Objective To systematically review the effectiveness and safety of autologous implantation of stem cells for diabetic peripheral neuropathy (DPN). Methods Randomized controlled trials on relevant studies were retrieved in databases including CBM (1978-2011.6), CNKI (1979-2011.6), MEDLINE (1950-2011.6), PubMed (1950-2011.6), EMbase (1970-2011.6) and The Cochrane Library (Issue 3, 2011). References of the included studies were also retrieved. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assess the methodological quality of the included studies. Then, meta-analysis was performed using RevMan 5.0 software.Results Four RCTs involving 68 patients (136 limbs) were included, most of which were low in methodological quality. The results of meta-analysis indicated that, autologous stem cell therapy improved or even eliminated DPN symptoms including pain, numbness, and cold sensation in the limbs, intermittent limping, and rest pain. Compared with the routine therapy, autologous stem cell therapy improved tibial sensory nerve conduction velocity (MD=5.75, 95%CI 3.86 to 7.64, Plt;0.000 01), tibial motor nerve conduction velocity (MD=4.04, 95%CI 0.90 to 7.18, P=0.001), sural sensory nerve conduction velocity (MD=7.47, 95%CI 4.00 to 10.94, Plt;0.000 1), and sural motor nerve conduction velocity (MD=3.38, 95%CI 0.07 to 7.58, P=0.05), with no adverse reaction reported. Conclusion Current evidence shows that, autologous stem cell therapy is effective in treating DPN. Due to the lack of high quality studies, more high quality RCTs are needed to verify the above conclusion.
目的 探讨原发性干燥综合征周围神经病变的发生与干燥综合征A型/B型抗体（抗SSA/SSB抗体）的关系。 方法 纳入2009年1月－2011年12月期间门诊及住院收治的原发性干燥综合征患者88例。所有患者均接受神经系统检查，采用蛋白质印迹法检测抗SSA抗体和抗SSB抗体，利用全自动化学发光仪检测血清维生素B12水平。 结果 88例原发性干燥综合征患者中有27例（30.7%）存在周围神经病变。有或无周围神经病变的患者在年龄、性别、病程等一般情况方面无明显不同。有周围神经病变和无周围神经病变的原发性干燥综合征患者抗SSA抗体阳性率分别为70.4%（19/27）、70.5%（43/61），差异无统计学意义（χ2=0.000，P=0.991）；抗SSA/SSB抗体双阳性率分别为63.0%（17/27）、14.8%（9/61），差异有统计学意义（χ2=17.416，P=0.000）；血清维生素B12水平分别为（390 ± 55）、（410 ± 86）pg/dL，差异无统计学意义（t=0.908，P=0.370）。 结论 周围神经病变在原发性干燥综合征患者中较常见，且周围神经病变的发生多伴随血清抗SSA/SSB抗体阳性。
Objective To evaluate the efficacy and safety of prostaglandin E1 (PGE1) for diabetic peripheral neuropathy (DPN). Methods We searched the Cochrane Library, PubMed, EMbase, CNKI, VIP and handsearched Chinese Journal of Metabolism, Chinese Journal of Diabetes and New Chinese Medicine. Randomized controlled trials of clinical therapeutic studies on PGE1 for DPN were included. The quality of included studies was evaluated and Meta-analysis was performed. Results Thirty-one trials involving 2 497 participants were included. Meta-analysis indicated that PGE1 was more effective than Vitamin B, Placebo and other microcirculation improving drugs in improving symptoms and signs of DPN. The RR (95%CI) were ［RR=1.75, 95％CI (1.54, 2.00)］, ［RRpooled=1.57, 95％CI (1.42, 1.74)］and［RR=1.31, 95％CI (1.19, 1.45)］respectively. PGE1 was more effective than Vitamin B, Placebo and other microcirculation improving drugs in improving nerve conduction velocity (NCV) of DPN patients. For spontaneous pain and hypesthesia of DPN patients, Lipo-PGE1 was more effective compared with PGE1-CD and the RR (95%CI) was［RR=1.43, 95％CI (1.16, 1.76)］. Slight adverse effects were reported in 16 studies. Conclusion Based on this review, PGE1 is effective for DPN. However, the evidence is not b enough due to the low quality of included trials. Further large-sample and multi-center studies are needed.
Objective To evaluate the safety and efficacy of venlafaxine and carbamazepine on painful peripheral diabetic neuropathy. Methods This was a randomized, parallel-group, double-blind, double-dummy clinical trial. 132 patients a venlafaxine group (n=66) and a carbamazepine group (n=66) with painful peripheral diabetic neuropathy were recruited from 3 clinical centers. The venlafaxine group took venlafaxine 25 mg plus one dummy carbamazepine tablet twice a day and the carbamazepine group took carbamazepine 0.1 g plus one dummy venlafaxine tablet twice a day both for 2 weeks. The primary efficacy measurement consisted of a numeric pain intensity scale and the secondary measurement assessed quality of life. Results One hundred and nineteen patients completed the trial. Venlafaxine was superior to carbamazepine in improving mean pain intensity scores at 5,7,10 and 14 days by per-protocol analysis (P=0.02, P=0.03, P=0.003 and P=0.001 respectively). The effects of venlafaxine on the improvement in the total quality of life scores were better than those of carbamazepine at 10 and 14 days (P=0.02 and P=0.01 respectively). Sleep interference and mood were improved by both venlafaxine and carbamazepine, but the efficacy of venlafaxine was superior to that of carbamazepine. The common adverse events of venlafaxine included mild gastrointestinal discomfort, dizziness and somnolence. The frequency of adverse events in the venlafaxine group was about 43.9% (4 patients withdrew because of adverse events) and in the carbamazepine group about 25.76% (2 patients withdrew because of adverse events) (P =0.06). Conclusions Venlafaxine and carbamazepine are effective in the treatment of painful diabetic neuropathy, venlafaxine is superior to carbamazepine in improving pain and quality of life. Both drugs may be safe and well tolerated.
