Methodologische Diskussion bestehender randomisierter klinischer Studien zur Behandlung von Polyneuropathie mit Akupunktur
摘要
Polyneuropathy is a debilitating condition characterized by widespread damage to the peripheral nerves, leading to sensory, motor, and autonomic symptoms. It arises from various causes, including metabolic disorders, toxic medications, infections, genetic predisposition, autoimmune diseases, tumors, trauma, or idiopathic conditions. It has a prevalence of 6–7% in the general population and a higher prevalence in individuals with diabetes mellitus. This condition frequently causes chronic pain and disability, significantly impairs quality of life, and necessitates intensive clinical research. Regarding the scientific investigation of treatment methods such as acupuncture, while existing instruments improve reporting and bias assessment, they fall short in evaluating content validity, methodological appropriateness, or correctness of conclusions.
This article discusses these data collection tools and proposes an initial two-stage roadmap for a new methodology for content and context validation. Step 1 involves a systematic literature search to identify relevant randomized controlled trials (RCTs). Step 2 includes an expert consensus process to develop a checklist for evaluating diagnosis, study design, results, and discussion.
This proposed roadmap for a content- and context-based assessment tool closes gaps in current frameworks and promotes standardized, transparent assessments to strengthen polyneuropathy research and the clinical application of acupuncture.