Factors associated with severe depressive symptoms among Chinese secondary school students in Hong Kong: a large cross-sectional survey.

Background: Many adolescents were reported to have severe depressive symptoms, and a careful assessment of its correlates is essential for prevention and intervention programs. This study aimed to gain insight into the prevalence of severe depressive symptoms and its association with factors at four levels (individual, relationship, school and society) in a large sample of Hong Kong Chinese secondary school students. Methods: Secondary school students from Secondary 1 through 7 were selected as participants using a cluster random sampling method. A questionnaire including inventories measuring 24 factors at the four levels (six individual factors, 11 relationship factors, three school factors, and four society factors) was completed by 8,963 participants (56.3% female) with a mean age of 15.1 (SD = 1.8) years. Students with a score of ≥15 on the Patient Health Questionnaire were defined as having severe depressive symptoms. The association between severe depressive symptoms and correlates were examined by t-test and χ2 test. Logistic regression models using a hierarchical approach then examined the individual contribution of these 24 factors to severe depressive symptoms with the control of other factors in the model. Results: 7.4% of the students have severe depressive symptoms. Twenty-two of the 24 factors were significantly associated with severe depressive symptoms in bivariate analyses. In the logistic regression, 11 factors (three individual factors: age, self-esteem and self-mastery; six relationship factors: tobacco use, alcohol drinking, drug use, paternal psychological control, dinner with parents, and perceived social support from friends; one school factor: felt pressure from homework; and one society factor: number of sibling) were statistically significant. Felt pressure from homework, alcohol drinking, and perceived social support from friends were the strongest correlates of severe depressive symptoms. Conclusion: The prevalence of self-reported severe depressive symptoms in Hong Kong Chinese secondary school students was high, and the identification of multiple associated factors at the four levels simultaneously provides a knowledge basis for the development of a comprehensive, multivariate model of factors influencing severe depressive symptoms in Chinese secondary school students. The factors identified in the present study may be helpful when designing and implementing preventive intervention programs.

Acupuncture for chemotherapy-associated insomnia in breast cancer patients: an assessor-participant blinded, randomized, sham-controlled trial.

BACKGROUND: Insomnia is a highly prevalent symptom occurred during and post-chemotherapy. Acupuncture may have beneficial effects in the management of chemotherapy-associated insomnia. This study was conducted to determine the efficacy and safety of acupuncture in improving chemotherapy-associated insomnia in breast cancer patients. METHODS: This assessor-participant blinded, randomized, sham-controlled trial was conducted from November 2019 to January 2022 (follow-up completed July 2022). Participants were referred by oncologists from two Hong Kong hospitals. Assessments and interventions were conducted at the outpatient clinic of School of Chinese Medicine, the University of Hong Kong. The 138 breast cancer patients with chemotherapy-associated insomnia were randomly assigned to receive either 15 sessions of active acupuncture regimen by combining needling into body acupoints and acupressure on auricular acupoints or sham acupuncture control (69 each) for 18 weeks, followed by 24 weeks of follow-up. The primary outcome was measured using Insomnia Severity Index (ISI). Secondary outcomes included the Pittsburgh Sleep Quality Index, Actiwatch and sleep diary for sleep parameters, depression and anxiety, fatigue and pain, and quality of life. RESULTS: There were 87.7% (121/138) participants who completed the primary endpoint (week-6). The active acupuncture regimen was not superior to the sham control in reducing ISI score from baseline to 6 weeks (mean difference: - 0.4, 95% CI - 1.8-1.1; P = 0.609), but produced short-term treatment and long-term follow-up better outcomes in improving sleep onset latency, total sleep time, sleep efficiency, anxiety, depression, and quality of life. Participants of the active acupuncture group had a pronouncedly higher cessation rate of sleeping medications than the sham control (56.5% vs. 14.3%, P = 0.011). All treatment-related adverse events were mild. No participants discontinued treatments due to adverse events. CONCLUSION: The active acupuncture regimen could be considered as an effective option for the management of chemotherapy-associated insomnia. It also could serve as a tapering approach to reduce and even replace the use of sleeping medications in breast cancer patients. Trial registration Clinicaltrials.gov : NCT04144309. Registered 30 October 2019.

