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The Effect of Pilocarpine on Dental

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The Effect of Pilocarpine on Dental Hsu et al. Arthritis Research & Therapy (2019) 21:251 https://doi.org/10.1186/s13075-019-2031-7 RESEARCH ARTICLE Open Access The effect of pilocarpine on dental caries in patients with primary Sjögren’s syndrome: a database prospective cohort study Chung-Yuan Hsu1†, Kuo-Chun Hung2†, Ming-Shyan Lin3, Chi-Hua Ko1, Yu-Sheng Lin4,5, Tien-Hsing Chen6, Chun-Yu Lin7* and Ying-Chou Chen1* Abstract Background: Primary Sjögren’s syndrome (pSS) is associated with dental caries. Pilocarpine, a salivary stimulant, can improve the amount and flow rate of saliva in patients with pSS. This study aimed to assess whether the risk of dental caries decreases with the use of pilocarpine in patients with pSS. Methods: For this prospective cohort study, we identified pSS patients from the catastrophic illnesses registry of the National Health Insurance Research Database of Taiwan between 2009 and 2013. We divided participants into pilocarpine and non-user groups based on the pilocarpine prescriptions available during the first 3-month follow- up. The primary endpoint was dental caries. The secondary endpoints were periodontitis and oral candidiasis. We compared the risk of these oral manifestations using the Cox proportional hazard model. Results: A total of 4973 patients with new-onset pSS were eligible for analysis. After propensity score matching, we included 1014 patients in the pilocarpine group and 2028 patients in the non-user group. During the mean follow-up of 2.6 years, the number of events was 487 in the pilocarpine group (48.0%) and 1047 in the non-user group (51.6%); however, the difference was not significant (hazard ratio [HR] 0.93, 95% confidence interval [CI] 0.82 to 1.06). Furthermore, there was no significant difference between groups regarding risk of periodontitis (HR 0.91, 95% CI 0.81 to 1.03) and oral candidiasis (HR 1.16, 95% CI 0.70 to 1.94). Conclusion: Pilocarpine may have no protective effect on dental caries, periodontitis, or oral candidiasis in patients with pSS. Keywords: Primary Sjögren’s syndrome, Pilocarpine, Dental caries Introduction dental caries and oral candidiasis [1]. Despite regular Primary Sjögren’s syndrome (pSS) is one of the most oral healthcare practices, pSS patients experience more common autoimmune diseases, mainly involving the dental caries than healthy subjects and are subjected to body’s exocrine glands, especially the salivary glands. It radical dental treatments [2]. Poor oral health is associ- can lead to a decrease in salivary flow rate and xerosto- ated with high mortality, although some unidentified mia. Changes in the oral environment lead to an accu- confounding factors may also exist [3]. mulation of oral pathogens, which subsequently causes Salivary stimulants, such as pilocarpine, are parasym- pathomimetic drugs that bind to the muscarinic recep- * Correspondence: [email protected]; [email protected] † tors on the exocrine glands and stimulate their Chung-Yuan Hsu and Kuo-Chun Hung contributed equally to this work. secretion. Theoretically, endogenous saliva is better than 7Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, No.138, Sheng Li Road, the saliva supplements traditionally used for preventing Tainan 704, Taiwan dental caries because it contains antimicrobial agents, 1 Division of Rheumatology, Allergy, and Immunology, Department of Internal such as secretory IgA and lysozyme [4]. Therefore, based Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, No. 123, Dapi Rd., Niaosong District, on expert opinions, the Sjögren’s Syndrome Foundation Kaohsiung City 833, Taiwan recommends that, in order to prevent caries, saliva Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Hsu et al. Arthritis Research & Therapy (2019) 21:251 Page 2 of 10 output should be increased by stimulating saliva secre- lupus erythematosus, systemic sclerosis, dermatomyo- tion in pSS patients with the dry mouth [5]. sitis, polymyositis, rheumatoid arthritis, and vasculitis), In an animal study, pilocarpine appears to exert the those with a diagnosis of SS before 2009 (which can be greatest caries-protective effect in partially desalivated tracked to 1997), or those with a history of malignancy, rats [6]. However, there is no clinical trial demonstrating hepatitis C, acquired immune deficiency syndrome, sar- that salivary stimulants are linked directly to the