scholarly journals Efficacy and Safety of Sanfu Herbal Patch at Acupoints for Persistent Allergic Rhinitis: Study Protocol for a Randomized Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
Xiankun Chen ◽  
Chuanjian Lu ◽  
Cecilia Stålsby-Lundborg ◽  
Yunying Li ◽  
Xiaoyan Li ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Controlled Trial ◽  
Treatment Session ◽  
Waiting List ◽  
Life Questionnaire ◽  
Efficacy And Safety ◽  
Persistent Allergic Rhinitis ◽  
One Year ◽  
Group B

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.

Efficacy and safety of laser therapy on axillary hyperhidrosis after one year follow-up: A randomized blinded controlled trial

2015 ◽  
Vol 47 (2) ◽  
pp. 173-179 ◽  
Author(s):  
Franck Marie Leclère ◽  
Javier Moreno-Moraga ◽  
Justo M. Alcolea ◽  
Peter M. Vogt ◽  
Josefina Royo ◽  
...  
Keyword(s):  
Laser Therapy ◽  
Controlled Trial ◽  
Efficacy And Safety ◽  
Axillary Hyperhidrosis ◽  
One Year

scholarly journals Self-administered acupressure for allergic rhinitis: Study protocol for a randomized controlled trial

2018 ◽  
Author(s):  
Yaqun Liang ◽  
George Binh Lenon ◽  
Angela Wei Hong Yang
Keyword(s):  
Allergic Rhinitis ◽  
Controlled Trial ◽  
Scientific Evidence ◽  
Trial Registration ◽  
Life Questionnaire ◽  
Efficacy And Safety ◽  
Non Invasive ◽  
Randomized Controlled ◽  
Ige Mediated ◽  
Clinical Trials Registry

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.

Effectiveness of a WeChat group-based parental intervention in preventing unintentional injuries among children aged 0–3 years in China: A randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Xueqi Ma ◽  
Qi Zhang ◽  
Ruo Jiang ◽  
Jun Lu ◽  
Kaiyue Chen ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Unintentional Injury ◽  
Control Group ◽  
Unintentional Injuries ◽  
Randomized Controlled ◽  
Parental Intervention ◽  
One Year ◽  
Group B

BACKGROUND Unintentional injuries are a major public health problem to children worldwide. With the widespread use of smartphones in China, social networking mobile applications, such as WeChat, are potential ways to implement parent-based interventions. OBJECTIVE This study aimed to evaluate the effectiveness of WeChat group-based parental intervention programs in preventing unintentional injuries in children aged 0–3 years in China. METHODS We conducted a randomized controlled trial from March 2019 to March 2020. A total of 365 parents of children aged 0–3 years in Shanghai were randomly allocated to intervention and control groups, and 276 participants completed the follow-up. We used generalized estimation equations to assess intervention effectiveness at baseline and after one year. Outcome measures included children’s unintentional injury incidences, parents’ knowledge, attitudes, and behaviors. RESULTS During the one year follow-up, unintentional injury incidences increased from 9.00% to 11.70% in the intervention group and from 9.90% to 22.90% in the control group. The changes did not differ between the groups (odds ratio [OR] 0.67, 95% confidence interval [CI] 0.13-3.48). Changes in the parents’ attitudes toward injury attribution (b 0.10, 95% CI 0.09-0.21) and preventability (b 0.16, 95% CI 0.01-0.33) did not differ between the two groups. Changes in parents’ attitudes toward responsibility in the intervention group were greater than those in the control group (b 0.33, 95% CI 0.15, 0.51). Changes in parents' daily supervision behavior in the intervention group was greater than those in the control group (b 0.43, 95% CI 0.02-0.84), and changes in behaviors of preventing specific injuries were significantly different between the groups (b 1.60, 95% CI 1.05-2.16). CONCLUSIONS Although WeChat group-based parental intervention cannot directly reduce the occurrence of children’s unintentional injuries, it can improve parents’ knowledge, attitudes, and behaviors pertaining to prevention of unintentional injuries. CLINICALTRIAL China Clinical Trials Registry ChiCTR1900020753; http://www.chictr.org.cn/index.aspx

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
Keyword(s):  
Allergic Rhinitis ◽  
Scientific Evidence ◽  
Life Questionnaire ◽  
Efficacy And Safety ◽  
Chi Square ◽  
Non Invasive ◽  
Ige Mediated ◽  
Single Blind

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.