Self-Acupressure for Symptom Management in Cancer Patients: A Systematic Review.

CONTEXT: Acupressure is a popular nonpharmacological intervention that is increasingly proven to effectively alleviate symptoms in patients with cancer. However, the effects of self-acupressure on cancer symptom management are less clear. OBJECTIVES: This systematic review is the first to summarize the current experimental evidence on self-acupressure for symptom management in cancer patients. METHODS: Eight electronic databases were searched for experimental studies that examined self-acupressure for cancer patients with symptoms and published in peer-reviewed English or Chinese journals. The methodological quality of the included studies was evaluated using the revised Cochrane risk-of-bias assessment tool and the JBI critical appraisal checklist for quasi-experimental studies. Data were extracted as predefined and synthesized narratively. The Template for Intervention Description and Replication checklist was used to report the intervention characteristics. RESULTS: A total of 11 studies were included in this study, six as feasibility or pilot trials. The methodological quality of included studies was suboptimal. Substantial heterogeneity was observed in acupressure training, acupoint selection, intervention duration, dosage, and timing. Self-acupressure was only associated with reduced nausea and vomiting (P = 0.006 and P = 0.001). CONCLUSION: The limited evidence from this review precludes the definitive conclusions on intervention effectiveness for cancer symptoms. Future research should consider developing the standard protocol for intervention delivery, improving the methodology of self-acupressure trials, and conducting large-scale research to advance the science of self-acupressure for cancer symptom management.

Invasive or noninvasive? A systematic review and network meta-analysis of acupuncture and acupressure to treat sleep disturbance in cancer patients.

BACKGROUND: Both acupuncture and acupressure have been suggested beneficial for reducing sleep disturbance in cancer patients. While acupuncture is invasive involving needle insertion, acupressure is noninvasive. Their comparative effectiveness is unclear, hindering clinical recommendations. AIMS: This study aimed to explore the comparative effectiveness of acupuncture and acupressure on sleep in cancer patients. METHODS: This is a systematic review and Bayesian network meta-analysis. Eight key English and Chinese databases were searched. Twenty-four randomized controlled trials involving 2002 cancer patients comparing the effects of six treatments (manual acupuncture, electroacupuncture, acupressure, sham, enhanced usual care, and no treatment) on sleep were found. RESULTS: Compared with enhanced supportive care, acupressure demonstrated the largest effect size for reducing self-reported sleep disturbance (standardized mean difference [SMD] = -2.67, 95% CrI: -3.46 to -1.90; GRADE = moderate), followed by acupuncture (SMD = -1.87, 95% CrI: -2.94 to -0.81, GRADE = moderate) and electroacupuncture (SMD = -1.60, 95% CrI: -3 to -0.21; GRADE = low). The surface under the cumulative ranking curve indicates that acupressure is most likely to rank highest. LINKING EVIDENCE TO ACTION: Based on available evidence, acupressure can be recommended as the optimal treatment for reducing sleep disturbance in cancer patients. More rigorous trials are warranted to confirm whether different forms of acupuncture or acupressure have different effects on sleep in cancer patients. Particularly, studies examining acupuncture interventions alone instead of in combination with other therapies are needed.

A combination of electroacupuncture and auricular acupuncture for postoperative pain after abdominal surgery for gynaecological diseases: A randomized controlled trial.

