1.Clinical efficacy analysis of seven pediatric patients with Acute myeloid leukemia and the t(16;21)(p11;q22) FUS::ERG fusion gene.
Lihuan SHI ; Shan HUANG ; Xing XIE ; Pengkai FAN ; Haili GAO ; Yanna MAO
Chinese Journal of Medical Genetics 2026;43(2):90-95
OBJECTIVE:
To analyze the clinical characteristics, treatment, and prognosis of seven pediatric patients with Acute myeloid leukemia (AML) positive for the t(16;21)(p11;q22) FUS::ERG fusion gene.
METHODS:
A retrospective analysis was carried out on the clinical data, treatment, and prognosis of seven AML patients with t(16;21)(p11;q22) FUS::ERG fusion gene admitted to Henan Children's Hospital between June 2015 and November 2024. Relevant literature was also reviewed. This study was approved by the Medical Ethics Committee of the Hospital (Ethics No.: 2024-102-001).
RESULTS:
Among 297 pediatric patients with AML, 7 cases (2.36%) were positive for the t(16;21)(p11;q22) FUS::ERG fusion gene, including 3 males and 4 females, with a median age of 11 years (range: 3 ~ 12 years). According to the FAB classification, these included 1 case of M2, 3 cases of M5, and 3 cases of AML-not otherwise specified (non-M3). All 7 patients were found to harbor the t(16;21)(p11;q22) translocation, with 3 cases showing additional chromosomal abnormalities. Immunophenotyping revealed universal expression of CD13, CD33, CD34, and CD117, with partial expression of CD56, CD4, CD64, CD123, CD15, CD38, CD11b, HLA-DR, cMPO, and CD16. One patient achieved complete remission (CR) after the first course of DAE (cytarabine + daunorubicin + etoposide) induction chemotherapy but relapsed and discontinued the treatment. Six patients received DAH (cytarabine + daunorubicin + homoharringtonine) induction therapy, of whom 2 achieved CR after two courses and underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT), resulting in an overall CR rate of 42.86%. Five children did not receive allo-HSCT and had a median overall survival of 9 months (range: 6 ~ 18 months). Two children who underwent transplantation achieved bone marrow morphological and molecular biological relapse at 6 and 9 months post-transplantation, respectively. After receiving combined chemotherapy and donor lymphocyte infusion, one child failed to achieve remission and died at 22 months post-transplantation, while the other has been followed up to date with positive fusion gene status. Their overall survival was 25 months and 30 months, respectively.
CONCLUSION
The t(16;21)(p11;q22) FUS::ERG fusion gene is rare in pediatric AML and associated with poor prognosis. Allo-HSCT may mitigate the adverse prognostic impact of the FUS::ERG fusion gene and contribute to prolonged survival.
Humans
;
Male
;
Child
;
Female
;
Leukemia, Myeloid, Acute/drug therapy*
;
Oncogene Proteins, Fusion/genetics*
;
Translocation, Genetic
;
Retrospective Studies
;
RNA-Binding Protein FUS/genetics*
;
Chromosomes, Human, Pair 16/genetics*
;
Adolescent
;
Child, Preschool
;
Chromosomes, Human, Pair 21/genetics*
;
Prognosis
;
Treatment Outcome
2.Quality of care among patients with acute heart failure at the emergency room and adherence of physicians at the University of the Philippines – Philippine General Hospital to the division of cardiovascular medicine – heart failure pathway:A retrospective cohort study.
Mark John D. Sabando ; Felix Eduardo R. Punzalan ; Frances Dominique V. Ho ; Tam Adrian P. Aya-ay ; Kevin Paul Da. Enriquez ; Marie Kirk A. Maramara ; Ronald Allan B. Roderos ; Lauren Kay M. Evangelista
Acta Medica Philippina 2026;60(2):22-32
OBJECTIVES
Clinical pathways (CPs) ensure adherence to heart failure (HF) management guidelines. To optimize quality care in a low resource setting, an evidence-based care pathway for the management of acute HF was implemented at the emergency department (ED) of the Philippine General Hospital (PGH), the designated national tertiary hospital and referral center. This study aimed to describe the characteristics of adults with acute HF admitted at the ED and evaluate the quality of care they received, measured using physician adherence to the hospital’s acute heart failure CP.
