Delayed Effect of Acupuncture Treatment in OA of the Knee: A Blinded, Randomized, Controlled Trial

To assess the efficacy in providing improved function and pain relief by administering 8 weeks of acupuncture as adjunctive therapy to standard care in elderly patients with OA of the knee. This randomized, controlled, blinded trial was conducted on 55 patients with OA of the knee. Forty-one patients completed the study (26 females, 15 males, mean age ± SD 71.7 ± 8.6 years). Patients were randomly divided into an intervention group that received biweekly acupuncture treatment (n= 28) and a control group that received sham acupuncture (n= 27), both in addition to standard therapy, for example, NSAIDS, cyclooxygenase-2 inhibitors, acetaminophen, intra-articular hyaluronic acid and steroid injections. Primary outcomes measures were changes in the Knee Society Score (KSS) knee score and in KSS function and pain ratings at therapy onset, at 8 weeks (closure of study) and at 12 weeks (1 month after last treatment). Secondary outcomes were patient satisfaction and validity of sham acupuncture. There was significant improvement in all three scores in both groups after 8 and 12 weeks compared with baseline (P< .05). Significant differences between the intervention and control groups in the KSS knee score (P= .036) was apparent only after 12 weeks. Patient satisfaction was higher in the intervention group. Adjunctive acupuncture treatment seems to provide added improvement to standard care in elderly patients with OA of the knee. Future research should determine the optimal duration of acupuncture treatment in the context of OA.

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Feasibility of a Pilot Randomized Controlled Trial Examining a Multidimensional Intervention in Women with Gynecological Cancer at Risk of Lymphedema

Current Oncology ◽

10.3390/curroncol28010048 ◽

2021 ◽

Vol 28 (1) ◽

pp. 455-470

Author(s):

Shirin M. Shallwani ◽

Anna Towers ◽

Anne Newman ◽

Shannon Salvador ◽

Angela Yung ◽

...

Keyword(s):

At Risk ◽

Risk Reduction ◽

Controlled Trial ◽

Gynecological Cancer ◽

Intervention Group ◽

Future Research ◽

Control Group ◽

Randomized Controlled ◽

Reduction Strategies ◽

Risk Reduction Strategies

There is limited knowledge on non-invasive lymphedema risk-reduction strategies for women with gynecological cancer. Understanding factors influencing the feasibility of randomized controlled trials (RCTs) can guide future research. Our objectives are to report on the design and feasibility of a pilot RCT examining a tailored multidimensional intervention in women treated for gynecological cancer at risk of lymphedema and to explore the preliminary effectiveness of the intervention on lymphedema incidence at 12 months. In this pilot single-blinded, parallel-group, multi-centre RCT, women with newly diagnosed gynecological cancer were randomized to receive post-operative compression stockings and individualized exercise education (intervention group: IG) or education on lymphedema risk-reduction alone (control group: CG). Rates of recruitment, retention and assessment completion were recorded. Intervention safety and feasibility were tracked by monitoring adverse events and adherence. Clinical outcomes were evaluated over 12 months: presence of lymphedema, circumferential and volume measures, body composition and quality of life. Fifty-one women were recruited and 36 received the assigned intervention. Rates of recruitment and 12-month retention were 47% and 78%, respectively. Two participants experienced post-operative cellulitis, prior to intervention delivery. At three and six months post-operatively, 67% and 63% of the IG used compression ≥42 h/week, while 56% engaged in ≥150 weekly minutes of moderate-vigorous exercise. The cumulative incidence of lymphedema at 12 months was 31% in the CG and 31.9% in the IG (p = 0.88). In affected participants, lymphedema developed after a median time of 3.2 months (range, 2.7–5.9) in the CG vs. 8.8 months (range, 2.9–11.8) in the IG. Conducting research trials exploring lymphedema risk-reduction strategies in gynecological cancer is feasible but challenging. A tailored intervention of compression and exercise is safe and feasible in this population and may delay the onset of lymphedema. Further research is warranted to establish the role of these strategies in reducing the risk of lymphedema for the gynecological cancer population.

