Acupuncture for Olfactory Dysfunction in Infected COVID-19 Patients: Study Protocol for a Single Blind, Randomized, Sham-Controlled Clinical Trial

Abstract Background: Olfactory dysfunction (OD) was recognized as one of common symptom of COVID-19. OD, defined as the reduced or distorted ability to smell during sniffing (orthonasal olfaction) and may represent one of early symptoms in the clinical course of COVID-19 infection. A large online questionnaire-based survey found that some of post COVID-19 patients showed no improvement at one month after they were discharged from hospital. Therefore, this clinical trial is designed to explore the efficacy of acupuncture for OD in infected COVID-19 patients and to determine whether acupuncture could have benefits than sham acupuncture for OD in post- COVID-19 patients.Methods: This is a single blind, randomized controlled, cross over trial. We plan to recruit forty post-COVID-19 patients who are presenting with smell loss or smell distortions more than one month. Qualified patients will be randomly allocated into the intervention group (real acupuncture) or the control group (sham acupuncture) in a 1:1 ratio. Each patient will receive 8 sessions of treatment over 4 week (Cycle 1), and 2-week follow-up. After the follow-up, the control group will be conducted with real acupuncture for another 4 weeks (Cycle 2), and the real acupuncture group will be conducted with the 4-week sham acupuncture. The primary outcomes are the scores change on the questionnaire of olfactory functioning and olfaction related quality of life at weeks 6, 8, 12 and 14 from the baseline. Secondary outcome is the change on the Olfactory Test score at the week 6 and 12 from the baseline measured by using the Traditional Chinese version of the University of Pennsylvania Smell Identification Test (UPSIT-TC).Discussion: The results of this trial will help to determine the effectiveness of acupuncture for OD in post-COVID-19 Patients. This may provide a new treatment option for patients.Trial registration: ClinicalTrials.gov, NCT04959747, Registered on July 13, 2021.

Download Full-text

Evaluating the effects of a mindfulness mobile application on student pharmacists’ stress, burnout, and mindfulness

American Journal of Health-System Pharmacy ◽

10.1093/ajhp/zxab467 ◽

2021 ◽

Author(s):

Angela Chu ◽

Tyler M Rose ◽

Danielle A Gundrum ◽

Tressa E McMorris ◽

Eytan A Klausner ◽

...

Keyword(s):

Mobile Application ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Intervention Period ◽

Entire Study ◽

Positive Effects ◽

Waitlist Control Group

Abstract Disclaimer In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Pharmacists report high levels of burnout. Mindfulness approaches have been demonstrated to have positive results in the general population and in other healthcare professions. However, limited studies have been performed evaluating mindfulness approaches in student pharmacists. The aim of this study was to evaluate the effectiveness of daily use of a mindfulness mobile application in improving student pharmacists’ perceived stress, burnout, and mindfulness. Methods This study was a randomized, longitudinal, waitlist-controlled trial. The intervention group was asked to meditate using the mindfulness application Headspace daily for at least 6 weeks. The waitlist control group was asked to abstain from using the application for the entire study. Stress, burnout, and mindfulness were assessed using validated survey instruments at baseline, 6 weeks, and 10 weeks. A secondary outcome was to assess the persistence of application use after the intervention period. Results Fifty-six participants completed the study. The intervention group reported significantly lower scores on stress and burnout at 6 weeks compared to the control group. The intervention group also reported significantly higher scores on mindfulness. The differences in stress, burnout, and mindfulness persisted at follow-up. The mean percentage of students in the intervention group who used the application each day was 90% over the intervention period and 62% over the follow-up period. Conclusion A mindfulness mobile application significantly improved student pharmacists’ stress, burnout, and mindfulness with daily use. Most participants continued to use the application for 4 weeks after the end of the intervention. Positive effects on stress and mindfulness persisted even with decreased use.

Download Full-text

Effects of acupuncture on anthropometric and serum metabolic parameters in premenopausal overweight and obese women: a randomized, patient- and assessor-blind, sham-controlled clinical trial

Acupuncture in Medicine ◽

10.1177/0964528420912259 ◽

2020 ◽

pp. 096452842091225

Author(s):

Koh-Woon Kim ◽

Woo-Chul Shin ◽

Min Sun Choi ◽

Jae-Heung Cho ◽

Hi-Joon Park ◽

...

