Abstract
Purpose-The aim of this study was to evaluate changes in the quality of life produced by Herbomineral Rasayana therapy in advanced stage cancer patients.
Methods–In this observational study we evaluated the effect of HerbomineralRasayana therapy in 30 advanced cancer patients, who were not receiving any conventional anticancer treatment. Quality of Life was measured thrice by self-assessment with Functional Assessment of Cancer Therapy scale (FACT-VERSION-4) at the beginning of Rasayana, after 3 months and at the end of the 6 months. During this phase all these patients were orally consuming herbomineral rasayana formulations once daily with honey.
Results- Three months after starting rasayana therapy( n=30),these patients showed significant improvement in physical wellbeing (from 18.69 to 22.68,p < 0.01 ) ,emotional well being (from 16 to 19.7 ,p<0.05 ) and functional wellbeing subscale ( from 17.94 to 23.3 ,p <0.01) . Significant improvement was also seen in FACT –G score (from 71.33 to 84.6 ,p< 0.01) .Scores of social wellbeing subscale remained unchanged .Improvement in Quality of life sustained even after six months ( n=25) in physical wellbeing subscale(from 18.69 to 22.79,p < 0.05 ) functional wellbeing subscale ( from 17.94 to 24.3 ,p <0.01) and FACT –G Score (from 71.33 to 85.8 ,p < 0.05 ).
Conclusion- These results points towards significant improvement due to Rasayana therapy in physical, functional and emotional components of QoLin advanced stage cancer patients.Rasayana therapy can be considered as important palliative care approach for improving QoL in advanced stage cancer patients.
Key Message- Rasayana therapy shows therapeutic potential to improve HRQoL in advanced stage cancer patients. It can be considered important palliative treatment option in advance stage of cancer patients.
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Introduction
In advanced cancer patients when curative goal becomes unfeasible, then the treatment is planned with palliative intent .In such end stage patients one of the important goal of treatment is to delay and relieve tumor related symptoms and maintain Patients Quality of Life. [ 1] According to the World Health Organization (WHO) quality of life (QoL) is defined as individual perception of life, values, objectives, standards, and interests in the framework of culture.[ 2] Many disease related factors and symptoms like pain, fatigue, anorexia etc exists that can directly affect patient’s daily life and can have negative impact on their QoL. Thus QoL is increasingly being used as an important outcome measure in studies to evaluate the effectiveness of treatment. In recent years the outcome variables in oncology studies have seen a paradigm shift. Earlier days survival was considered as an important outcome. Today various Patient Reported Outcome Measures (PRO) have also got much importance in deciding clinical benefit of
a therapy. Nowadays in oncology an increasingly important
factor is to evaluate QoL in cancer patients Maintaining quality of life (QOL) in advanced or end stage cancer patients is an emerging issue due to limitations for use of conventional cytotoxic therapies in such patients.Currently patients are seen to be attracted towards various complimentary therapies to improve their quality of life.. Ayurvedic Rasayana therapy is known to increase a person’s Health related Quality of life (HRQoL) with better tolerability and safety. Rasayana formulations prepared from Herbometalic complexes are emerging as important therapy to treat various malignancies. Experimental studies on various metal and mineral complexes have indicated the beneficial role of such complexes in treating malignancies.[ 3] In our Rasayu cancer Clinic thousands of patients have been treated for malignancies using Ayurvedic therapies and formulations . Systematic documentation exists for various variables like tumor regression, increased survival, tolerability to chemotherapy and Improvement in patients HRQOL.
The aim of this study was to systematically evaluate the change in QoL in advanced stage cancer patients with solid tumors who were treated with palliative intent exclusively by Rasayana therapy.