METHODSThis was a retrospective, descriptive cohort study. We reviewed the inpatient charts of all adult patients with acute HF admitted to the ED of the PGH and referred to the Division of Cardiovascular Medicine between December 1, 2022 and May 31, 2023. Quality of care was assessed based on adherence to quality indicators adapted from routine and conditional order sets detailed in the pathway. Descriptive statistics was utilized to describe patient characteristics, quality of care, and outcomes.
RESULTSTwo hundred thirty-six (236) patients were included, with a mean age of 51.8 years. Majority were male (53.4%); hypertension (61.4%) and ischemic heart disease (53.8%) were the most common comorbidities, and infection the most common precipitant of decompensation (60.6%). There were optimal adherence rates to routine orders, which included referrals to Internal Medicine and Cardiology, baseline vital signs monitoring, fluid intake and output monitoring, chest radiograph, complete blood count, blood urea nitrogen, sodium, potassium, prothrombin time, partial thromboplastin time, arterial blood gas, urinalysis, and N-terminal pro b-type natriuretic peptide. Conditional orders, such as oxygen support, focused echocardiography, thyroid - stimulating hormone, and the use of vasopressors, diuretics, and venous thromboembolism prophylactic agents, were optimally performed when warranted. However, we noted suboptimal adherence to certain resource-intensive conditional orders, such as hourly monitoring of urine output (61.4%), hooking to cardiac monitor (53.8%), and performance of 12-lead ECG within 10 minutes (56.8%). Further, only 43.9% of patients were referred to the intensive care unit. Troponin I, calcium, magnesium, and albumin were ordered in excess.
CONCLUSIONOverall adherence rate of physicians to the hospital’s Acute Heart Failure Pathway was satisfactory. Work is needed to improve adherence to hourly urine output monitoring, consistent hooking to cardiac monitor, and timely performance of 12-lead ECG – an effort that begins with expanding in-hospital diagnostic equipment and human resource supply. We recommend continuous pathway implementation with periodic evaluation and stakeholder feedback to further improve quality of care.
Human ; Male ; Female ; Middle Aged: 45-64 Yrs Old ; Adult ; Albumins ; Blood ; Blood Urea Nitrogen ; Calcium ; Cardiology ; Chart ; Charts ; Cohort Studies ; Critical Care ; Critical Pathways ; Diagnostic Equipment ; Disease ; Diuretics ; Echocardiography ; Electrocardiography ; Emergencies ; Emergency Service, Hospital ; Equipment And Supplies ; Evaluation Studies As Topic ; Feedback ; Heart ; Heart Diseases ; Heart Failure ; Hormones ; Hospitals ; Hospitals, General ; Humans ; Hypertension ; Indicators And Reagents ; Infection ; Infections ; Inpatients ; Intensive Care Units ; Internal Medicine ; Lead ; Magnesium ; Male ; Medicine ; Myocardial Ischemia ; Natriuretic Peptide, Brain ; Natriuretic Peptides ; Nitrogen ; Overall ; Oxygen ; Partial Thromboplastin Time ; Patients ; Peptides ; Philippines ; Physicians ; Potassium ; Prothrombin ; Prothrombin Time ; Quality Of Health Care ; Referral And Consultation ; Sodium ; Statistics ; Tertiary Care Centers ; Thorax ; Thromboembolism ; Thromboplastin ; Thyroid Gland ; Time ; Troponin ; Troponin I ; Universities ; Urea ; Urinalysis ; Urine ; Venous Thromboembolism ; Vital Signs ; Work ; Workforce
3.Facility assessment for the implementation of the Philippine package of essential noncommunicable disease interventions (PhilPEN) in primary health care centers in Metro Manila.
