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Abstract Background Many individuals consider nocturia a significant nuisance, leading to a reduced health-related quality of life (HRQOL). However, there has been a lack of psychometrically sound patient-reported outcome measures to assess the impact of nocturia on patients in Chinese contexts. This study aimed to translate, culturally adapt, and validate the International Consultation on Incontinence Questionnaire Nocturia Quality of Life Module (ICIQ-NQOL) for use among primary care patients in Hong Kong, China. Additionally, it sought to investigate the mechanisms that link nocturia and sleep quality with HRQOL by employing moderated mediation analysis. Methods The traditional Chinese version of the ICIQ-NQOL was developed through iterative translations, cognitive debriefing interviews, and panel reviews. The psychometric evaluation included assessments of factor structure, convergent validity, concurrent validity, known-group validity, internal consistency, test-retest reliability and responsiveness. Study instruments included the ICIQ-NQOL, International Prostate Symptom Score (IPSS), Pittsburgh Sleep Quality Index (PSQI), and a modified Incontinence Impact Questionnaire-Short Form (IIQ-7). Results A total of 419 primary care patients were recruited from general outpatient clinics, among whom 228 experiencing an average of two or more nocturia episodes per night over the past four weeks. Confirmatory factor analysis supported the two-factor structure of the ICIQ-NQOL. Concurrent validity was confirmed by moderate correlations between the IIQ-7 total score and the total score as well as two domain scores of the ICIQ-NQOL (r ranging from 0.43 to 0.49, all p

Background Loneliness is a prevalent and alarming issue among older adults that requires effective interventions. While randomised controlled trials have been commonly undertaken to explore reduction in loneliness, there is a growing recognition that a comprehensive treatment strategy involving multiple interventions may yield better outcomes. Therefore, this study aims to develop and identify a two-stage adaptive intervention that combines telephone-delivered behavioural activation (Tele-BA) and mindfulness techniques (Tele-MF) to reduce loneliness in older adults in Hong Kong.Methods A Sequential, Multiple Assignment, Randomised Trial (SMART) design will be adopted. 244 lonely older adults will be recruited from the community and randomly assigned to either one of the 4-week two-stage, embedded adaptive interventions involving different sequences and dosages of Tele-BA and Tele-MF (eg, 4 weeks of Tele-BA followed by booster sessions for responders or 4 weeks of Tele-BA followed by 4 weeks of Tele-BA with motivational component or 4 weeks of Tele-MF for non-responders) based on a set of decision rules. The primary outcome will be loneliness measured by the Revised University of California Los Angeles (UCLA) Loneliness Scale. Secondary outcomes, such as De Jong Gierveld Loneliness Scale, perceived stress, sleep quality and depressive and anxiety symptoms, will be assessed. Adhering to the intention-to-treat principles, the data will be analysed using linear mixed models. The findings may have implications for the development of psychosocial adaptive interventions involving BA and MF to reduce loneliness and improve well-being among older adults in Hong Kong using the SMART design.Ethics and dissemination Ethical approval was obtained by the Human Research Ethics Committee at The Education University of Hong Kong (reference: 2022-2023-0117). The findings from this study will be presented in academic conferences and submitted for publication.Trial registration number ChiCTR2300077472.

Abstract Neurodegenerative diseases (NDDs) are characterized by neuronal damage and progressive loss of neuron function. Microbiome-based interventions, such as dietary interventions, biotics, and fecal microbiome transplant, have been proposed as a novel approach to managing symptoms and modulating disease progression. Emerging clinical trials have investigated the efficacy of interventions modulating the GM in alleviating or reversing disease progression, yet no comprehensive synthesis have been done. A systematic review of the literature was therefore conducted to investigate the efficacy of microbiome-modulating methods. The search yielded 4051 articles, with 15 clinical trials included. The overall risk of bias was moderate in most studies. Most microbiome-modulating interventions changed the GM composition. Despite inconsistent changes in GM composition, the meta-analysis showed that microbiome-modulating interventions improved disease burden (SMD, − 0.57; 95% CI − 0.93 to − 0.21; I2 = 42%; P = 0.002) with a qualitative trend of improvement in constipation. However, current studies have high methodological heterogeneity and small sample sizes, requiring more well-designed and controlled studies to elucidate the complex linkage between microbiome, microbiome-modulating interventions, and NDDs.

