Objective. This pilot study aims to evaluate the effectiveness and safety of acupuncture in the treatment of chemotherapy-induced peripheral neuropathy (CIPN). Methods. This study was a pilot randomized controlled trial, which was conducted with cooperation between Beijing University of Chinese Medicine (BUCM), China, and Tehran University of Medical Science (TUMS), Iran. Forty participants with CIPN were randomly assigned (1 : 1) to receive twelve sessions of acupuncture (20 minutes each session over 4 weeks) or take one 300 mg tablet of vitamin B1 and three 300 mg capsules of gabapentin per day for 4 weeks, after which both groups were followed up for 4 weeks. The primary endpoint was CIPN symptom severity measured by the Numerical Rating Scale (NRS). The secondary endpoints included sensory neuropathy grade evaluated by the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE), neurophysiological assessment of CIPN by the nerve conduction study (NCS), and the patient overall satisfaction with treatment. Safety was assessed at each visit. Results. The NRS and NCI-CTCAE sensory neuropathy grading scales decreased significantly over time in both groups (both P<0.001), with a significantly higher reduction in the acupuncture group (P<0.001 and P=0.03, respectively). In addition, the acupuncture group showed a higher overall satisfaction with the treatment at the end of treatment and after 4 weeks follow-up, in comparison with the vit B1 and gabapentin group (P=0.01 and P=0.001, respectively). The NCS (except for the latency of the sural nerve) in the acupuncture group improved significantly (P<0.05), while improvement in the vit B1 and gabapentin group was not observed (P>0.05). Conclusion. Our study revealed that acupuncture, as a kind of traditional Chinese therapeutic method, is significantly effective and safe in the treatment of CIPN. Moreover, acupuncture is more effective than using vitamin B1 and gabapentin as the conventional treatment. Trial registration. This trial is registered with the Iranian Registry of Clinical Trials (IRCT20190615043900N1).
Despite several introduced preventive modalities, cisplatin nephrotoxicity remains a clinical problem. Some in vitro and in vivo studies have addressed the protective effects of silymarin against cisplatin nephrotoxicity. This study evaluated the effects of silymarin administration on cisplatin nephrotoxicity as the first human study. During this pilot, randomized, double-blinded, placebo-controlled clinical trial, the effect of oral silymarin 420 mg daily in three divided doses starting 24-48 h before the initiation of cisplatin infusion and continuing to the end of three 21-day cisplatin-containing chemotherapy courses on cisplatin-induced renal electrolytes wasting and kidney function were assessed. Cisplatin-associated acute kidney injury (AKI) occurred in 8% of the patients. Urine neutrophil gelatinase-associated lipocalin to urine creatinine ratio (NGAL/Cr) and urinary magnesium and potassium wasting increased significantly after cisplatin infusion in both groups. Significant positive correlation was found between cumulative dose of cisplatin and urine NGAL/Cr after three courses of cisplatin infusion. Incidence of AKI and the magnitude of urinary magnesium and potassium wasting did not differ between silymarin and placebo groups. No adverse reaction was reported by silymarin administration. Prophylactic administration of conventional form of silymarin tablets could not prevent cisplatin-induced urine electrolyte wasting or renal function impairment.
The task of breaking bad news (BBN) may be improved by incorporating simulation with art-based teaching methods. The aim of the present study was to assess the effect of an integrating simulation with art-based teaching strategies, on fellows' performance regarding BBN, in Iran. The study was carried out using quasi-experimental methods, interrupted time series. The participants were selected from medical oncology fellows at two teaching hospitals of Tehran University of Medical Sciences (TUMS), Iran. Participants were trained through workshop, followed by engaging participants with different types of art-based teaching methods. In order to assess the effectiveness of the integrating model, fellows' performance was rated by two independent raters (standardized patients (SPs) and faculty members) using the BBN assessment checklist. This assessment tool measured seven different domains of BBN skill. Segmented regression was used to analyze the results of study. Performance of all oncology fellows (n = 19) was assessed for 228 time points during the study, by rating three time points before and three time points after the intervention by two raters. Based on SP ratings, fellows' performance scores in post-training showed significant level changes in three domains of BBN checklist (B = 1.126, F = 3.221, G = 2.241; p < 0.05). Similarly, the significant level change in fellows' score rated by faculty members in post-training was B = 1.091, F = 3.273, G = 1.724; p < 0.05. There was no significant change in trend of fellows' performance after the intervention. Our results showed that using an integrating simulation with art-based teaching strategies may help oncology fellows to improve their communication skills in different facets of BBN performance. Iranian Registry of Clinical Trials ID: IRCT2016011626039N1.
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