scholarly journals Efficacy of abdomen-rubbing qigong exercise for chronic insomnia: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Chong Guan ◽  
Ziji Cheng ◽  
Fangfang Xie ◽  
Ruiping Wang ◽  
Jing Zhang ◽  
...  

Abstract Background Insomnia is a common sleeping disorder which affects the quality of life which can bring harms to physical and mental health of human beings and even economic development. Traditional Chinese medicine (TCM) plays an outstanding role in treating chronic diseases and alleviating their symptoms. Therefore, the purpose of this study is to assess the treatment efficacy in patients with insomnia treated with abdomen-rubbing qigong exercise (ARQE). In addition, the brain function changes of patients will be explored by resting state functional magnetic resonance imaging (rs-fMRI). Method/design This trial is a randomized, single-blind, controlled study planned to transpire between July 1, 2020, and July 31, 2021. A sample size of 114 participants (57 per group) with chronic insomnia will be randomly assigned to receive ARQE or CBTI for 8 weeks. The study duration will be 13 weeks, including a 1-week screening period, 8 weeks of intervention, and another 4 weeks of follow-up. The primary outcome is the Pittsburgh sleep quality index scores. Secondary outcomes include insomnia severity index, gastrointestinal symptom rating scale, the Hamilton Depression Scale, and rs-fMRI scan. The adverse events will be in control. Discussion The results of this study will help to clarify the efficacy of ARQE in the treatment of insomnia and try to use rs-fMRI technology to explore the brain function changes of ARQE in improving sleep quality in patients with insomnia disorder. If the results are as expected, this study will provide high-quality evidence for the treatment of insomnia with ARQE. Trial registration China Clinical Registration Agency ChiCTR1900028009. Registered on 19 December 2019.

2021 ◽  
Author(s):  
Chong Guan ◽  
Ziji Cheng ◽  
Fangfang Xie ◽  
Ruiping Wang ◽  
Jing Zhang ◽  
...  

Abstract BackgroundInsomnia is a common sleeping disorder which affects the quality of life which can bring harms to physical and mental health of human beings and even economic development. Traditional Chinese medicine (TCM) plays an outstanding role in treating chronic diseases and alleviating their symptoms. Therefore, the purpose of this study is to assess the treatment efficacy in patients with insomnia treated with abdomen-rubbing qigong exercise (ARQE). In addition, the brain function changes of patients will be explored by resting state functional magnetic resonance imaging(rs-fMRI).Method/designThis trial is a randomized, single-blind, controlled study planned to transpire between July 1, 2020, and July 31, 2021. A sample size of 114 participants (57 per group) with chronic insomnia will be randomly assigned to receive ARQE or CBTI for 8 weeks. The study duration will be 13 weeks, including a 1-week screening period, 8 weeks of intervention, and another 4 weeks of follow-up. The primary outcome is the Pittsburgh sleep quality index scores. Secondary outcomes include insomnia severity index, gastrointestinal symptom rating scale, the Hamilton depression scale, and rs-fMRI scan. The adverse events will be in control. DiscussionThe results of this study will help to clarify the efficacy of ARQE in the treatment of insomnia, and try to use rs-fMRI technology to explore the brain function changes of ARQE in improving sleep quality in patients with insomnia disorder. If the results are as expected, this study will provide high-quality evidence for the treatment of insomnia with ARQE. Trial registrationChina Clinical Registration Agency (registration number: ChiCTR1900028009). Registered on 19 December 2019. http://www.chictr.org.cn/showproj.aspx?proj=46679


2021 ◽  
Vol 12 ◽  
Author(s):  
Sha Zhu ◽  
Min Zhong ◽  
Yu Bai ◽  
Zhuang Wu ◽  
Ruxin Gu ◽  
...  