Keyword(s):

Clinical Trial ◽

Treatment Group ◽

Serum Lipid ◽

Sham Acupuncture ◽

Metabolic Parameters ◽

Secondary Outcome ◽

Control Group ◽

Lipid Levels ◽

Serum Lipid Levels

Objective: The aim of this study was to examine the effect of acupuncture on obesity-related parameters with regard to metabolomics. Methods: This two-arm parallel, patient- and assessor-blind, sham-controlled randomized clinical trial included 120 obese participants. Participants were randomized into two groups. The treatment group received a combined intervention of manual acupuncture (MA) plus electroacupuncture (EA), while the control group received a combination of sham acupuncture interventions consisting of sham MA plus sham EA for 6 weeks. The serum lipid levels were measured as the primary outcome measure and anthropometric parameters and serum metabolic profiles including amino acids and carnitines were measured as secondary outcome measures. Results: The serum lipid levels and anthropometric measurements did not significantly differ between groups, while body weight, body mass index (BMI), and waist circumference were improved within each group and the level of high-density lipoprotein cholesterol increased over time in the treatment group. There were no significant differences in amino acid levels between groups, while certain carnitine (C2, C4, C6, and l-carnitine) levels were significantly increased ( p < 0.05) in the treatment group compared to the control group. Conclusion: In summary, 6 weeks of acupuncture treatment did not affect anthropometric and serum metabolic parameters, with the exception of certain carnitines, when compared to sham acupuncture. The observation of increased carnitine levels in the acupuncture group could result in potential long-term benefits to obese individuals. Additional studies are needed to investigate the long-term effects of acupuncture on lipid metabolism and the underlying mechanism of action. Trial registration number: This study is registered at ClinicalTrials.gov (NCT02066090).

Download Full-text

Effectiveness of a home care teaching program for prostatectomized patients: a randomized controlled clinical trial

Revista da Escola de Enfermagem da USP ◽

10.1590/s1980-220x2018012503421 ◽

2019 ◽

Vol 53 ◽

Author(s):

Luciana Regina Ferreira da Mata ◽

Cissa Azevedo ◽

Mariana Ferreira Vaz Gontijo Bernardes ◽

Tânia Couto Machado Chianca ◽

Maria da Graça Pereira ◽

...

Keyword(s):

Clinical Trial ◽

Home Care ◽

Self Efficacy ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Teaching Program ◽

Significant Difference ◽

The Times

ABSTRACT Objective: To evaluate the effectiveness of a teaching program for hospital discharge of patients submitted to radical prostatectomy based on the self-efficacy construct of the Cognitive Social Theory. Method: A controlled clinical trial carried out on a 2-month follow-up of 68 prostatectomized men randomized into intervention group (n = 34) and control (n = 34). The intervention group received routine guidance from the service plus the teaching program. The control group only received routine guidance from the service. The data collection instruments were: sociodemographic and clinical questionnaire, self-efficacy scale, hospital depression and anxiety scale, household care knowledge questionnaire, and an item on satisfaction with a score of 1 to 5. Results: There was a significant difference between the intragroups for satisfaction (p<0.001) and knowledge (p<0.001) of the pre-test to the post-test. In the intervention group, there were significant changes between the times for anxiety (p=0.011) and knowledge (p<0.001). Conclusion: The teaching program with a combination of oral guidance, written instruction and telephone follow-up was effective in improving knowledge about home care and personal satisfaction. Brazilian Registry of Clinical Trials: RBR-5n95rm.

Download Full-text

Effect of Auricular Acupressure on Uremic Pruritus in Patients Receiving Hemodialysis Treatment: A Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2015/593196 ◽

2015 ◽

Vol 2015 ◽

pp. 1-8 ◽

Cited By ~ 14

Author(s):

Cui-na Yan ◽

Wei-guo Yao ◽

Yi-jie Bao ◽

Xiao-jing Shi ◽

Hui Yu ◽

...

