scholarly journals The Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-Management of Irritable Bowel Syndrome: a Cross-Over, Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Melissa Hunt ◽  
Sofia Miguez ◽  
Benji Dukas ◽  
Obinna Onwude ◽  
Sarah White
Keyword(s):  
Irritable Bowel Syndrome ◽  
Treatment Group ◽  
Controlled Trial ◽  
Post Treatment ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Irritable Bowel ◽  
Intent To Treat

BACKGROUND Patients with irritable bowel syndrome (IBS) experience abdominal pain, altered bowel habits, and defecation-related anxiety which can result in reduced productivity and impaired health related quality of life (HRQL). Cognitive-behavioral therapy (CBT) has been shown to reduce symptoms of IBS and to improve HRQL, but access to qualified therapists is limited. Smartphone-based digital therapeutic interventions have the potential to increase access to guided CBT at scale but require careful study to assess their benefits and risks. OBJECTIVE To test the efficacy of a novel app, Zemedy - a mobile digital therapeutic that delivers a comprehensive CBT program to individuals with IBS. METHODS This was a cross-over randomized controlled trial (registration number NCT04170686). Participants were recruited online. Patients were randomly allocated to either immediate treatment (N = 62) or waitlist control (N = 59). The Zemedy app consists of 8 modules focusing on psychoeducation, relaxation training, exercise, the cognitive model of stress management, applying CBT to IBS symptoms, reducing avoidance through exposure therapy and behavioral experiments, and information about diet. Users interact with a chatbot that presents the information and encourages specific plans, homework and exercises. The treatment was fully automated, with no therapist involvement or communication. At baseline and after 8 weeks, participants were asked to complete the battery of primary (Irritable Bowel Syndrome Quality of Life (IBS-QoL), Gastrointestinal Symptom Rating Scale (GSRS)) and secondary outcome measures (the Fear of Food Questionnaire (FFQ), the Visceral Sensitivity Index (VSI), the GI Cognition Questionnaire (GI-COG), the Depression, Anxiety Stress Scale (DASS) and the Patient Health Questionnaire (PHQ-9)). Waitlist controls were then offered the opportunity to cross over. All participants were assessed one more time at 3 months post-treatment completion. RESULTS Both intent-to-treat and completer analyses at post-treatment revealed significant improvement for the immediate treatment group compared to the waitlist control group on both primary and secondary outcome measures. Gains were generally maintained at 3 months post-treatment. Scores on the GSRS, IBS-QoL, GI-COG, and VSI all improved significantly more in the treatment group [F(1,79) = 20.49, P < .001, Cohen’s d = 1.01; F(1,79) = 20.12, P < .001, d = 1.25; F(1,79) = 34.71, P < .001, d = 1.47 and F(1,79) = 18.7, P < .001, d = 1.07]. Fear of food also decreased for the treatment group relative to the control group [F(1,79) = 12.13, P = .001, d = .62]. Depression improved significantly as measured by both the PHQ9 [F(1,79) = 10.5, P = .002, d = 1.07] and the DASS Depression Subscale [F(1,79) = 6.03, P = .016, d = .83], as did the stress subscale of the DASS [F(1,79) = 4.47, P = .04, d = .65] in the completer analysis but not the intent-to-treat analysis. The impact of treatment on HRQL was mediated by reductions in catastrophizing and visceral sensitivity. CONCLUSIONS Despite its relatively benign physical profile, IBS can be an extraordinarily debilitating condition. Zemedy is an effective modality to deliver CBT for individuals with IBS, and could increase accessibility of this evidence based treatment. CLINICALTRIAL This trial was registered at ClinicalTrials.gov as NCT04170686

Electroacupuncture for post-stroke overactive bladder: a multi-centre pilot randomized controlled trial

2020 ◽  
pp. 096452842092548
Author(s):  
Haiyong Chen ◽  
Changde Wang ◽  
Minjie Zhou ◽  
Pui Yan Chan ◽  
Lo Lo Yam ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Overactive Bladder ◽  
Controlled Trial ◽  
Post Treatment ◽  
Secondary Outcome ◽  
Control Group ◽  
Bladder Diary ◽  
Post Stroke ◽  
Randomized Controlled

