Efficacy and safety of puerarin injection in treatment of diabetic peripheral neuropathy

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Efficacy and safety of puerarin injection in treatment of diabetic peripheral neuropathy
Key Take-Away: 

Puerarin injection was effective for the treatment of diabetic peripheral neuropathy by improving the total effective rate, nerve conduction velocity that was decreased by diabetes, and improve the hemorheology index and also relatively safe clinically.

Diabetic peripheral neuropathy (DPN) is one of the most common neuropathies caused by diabetes mellitus (DM), with prevalence of 30-90%.

ABSTRACT: 
Background: 

Diabetic peripheral neuropathy (DPN) is one of the most common neuropathies caused by diabetes mellitus (DM), with prevalence of 30-90%. It is one of the most debilitating factors in DM and clinical symptoms of DPN are intermittent, persistent limb pain, featuring burning or chisel-like sensations. If DPN is diagnosed earlier, given timely positive blood glucose control and necessary foot care, they can avoid foot ulcers, gangrene, amputation and other serious consequences.

In Western Medicine, no effective therapy is available. Methylcobalamin and neurotrophin are usually used clinically, but they are expensive and have a long course of treatment. Modern pharmacological studies confirmed that puerarin can lower blood sugar, improve microcirculation, expand coronary arteries, reduce platelet aggregation and blood viscosity, and improve the sensitivity of insulin receptors. Therefore, we aimed to evaluate the efficacy and safety of puerarin injection for treating DPN to provide a scientific basis for its use.

Rationale behind research

  1. Methylcobalamin and neurotrophin are usually used clinically, but they are expensive and have a long course of treatment

Objective

  • To systematically evaluate the clinical efficacy and safety of puerarin injection in the treatment of diabetic peripheral neuropathy (DPN)
Methods: 

 

Study outcomes

  • Primary outcomes:
  • The total effective rate = (number of patients with significant effect + number of patients with effect)/total number of patients.
  • “Significant effect" meant that limb pain, numbness and fatigue were reduced, nighttime sleep improved, and nerve conduction velocity (NCV) from electromyography increased >5 m/s or became normal.
  • Secondary outcomes:
  • Included hemorheology index with glycosylated hemoglobin (HbA1c), fibrinogen (Fb), and plasma viscosity (ηp).
  • NCV index of peroneal & median nerve included motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV).
  • The number of adverse drug reactions (ADR)/adverse drug events (ADE) occurred was counted.
Results: 

 

 

  • Study outcomes
  • Primary outcomes:
  • Total effective rates: cause of the differences in clinical medicine used, all of the studies were divided into subgroups.
  • Puerarin+ control+ basic treatment vs control+ basic treatment group
  • The results showed that the puerarin combined with nimodipine therapy was more effective than nimodipine used alone
  • The results showed that puerarin combined with vitamin B (VB) therapy was more effective than vitamin B (VB) used alone
  • Results showed that puerarin combined with mecobalamin and VB therapy was more effective than mecobalamin and VB combined
  • The results showed that puerarin combined with mecobalamin therapy was more effective than mecobalamin used alone
  • Puerarin+basic treatment vs control+ basic treatment:
  • Results showed that puerarin was more effective than VB
  • Results showed that puerarin was more effective than Danshen injection
  • The result showed that the puerarin was more effective than 654-2
  • Secondary outcomes
  • The Meta-analysis showed that the improvement of MNCV and SNCV were more efficient than the control group
  • The results of "Puerarin vs Danshen" injection were significantly different [ P<0.000 01], which means that puerarin was more effective than Danshen injection. However, the results of "Puerarin + VB vs VB" were not significantly different for HbA1c
  • Results of "Puerarin vs VB and puerarin+ mecobalamin vs mecobalamin" were significantly different. The results of "Puerarin vs vasodilator" were significantly different [P< 0.000 01], which means that puerarin is more effective than vasodilator medication in reducing fibrinogen
  • Puerarin is more effective than conventional therapy in reducing plasma viscosity (ηp)
  • No serious ADRs occurred
Conclusion: 
  • Puerarin injection was effective for the treatment of DPN. Puerarin can improve the total effective rate, correct NCV that was decreased by diabetes, and improve hemorheology index. Puerarin was relatively safe clinically. Since, articles in the study were not high-quality, more studies should be conducted to strengthen the findings

The results of the two previous systematic reviews of puerarin for the treatment of DPN also supported the conclusion of the Meta-analysis. Currently, studies show that DPN is the result of multiple factors: sorbitol, inositol metabolic abnormalities, microvascular disorders, and non-enzymatic protein glycosylation. Some pharmacological experiments show that puerarin can inhibit platelet aggregation, improve PGI2 content, inhibit protein glycosylation, expand blood vessels, improve microcirculation, increase blood flow around nerves, and improve NCV. Another experiment showed that puerarin was able to significantly reduce HbA1c levels, which may promote the repair of nerve tissue. Based on these pathological and pharmacological studies and our findings, puerarin may benefit patients with DPN. This systematic review included only published studies in databases, and lacked articles from relevant gray literature, which may cause a selection bias. Only five articles reported ADRs/ADEs from puerarin. Therefore, more studies should be done to verify its safety.

J Tradit Chin Med 2014 August 15;34(4):401-410
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