BACKGROUND: Postoperative pain following laparotomy for gynaecological diseases is a common problem that requires effective management to ensure patient satisfaction and recovery. Despite the wide use of acupuncture for pain management, knowledge of its efficacy in managing postoperative pain is limited. Previous literature used either acupuncture or auricular acupuncture alone. However, the combined use of acupuncture and auricular acupuncture have not been studied yet. PURPOSE: This study examined the efficacy and feasibility of combined electroacupuncture and auricular acupuncture compared to a sham control in reducing pain during 5 days after a laparotomy for gynaecological diseases. This combined therapy was hypothesized to provide greater pain reduction than previous studies with less frequent treatment. STUDY DESIGN: Randomized sham-controlled, patient- and- assessor-blinded trial. METHODS: This trial recruited 72 patients scheduled for laparotomy in Hong Kong. Either acupuncture (n = 36) or non-invasive sham acupuncture (n = 36) was performed on the patients preoperatively (1 session) and postoperatively (once a day, up to 6 sessions). The primary outcome was pain at rest, measured using a numerical rating scale from postoperative days 0-5. Secondary outcomes such as analgesics consumption were also assessed. A data and safety monitoring board (DSMB) was established. RESULTS: All 72 randomized patients were included in the analysis. The acupuncture group had a smaller pain score at rest at 22 hrs (mean = 2.6) than the sham control group (mean = 4.0) (Post hoc intention to treat analysis, Linear regression, mean difference = -1.4, 95% confidence interval = [-0.2] -2.7, p = 0.029). No statistically significant between-group difference was found in other outcomes. No serious adverse event was observed. CONCLUSION: Perioperative acupuncture treatments are safe and feasible, but the efficacy of acupuncture is inconclusive.

Patient-centred, self-administered acupressure for Chinese advanced cancer patients experiencing fatigue and co-occurring symptoms: A pilot randomised controlled trial.

OBJECTIVES: To evaluate the feasibility and potential effects of patient-centred self-administered acupressure for alleviating fatigue and co-occurring symptoms among Chinese advanced cancer patients receiving treatment. METHODS: Thirty advanced cancer patients who screened positive for moderate/severe fatigue with symptoms of insomnia and/or pain were recruited from a hospital in Hong Kong. They were randomly assigned (1:1) to receive a 4-week patient-centred self-administered acupressure intervention or health education. Fatigue (primary outcome) and secondary outcomes (sleep quality, pain, fatigue-sleep disturbance-pain symptom cluster severity, anxiety, depression and quality of life) were measured by questionnaires and actigraphy. RESULTS: Twenty-four participants (80%) completed the study. Adherence to self-administered acupressure practice was satisfactory, with all retained participants attending all sessions and 90.9% practising acupressure daily. All completers rated the class as very enjoyable or quite enjoyable. Fatigue, pain, symptom cluster severity, anxiety, depression and quality of life appeared to improve from baseline to post-intervention in the intervention group. Among these outcomes, only the between-group difference in anxiety post-intervention was significant. The group × time interaction effect was nonsignificant for all outcomes. CONCLUSIONS: Patient-centred self-administered acupressure appears to be feasible and acceptable among advanced cancer patients. A fully powered trial is warranted to confirm the intervention effect.

Randomized double-blind trial comparing low dose and conventional dose of a modified traditional herbal formula Guizhi Fuling Wan in women with symptomatic uterine fibroids.

