The efficacy and safety of silymarin in the treatment of
chemotherapy-induced peripheral neuropathy, a randomized double-blinded
clinical trial
Abstract
Aim: The aim of this study was to evaluate the efficacy and side effects
of silymarin in the treatment of CIPN. Methods: Patients who referred to
outpatient oncology department of a referral educational hospital
affiliated to Mazandaran University of Medical Sciences and experienced
CIPN were randomized to receive silymarin or placebo. Intervention group
received 140 mg of the Silymarin twice daily accompanied and 300 mg/day
Gabapentin, whereas control group received 300 mg/day of Gabapentin and
placebo twice daily for 3 months. The grade of neuropathy was determined
according to the CTCAE criterion. The improvement of neuropathy was
defined as the reduction of at least one neuropathic score. The visual
analogue scale (VAS) was used to assess the severity of patients’ pain
and the EORTC-QLQ-C30 criterion was used to assess the quality of life.
Patients were evaluated initially and at the follow up visit 3 months
after the enrollment. Results: A total of 80 patients were enrolled in
the study. There was no significant difference between the groups in
terms of severity of neuropathy at baseline. At the end of the study,
the number of people with improved neuropathy in the silymarin group was
82.8% patients, which was significantly higher than 48.4% observed in
the patients received placebo (P= 0.005). The silymarin-treated group
showed a significant reduction in pain compared with those receiving
placebo. Despite the improvement in quality of life in the intervention
group compared to the comparison group, this difference was not
statistically significant. Gastrointestinal symptoms were the only
reported side effects with a similar incidence in two groups.
Conclusion: The present data demonstrate the potential clinical use of
silymarin as an adjuvant therapy to reduce CIPN symptoms.