Abstract The effects of technology-supported behavior change interventions for reducing sodium intake on health outcomes in adults are inconclusive. Effective intervention characteristics associated with sodium reduction have yet to be identified. A systematic review and meta-analysis were conducted, searching randomized controlled trials (RCTs) published between January 2000 and April 2023 across 5 databases (PROSPERO: CRD42022357905). Meta-analyses using random-effects models were performed on 24-h urinary sodium (24HUNa), systolic blood pressure (SBP), and diastolic blood pressure (DBP). Subgroup analysis and meta-regression of 24HUNa were performed to identify effective intervention characteristics. Eighteen RCTs involving 3505 participants (51.5% female, mean age 51.6 years) were included. Technology-supported behavior change interventions for reducing sodium intake significantly reduced 24HUNa (mean difference [MD] −0.39 gm/24 h, 95% confidence interval [CI] −0.50 to −0.27; I 2 = 24%), SBP (MD −2.67 mmHg, 95% CI −4.06 to −1.29; I 2 = 40%), and DBP (MD −1.39 mmHg, 95% CI −2.31 to −0.48; I 2 = 31%), compared to control conditions. Interventions delivered more frequently (≤weekly) were associated with a significantly larger effect size in 24HUNa reduction compared to less frequent interventions (>weekly). Other intervention characteristics, such as intervention delivery via instant messaging and participant-family dyad involvement, were associated with larger, albeit non-significant, effect sizes in 24HUNa reduction when compared to other subgroups. Technology-supported behavior change interventions aimed at reducing sodium intake were effective in reducing 24HUNa, SBP, and DBP at post-intervention. Effective intervention characteristics identified in this review should be considered to develop sodium intake reduction interventions and tested in future trials, particularly for its long-term effects.

Abstract Background Family caregiver interventions are essential to support dementia caregiving. However, such interventions are typically complex and consist of multiple components. Existing evidence rarely delineates the effectiveness and interactions between individual components. To optimise intervention, we adopt the multiphase optimisation strategy (MOST) to test the implementation fidelity and determine the effect of each component and the interactions between each component and the corresponding outcome. Methods A prospective, assessor-blinded, randomised clinical trial with fractional factorial design using the MOST principle. Two hundred fifty family dementia caregivers will be randomised to one of 16 experimental conditions in a fractional factorial design involving six intervention components: (1) dementia and caregiving education; (2) self-care skills; (3) behavioural symptom management; (4) behavioural activation; (5) modified mindfulness-based cognitive therapy; and (6) support group. The first one is the core component, and the five remaining will be examined. Physical health, caregiver burden, stress, psychological well-being, anxiety and depressive symptoms, and social support will be assessed over the 12-month study period. Following the intention-to-treat principle, linear mixed models and regression analyses will be used to examine the specific effect of the five components and their two-way interactions to propose the most effective combination. Discussion This is the first study adopting the multiphase optimisation strategy to identify the most active and engaging components of a psychological intervention for caregivers of patients with dementia. In view that dementia caregiver interventions are increasingly diversified and complex, such knowledge is important to maximise the intervention efficacy and allow the intervention to be implemented within an efficient timeframe and dosage. The optimisation of caregiver support interventions is critical to enhance the health outcomes of caregivers and care recipients, thereby, delaying possible institutionalisation and reducing the costs of long-term dementia care. Trial registration This study was retrospectively registered in the WHO Primary Registry – Chinese Clinical Trials Registry (ChiCTR2300071235). (Protocol date 30/10/2020; version identifier 2020–2021-0045). Registered on 9 May, 2023. Reporting method SPIRIT guideline was followed. Patient or public contribution No patient or public involvement.