ETHNOPHARMACOLOGICAL RELEVANCE: The herbal formula Guizhi Fuling Wan is one common remedy for treating uterine fibroids (UFs) and the relevant symptoms in Traditional Chinese Medicine (TCM). Previous systematic reviews showed that Guizhi Fuling Formula appeared to have additional benefit based on mifepristone treatment in reducing volume of fibroids. AIM OF STUDY: To study the efficacy and safety of the conventional dose of a modified herbal formula Guizhi Fuling Wan in patients with symptomatic uterine fibroids in comparison with a sub-effective dose control. MATERIALS AND METHODS: This randomized double-blind, dosage-controlled trial was carried out in an outpatient clinic of traditional Chinese medicine in Hong Kong. Women with symptomatic uterine fibroids diagnosed according to the WHO International Classification of Diseases (ICD-10) were recruited and randomly assigned to one of two groups that received modified Guizhi Fuling Wan at either a low dose or the conventional dose on a daily basis for 16 weeks. This study was quality controlled by a data safety monitoring board. The primary outcome was the symptom severity as measured with the Uterine Fibroid Symptom-Quality of Life questionnaire. The secondary outcomes included quality of life, menstrual bleeding (measured on a pictorial blood loss assessment chart), pain severity (measured on the 6-point behavioral rating scale), change in Chinese medicine syndrome score, fibroid volume (measured by magnetic resonance imaging), hemoglobin level, and hormone levels. RESULTS: Seventy-eight women were recruited for this study. Between-groups comparison showed no significant difference at the endpoint for all outcomes except for the Chinese medicine syndrome score; however, at the endpoint, within-group comparison showed significant improvement in both groups relative to baseline in symptom severity, functional influence of pelvic pain, Chinese medicine syndrome score, and fibroid volume and uterus condition on magnetic resonance imaging (p < 0.05).The low-dose group yielded greater endpoint improvement in the Chinese medicine syndrome score than the conventional-dose group (p=0.024). No serious adverse events related to the intervention were noted. CONCLUSION: Both low-dose and conventional-dose preparations significantly ameliorated uterine fibroid-related symptoms and fibroid volume, although no significant difference was found between the low-dose and conventional-dose groups. The herbal formula GuizhiFuling Wan is safe in women with uterine fibroids.

Electroacupuncture Plus Auricular Acupressure on Chemotherapy-Related Insomnia in Patients With Breast Cancer (EACRI): Study Protocol for a Randomized, Sham-Controlled Trial.

OBJECTIVE: Insomnia is a highly prevalent and disturbing symptom in breast cancer patients under or post chemotherapy. If not appropriately treated, it can persist for years after the completion of cancer treatments. Acupuncture has been widely used for alleviating insomnia. The aim of this study is to examine the feasibility, efficacy and safety of acupuncture for chemotherapy-related insomnia among patients with breast cancer. MATERIALS AND METHODS: This is a trial protocol for a randomized, sham-controlled, subject- and assessor-blinded clinical trial. A total of 138 eligible participants will be assigned randomly to acupuncture or sham control group at a ratio of 1:1. Participants in acupuncture group will receive electroacupuncture (EA) plus auricular acupressure (AA) treatment, while subjects in sham acupuncture group will receive sham EA plus sham AA. Both acupuncture and sham treatments will be given twice weekly for 6 weeks, followed by maintenance treatments once every 4 weeks for 12 weeks (15 sessions totally). The primary outcome is the change of Insomnia Severity Index score between baseline and the end of 6-week treatment. Secondary outcome measurements include Actiwatch, sleep diary, Pittsburgh Sleep Quality Index, Functional Assessment of Cancer Therapy-Breast Cancer, Hospital Anxiety and Depression Scale, Brief Pain Inventory-Short Form, Brief Fatigue Inventory, Acupuncture Expectancy Scale, credibility, and adverse events. Participants will be followed up to 42 weeks. CONCLUSIONS: This trial will expand our understanding of the feasibility, efficacy, and safety of acupuncture as a treatment for alleviating chemotherapy-related insomnia in patients with breast cancer. EA plus AA, if proven to be effective, can be implemented into routine settings to play a role in insomnia management for patients with breast cancer.

Effect of qigong for sleep disturbance-related symptom clusters in cancer: a systematic review and meta-analysis.