Joyce P. Parco ; Kim Leonard G. dela Luna ; Maria Theresa M. Talavera
Acta Medica Philippina 2026;60(6):18-25
BACKGROUND AND OBJECTIVE
The Philippine Package of Essential Noncommunicable Disease Interventions (PhilPEN) was introduced by the Department of Health through AO 2012-0029. This is anchored to WHO PEN, a prioritized set of cost-effective interventions that can be carried out to provide an acceptable standard of care at the primary health care level, even in low-resource settings. The study aims to evaluate the availability and adequacy of primary health care facilities in providing the PhilPEN package of interventions using the WHO assessment tool.
METHODSA cross-sectional survey was conducted in 25 randomly selected primary health care facilities in Metro Manila. Data were collected through structured interviews with facility staff and direct observation using a standardized questionnaire aligned with PhilPEN and WHO PEN guidelines. The tool assessed PhilPEN inputs (infrastructure, human resources, basic tools and equipment, essential medicines, record-keeping, financing) and services (risk assessment and screening, early diagnosis and monitoring, treatment and follow-up, counseling, referral of patients).
RESULTSAll facilities met the basic standards for infrastructure, human resources, record keeping, and financing. However, only 40% had all essential medicines, and just 16% had complete tools, including urine ketone/protein test strips. Risk assessment and patient counseling were consistently implemented, but early diagnosis and follow-up services were inconsistent due to training and supply gaps.
CONCLUSIONPrimary health care centers in Metro Manila demonstrate partial readiness for PhilPEN implementation. Gaps in tools, medicines, and protocol availability should be addressed to optimize NCD service delivery.
Human ; Primary Health Care ; Noncommunicable Diseases ; Delivery Of Health Care ; Standard Of Care ; Cardiovascular Diseases
4.Clinical competence of graduating student nurses in higher education institutions.
Ryan Matthew A. Aquino ; Genevive Claire B. Antonio ; Jolieca Lae E. Boado ; Alexandra Mae I. Cruz ; Stephany Gwen S. Domingo ; Fernando Guiller O. Gamboa ; Janna Lilac Laguatan ; Samantha Eronicka S. Manangan ; Reion Gabriel T. Ordonio ; Alexandra A. Quisias ; Allanisse R. Tamondong
Acta Medica Philippina 2026;60(7):42-50
BACKGROUND
Graduating student nurses are crucial to healthcare delivery, yet concerns about their clinical performance persist. They often face challenges translating theoretical knowledge into practice, leading to a theory-practice gap. Clinical competence is essential for ensuring safe and effective nursing care.
OBJECTIVESThis study assessed the clinical competence of graduating student nurses in HEIs within Baguio City. It specifically evaluated their proficiency in professional behavior, general performance, core nursing competency, and advanced nursing skills. Additionally, it examined whether significant differences in clinical competence existed based on sex, area of duty, and accreditation status.
METHODSA descriptive-quantitative non-experimental research design was employed. The study surveyed 285 graduating student nurses from six HEIs in Baguio City, selected through fishbowl sampling. Data was collected using the Clinical Competence Questionnaire (CCQ), a 47-item questionnaire with an I-CVI rating of 1.0 and a Cronbach’s Alpha of 0.94. Data analysis included descriptive statistics, Welch's T-test, One-way ANOVA, and Welch's ANOVA.
RESULTSStudents demonstrated high competence with the following means: 4.42 in nursing professional behaviors, 4.32 in general performance, 4.35 in core nursing skills, and 3.92 in advanced nursing skills. While the results were interpreted as high competence, specific advanced nursing skills require further enhancement. No significant differences (p-value < 0.05) in clinical competence were found concerning sex (0.38), duty area (0.92), or accreditation status (0.07).
