The aim of this report was to evaluate the efficacy and safety of prostaglandin E1(PGE1)plus lipoic acid(LA)for the treatment of diabetic peripheral neuropathy(DPN)compared with that of PGE1 or LA monotherapy,in order to provide the basis and reference for clinical rational drug use.Randomized controlled trials(RCTs)published up to August 3,2014 were searched.A random or fixed effect model was used to analyse outcomes expressed as risk ratios(RRs)or mean difference(MD)with a 95%confidence interval(CI).I2 statistic was used to assess heterogeneity.Subgroup and sensitivity analyses were performed.The outcomes measured were as follows: the clinical efficacy,median motor nerve conduction velocity(MNCV),median sensory nerve conduction velocity(SNCV),peroneal MNCV,peroneal SNCV and adverse effects.Thirty-one RCTs with 2676 participants were included.Clinical efficacy of PGE1+LA combination therapy was significantly better than monotherapy(p < 0.00001,RR = 1.32,95%CI 1.26 to 1.38).Compared with monotherapy,PGE1+LA combination therapy led to significant improvements in median MNCV(p < 0.00001,MD = 4.69,95%CI 3.16 to 6.23),median SNCV(p < 0.00001,MD = 5.46,95%CI 4.04 to 6.88),peroneal MNCV(p < 0.00001,MD = 5.19,95%CI 3.71 to 6.67)and peroneal SNCV(p < 0.00001,MD = 5.50,95%CI 3.30 to 7.70).There were no serious adverse events associated with drug intervention.PGE1 plus LA combination therapy is superior to PGE1 or LA monotherapy for improvement of neuropathic symptoms and nerve conduction velocities in patients with DPN.These findings should be further validated by larger well-designed or high-quality RCTs.