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Evaluation of FunFRIENDS program in prevention of anxiety in Brazilian children: a randomized controlled pilot trial

Ciência & Saúde Coletiva ◽

10.1590/1413-812320202511.33072018 ◽

2020 ◽

Vol 25 (11) ◽

pp. 4497-4508

Author(s):

Lina Maria Herrera Nunez Rivero ◽

André Luiz Monezi Andrade ◽

Larissa Zeggio Perez Figueredo ◽

Bruno de Oliveira Pinheiro ◽

Denise De Micheli

Keyword(s):

Pilot Trial ◽

Intervention Group ◽

Anxiety Symptoms ◽

Future Research ◽

Control Group ◽

Behavioral Profile ◽

Intention To Treat ◽

Randomized Controlled ◽

Allocation Ratio ◽

The City

Abstract This study aimed to evaluate the effects of the FunFRIENDS protocol on anxiety symptoms, internalizing problems and prosocial behavior in 4- to 5-year old children. Participated of this study 43 children with an allocation ratio of 1:1 between groups (Intervention Group [IG], N = 21; Control Group [CG], N = 22) from a public school in the city of Sao Paulo participated in the study. Behaviors were evaluated by using standardized questionnaires (PAS, CBCL, SDQ, SCBE) assessing the behavioral profile of the children at three different periods; baseline (T0), one month (T1) and three months (T2) after the intervention. It was observed a reduction in the intensity of anxiety symptoms in the IG after the intervention but with no significant effect. Overall, there were no significant differences between the IG and the CG in most behaviors on all periods evaluated. On both Intention-to-Treat analyses also it was not detected significant effects of the intervention. This is the first Brazilian study evaluating the effects of FunFRIENDS program and the implications of these findings are discussed and its significance for future research.

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Effects of Acupuncture on Cardiac Remodeling in Patients with Persistent Atrial Fibrillation: Results of a Randomized, Placebo-Controlled, Patient- and Assessor-Blinded Pilot Trial and Its Implications for Future Research

Medicina ◽

10.3390/medicina58010041 ◽

2021 ◽

Vol 58 (1) ◽

pp. 41

Author(s):

Jung Myung Lee ◽

Seung Min Kathy Lee ◽

Jungtae Leem ◽

Jin-Bae Kim ◽

Jimin Park ◽

...

Keyword(s):

Atrial Fibrillation ◽

Treatment Group ◽

Cardiac Remodeling ◽

Acupuncture Treatment ◽

Sham Acupuncture ◽

Acupuncture Group ◽

Future Research ◽

Control Group ◽

Sham Acupuncture Group ◽

Af Recurrence

Background and Objectives: In this study, we attempted to determine the effects of acupuncture on cardiac remodeling and atrial fibrillation (AF) recurrence rates in patients with AF after electrical cardioversion (EC). Materials and Methods: We randomly assigned 44 patients with persistent AF to an acupuncture group or a sham acupuncture group. An electroacupuncture treatment session was administered once weekly for 12 weeks at four acupuncture points (left PC5, PC6, ST36, and ST37). Results: Among the 44 recruited participants, 16 (treatment group) and 15 (control group) completed the trial. The three-month AF recurrence rate (primary outcome) was not significantly different between the two groups. Following the completion of treatment, patients who had been treated with acupuncture had a significant reduction in left atrial volume index (42.2 ± 13.9 to 36.1 ± 9.7 mL/m2; p = 0.028), whereas no change in atrial size was observed in the sham acupuncture group. No serious adverse events were observed. The AF recurrence rate and cardiac function did not differ significantly between the two groups. At three months, the acupuncture treatment group showed more favorable atrial structural remodeling compared to the sham acupuncture group. Conclusion: In future research on acupuncture in AF management, it is recommended that the inclusion criteria be amended to include only symptomatic AF, that an appropriate control group is designed, and that the acupuncture treatment frequency is increased to several times per week.

