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Effects of Herbal Medicine for Xerostomia in Head and Neck Cancer Patients: an Observational Study in a Tertiary Cancer Hospital

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Effects of Herbal Medicine for Xerostomia in Head and Neck Cancer Patients: an Observational Study in a Tertiary Cancer Hospital Supportive Care in Cancer (2019) 27:3491–3498 https://doi.org/10.1007/s00520-019-4646-2 ORIGINAL ARTICLE Effects of herbal medicine for xerostomia in head and neck cancer patients: an observational study in a tertiary cancer hospital Ren Jye Lim1,2 & Wan Najbah Nik Nabil1,3 & Si Yan Chan3,4 & Yoke Fui Wong5 & Li Xian Han1 & Jia Ying Gong1,3 & Kun Ling Ho1 & Yee Siang Shew6 & Li Xu2 Received: 12 July 2018 /Accepted: 14 January 2019 /Published online: 24 January 2019 # Springer-Verlag GmbH Germany, part of Springer Nature 2019 Abstract Purpose More than 80% head and neck cancer patients endured radiotherapy-induced xerostomia which impacts their quality of life (QoL). This observational study evaluated the effect of herbal treatment on head and neck cancer patients’ xerostomia and QoL. Methods Head and neck cancer patients were recruited from July 2016 till March 2017 at National Cancer Institute, Ministry of Health, Malaysia. All study participants continued their standard oncology surveillance. Treatment group participants addition- ally received Chinese herbal treatment. The assessments included unstimulated salivary flow rate (USFR), stimulated salivary flow rate (SSFR), and QoL questionnaire. Results Of 42 recruited participants, 28 were in the treatment group and 14 were in the control group. Participants were mainly Chinese (71.4%), stage III cancer (40.5%), and had nasopharynx cancer (76.2%). The commonly used single herbs were Wu Mei, San Qi, and Tian Hua Fen. Sha Shen Mai Dong Tang, Liu Wei Di Huang Wan, and Gan Lu Yin were the frequently prescribed herbal formulas. The baseline characteristics, USFR, SSFR, and QoL between control and treatment groups were comparable (p > 0.05). USFR between control and treatment groups were similar throughout the 6-month study period. SSFR for the treatment group significantly improved from 0.15 ± 0.28 ml/min (baseline) to 0.32 ± 0.22 ml/min (p = 0.04; at the 3rd month) and subsequently achieved 0.46 ± 0.23 ml/min (p = 0.001; at the 6th month). The treatment group had better QoL in terms of speech (p = 0.005), eating (p = 0.02), and head and neck pain (p = 0.04) at the 6th month. Conclusion Herbal treatment may improve xerostomia and QoL in post-radiotherapy head and cancer patients. Keywords Chinese herbal drugs . Xerostomia . Radiotherapy . Head and neck neoplasms * Ren Jye Lim [email protected] Abbreviations 1 Traditional & Complementary Medicine (T&CM) Unit, National Gy Gray Cancer Institute (NCI), Ministry of Health, Prescint 7, IQR Interquartile range 62250 Putrajaya, Malaysia M Mean 2 First Clinical Medicine College, Jiangsu Province Hospital of NCI National Cancer Institute Traditional Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, 138 Xianlin Road, Nanjing 210023, QoL Quality of life People’s Republic of China SD Standard deviation 3 Pharmacy Department, National Cancer Institute (NCI), Ministry of SSFR Stimulated salivary flow rate Health, Precinct 7, 62250 Putrajaya, Malaysia T&CM Traditional and complementary medicine 4 Department of Chinese Pharmaceutical Sciences and Chinese USFR Unstimulated salivary flow rate Medicine Resources, College of Chinese Medicine, China Medical University, Taichung 40402, Taiwan 5 Department of Radiotherapy and Oncology, National Cancer Institute (NCI), Ministry of Health, Prescint 7, Introduction 62250 Putrajaya, Malaysia 6 Cancer Centre, Tung Shin Hospital, 102, Jalan Pudu, Bukit Bintang, Head and neck cancer has become the sixth leading cancer 55100 Kuala Lumpur, Malaysia worldwide—approximately 630,000 new patients have been 3492 Support Care Cancer (2019) 27:3491–3498 diagnosed annually [1]. The principal treatment for head and breastfeeding; vulnerable patients; and patients who had re- neck cancer is radiotherapy, whether as a single treatment currence, relapse, or metastases post-radiotherapy. (stage I) or concurrent with chemotherapy (stage II, III, and We recruited study participants from 1st July 2016 until IV) [2–4]. However, more than 80% head and neck cancer 31st March 2017 and participants decided themselves to enroll patients who have undergone radiotherapy endured either in the treatment or in the control group. Based on the xerostomia [5]. primary outcome measure, i.e., salivary flow [15], the sample Xerostomia is progressive within 6 months post- size was calculated using comparing 2 means formula [20]. radiotherapy [6], and may even be irreversible [7]. Taking into account α of 0.05, desired power at 80% (β =0.2) Xerostomia impacts the patients’ quality of life (QoL) as it and an expected difference between the 2 means of 4.42, 12 