Keyword(s):

Intervention Group ◽

Maintenance Hemodialysis ◽

Control Group ◽

Common Symptom ◽

Uremic Pruritus ◽

Auricular Acupressure ◽

Significant Difference ◽

Vas Scores ◽

And Control

Background. Uremic pruritus (UP) is a common symptom in patients undergoing maintenance hemodialysis for end-stage renal disease (ESRD).Objective. To determine the clinical efficacy of auricular acupressure therapy on pruritus in hemodialysis patients and to explore possible underlying mechanisms.Methods. Patients receiving maintenance hemodialysis at a referral medical center were recruited and assigned to intervention (n=32) and control (n=30) groups. The intervention group underwent auricular acupressure treatment three times a week for six weeks. Auricular acupressure was not applied to patients in the control group. However, tape withoutVaccariaseeds was applied to the same six auricular acupoints as the intervention group. Pruritus scores were assessed using VAS scores, and enzyme-linked immunosorbent assays (ELISA) were used to measure levels of other possible contributory biochemical factors.Results. There was a significant difference in mean VAS scores between the postintervention and control groups during follow-up (3.844 ± 1.687 versus 5.567 ± 2.285,F=22.32,P<0.0001). Compared to the control group, serum histamine levels in the postintervention group at the six-week follow-up had decreased significantly (F=5.01,P=0.0290).Conclusion. Our findings suggest that auricular acupressure may be a useful treatment in the multidisciplinary management of UP in ESRD patients.

Download Full-text

Efficacy and Safety of Modified Qing-Ying Decoction for Atopic Dermatitis in Children: Study Protocol for a Randomized Controlled Trial

10.21203/rs.3.rs-66124/v1 ◽

2021 ◽

Author(s):

Mei Kwan LAI ◽

Chi Him SUM ◽

Connie YC KAM ◽

Tianhe SONG ◽

Pui Kuan CHEONG ◽

...

Keyword(s):

Clinical Trial ◽

Chinese Medicine ◽

Atopic Eczema ◽

Gut Microbiome ◽

Secondary Outcome ◽

Control Group ◽

Placebo Control ◽

Efficacy And Safety ◽

Long Term Treatment

Abstract BackgroundAtopic Dermatitis (AD), also known as atopic eczema, is a chronic skin disease characterized by recurring episodes of itchiness with skin erythema and surface damages, such as dry skin, skin thickening and swelling. Long-term treatment with conventional medicine for subacute and moderate atopic eczema is not satisfactory. Evidence from randomized clinical trials suggests the effectiveness of Chinese medicine for the treatmement of AD. The purpose of this study is to explore the efficacy and safety of the modified Qing-Ying Decoction (mQYD) for the treatment of subacute and chronic AD in children through examining the clinical symptoms, quality of life, gut microbiome, and Chinese medicine (CM) body constitution.Methods/designThis is a parallel, randomized, placebo-controlled, double-blind clinical trial with a 12-week treatment and a 4-week follow-up period. A total of 64 participants will be randomly allocated to the treatment group receiving oral mQYD granules or the placebo control group receiving oral placebo granules. Eczema Area and Severity Index (EASI) score will be the primary outcome. Secondary outcome measures include change in symptoms using the Patient-Oriented Eczema Measure (POEM), the Children’s Dermatology Life Quality Index (CDLQI), and the use of concomitant medicines as well as the change in the gut microbiome and CM body constitution types after the 12-week treatment of the mQYD and 4-week follow-up compared to placebo control. Safety parameters include report of adverse events and pathology tests during the trial period.DiscussionThis is the first clinical trial of its kind to test the efficacy and gut microbiome of an innovative Chinese herbal formula modified from a famous ancient formula for the treatment of AD. The outcomes of this trial will provide clinical evidence on the effectiveness and safety of mQYD for the treatment of AD.Trial registrationClinicalTrials.gov, ID: NCT04419584. Registered on 28 July 2020.

Download Full-text

Efficacy of an online intervention for treatment of depressive disorders: a three-arm randomized controlled trial comparing guided and unguided self-help with waitlist control (Preprint)

10.2196/preprints.34028 ◽

2021 ◽

Author(s):

Krämer Rico

Keyword(s):