OBJECTIVES: To examine the effects of qigong interventions on sleep disturbance-related symptom clusters for cancer patients and to explore the possible mediating role of fatigue and depression in affecting sleep. METHODS: In this systematic review and meta-analysis, a systematic search was conducted through October 2020 by searching multiple English and Chinese databases. Inclusion was limited to randomized controlled trials that measured the effect of qigong on sleep and fatigue/depressive symptoms in cancer patients. Eleven studies involving 907 cancer patients were included in the systematic review, whereas the meta-analysis included ten studies with 851 cancer patients. RESULTS: The most commonly investigated form of qigong was Taichi, and the intervention length ranged from 10 days to 6 months. All studies employed self-reported measurements. Overall, qigong significantly improved sleep (SMD = -1.28, 95% CI: -2.01, -0.55) and fatigue (SMD = -0.89, 95% CI: -1.59, -0.19) in cancer patients post-intervention, but not depressive symptoms (SMD = -0.69, 95% CI: -1.81, 0.42). Notably, the benefits on sleep and fatigue became non-significant after 3 months. Qigong's effect on sleep was significantly mediated by its effect on fatigue (ß = 1.27, SE = 0.24, p = 0.002), but not depressive symptoms (ß = 0.53, SE = 0.26, p = 0.106). CONCLUSIONS: Qigong can be recommended for improving sleep disturbance-fatigue symptom clusters in the cancer population, while qigong's benefit on sleep is likely based on its effect on reducing fatigue. Future qigong studies should adopt more rigorous design and employ strategies to maintain longevity of intervention benefits.

Assessing the effect of a mind-body exercise, qigong Baduanjin, on sleep disturbance among women experiencing intimate partner violence and possible mediating factors: a randomized-controlled trial.

STUDY OBJECTIVES: To evaluate the effects of a mind-body exercise, qigong Baduanjin, on sleep disturbances in women experiencing intimate partner violence and explore the mediating role of depressive symptoms, perceived stress, and inflammation in producing the effects. METHODS: A subgroup of a parent randomized controlled trial was randomized for a 22-week Baduanjin intervention (n = 94) or wait-list control (n = 92). Questionnaires, including the General Sleep Disturbance Scale, Perceived Stress Scale, and Beck Depression Inventory version II, were administered at baseline, posttraining (6 weeks), and postintervention (22 weeks), and blood samples were collected to assess tumor necrosis factor and interleukin 6 levels at baseline and postintervention only. RESULTS: Of the 186 participants, 170 completed the study. Results indicate that the total sleep disturbance scores for the intervention group were significantly lower than those for the wait-list control group at week 6 (difference = -7.96; 95% confidence interval [CI], -13.63 to -2.30; P = .006) and week 22 (difference = -7.17; 95% CI, -12.58 to -1.76; P = .01). Mediation analysis showed a statistically significant indirect effect of the intervention on sleep improvement through reducing depressive symptoms (ß = 2.58, 95% CI, 0.69 to 5.09), while the mediating effects of perceived stress and inflammation were not significant. CONCLUSIONS: Qigong Baduanjin can be recommended for women who experience intimate partner violence and report sleep disturbances. More research is needed to understand the clinical significance of the observed sleep improvements. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Qigong Intervention Program for Abused Chinese Women; URL: https://clinicaltrials.gov/ct2/show/NCT02060123; Identifier: NCT02060123.

Electroacupuncture trigeminal nerve stimulation plus body acupuncture for chemotherapy-induced cognitive impairment in breast cancer patients: An assessor-participant blinded, randomized controlled trial.

Chemotherapy causes various side effects, including cognitive impairment, known as 'chemobrain'. In this study, we determined whether a novel acupuncture mode called electroacupuncture trigeminal nerve stimulation plus body acupuncture (EA/TNS + BA) could produce better outcomes than minimum acupuncture stimulation (MAS) as controls in treating chemobrain and other symptoms in breast cancer patients. In this assessor- and participant-blinded, randomized controlled trial, 93 breast cancer patients under or post chemotherapy were randomly assigned to EA/TNS + BA (n = 46) and MAS (n = 47) for 2 sessions per week over 8 weeks. The Montreal Cognitive Assessment (MoCA) served as the primary outcome. Digit span test was the secondary outcomes for attentional function and working memory. The quality of life and multiple functional assessments were also evaluated. EA/TNS + BA treated group had much better performance than MAS-treated group on reverse digit span test at Week 2 and Week 8, with medium effect sizes of 0.53 and 0.48, respectively, although no significant differences were observed in MoCA score and prevalence of chemobrain between the two groups. EA/TNS + BA also markedly reduced incidences of diarrhoea, poor appetite, headache, anxiety, and irritation, and improved social/family and emotional wellbeing compared to MAS. These results suggest that EA/TNS + BA may have particular benefits in reducing chemotherapy-induced working memory impairment and the incidence of certain digestive, neurological, and distress-related symptoms. It could serve as an effective intervention for breast cancer patients under and post chemotherapy (trial registration: https://www.clinicaltrials.gov: NCT02457039).

