Comparative study among glutamine, acetyl-L-carnitine, vitamin-E and methylcobalamine for treatment of paclitaxel-induced peripheral neuropathy

Context: One of the major toxicity of paclitaxel is peripheral neuropathy. Sensory components are affected more than motor and autonomic dysfunction. Aims: Acetyl-L-carnitine (ALC), methylcobalamine, vitamin E and glutamine have been used in various trials against placebos. With head on trials among these four drugs missing, this randomized study was conducted to compare the efficacy in relieving symptoms of paclitaxel induced peripheral neuropathy. Settings and Design : This single institutional, prospective, multi-arm, randomized study was conducted as per Helsinki protocol and with local ethical committee clearances. Materials and Methods: Patients of carcinomas of lung, breast and ovary recruited, would receive paclitaxel 175 mg/m ² intravenous as 1 ^st or 2 ^nd line drug. They underwent randomization to any of four treatment arms: Arm A (vitamin E 400 mg OD day 1 of the cycle to 1 month after completion of clinical trial [CT]); Arm B (ALC 250 mg OD from day 1 to day 7 in each cycle of CT); Arm C (glutamine 10 mg TDS from day 2 to day 5 in each cycle) and Arm D (methylcobalamine 500 μg TDS from day 1 of the first cycle to 1 month after completion of CT). All drugs were started at the onset of symptoms. CTCAE v 4.02 was used for assessments. Statistical Analysis Used : Changes in scores for sensory, motor and pain symptoms over the study period were compared using repeated measures of General Linear Model of SPSS version 17. Results : 22, 24, 21 and 23 patients were eligible for analysis in four arms. Vitamin E was producing comparable relief as methylcobalamine of peripheral neuropathy. Both vitamin E and methylcobalamine was superior to glutamine and ALC in relieving sensory, motor and pain symptoms. Glutamine and ALC had comparable effects. Conclusions: All four drugs were effective in the alleviation of symptoms with vitamin E and methylcobalaine more effective than glutamine and ALC in control of symptoms of paclitaxel induced peripheral neuropathy.