Electroacupuncture efficacy in diabetic polyneuropathy: Study protocol for a double-blinded randomized controlled...

Area of Science:

• Neurology
• Diabetology
• Integrative Medicine

Background:

• Diabetic peripheral neuropathy (DPN) is a common complication of type 2 diabetes mellitus (T2DM).
• Current treatments for DPN have adverse effects, prompting investigation into alternative therapies like electroacupuncture (EA).
• The efficacy and mechanisms of EA for DPN remain unclear, necessitating rigorous clinical investigation.

Purpose of the Study:

• To investigate the effectiveness of electroacupuncture (EA) as a treatment for diabetic peripheral neuropathy (DPN).
• To compare EA with sham EA in patients with T2DM and DPN.
• To explore the potential mechanisms of EA, including its effects on nerve conduction, symptoms, oxidative stress, inflammation, and gene expression.

Main Methods:

• A four-armed, randomized, controlled, multicenter clinical trial involving 48 T2DM patients with DPN.
• Patients were randomized to receive either EA or sham EA, stratified by DPN type (short fiber or axonal).
• The intervention comprised 32 sessions of EA/sham EA over 20 weeks, with assessments of nerve conduction, symptoms, pain, quality of life, oxidative stress, inflammation, and gene expression.

Main Results:

• Primary outcome: Nerve Conduction Study (NCS) parameters.
• Secondary outcomes: DPN symptoms and pain (MNSI, MDNS, DN-4, NRS), quality of life (SF-36).
• Exploratory outcomes: Oxidative stress, inflammatory response, and genetic expression.

Conclusions:

• This trial will compare EA versus sham EA for DPN management.
• EA may improve NCS parameters, neuropathic pain, and symptoms.
• EA could be a potential coadjuvant treatment for DPN, possibly with a remyelinating effect.