Background Although acupuncture has been shown to be effective at treating overactive bladder (OAB) following stroke, to our knowledge, no randomized controlled trial (RCT) examining the effects of acupuncture on patients with post-stroke OAB has been conducted. The aim of this preliminary study was to explore the effects of electroacupuncture (EA) in the treatment of post-stroke OAB. Methods This study was a multi-site randomized, assessor-blind, controlled pilot trial of patients with post-stroke OAB. In all, 34 post-stroke subjects (mean age: 71.0 years; 32.4% female) with OAB symptoms were randomly assigned to the treatment group or control group in a 1:1 ratio. The subjects in the treatment group were treated with six sessions of EA for 4 weeks, while the subjects in the control group received usual care. The primary outcome measure was the overactive bladder symptom scale (OABSS). Secondary outcome measures included a three day bladder diary and the stroke-specific quality-of-life scale (SSQoL). Results EA showed a moderate effect size (ES) on the perceived severity of OAB symptoms as measured by the OABSS at week 5 (one week post-treatment, ES 0.57; p = 0.034) and week 8 (three weeks post-treatment, ES 0.60; p = 0.021), although the results did not remain statistically significant after Bonferroni correction for multiple testing. No significant differences in bladder diary parameters or SSQoL score were found. The EA treatment was well tolerated by the post-stroke subjects. Conclusion A six-session EA treatment was feasible and appeared to reduce OAB symptoms in post-stroke patients. Further fully powered trials are warranted to confirm the efficacy of EA for those with post-stroke OAB.

scholarly journals Immediate effect of an acupressure strap simulating wrist-ankle acupuncture on menstrual pain in young women: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Shu-jie Zhai ◽  
Yi Ruan ◽  
Yue Liu ◽  
Zhen Lin ◽  
Chen Xia ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Analgesic Effect ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Pain Intensity Score ◽  
Primary Dysmenorrhea ◽  
Randomized Controlled

Abstract Background: Dysmenorrhea seriously affects the ability to perform normal social activities and decreases quality of life. Primary dysmenorrhea can be effectively treated with acupuncture. Based on the wrist-ankle acupuncture (WAA) theory, we designed a portable WAA point compression treatment strap that treats diseases by automatically applying pressure to acupuncture points. The proposed study aims to evaluate the analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. Methods: The study will be a randomized controlled trial conducted from 1 May 2019 30 May 2020 that includes 78 students from Shanghai University of Traditional Chinese Medicine who have primary dysmenorrhea and meet the eligibility criteria. Participants will be randomly divided into two groups in a 1:1 allocation ratio. The intervention group will use the acupressure wrist-ankle strap equipped with tip compression component parts on the internal side; the control group will use the non-acupressure wrist-ankle strap with the tip compression parts removed. All participants will be treated for 30 min on the first day of menstruation. The main outcome measures are the pain intensity score measured by the visual analogue scale, and the onset time of analgesia. The secondary outcome measures are the pain threshold at Yinlingquan (SP 9) , skin temperature at Guanyuan (CV 4) , and expectations and satisfaction of patients as investigated via the Expectation and Treatment Credibility Scale. Discussion: This trial will be the first study to evaluate the analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. The quality of this study is ensured by the strict randomization, non-acupressure control, and blinded design. The results may provide a potential alternative treatment for primary dysmenorrhea and evidence-based proof of the analgesic effect of WAA. Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR1900021727. Registered on 7 March 2019. http://www.chictr.org.cn/listbycreater.aspx

Psychodynamic therapy for adolescents suffering from co-morbid disorders of conduct and emotions in an in-patient setting: a randomized controlled trial

2013 ◽  
Vol 44 (10) ◽  
pp. 2213-2222 ◽  
Author(s):  
S. Salzer ◽  
C. Cropp ◽  
U. Jaeger ◽  
O. Masuhr ◽  
A. Streeck-Fischer
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Academic Failure ◽  
Psychodynamic Therapy ◽  
Post Treatment ◽  
Control Group ◽  
Global Severity Index ◽  
Randomized Controlled

BackgroundCo-morbid disorders of conduct and emotions can be regarded as childhood antecedents of further negative developments (e.g. manifestation of personality disorders in adulthood). We evaluated a manualized psychodynamic therapy (PDT) for adolescents with these co-morbid disorders.MethodIn a randomized controlled trial (RCT), 66 adolescents diagnosed with mixed disorders of conduct and emotions (F92 in ICD-10) were randomly assigned to a manualized in-patient PDT group or a waiting list/treatment-as-usual (WL/TAU) control condition. Diagnoses according to DSM-IV were also documented. Patients were compared using rates of remission as the primary outcome. The Global Severity Index (GSI) and the Strengths and Difficulties Questionnaire (SDQ) were used as secondary measures. Assessments were performed at baseline, post-treatment and at the 6-month follow-up.ResultsThe sample consisted of severely impaired adolescents with high rates of further co-morbid disorders and academic failure. Patients in the treatment group had a significantly higher rate of remission [odds ratio (OR) 26.41, 95% confidence interval (CI) 6.42–108.55, p < 0.001]. Compared with the control group, the PDT group resulted in significantly better outcomes on the SDQ (p = 0.04) but not the GSI (p = 0.18), with small between-group effect sizes (SDQ: d = 0.38, GSI: d = 0.18). However, the scores of patients treated with PDT were post-treatment no longer significantly different from normative data on the GSI and within the normal range on the SDQ. The effects in the treatment group were stable at follow-up. Furthermore, most patients were reintegrated into educational processes.ConclusionPDT led to remarkable improvement and furthered necessary preconditions for long-term stabilization. In future, PDT should be compared to other strong active treatments.

