The Efficacy and Safety of Traditional Chinese Medicine Qufenghuoxue Formula on Treating Peripheral Neuropathy Induced by Paclitaxel in Advanced Lung Cancer: A Randomized Clinical Trial.

[PURPOSE] To assess the benefits of the traditional Chinese medicine (TCM) Qufenghuoxue formula, on the treatment of chemotherapy-induced peripheral neuropathy (CIPN) in patients with lung cancer receiving paclitaxel (PTX).

[METHODS] Patients with CIPN grading 2-3 were randomly assigned to three groups of TCM, vitamin B1, or warm water. The intervention duration consisted of four cycles, 3 weeks each, coinciding with the follow-up period. Primary efficacy endpoint was the proportion of patients achieving CIPN relief, defined by reduction in CIPN severity grade, while secondary endpoint evaluated completion of the recommended PTX dosing.

[RESULTS] TCM significantly reduced grade 2-3 CIPN incidence and increased symptom relief (48.6% vs 12.0% vs 7.5%; P < 0.001) with a shorter median time to recovery compared with vitamin B1 and warm water, respectively. Additionally, it improved scores of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity subscale (11.5 vs 20.4 vs 22.4), neuropathy pain scale (16.8 vs 27.7 vs 29.2) and quality of life (42.6 vs 36.0 vs 33.6; all P < 0.001) and also showed greater potential of completing the recommended dose level of PTX (83.8% vs 74.6% vs 59.7%; P = 0.0034) compared with vitamin B1 and warm water. With warm water as reference, the hazard ratio of PTX dose reductions/cessation due to CIPN was 0.34 (95% confidence interval [CI]: 0.168-0.67, P = 0.002) for TCM and 0.56 (95% CI: 0.314-1.008; P = 0.053) for vitamin B1.

[CONCLUSION] Qufenghuoxue formula may be a promising strategy for the treatment of CIPN in patients receiving PTX. Trial Registration Chinese Clinical Trial Registry; No.: ChiCTR2300069949. Registered 30 March 30, 2023, URL: www.chictr.org/cn/ .