Dataset Information

Auricular acupressure on specific points for hemodialysis patients with insomnia: a pilot randomized controlled trial.

ABSTRACT:

Objectives

To assess the feasibility and acceptability of a randomized controlled trial compared auricular acupressure (AA) on specific acupoints with AA on non-specific acupoints for treating maintenance hemodialysis (MHD) patients with insomnia.

Methods

Sixty three (63) eligible subjects were randomly assigned into either AA group received AA on specific acupoints (n=32), or sham AA (SAA) group received AA on points irrelevant to insomnia treatment (n=31) for eight weeks. All participants were followed up for 12 weeks after treatments. The primary outcome was clinical response at eight weeks after randomization, defined as a reduction of Pittsburgh Sleep Quality Index (PSQI) global score by 3 points and more.

Results

Fifty-eight (58) participants completed the trial and five dropped out. Twenty participants in AA group (62.5%) and ten in SAA group (32.3%) responded to the eight-week interventions (?2 = 5.77, P = 0.02). PSQI global score declined 3.75 ± 4.36 (95%CI -5.32, -2.18) and 2.26 ± 3.89 (95%CI -3.68, -0.83) in AA group and SAA group respectively. Three participants died during the follow-up period. No evidence supported their deaths were related to the AA intervention. No other adverse event was observed.

Conclusion

Feasibility and logistics of patient recruitment, randomization procedure, blinding approach, interventions application and outcome assessment had been tested in this pilot trial. The preliminary data appeared to show a favorable result on AA treatment. A full-scale trial is warranted.

Trial registration

Chinese Clinical Trial Registry ChiCTR-TRC-12002272.

SUBMITTER: Zou C

PROVIDER: S-EPMC4398355 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Publications

Auricular acupressure on specific points for hemodialysis patients with insomnia: a pilot randomized controlled trial.

Zou Chuan C Yang Lihong L Wu Yuchi Y Su Guobin G Chen Shuhui S Guo Xinfeng X Wu Xiuqing X Liu Xusheng X Lin Qizhan Q

PloS one 20150415 4

<h4>Objectives</h4>To assess the feasibility and acceptability of a randomized controlled trial compared auricular acupressure (AA) on specific acupoints with AA on non-specific acupoints for treating maintenance hemodialysis (MHD) patients with insomnia.<h4>Methods</h4>Sixty three (63) eligible subjects were randomly assigned into either AA group received AA on specific acupoints (n=32), or sham AA (SAA) group received AA on points irrelevant to insomnia treatment (n=31) for eight weeks. All pa ...[more]

PMID: 25874938

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Project description:BACKGROUND:Patients on maintenance hemodialysis (MHD) frequently complain of insomnia. Poor sleep quality impairs their quality of life and adversely affects long-term outcome. Previously we applied auricular acupressure therapy (AAT) for MHD patients with insomnia and yielded favorable results. AAT probably improves sleep quality by stimulating the vagus nerve and inhibiting sympathetic overactivity. However, the efficacy of AAT for insomnia in this population is still lacking. The proposed randomized controlled trial (RCT) will evaluate the efficacy and safety of AAT for improvement of sleep quality in MHD patients with insomnia. METHODS/DESIGN:The proposed study is a multi-center, double-blind (participants and assessors), parallel-group RCT. A total of 112 participants with insomnia will be recruited from six hemodialysis centers in Guangzhou, China, and randomly allocated in a 1:1 ratio to receive auricular acupressure on either active points (AA group) or control points (points irrelevant to insomnia management, SAA group). The treatment will last for 8 weeks prior to a follow-up period of 12 weeks. Evaluation by blinded assessors at baseline, at 8 weeks (end of treatment) as well as at 4-week, 8-week and 12-week follow-ups (after intervention) will include Pittsburgh Sleep Quality Index (PSQI) scores and average weekly dose of hypnotics. The primary endpoint is clinical response rate (percentage of participants who reach a reduction of PSQI global score ??3 in each group) at 8 weeks from baseline. Secondary endpoints include the changes in PSQI scores over time from baseline, as well as the changes in weekly dose of hypnotics. DISCUSSION:This paper describes the rationale and design of a double-blind RCT that aims to determine the efficacy and safety of AAT for insomnia of hemodialysis patients. If successful, this project will provide evidence of the efficacy and safety of AAT for insomnia of hemodialysis patients. TRIAL REGISTRATION:ClinicalTrials.gov , Identifier: NCT03015766 . Registered on 22 December 2016.

Project description:BackgroundDysmenorrhoea is the medical term for menstrual pain. The World Health Organization estimates that up to 81% of women of childbearing age are affected by this condition, and it is one of the leading causes of absenteeism from work and school among women. Although there are pharmacological treatments available for menstrual-pain relief, they do not respond to all women's needs. Therefore, there is a need to study and develop non-pharmacological alternatives to broaden the individualised treatment options for dysmenorrhea. There are scarce studies published on non-pharmacological treatments, such as kinesio tape and auricular acupressure for the relief of menstrual pain, but the scientific evidence available suggest that these techniques may be beneficial in addressing this problem. The objective of this pilot study was to assess and compare the effectiveness of kinesio tape and auricular acupressure to decrease pain and drug intake in women with primary dysmenorrhoea.MethodsThis was a double-blind randomized clinical controlled trial. The period of study was from September 2017 to August 2018. Women enrolled in the University of Extremadura and who had primary dysmenorrhoea were randomized to five groups: control (n = 23), kinesio tape (n = 23), placebo kinesio tape (n = 23), auricular acupressure (n = 23) and placebo auricular acupressure (n = 22). Measures were taken during the pretreatment phase (at four menstrual cycles), during the post-intervention phase (at four menstrual cycles) and during the follow-up phase (at the first and third menstrual cycles after the treatment was completed). The primary outcome measures were mean pain intensity, maximum pain intensity, number of painful days and dose of drug intake during menstruation, measured with the Visual Analogue Scale. The secondary outcome measures were the length of the cycle, the length of menstruation, the drug intake and the type of drug.ResultsIn all, 108 participants completed the study. The statistical analysis (MANOVA, ANOVA, t-paired and McNemar tests) showed that kinesio tape and auricular acupressure have a beneficial effect on pain relief (mean pain intensity, p < 0.001; maximum pain intensity, p < 0.001; number of painful days, p = 0.021; dose of drug intake, p < 0.001). In addition, once the treatments were withdrawn, the auricular-acupressure group maintained lower scores during the first follow-up cycle (p < 0.001).ConclusionsKinesio tape and auricular acupressure decrease pain and drug intake in women with primary dysmenorrhoea. The changes in the auricular-acupressure group seemed to last longer. The results suggest that these techniques could be used as complementary personalised therapies to the pharmacological treatment and not as a substitution.