Background and Purpose: The unilateral onset and persistent asymmetry of motor symptoms are important characteristics of Parkinson's disease (PD). By using scales and wearable sensors, this study explored whether motor symptom laterality could affect non-motor symptom and gait performance.Methods: A total of 130 right-handed patients with PD were enrolled in our study and were divided into two groups according to the side of predominant motor symptom presentation by using the Unified Parkinson's Disease Rating Scale part III. We measured the non-motor symptoms with the Non-motor symptoms Scale, sleep quality with the Parkinson's Disease Sleep Scale and Pittsburgh sleep quality index, cognitive function with the Mini-mental State Examination and Montreal Cognitive Assessment, quality of life with the Parkinson's Disease Questionnaire-39, and the severity of anxiety and depression with the Hamilton Anxiety Scale and Hamilton Depression Scale, respectively. All participants underwent the instrumented stand and walk test, and gait data were collected using a set of JiBuEn gait analysis system.Results: We observed that left-dominant symptom PD patients (LPD) were associated with a greater impairment of sleep quality than right-dominant symptom PD patients (RPD). We found no difference between LPD and RPD in terms of gait performance. However, compared with the severe asymmetry RPD patients (RPD-S), severe asymmetry LPD patients (LPD-S) showed a shorter stride length and decreased range of motion of hip joints.Conclusions: In this study, LPD was associated with a more severe sleep-related dysfunction than RPD. In addition, LPD-S exhibited more gait impairments than RPD-S. Considering that motor symptom laterality may affect the non-motor symptom and gait performance, it should be taken into account when evaluating and treating PD patients.


2016 ◽  
Vol 125 (6) ◽  
pp. 1513-1522 ◽  
Author(s):  
Nir Shimony ◽  
Uri Amit ◽  
Bella Minz ◽  
Rachel Grossman ◽  
Marc A. Dany ◽  
...  

OBJECTIVE The aim of this study was to assess in-hospital (immediate) postoperative pain scores and analgesic consumption (primary goals) and preoperative anxiety and sleep quality (secondary goals) in patients who underwent craniotomy and were treated with pregabalin (PGL). Whenever possible, out-of-hospital pain scores and analgesics usage data were obtained as well. METHODS This prospective, randomized, double-blind and controlled study was conducted in consenting patients who underwent elective craniotomy for brain tumor resection at Tel Aviv Medical Center between 2012 and 2014. Patients received either 150 mg PGL (n = 50) or 500 mg starch (placebo; n = 50) on the evening before surgery, 1.5 hours before surgery, and twice daily for 72 hours following surgery. All patients spent the night before surgery in the hospital, and no other premedication was administered. Opioids and nonsteroidal antiinflammatory drugs were used for pain, which was self-rated by means of a numerical rating scale (score range 0–10). RESULTS Eighty-eight patients completed the study. Data on the American Society of Anesthesiologists class, age, body weight, duration of surgery, and intraoperative drugs were similar for both groups. The pain scores during postoperative Days 0 to 2 were significantly lower in the PGL group than in the placebo group (p < 0.01). Analgesic consumption was also lower in the PGL group, both immediately and 1 month after surgery. There were fewer requests for antiemetics in the PGL group, and the rate of postoperative nausea and vomiting was lower. The preoperative anxiety level and the quality of sleep were significantly better in the PGL group (p < 0.01). There were no PGL-associated major adverse events. CONCLUSIONS Perioperative use of twice-daily 150 mg pregabalin attenuates preoperative anxiety, improves sleep quality, and reduces postoperative pain scores and analgesic usage without increasing the rate of adverse effects. Clinical trial registration no.: NCT01612832 (clinicaltrials.gov)


Nutrients ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 3598
Author(s):  
Bridgette Wilson ◽  
Özge Eyice ◽  
Ioannis Koumoutsos ◽  
Miranda C. Lomer ◽  
Peter M. Irving ◽  
...  

Prebiotics may promote immune homeostasis and reduce sub-clinical inflammation in humans. This study investigated the effect of prebiotic galactooligosaccharide (GOS) supplementation in colonic inflammation. Seventeen patients with active ulcerative colitis (UC) consumed 2.8 g/d GOS for 6 weeks. At baseline and 6 weeks, gene expression (microarray), fecal calprotectin (ELISA), microbiota (16S rRNA), short-chain fatty acids (SCFAs; gas-liquid chromatography), and clinical outcomes (simple clinical colitis activity index (SCCAI), gastrointestinal symptom rating scale (GSRS), and Bristol stool form scale (BSFS)) were measured. Following prebiotics, clinical scores (SCCAI), fecal calprotectin, SCFAs, and pH were unchanged. Five genes were upregulated and two downregulated. Normal stool proportion (BSFS) increased (49% vs. 70%, p = 0.024), and the incidence (46% vs. 23%, p = 0.016) and severity (0.7 vs. 0.5, p = 0.048) of loose stool (GSRS), along with urgency (SCCAI) scores (1.0 vs. 0.5, p = 0.011), were reduced. In patients with a baseline SCCAI ≤2, prebiotics increased the relative abundance of Bifidobacterium from 1.65% (1.97) to 3.99% (5.37) (p = 0.046) and Christensenellaceae from 0.13% (0.33) to 0.31% (0.76) (p = 0.043). Prebiotics did not lower clinical scores or inflammation but normalized stools. Bifidobacterium and Christensenellaceae proportions only increased in patients with less active diseases, indicating that the prebiotic effect may depend on disease activity. A controlled study is required to validate these observations.


