|Ahead of print publication
Herbal supplement usage among cancer patients: A questionnaire-based survey
Thirunavukkarasu Kanimozhi1, Kalluru Hindu1, Yuvaraj Maheshvari1, Y Gulab Khushnidha1, Mahendrian Kumaravel1, K Satish Srinivas2, M Manickavasagam3, Kalachaveedu Mangathayaru1
1 Department of Pharmacognosy, Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Chennai, Tamil Nadu, India
2 Department of Radiation Oncology, Faculty of Medicine, Sri Ramachandra Medical College and Research Institute, Chennai, Tamil Nadu, India
3 Department of Medical Oncology, Faculty of Medicine, Sri Ramachandra Medical College and Research Institute, Chennai, Tamil Nadu, India
|Date of Submission||20-Sep-2018|
|Date of Decision||15-Feb-2019|
|Date of Acceptance||11-May-2019|
|Date of Web Publication||29-Jan-2020|
Department of Pharmacognosy, Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Porur, Chennai - 600 116, Tamil Nadu
Source of Support: None, Conflict of Interest: None
Background: Herbal supplements (HS) are one of the most commonly used complementary and alternative medicines in cancer. Reduced therapeutic efficacy of prescription anticancer agents through unwarranted herb–drug interactions is a major efficacy/safety concern. In view of the rising cancer prevalence in India along with a high degree of reliance and cultural acceptability in favor of traditional medicine drugs, prevalence data exclusively of HS usage during cancer treatment are of considerable epidemiological significance.
Methodology: This questionnaire-based prospective observational study aimed at estimating the prevalence of HS among cancer patients during treatment at our tertiary care medical center. Taken on a population of 220 patients within a period of 9 months, data were generated by a customized validated questionnaire and the same processed by IBM SPSS Statistics for Windows, version XXIV, Armonk, NY: IBM Corp. Differences between HS use and nonuse with respect to demographic, disease, and treatment characteristics were assessed by Chi-square test. For examining the latter variables as possible predictors of HS usage, they were entered into bivariate logistic regression with odds ratio and confidence intervals calculated for each.
Results: Out of 220 patients, 57 (26%) were HS users and 163 (74%) were nonusers. Majority of the users (42.1%) were on self-prepared folklore herbal medicine postdiagnosis of cancer (57.9%), the most common reason cited being symptom palliation (35.1%) on the advice of friends and family (64.9%). Fear of disapproval was the most common reason cited (68.4%) for not disclosing HS usage to the physician.
Conclusion: Chemotherapy and unemployment are predictors of HS usage, and there is a significant association between occupation status and HS usage. This first study on HS prevalence among South Indian population proposes the need for a more robust evidence base for understanding all aspects of HS use in cancer.
Keywords: Chemotherapy, complementary and alternative medicine, herbal supplements, questionnaire, Tamil Nadu
|How to cite this URL:|
Kanimozhi T, Hindu K, Maheshvari Y, Khushnidha Y G, Kumaravel M, Srinivas K S, Manickavasagam M, Mangathayaru K. Herbal supplement usage among cancer patients: A questionnaire-based survey. J Can Res Ther [Epub ahead of print] [cited 2020 Apr 2]. Available from: http://www.cancerjournal.net/preprintarticle.asp?id=277276
| > Introduction|| |
The usage of herbal drug adjuvants in cancer is increasingly reported worldwide. India has some of the highest cancer rates in the world with more than 1300 Indians succumbing to the disease each day. Worldwide, there is a widespread use of complementary and alternative medicine (CAM) by cancer patients, and herbal supplements (HSs) are one of the most commonly used CAMs.,,, Depending on the sample size, definition of the CAM used in the studies, the questionnaire used to collect the data, and the study population, studies report CAM usage ranging from 37% to 87%.,,, The most common reasons cited for CAM usage are minimizing the adverse effects of chemotherapy, controlling progression of cancer, and improving quality of life.,
While prevalence assessment studies of CAM – which includes a wide range of products (herbs, vitamins, and probiotics) and medical practices – in cancer are reported, there are scant authoritative data on the prevalence rates exclusively of HS. India's rich herbal medical tradition notwithstanding, there are not many studies concerning the extent of HS use by cancer patients in India. Global renaissance in herbal medicine popularity, unregulated sale of and self-medication involving herbs/cocktails of proprietary herbals mass manufactured outside the dictum, and therapeutic basis of traditional medicine, is a definite cause for concern. In India, there is a high degree of reliance and cultural acceptability in favor of traditional systems of medicine and folklore use of medicinal plants. Around 40%–70% of cancer patients in India reportedly use CAM in combination with conventional cancer therapy., Given the fact that HS are themselves pharmacologically active, their additive, synergistic/antagonistic activity toward prescription anticancer drugs could precipitate clinically significant herb–drug interactions. Literature reports of clinically relevant interactions were reported for herbs such as St. John's wort, garlic, Silybum, ginseng, and ginkgo affecting the pharmacokinetic parameters of the drugs.