burdens chewing, speaking, and swallowing and also causes participants were required for treatment and control group a higher incidence of oral candidiasis and dental caries [8]. respectively. Allowing for 20% dropout, the calculated sample Recommended pharmacologic treatments, such as pilocarpine size was 14 participants for treatment and control groups and cevimeline [2], relieve xerostomia temporarily [9, 10]. respectively. However, pilocarpine causes intolerable adverse effects (such All study participants continued their standard oncology as sweating, headache, frequent urination) [10] and requires surveillance at the oncology clinic, NCI. In addition to the caution in patients with cardiovascular and respiratory condi- routine oncology care, participants of the treatment group re- tions [11]. Similarly, non-pharmacological treatments (such as ceived Chinese herbal treatment from the T&CM unit, NCI. oral lubricants or saliva substitutes) offer transitory relief of The provided herbal treatment was plant-based Chinese herbal xerostomia [10]. extract and in powder form. The participants of the treatment Traditional and complementary medicine (T&CM) units in group were required to take the herbal treatment orally twice four government hospitals in Malaysia (including the National daily. Trained and qualified Chinese medicine practitioners Cancer Institute, NCI) offer Chinese herbal treatment as an tailored the herbal treatment monthly to address the partici- adjunct to conventional cancer treatment [12]. Systematic re- pants’ chief complaints, including their xerostomia com- views showed that Chinese herbal treatment may alleviate plaints. Participants’ de-identified demographic, clinical data xerostomia [13, 14] and other sequelae of radiotherapy (e.g., and prescribed herbal treatment were extracted from the hos- oral mucositis, loss of appetite) [13]. Though previous system- pital electronic medical record. Study follow-up was 6 months atic reviews and randomized controlled trials demonstrated and all participants were assessed at baseline, 1st month, 3rd the effectiveness of Chinese herbs in improving month, and 6th month. The assessment for xerostomia prog- radiotherapy-induced xerostomia [15–18], only few studies ress included unstimulated salivary flow rate (USFR) and had concurrently examined xerostomia improvement objec- stimulated salivary flow rate (SSFR) [21] and administering tively and assessed QoL. Considering the paucity of herbal the validated BHead and Neck Cancer-Specific Quality of Life study on post-radiotherapy xerostomia (particularly in the lo- Questionnaire^ [22]. In assessing USFR, participants had a cal hospital setting), we conducted an observational study pre-weighed gauze under their tongue for 5 min. The soaked aimed to evaluate the effect of Chinese herbal treatment in gauzes were then weighed [23]. The participants rinsed their relieving participants’ xerostomia (i.e., salivary flow) and mouth and rested for 3 min [21] before proceeding to SSFR QoL. whereby participants chewed another pre-weighed gauze over 5min[23]. Flow rate was calculated as milliliters per minute. The QoL questionnaire comprised of 4 domains: speech, head Methods and neck pain, eating, and emotion. The QoL score ranged from 0 to 100, which the higher score indicated a better out- This was a prospective observational study on post- come [22]. radiotherapy head and neck cancer patients. Medical Data were analyzed using SPSS software (IBM SPSS Research and Ethics Committee (MREC), Ministry of Statistics for Windows, Version 22.0; IBM Corp., Armonk, Health, Malaysia, approved the study protocol (NMRR-14- NY, USA). Descriptive statistics (frequency with percentage 1925-22,407). All referred head and neck cancer patients to (%) mean and standard deviation (M ±SD)andmedianand the T&CM unit, NCI, were screened for enrollment eligibility. interquartile ranges (IQR)) were presented for participants’ The inclusion criteria were histopathologically confirmed di- age and their radiotherapy details. The independent t test and agnosis of head and neck cancer [19]; aged ≥ 18; received ≥ Mann-Whitney U test (for non-normally distributed data) 52 Gy of radiotherapy on the head and neck area; and com- were used to compare the salivary flow rate and quality of life pleted radiotherapy ≤ 6 months. We excluded patients with between control and treatment groups. Missing data were ex- head and neck cancer stage IVC; thyroid cancer; medical his- cluded from the analysis. Values of p < 0.05 indicated statisti- tory of xerostomia; history of taking medications which may cally significant. affect saliva secretion (e.g., pilocarpine); pregnant or Support Care Cancer (2019) 27:3491–3498 3493 Results formula, and 88 single herbs were involved within 6 months of the study period. The top 3 commonly prescribed single We examined 50 potential participants who met the inclusion herbs
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