Ayruvedic Drugs

To assess the effectiveness of a combination of Ayurvedic drugs in alleviating cancer- and treatment-related symptoms

Patients initially were divided into two groups. Group 1 did not receive any Ayurvedic drugs. Patients in group 2 received Ayurvedic herbal combinations at various time points during chemotherapy. Within group 2, arm 1 received the same drugs and a full course of chemotherapy while arm 2 received the same drugs at the start of the sixth chemotherapy cycle and arm 3 received them after completing the sixth cycle. Treatment was continued for 16 weeks. Drugs used were maukitkyukta kamdudha (MKD) and mauktikyukta praval panchamruta (MPP) in all treatment arms. Arm 3 also received suvarnabhasmadi (SBD) according to clinician preference based on Eastern Cooperative Oncology Group scores. MKD and MPP at 250 mg each were given orally twice daily. SBD was given orally at a dose of 395 mg twice daily in cow’s ghee. Patients were followed for six months. Outcomes were measured after the first cycle of chemotherapy, after the sixth cycle of chemotherapy, and one month after the sixth cycle.

• N = 64
• AGE: Not provided
• MALES (%): Not provided, FEMALES (%): Not provided
• KEY DISEASE CHARACTERISTICS: Patients with various tumor types receiving different chemotherapy agents including highly emetogenic agents
• OTHER KEY SAMPLE CHARACTERISTICS: None were receiving radiation therapy 

• SITE: Single site 
• SETTING TYPE: Not specified
• LOCATION: India

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Palliative care 

Prospective study

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
• Eastern Cooperative Oncology Group (ECOG) score to reflect symptoms such as pain

Patients in arm 1 of the treatment group showed the least symptom severity of all groups. However, there were no statistically significant differences between the groups in any outcome measure. Symptoms declined in all patients after the first chemotherapy cycle. There were no significant differences in other chemotherapy-related toxicities.

This study showed some interesting but insignificant differences in chemotherapy-associated symptoms between patients receiving Ayurvedic drugs throughout chemotherapy, patients receiving the experimental drugs at difference time points, and patients who did not receive any of these drugs. This study's findings did not show that Ayurvedic drugs were effective in reducing symptoms compared to controls overall. This report had numerous design and reporting limitations.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement validity/reliability questionable
• Other limitations/explanation: The report states that patients who were lost to follow-up were not included in the analysis, but it provides no information on those patients or how many there were. There was no ITT analysis. Measurements such as ECOG scores were insufficient as measures of symptom severity. This report does not provide demographic information about participants and those lost to follow-up. Some interventions were at the physician's discretion, and there was no related subgroup analysis. There was no information about any other interventions for symptom management. No information was provided regarding the actual contents of the drugs used.

Little research has been done on the effects of Ayurvedic drug combinations among patients with cancer as a form of complementary and alternative medicine to manage treatment-related symptoms. This study did not demonstrate the efficacy of the particullar combination tested, and the study had several design and reporting flaws. Additional well-designed and clearly reported research for this type of intervention is needed to determine what role, if any, Ayurvedic drugs have for symptom management in cancer care.