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The impact of medication reviews conducted in primary care on hospital admissions and mortality - a randomized controlled trial

10.21203/rs.2.11674/v1 ◽

2019 ◽

Author(s):

Veronica Milos Nymberg ◽

Cecilia Lenander ◽

Beata Borgström Bolmsjö

Keyword(s):

Primary Care ◽

Elderly Patients ◽

Usual Care ◽

Frail Elderly ◽

Hospital Admissions ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Medication Reviews ◽

The Impact

Abstract Background Drug-related problems among the elderly population are common and increasing. Multi-professional medication reviews (MR) have arisen as a method to optimize drug therapy for frail elderly patients. Research has not yet been able to show conclusive evidence of the effect of MRs on mortality or hospital admissions. Aim The aim of this study was to assess the impact of MRs’ on hospital admissions and mortality after six and 12 months in a frail population of 369 patients in primary care in a randomized controlled study. Methods Patients were blindly randomized to an intervention group (receiving MRs) and a control group (receiving usual care). Descriptive data on mortality and hospital admissions at six and 12 months were collected. Survival analysis was performed for time to death and time to the first hospital admission within 12 months. Results Of the total number of 369 included patients, 182 were randomized to the intervention group and 187 to the control group. Most of the patients (75%) were females and lived in nursing homes. At six months, 50 patients of the baseline population (27%) in the control group had been admitted to hospital at least once, compared to 40 patients (21%) in the intervention group. At 12 months, the percentage had increased to 70 (37%) in the control group compared to 53 (29%) in the intervention group. Compared to usual care, we found that MRs reduced the risk of hospital admissions within 12 months by 36% (HR = 0.64, 95% CI 0.45-0.90), but found no difference on mortality (HR = 1.12, 95% CI 0.78-1.61) between the groups. Conclusion We suggest that MRs should be recommended in the care of frail elderly patients with expected benefits on hospital admissions.

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Assessing the Efficacy of an Educational Smartphone or Tablet App With Subdivided and Interactive Content to Increase Patients’ Medical Knowledge: Randomized Controlled Trial (Preprint)

10.2196/preprints.10742 ◽

2018 ◽

Author(s):

Thomas Timmers ◽

Loes Janssen ◽

Yvette Pronk ◽

Babette C van der Zwaard ◽

Sander Koëter ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Standard Care ◽

Controlled Trial ◽

Treatment Options ◽

Intervention Group ◽

Control Group ◽

Perceived Knowledge ◽

Actual Knowledge ◽

Positive Effects ◽

Randomized Controlled

BACKGROUND Modern health care focuses on shared decision making (SDM) because of its positive effects on patient satisfaction, therapy compliance, and outcomes. Patients’ knowledge about their illness and available treatment options, gained through medical education, is one of the key drivers for SDM. Current patient education relies heavily on medical consultation and is known to be ineffective. OBJECTIVE This study aimed to determine whether providing patients with information in a subdivided, categorized, and interactive manner via an educational app for smartphone or tablet might increase the knowledge of their illness. METHODS A surgeon-blinded randomized controlled trial was conducted with 213 patients who were referred to 1 of the 6 Dutch hospitals by their general practitioner owing to knee complaints that were indicative of knee osteoarthritis. An interactive app that, in addition to standard care, actively sends informative and pertinent content to patients about their illness on a daily basis by means of push notifications in the week before their consultation. The primary outcome was the level of perceived and actual knowledge that patients had about their knee complaints and the relevant treatment options after the intervention. RESULTS In total, 122 patients were enrolled in the control group and 91 in the intervention group. After the intervention, the level of actual knowledge (measured on a 0-36 scale) was 52% higher in the app group (26.4 vs 17.4, P<.001). Moreover, within the app group, the level of perceived knowledge (measured on a 0-25 scale) increased by 22% during the week within the app group (from 13.5 to 16.5, P<.001), compared with no gain in the control group. CONCLUSIONS Actively offering patients information in a subdivided (per day), categorized (per theme), and interactive (video and quiz questions) manner significantly increases the level of perceived knowledge and demonstrates a higher level of actual knowledge, compared with standard care educational practices. CLINICALTRIAL International Standard Randomized Controlled Trial Number ISRCTN98629372; http://www.isrctn.com/ISRCTN98629372 (Archived by WebCite at http://www.webcitation.org/73F5trZbb)

