Effects and safety of acupuncture versus non-penetrating sham acupuncture for senile pruritus: Rationale and design for a randomized controlled trial.

Background: Senile pruritus (SP), characterized by idiopathic itch in individuals aged 60 years and older without primary skin lesions, significantly impacts sleep and quality of life. Effective alternative treatments are needed. Acupuncture has been suggested as a potential intervention to alleviate pruritus; however, its role in managing SP remains uncertain. This study aims to evaluate the efficacy and safety of acupuncture for SP. Methods: This single-center, parallel, two-arm, randomized, sham-controlled trial will enroll 200 patients diagnosed with SP in a 1:1 ratio to either the acupuncture or sham acupuncture group, receiving acupuncture or sham acupuncture three sessions weekly for six weeks. Participants, outcome assessors, and the statisticians will be blinded. The primary outcome is the change from baseline in the Average Pruritus Numerical Rating Scale (AP-NRS) score at week 6. Secondary outcomes include changes in AP-NRS (at other timepoints), Peak Pruritus Numerical Rating Scale (PP-NRS), number of scratch episodes, itchy area of body surface, overall dry skin score (ODS), the Dermatology Life Quality Index (DLQI), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and Patient Global Impression of Change (PGIC). Long-term effects of acupuncture will also be explored. Adverse events and additional treatments will be monitored throughout the study period. The modified intention-to-treat (mITT) population which includes participants who complete baseline assessments and receive at least one treatment session will be analyzed. Discussion: This trial represents the first rigorously designed, single-center, randomized, sham-controlled study assessing the effects and safety of acupuncture for senile pruritus. We used valid outcome measurements which can provide valuable insights into the patient's symptoms and facilitate tracking symptoms over time and evaluate treatment effectiveness. This study may provide valuable insights into the research topic and inform future research. Ethics and dissemination: This study has received ethical approval from the Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences (2024-087-KY). Trial registration: Registered with ClinicalTrials.gov (NCT06506240) on July 11, 2024.