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.
Highlights
Chemotherapy-induced peripheral neuropathy (CIPN) is common and can be dose limiting for several cytotoxic drugs, for example, the antitubulins, platinum analogs, and the proteasome inhibitors bortezomib and thalidomide
Patients and physicians were blind to the vitamin B1 and B6 (VitB) and placebo treatment but not to EA or hydroelectric baths (HB)
From September 2000 to February 2003 a total of 199 cancer patients with CIPN were assessed for eligibility and 60 were randomized into one of the four treatment groups (Figure 1)
Summary
Chemotherapy-induced peripheral neuropathy (CIPN) is common and can be dose limiting for several cytotoxic drugs, for example, the antitubulins (paclitaxel, docetaxel, ixabepilone, and vincristine), platinum analogs (cisplatin, carboplatin, and oxaliplatin), and the proteasome inhibitors bortezomib and thalidomide. Typical symptoms include numbness and tingling, whereas neuropathic pain appears less frequently. Glutathione, vitamin E, glutamic acids, intravenous calcium and magnesium infusions, and neurotrophic growth factors have been examined in clinical studies as a prophylaxis against chemotherapy-induced neurotoxic effects. Anticonvulsants (e.g., carbamazepine and in particular gabapentin), tricyclic antidepressants (e.g., amitriptyline), and Evidence-Based Complementary and Alternative Medicine selective serotonin reuptake inhibitors (e.g., venlafaxine) play a clinical role in the prevention and treatment of neuropathic pain. These drugs are ineffective for the treatment of the typical sensory CIPN symptoms and cannot induce neuroprotection or neuroregeneration [5,6,7,8]
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