In this context, data on the prevalence of HS usage during cancer treatment are of considerable epidemiological significance. We herein report results of our questionnaire-based prospective observational study to assess the prevalence of HS usage among cancer patients attending our tertiary care medical center. Data collected through the questionnaire pertained to prevalence, reasons for HS usage, the extent of palliation by the same, patient source of information, and factors influencing HS usage.
| > Methodology|| |
Subjects and methods
This is a prospective observational study carried out with the approval of the Institutional Ethics Committee, and written informed consent was obtained from all the participants. The study was taken on 220 cancer patients attending the oncology department of a tertiary care teaching hospital for a period of 9 months (June 2016–February 2017). Patients diagnosed with histological and cytological proof of cancer, willing to give consent to participate in the survey, and above 18 years of age were included in the study.
The questionnaire for the study was developed based on previously used questionnaires to report CAM usage among cancer patients in other research studies. The study questionnaire was modified and applied focusing only on HS usage customized to Indian settings.
The validation of the questionnaire was performed by conducting a pilot trial taken on 30 patients with the same being sent for evaluation to experts – an oncologist, a pharmacognocist, a psychiatrist, a clinical pharmacist, and a statistician. On their appraisal and approval, the same was submitted to the Institutional Ethics Committee for their scrutiny. The questionnaire consisted of 18 questions categorized under sections given in [Table 1]. Complete questionnaire was provided at the end of the article as Appendix 1.
Patients were identified through consecutive registrations in the oncology ward registry, Sri Ramachandra Medical Center. After obtaining written informed consent from the patients at the clinic, the research assistants introduced the study describing it as a survey to learn about HS use and then determined patient eligibility. As part of the consent process, patients were informed that they could withdraw from the study at any time and skip any survey question. To increase the response accuracy, patients were provided with the choice of taking the questionnaire either in English or regional language (Tamil). To illiterate patients, questions were asked and the responses were recorded by the interviewer. Literate patients recorded their responses directly onto the questionnaire and returned them to the research assistant. If patients reported no past or current use of HSs after completing the sociodemographic and clinical section of the questionnaire, the patients were thanked for their contribution and asked to stop completing the questionnaire at that stage. If patients reported past or current use of HSs, they were asked to continue.
The study population was classified into HS users and nonusers. Participants were classified as users if they used at least one HS and HS nonusers if they have not used any HS. Some of the variables such as educational status, occupation status, socioeconomic status, and types of herbal medicines used were categorized and coded for ease of analysis.
The data obtained were tabulated, and the baseline characteristics such as patient demographics (age, gender, socioeconomic status, educational status, occupational status, and place of living), stage of disease, type of cancer, and type of therapy were expressed as descriptive statistics. The duration and frequency of HS usage were expressed as mean and standard deviation. Differences between HS users and nonusers with respect to demographic, disease, and treatment characteristics were assessed by Chi-square tests based on the measurement of the variable (as the variables were categorical). Candidate variables were entered into a bivariate logistic regression model to assess their relationship with HS use by estimating the odds ratio (OR) at 95% confidence interval (CI). IBM SPSS Statistics for Windows, version XXIV, Armonk, NY: IBM Corp. was used to perform all the statistical analyses.
| > Results|| |
Summary of the baseline characteristics of study population [Table 2] reveals that the age range of the study population was found to be 18–80 years, with a mean age of 51.75 ± 12.34 years. The majority of the patients were above the age of 50 years. Among the total study participants majority were female (74.7%), married (97.3%), illiterate (37.3%), unemployed (54.1%) and class IV socioeconomic status (47.7%). The type of cancer of the study population is as follows: breast cancer (69 patients, 31.4%), lung cancer (12 patients, 5.5%), cancer in the gastrointestinal tract (GIT) (59 patients, 26.85%), gynecological cancer (31 patients, 14.1%), head-and-neck cancer (19 patients, 9.7%), blood cancer (7 patients, 3.2%), and other types of cancer (23 patients, 10.5%) which include bone cancer and pancreatic cancer. Of the study population, 90 (40.9%) patients were in the beginning stage, 46 (20.9%) patients were in advanced stage, 81 (36.8%) of patients were not aware of their stage of cancer, and 3 (1.4%) patients' stage was undetermined. The type of treatment of the study population included 112 (50.9%) patients on chemotherapy, 46 (20.9%) patients on both chemotherapy and surgery, 25 (11.4%) patients on both chemotherapy and radiation, and 37 (16.8%) patients on other treatment combinations such as chemotherapy with radiation as well as surgery, hormonal therapy, radiation only, and surgery only.
