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Tian Jiu therapy for allergic rhinitis: study protocol for a randomized controlled trial.

ABSTRACT: Allergic rhinitis (AR) is one of the most common allergic diseases. The conventional treatments of allergic rhinitis are oral anti-histamines, the use of intranasal corticosteroids, and immunotherapy. Dissatisfied with the ineffectiveness and side effects of these treatments, substantial numbers of patients are turning to alternative treatments like Chinese herbal medicine, particularly Tian Jiu (TJ). TJ is a form of moxibustion in which herbal patches are applied to specific acupoints on the skin. This study aims to investigate the efficacy and safety of TJ in the treatment of allergic rhinitis.This will be a prospective, randomized, single-blinded, controlled trial in patients with AR. After a 1-week run-in period, eligible subjects will be randomly assigned to the TJ group, placebo-control group or waitlist-control group. The TJ and placebo-control groups will undergo a 4-week treatment with one session per week and one 4-week post-treatment follow-up. Participants in the waitlist-control group will not receive any treatment during the first 4 weeks but will be required to be assessed. The primary outcome will be the change in the weekly average of the Total Nasal Symptom Score recorded from baseline to the end of treatment. The secondary outcomes will be change in symptoms and change in need for medication between baseline and the end of treatment by using the Rhinitis Quality of Life Questionnaire. Rescue medication (RM) needs will be measured using an RM score, comprising the weekly sum of daily assessments and any form of systemic steroids for allergic rhinitis.This study will be the first study to compare TJ treatment for allergic rhinitis with a placebo-control group, and a waitlist-control group. The investigation of TJ for allergic rhinitis will also suggest recommendations for clinical practice. The results of this study are expected to provide consolidated evidence for the effectiveness and safety of TJ for the treatment of patients with allergic rhinitis.NCT02470845 (17 May 2015).

SUBMITTER: Kun W

PROVIDER: S-EPMC4869399 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Tian Jiu therapy for allergic rhinitis: study protocol for a randomized controlled trial.

Kun Wai W Zhong Linda L D LL Dai Liang L Cheng Chung-Wah CW Lu Ai-Ping AP Bian Zhao-Xiang ZX

Trials 20160517 1

<h4>Background</h4>Allergic rhinitis (AR) is one of the most common allergic diseases. The conventional treatments of allergic rhinitis are oral anti-histamines, the use of intranasal corticosteroids, and immunotherapy. Dissatisfied with the ineffectiveness and side effects of these treatments, substantial numbers of patients are turning to alternative treatments like Chinese herbal medicine, particularly Tian Jiu (TJ). TJ is a form of moxibustion in which herbal patches are applied to specific ...[more]

PMID: 27189087

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Project description:BackgroundAllergic rhinitis (AR) is an IgE-mediated inflammatory disease. Current conventional therapies for AR are unsatisfactory. Acupuncture has been recommended as an optional treatment for AR patients who are interested in non-pharmacotherapy in the new clinical practice guidelines for AR. Acupressure is a sub-type of acupuncture which is non-invasive with a low risk and can be self-administered. However, the current limited evidence is compromised by the high risk of bias and heterogeneity of methodology. Therefore, rigorously designed randomized controlled trials (RCTs) are needed. This proposed RCT aims to evaluate the efficacy and safety of self-administered acupressure for the management of AR.Methods/designWe have designed a randomized, single-blind, non-specific controlled, two-arm, parallel clinical trial involving a 2-week run-in period, a 4-week intervention period and an 8-week follow-up period. The eligible participants will be randomized into either a specific or a non-specific acupressure group. They will be required to perform self-administered acupressure on either five specific acupressure points or five non-specific acupressure points, 1 min for each point, twice a day for 4 weeks. Participants will be asked to complete self-administered questionnaires for outcome measures including a 7-point scale of symptom severity, the Rhinoconjunctivitis Quality of Life Questionnaire with Standardized Activities (RQLQs), relief medication scores, adverse events and participants' opinion of this study at the different assessment points throughout the trial period. Data will be analyzed by the chi-square or t test using Statistical Package for Social Science (SPSS) software.DiscussionThe findings from this study should provide scientific evidence for the efficacy and safety of self-administered acupressure for the management of AR. This study may assist the development of a non-cost, non-invasive self-management method for AR sufferers.Trial registrationAustralian and New Zealand Clinical Trials Registry (ANZCTR), ID: ACTRN12617001106325 Registered on 28 July 2017.