Depressive Symptoms ◽

Depressive Disorders ◽

Depressive Symptomatology ◽

Controlled Trial ◽

Intervention Group ◽

Online Intervention ◽

Self Report ◽

Secondary Outcome ◽

Control Group

BACKGROUND Digital health applications are efficacious treatment options for mild-to-moderate depressive disorders. However, the extent to which psychological guidance increases the efficacy of these applications is controversial. OBJECTIVE We evaluated the efficacy of the online intervention “Selfapy” for unipolar depression. We also investigated differences between a psychotherapist-guided vs. unguided version compared with those from a control group. METHODS A cohort of 401 participants with mild-to-severe depressive disorders were assigned randomly to either participate in a guided version of Selfapy (involving weekly telephone calls of 25-min duration), an unguided version of Selfapy, or to the waiting list (control group). Selfapy is a cognitive behavioral therapy-based intervention for depressive disorders of duration 12 weeks. Symptom assessment was undertaken at T1 (before study entrance), T2 (after 6 weeks), T3 (post-treatment, after 12 weeks), and T4 (follow-up, after 6 months). The main outcome was reduction in depressive symptoms in the Beck Depression Inventory (BDI-II) from T1 to T3. Secondary-outcome parameters were the Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR 16) and Beck Anxiety Inventory (BAI). RESULTS A total of 297 out of 401 participants (74.06%) completed the post-measurement at T3. In the primary analysis, both intervention groups showed a significantly higher reduction in depressive symptoms (BDI-II) from T1 to T3 compared with that in the control group, with high within-effect sizes (guided: d = 1.46; unguided d = 1.36). No significant differences were found for guided vs. unguided treatment groups. The response rate (BDI-II) for intention-to-treat data in the guided version was 46.4%, 40.0% for the unguided version, and 2.0% in the control group. After 6 months (T4), treatment effects could been maintained for both intervention groups (BDI-II) without differences between either intervention group. CONCLUSIONS Conclusions: Selfapy can help to reduce depressive symptoms in guided or unguided version. Follow-up data suggest that these effects could be maintained. The guided version was not superior to the unguided version. CLINICALTRIAL Trial Registration: Current Controlled Trial DRKS00017191 Date of registration: 14 May 2019 INTERNATIONAL REGISTERED REPORT RR2-https://doi.org/10.1186/s13063-021-05218-4

Download Full-text

The Effect of Black Tea (Camellia sinensis (L) Kuntze) on Pediatrics With Acute Nonbacterial Diarrhea

Journal of Evidence-Based Complementary & Alternative Medicine ◽

10.1177/2156587216654600 ◽

2016 ◽

Vol 22 (1) ◽

pp. 114-119 ◽

Cited By ~ 2

Author(s):

Sareh Doustfatemeh ◽

Mohammad Hadi Imanieh ◽

Abdolali Mohagheghzade ◽

Mohammad M. Zarshenas ◽

Zahra Torkamani ◽

...

Keyword(s):

Standard Treatment ◽

Intervention Group ◽

Black Tea ◽

Control Group ◽

Old Patients ◽

Significant Difference ◽

The Mean ◽

And Control ◽

Single Blind

We aimed to evaluate the antidiarrheal effect of black tea in pediatric patients with acute nonbacterial diarrhea. This single-blind randomized clinical trial study was performed on 2 to 12-year-old patients, with acceptable criteria for acute nonbacterial diarrhea in Shiraz, Iran. In total, 120 patients took part in this study. Blocked randomization method was used to allocate them into 2 groups of intervention (black tea tablet + standard treatment) and control group (standard treatment; 60 patients in each). Frequency of defecation, volume, and consistency of stool were registered on arrival and 24 hours later. We used χ2 test, t test, and Mann-Whitney U test. After a 24-hour follow-up, the proportion of patients with formed stool was higher in the intervention group when compared with the control group ( P < .001). There was a significant difference between the mean number of defecations per 24 hours in both groups, after treatment ( P < .001). We found a possible antidiarrheal effect of black tea.

Download Full-text

Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

BMC Public Health ◽

10.1186/s12889-020-09878-w ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Lucie Waedel ◽

Anne Daubmann ◽

Antonia Zapf ◽

Olaf Reis

Keyword(s):

Substance Use ◽

Randomised Controlled Trial ◽

Intellectual Disabilities ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Post Intervention ◽

Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

Download Full-text

Acupuncture (superficial dry-needling) as a treatment for chronic postherpetic neuralgia – a randomized clinical trial

British Journal of Pain ◽

10.1177/20494637211023075 ◽

2021 ◽

pp. 204946372110230

Author(s):