scholarly journals Feasibility Study of a Randomized Controlled Trial Investigating Renal Denervation as a Possible Treatment Option in Patients With Loin Pain Hematuria Syndrome

2020 ◽  
Vol 7 ◽  
pp. 205435812095139
Author(s):  
Bhanu Prasad ◽  
Maryam Jafari ◽  
Kaval Kour ◽  
Kunal Goyal ◽  
Francisco Garcia
Keyword(s):  
Treatment Group ◽  
Renal Denervation ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Control Group ◽  
Single Center ◽  
Randomized Controlled ◽  
Loin Pain

Background: Loin Pain Hematuria Syndrome (LPHS) is a poorly understood clinical condition characterized by severe pain localized to the kidney but in the absence of identifiable urinary tract disease. There is no consensus on optimal treatment strategies for LPHS. Case reports and series have shown renal denervation via catheter-based radiofrequency ablation to be an effective therapeutic option for the treatment of LPHS. To determine whether catheter-based renal denervation is a meaningful addition to the treatment options in these often-difficult-to-treat LPHS patients, a randomized clinical trial is needed. Prior to conducting a definitive trial that focuses on patient outcomes, ensuring the feasibility of undertaking such a trial is required. As such, we will conduct a single-center randomized control feasibility trial designed to determine viability and provide framework and direction for a larger trial. Objective: The objective of the study is to determine whether conducting a randomized trial of renal denervation versus sham procedure is feasible in terms of recruitment and eligibility, and adequacy of follow-up in LPHS patients. Design: Single-center double-blinded, parallel-group, partial crossover, sham-controlled, randomized feasibility trial of 10 LPHS patients. Setting: Regina General Hospital in Regina, Saskatchewan, Canada. Patients: Ten LPHS patients who require opioid therapy. Measurements: The main feasibility outcome measures include proportion of target patients who undergo the procedure (treatment or sham) within 6 months; proportion of randomized participants (treatment or control) who entirely complete the follow-up measures at 6 weeks, 3 and 6 months; proportion of the participants who were randomized to control group, cross over after 6 months and opt-in renal denervation treatment; proportion of the crossover participants who complete the follow-up measures at 6 weeks, 3 and 6 months. Pain will be assessed using Brief Pain Inventory Score, McGill Pain Questionnaire, and a pain diary. Mood, disability, and quality of life will be measured by Center for Epidemiologic Studies Depression Scale, Oswestry Disability Index, EuroQol-5D, and Short Form Health Survey Questionnaire, respectively. Methods: Eligible participants will be randomized into either renal denervation (treatment group) or a sham treatment (control group). Data (pain, quality of life, mood, disability) will be collected from both groups at baseline, 6 weeks, 3 and 6 months after the intervention. After the initial 6-month follow-up is over, the participants who received the sham procedure will cross over into the treatment group and will be followed for an additional 6 months in the same manner as the treatment group. Descriptive statistics will be used to report outcomes for all patients. Limitations: Single-center study, small sample size. Conclusions: The lessons learnt from this trial will lay the framework and direction for conducting a multisite randomized controlled trial involving a larger cohort of patients. Trial registration: ClinicalTrials.gov (NCT04332731).

scholarly journals Effect of posterior quadratus lumborum blockade on the quality of recovery after major gynaecological laparoscopic surgery: A randomized controlled trial

2019 ◽  
Vol 47 (2) ◽  
pp. 146-151 ◽  
Author(s):  
Hiroko Fujimoto ◽  
Tomoya Irie ◽  
Takahiro Mihara ◽  
Yusuke Mizuno ◽  
Takeshi Nomura ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Laparoscopic Surgery ◽  
Postoperative Pain ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Quality Of Recovery ◽  
Randomized Controlled ◽  
Quadratus Lumborum