Project description:INTRODUCTION:Psoriasis vulgaris is a common skin disease characterized by persistent localized erythematous scaly plaques, typically on the elbows, knees, and scalp. It is an immune-abnormal disease that progresses slowly over a long period with frequent symptom recurrence. Current studies have shown that acupuncture is an effective therapy for psoriasis. However, the scientific evidence of the efficacy of auricular acupressure treatment for patients with psoriasis is still insufficient. Therefore, we designed a randomized controlled clinical trial to investigate the effect, safety, and cost-effectiveness of auricular acupressure in addition to medication in patients with psoriasis. METHODS AND ANALYSIS:This on-going study is a two-arm parallel, assessor-blinded, randomized controlled trial in which 180 participants with psoriasis will be recruited and then randomly allocated into two groups in a 1:1 ratio. Equal randomization will be conducted using a computer-generated random allocation sequence. Participants in the intervention group will receive auricular acupressure treatment once per week for 4 weeks, and calcipotriol betamethasone ointment for topical use once daily for 4 weeks. Participants in the control group will receive only calcipotriol betamethasone ointment treatment once daily for 4 weeks. All patients will be followed up for 12 weeks. The primary outcome is relapse rate. The secondary outcomes include time to relapse, rebound rate, time to new onset, Psoriasis Area and Severity Index score improvement rate, body surface area affected, a visual analogue scale, and Dermatology Life Quality Index. Cost-effectiveness analysis will be carried out from a health and community care provider perspective. DISCUSSION:This multicenter randomized controlled trial will provide important clinical evidence for the effect and safety of auricular acupressure as a complementary therapy in patients with psoriasis. TRIAL REGISTRATION:Chinese Clinical Trial Registry, ChiCTR-TRC-14004916 . Registered on 20 May 2014. This protocol is version 3.0 which was updated on 24 September 2016.

Project description:BackgroundObesity is a common global health problem and increases the risk of many chronic illnesses. Given the adverse effects of antiobesity agents and bariatric surgeries, the exploration of noninvasive and nonpharmacological complementary methods for weight reduction is warranted.ObjectiveThe study aimed to determine whether self-administered auricular acupressure (AA) integrated with a smartphone app was more effective than using AA alone or the controls for weight reduction.MethodsThis study is a 3-arm randomized waitlist-controlled feasibility trial. A total of 59 eligible participants were randomly divided into either group 1 (AA group, n=19), group 2 (AA plus smartphone app, n=19), or group 3 (waitlist control, n=21). A total of 6 reflective zones or acupoints for weight reduction were chosen. The smartphone app could send out daily messages to the subjects to remind them to perform self-pressing on the 6 ear acupoints. A "date picker" of the 8-week treatment course was used to enable the users to input the compliance of pressing and the number of bowel movement daily instead of using the booklet for recordings. The app also served as a reminder for the subjects regarding the dates for returning to the center for acupoint changing and assessments. Treatment was delivered 2 times a week, for 8 weeks. Generalized estimating equations were used to examine the interactions among the groups before and after intervention.ResultsSubjects in group 2 expressed that the smartphone app was useful (7.41 out of 10). The most popular features were the daily reminders for performing self-pressing (88%), the ear diagram indicating the locations and functions of the 6 ear points (71%), and ear pressing method demonstrated in the video scripts (47%). Nearly 90% of the participants completed the 8-week intervention, with a high satisfaction toward the overall arrangement (8.37 out of 10). The subjects in group 1 and 2 achieved better therapeutic effects in terms of body weight, body mass index (BMI), waist circumference, and hip circumference and perceived more fullness before meals than the waitlist controls. Although no significant differences in the pairwise comparisons between the 2 groups were detected (P>.05), the decrease in body weight, BMI, body fat, visceral fat rating and leptin level, and increase in adiponectin level were notable in group 2 before and after the intervention.ConclusionsThe high compliance rate and high satisfaction toward the trial arrangement indicate that AA can be used to achieve weight reduction and applied in future large-scale studies. AA integrated with the smartphone app has a more notable effect than using AA alone for weight reduction. Larger sample size should be considered in future trials to determine the causal relationship between treatment and effect.Trial registrationClinicalTrials.gov NCT03442712; https://clinicaltrials.gov/ct2/show/NCT03442712 (Archived by WebCite at http://www.webcitation.org/78L2tO8Ql).

Dataset Information

Auricular acupressure on specific points for hemodialysis patients with insomnia: a pilot randomized controlled trial.

Objectives

Methods

Results

Conclusion

Trial registration

Publications

Auricular acupressure on specific points for hemodialysis patients with insomnia: a pilot randomized controlled trial.

Similar Datasets

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