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 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.
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 analyze the diagnostic value of shear wave elastography (SWE) combined with vascular endothelial growth factor B (VEGF-B) and hemoglobin A1c (HbA1c) in early diabetic peripheral neuropathy (DPN). Methods A total of 100 patients with type 2 diabetes mellitus (T2DM) admitted to Mianyang Central Hospital between October 2020 and October 2023 were selected and divided into a T2DM with DPN group (n=31) and a T2DM without DPN group (n=69) based on the presence or absence of DPN. Additionally, 50 healthy individuals from the same hospital’s health examination center were included as a healthy control group. The basic clinical characteristics, mean elasticity (Emean) values of the left and right median and tibial nerves, serum VEGF-B, and HbA1c levels were compared among the three groups. The diagnostic efficacy of SWE, VEGF-B, and HbA1c for DPN was evaluated using receiver operating characteristic (ROC) curves, and Pearson correlation analysis was performed to assess the relationships between median/tibial nerve Emean and VEGF-B/HbA1c. Results The Emean values of the left and right median nerves, Emean values of the left and right tibial nerves, serum VEGF-B, and HbA1c levels in the T2DM with DPN group were significantly higher than those in the T2DM without DPN group and the healthy control group (P<0.05). The Emean values of the left and right median and tibial nerves, Emean values of the left and right tibial nerves, and HbA1c level in the T2DM without DPN group were significantly higher than those in the healthy control group (P<0.05), while no significant difference was observed in serum VEGF-B level between the T2DM without DPN group and the healthy control group (P>0.05). The area under the ROC curve for the combined diagnosis of DPN using SWE, VEGF-B, and HbA1c was 0.859 [95% confidence interval (0.828, 0.955)]. The sensitivity of the combined diagnosis (93.72%) was significantly higher than that of individual diagnoses (78.82%, 75.39%, and 71.05%, respectively; P<0.05), while the specificity (88.64%) showed no significant difference compared to individual diagnoses (80.18%, 78.96%, and 82.88%, respectively; P>0.05). Positive correlations were observed between median/tibial nerve Emean and VEGF-B/HbA1c levels (r=0.428, 0.395, 0.416, and 0.416, respectively; P<0.05). Conclusions Elevated median/tibial nerve Emean, serum VEGF-B, and HbA1c levels are closely associated with DPN. The combination of SWE, VEGF-B, and HbA1c improves diagnostic sensitivity for DPN, demonstrating significant clinical value.
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.
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.