Effectiveness of combinations of Ayurvedic drugs in alleviating drug toxicity and improving quality of life of cancer patients treated with chemotherapy.

PURPOSE: This study was conducted to assess the effectiveness of combinations of Ayurvedic drugs in alleviating the toxicity of chemotherapy and improving the quality of life of cancer patients. The following was the research question: Can Ayurvedic drugs be used to alleviate the side effects of chemotherapy and improve the quality of life of cancer patients?
METHOD: Random patients with malignancies of different tissues, grades, and stages were divided into two groups according to their treatment modality. Group 1 consisted of 15 patients treated with six cycles of chemotherapy alone and who did not receive any Ayurvedic drugs (control group). Group 2 consisted of patients (divided into three arms) who received Ayurvedic drugs during chemotherapy and after chemotherapy. Nineteen patients in arm 1 received the Ayurvedic drugs Mauktikyukta Kamdudha (MKD) and Mauktikyukta Praval Panchamruta (MPP) along with a full course of chemotherapy. Fifteen patients in arm 2 received the same Ayurvedic treatment, but the treatment was started after completing the sixth cycle of chemotherapy. Eighteen patients in arm 3 received the Suvarnabhasmadi formulation (SBD) in addition to MKD and MPP after completing the sixth cycle of chemotherapy. Treatment was given for 16 weeks in all three arms. Patients from both groups were observed for a period of 6 months. The assessment criteria depended on Common Toxicity Criteria (CTC designed by NIH and NCI): haemogram; weight; physical examination including Quality of Life Questionnaire (QLQ designed by the European Organization of Research and Treatment of Cancer (EORTC)) for functional, symptom and global scores; and Karnofsky score for assessment of general well-being and activities of daily life. ECOG (Eastern Cooperation Oncology Group) score was also additionally included for assessment of symptoms.
RESULTS: From amongst the symptomatic criteria, there was significant improvement in all the three arms compared with the control group in nausea, loss of appetite, constipation, and fatigue. There was significant improvement in the Karnofsky score and global score of the QLQ, which in fact incorporate symptomatic criteria, general condition, functional ability and disease-related symptoms. These significant differences were observed in group 2 (arms 1, 2, 3) in comparison with group 1 (control), in spite of the fact that in arms 2 and 3, the Ayurvedic treatment was started after completion of chemotherapy. The haemogram did not show a significant difference between the control and the three arms of group 2.
CONCLUSION: Adjunct treatment with herbo-mineral and metallic Ayurvedic drugs appears to have a significant effect on reducing the toxic side effects of chemotherapy drugs in cancer patients. Our preliminary data suggests that Ayurvedic treatment should be given simultaneously from the beginning of chemotherapy to have the desired effect. However, there is a need to extend this work by conducting a well-planned two-armed study on cancer patients with defined cancer sites with selected Ayurvedic drug combinations, and observing the patients for a longer period of time to confirm the effectiveness of Ayurvedic drugs in reducing the side effects of chemotherapy.

RCT Entities:   Population Interventions Outcomes