Methodology
A total of 30 cancer patients who have taken treatment in Rasayu cancer clinic were included in this study. This study was a retrospective chart review involving no more than minimal risk to the subjects. Moreover the study involves analysis of data from patients who have completed treatment earlier and has no follow-up with the research centre, hence this study could not be practically carried out without the Consent waiver. Hence the investigators obtained wavier of consent from the IEC. According to following inclusion and exclusion criteria patients were included to this study (Table-1).
| Inclusion criteria: | |
| 1 | Patient presenting with cancer of stage III or IV diagnosed with Biopsy ( Solid Tumors only) |
| 2 | Patients not treated currently with concurrent Chemotherapy/Radiotherapy. |
| 3 | Patients in whom HRQOL was measured using FACT questionnaire at baseline |
| 4 | Patient in whom HRQOL is measured at regular intervals. |
| 5 | Patient who took Rasayana treatment for at least 3 months. |
| 6 | Patient aged 18-70 years |
| Exclusion criteria: | |
| Patients who was suffering from any concomitant illness or taking any concomitant medication which in the opinion of investigator would have confounded with outcome efficacy variables. | |
| Patient who were receiving Opoid analgesics. | |
| Patient who were receiving other CAM modalities |
As a part of systematic clinical documentation practice Quality of Life was measured in all the patients by self-assessment with Functional Assessment of Cancer Therapy scale (FACT-VERSION- 4) [ 4] [ 5] .We selected QoL scores documented at the beginning of Rasayana, after 3 months and at the end of the 6 months. This questionnaire consisted of 27 questions and had arranged into four sub domains. Data from only those patients who continued treatment for three months or more were selected for analysis.
Results-
Three months after starting Rasayana therapy( n=30),these patients showed significant improvement in physical wellbeing (from 18.69 to 22.68,p < 0.01 ) ,emotional well being (from 16 to 19.7 ,p<0.05 ) and functional wellbeing subscale ( from 17.94 to 23.3 ,p <0.01) . Significant improvement was also seen in FACT –G score (from 71.33 to 84.6 ,p< 0.01) .In the chart review of these patients after 6 months we observed that 5 patients have lost follow-up as 4 of these patients died due to disease progression and 1 patient stopped treatment after 4 months. Scores of social wellbeing subscale remained unchanged. Improvement in Quality of life sustained even after six months ( n=25) in physical wellbeing subscale(from 18.69 to 22.79,p < 0.05 ) functional wellbeing subscale ( from 17.94 to 24.3 ,p <0.01) and FACT –G Score (from 71.33 to 85.8 ,p < 0.05 ).
Discussion
Patients with cancer have seen to use Complimentary and Alternative Medcine (CAM) to boost their immunity [ 6] prevent disease progression [ 7], cure cancer [ 8], or improve their quality of life [ 9] . Studies have showed that cancer patients using CAM have better QoL as compared to those who not received CAM [ 10].
In India Ayurveda is considered to be an important therapy used by patients to improve QoL. Rasayana therapy is an branch of Ayurveda which is known to increases an persons immunity,leads to formation of good quality of tissue/cells and also increase life span .It also possess properties like Antiaging ,antioxidant, immunomodular, nutritive etc[ 11] Rasayana is also indicated to improve well being and Quality of life and restoring vitality in patients of chronic illness. The findings of the present study clearly indicates that rasayana therapy can play an important role in improving QoL in advanced stage cancer patiemts.
It is now considered that putting too much emphasis on overuse of therapy with severe side effects had a negative consequence in a way that patients are prevented from preparing themselves for death. Rasayana therapy seems to be an ideal therapeutic approach for advanced stage cancer patients as it improves patient quality of life and moreover it can be administered in an outpatient setting.
Limitations of the study :
The present study only includesthose patients whohave taken rasayana therapy at least for 3 months. Thus it is possible that this study excludes those patients who dropped out from the treatment .. Dropout of patients have various reasons which may or may not be related to efficacy and safety of the therapy. Since the present study is a retrospective study we were unable to document the reason for patients dropout ;Hence we analysed only those patients who had a good compliance with therapy for at least 3 months.Thus the findings of this study highlights the effect of Ayurveda therapy only in those patients who were able to take the therapy for 3 months or more. The heterogenous group and retrospective study design does not generate a highlevelhigh-level of evidence .But certainly it indicates the potential of Rasayana therapy in improving QoL in advanced stage cancer patients who are treated with palliative intent.
Prospective study with a large sample size can further.
Conclusion
Rasayana therapy can be considered as an important component of palliative care in advanced stage cancer patients. Considering the limitations of this observational study, larger controlled studies with more objective parameters are needed to generate higher evidence to systematically explore the effects of Ayurveda Rasayana therapy for improving QoL in advanced stage cancer patients .
