scholarly journals Self-administered acupressure for allergic rhinitis: Study protocol for a randomized, single blind, non-specific controlled, parallel trial

2019 ◽  
Author(s):  
Yaqun Liang ◽  
George Binh Lenon ◽  
Angela Wei Hong Yang

Abstract Background Allergic 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/design We 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 specific or non-specific acupressure group. They will be required to perform self-administered acupressure on either 5 specific acupressure points or 5 non-specific acupressure points, one minute for each point, twice a day for 4 weeks. Participants will be asked to complete self-administered questionnaires for outcome measures including 7-point scale of symptom severity, 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 chi-square or t-test using Statistical Package for Social Science (SPSS) software. Discussion The findings from this study will provide scientific evidence for the efficacy and safety of self-administered acupressure for the management of AR. This study may assist to develop a non-cost, non-invasive self-management method for AR sufferers.

2019 ◽  
Author(s):  
Yaqun Liang ◽  
George Binh Lenon ◽  
Angela Wei Hong Yang

Abstract Background Allergic 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/design We 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 specific or non-specific acupressure group. They will be required to perform self-administered acupressure on either 5 specific acupressure points or 5 non-specific acupressure points, one minute for each point, twice a day for 4 weeks. Participants will be asked to complete self-administered questionnaires for outcome measures including 7-point scale of symptom severity, 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 chi-square or t-test using Statistical Package for Social Science (SPSS) software. Discussion The findings from this study will provide scientific evidence for the efficacy and safety of self-administered acupressure for the management of AR. This study may assist to develop a non-cost, non-invasive self-management method for AR sufferers.


2018 ◽  
Author(s):  
Yaqun Liang ◽  
George Binh Lenon ◽  
Angela Wei Hong Yang

Abstract Background: Allergic 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/design: We 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 specific or non-specific acupressure group. They will be required to perform self-administered acupressure on either 5 specific acupressure points or 5 non-specific acupressure points, one minute for each point, twice a day for 4 weeks. Participants will be asked to complete self-administered questionnaires for outcome measures including 7-point scale of symptom severity, 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 chi-square, t-test or ANOVA using Statistical Package for Social Science (SPSS) software. Discussion: The findings from this study will provide scientific evidence for the efficacy and safety of self-administered acupressure for the management of AR. This study may assist to develop a non-cost, non-invasive self-management method for AR sufferers. Trial registration: Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12617001106325 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373370). Registered on 28 July 2017. Keywords: Hay fever; allergic disease; acupuncture; self-massage; evidence-based Chinese medicine.


2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Min-Hee Kim ◽  
Jaewoong Son ◽  
Hae Jeong Nam ◽  
Seong-Gyu Ko ◽  
Inhwa Choi

Hyeonggaeyeongyo-tang (HYT) is an ancient formula of oriental medicine traditionally used to treat rhinitis; however, clinical evidence has not yet been established. The aim of this study was to investigate the short-term and long-term efficacy and safety of HYT for chronic rhinitis. Adult subjects with chronic rhinitis symptoms were recruited. The subjects received HYT for 4 weeks and had follow-up period of 8 weeks. Any medicines used to treat nasal symptoms were not permitted during the study. The skin prick test was performed to distinguish the subjects with allergic rhinitis from those with nonallergic rhinitis. After treatment, the total nasal symptoms score and the Rhinoconjunctivitis Quality of Life Questionnaire score significantly improved in the whole subject group, in the allergic rhinitis group, and in the nonallergic rhinitis group, with no adverse events. This improvement lasted during a follow-up period of 8 weeks. Total IgE and eosinophil levels showed no significant difference after treatment in the allergic rhinitis group. HYT improved nasal symptoms and quality of life in patients with allergic rhinitis and nonallergic rhinitis. This is the first clinical study to evaluate the use of HYT to treat patients with rhinitis. This trial has been registered with the ClinicalTrials.gov IdentifierNCT02477293.


Author(s):  
Monika Bansal ◽  
Komaldeep Kaur ◽  
Aditi Gupta ◽  
Deepak Goyal ◽  
Nidhi Girdhar ◽  
...  

Allergic rhinitis (AR) is a chronic allergen specific, IgE-mediated hypersensitivity disorder which significantly impairs the quality of life in affected patients. Many aeroallergens and molds are responsible for AR. This study was  conducted to find prevalence of Aspergillus fumigatus skin hypersensitivity in patients of AR by skin prick test (SPT).  150 clinically diagnosed AR patients visiting our OPD were enrolled. Skin hypersensitivity for Aspergillus f. was done by SPT in all the enrolled patients. Chi square test and Student’s t-test were applied for statistical analysis. Out of 150 patients, 60 (40%) were positive for Aspergillus fumigatus SPT. Majority of the positive patients had persistent AR and among those 39/60 (65%) had moderate to severe persistent AR and 12/60 (20%) had mild persistent AR.  Our study concluded that there is high (40%) prevalence of Aspergillus f. skin hypersensitivity among AR patients. The hypersensitivity to Aspergillus f. was found more in severe AR patients and it was statistically significant.