Application of Acupuncture to Attenuate Immune Responses and Oxidative Stress in Postoperative Cognitive Dysfunction: What Do We Know So Far?

Postoperative cognitive dysfunction (POCD) is a common sequela following surgery and hospitalization. The prevention and management of POCD are important during clinical practice. POCD more commonly affects elderly patients who have undergone major surgery and can result in major decline in quality of life for both patients and their families. Acupuncture has been suggested as an effective intervention for many neurological disorders. In recent years, there are increasing interest in the use of acupuncture to prevent and treat POCD. In this review, we summarized the clinical and preclinical evidence of acupuncture on POCD using a narrative approach and discussed the potential mechanisms involved. The experimental details and findings of studies were summarized in tables and analyzed. Most of the clinical studies suggested that acupuncture before surgery could reduce the incidence of POCD and reduce the levels of systematic inflammatory markers. However, their reliability is limited by methodological flaws. Animal studies showed that acupuncture reduced cognitive impairment and the associated pathology after various types of surgery. It is possible that acupuncture modulates inflammation, oxidative stress, synaptic changes, and other cellular events to mitigate POCD. In conclusion, acupuncture is a potential intervention for POCD. More clinical studies with good research design are required to confirm its effectiveness. At the same time, findings from animal studies will help reveal the protective mechanisms, in which systematic inflammation is likely to play a major role.

Insomnia identity and its correlates in adolescents.

OBJECTIVE: Insomnia identity, defined as a conviction that one has insomnia, is a cognitive appraisal process that influences help-seeking, diagnosis, and treatment of insomnia. Previous studies in adults showed that about 50% of poor sleepers did not label themselves as having insomnia, while 10% of good sleepers endorsed insomnia identity. This analysis aimed to examine the proportions and characteristics of complaining and noncomplaining poor and good sleepers and the factors that determine self-labeling of insomnia in adolescents. METHODS: Data from a school-based study were analyzed. We defined insomnia identity as an endorsement of "insomnia" occurring 3-7 nights per week, while 3 criteria of poor sleep were examined. A total of 1447 students were included, the mean age was 14.5 years and 55.5% were females. RESULTS: Using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria to define poor sleep (insomnia symptoms ≥ 3 times per week), the proportions of complaining and noncomplaining poor sleepers were 2.3% and 8.8%, while complaining and noncomplaining good sleepers were 0.8% and 88.2%, respectively. The ratio between complaining and noncomplaining poor sleepers was 1 to 3.8. Complaining poor sleepers had the highest level of insomnia and daytime symptoms, while complaining good sleepers had the highest proportion of smokers and drinkers. Multivariate logistic regression showed that insomnia symptoms and sleep dissatisfaction were independent predictors of insomnia identity. CONCLUSIONS: In view of the high proportion of noncomplaining poor sleepers, educational programs should address the under-appraisal of insomnia among adolescents.

Combined electroacupuncture and auricular acupuncture for postoperative pain after abdominal surgery for gynecological diseases: study protocol for a randomized controlled trial.