Background: Interventions to reduce loneliness in older adults usually do not show sustained effects. One potential way to combat loneliness is to offer meaningful social activities. Volunteering has been suggested as one such activity – however, its effects on loneliness remain to be tested in randomized controlled trials (RCT). Methods: This planned Dual-RCT aims to recruit older adults experiencing loneliness, with subsequent randomization to either a volunteering condition (6 weeks of training before delivering one of three tele-based loneliness interventions to older intervention recipients twice a week for 6 months) or to an active control condition (psycho-education with social gatherings for six months). Power analyses require the recruitment of N = 256 older adults to detect differences between the volunteering and the active control condition (128 in each) on the primary outcome of loneliness (UCLA Loneliness Scale). Secondary outcomes comprise social network engagement, perceived social support, anxiety and depressive symptoms, self-rated health, cognitive health, perceived stress, sleep quality, and diurnal cortisol (1/3 of the sample). The main analyses will comprise condition (volunteering vs. no-volunteering) × time (baseline, 6-, 12-, 18-, 24-months follow-ups) interactions to test the effects of volunteering on loneliness and secondary outcomes. Effects are expected to be mediated via frequency, time and involvement in volunteering. Discussion: If our trial can show that volunteers delivering one of the three telephone-based interventions to lonely intervention recipients benefit from volunteer work themselves, this might encourage more older adults to volunteer, helping to solve some of the societal issues involved with rapid demographic changes.

Abstract Background Between 40 and 50% of patients with Parkinson’s disease (PD) experience anxiety and depression, associated with impaired physical function, high care dependency and mortality. Recently, the United States National Institutes of Health has urged the implementation of mindfulness practices in chronic illness care. Most research to date has examined the effects on chronically ill patients of complex interventions using a combination of mindfulness techniques. In PD patients, however, such complex modalities appear to hinder the technique mastery. Hence, the aim of this trial is to investigate the effects and underlying mechanism of individual mindfulness techniques among PD patients, as well as exploring participants’ experience in using individual mindfulness techniques as a lifestyle intervention for stress and symptom management. Methods We will conduct an assessor-blind three-arm randomized waitlist-controlled trial with a descriptive qualitative evaluation. Up to 168 PD patients will be recruited from community settings and out-patient clinics, and randomized to meditation, yoga, or usual care group. Meditation and yoga sessions of 90-minute are held weekly for 8 weeks. Primary outcomes include anxiety and depression. Secondary outcomes include PD-related motor and non-motor symptoms and quality-of-life; and level of mindfulness and biomarkers of stress and inflammatory responses will be measured as mediating variables. All outcome evaluations will be assessed at baseline, 8 weeks, and 24 weeks. Following the intention-to-treat principle, generalized estimating equation models and path analysis will be used to identify the treatment effects and the mediating mechanisms. A subsample of 30 participants from each intervention group will be invited for qualitative interviews. Discussion The study would also generate important insights to enhance the patients’ adaptation to debilitating disease. More specifically, symptom management and stress adaptation are highly prioritized healthcare agenda in managing PD. The research evidence will further inform the development of community-based, nurse-led compassionate care models for neurodegenerative conditions, which is complementary to existing health services. Trial registration WHO Primary Registry – Chinese Clinical Trials Registry number: ChiCTR2100045939; registered on 2021/04/29 ( https://www.chictr.org.cn/showproj.html?proj=125878 ).