2018 ◽  
Vol 32 (3) ◽  
pp. 139-146 ◽  
Author(s):  
Jingang Ai ◽  
Zuozhong Xie ◽  
Xiang Qing ◽  
Wei Li ◽  
Honghui Liu ◽  
...  

Background The prevalence of both allergic rhinitis and bronchial asthma is high throughout the world; their mutual influence on each other has been documented in many studies. However, studies regarding surgical intervention are limited. Objective To evaluate the clinical significance of endoscopic vidian neurectomy on bronchial asthma outcomes in patients with coexisting refractory allergic rhinitis and asthma. Methods A total of 109 patients with moderate to severe persistent intractable allergic rhinitis and mild/moderate asthma were allocated to the bilateral endoscopic vidian neurectomy group (group 1) or conservative medication group (group 2) according to the patients’ self-selection. The Rhinoconjunctivitis Quality of Life Questionnaire, Visual Analog Scale, Asthma Quality of Life Questionnaire, Total Asthma Symptom Score, and medication scores were evaluated at six months, one year, and three years after undergoing the initial treatments. Multivariate analysis was performed to determine which triggers of asthma attacks were associated with improved asthma outcomes in patients. Results Ninety-five patients were followed up for at least three years. Postoperative scores of Rhinoconjunctivitis Quality of Life Questionnaire and Visual Analog Scale were significantly lower than preoperative scores during follow-up in group 1 and were significantly lower than those of group 2. Postoperative scores of Asthma Quality of Life Questionnaire at the three follow-up time points were higher than the preoperative scores in group 1. The Total Asthma Symptom Score was not significantly decreased in group 1. The medication scores for allergic rhinitis and asthma were gradually reduced after surgery. At the end of the follow-up, the improvement rates for allergic rhinitis and asthma were 90.6% and 45.3%, respectively. Asthma outcomes were significantly improved by controlling rhinitis symptoms in patients whose asthma attacks were induced by “rhinitis onset” or “weather change.” Conclusion Controlling allergic rhinitis symptoms by bilateral endoscopic vidian neurectomy can significantly improve asthma outcomes in patients whose asthma attacks are induced by rhinitis onset and/or cold air.


2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
Xiankun Chen ◽  
Chuanjian Lu ◽  
Cecilia Stålsby-Lundborg ◽  
Yunying Li ◽  
Xiaoyan Li ◽  
...  

Background. The Sanfu herbal patch (SHP) has been widely used to treat allergic rhinitis (AR) in China. SHP has been reported to be effective for managing the symptoms of AR, but the evidence suffers from methodological limitations. Therefore, we designed a three-armed, randomized, and placebo-controlled trial to evaluate the efficacy and safety of SHP for persistent allergic rhinitis (PAR).Methods. The trial consists of 5 treatment sessions along with a one-year follow-up. This process is then repeated in the second and third years. Eligible participants diagnosed with PAR were randomized at a ratio of 2 : 2 : 1 into one of three groups: (a) SHP group; (b) placebo group; or (c) waiting-list group. The waiting-list group will receive no treatment in the first year but will receive SHP in the following two years. The primary outcome, total nasal symptoms score, is self-assessed at the beginning of each treatment session and during each annual follow-up. Secondary outcomes include the Rhinoconjunctivitis Quality-of-Life Questionnaire, allergic rhinitis attacks, and relief medications. The trial will be stopped if early termination criteria are met during the interim analysis.Ethics. This protocol has been approved by site ethics committee (number B2014-014-01) and is registered with ClinicalTrials.govNCT02192645.


2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
K. P. K. R. Karunagoda ◽  
P. K. Perera ◽  
H. Senanayake ◽  
S. De Silva Weliange

This study aims to assess the efficacy and safety of two Ayurveda drug regimens for the treatment of uterine fibroids (UF) in a randomized single-blind clinical trial. 120 participants with UF (volume ≥ 2 cm3) were randomly allocated at a 1 : 1 : 1 ratio to 2 experimental groups and the control group. The 12-week intervention period was followed by 12-week follow-up. The primary efficacy endpoint was the change of the largest UF volume. The secondary efficacy endpoints were assessed by the pictorial bleeding assessment score (PBAC), UF symptoms, and quality of life score. The safety endpoints were changed in hepatic and renal safety parameters and patients experiencing adverse effects. Significant decrease was observed in the volume of UF in the arm II but not in arm I, while a significant increase was observed in the volume of the largest UF in the control group at 12th week. The PBAC score remained stable in all groups. Further mean value of the intervention arms symptom severity subscale (SSS) was significantly reduced compared to the control arm. Health-related quality of life (HRQL) value improved in 12th week of both experimental arms compared to baseline. Control arm HRQL value was reduced compared to baseline. The volume of the largest UF and both SSS and HRQL values remained stable within the follow-up period in the tested arms. The findings of this study demonstrated the safety and efficacy of selected two Ayurveda drug regimens in reducing the volume of UF and related symptoms and improving quality of life.


