Jo, S.J., Shin, H., Jo, S., Kwon, O., & Myung, S.K. (2015). Prophylactic and therapeutic efficacy of pyridoxine supplements in the management of hand-foot syndrome during chemotherapy: A meta-analysis. Clinical and Experimental Dermatology, 40, 260–270. 

DOI Link

Purpose

STUDY PURPOSE: To measure the preventive and treatment efficacy of pyridoxine supplementation through a meta-analysis of hand-foot syndrome (HFS) incidence and improvement rates
 
TYPE OF STUDY: Meta-analysis

Search Strategy

DATABASES USED: PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials
 
KEYWORDS: Hand-foot syndrome, acral erythema, palmar plantar erythrodysesthaesia, pyridoxine, vitamin B6
 
INCLUSION CRITERIA: Randomized, controlled trials (RCTs); prospective comparative trials; and retrospective studies that reported the efficacy of pyridoxine supplements to manage HFS compared to controls (placebo or no treatment)
 
EXCLUSION CRITERIA: Studies without a control group

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 238
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: All studies that were published in full-text, abstract, or poster form were eligible for inclusion. Excluded were duplicates, irrelevant studies, and studies with insufficient data or an identical population. Relative risk (RR) was calculated with a 95% confidence interval (CI) to evaluate the efficacy of pyridoxine supplements in the prevention of HFS. Treatment efficacy of pyridoxine supplements was evaluated by the number of patients with symptom improvement/the total number of patients with HFS. The methodological quality of RCTs was assessed by a validated five-point quality scale. Scores less than or equal to 2 were of low quality; scores 3 or greater were of high quality.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 9 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 890 patients, 441 assigned to intervention groups and 449 assigned to control groups
  • KEY SAMPLE CHARACTERISTICS: The mean age was 59 years (20–91), and 65.6% of patients were women. Cancer diagnoses included multiple myeloma, breast, metastatic breast, colorectal, ovarian, endometrial, and gastrointestinal tract cancers. Chemotherapy included (a) PLD/vincristine/capecitabine; (b) PLD/paclitaxel; (c) PLD 4; (d) capecitabine alone or in combination with cyclophosphamide; (e) capecitabine alone or in combination with cisplatin, or cisplatin with docetaxel; (f) capecitabine; (g) 5-fluorouracil; or (h) capecitabine alone or in combination with cisplatin, or cisplatin and docetaxel.

Phase of Care and Clinical Applications

PHASE OF CARE: Active treatment

Results

Eight studies (two retrospective, two prospective comparative trials, four RCTs) for preventive efficacy and three studies (one RCT and two non-RCTs) for treatment efficacy. Random-effects meta-analysis did not reveal any significant associations between ppx pyridoxine supplementation and HFS development (RR = 0.95%, 95% CI [0.87, 1.05]) or any significant preventive efficacy against HFS in subgroup meta-analyses of study design, chemotherapeutic agents, pyridoxine dose, HFS severity, publication year, or observation period. However, pyridoxine did show significant efficacy in treating HFS (RR = 1.75, 95% CI [1.09, 2.8]) but did not show efficacy in the only RCT (RR = 1.12, 95% CI [0.58, 2.14]).

Conclusions

No evidence to support the use of pyridoxine supplements to prevent HFS during chemotherapy exists.

Limitations

  • Only four RCTs
  • Chemotherapeutic agents included PLD or capecitabine

Nursing Implications

Further nursing research on the alternative uses of topical and oral therapies for HFS is warranted given that no evidence of clinical benefit was revealed.

Legacy ID

6184