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A Community Pharmacist-led Smoking Cessation Intervention Using a Smartphone App (PharmQuit): A Randomized Controlled Trial

10.21203/rs.3.rs-108689/v1 ◽

2020 ◽

Author(s):

Narong Asayut ◽

Phayom Sookaneknun Olson ◽

Juntip Kanjanasilp ◽

Preut Thanarat ◽

Bhattaraporn Senkraigul ◽

...

Keyword(s):

Smoking Cessation ◽

Standard Care ◽

Controlled Trial ◽

Intervention Group ◽

Community Pharmacists ◽

Adherence Rate ◽

Smartphone App ◽

Control Group ◽

Randomized Controlled ◽

Smoking Cessation Services

Abstract Background: WHO supports the harnessing of mobile technologies to improve access to smoking cessation services. PharmQuit, a smartphone app, was developed to support smoking cessation efforts by pharmacists taking into consideration the design of the app according to the needs of smokers. This study evaluated the effectiveness of smoking cessation services conducted by community pharmacists using PharmQuit compared with standard care.Methods: An open-label prospective, randomized, controlled trial was conducted. Stratified random sampling by sex, age, and nicotine addiction was used to allocate participants to either the intervention group or control group. Eligible participants were smokers 18 years old or older who smoked at least one cigarette daily for a month, were ready to quit, willing to participate, and had a smartphone. The study was performed at seven community pharmacies situated in three provinces in Thailand. In the intervention group, participants received smoking cessation services by community pharmacists using PharmQuit. The control group received standard care delivered by community pharmacists. Both groups were scheduled follow-ups at day 7, 14, 30, 60, 120, and 180. The primary outcomes were quit rate and number of cigarettes smoked per day. Secondary outcomes were exhaled carbon monoxide levels, adherence rate to the program, and satisfaction with PharmQuit. Analysis using the intent-to-treat principle was carried out. Results: A total of 156 smokers were randomly assigned to either the intervention (n=78) or control (n=78) group. Smoking cessation rates and the number of cigarettes smoked per day were significantly better over the follow-up visits in both groups (p<0.05). However, there were no statistically significant differences between the two groups. Adherence rate to the smoking cessation program was higher in the intervention group than the control group (74 days vs 60 days, p>0.05). Relapse rate was found to be lower in the intervention group as compared to the control group (28.6% vs 71.4%). Conclusions: The results showed obvious benefits of the community pharmacist’s contribution in helping smokers quit smoking. PharmQuit was not better than just pharmacist’s counselling but it might help to obtain better adherence to smoking cessation programs, and have less likelihood of relapse. Trial registration: Thai Clinical Trials Registry: TCTR20200925004. Registration date September 25, 2020 – Retrospectively registered, http://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=6841

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Evaluation of the efficacy of sofosbuvir plus daclatasvir in combination with ribavirin for hospitalized COVID-19 patients with moderate disease compared with standard care: a single-centre, randomized controlled trial

Journal of Antimicrobial Chemotherapy ◽

10.1093/jac/dkaa332 ◽

2020 ◽

Vol 75 (11) ◽

pp. 3373-3378 ◽

Cited By ~ 9

Author(s):

Hamideh Abbaspour Kasgari ◽

Siavash Moradi ◽

Amir Mohammad Shabani ◽

Farhang Babamahmoodi ◽

Ali Reza Davoudi Badabi ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Hospital Stay ◽

