Hoerder Sebastian, Habermann Isabel Valentina, Hahn Katrin, Meyer-Hamme Gesa, Ortiz Miriam, Grabowska Weronika, Roll Stephanie, Willich Stefan N, Schroeder Sven, Brinkhaus Benno, Dietzel Joanna
Institute of Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin, Berlin 10117, Germany.
Department of Neurology, Charité Universitätsmedizin, Charitéplatz 1, Berlin 10117, Germany.
World J Diabetes. 2023 Dec 15;14(12):1813-1823. doi: 10.4239/wjd.v14.i12.1813.
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.
To investigate the effectiveness of acupuncture on improving neurological deficits in patients suffering from type 2 DPN.
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.
Sixty-two participants were included. The NRS for numbness showed a difference of 2.3 ( < 0.001) in favor of the acupuncture group, the effect persisted until week 16 with a difference of 2.2 ( < 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 ( < 0.001) at week 8, the NSS score at week 8 with a difference of 1.3 ( < 0.001); the NDS and the TNSc score improved for the acupuncture group in week 8, with a difference of 2.0 points ( < 0.001) compared to the control group. Effects were persistent in week 16 with a difference of 1.8 points ( < 0.05). The NCS showed no meaningful changes. In both groups only minor side effects were reported.
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.
糖尿病周围神经病变（DPN）是糖尿病常见的并发症，可导致严重后果。虽然有控制疼痛的治疗策略，但影响诸如麻木等神经功能缺损的方法却很少。
探讨针刺改善2型糖尿病周围神经病变患者神经功能缺损的有效性。
糖尿病周围神经病变针刺治疗（ACUDPN）研究是一项双臂、随机、对照、平行组、开放、多中心临床试验。患者按1:1比例随机分为两组：针刺组在8周内接受12次针刺治疗，对照组在最初16周内等待，之后接受与另一组相同的治疗。两组均接受常规护理。在第8、16和24周评估结果参数，包括神经学评分，如用于感觉减退的11点数字评定量表（NRS）、神经病理性疼痛症状量表（NPSI）、神经病变缺损评分（NDS）、神经病变症状评分（NSS）；使用手持式即时检测设备评估神经传导研究（NCS）。
纳入62名参与者。麻木的NRS显示针刺组有2.3的差异（<0.001），该效果持续到第16周，两组间差异为2.2（<0.001），与基线相比，第24周差异为1.8分。针刺组在第8周时NPSI改善了12.6分（<0.001），第8周时NSS评分差异为1.3（<0.001）；针刺组在第8周时NDS和TNSc评分改善，与对照组相比差异为2.0分（<0.001）。在第16周时效果持续存在，差异为1.8分（<0.05）。NCS未显示有意义的变化。两组均仅报告了轻微的副作用。
研究结果表明针刺可能对2型糖尿病性DPN有益，似乎能减少神经功能缺损。未记录到严重不良事件，治疗依从性高。需要进行有足够患者数量的验证性随机假针刺对照临床研究来证实这些结果。