Herbal supplement users
Out of the total study population of 220 patients, 57 (26%) patients reported using HS and 163 (74%) reported not having used HS. Among the HS users majority of the patients were in the age group of 25-50 years (62.7%), female (69.4%), married (96.4%), illiterate (43.8%) and class IV economic status (52.6%). Based on the type of cancer, majority of the HS users were suffering from GIT cancer (36.85) and breast cancer (22.8%). Depending on the stage of cancer, majority of the HS users were in the beginning stage (36.8%). Among 57 HS users, 34 (59.6%) patients were under chemotherapy, 12 (21%) patients were under chemotherapy with a past history of surgery, 7 (12.2%) patients were under chemotherapy with radiation, and 4 (7%) patients were under other treatment combinations [Table 2].
Types of herbal supplements used
Of the 57 patients, 16 (28.07%) patients were using herbal preparations prescribed by traditional medicine practitioners, 39 (66.66%) patients were using self-prepared folklore medicines, and 3 (5.26%) were using finished herbal products from the market. A list of the most commonly used herbs by the study participants is presented in [Table 3]. These HSs were self-administered orally by the study participants.
|Table 3: List of most commonly used herbal supplements among the study population|
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Initiation and duration of use of herbal supplements
Thirty-three (57%) patients initiated their use of HS after the diagnosis of cancer, 22 (38.6%) patients after chemotherapy or radiation treatment, and 2 (3.5%) patients after surgery. Of 57 users, 47 (82.5%) patients used one herbal product, 9 (15.8%) patients used two herbal products, and 1 (1.7%) patient used more than two herbal products. The majority of the patients used HSs only for 1 month.
Source of information, reasons for use of herbal supplements, and effects after use of herbal supplements
The major source of information on HS was family and friends. Reasons cited in the study for the use of HS are summarized in [Table 4]. The majority of the HS users reported enhancement of their overall well-being.
Majority of the patients (39, 68.4%) did not mention their HS usage to the physicians. The reason for not informing the physician was found to be that the physician did not enquire about HS usage. Among the patients who informed the physician about their HS use, 50% of them were asked to discontinue the same.
Predictors of herbal supplement use
Preliminary comparisons by Chi-square analyses suggested that the majority of the patients using HSs were found to be in the age range of 25–50 years. Patients, who were unemployed, were found to be using HSs more than patients of other occupational status (P< 0.001). Age (P = 0.374), gender (P = 0.568), religion (P = 0.440), marital status (P = 0.674), education (P = 0.541), socioeconomic status (P = 0.147), and type of treatment (P = 0.132) did not have any statistically significant impact on HS usage. In other words, HS users did not differ from non-HS users with respect to these variables.
Candidate variables were next entered into a binary logistic regression model to assess their relationship with HS use. Of the examined variables as predictors of the HS usage in binary logistic regression, gender, education, occupation, breast cancer, and stage of cancer (early) showed an OR of >1 though P values did not reach the level of significance (<0.05). However, chemotherapy and occupation showed an OR of >1 at a significant P = 0.037 and 0.001, respectively. Socioeconomic status, on the other hand, showed an OR of 0.715 at a narrow 95% CI (0.5160–0.990) at a significant P = 0.043. Logistic regression model, therefore, indicates chemotherapy and unemployment as predictors of HS usage with a significant precise OR of >1 [Table 5].
|Table 5: Logistic regression analysis of risk factors of herbal supplement use|
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| > Discussion|| |
In this study of 220 outpatients at the oncology department of our tertiary care teaching hospital, 57 (26%) patients reported HS usage with majority having used self-prepared and folklore herbal preparations – largely single herbs after their diagnosis. The most common reason cited for HS usage was cancer symptom reduction on advice from friends/family. Most of them were not specifically asked by their physician about HS usage, and they too did not mention it to the physician. The reason mentioned for the latter was their perception that physicians may not approve such usage. The differences between HS users and nonusers with respect to demographic, disease, and treatment characteristics as assessed by the Chi-square test (χ2) showed a significant association between occupation status and HS usage (P< 0.001). Logistic regression analysis indicated that unemployed patients and patients on chemotherapy are more likely to use HSs after cancer diagnosis.