Standard Care ◽

Controlled Trial ◽

Intervention Group ◽

Length Of Hospital Stay ◽

Control Group ◽

Single Centre ◽

Mazandaran Province ◽

Randomized Controlled

Abstract Background New therapeutic options are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). Repurposing existing pharmaceuticals provides an immediate treatment opportunity. We assessed the efficacy of sofosbuvir and daclatasvir with ribavirin for treating patients with COVID-19. Methods This was a single-centre, randomized controlled trial in adults with moderate COVID-19 admitted to the Ghaem Shahr Razi Hospital in Mazandaran Province, Iran. Patients were randomly assigned to 400 mg sofosbuvir, 60 mg daclatasvir and 1200 mg ribavirin (intervention group) or to standard care (control group). The primary endpoint of this study was length of hospital stay. This study is registered by IRCT.ir under the ID: IRCT20200328046886N1. Results Between 20 March 2020 and 8 April 2020, 48 patients were recruited; 24 patients were randomly assigned to the intervention group and 24 to the control group. The median duration of hospital stay was 6 days in both groups (P = 0.398). The number of ICU admissions in the sofosbuvir/daclatasvir/ribavirin group was not significantly lower than the control group (0 versus 4, P = 0.109). There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234). The cumulative incidence of recovery was higher in the sofosbuvir/daclatasvir/ribavirin arm (Gray’s P = 0.033). Conclusions This randomized trial was too small to make definitive conclusions. There were trends in favour of the sofosbuvir/daclatasvir/ribavirin arm for recovery and lower death rates. However, there was an imbalance in the baseline characteristics between the arms. Larger randomized trials should be conducted to investigate this treatment further.

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A web-based dietary intervention in early pregnancy and neonatal outcomes: a randomized controlled trial

Journal of Public Health ◽

10.1093/pubmed/fdy117 ◽

2018 ◽

Vol 41 (2) ◽

pp. 371-378 ◽

Cited By ~ 2

Author(s):

R A K Kennedy ◽

C M E Reynolds ◽

S Cawley ◽

E O’Malley ◽

D M McCartney ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Standard Care ◽

Dietary Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Neonatal Outcomes ◽

Dietary Behaviour ◽

Control Group ◽

Evidence Based ◽

Randomized Controlled

Abstract Background Maternal nutrition is a determinant of pregnancy outcomes. Few studies have evaluated the potential of online nutrition resources to modify behaviour. This randomized controlled trial aimed to determine whether access to a customized evidence-based nutrition website in pregnancy improved neonatal outcomes. Methods Women <18 weeks gestation were recruited at their convenience. The control group received standard care. In addition to standard care, the intervention group received access to an evidence-based nutrition website, customized to the preferences of pregnant women. Results Of the 250 women, there were no differences in characteristics between the two groups. Of the women, 91.0% reported they make a conscious effort currently to eat a healthy diet. However, only 19.6% met dietary requirements for calcium, 13.2% for iron, 2.7% for folate and 2.3% for iodine. The most popular website section was pregnancy nutrition advice but engagement was not sustained. Access to the website was not associated with any improvement in clinical outcomes (P > 0.05). Conclusions We found that provision of a customized website providing nutrition information, did not improve neonatal outcomes. Future studies should explore whether redesign with website interactivity or embedding information on popular digital platforms sustains women’s engagement and modifies dietary behaviour.

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AYUSH-64 as add-on to standard care in asymptomatic and mild cases of COVID-19: A randomized controlled trial

10.31219/osf.io/pgraf ◽

2021 ◽

Author(s):

R. Govind Reddy ◽

Rajesh V Gosavi ◽

Babita Yadav ◽

Amit Kumar Rai ◽

Madhuri P Holay ◽

...

Keyword(s):

