Effectiveness Not Established

B Vitamins

for Peripheral Neuropathy

B vitamins include thiamine, riboflavin, niacin, pantothenic acid, pyridoxine, biotin, folate, and cobalamin. B vitamins are essential for normal nerve function, so they have been used to treat neuropathy.

Research Evidence Summaries

Schloss, J., Colosimo, M., Airey, C., Masci, P., Linnane, A., Vitetta, L., . . . Linnane, A.W. (2017). A randomised, placebo-controlled trial assessing the efficacy of an oral B group vitamin in preventing the development of chemotherapy-induced peripheral neuropathy (CIPN). Supportive Care in Cancer, 25, 195–204.

Study Purpose

To assess the effects of oral B vitamin complex for the prevention of chemotherapy-induced peripheral neuropathy (CIPN)

Intervention Characteristics/Basic Study Process

Patients newly diagnosed with cancer who were to receive oxaliplatin, taxanes, or vincristine were randomly assigned to receive B complex vitamins or placebo. The intervention was begun about one week prior to the first cycle of chemotherapy and continued for 12 weeks after chemotherapy was completed. Vitamins or placebo were taken twice daily with or after meals. Evaluations were conducted at baseline, after chemotherapy (two to four weeks), and at 12 weeks after completion of chemotherapy.

Sample Characteristics

  • N = 50 at three months, 15 at nine months   
  • MEDIAN AGE = 53.81 years (experimental), 55.18 years (control)
  • AGE RANGE = 29–75 years
  • MALES: 33.3%, FEMALES: 66.7%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Varied tumor types; breast and lymphoma were most common.
  • OTHER KEY SAMPLE CHARACTERISTICS: Taxanes were the most frequent treatment in the sample.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: Australia

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Placebo-controlled, blinded, randomized, controlled trial

Measurement Instruments/Methods

  • Brief Pain Inventory (BPI)
  • European Organization for Research and Treatment in Cancer Quality of Life Questionnaire (EORTC QLQ) 
  • Patient Neurotoxicity Questionnaire (PNQ)
  • Blood assays for B vitamins
  • Total neuropathy score (TNS)

Results

No significant differences existed between groups in total neuropathy scores at any time. Significant differences existed between groups in PNQ results at baseline (for motor) and at 12, 24, and 36 weeks for sensory items (p < 0.05). Blood tests showed that B vitamin supplementation increased levels of thiamine, pyridoxine, cobalamin, and folate compared to placebo.

Conclusions

This study did not provide clear evidence regarding the potential role of B vitamin supplementation for the prevention of chemotherapy-induced neuroxicity.

Limitations

  • Small sample (< 100)
  • Measurement validity/reliability questionable
  • Subject withdrawals ≥ 10%  
  • Assessment tools for CIPN have questionable validity and clinical utility.
  • The study was underpowered.

Nursing Implications

The aim of this study was to assess the prophylactic use of B vitamin supplementation; however, the study sample was insufficient to provide a valid assessment.

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