Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients: A Four-Arm Randomized Trial on the Effectiveness of Electroacupuncture

Abstract

Purpose. Chemotherapy-induced peripheral neuropathy (CIPN) is a common and dose-limiting side effect of cytostatic drugs. Since there are no proven therapeutic procedures against CIPN, we were interested to define the role of electroacupuncture (EA) from which preliminary data showed promising results. Methods. In a randomized trial with a group sequential adaptive design in patients with CIPN, we compared EA (LV3, SP9, GB41, GB34, LI4, LI11, SI3, and HT3; n = 14) with hydroelectric baths (HB, n = 14), vitamin B1/B6 capsules (300/300 mg daily; VitB, n = 15), and placebo capsules (n = 17). The statistical power in this trial was primarily calculated for proving EA only, so results of HB and VitB are pilot data. Results. CIPN complaints improved by 0.8 ± 1.2 (EA), 1.7 ± 1.7 (HB), 1.6 ± 2.0 (VitB), and 1.3 ± 1.3 points (placebo) on a 10-point numeric rating scale without significant difference between treatment groups or placebo. In addition no significant differences in sensory nerve conduction studies or quality of life (EORTC QLQ-C30) were found. Conclusions. The used EA concept, HB, and VitB were not superior to placebo. Since, contrary to our results, studies with different acupuncture concepts showed a positive effect on CIPN, the effect of acupuncture on CIPN remains unclear. Further randomized, placebo controlled studies seem necessary. This trial is registered with DRKS00004448.

Natural products and complementary therapies for chemotherapy-induced peripheral neuropathy: A systematic review

“…In this four-arm study, Rostock et al [42] evaluated the effectiveness of electroacupuncture (EA, ~8 sessions) compared with hydroelectric bath (~8 sessions), daily vitamin B, or daily placebo capsules in 60 patients over a 3-week period, with additional follow-up at 12 weeks. Although no significant between-group differences were observed, baseline complaints of CIPN were unexpectedly low, especially in the EA group, while study design including sample size calculations was based on expectations of more severe CIPN symptoms.…”

Chemotherapy-induced peripheral neuropathy in the adult

“…For historical reasons, in most clinical trials the occurrence and severity of CIPN are assessed by the United States National Cancer Institute common toxicity criteria (NCI-CTC) scales despite notable interobserver disagreement in clinical studies of anticancer treatments [18] or neuroprotective strategies [19][20][21][22][23][24][25] …”

“…Other questionnaires, such as the neuropathic pain scale (10 items, including self-reported visual analog scales to quantify pain intensity and discomfort), the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (a 38-item measurement tool to evaluate the impact of CIPN on the quality of life) [13 & ], the numeric rating scale for pain (pain is rated on a numeric rating scale from 0 to 10) [14], the European Organisation for Research and Treatment of Cancer Quality of life questionnaireChemotherapy induced peripheral neuropathy 20 (EORTC QOL-CIPN20, a 20-item quality of life questionnaire) [10] and other descriptive questionnaires (yes/no questionnaire) or detailed questionnaires about the extent and intensity of CIPN (numbness, swelling, tingling, pain and subjective impairment in everyday life and at work) have recently been used in association with other CIPN assessment tools [19] but not in studies that provided specificity and sensitivity rates.…”

Patient-reported Outcomes of Acupuncture for Symptom Control in Cancer

“…These results are promising, but the possibility of a placebo effect must be considered. Randomized controlled trials that compare true acupuncture with sham acupuncture in cancer samples [7,33] and noncancer samples [34] showed similar positive results for both groups. Patients willing to receive and pay for acupuncture services may be a unique, self-selected group with higher expectations for a positive result.…”