Martin Sollie ◽

Robert Pind ◽

Christoffer Bing Madsen ◽

Jens Ahm Sørensen

Keyword(s):

Clinical Trial ◽

Neuropathic Pain ◽

Randomized Clinical Trial ◽

Postherpetic Neuralgia ◽

Short Form ◽

Intervention Group ◽

Sham Acupuncture ◽

Control Group ◽

Dry Needling ◽

Painful Condition

Background: Postherpetic neuralgia is a painful condition where finding sufficient treatment poses a great challenge. Acupuncture is often used as an alternative treatment for these pains, yet no randomized trials, using a sham-placebo have been performed to confirm its effect. Our objective was to investigate the efficacy of acupuncture compared to sham-acupuncture when treating chronic postherpetic dermal pain. Methods: We performed a sham-controlled double-blinded randomized clinical trial (RCT) with two arms. The intervention group received superficial dry-needling, and the control group received sham acupuncture using blunted needles. Twenty-six patients received two treatments. They filled out questionnaires at baseline and 1 month after treatment: (1) average and maximum pain (Numeric Rating Scale), (2) neuropathic pain (Neuropathic Pain Scale Inventory) and (3) Quality of Life (QoL) (Short-form 36). Results: Thirteen patients were allocated to the intervention group and 15 to the control group. We did not detect any significant changes in levels of pain and neuropathic pain. One QoL parameter, regarding emotional problems, reached a level of statistical significance. The sham-blinding was successful. This is the first RCT on the effect of acupuncture (superficial dry-needling) on postherpetic neuralgia (PHN), using a sham procedure as control. We observed no significant changes or tendencies in the measured levels of pain. One QoL parameter had significant improvement in the intervention group compared to the control group. Conclusion: In conclusion, acupuncture was not superior to treatment with sham acupuncture. Though individual patients may experience some pain relief from acupuncture, our results do not support the routine use of this type of acupuncture to treat PHN.

Download Full-text

Effectiveness of screening for tuberculosis in HIV: a pragmatic clinical trial

Revista de Saúde Pública ◽

10.11606/s1518-8787.2021055002936 ◽

2021 ◽

Vol 55 ◽

pp. 45

Author(s):

Marcela Lopes Santos ◽

Joanna d’Arc Lyra Batista ◽

Cynthia Braga ◽

Adriana Paula da Silva ◽

Magda Maruza ◽

...

Keyword(s):

Clinical Trial ◽

Intervention Group ◽

World Health ◽

Control Group ◽

Sputum Smear ◽

Smear Microscopy ◽

Molecular Testing ◽

Newly Diagnosed ◽

Cumulative Mortality

OBJECTIVE: To verify the effectiveness of screening for tuberculosis (TB) on all-cause mortality and tuberculosis cases in newly diagnosed HIV-infected patients through a clinical algorithm based on recommendations of the World Health Organization. METHODS: From March 2014 to April 2016, a pragmatic randomized clinical trial was conducted with newly diagnosed and TB-free HIV-infected adults undergoing antiretroviral therapy for up to one month at a major tertiary hospital for HIV in the state of Pernambuco, Brazil. Participants were randomized into intervention and control groups using an automatically-generated random list, and followed-up for at least 6 months. The intervention group was screened for TB at hospital admission and at every follow-up visit through a series of questions addressing TB-related symptoms (cough, fever, night sweating, and weight loss). Patients presenting with any of these symptoms were referred to a pulmonologist and underwent sputum smear microscopy, sputum culture, and rapid molecular testing (GeneXpert). When at least one test result came back positive, TB treatment was initiated. In turn, if patients tested negative but presented with severe clinal symptoms, TB preventive treatment was initiated. Screening for TB was not performed systematically in the control group. The primary outcome assessed in this study was death from all causes, and secondary outcomes included sensitivity and specificity of this screening test, as well as its detection time. RESULTS: This study evaluated 581 patients, 377 in the intervention group (64.9%) and 204 in the control group (35.1%). In total, 36 patients died during the follow-up period. Of these, 26 (6.9%) were from the intervention group, reaching a cumulative mortality coefficient of 69 per 1,000 inhabitants, and 10 (4.9%) from the control group (p = 0.341), with a cumulative mortality coefficient of 49 per 1,000 inhabitants (p = 0.341).

Download Full-text