Project description:The traditional Chinese theory of acupuncture emphasizes that the intensity of acupuncture must reach a threshold to generate de qi (a specific and compound sensation during the acupuncture), which is necessary to achieve the best therapeutic effect. However, the notion that de qi must be achieved for maximum benefit has not been confirmed by modern scientific evidence. This study aims to compare the efficacy of acupuncture with either strong (intended to elicit de qi) or weak stimulation among patients with allergic rhinitis.This study compares real versus sham acupuncture in 140 patients with a history of persistent allergic rhinitis (PER) or intermittent allergic rhinitis (IAR) and with a positive skin prick test (SPT). The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine (China). In the study, patients will be randomly assigned into two groups by computer-generated randomization and assessed prior to treatment. They will then receive 12 sessions of treatments for 4 consecutive weeks and have a follow-up phase lasting 12 weeks. The main outcome measures include the primary and secondary indicators. Primary indicators are subjective symptoms scores as evaluated by visual analogue scales (VAS), rhinoconjunctivitis quality of life questionnaires (RQLQ), and the Modified Massachusetts General Hospital acupuncture sensation scale, Chinese version (C-MMASS). The secondary indicators are the results of laboratory examinations, such as serum allergen-specific immunoglobulin E (sIgE) nasal inflammatory cells counts (mast cells, eosinophils, and T cells), and nitric oxide concentration in nasal excretion. The use of anti-allergic medication will also be recorded as one of the secondary indicators. Furthermore, adverse events will be recorded and analyzed. Intention-to-treat analysis (ITT) and per-protocol (PP) analysis will be performed to test and verify the results in this trial.The results of this trial will demonstrate the efficacy of using acupuncture to treat allergic rhinitis and verify whether the effectiveness of acupuncture is related to the needle sensation de qi.Chinese Clinical Trial Registry: ChiCTR-TRC-13003594 (registered on 16 August 2013, and the first patient was randomized on 27 September 2013).

Project description:BackgroundMany previous studies have shown the potential therapeutic effect of acupuncture for allergic rhinitis. Most of these studies, however, were limited by the short duration of observations and lack of sham acupuncture as the control group. Our preliminary experiments showed that the use of a warm needling achieved a much more persistent effect in the treatment of allergic rhinitis (AR) compared with simple acupuncture therapy. Hence, we have designed a multicenter, randomized controlled trial (RCT) in which the first-line medication loratadine will be used as the control group, and the effect of warm needling therapy will be evaluated through long-term observation.Methods/designThe trial is designed as a multicenter, parallel-group, randomized, single-blinded (outcome assessors), non-inferiority trial. A total of 98 patients with persistent AR will be randomly assigned into two groups. Patients in the treatment group will be treated with warm needling at GV14 and acupuncture at EX-HN3, ST2, LI20, EX-HN8, GV23, LU7, LU5 and LI4 three times a week, for a total of 4 weeks. Patients in the control group will be treated with oral loratadine 10 mg/day for 4 weeks. The primary outcome will be the change in the Total Nasal Symptom Score (TNSS) from baseline to that at 6 months after treatment during the follow-up period. The secondary outcomes will include the Total Non-nasal Symptom Score and the Rhinoconjunctivitis Quality of Life Questionnaire, changes in the TNSS from baseline to that at 2 and 4 weeks during treatment, and 3 months after treatment during the follow-up period. Outcomes will be measured at 2 and 4 weeks, and 3 and 6 months after treatment. Any side effects of treatment will be observed and recorded.DiscussionWe expect that the study results will provide evidence to determine the effects of warm needling compared with loratadine. Our final goal of the study is to evaluate the difference in the short-term and long-term effects between the two therapeutic methods, especially the long-term effect of warm needling.Trial registrationClinicalTrials.gov NCT02339714 . Registered on 14 January 2015.

