Effectiveness Not Established

Berbamine

for Prevention of Infection: General

Berbamine is an alkaloid plant extract that has been used in Asian countries in managing leukopenia with chemotherapy. Berbamine has been studied in patients with cancer related to the prevention of infection.

Research Evidence Summaries

Zhao, Y., Tan, Y., Wu, G., Liu, L., Wang, Y., Luo, Y., . . . Huang, H. (2011). Berbamine overcomes imatinib-induced neutropenia and permits cytogenetic responses in Chinese patients with chronic-phase chronic myeloid leukemia. International Journal of Hematology, 94, 156–162.

Study Purpose

The purpose of this study was to investigate whether berbamine has clinical benefit in reversing imatinib-related neutropenia. Berbamine is an alkaloid derived from the Berberis aristata plant that has been used in China for managing leukopenia associated with cancer and chemotherapy.

Intervention Characteristics/Basic Study Process

Patients self-selected, with consultation with their doctors, which treatment approach they wanted to have.

In patients who did not receive berbamine, the imatinib dose was adjusted according to guidelines so that those who developed an absolute neutrophil count (ANC) of less than 1.0 x 109/L had imatinib withheld until their ANC was 1.5 x 109/L or higher.

In the berbamine group, a daily dose of 336 mg orally was given to patients who developed grade 2 neutropenia (between the above 2 ANC levels) to prevent development of grade 3 or above. If grade 3 or above, the patients had imatinib withheld until they recovered to grade 1 or lower, and berbamine was continued until they had a stable count of an ANC of 2 x 109/L or greater for more than four weeks.

Sample Characteristics

  • The sample consisted of 33 patients with a median age of 38 years and a range of 14–69 years.
  • Fifty-four percent of the sample were male, 46% were female.
  • All had chronic phase chronic myeloid leukemia. 
  • Most had had previous therapy with interferon- or hydroxyruea-based chemotherapy.
  • All had previous grade 2 or higher neutropenia with imatinib.
     

Setting

A single-site setting in China

Phase of Care and Clinical Applications

Active antitumor treatment

Study Design

Non-randomized two group comparison

Results

Twenty patients chose to use berbamine and were treated preemptively. Incidence of grade 3 or higher neutropenia was 15% in the berbamine group and 38.5% in the comparison group—which was not a statistically significant difference.

Recovery time for patients treated with berbamine was a median of 42 days compared to 79 days in controls (p = 0.043). There was no difference between groups in disease response to treatment rates. The only adverse events with berbamine reported were symptoms of nausea in two patients.

Conclusions

Berbamine appears to be well tolerated by these patients overall. No firm conclusions can be drawn from this study.

Limitations

  • Small sample size (less than 100 participants)
  • Risk of bias (no control group) 
  • Risk of bias (no blinding)  
  • Risk of bias (no random assignment)
  • Findings not generalizable

Nursing Implications

Berbamine, a naturally occurring alkaloid compound from a Chinese traditional plant, may have some applicability and benefit for patients receiving imatinib for chronic myeloid leukemia. This particular study does not provide strong support for this use due to numerous study limitations. Further well-designed research with appropriate sample sizes in these types of patients, as well as other groups at risk for development of severe neutropenia, is warranted.

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