VASA ◽  
2010 ◽  
Vol 39 (2) ◽  
pp. 169-174 ◽  
Author(s):  
Reich-Schupke ◽  
Weyer ◽  
Altmeyer ◽  
Stücker

Background: Although foam sclerotherapy of varicose tributaries is common in daily practice, scientific evidence for the optimal sclerosant-concentration and session-frequency is still low. This study aimed to increase the knowledge on foam sclerotherapy of varicose tributaries and to evaluate the efficacy and safety of foam sclerotherapy with 0.5 % polidocanol in tributaries with 3-6 mm in diameter. Patients and methods: Analysis of 110 legs in 76 patients. Injections were given every second or third day. A maximum of 1 injection / leg and a volume of 2ml / injection were administered per session. Controls were performed approximately 6 months and 12 months after the start of therapy. Results: 110 legs (CEAP C2-C4) were followed up for a period of 14.2 ± 4.2 months. Reflux was eliminated after 3.4 ± 2.7 injections per leg. Insufficient tributaries were detected in 23.2 % after 6.2 ± 0.9 months and in 48.2 % after 14.2 ± 4.2 months, respectively. Only 30.9 % (34 / 110) of the legs required additional therapy. In 6.4 % vein surgery was performed, in 24.5 % similar sclerotherapy was repeated. Significantly fewer sclerotherapy-sessions were required compared to the initial treatment (mean: 2.3 ± 1.4, p = 0.0054). During the whole study period thrombophlebitis (8.2 %), hyperpigmentation (14.5 %), induration in the treated region (9.1 %), pain in the treated leg (7.3 %) and migraine (0.9 %) occurred. One patient with a history of thrombosis developed thrombosis of a muscle vein (0.9 %). After one year there were just hyperpigmentation (8.2 %) and induration (1.8 %) left. No severe adverse effect occurred. Conclusions: Foam sclerotherapy with injections of 0.5 % polidocanol every 2nd or 3rd day, is a safe procedure for varicose tributaries. The evaluation of efficacy is difficult, as it can hardly be said whether the detected tributaries in the controls are recurrent veins or have recently developed in the follow-up period. The low number of retreated legs indicates a high efficacy and satisfaction of the patients.


Crisis ◽  
2003 ◽  
Vol 24 (2) ◽  
pp. 73-78 ◽  
Author(s):  
Yves Sarfati ◽  
Blandine Bouchaud ◽  
Marie-Christine Hardy-Baylé

Summary: The cathartic effect of suicide is traditionally defined as the existence of a rapid, significant, and spontaneous decrease in the depressive symptoms of suicide attempters after the act. This study was designed to investigate short-term variations, following a suicide attempt by self-poisoning, of a number of other variables identified as suicidal risk factors: hopelessness, impulsivity, personality traits, and quality of life. Patients hospitalized less than 24 hours after a deliberate (moderate) overdose were presented with the Montgomery-Asberg Depression and Impulsivity Rating Scales, Hopelessness scale, MMPI and World Health Organization's Quality of Life questionnaire (abbreviated versions). They were also asked to complete the same scales and questionnaires 8 days after discharge. The study involved 39 patients, the average interval between initial and follow-up assessment being 13.5 days. All the scores improved significantly, with the exception of quality of life and three out of the eight personality traits. This finding emphasizes the fact that improvement is not limited to depressive symptoms and enables us to identify the relative importance of each studied variable as a risk factor for attempted suicide. The limitations of the study are discussed as well as in particular the nongeneralizability of the sample and setting.


2021 ◽  
Author(s):  
Yi-chen Lee ◽  
Yi-chun Li ◽  
KEH-CHUNG LIN ◽  
Chia-ling Chen ◽  
Yi-hsuan Wu ◽  
...  

Abstract BackgroundThe sequence of establishing proximal stability or function before facilitation of the distal body part has long been recognized in stroke rehabilitation practice but lacks scientific evidence. This study plans to examine the effects of proximal priority robotic priming and impairment-oriented training (PRI) and distal priority robotic priming and impairment-oriented training (DRI). MethodsThis single-blind, randomized, comparative efficacy study will involve 40 participants with chronic stroke. Participants will be randomized into PRI or DRI groups and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the chi-square automatic interaction detector method will be used to examine the comparative efficacy and predictors of outcome, respectively, after PRI and DRI. DiscussionThrough manipulating the sequence of applying wrist and forearm robots in therapy, this study will attempt to examine empirically the priming effect of proximal or distal priority robotic therapy in upper extremity impairment-oriented training for people with stroke. The findings will provide directions for further studies and empirical implications for clinical practice in upper extremity rehabilitation after stroke.Trial RegistrationThis trial was registered on June 23, 2020, at www.clinicaltrials.gov (NCT04446273).


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