of outcomes, so this conclusion still needs to be further proved by conducting more high-quality, large-scale and double-blinded RCTs.

Citation： YUAN Tingting,WU Bo,ZOU Xiaoyi. Effectiveness and Safety of Progabide for Refractory Epilepsy: A Meta-Analysis. Chinese Journal of Evidence-Based Medicine, 2012, 12(7): 810-816. doi: 10.7507/1672-2531.20120124 Copy

1.	Kwan P, Schachter SC, Brodie MJ. Drug-resistant epilepsy. N Engl J Med, 2011, 365(10): 919-926.
2.	Granata T, Marchi N, Carlton E, et al. Management of the patient with medically refractory epilepsy. Expert Rev Neurother, 2009, 9(12): 1791-1802.
3.	Kwan P, Arzimanoglou A, Berg A, et al. De?nition of drug resistant epilepsy: Consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia, 2010, 51(6): 1069-1077.
4.	Kwan P, Brodie MJ. Definition of refractory epilepsy: defining the indefinable? Lancet Neurol, 2010, 9(1): 27-29.
5.	Lloyd KG, Munari C, Worms P, et al. The role of GABA mediated neurotransmission in convulsive states. Adv Biochem Psychopharmacol, 1981, 26: 199-206.
6.	Lloyd KG, Arbilla S, Beaumont K, et al. gamma-Aminobutyric acid (GABA) receptor stimulation. II. Specificity of progabide (SL 76002) and SL 75102 for the GABA receptor. J Pharmacol Exp Ther, 1982, 220(3): 672-677.
7.	De Pasquet EG, Scaramelli A, de Cáceres MP, et al. Double-blind, placebo-controlled, cross-over trial of progabide as add-on therapy inepileptic patients. Epilepsia, 1991, 32(1): 133-139.
8.	Martinez-Lage JM, Bossi L, Morales G, et al. Progabide treatment in severe epilepsy: a double-blind cross-over trial versus placebo. Epilepsia, 1984, 25(5): 586-593.
9.	Schmidt D, Utech K. Progabide for refractory partial epilepsy:a controlled add-on trial. Neurology, 1986, 36(2): 217-221.
10.	Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials, 1996, 17(1): 1-12.
11.	Crawford P, Chadwick D. A comparative study of progabide, valproate, and placebo as add-on therapy in patients with refractory epilepsy. J Neurol Neurosurg Psychiatry, 1986, 49(11): 1251-1257.
12.	Musch B, Cambier J, Loiseau P, et al. Long-term treatment of epilepsy: open multicenter trial with progabide in epileptic patients. Eur Neurol, 1987, 26(2): 113-119.
13.	Leppik IE, Dreifuss FE, Bowman T, et al. A double-blind crossover evaluation of progabide in partial seizures. Neurology, 35 Suppl 1(4): 285, 1985.
14.	Leppik IE, Dreifuss FE, Porter R, et al. A controlled study of progabide in partial seizures: methodology and results. Neurology, 1987, 37(6): 963-968.
15.	Dam M, Gram L, Philbert A, et al. Progabide: a controlled trial in partial epilepsy. Epilepsia,1983, 24(2): 127-134.
16.	Schmidt D. Progabide as an add-on drug for epilepsy refractory to high dose antiepileptic drugtherap. Neurosci Lett, 1984, 47(3): 357-360.
17.	Loiseau P, Bossi L, Guyot M, et al. Double-blind crossover trial of progabide versus placebo in severe epilepsies. Epilepsia, 1983, 24(6): 703-715.
18.	Brundage RC, Cloyd JC, Leppik IE, et al. Effect of progabide on serum phenytoin and carbamazepine concentrations. Clin Neuropharmacol, 1987, 10(6): 545-554.

1. Kwan P, Schachter SC, Brodie MJ. Drug-resistant epilepsy. N Engl J Med, 2011, 365(10): 919-926.
2. Granata T, Marchi N, Carlton E, et al. Management of the patient with medically refractory epilepsy. Expert Rev Neurother, 2009, 9(12): 1791-1802.
3. Kwan P, Arzimanoglou A, Berg A, et al. De?nition of drug resistant epilepsy: Consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia, 2010, 51(6): 1069-1077.
4. Kwan P, Brodie MJ. Definition of refractory epilepsy: defining the indefinable? Lancet Neurol, 2010, 9(1): 27-29.
5. Lloyd KG, Munari C, Worms P, et al. The role of GABA mediated neurotransmission in convulsive states. Adv Biochem Psychopharmacol, 1981, 26: 199-206.
6. Lloyd KG, Arbilla S, Beaumont K, et al. gamma-Aminobutyric acid (GABA) receptor stimulation. II. Specificity of progabide (SL 76002) and SL 75102 for the GABA receptor. J Pharmacol Exp Ther, 1982, 220(3): 672-677.
7. De Pasquet EG, Scaramelli A, de Cáceres MP, et al. Double-blind, placebo-controlled, cross-over trial of progabide as add-on therapy inepileptic patients. Epilepsia, 1991, 32(1): 133-139.
8. Martinez-Lage JM, Bossi L, Morales G, et al. Progabide treatment in severe epilepsy: a double-blind cross-over trial versus placebo. Epilepsia, 1984, 25(5): 586-593.
9. Schmidt D, Utech K. Progabide for refractory partial epilepsy:a controlled add-on trial. Neurology, 1986, 36(2): 217-221.
10. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials, 1996, 17(1): 1-12.
11. Crawford P, Chadwick D. A comparative study of progabide, valproate, and placebo as add-on therapy in patients with refractory epilepsy. J Neurol Neurosurg Psychiatry, 1986, 49(11): 1251-1257.
12. Musch B, Cambier J, Loiseau P, et al. Long-term treatment of epilepsy: open multicenter trial with progabide in epileptic patients. Eur Neurol, 1987, 26(2): 113-119.
13. Leppik IE, Dreifuss FE, Bowman T, et al. A double-blind crossover evaluation of progabide in partial seizures. Neurology, 35 Suppl 1(4): 285, 1985.
14. Leppik IE, Dreifuss FE, Porter R, et al. A controlled study of progabide in partial seizures: methodology and results. Neurology, 1987, 37(6): 963-968.
15. Dam M, Gram L, Philbert A, et al. Progabide: a controlled trial in partial epilepsy. Epilepsia,1983, 24(2): 127-134.
16. Schmidt D. Progabide as an add-on drug for epilepsy refractory to high dose antiepileptic drugtherap. Neurosci Lett, 1984, 47(3): 357-360.
17. Loiseau P, Bossi L, Guyot M, et al. Double-blind crossover trial of progabide versus placebo in severe epilepsies. Epilepsia, 1983, 24(6): 703-715.
18. Brundage RC, Cloyd JC, Leppik IE, et al. Effect of progabide on serum phenytoin and carbamazepine concentrations. Clin Neuropharmacol, 1987, 10(6): 545-554.

Chinese Journal of Evidence-Based Medicine

Effectiveness and Safety of Progabide for Refractory Epilepsy: A Meta-Analysis

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