Acupuncture in diabetic peripheral neuropathy-neurological outcomes of the randomized acupuncture in diabetic peripheral neuropathy trial

Abstract

Background: Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus and can lead to serious complications. Therapeutic strategies for pain control are available but there are few approaches that influence neurological deficits such as numbness.

Aim: To investigate the effectiveness of acupuncture on improving neurological deficits in patients suffering from type 2 DPN.

Methods: The acupuncture in DPN (ACUDPN) study was a two-armed, randomized, controlled, parallel group, open, multicenter clinical trial. Patients were randomized in a 1:1 ratio into two groups: The acupuncture group received 12 acupuncture treatments over 8 wk, and the control group was on a waiting list during the first 16 wk, before it received the same treatment as the other group. Both groups received routine care. Outcome parameters were evaluated after 8, 16 and 24 wk and included neurological scores, such as an 11-point numeric rating scale (NRS) 11 for hypesthesia, neuropathic pain symptom inventory (NPSI), neuropathy deficit score (NDS), neuropathy symptom score (NSS); nerve conduction studies (NCS) were assessed with a handheld point-of-care device.

Results: Sixty-two participants were included. The NRS for numbness showed a difference of 2.3 (P < 0.001) in favor of the acupuncture group, the effect persisted until week 16 with a difference of 2.2 (P < 0.001) between groups and 1.8 points at week 24 compared to baseline. The NPSI was improved in the acupuncture group by 12.6 points (P < 0.001) at week 8, the NSS score at week 8 with a difference of 1.3 (P < 0.001); the NDS and the TNSc score improved for the acupuncture group in week 8, with a difference of 2.0 points (P < 0.001) compared to the control group. Effects were persistent in week 16 with a difference of 1.8 points (P < 0.05). The NCS showed no meaningful changes. In both groups only minor side effects were reported.

Conclusion: Study results suggest that acupuncture may be beneficial in type 2 diabetic DPN and seems to lead to a reduction in neurological deficits. No serious adverse events were recorded and the adherence to treatment was high. Confirmatory randomized sham-controlled clinical studies with adequate patient numbers are needed to confirm the results.

Keywords: Acupuncture; Diabetic peripheral neuropathy; Nerve conduction study; Numbness.

Figure 1

Mandatory acupuncture points used in the acupuncture in diabetic peripheral neuropathy study. Anatomical presentation of acupuncture points in relation to major nerves of the lower extremity; A: Anterior aspect of leg with points on stomach-meridian 34 and 40; B: Medial aspect of ankle with point 6 on spleen-meridian and point 3 on kidney–meridian; C: Dorsal foot with point 3 on liver-merdian and extra-points lower-extremity. ST: Stomach-meridian; SP: Spleen-meridian; KI: Kidney–meridian; LV: Liver-merdian; EX-LE: Extra-points lower-extremity.

Figure 2

Flow-chart of the acupuncture in diabetic peripheral neuropathy-trial.

Figure 3

11 point numeric ratings scale, neuropathic pain symptom inventory neuropathy deficit score, neuropathy symptom score, total neuropathy score clinical, week 8 and week 16. NRS-11: 11 point numeric ratings scale; NDS: Neuropathy deficit score; NSS: Neuropathy symptom score; TNSc: Total neuropathy score clinical.