BACKGROUND: Postoperative pain is a major complaint following abdominal surgery for gynecological diseases. Effective postoperative pain control after abdominal surgery is particularly important for patient recovery, mobility, and satisfaction. Acupuncture has been commonly used for pain management. However, its efficacy in postoperative pain control is inconclusive and health economic evaluation is limited. METHODS: A randomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of acupuncture in managing postoperative pain following abdominal surgery of gynecological diseases. Patients who are eligible for laparotomy with a midline incision for gynecological neoplasia, including ovarian mass, uterine mass, and cervical lesions, will be recruited. Seventy-two participants will be randomly allocated to an acupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 h before operation, upon arrival to the ward and once daily for 5 days. The Pain Numerical Rating Scale (NRS) on the first 5 days during hospitalization will be the primary outcome and will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include frequency of rescue analgesic use during hospital stay, cumulative morphine consumption; quality of recovery as measured by time to recovery variables and the Quality of Recovery-9 (QoR-9); quality of life as measured by the Short Form-6 dimension (SF-6D) and EuroQol-5 Dimension-5 Level (EQ-5D-5 L). The incremental cost-effectiveness ratio of acupuncture vs sham acupuncture will be calculated. DISCUSSION: This study protocol provides an example of integrative medicine practice in a hospital setting for the management of postoperative pain using acupuncture treatment. The acupuncture treatment protocol, if proven to be effective, can be implemented in routine settings to play a role in postoperative pain management for patients who have undergone abdominal surgery for gynecological diseases. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02851186 . Registered on 19 July 2016.

Quality and safety control of tumor-shrinking decoction (TSD): A Chinese herbal preparation for the treatment of uterine fibroids.

Reproducible efficacy assessments of Chinese herbal medicines are largely based on well-established quality control procedures. This study presents a comprehensive quality control procedure for tumor-shrinking decoction (TSD), a 15-herb preparation under study as a potential therapy for uterine fibroids. Morphological, microscopic, and physicochemical authentications were first carried out on individual herbal medicines composing TSD. Contaminant tests on TSD for the presence of heavy metals and pesticide residues were performed by atomic absorption spectrophotometry and gas chromatography-mass spectrometry analysis. Furthermore, batch-to-batch quality monitoring of the decoction was investigated via ultra-performance liquid chromatography (UPLC) and high-performance liquid chromatography (HPLC). An aqueous extract of the herbal medicines was prepared and formulated into TSD. The tested contaminants were within the maximum permitted levels of the Hong Kong government in proprietary Chinese medicines. UPLC and HPLC fingerprints for quality tracking on TSD were established. The decoction was quantitatively standardized by UPLC and HPLC, respectively, with five and three chemical compounds serving as references. Collectively, the procedure established in this study will not only serve as a fundamental basis for the investigation and development of TSD as a novel therapy for uterine fibroids, but also as a protocol for studying other polycomponent herbal preparations.

Effect of YH0618 soup on chemotherapy-induced toxicity in patients with cancer who have completed chemotherapy: study protocol for a randomized controlled trial.

BACKGROUND: The incidence of cancer has been staying at a high level worldwide in recent years. With advances in cancer diagnosis and therapy strategy, the survival rate of patients with cancer has been increasing, but the side effects of these treatments, especially chemotherapy, are obvious even when the chemotherapy ceases. YH0618, a prescription, has showed efficacy in reducing chemotherapy-induced toxicity through long clinical practice. However, there is no scientific research exploring the effects of YH0618 in patients with cancer. Therefore, using a randomized controlled trial, this study will explore the efficacy of YH0618 on ameliorating chemotherapy-induced toxicity including dermatologic toxicity, myelosuppression, hepatotoxicity and nephrotoxicity and improving fatigue in cancer patients who have completed chemotherapy. METHODS/DESIGN: This is a prospective assessor-blinded, parallel, randomized controlled trial. Patients with cancer at any stage who have completed chemotherapy within two weeks will be randomly divided into group A (YH0618) and group B (wait-list) using a 1:1 allocation ratio. The chemotherapeutic agents include taxanes or anthracyclines. Subjects assigned to group A will receive YH0618 soup 6 days a week for 6 weeks and uncontrolled follow-up for 6 weeks, while group B are required to wait for 6 weeks before receiving YH0618 intervention. The primary outcome of this study is the incidence of protocol-specified grade ≥2 dermatologic toxicities graded by NCI CTCAE Chinese version 4.0 and changes of fingernail color, face skin color and tongue color evaluated by the L*a*b system within 6 weeks. There are some secondary outcomes associated with dermatologic toxicity including fatigue and clinical objective examination. DISCUSSION: There are few scientific and safe methods in ameliorating chemotherapy-induced toxicity. The proposed study may provide direct and convincing evidence to support YH0618 as an adjuvant treatment for reducing chemotherapy-induced toxicity, which could be introduced into clinical settings. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR-IOR-15006486 . Registered on 21 May 2015.