Inflammatory Markers ◽

Clinical Cure ◽

Standard Care ◽

Intervention Group ◽

Conventional Care ◽

Control Group ◽

Rt Pcr ◽

Clinical Recovery ◽

Randomized Controlled ◽

And Control

Background: The evidence on the efficacy and safety of Ayurveda interventions as add-on to the standard conventional care for COVID-19 is limited. This study was planned to explore the potential of AYUSH-64 as add-on to conventional care in improving the clinical recovery and negative RT-PCR conversion in asymptomatic and mild COVID-19 cases. Materials and Methods: An open-label randomized controlled study was conducted at Government Medical College, Nagpur, Maharashtra, India with a sample size of 60 participants. In this study, asymptomatic or mild COVID-19 patients were randomized and allocated into intervention and control group in 1:1 ratio. AYUSH-64 two capsules (500 mg each) were administered thrice daily, after food with water for 30 days along with standard care in the intervention group, while the control group received only standard care. The effect of the interventions was assessed in terms of negative RT-PCR for COVID-19, clinical cure rate and inflammatory cytokines.Outcome measures: Primary outcome was the time to attain negative RT-PCR for COVID-19 and proportion of participants turned RT-PCR negative for COVID-19 at 7th, 15th, 22nd and 30th day respectively in the intervention group compared to the control group. Secondary outcomes were the proportion of participants who attained clinical recovery at 7th, 15th, 22nd, and 30thday; improvement in laboratory parameters on the 30th day (as compared to baseline) and incidence of Adverse Drug Reactions/Adverse Events (ADRs/AEs). The data was compared within group using paired sample t-test/ Wilcoxon signed rank test and between group using independent sample t-test/Mann-Whitney test. Results: Statistically significant difference was not observed in the proportion of participants who turned RT-PCR negative during each of the follow-ups (p=0.134) and both groups demonstrated comparable efficacy. The clinical recovery rate in terms of time taken for complete cure of symptoms in the symptomatic participants was 60% and 37% on day 15 (p=0.098) and 100% and 85.2% on day 30 (p=0.112), in the intervention and control group respectively which is numerically a better clinical outcome in the intervention group. The improvement in the inflammatory markers such as IL-6, TNF-α and D-dimer was statistically significant in the intervention group (p<0.05). None of the participants developed any complications nor were any significant ADR/AE observed in both the groups.Conclusion: In patients with asymptomatic and mild COVID-19, AYUSH-64 as add-on to standard conventional care, contributed to improving the duration for attaining complete clinical cure and demonstrated potential in reducing the levels of pro-inflammatory markers in the body.

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The Effect of Pre-Consultation Information Videos on Patients Undergoing Carpal Tunnel Surgery: A Randomised Control Trial (Preprint)

10.2196/preprints.23291 ◽

2020 ◽

Author(s):

Reece Tso ◽

Tristan Symonds ◽

Justin Smith ◽

Peter Bovey

Keyword(s):

Patient Satisfaction ◽

Carpal Tunnel ◽

Intervention Group ◽

Randomised Control Trial ◽

Future Research ◽

Control Group ◽

Web Based ◽

Carpal Tunnel Surgery ◽

Consultation Time ◽

Web Based Education

BACKGROUND Preoperative patient education is essential in ensuring patient satisfaction and optimising outcomes. With advances in technology, web-based education for preoperative care has become a useful tool to enhance in person consultations. OBJECTIVE The aim of this study was to determine the effect of web-based pre-consultation education videos on patient satisfaction and consultation time for patients undergoing carpal tunnel surgery (CTS). METHODS A randomised control study was conducted in Townsville. Participants were randomised in a 1:1 ratio to receive either a web-based or no pre-consultation video prior to consultation. After the consultation, patients completed a Likert scale questionnaire on the content of the video and their overall satisfaction with it. Consultation time was measured from the time patients entered the room to when they exited the room. Statistical analysis was performed using Stata V16. RESULTS There were 60 patients included in the analysis, with 30 in the intervention group and 30 in the control group. The results demonstrated a marginally higher satisfaction rate with the intervention group compared to the control group however this was not statistically significant (77% vs 70%, p = 0.559). Additionally, consultation time was found to be lower in the intervention group (6.4 minutes) when compared to the control group (12 minutes), with very strong evidence to suggest an association (p < 0.0001). CONCLUSIONS This study demonstrated that participants undergoing carpal tunnel surgery who engaged in pre consultation web-based education had a decreased consultation time and similar overall satisfaction. This suggests that web-based education may have a beneficial role for both surgeons and patients. Future research should be conducted to determine the optimal web-based education and to consider needs based education as a means of increasing patient satisfaction.

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