Objectives To compare the associations of COVID-19 preventive behaviours and depressive and anxiety symptoms with eHealth literacy and COVID-19 knowledge among Korean adults.Design A cross-sectional online survey was conducted in April 2020.Setting Seoul metropolitan area in South Korea.Participants 1057 Korean adults were recruited.Main outcome measures Associations between eHealth literacy, COVID-19 knowledge, COVID-19 preventive behaviours and psychological distress were computed using Pearson’s correlation and logistic regression analyses. eHealth literacy, COVID-19 knowledge, COVID-19 preventive behaviours and psychological distress were weighted by sex and age distribution of the general population in Seoul Metropolitan area.Results 68.40% (n=723) perceived high eHealth literacy level (eHEALS ≥26), while 57.43% (n=605) had high levels of COVID-19 knowledge (score ≥25). No significant association between eHealth literacy and COVID-19 knowledge was identified (r=0.05, p=0.09). eHealth literacy and COVID-19 knowledge were significantly associated with COVID-19 preventive behaviours (aOR=1.99, 95% CI 1.51 to 2.62 L; aOR=1.81, 95% CI 1.40 to 2.34, respectively). High eHealth literacy was significantly associated with anxiety symptom (aOR=1.71, 95% CI 1.18 to 2.47) and depressive symptom (aOR=1.69, 95% CI 1.24 to 2.30). COVID-19 knowledge had negative and no associations with the symptoms (aOR=0.62, 95% CI 0.46 to 0.86; aOR=0.79, 95% CI 0.60 to 1.03, respectively). High eHealth literacy with low COVID-19 knowledge was positively and significantly associated with COVID-19 preventive behaviours (aOR=2.30, 95% CI 1.52 to 3.43), and anxiety (aOR=1.81, 95% CI 1.09 to 3.01) and depressive symptoms (aOR=2.24, 95% CI 1.41 to 3.55). High eHealth literacy with high COVID-19 knowledge were significantly associated with more preventive behaviours (aOR=3.66, 95% CI 2.47 to 5.42) but no significant associations with anxiety and depressive symptoms.Conclusion We identified that eHealth literacy and COVID-19 knowledge were not associated each other, and differently associated with individuals’ COVID-19 preventive behaviours and psychological well-being. Public health strategies should pay attention to enhancing both eHealth literacy and COVID-19 knowledge levels in the public to maximise their COVID-19 preventive behaviours and mitigate their psychological distress during COVID-19 pandemic.

Abstract Clinical practice guidelines support resilience training and exercise for patients with Parkinson’s disease (PD). This assessor-blinded, randomized clinical trial aimed to compare the effects of a modified mindfulness meditation program versus stretching and resistance training exercise (SRTE) in patients with mild-to-moderate PD. A total of 126 potential participants were enrolled via convenience sampling, of which 68 eligible participants were randomized 1:1 to receive eight weekly 90-min sessions of mindfulness meditation or SRTE. Compared to the SRTE group, generalized estimating equation analyses revealed that the mindfulness group had significantly better improvement in outcomes, particularly for improving depressive symptoms (d, −1.66; 95% CI, −3.31 to −0.02) at week 8 and maintaining emotional non-reactivity at week 20 (d, 2.08; 95% CI, 0.59 to 3.56). Both groups demonstrated significant immediate, small-moderate effects on cognition (effect size [d] = 0.36–0.37, p = 0.006–0.011). Compared with the SRTE, mindfulness meditation appeared to be a feasible and promising strategy for managing depressive symptoms and maintaining emotional stability, with comparable benefits on cognitive performance. To combat the psychospiritual and cognitive sequelae of social unrest and COVID-19 pandemic, the integration of mindfulness training into motor-oriented PD rehabilitation protocols is recommended to strengthen the resilience and minimize the psycho-cognitive comorbidities among patients with mild-to-moderate PD. Trial Registration: HKU Clinical Trials Registry identifier: HKUCTR-2681.