Assessment of fatigue using the Multidimensional Fatigue Inventory in patients with major depressive disorder.

OBJECTIVES: There are problems with the fatigue measures currently used in depressed patients. The Multidimensional Fatigue Inventory (MFI-20) covering general fatigue, physical fatigue, mental fatigue, reduced activity and reduced motivation has been widely used in patients with cancer and chronic fatigue syndrome. To address the multidimensional nature of fatigue, we examined the validity and reliability of a Chinese version of the MFI-20 in major depressive disorder (MDD). METHODS: Data were derived from a randomized controlled trial of acupuncture in 137 patients with partially remitted MDD. The test-retest reliability, internal consistency, construct and concurrent validity and sensitivity to change of the MFI-20 were analyzed. RESULTS: The MFI-20 was found to have good internal consistency (Cronbach's alpha=0.89) and 1-week test-retest reliability (Pearson correlation of the total score=0.73). Factor analysis showed 5 factors, but the factor structure was different from that in medical conditions. The 2 most prominent factors, explaining 46% of the total variance, were both associated with physical and mental energy but different in directions. There were adequate concurrent validity and sensitivity to change as evidenced by the significant correlations between the MFI-20 scores and depressive and anxiety symptoms, general health and quality of life. CONCLUSION: The Chinese MFI-20 is a valid and reliable instrument for the assessment of fatigue in MDD patients with residual symptoms. The construct of fatigue in MDD seems to be different from that in medical conditions. Further studies are needed to examine the MFI-20 in MDD patients from other cultures.

Assessing insomnia in adolescents: comparison of Insomnia Severity Index, Athens Insomnia Scale and Sleep Quality Index.

OBJECTIVES: To compare the psychometric properties of the Chinese versions of Insomnia Severity Index (ISI), Athens Insomnia Scale (AIS) and Sleep Quality Index (SQI) for assessment and screening of insomnia in adolescents. METHODS: This is a school-based survey of 1516 adolescents aged 12-19 years. Sleep-wake habit questionnaire, ISI, AIS, SQI, Epworth Sleepiness Scale (ESS) and 12-item General Health Questionnaire (GHQ-12) were administered. Insomnia Interview Schedule was used to assess the severity of insomnia symptoms and DSM-IV-TR diagnosis of insomnia. RESULTS: The Cronbach's alpha of ISI, AIS and SQI were 0.83, 0.81 and 0.65, respectively, and the 2-week test-retest reliability were 0.79, 0.80 and 0.72. All three scales had a 2-factor structure, and their scores were significantly correlated with sleep-wake variables, ESS and GHQ-12 scores, smoking and drinking habits, and academic performance. The areas under curve of ISI, AIS and SQI for detecting clinical insomnia were 0.85, 0.80 and 0.85, respectively. The optimal cut-offs for ISI, AIS and SQI were a total score of nine (sensitivity/specificity: 0.87/0.75), seven (sensitivity/specificity: 0.78/0.74) and five (sensitivity/specificity: 0.83/0.79), respectively. CONCLUSION: The Chinese versions of ISI, AIS and SQI are reliable and valid instruments. The ISI and AIS appear to have better psychometric properties than the SQI.