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      The immediate effect of facial candling on inflammatory mediators, substance P, symptoms severity, and quality of life in allergic rhinitis patients : Study protocol for a randomized controlled trial

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          Abstract

          Introduction:

          Asian countries have a variety of ethnic groups and culture that provide their own traditional treatment in health care. Facial candling appears to be one of the popular traditional treatments in Southeast Asian. The complementary medicine practitioners promote that the facial candling treatment would help in reducing the symptoms of allergic rhinitis and other problems related to sinus. Due to the lack of evidence available, the effectiveness of this treatment method and its mechanism, however, remains unknown. The objective of this research is therefore to study impact of facial candling on inflammatory mediators, substance P (SP), symptoms severity, and quality of life (QoL) in allergic rhinitis patients.

          Method and analysis:

          A randomized, nonblinded, controlled trial will be carried out by recruiting a total of 66 eligible allergic rhinitis patients who fulfill the inclusion criteria from a university health center. The subjects will be randomly assigned into 2 groups: intervention group receiving facial candling treatment and control group (no treatment given). Samples of blood and nasal mucus will be collected right before and after intervention. Samples collected will be analyzed. The primary outcomes are the changes in the level of SP in both blood and mucus samples between both groups. The secondary outcomes include the levels of inflammatory mediators (ie, tumor necrosis factor alpha, interleukin (IL)-3, IL-5, IL-6, IL-10, and IL-13) and the severity of allergic rhinitis symptoms as measured by a visual analogous scale and QoL using the Rhinitis Quality of Life Questionnaire (RQLQ).

          Ethical and trial registration:

          The study protocols are approved from the Ethical and Research Committee of the Universiti Teknologi MARA (REC/113/15). The trial is registered under the Australia New Zealand Clinical Trial Registry (ACTRN12616000299404). The trial was registered on 03/07/2016 and the first patient was enrolled on 10/12/2016.

          Conclusion:

          Facial candling is one of the unique treatments using candles to reduce the severity of symptoms and inflammation. This is the first ever study conducted on facial candling that will give rise to new knowledge underlying the effects of facial candling on severity of symptoms and inflammation relief mechanism mediated by substance P and inflammatory mediators.

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          Most cited references30

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          The diagnosis and management of rhinitis: an updated practice parameter.

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            The role of substance P in inflammatory disease.

            The diffuse neuroendocrine system consists of specialised endocrine cells and peptidergic nerves and is present in all organs of the body. Substance P (SP) is secreted by nerves and inflammatory cells such as macrophages, eosinophils, lymphocytes, and dendritic cells and acts by binding to the neurokinin-1 receptor (NK-1R). SP has proinflammatory effects in immune and epithelial cells and participates in inflammatory diseases of the respiratory, gastrointestinal, and musculoskeletal systems. Many substances induce neuropeptide release from sensory nerves in the lung, including allergen, histamine, prostaglandins, and leukotrienes. Patients with asthma are hyperresponsive to SP and NK-1R expression is increased in their bronchi. Neurogenic inflammation also participates in virus-associated respiratory infection, non-productive cough, allergic rhinitis, and sarcoidosis. SP regulates smooth muscle contractility, epithelial ion transport, vascular permeability, and immune function in the gastrointestinal tract. Elevated levels of SP and upregulated NK-1R expression have been reported in the rectum and colon of patients with inflammatory bowel disease (IBD), and correlate with disease activity. Increased levels of SP are found in the synovial fluid and serum of patients with rheumatoid arthritis (RA) and NK-1R mRNA is upregulated in RA synoviocytes. Glucocorticoids may attenuate neurogenic inflammation by decreasing NK-1R expression in epithelial and inflammatory cells and increasing production of neutral endopeptidase (NEP), an enzyme that degrades SP. Preventing the proinflammatory effects of SP using tachykinin receptor antagonists may have therapeutic potential in inflammatory diseases such as asthma, sarcoidosis, chronic bronchitis, IBD, and RA. In this paper, we review the role that SP plays in inflammatory disease. Copyright 2004 Wiley-Liss, Inc.
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              Clinical practice guideline: Allergic rhinitis.

              Allergic rhinitis (AR) is one of the most common diseases affecting adults. It is the most common chronic disease in children in the United States today and the fifth most common chronic disease in the United States overall. AR is estimated to affect nearly 1 in every 6 Americans and generates $2 to $5 billion in direct health expenditures annually. It can impair quality of life and, through loss of work and school attendance, is responsible for as much as $2 to $4 billion in lost productivity annually. Not surprisingly, myriad diagnostic tests and treatments are used in managing this disorder, yet there is considerable variation in their use. This clinical practice guideline was undertaken to optimize the care of patients with AR by addressing quality improvement opportunities through an evaluation of the available evidence and an assessment of the harm-benefit balance of various diagnostic and management options.
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                Author and article information

                Journal
                Medicine (Baltimore)
                Medicine (Baltimore)
                MEDI
                Medicine
                Wolters Kluwer Health
                0025-7974
                1536-5964
                July 2017
                28 July 2017
                : 96
                : 30
                : e7511
                Affiliations
                [a ]Faculty of Pharmacy, Universiti Teknologi MARA (UiTM), Puncak Alam
                [b ]Collaborative Drug Discovery Research (CDDR) Group, Pharmaceutical and Life Sciences CoRe, UiTM, Shah Alam, Selangor
                [c ]Environmetal Health Department, Faculty of Health Sciences, UiTM, Bertam, Penang
                [d ]Vector-Borne Diseases Research Group (VERDI), Pharmaceutical and Life Sciences CoRe, UiTM, Shah Alam, Selangor
                [e ]Medical Laboratory Department, Faculty of Health Sciences, UiTM, Puncak Alam, Johor
                [f ]Faculty of Medicine, UiTM, Puncak Alam, Selangor
                [g ]School of Pharmacy, KPJ Healthcare University College, Nilai, Negeri Sembilan, Malaysia.
                Author notes
                []Correspondence: Long Chiau Ming, School of Pharmacy, KPJ Healthcare University College, Nilai, Negeri Sembilan, Malaysia, Lot PT 17010 Persiaran Seriemas, Kota Seriemas, 71800 Nilai, Negeri Sembilan, Malaysia (e-mail: longchiauming@ 123456gmail.com ).
                Article
                MD-D-17-03146 07511
                10.1097/MD.0000000000007511
                5627821
                28746195
                7d6f73c6-b9b1-4c58-a64f-c3bb3c4ad1f7
                Copyright © 2017 the Author(s). Published by Wolters Kluwer Health, Inc.

                This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0

                History
                : 15 June 2017
                : 23 June 2017
                Categories
                3800
                Research Article
                Study Protocol Clinical Trial
                Custom metadata
                TRUE

                complementary therapies,ethnomedicine,folk medicine,immune system diseases,otorhinolaryngologic diseases,respiratory hypersensitivity,traditional medicine

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