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
Keyword(s):  
Allergic Rhinitis ◽  
Scientific Evidence ◽  
Life Questionnaire ◽  
Efficacy And Safety ◽  
Chi Square ◽  
Non Invasive ◽  
Ige Mediated ◽  
Single Blind

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.

scholarly journals Immunotherapy and probiotic treatment for allergic rhinitis in children

2018 ◽  
Vol 58 (6) ◽  
pp. 280-5
Author(s):  
Sumadiono Sumadiono ◽  
Cahya Dewi Satria ◽  
Nurul Mardhiah ◽  
Grace Iva Susanti
Keyword(s):  
Allergic Rhinitis ◽  
Standard Therapy ◽  
Clinical Symptoms ◽  
Therapy Group ◽  
Controlled Trial ◽  
Standard Therapy Group ◽  
Persistent Allergic Rhinitis ◽  
Probiotic Treatment ◽  
Group A ◽  
Group B

Background Allergic rhinitis is a global health problem that is increasing in prevalence. Many kinds of therapy have been tried, such as antihistamines, probiotics, and immunotherapy. Immunotherapy may restore the patient’s normal immunity against the specific allergen, while probiotics may modify the natural course of allergy. Objective To evaluate probiotics and immunotherapy for improving clinical symptoms of allergic rhinitis. Methods This randomized controlled trial (RCT) involved 64 patients, aged 3-18 years, and diagnosed with persistent allergic rhinitis in the Department of Child Health, Sardjito General Hospital from April 2016 until May 2017. Patients were randomly allocated into three therapy groups: group A (standard therapy/cetirizine only), group B (standard and probiotic therapy), and group C (standard therapy and immunotherapy). Clinical symptoms of allergic rhinitis including sneezing, rhinorrhea, and itchy nose, were evaluated for 7 weeks and classified as improved or not improved. The significance of the data was analyzed using proportion test. Results Sixty-four patients completed 7 weeks of therapy, 15 subjects in group A, 26 in group B, and 23 in group C. Group C showed significantly more improvement of sneezing and rhinorrhea compared to both group A (Z=5.71; Z=7.57, respectively) and group B (Z=2.82; Z=6.90, respectively). However, itchy nose was not significantly improved in group C compared to group B (Z=0.50), but was significantly improved in group C compared to group A (Z=10.91). Group B had significant improvement of sneezing, rhinorrhea, and itchy nose compared to group A (Z=3.81, Z=2.86, and Z=10.91, respectively). Conclusion The combined standard-immunotherapy group has significantly superior improvement compared to the combined standard-probiotic group and the standard therapy group, in terms of sneezing and rhinorrhea in children with persistent allergic rhinitis.

scholarly journals Evaluating the efficacy and safety of electro-acupuncture in patients with antipsychotic-related constipation: protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Fang-Ting Yu ◽  
Di-He Long ◽  
Guang-Xia Shi ◽  
Li-Qiong Wang ◽  
Jian-Feng Tu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Rating Scale ◽  
Controlled Trial ◽  
Common Adverse Effect ◽  
Life Questionnaire ◽  
Efficacy And Safety ◽  
Patient Assessment ◽  
Randomized Controlled ◽  
Bowel Movements

Abstract Background Constipation is known as a common adverse effect of antipsychotics. Advice for its management remains inadequate. This study is designed to investigate the efficacy and safety of electro-acupuncture (EA) for antipsychotic-related constipation. Methods This is a single-centric, parallel-group, randomized controlled trial with blinded participants, outcome assessor, and statistician. One hundred twelve participants will be randomly assigned into the EA group or sham acupuncture (SA) group in a 1:1 ratio. The study will last for 22 weeks for each participant, including a 2-week baseline assessment period, an 8-week treatment period, and a follow-up for 12 weeks. The primary outcome is the change of mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1 to 8 from baseline. Secondary outcomes include the change from baseline of mean weekly CSBMs during the follow-up period, mean weekly spontaneous bowel movements (SBMs), overall CSBM response rate, scores on Bristol Stool Form Scale (BSFS), straining level, Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Constipation Quality of life questionnaire (PAC-QOL), and Brief Psychiatric Rating Scale (BPRS). Adverse events and medicine use will be recorded as well. Discussion The study is designed based on a rigorous methodology to evaluate the efficacy and safety of EA for antipsychotic-related constipation. The finding will be published in peer-reviewed journals as reliable evidence. Trial registration ClinicalTrials.gov ChiCTR2000032582. Registered May 3, 2020, with the Chinese Clinical Trial Registry.

Treatment of varicose tributaries with sclerotherapy with polidocanol 0.5 % foam

VASA ◽  
2010 ◽  
Vol 39 (2) ◽  
pp. 169-174 ◽  
Author(s):  
Reich-Schupke ◽  
Weyer ◽  
Altmeyer ◽  
Stücker
Keyword(s):  
Scientific Evidence ◽  
Daily Practice ◽  
Severe Adverse Effect ◽  
Safe Procedure ◽  
Efficacy And Safety ◽  
Foam Sclerotherapy ◽  
History Of ◽  
One Year ◽  
Additional Therapy

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.

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