The limitations of the study are possible existence of an element of investigator and patient bias and the fact that it is a single medical center assessment. The patients may have been hesitant to disclose their HS usage. Further emotional distractions and anxiety associated with a visit to see the physician regarding their cancer could have influenced patient responses to the survey questions. Despite these limitations, the frequency of cancer diagnosis in our sample being much similar to the cancer registry figures of our medical center, the study may be taken to represent HS prevalence of the urban/semi-urban poor from the state of Tamil Nadu in India.
It is to be noted that univariate analysis using Chi square was exploratory and meant to identify variables of significance. Although P values were used to identify the relative significance levels between the variables tested, all conclusions on HS usage predictors are based on binary logistic regression analysis.
| > Conclusion|| |
This study, first to assess the prevalence of HS usage in South India, is a value addition to the scant data on HS use in cancer in India. Rising prevalence of herbal supplementation in cancer and potential for adverse effects and drug interaction necessitates a robust evidence base in the subcontinent for understanding all aspects of oncology-related herbal medicine use. Furthermore, routine clinical questioning should encompass herbal medicine use before all treatment episodes. The provision of educational resources for both medical consultants and patients on herbal medicine usage, along with conventional care, is thus vitally important.
Financial support and sponsorship
The authors acknowledge the support to the work in the form of “Chancellors Summer Research Fellowship” – an intramural research grant of SRIHER.
Conflicts of interest
There are no conflicts of interest.
| > Appendix|| |
Appendix 1: Questionnaire on the usage of herbal products by cancer patients in India
Patient Name:––––– Id No:––––– Age/Sex:––––
Marital status:––––––– Education status:––––– Occupation:––––– Monthly income:––––– Address:––––
1. Primary cancer site
- Don't know □
- Breast □
- Lung □
- GIT □
- Gynecological □
- Head and Neck □
- Blood □
- Others □
2. Duration of the disease
- <6 months □
- 6 months–1 year □
- 1 year–5 years □
- >5 years □
3. Stage of the cancer
- Beginning □
- Advanced □
- Undetermined □
- Unknown □
4. What type of treatment are you receiving for cancer
- Chemotherapy □
- Radiation therapy □
- Surgery □
- Both chemotherapy and radiation therapy □
5. Have you familiar with herbal products?
- Yes, extremely familiar □
- Yes moderately familiar □
- Slightly familiar □
- Not at all familiar □
6. Have you taken herbal products for cancer Palliation?
- Yes currently □
- Never □
- In the past □
7. Do you take any alternative system of medicine?
- Herbal preparations from traditional medical practitioners □
- Self-prepared folklore medicine □
- Finished herbal products from the market □
8. When did you start taking herbal products?
- Before cancer diagnosis □
- After cancer diagnosis □
- After chemotherapy or radiation □
- After surgery □
- Not at all □
9. How many herbal products do you take?
- One □
- Two □
- Three □
- More than three □
10. What is the name of the herbal product/products you use?
11. What is the duration of the use of herbal product?
- <1 month □
- 1 month–6 months □
- 6 months–1 year □
- >1 year □
12. What is the reason for taking the herbal product?
- As a supportive measure to control symptoms □
- To enhance well being □
- To reduce side effects of chemotherapy □
- To slow the progression of cancer □
13. How did you come to know the use of this product?
- Friends/Family □
- Own free will □
- Television/Internet □
- Health-care professional □
- Cancer survivors □
- Vendor □
- Others □
14. What were the results you saw after the use of this product?
- Improvement of health condition □
- Worsening of health condition □
- No changes in Health condition □
15. Did your doctor ask you about your herbal products use?
16. Did you inform the doctor about your herbal product usage?
17. If yes, to question no. 16, how did your doctor respond?
- Agreed □
- Disagre □
- Neutral □
18. If No, to the question no. 16, what are the reasons?
- Doctors need not know □
- They never ask, I never tell □
- Doctors have little knowledge about herbal products □
- Fear that doctor may advice to stop using it □
- Fear of stoppage of regular treatment □
19. How much did you spend every month to use this herbal product (in rupees)?
- <500 □
- 500–1000 □
- 1000–5000 □
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]