BackgroundThe Cognitive Functioning Self-Assessment Scale (CFSS) was developed to allow the self-assessment of perceived cognitive functioning. It has been tested with satisfactory reliability and validity but was not available for the Chinese population. This study aimed to adapt and validate the Chinese version of the CFSS for community-dwelling adults.MethodsA cross-sectional study of a sample of 1,002 Chinese adults from the general population was conducted online (July–August 2022). The Chinese version of the CFSS with 18 items was created through translation, cognitive debriefing, and psychometric evaluation. Exploratory factor analysis (EFA) was performed on the first half of the randomly split sample. A model derived from EFA was confirmed by confirmatory factor analysis (CFA) in the second half of the sample. The model fits were further evaluated with and without subgrouping by age, gender, and education level. Internal consistency was assessed using Cronbach’s alpha (α) and McDonald’s omega hierarchical coefficients (ωH).ResultsEFA (n = 460) revealed a three-factor solution, including spatio-temporal orientation, attention, and memory, which explained 51% of the total variance. The second-order CFA (n = 510) demonstrated a good fit: CFI = 0.951, TLI = 0.944, RMSEA = 0.054, SRMR = 0.040. A second-order multiple-group analysis showed that the structure was invariant by age, gender, and education level. The total CFSS score was significantly associated with the Chinese version of the nine-item Patient Health Questionnaire (r = 0.56, p

Abstract Importance Patients with long-term neurological conditions, such as Parkinson’s disease (PD), are particularly vulnerable to the public health measures taken to combat the COVID-19 pandemic. The inaccessibility of center-based rehabilitation further aggravated their motor dysfunctions as well as mental distress, leading to exacerbation of motor and non-motor symptoms, high healthcare utilization and worsened health-related quality of life (HRQOL). Objective This study aimed to evaluate the feasibility, safety, and preliminary effects of the mHealth-delivered home-based mindfulness yoga program on functional balance, motor symptoms, mental health and HRQOL in patients with PD. Design, setting and participants This prospective, single-arm, non-randomized feasibility study adopted a sequential explanatory mixed-method design. Adults (aged ≥ 18) with a clinical diagnosis of idiopathic Parkinson’s disease (Hoehn and Yahr stage I to III) who were able to stand unaided and walk with or without an assistive device were enrolled via convenience sampling. Intervention Home-based mindfulness yoga training were delivered via video-conferencing software (Zoom) in eight bi-weekly 90-min sessions. Main outcomes and measures This current study measured functional balance, motor symptoms, perceived balance confidence, perceived freezing of gait symptoms, anxiety and depression, mindfulness and HRQOL using a tele-assessment approach at baseline and 1-week post-intervention. All participants were invited to attend qualitative individual interviews to explore their experience of using online mindfulness yoga program as a lifestyle intervention for PD rehabilitation. Results Among the ten patients, 80% completed the program with an adherence rate of 98.4%. All participants were able to learn and practice mindfulness yoga following the eight bi-weekly online mindfulness yoga training sessions, without any significant adverse events. Tele-assessment of outcomes were feasible and uneventful. Qualitative feedback revealed participants had a high preference of using the tele-rehabilitation approach to stay mindful and being active, both physically and socially, while confronting the changes brought by COVID-19 pandemic. Conclusions and relevance The mHealth-delivered home-based mindfulness yoga intervention was feasible, safe, and well-accepted among people with PD to relieve the burden brought by COVID-19 pandemic. Future studies should adopt a design with enhanced rigor, a comparison group, and enlarged sample size to evaluate the efficacy of the program in patients with long-term neurological conditions and/or physical impairments. We recommend a longer intervention duration of at least 8 weeks to enhance the psychophysiological effects.

