Effect of Persian Medicine Remedy on Chemotherapy Induced Nausea and Vomiting in Breast Cancer: A Double Blind, Randomized, Crossover Clinical Trial

Abstract

BackgroundChemotherapy induced nausea and vomiting (CINV) is a side effect, and has negative effect on quality of life and continuation of chemotherapy. Despite new regimen and drugs, the problems still remain and standard guidelines, effective treatment and supportive care for refractory CINV are still not yet established. Persian medicine, the old Iranian medical school, offer Persumac (prepared from Rhus Coriaria and Bunium Persicum Boiss).ObjectiveThe specific objectives were to assess the effect of Persumac on the number and severity of nausea and vomiting in refractory CINV in acute and delayed phase.MethodsThis randomized, double blind, crossover clinical trial study was carried out on 93 patients with breast cancer and refractory CINV, who received outpatient high emetogenic chemotherapy in Imam Reza hospital, Mashhad, Iran from October 2015 to May 2016. The study has three stages: in stage I patients received a questionaire and completed it after chemotherapy. In stage II they were randomly divided into intervention group with Persumac and control group with placebo (lactose were used). In stage III, wash out and crossover was conducted. Both groups in all stages received standard antiemetic therapy for CINV. The following were set as the inclusion criteria of the study: female, Age ≥18 years, clinical diagnosis of breast cancer, history of refractory CINV, normal blood tests and at least three courses of chemotherapy remaining. Exclusion criteria of this study were: Total or upper abdominal radiation therapy along with chemotherapy, drugs/therapy for nausea and vomiting not prescribed in this study, hypersensitivity to Sumac or Bunium Persicum, use of sumac and Bunium Persicum in seven days prior to the intervention, clinical diagnosis of digestion disorders, non-chemotherapy induced nausea and vomiting, milk allergy, loss of two consecutive or three intermittent doses of Persumac or placebo. Outcomes were gathered by Persian questionnaire. Number and severity of nausea and vomiting was measured with a self-reporting tool; visual analog scale.ResultsDemographic data and other characters in both groups have no significant diffrence. Eighty of 93 eligible patients in stage I completed the study and in stage II, eleven declined participation for stage III (crossover). P value of carry over, period and treatment effects demonstrated that they had not affected the results before and after crossover. The mean severity of nausea in acute phase was in stage I: 4.83 ± 1.40, stage II: 4.54 ± 2.0 and stage III: 4.15 ± 0.92 in sequence AB (first Persumac and then placebo in crossover), and in sequence BA (first placebo and then Persumac in crossover) was respectively 4.83 ± 1.40, 4.54 ± 2.0, 4.15 ± 0.92 with p value of carry over effect: 0.03 and period effect: 0.22. Except for severity of nausea in acute phase, the mean number and severity of nausea and vomiting scores significantly decreased in acute and delayed phase of CINV.ConclusionPersumac may control the refractory CINV. The implicable and clinical importan...

Natural Product Interventions for Chemotherapy and Radiotherapy-Induced Side Effects

“…Bunium persicum is a perennial plant in Iran. A randomized, double blind, crossover clinical trial shows that Persumac, a combination of R. coriaria and B. persicum , may be helpful in patients with refractory chemotherapy - induced nausea and vomiting (Nazari et al, 2017 ).…”

Medicinal herbs in treating chemotherapy‐induced nausea and vomiting: A review

“…Outcomes showed that Persumac decreased the frequency and severity of nausea and vomiting significantly. However, in the acute phase, a reduction in the severity of nausea was not significant (Nazari et al, 2017).…”

“…Persumac is a traditional Persian medication that is made of sumac (Rhus Coriaria) and Kermani Black Zira (Bunium persicum) (Nazari et al, 2017).…”

A New Concept on Chemotherapy-Induced Nausea and Vomiting: Persian Medicine Viewpoint

“…In Persian medicine (PM), nausea is commonly known as "Ghathayan" that means the GI attempt to expel the substances accumulated in the stomach, without success, and vomiting is known as "Ghey" means GI motility in order to repel the accumulated substances through the mouth successfully [3]. Both of these definitions are corresponding to the states of nausea and vomiting in modern medicine [4]. According to the holistic viewpoint of PM, the human body is made up of four main substances called "Humor" (Khelt), each of which has a unique temperament (Mizaj), and, on the basis of temperament, they play certain roles in the body.…”

“…Comparison of the structural and functional properties between abnormal yellow bile and free radicals, which produce by chemotherapy agents and cause GI mucosal layer damage, reveals similarities as shown in Table-1. It seems that free radicals are considered to be a kind of abnormal yellow bile GMJ.2019;8:e1412 www.gmj.ir in PM [4]. On the other hand, In PM viewpoint, important organs have close physiological links and interactions with each other, so that the health and illness of each one can directly affect another.…”