2020 ◽  
Vol 91 (12) ◽  
pp. 1343-1348
Author(s):  
Qingpei Hao ◽  
Dongliang Wang ◽  
Jia OuYang ◽  
Hu Ding ◽  
Gaungyong Wu ◽  
...  

ObjectivesTo study the efficacy and safety of bilateral globus pallidus internus deep brain stimulation (GPi-DBS) in refractory Meige syndrome (MS) and evaluate the psychiatric disorders before and after surgery.MethodsTwenty-two patients with MS treated with bilateral GPi-DBS were retrospectively analysed before surgery and after continuous neurostimulation. Before surgery, patients were assessed by the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS), Self-Rating Depression Scale, Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) and Pittsburgh Sleep Quality Index (PQSI), which corresponded to motor symptoms, depressive state, quality of life and sleep quality, respectively. The implantable pulse generator of each patient was activated at 1 month after surgery. At 1 month, 3 months, 6 months and 12 months after continuous neurostimulation, all patients were evaluated by the same scales above.ResultsThe BFMDRS movement scores decreased from 15.0±5.3 before surgery to 3.5±4.5 at 12 months after neurostimulation, with a mean improvement of 78% (p<0.001). The BFMDRS disability scores improved from 7.4±4.9 before surgery to 4.0±4.6 at 12 months after neurostimulation, with a mean improvement of 56% (p<0.001). The postoperative SF-36 scores had the remarkable improvement compared with baseline scores. Impaired sleep quality was found in 82% of patients and depression in 64% before surgery, which didn’t neither obtained amelioration after continuous neurostimulation.ConclusionsBilateral pallidal neurostimulation is a beneficial therapeutic option for refractory MS, which could improve the motor symptoms except for depression and sleep quality.


2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
W. Drozdz ◽  
A. Borkowska

Current diagnostic systems (DSM-IV-TR and ICD-10) do not include depressive mixed state (DMS) as a separate category. However, both historical descriptions and data from recent research clearly indicate that cooccurrence of (hypo)maniacal and depressive symptoms is standard in clinical picture of affective disorders. Most frequently employed criterion for DMS is the presence of at least three symptoms of (hypo)mania for 7 days during a major depressive episode. Not only formal diagnostic criteria for DMS are lacking but also psychometric assessment tools (for example the Hamilton Depression Scale or the MADRS) were designed around the features of “classical” depression. The other obstacles to recognize DMS could be lack of insight into the (hypo)maniacal symptoms in patients and cognitive dysfunctions present during an episode. On the other hand, newly created instrument, the Bipolar Depression Rating Scale, may assist clinical evaluation of DMS. Despite predominating depressive symptomatology, the principles of treatment of DMS suggest avoidance of antidepressant monotherapy in favor of mood stabilizers' administration. Actually DMS may emerge as a complication of antidepressant monotherapy in some bipolar patients or may be induced with interferon-alpha treatment in some chronic hepatitis C patients. Important consequences of both spontaneous and drug-induced DMS could be the roughening of affective symptomatology, resistance to antidepressants and the increase of suicidality. Thorough appraisal of symptoms seen in patients with affective disorders for indicators of DMS could have critical consequences for functional outcomes.


