Comparative Efficacy and Adherence to Therapy with Duloxetine and Thioctic Acid in Chemotherapy-Induced Neuropathy: Results of a Randomized Study

Background. Despite the positioning of duloxetine as a first-line agent for chemotherapy-induced neuropathy therapy, there are no direct comparative studies of its efficacy versus alternative medications, particularly considering the critically important factor of patient adherence to long-term treatment.

Objective. To compare the efficacy of duloxetine and thioctic acid in patients with chemotherapy-induced peripheral neuropathy (CIPN) with emphasis on treatment adherence.

Material and methods. A prospective randomized study included 59 patients (26 in the duloxetine group, 33 in the thioctic acid group). Efficacy was assessed using a battery of validated scales: Neurological Disability Score (NDS), Visual Analog Scale for pain (VAS), DN4 questionnaire for verification of neuropathic pain component (Neuropathic Pain Diagnostic Questionnaire, DN4). Safety was recorded according to the principles of Good Clinical Practice (International Council for Harmonisation — Good Clinical Practice, ICH-GCP). Adherence was evaluated by direct patient interviews at 1 month with registration of discontinuation reasons.

Results. Analysis of DN4 and NDS scores revealed no statistically significant differences. However, VAS showed a statistically significant difference (p = 0.02): pain increased in the duloxetine group (+ 0.94 ± 2.03 points) and decreased in the thioctic acid group (–0.11 ± 1.32 points). Adherence to duloxetine was 76.9% (20/26) versus 90.9% (30/33) for thioctic acid. Analysis of discontinuation reasons showed that in the duloxetine group, 83.3% of discontinuations were due to adverse effects and 16.7% to psychological barriers related to antidepressant positioning. Adverse effects were registered in 30.8% of duloxetine group patients and 9.1% of thioctic acid group (p = 0.07).

Conclusion. Given comparable objective efficacy and more favorable subjective pain dynamics in the thioctic acid group, adherence emerges as the key differentiating factor (76.9% vs 90.9%). The superior safety profile of thioctic acid and absence of psychological barriers make it the drug of first choice for long-term CIPN therapy.

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