Project description:BackgroundAllergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose, and sneezing. The symptoms of allergic rhinitis may significantly affect a patient's quality of life and can be associated with conditions such as fatigue, headache, cognitive impairment, and sleep disturbances. Various complementary and alternative medicine treatments have been used for this condition in clinical practice. The Ayurveda system of medicine is the most common complementary medicine system practiced in Sri Lanka. The aim of this study is to examine the efficacy and safety of a decoction used in traditional Ayurveda for allergic rhinitis and its ready- to-use freeze dried formulation in comparison to an antihistamine over a period of 4 weeks on relief of symptoms in allergic rhinitis.Study designThis is a three-arm, open-label, non-inferiority, randomized controlled clinical trial enrolling patients with AR. Tamalakyadi decoction containing 12 ingredients (TMD12), used in traditional Ayurveda and its freeze-dried formulation are the test products. The efficacy and safety of the two Ayurvedic dosage forms will be tested against the antihistamine loratadine. Patients with symptoms of AR will be allocated randomly into the three arms after a 1-week run-in period and the medications will be given orally for 28 days. Total Nasal symptom Score (TNSS) of the patients will be used as the primary efficacy endpoint. TNSS will be recorded and compared between the three arms prior to visit 1, at the end of 28 days, and end of the first and second months of follow-up. Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and health-related quality of life questionnaire are used as secondary end points.DiscussionThis clinical trial will be able to provide evidence-based scientific data on Ayurvedic dosage form, TMD12, and the freeze-dried formulation in the treatment of allergic rhinitis. This trial is expected to develop capacity to scientifically evaluate various Ayurvedic treatments that are claimed to have efficacy in treatment of various disease conditions.Trial registrationISRCTN18149439 (6 May 2019).

Project description:BackgroundIntranasal corticosteroids are the most efficacious anti-inflammatory medications for allergic rhinitis (AR). However, the efficacy and safety of intranasal corticosteroids in children have not yet been subject to specific research in China. The aim of this study was to investigate the efficacy and safety of fluticasone furoate nasal spray (FFNS) in a Chinese pediatric population.MethodsIn this phase 4 randomized, double-blind, placebo-controlled, multicenter study, pediatric AR patients aged 2-12 years were randomized 1:1:1, receiving either FFNS 55 µg or 110 µg or placebo. Electronic diary cards were completed to record symptoms, rescue medication use, and treatment compliance. Anterior rhinoscopy and overall response to therapy were evaluated and recorded.ResultsPatients treated with FFNS at either dose experienced a significantly greater reduction in daily reflective total nasal symptom score compared with placebo. This was maintained in a younger subset of patients (2-6 years). Drug-related adverse events occurred in <20% of patients in all groups. FFNS was well tolerated at both doses.ConclusionsThis study demonstrates favorable efficacy and safety profiles for FFNS 55 µg or 110 µg in Chinese pediatric populations (2-12 years), supporting its use in clinical treatment for AR children, including younger children aged 2-6 years.ImpactThe aim of this study was to investigate the efficacy and safety of intranasal fluticasone furoate in Chinese pediatric allergic rhinitis. This research not only addresses the deficiency in efficacy and safety data for intranasal corticosteroids in very young patients (aged 2-6 years) worldwide but also demonstrates that fluticasone furoate nasal spray shows a favorable benefit/risk profile at different dose levels. Our data will be of interest to the broad readership of Pediatric Research and will positively contribute to the dialog regarding the treatment of allergic rhinitis in children aged 2-6 years.