2019 ◽  
Vol 6 (6) ◽  
pp. 1706
Author(s):  
Karthik Nagaraj ◽  
Ramesh Patil

Background: An association between migraine and Restless Legs Syndrome (RLS) has been proposed due to shared dopaminergic dysfunction. Both have substantial effects on the quality of life. Identifying co morbidities of migraine helps in optimizing patient management. Objectives To study the prevalence of RLS in patients of migraine without aura, and associated co morbidities of RLS.Methods: This was a hospital based prospective observational study. All patients diagnosed as Migraine without aura as per ICHD-3 criteria completed the questions regarding migraine headache, Migraine Disability Assessment (MIDAS) questionnaire, Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI) and International RLS Study Group (IRLSSG) Rating Scale. RLS was diagnosed using the IRLSSG criteria. Serological investigations were done to look for secondary causes of RLS.Results: Out of 200 consecutive patients of migraine without aura were included in the study over a period of 18 months. Frequency of RLS was 13.5% (n=27). All patients had primary RLS. Mean PSQI score was higher in the patients of migraine without aura with RLS than in non RLS patients of migraine without aura (3.30±2.66 vs 2.24±2.03 p≤0.0168). Poor sleep quality, anxiety, depression was found in 9%, 8% and 2.5% respectively in patients of migraine without aura.Conclusions: An association between migraine without aura and RLS was demonstrated. Migraine without aura was associated with increased frequency of poor sleep quality, anxiety and depression.


2001 ◽  
Vol 13 (2) ◽  
pp. 233-240 ◽  
Author(s):  
Gustavo M. Petracca ◽  
Eran Chemerinski ◽  
Sergio E. Starkstein

Objective: To examine the efficacy of fluoxetine in the treatment of depression in patients with probable Alzheimer's disease (AD). Methods: This double-blind, parallel-design study included a consecutive series of 41 AD subjects meeting DSM-IV criteria for major or minor depression who were randomized to receive fluoxetine (up to 40 mg/day) or identical-appearing placebo. All patients received biweekly evaluations consisting of the Hamilton Depression Scale (HAM-D) and the Clinical Global Impression as primary efficacy measures, and the Mini-Mental State Exam, Hamilton Rating Scale for Anxiety, and the Functional Independence Measure as secondary efficacy measures. Results: Complete remission of depression was found in 47% of subjects treated with fluoxetine and in 33% of subjects treated with placebo. Both the fluoxetine and the placebo groups showed a significant decline in HAM-D scores over time, but the magnitude of mood improvement was similar for both groups. Fluoxetine was well tolerated, and most side effects were mild. Conclusion: Fluoxetine treatment for depression in AD did not differ significantly from treatment with placebo. Our study also confirms the presence of a placebo effect in the treatment of depression in AD.


2014 ◽  
Vol 26 (5) ◽  
pp. 272-279 ◽  
Author(s):  
Birgit Straasø ◽  
Lise Lauritzen ◽  
Marianne Lunde ◽  
Maj Vinberg ◽  
Lone Lindberg ◽  
...  

ObjectiveTo evaluate to what extent a twice daily dose of Transcranial Pulsating ElectroMagnetic Fields (T-PEMF) was superior to once daily in patients with treatment-resistant depression as to obtaining symptom remission after 8 weeks of augmentation therapy.MethodsA self-treatment set-up of the T-PEMF device was used allowing self-administration by patients in own homes. All patients were treated for 30 min per T-PEMF session. The antidepressant medication the patients were receiving at baseline remained unchanged during the trial. The patients were randomised to either one T-PEMF dose (active dose in the morning and sham in the afternoon) or two T-PEMF doses (active dose both morning and afternoon) in a double-blind procedure. A score of 7 or less on the Hamilton Depression Scale (HAM-D17) was the criterion of remission.ResultsIn total 34 patients received active T-PEMF once a day and 31 patients twice daily. After 5 weeks of therapy remission was obtained in 26.5% and 32.3% on one dose and two doses of T-PEMF, respectively. After 8 weeks the rate of remission was 73.5% and 67.7%, respectively. The side effects as measured by the Udvalget for Kliniske Undersøgelser scale showed a better toleration of the antidepresssive medication in both treatment groups, which was reflected by the WHO-5 well-being scale with increased scores in both groups of patients.ConclusionThe high remission rate obtained by the T-PEMF augmentation was not a dose effect (one versus two daily T-PEMF sessions) but was explained by the extension of the treatment period from 5 to 8 weeks.


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