Objective To review systematically whether there is enough existing evidence that methylcobalamin is effective and safe in the treatment of the patients with diabetic peripheral neuropathy.Methods A Cochrane systematic review of all relevant randomized or quasi-randomized controlled trials of methycobalamin for diabetic peripheral neuropathy was performed. Clinical trials were searched from Cochrane Controlled Trials Register (Issue 4, 2003), MEDLINE (January 1966 to January 2004), EMBASE (January 1980 to January 2004), the Chinese Biological Medicine Database (1978 to January 2004), the Chinese Science and Technology Journal Full-text Database (1989 to January 2004) and references of all included trials. The selection of studies, data extraction and assessment of methodological quality were performed independently by two reviewers. The following outcomes were assessed: effectiveness of clinical signs and symptoms, sensory nerve and motor nerve conduction velocities and serious adverse events of methylcobalamin. Results Thirty randomized clinical trials including 1 949 patients met the inclusion criteria. The quality of the most included trials was of low level. The "funnel plot" of the comparison of thirteen studies of methylcobalamin with other B Vitamins studies showed symmetry, which indicated less possible publication bias and the result was partly reliable, but it could not indicate the whole publication biases. The results of meta-analysis indicated that methylcobalamin showed significantly positive effects on the improvement of the signs and symptoms of peripheral neuropathy, and the effects were better than the other vitamin B agents. The increase of some nerves conduction velocities by methylcobalamin was better than by the other vitamin B. No serious adverse events were observed during the treatment period.Conclusions Methylcobalamin appears to be a safe and effective treatment on diabetic peripheral neuropathy. However, the evidence is not b because of the low quality of most trials. Rigorously designed, randomized, double-blinded, placebo-controlled trials of methylcobalamin for diabetic peripheral neuropathy are needed to further assess the effect.
Objective To evaluate the efficacy and safety of tetramethylpyrazine (TMP) for diabetic peripheral neuropathy (DPN). Methods Randomized controlled trials were identified from CBM (1978-2003.3), TCMLRS (1980-2003.3), Medline (1970-2003.3), EMbase (1970-2003.3) and Cochrane Library (issue 3, 2003). We handsearched Journal of Traditional Chinese Medicine (1990-2002), New Chinese Medicine (1990-2002), Chinese Journal of Integrated Traditional and Western Medicine (1990-2002) and Research of Traditional Chinese Medicine (1990-2002). Papers of the controlled trials of clinical therapeutic studies on DPN treatment by Chinese medicine herb TMP were included and analyzed according to the criteria of the Cochrane Handbook in 1997. Results Six RCTs involving 669 patients were included, with all trials of low methodological quality. Meta-analysis indicated TMP was more effective than western medicine on pain or numbness of extremities of DPN [The pooled OR = 10.12, 95%CI (6.70 to15.28), P=0.000] and motor nerve conduction velocity change of common peroneal nerves and median nerves . Only one trial reported the side effects of TMP, such as dizziness and headache. Conclusions Based on the review, TMP infusion may have positive effect on DPN. However, the evidence is not b enough due to the general low methodological quality, so we can’t draw a reliable conclusion about the effects of TMP for DPN at the moment. Further large randomized, double blind, placebo-controlled trial are needed.
Objective To systematically evaluate the effectiveness and safety of Puerarin on diabetic peripheral neuropathy. Methods A systematic review and evaluation of all available relevant randomized or quasi-randomized controlled trials of Puerarin for diabetic peripheral neuropathy from Cochrane Controlled Trials Register (150 issue of 2003), Medline (1966-2003. 2), EMbase (1984-2001. 12. 4), and the Chinese Biological Medicine Database (1978-2003. 2) were performed. The selection of studies, data extraction, and assessment of methodological quality were performed independently by two reviewers. The following outcomes were assessed: effectiveness of clinical symptoms, sensory nerve and motor nerve conduction velocities, and severe adverse events of Puerarin. Results Ten randomized controlled clinical trials including 726 patients met the inclusion criteria. At the end of the treatment, compared to general treatment or vitamin B, Puerarin showed significant positive effects on the total effect rate of therapy and increased peripheral nerve conduction velocity. No severe adverse events were observed during the treatment period. However, most included trials show some degree of study design or analysis defect. Conclusions Our analysis suggests that Puerarin appears to be an effective and safe treatment for diabetic peripheral neuropathy. However, due to the low quality trials included in this review, more rigorously designed, randomized, double-blind, placebo-controlled trials of Puerarin for diabetic peripheral neuropathy are needed to further assess its usefulness in diabetes peripheral neuropathy patients.