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Efficacy of Plantago major, chlorhexidine 0.12% and sodium bicarbonate 5% solution in the treatment of oral mucositis in cancer patients with solid tumour: A feasibility randomised triple-blind phase III clinical trial.

  • 2018-02
  • European journal of oncology nursing : the official journal of European Oncology Nursing Society 32
    • Sandra Cabrera-Jaime
    • Cristina Martínez
    • Tarsila Ferro-García
    • Pilar Giner-Boya
    • Teresa Icart-Isern
    • Joan M Estrada-Masllorens
    • Paz Fernández-Ortega

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 50
Population
45 solid tumour cancer patients with grade II-III mucositis
Methods
Multicentre randomised controlled trial, three groups: double sodium bicarbonate 5%, Plantago major extract, or chlorhexidine 0.12%
Duration
14 days

Purpose

Oral mucositis is one of the most common adverse effects of chemotherapy and radiotherapy. The aim of this study was to compare the efficacy of Plantago major extract versus chlorhexidine 0.12% versus sodium bicarbonate 5% in the symptomatic treatment of chemotherapy-induced oral mucositis in solid tumour cancer patients.

Method

Multicentre randomised controlled trial estimated sample of 45 solid tumour patients with grade II-III mucositis. The participants were randomised to one of three treatments, consisting of sodium bicarbonate 5% aqueous solution together with: an additional dose of sodium bicarbonate 5% aqueous solution, Plantago major extract, or chlorhexidine 0.12%. The primary outcomes were severity of mucositis, pain intensity, oral intake capacity and quality of life. The independent variable was treatment group, and confounders included sociodemographic data, neutrophil count, chemotherapy drug and dose received.

Results

Of the 50 patients enrolled, 68% (n = 34) achieved grade 0 mucositis (none), with those using the double sodium bicarbonate rinse healing in five days on average (95% CI 3.9, 6.5) versus seven days (95% CI 5.3, 9,0) for the chlorhexidine group and seven days (95% CI 5.3, 8.5) for the Plantago major group. The pain experienced by the participants lessened over the 14 days of treatment, but differences in pain intensity between the three groups did not show statistical significance (p = 0.762).

Conclusions

Healing time was shorter with the double sodium bicarbonate solution compared to the other two rinses, but the differences were not significant. Our results suggest it may be time to reconsider the use of Plantago major extract in the management of oral mucositis.

Research Insights

  • plantain leaf→Reduced Oral Mucositis Severity

    healing in ... seven days (95% CI 5.3, 8.5) for the Plantago major group

    Effect
    Neutral
    Effect size
    Small
    Dose
    not stated
  • plantain leaf→Reduced Pain Intensity

    pain experienced by the participants lessened over the 14 days of treatment, but differences in pain intensity between the three groups did not show statistical significance (p = 0.762)

    Effect
    Neutral
    Effect size
    Small
    Dose
    not stated
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