Nazari, M., Taghizadeh, A., Bazzaz, M. M., Rakhshandeh, H., & Shokri, S. (2017). Effect of Persian medicine remedy on chemotherapy induced nausea and vomiting in breast cancer: A double blind, randomized, crossover clinical trial. Electronic Physician, 9, 3535–3543.

DOI Link

Study Purpose

To assess the effects of Persumac, a Persian herbal preparation, on refractory CINV.

Intervention Characteristics/Basic Study Process

Patients were randomized to two study sequence groups. One group received Persumac first and then placebo in crossover. The other group received the opposite sequence. Patients were entered in the second course of chemotherapy. Crossover was done in the third course of chemotherapy. Persumac and placebo were taken three times daily before meals. A washout period of six days was done prior to the third chemotherapy course. Patients were studied for 33 days. Patients recorded information about the severity and number of nausea and vomiting episodes on a visual analog scale and answered questions related to frequency of forgetting to take the study drug or other antiemetics. All patients received standard triple antiemetic regimens. Persuma included sumac and Bunium persicum.

Sample Characteristics

  • N = 69   
  • AGE: Median across groups = 47.5 and 46.8 years, range = 26-64
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Breast cancer. All were receiving moderate or high emetic risk chemotherapy and had continued problems with CINV despite us of triple drug antiemetic regimens.

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Iran

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Double blind, randomized, crossover clinical trial

Measurement Instruments/Methods

VAS for nausea and vomiting (1-10 scale)

Results

Average nausea severity was significantly lower during the period when using the persumac (p < 0.001), with reduction in at least two points on the VAS in the delayed phase compared to baseline results. There was no significant effect for acute phase CINV. The number of vomiting episodes was reduced. There were very few patients who had complete response for CINV (range = 0%-23%)

Conclusions

Persumac appeared to have some benefit in reduction of the severity of delayed CINV in this study.

Limitations

  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: Timing of baseline measures not clear

Nursing Implications

Findings suggest that the Persian herbal medicine, Persumac, may have some benefit in reducing delayed CINV in women receiving moderate to severe emetic chemotherapy. Further evidence is needed to determine potential benefit.