BackgroundMen who have sex with men (MSM) who practice chemsex have a higher likelihood of engaging in risky sexual behaviors and higher rates of HIV infection and other sexually transmitted infections (STIs) than those who do not. ObjectiveThis trial aimed to evaluate the effectiveness of a web-based intervention in reducing the sexual harms of chemsex among MSM. MethodsThe study was a 2-arm, assessor-blinded, randomized, parallel-group trial with a 3-month follow-up period. The study was conducted in the year 2021 in Hong Kong. Underpinned by the theory of planned behaviors and a harm reduction approach, the intervention consisted of interactive components and knowledge-based information about chemsex. Participants in the control group received brief information and content about sexual violence. The primary outcome was self-efficacy in refusing risky sexual behaviors and chemsex, as measured by the Condom Self-Efficacy Scale (CSES), Self-Efficacy for Sexual Safety (SESS) instrument, and Drug Avoidance Self-Efficacy Scale (DASES). The secondary outcomes included intentions to have chemsex, actual engagement in chemsex, HIV and other STI testing, and condom use in the last 3 months. All outcomes were self-reported. An online structured questionnaire was used to collect data. ResultsIn total, 316 MSM enrolled in the study. The intervention group demonstrated a significantly larger improvement in condom-use self-efficacy (as measured by CSES scores; time-by-group interaction: β=4.52, 95% CI 2.03-7.02; P

Abstract Background Even though the negative impacts of nocturia on sleep quality and health-related quality of life (HRQOL) have been documented in previous research, their interrelationship has been poorly studied. This study aimed to explore whether nocturia would affect sleep quality, which in turn affects HRQOL. Methods Participants aged 40 and above were randomly recruited from a Hong Kong public primary care clinic. Participants were asked to report the average number of nocturia (waking up at night to void) pisodes per night over a 1-month period. The Pittsburgh Sleep Quality Index (PSQI) and the 12-Item Short Form Health Survey version 2 (SF-12 v2) were administered. The mediation analysis was tested using multistage regression approach and bootstrap method. Results Of the 500 subjects who completed the survey, 31.2% reported symptomatic nocturia (having ≥2 nocturia episodes per night), and 60.4% experienced poor sleep quality (a PSQI global score > 5). Respondents with symptomatic nocturia had a poorer HRQOL in the domains of physical functioning (PF), role physical (RP) and social functioning (SF), general health (GH), vitality (VT) and physical component summary (PCS) of the SF-12 v2 than those without. Compared with the respondents without poor sleep quality, those with poor sleep quality had poorer HRQOL across all domains and summaries of the SF-12 v2. Mediation analysis found that sleep quality fully mediated the association between nocturia and the PF, RP and SF domains of the SF-12 v2, respectively, and partially mediated the association between nocturia and the GH, VT and PCS domains of the SF-12 v2, respectively. Conclusions We found that sleep quality mediated the association between nocturia and HRQOL. To enhance the HRQOL of patients with nocturia, clinicians should not only focus on nocturia symptoms, but also on their sleep quality.

BackgroundAnxiety, nausea and vomiting are common side effects suffered by paediatric patients receiving chemotherapy. Emerging evidence supports the efficacy of immersive virtual reality (IVR) on improving anxiety and distress symptoms including nausea and vomiting among this vulnerable group. This trial aims to assess the feasibility and acceptability of IVR for preventing and managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy.Method and analysisAn exploratory trial supplemented by qualitative methods will be conducted. We will recruit 20 paediatric patients who are aged between 6 and 12 years, chemotherapy naïve, scheduled to receive their first intravenous chemotherapy and able to understand Chinese. Participants will be randomly allocated to intervention or control groups. The intervention group will receive the IVR intervention for three sessions as follows: 4 hours before chemotherapy, 5 minutes before and during their first course chemotherapy and 5 minutes before and during their second course chemotherapy. The control group will receive standard care only. Main outcome measures included (1) key parameters for the design of a definitive trial (i.e. screening, eligibility, consent and withdrawal rates); (2) anxiety, anticipatory and acute chemotherapy-induced nausea and vomiting for collection of preliminary data; (3) feasibility and acceptability of the intervention. Semi-structured interviews will be conducted with patients, parents and oncology nurses. Generalized estimating equations model will be used to compare each of the outcome measures across the time points between the two groups. Qualitative data will be analysed by conventional content analysis.Expected resultsThe results of this exploratory trial will inform the design and conduct of future definitive trial.Trial registration numberChiCTR1900021694; Pre-results.