preven- coidosis, amyloidosis, or organ transplantation. tion of caries or a reduction in existing caries in patients Patients with contraindications for salivary stimulants, with salivary dysfunction. As the guideline recommends such as severe asthma, acute iritis, and narrow-angle the use of salivary stimulants, there should be at least glaucoma, were excluded. Furthermore, patients with a one human study to confirm this effect. Therefore, we follow-up of less than 3 months were excluded because designed this study to investigate whether pilocarpine the use of salivary stimulants was identified during the can prevent dental caries and other oral manifestations first 3-month follow-up starting from the index date. Pa- in patients with pSS. tients who suffered from an episode of dental caries, periodontitis, or oral candidiasis during the first 3- Methods month follow-up were also excluded. Finally, we Data source excluded patients who were prescribed with cevimeline The National Health Insurance program was estab- between 1997 and 2013 because the primary interest of lished by the Taiwanese government in 1995. It cur- this study was pilocarpine. A total of 4973 patients with rently covers 23 million enrolees, which is more than new-onset pSS were eligible for final analysis. Of these, 99% of the Taiwanese population. We selected patients 1410 (28.4%) were pilocarpine users and 3563 (71.6%) with pSS from the National Health Insurance Research were non-users (Fig. 1). Database (NHIRD) of Taiwan by determining whether they had a catastrophic disease certificate with pSS [7]. Outcomes If a specialist diagnoses a patient as having pSS (Inter- We detected the time-to-event outcomes according to national Classification of Diseases (ICD)-9: 7102), a the International Classification of Diseases, Ninth Revi- condition classified as a catastrophic illness by the Min- sion, Clinical Modification Codes (Additional file 1: istry of Health and Welfare of Taiwan, they can apply Table S1). The primary outcome was dental caries, de- for a catastrophic illness certificate for the patient. In fined as a clinic visit due to tooth decay and receiving order to apply for a certificate, the diagnosis must be the necessary interventions. The event of dental caries based on the 1993 classification criteria established by was detected using diagnosis codes along with the rele- the European Community Study Group [8]. Further- vant dental interventions at the dental outpatient visit. more, a comprehensive application document and rele- Secondary outcomes were the events related to other vant information, including a detailed medical record, oral manifestations of pSS including periodontitis, oral laboratory data, imaging report, and pathological study candidiasis, and annual number of dentist visits for den- are required to be reviewed by an anonymous rheuma- tal caries and periodontitis. The definition of secondary tology expert assigned by the NHI Administration. If a outcomes has also been frequently adopted in previous patient passes a strict review and obtains a certificate, studies [12, 13]. The follow-up period was based on the they are no longer required to make the co-payment duration between the index date of pSS diagnosis and for the treatment of the SS-related condition. Patients the onset date of dental caries, date of death, or 31 De- having a catastrophic illness certificate for pSS were cember 2013, whichever came first. defined as a SS case. The definition of SS has been widely reported in previous NHIRD studies [9–11]. The Covariate measurement present study was approved by the Chang Gung Med- Comorbidities included diabetes mellitus, chronic kidney ical Foundation Institutional Review Board (No. disease, cirrhosis, chronic obstructive pulmonary disease, 201801950B1). stroke, and dementia. The detection of comorbidities was defined as having at least two outpatient diagnoses Identification of study patients or any one diagnosis at admission of the comorbidities Patients with SS were identified in the NHIRD registry during the year before the index date. (Additional file 1: of patients with catastrophic illnesses between 2009 Table S1). Medications prescribed during the first 3- and 2013. The date of approval of the catastrophic ill- month follow-up including systemic glucocorticoids, ness certificate was assigned as the index date. The ex- azathioprine, cyclophosphamide, hydroxychloroquine clusion criteria were as
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