Project description:BackgroundPlacebos can reduce physical symptoms even when provided with full honesty and disclosure. Yet, the precise mechanisms underlying the effects of "open-label placebos" (OLPs) have remained subject of debate. Furthermore, it is unclear whether OLPs are similarly effective when provided remotely, as is sometimes required e.g. in the current COVID-19 pandemic.MethodsIn a randomized-controlled trial, we examined the effects of OLP plus treatment as usual (TAU) compared to TAU alone on symptom reduction in people with allergic rhinitis (N = 54) over the course of two weeks. Due to the COVID-19 pandemic, OLP was provided remotely (i.e. sent via postal service). To investigate the potential influence of the clinical encounter on the effects of OLP, we manipulated the perception of the virtual clinical encounter, both with respect to verbal and nonverbal factors (augmented vs. limited encounter).ResultsThe results of the manipulation check confirmed that the augmented clinical encounter was evaluated more positively than the limited encounter, in terms of perceived warmth of the provider. Participants from all treatment groups showed significant symptom reduction from baseline to two weeks later, but OLP had no incremental effect over TAU. Participants benefitted more from OLP when they did not take any other medication against allergic symptoms than when taking medication on demand. When controlling for baseline symptoms, a significant treatment by encounter interaction was found, pointing to greater symptom improvement in the OLP group when the encounter was augmented, whereas the control group improved more when the encounter was limited.DiscussionThe study demonstrates that providing OLP and enhancing the encounter remotely is possible, but their effectiveness might be lower in comparison to previous studies relying on physical patient-provider interaction. The study raises questions for future research about the potential and challenges of remote placebo studies and virtual clinical encounters. The study has been registered as a clinical trial at ISRCTN (record number: 39018).

Project description:BackgroundAcupuncture has shown beneficial effects for seasonal allergic rhinitis (SAR); however, it is time and cost intensive. We investigated feasibility and effects of self-administered body acupressure as a self-care technique that stimulates acupuncture points with manual pressure in SAR patients.MethodsWe conducted a two-armed randomized controlled exploratory trial to compare effects of self-administered acupressure over 4 weeks at five acupuncture points plus rescue medication (RM) with cetirizine compared to RM alone in SAR patients. Among other outcome parameters, we assessed disease-related quality of life (Rhinitis Quality of Life Questionnaire [RQLQ]), overall SAR symptoms by a visual analogue scale (VAS) and a rescue medication score (RMS) after 4 and 8 weeks.ResultsForty-one SAR patients (mean age 38.5 ± 10.0 years, n = 21, 51.2% women) were randomized. Compared to RM alone (n = 21), acupressure plus RM (n = 20) was associated with relevant improvements after 4 weeks, shown by the difference between groups in adjusted means of RQLQ: - 0.9 points (95% CI - 1.6 to - 0.2; p = 0.011) and VAS overall SAR symptoms: - 21.6 mm (95% CI - 36.3 to - 6.8; p = 0.005). The RMS was lower in the acupressure group than in the control group: 1.9 points (95% CI - 3.8 to - 0.1; p = 0.120). Group differences decreased slightly until week 8. The acupressure was feasible and safe.ConclusionResults of this exploratory study indicate that self-applied acupressure is feasible, may improve disease-specific quality of life and reduce disease-related symptoms as well as anti-allergic medication intake in SAR patients. High-quality confirmatory studies including a sham-control group are needed in the future. Trial registration DRKS-ID: DRKS00014310. Date of registration in DRKS: 2018/04/24. Investigator sponsored/initiated trial (IST/IIT): yes. Ethics approval/approval of the ethics committee: Approved (leading) Ethics Committee No. EA1/033/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin. URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014310.

Dataset Information

Tian Jiu therapy for allergic rhinitis: study protocol for a randomized controlled trial.

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Tian Jiu therapy for allergic rhinitis: study protocol for a randomized controlled trial.

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