Abstract Background Psychological distress is prevalent among people with Parkinson’s disease (PD) and aggravates their motor symptoms, thereby leading to increased disability, high healthcare costs, and poor health-related quality of life (HRQoL). The under-recognition and adverse effects of the pharmacological management of anxiety and depression among the PD population are considerable. Thus, adopting a Complementary and Alternative Management (CAM) approach to address this problem is important. Yoga, one of the most common “mind-body” CAM therapies, can improve the psychological wellbeing of people with chronic illnesses. However, limited research on the effects of yoga in people with PD has been conducted. This study will determine the effects of yoga on the psychological wellbeing of people with mild-to-moderate PD and will compare these effects with those of stretching and resistance training exercises. Methods A community-based, single-blind, randomized trial will be conducted. A total of 126 subjects will be recruited and randomly divided into yoga (n = 63) or stretching and resistance exercise (n = 63) groups. For 8 weeks, the yoga group will receive a weekly 90-min session of yoga, and the control group will receive a weekly 60-min session of stretching and resistance exercises. The primary outcome will be the level of psychological distress measured using the Hospital Anxiety and Depression Scale. The secondary outcomes will include the severity of motor symptoms measured by the Movement Disorders Society – Unified Parkinson’s Disease Scale − Part III Motor Examination; mobility, balance, and fall risk measured by the Timed Up and Go test; spiritual wellbeing measured by the Holistic Wellbeing Scale; and HRQoL measured by the Parkinson’s Disease Questionnaire-8. Assessment will be conducted at baseline, 8th, and 20th weeks of follow-ups. Discussion This study will be the first randomized trial to compare the effect of yoga versus stretching and resistance training exercises in a PD population. Results will contribute to the value of yoga as a therapeutic option for managing psychological distress in PD patients. Multiple outcomes including psychological, physiological, and spiritual and HRQoL will also be measured to elucidate the potential mechanisms of yoga. The effect of yoga on people with chronic illnesses will further be elucidated. This information should contribute to future research, practice, and policy related to PD management. Trial registration WHO Primary Registry – Chinese Clinical Trials Registry (ChiCTR): CUHK_CCRB00522 Registered on 8 October 2016; date of approval 19 August 2016.

Abstract Background Total knee arthroplasty (TKA) is associated with significant perioperative blood loss and postoperative allogenic blood transfusion. Tranexamic acid (TXA) reversibly blocks lysine binding sites on plasminogen molecules and inhibits plasmin formation. Comparisons of the efficacy and safety of intra-articular and intravenous TXA in primary TKA have not previously been reported. Methods A prospective randomized trial was conducted in 150 patients who underwent TKA, and these patients were randomized into three groups. Patients in Group A were injected by intra-articular TXA according to body weight (20 mg/kg). Patients in Group B received a standard dose of intra-articular TXA (2000 mg), and those in Group C were infused with TXA according to body weight (20 mg/kg) before tourniquet deflation and again 3 h later. Baseline characteristics and data collected at blood transfusion were compared. Differences among four time points (baseline, day 0, day 2, and day 5) were carried out using ANOVA. Results The hemoglobin levels at postoperative day 5 were 10.6 g/dL for Group A, 10.6 g/dL for Group B, and 10.7 g/dL for Group C. The drain output was 399 ml for Group A, 314 ml for Group B, and 305 ml for Group C (p = 0.03). Group C had significantly less drain output than Group A after post hoc comparisons (p = 0.05), whereas no significant difference was observed between Group A and B (p = 0.09) or between Group B and C. Conclusion The weight-adjusted dose of TXA administered intravenously significantly reduced the drain output but not the total blood loss when compared with the weight-adjusted dose of TXA administered intra-articularly. No significant difference was observed in the other parameters among the three groups. Trial registration The Joint CUHK-NTEC CREC, CRE-2013.644-T . Registered 1 March 2014.