Garcia, M.K., Cohen, L., Guo, Y., Zhou, Y., You, B., Chiang, J., . . . Wang, M. (2014). Electroacupuncture for thalidomide/bortezomib-induced peripheral neuropathy in multiple myeloma: A feasibility study. Journal of Hematology and Oncology, 7, 41-8722-7-41. 

To evaluate the safety and initial efficacy of acupuncture for the treatment of thalidomide and bortezomib-induced chronic peripheral neuropathy (PN)

Standardized acupuncture medication and equipment was used by two licensed acupuncturists three times per week for four weeks (one week of rest; two times per week for four weeks). Both upper extremities and both lower extremities had the same point sites of treatment. After participants experienced a sensation of numbness, tingling, or warmth at the needle insertion site, an electrical stimulation was applied bilaterally for 20 minutes after completion of 80% of treatment sessions.

• N = 19  
• AGE RANGE = 46–79 years
• MALES: 74%, FEMALES: 26%
• KEY DISEASE CHARACTERISTICS: Multiple myeloma 95%; amyloidosis 5%; for peripheral neuropathy (PN), all patients had symptoms in upper and lower extremities
• OTHER KEY SAMPLE CHARACTERISTICS: PN treatment, pain management, and prior therapy were allowed. Dose ranges and the number of months since last dose were recorded. Participants had Eastern Cooperative Oncology Group statuses < 2. Patients were allowed to remain on the same medication regimens for PN and pain. Minor adjustments to medications were allowed.

• SITE: Single-site
• SETTING TYPE: Outpatient
• LOCATION: MD Anderson Cancer Center in Houston, TX, United States

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care, palliative care

Nonrandomized, pilot feasibility, safety and efficacy study with a quasi-experimental design

The National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) were used to evaluate for PN prior to beginning the study. The General Functional Assessment of Cancer Therapy (FACT-G) and the Brief Pain Inventory Short Form (BPI-SF) were used to evaluate patient-reported outcomes and baseline and at weeks 4, 9, and 13 during the study. Objective measurements (coin test, button test, walking test, postural stability/fall risk) and bilateral tibial and sural sensory nerve conduction tests were conducted at baseline and at week 13. The FACT and Gynecologic Oncology Group-Neurotoxicity (GOG-NTX) scales were used to assess the primary thee endpoints for PN at baseline and at weeks 4, 9, and 13. Evaluable patients completed 80% of the study medication.

BPI-SF scores significantly improved in regard to pain severity with the worst pain occurring at 24 hours at all time points with large effect sizes in weeks 9 and 13. There was a significant improvement in BPI-SF pain interference in weeks 9 and 13 with a moderate effect size. FACT and GOG-NTX scores showed significant improvement in weeks 4, 9, and 13. Timed motor function tests from baseline to one month after the beginning of the study showed significant improvement. There was no statistically significant difference for fall risk, and nerve conduction studies demonstrated no change.

This feasibility, safety, and efficacy trial of electroacupuncture in 19 patients experiencing bortezomib- or thalidomide-induced PN demonstrated significant improvements in patient-reported outcomes for pain severity and interference according to the BPI-SF, FACT and GOG-NTX scores, and objective timed motor function tests from baseline to 13 weeks. No safety issues were reported.

• Small sample (< 30)
• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Key sample group differences that could influence results
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Findings not generalizable
• Treatment group differences: Previous medications were 84% bortezomib versus 16% thalidomide. 68% of patients experienced grade 2 PN while 32% experienced grade 3 PN. At baseline, PN occurrences were 74% male and 26% female. 58% of patients were taking pregabalin and 32% were taking gabapentin; 41% of patients were taking opioids. The frequency of pain medication use during treatment was not measured. The nerve conduction studies that were performed were not reported. The method of assessment was not well described. The reliability and validity of tools was not reported.

The use of electroacupuncture requires additional study in large, randomized, controlled trials to establish safety, benefits, the duration and sustainability of benefits, and treatment recommendations as an adjunct therapy for bortezomib- and thalidomide-induced PN.