Dataset Information

Efficacy and safety of electric heating moxibustion for perennial allergic rhinitis: protocol for a randomized controlled trial.

ABSTRACT:

Background

Allergic rhinitis (AR) is an IgE-mediated disease that adversely affects quality of life. Many studies report that moxibustion is an effective treatment for perennial allergic rhinitis (PAR). However, it is difficult to perform moxibustion on the face because of possible burning of the skin and the noxious effects of smoke. Electric heating moxibustion does not have these limitations. The purpose of this clinical trial is to assess the possibility of treating PAR with electric heating moxibustion and to assess the feasibility of conducting a clinical test on a larger scale.

Methods

This is a randomized, open-label, assessor-blind, parallel-design pilot clinical study. We will recruit 40 eligible participants and randomly allocate them into an electric heating moxibustion group or an acupuncture group at a 1:1 ratio. Patients in both groups will receive eight treatments over 4 weeks, and the final follow-up will be 4 weeks after the last treatment. Eleven acupuncture points will be used for patients in both groups (EX-HN3 and bilateral EX-HN-8, LI20, LI4, GB20, and ST36). The primary outcome measure is change in the Total Nasal Symptom Score, and the secondary outcome measures are changes in the Rhinoconjunctivitis Quality of Life Questionnaire, nasal endoscopy index for pattern identification, pattern identification questionnaire for AR, total IgE, eosinophil count, and adverse effects.

Discussion

This clinical trial will examine the effect of electric heating moxibustion on PAR.

Trial registration

ClinicalTrials.gov, NCT03342105 . Registered on 14 November 2017.

SUBMITTER: Jung CY

PROVIDER: S-EPMC6642592 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy and safety of electric heating moxibustion for perennial allergic rhinitis: protocol for a randomized controlled trial.

Jung Chan-Yung CY Cho Min-Jin MJ Kang Ha-Ra HR Hong Seung-Ug SU Sung Won-Suk WS Kim Eun-Jung EJ

Trials 20190719 1

<h4>Background</h4>Allergic rhinitis (AR) is an IgE-mediated disease that adversely affects quality of life. Many studies report that moxibustion is an effective treatment for perennial allergic rhinitis (PAR). However, it is difficult to perform moxibustion on the face because of possible burning of the skin and the noxious effects of smoke. Electric heating moxibustion does not have these limitations. The purpose of this clinical trial is to assess the possibility of treating PAR with electric ...[more]

PMID: 31324214

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Project description:BackgroundMany studies have shown the potential therapeutic effect of acupuncture on allergic rhinitis. Most of these studies were limited by low-quality evidence. Preliminary experiments showed that the use of acupuncture at three nasal acupoints plus acupoint application (AAP) achieves a more persistent effect in the treatment of perennial allergic rhinitis than acupuncture alone. In this study, a multicenter, single-blind, randomized controlled trial will be performed, in which acupuncture at nonmeridian acupoints and sham AAP will be used as the control group to evaluate the effect of AAP through long-term observation.MethodsThe trial is designed on the basis of the Consolidated Standards of Reporting Trials 2010 guidelines and Standards for Reporting Interventions in Controlled Trials of Acupuncture. A total of 120 participants with perennial allergic rhinitis will be randomly assigned to a treatment or control group. A specially appointed investigator will be in charge of randomization. The participants in the treatment group will be treated with acupuncture at EX-HN3, LI20, and EX-HN8 thrice per week for a total of 12 sessions. In addition, they will undergo AAP at DU14, BL13, EX-BI, and RN22. The participants in the control group will be treated with sham AAP. The primary outcome will be the change in the Total Nasal Symptom Score from baseline to the completion of 4-week treatment. Secondary outcomes include changes in visual analog scale and total non-nasal symptom scores from baseline to the second and fourth weeks of treatment, as well as 1, 3, and 6 months after the completion of treatment. Peripheral blood IL-4, IL-5, IL-6, IL-8, and IL-10 levels will be measured, and any side effects related to treatment will be observed and recorded.DiscussionIt is expected that this randomized clinical trial will provide evidence to determine the effects of AAP compared with acupuncture at nonmeridian acupoints and sham AAP, particularly the long-term effect. These findings will help improve the clinical application of this technique.Trial registrationAcupuncture-Moxibustion Clinical Trial Registry AMCTR-ICR-18000179. Registered on 12 April 2018.

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:IntroductionAllergic rhinitis is a global health problem that can potentially be managed through acupressure. Our clinical observations have identified Allergic Rhinitis Acupressure Therapeutic (ARAT) as a novel acupressure treatment acting on specific acupoints, which may enhance the effectiveness of acupressure. Therefore, we propose a three-arm randomized controlled trial will be conducted to investigate the efficacy and safety of ARAT for perennial allergic rhinitis (PAR).Methods/designIn this trial, eligible 111 participants diagnosed with PAR will be randomly assigned to one of three groups: the ARAT group, the non-specific acupoints group, or the blank control group. The primary outcome will be the change in the total nasal symptom score, and the secondary outcomes will include: 1) changes in the scores of the standard version of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQs); 2) acoustic rhinometry and anterior rhinomanometry; 3) changes in the scores of relief medication usage; 4) incidence of adverse events. Additionally, we will measure and compare the changes in cytokine levels (IL-5, IL-13, IFN-γ, and TSLP) in nasal secretions. The RQLQs and primary outcomes will be assessed at the beginning, middle, and end stages of the treatment period, with monthly follow-ups conducted over a total of three months. The secondary outcomes and biomarkers in nasal secretions will be measured at the beginning and end of the treatment period. Any adverse events or need for rescue medication will be carefully noted and recorded.DiscussionThis study may produce a new acupressure treatment prescription that is easy to learn, more targeted, and adaptable. This trial represents the first clinical investigation comparing ARAT treatment for PAR with the non-specific acupoints group and blank control group. Our data is expected to provide evidence demonstrating the safety and efficacy of ARAT for PAR patients, while also exploring the functional mechanism underlying ARAT treatment, moreover, the results offer valuable insights for healthcare professionals in managing PAR symptoms.Trial registrationChinese Clinical Trial Registry, ChiCTR2300072292. Registered on June 08, 2023.

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).

Dataset Information

Efficacy and safety of electric heating moxibustion for perennial allergic rhinitis: protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Efficacy and safety of electric heating moxibustion for perennial allergic rhinitis: protocol for a randomized controlled trial.

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