Effect of Acupuncture vs Sham Procedure on Chemotherapy-Induced Peripheral Neuropathy Symptoms: A Randomized Clinical Trial

Chemotherapy-induced peripheral neuropathy (CIPN) represents one of the most debilitating and long-lasting adverse effects of oncologic treatments with neurotoxic agents, significantly affecting the quality of life of cancer survivors. This pioneering study investigated the efficacy of acupuncture as a therapeutic intervention for this challenging condition. The randomized clinical trial was conducted at Memorial Sloan Kettering Cancer Center between July 2017 and June 2018, rigorously following CONSORT guidelines. Seventy-five patients with solid tumors who had moderate to severe CIPN were recruited, with persistent symptoms of numbness, tingling, or pain at an intensity of 4 or greater on a 0-10 numeric scale.

Participants had completed at least three months of chemotherapy and were not on stable use of neuropathic medications. The study population had a median age of 59.7 years, with 80% women, 73% White, 53% with breast cancer, and 16% with colorectal cancer. The experimental design included three groups: real acupuncture (n=24), placebo acupuncture (n=23), and usual care (n=21). The real acupuncture group received auricular treatment at Shen Men, zero point, and a third electrodermally active point, in addition to bilateral body acupuncture at LI-4, PC-6, SI-3, LR-3, GB-42, ST-40, Bafeng 2, and Bafeng 3.

Additionally, bilateral electroacupuncture was applied connecting LR-3 (negative) to GB-42 (positive) at a frequency of 2 to 5 Hz for 20 minutes. The placebo group received a non-invasive procedure at non-acupuncture points, while the control group received no intervention. The study maintained adequate blinding of investigators, coordinators, and statistician regarding treatment allocations. The primary outcome was CIPN symptom severity measured by the numeric scale at week 8.

The results demonstrated significant therapeutic benefits of real acupuncture compared to usual care. At week 8, real acupuncture produced a mean absolute reduction of 1.75 points in pain (95% CI: -2.69 to -0.81, p=0.05), compared to only 0.19 points in the usual care group (95% CI: -1.13 to 0.75). For tingling, the reduction was 1.83 points in the real acupuncture group versus 0.14 points in the control group (p=0.02). Numbness showed even more pronounced improvement, with a reduction of 1.54 points with real acupuncture compared to an increase of 0.57 points with usual care (p=0.005).

The placebo acupuncture group showed intermediate results, with a reduction of 0.91 points in pain. Importantly, benefits were maintained at the 12-week follow-up, with real acupuncture sustaining a 1.74-point reduction in pain, while the placebo group showed only a 0.34-point improvement. Adverse events were rare and of mild intensity, demonstrating the favorable safety profile of the intervention. This study represents a significant milestone in oncologic acupuncture research as the first to simultaneously incorporate a placebo control and an untreated group to evaluate the specific efficacy of acupuncture in CIPN.

The inclusion of a placebo control is methodologically challenging in acupuncture research due to the difficulty of creating a truly inert placebo, but this study demonstrated the feasibility of this approach. The results suggest that acupuncture offers clinically relevant benefits beyond placebo effects, representing a promising therapeutic option for patients with CIPN. The clinical implications are substantial, considering the scarcity of effective and well-tolerated treatments for this condition. Acupuncture emerges as a safe non-pharmacological intervention that can be integrated into supportive oncology care, potentially improving the quality of life of cancer survivors.