Bilateral quadratus lumborum blockade (QLB) using ultrasound guidance has been introduced as an abdominal truncal block to improve postoperative analgesia and quality of recovery (QoR) after abdominal surgery, but efficacy remains controversial. The primary aim of this study was to evaluate the efficacy of posterior QLB on the postoperative QoR, and secondarily to evaluate postoperative pain after gynaecological laparoscopic surgery (LS). This study was a single-centre randomized controlled trial. QLB group patients underwent bilateral posterior quadratus lumborum injections with 25–30 mL of 0.25% levobupivacaine after induction of general anaesthesia; the control group underwent no block. Both groups were administered fentanyl-based intravenous patient-controlled analgesia postoperatively. The postoperative QoR was measured using the Quality of Recovery 40 (QoR-40) questionnaire score; postoperative pain was evaluated using the visual analogue scale (VAS) and the cumulative postoperative fentanyl dose. Thirty-one and 29 patients were randomised to the QLB and control groups, respectively. The intraoperative remifentanil dosage was significantly less in the QLB group. The median (interquartile range) for the QoR-40 score was not different between the groups: 154 (133–168) in the QLB group and 158 (144–172) in the control group. There were no statistically significant differences in secondary outcome variables. Single-shot QLB did not improve the QoR or postoperative pain in patients managed by multimodal analgesia after gynaecological LS.

scholarly journals Acupuncture for osteoporosis: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
M Huang ◽  
MX Lai ◽  
XY Wang ◽  
YF Wang ◽  
J Yang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Primary Osteoporosis ◽  
Randomized Controlled ◽  
Acupuncture And Moxibustion ◽  
One Year ◽  
Experimental Group

Abstract Background: The rapid increase in the prevalence of osteoporosis and the rate of fractures after osteoporosis indicates that osteoporosis has become a serious global public health problem. A recent meta-analysis showed that oral alendronate and parenteral injection of zoledronate had no statistical significance in preventing postmenopausal hip fractures. Acupuncture and moxibustion are widely used in the treatment of osteoporosis due to their good analgesic effects. Early observation showed that integral adjustment of acupuncture and moxibustion therapy could improve the quality of life of patients with osteoporosis and prevent the occurrence of osteoporosis fractures. As the observation period of fracture is too long, it is necessary to carry out a large and strictly designed multi-center randomized trial covering the risk factors of fracture and fracture induction, so as to evaluate the effectiveness of acupuncture and moxibustion in the treatment of primary osteoporosis.Methods/Design: A multicenter randomized controlled trial will be performed in three hospitals. 312 participants patients within primary osteoporosis will be divided into an experimental group and a control group randomly. The experimental group is treated with acupuncture and western medicine while the control group is treated with Western medicine. All the patients will receive a 3-month treatment and 6-month,and one year follow-ups. The primary outcome is the bone mineral density (BMD), the secondary outcome is Bone-derived alkaline phosphatase(BALP), bone glaprotein(BGP), visual pain scale score(VAS),Traditional Chinese Medicine (TCM) syndrome scores, quality of daily life score(QOL) and adverse events. Outcome measures (including primary and secondary outcome measures) are collected at baseline,3 months of the intervention, Causes and number of falls are collected at 6 months and one year after the intervention.Discussion: This study will provide clinical evidence for the treatment of primary osteoporosis with holistic adjustment acupuncture. This study will evaluate the synergistic effect of acupuncture treatment for primary osteoporosis and provide evidence for clinical treatment.Trial registration: This trial was registed at Chinese Clinical Trial Registry, registration date: 5 August 2018.URL:http://www.chictr.org.cn,registration number:ChiCTR1800017581.

scholarly journals Therapeutic Analysis of Fuzi Lizhong Wan with Trimebutine in the Treatment of Diarrhea Type Irritable Bowel Syndrome

2020 ◽  
Vol 4 (4) ◽  
Author(s):  
Ying Chang ◽  
Quanwei Di ◽  
Gaixian Di
Keyword(s):  
Irritable Bowel Syndrome ◽  
Treatment Group ◽  
Clinical Efficacy ◽  
Combined Therapy ◽  
Control Group ◽  
Symptom Scores ◽  
Before And After ◽  
Random Number Table ◽  
Irritable Bowel

Objective: To evaluate the clinical efficacy of Fuzi Lizhong Wan and trimebutine in the treatment of diarrhea irritable bowel syndrome. Methods: A total of 90 patients with diarrhea irritable bowel syndrome were divided into control group  (n=45) and treatment group (n=45) using the random number table method. Patients in the control group were po administered with trimebutine 0.2 g, three time daily for 4 weeks. Patients in the treatment group were po administered with Fuzi Lizhong Wan 9 g, three time daily for 4 weeks on the basis of the control group. The clinical efficacy and the TCM symptom scores were evaluated after treatment. The serological indicators in two groups were compared before and after treatment. Results: After treatment, the clinical efficacy and the TCM symptom scores in treatment group were significantly lower than that in control group(P<0.05).The levels of serological indicators in both groups improved significantly, and those in the treatment group were better than the control group(P<0.05). Conclusion: Combined therapy of Fuzi Lizhong Wan and trimebutine in the treatment of diarrhea type irritable bowel syndrome has a significant effect, which can relieve clinical symptom, and reduce visceral sensitivity, and improve levels of inflammatory and quality of life. So it is suggested to be applied.

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