Strobel Alexandra, Laputsina Volha, Heinze Viktoria, Schulz Susanne, Wienke Andreas, Reer Marco, Schlitt Axel
Institute of Medical Epidemiology, Biostatistics, and Informatics, Martin-Luther-University Halle, Halle (Saale), Germany.
Department of Cardiology and Diabetology, Paracelsus-Harz-Clinic, Quedlinburg, Germany.
BMC Complement Med Ther. 2025 Mar 6;25(1):93. doi: 10.1186/s12906-025-04830-0.
For Diabetic polyneuropathy, the most prevalent form of polyneuropathy, there is a lack of evidence-based treatment options. Current approaches include pain management, alpha-lipoic acid, and antidepressants. Physical interventions, such as electrical stimulation (four-chamber galvanic bath) have been suggested but have limited supporting evidence. Heated granular stone therapy is another option to consider.
An unblinded randomized controlled trials was conducted in 68 diabetic patients with distal sensorimotor polyneuropathy undergoing rehabilitation for diabetes mellitus as a primary or secondary diagnosis in the Paracelsus-Harz-Clinic (Quedlinburg, Germany). Patients were randomized into either the intervention group receiving heated granulated stone footbaths, or the control group receiving four-chamber galvanic baths. The primary endpoint was the assessment of any change in polyneuropathy using a vibration sensation test (Rydel-Seiffer scale, 8/8) from admission to discharge, analyzed by t-test and multivariable regression. Additionally, serum TNF-α and IL-6 as potential markers for polyneuropathy were compared over time using paired t-test.
The mean age of the patients was 66.8 ± 7.8 years; 63.2% were male and mean BMI was 32.2 ± 6.4 kg/m. Of the patients, 98.5% suffered from type 2 diabetes (one patient with type I diabetes); 82.4% were receiving oral antidiabetic medication; and 58.8% were insulin dependent. Distal sensorimotor polyneuropathy improved in both groups. The sum score increased from 16.7 to 22.6 in the study group and from 20.3 to 23.6 in the control group. A t-test showed a non-significant difference in the change of sum score between the treatment groups (2.6 points, p = 0.092), but adjusting for potential risk factors favors the intervention group (p = 0.043). Both analyzed markers decreased over time in each treatment group with IL-6 showing a clinical and significant reduction in the control group (p = 0.03).
Diabetic patients with distal sensorimotor polyneuropathy benefit from physical treatment with administration of electrical stimulation (four-chamber galvanic bath) or a therapy with heated granulated stones three times a week. Our results indicate that heated stone therapy may be a potential treatment option. However, further research is required to understand the underlying biological processes.
The study was registered in clinical trials.gov (identifier: NCT05622630, registration date: 18/11/2022).
糖尿病性多发性神经病是最常见的多发性神经病类型，目前缺乏循证治疗方案。当前的治疗方法包括疼痛管理、α-硫辛酸和抗抑郁药。有人提出了物理干预措施，如电刺激（四腔直流电浴），但支持证据有限。热颗粒石疗法是另一种可考虑的选择。
在德国奎德林堡的帕拉塞尔苏斯-哈尔茨诊所，对68例患有远端感觉运动性多发性神经病且将糖尿病作为主要或次要诊断正在接受康复治疗的糖尿病患者进行了一项非盲随机对照试验。患者被随机分为接受热颗粒石足浴的干预组或接受四腔直流电浴的对照组。主要终点是使用振动感觉测试（里德尔-西费尔量表，8/8）评估从入院到出院时多发性神经病的任何变化，通过t检验和多变量回归进行分析。此外，使用配对t检验比较随时间变化的血清TNF-α和IL-6作为多发性神经病的潜在标志物。
患者的平均年龄为66.8±7.8岁；63.2%为男性，平均BMI为32.2±6.4kg/m²。在这些患者中，98.5%患有2型糖尿病（1例1型糖尿病患者）；82.4%正在接受口服抗糖尿病药物治疗；58.8%依赖胰岛素。两组的远端感觉运动性多发性神经病均有改善。研究组的总分从16.7分增加到22.6分，对照组从20.3分增加到23.6分。t检验显示治疗组之间总分变化的差异无统计学意义（2.6分，p=0.092），但对潜在风险因素进行调整后有利于干预组（p=0.043）。每个治疗组中分析的两种标志物均随时间下降，IL-6在对照组中显示出临床显著降低（p=0.03）。
患有远端感觉运动性多发性神经病的糖尿病患者从每周三次的电刺激（四腔直流电浴）物理治疗或热颗粒石疗法中获益。我们的结果表明热石疗法可能是一种潜在的治疗选择。然而，需要进一步研究以了解其潜在的生物学过程。
该研究已在ClinicalTrials.gov注册（标识符：NCT05622630，注册日期：2022年11月18日）。