CONCLUSIONGraduating student nurses show high competency upon entering level IV, emphasizing ongoing skill development for quality patient care. Both genders exhibit proficiency, indicating fair training and effective education regardless of duty area exposure and accreditation status.
Human ; Clinical Competence
5.Primary aldosteronism in a Malaysian Tertiary Centre: A retrospective audit of clinical characteristics, diagnostic pathways, and treatment outcomes (2018–2025)
Ahmad Hambal Bin Zamari ; Yusniza Yusof
Journal of the ASEAN Federation of Endocrine Societies 2026;41(S1):19-20
Introduction:
Primary aldosteronism (PA) is a common yet underdiagnosed cause of secondary hypertension, associated
with increased cardiovascular and renal morbidity. Early
detection and subtype-directed management significantly
improve outcomes. However, adherence to recommended
diagnostic pathways in real-world practice remains
variable.
Case:
We conducted a retrospective audit of patients diagnosed
with PA in a Malaysian tertiary centre from January 2018
to December 2025. Data collected included demographics,
clinical presentation, biochemical parameters, diagnostic
workup (aldosterone-renin ratio [ARR], confirmatory
testing, adrenal imaging, and adrenal venous sampling
[AVS]), treatment modality, and outcomes. Audit standards
were based on established international guidelines.
A total of 14 patients were included, with equal gender
distribution. The cohort comprised 57% Malay and 43%
Chinese. Most patients presented with hypertension
(mean ~170/100 mmHg), and hypokalemia was present
in approximately 70% of the patients. ARR and adrenal
imaging were performed in all patients (100%), while
confirmatory testing was conducted in 85% of the patients.
However, AVS utilization remained limited (50%).
Contributing factors included failed cannulation, technical
challenges in overweight patients, preference for medical
therapy, refusal of surgery, and limited access to AVS
services. The majority had unilateral adrenal adenoma
(~75%). Treatment was divided between surgical (55%) and
medical (45%) approaches. Post-treatment, hypokalemia
resolved in 90% of patients, with a significant reduction
in antihypertensive burden and complete hypertension
resolution in approximately 35% of the patients. Quality of
life improved in most patients.
Conclusion
This audit demonstrates good adherence to initial screening
and imaging in PA but highlights suboptimal utilization
of AVS. Barriers to AVS utilization are multifactorial,
encompassing technical, patient-related, and system level limitations. Addressing these barriers is essential to
optimize subtype-directed management and improve longterm cardiovascular outcomes in patients with PA. Despite
this, clinical outcomes were favorable. Strengthening
adherence to diagnostic pathways, particularly subtype
confirmation, may further improve patient outcomes.
Hyperaldosteronism
;
Treatment Outcome
;
Retrospective Studies
6.Impact of Glycemic Control on Tuberculosis Treatment Outcomes in Patients With Diabetes Mellitus: A Retrospective Audit
Chitra Devi Balasubramaniyam ; Mohammad Ulilamri Tukiman ; Yusniza Yusoff ; Mohammad Nur Syafiq Mohammad Azman ; Choo Jia Qing
Journal of the ASEAN Federation of Endocrine Societies 2026;41(S1):37-38
Introduction:
Diabetes mellitus (DM) is a significant comorbidity
associated with adverse tuberculosis (TB) treatment
outcomes and remains an ongoing clinical challenge.
Chronic hyperglycemia impairs host immune responses,
particularly macrophage function, leading to delayed
bacillary clearance. This contributes to poorer outcomes,
including delayed sputum conversion, prolonged
treatment duration, relapse, and increased mortality. Poor
glycemic control is a key modifiable factor influencing
these outcomes. This study aimed to evaluate the impact
of glycemic control at diagnosis on TB treatment outcomes
in a Malaysian cohort.
Methodology:
A retrospective cross-sectional audit was conducted using
the TB clinic registry at Hospital Sungai Buloh from 2022
to 2025. Adult patients (≥18 years) with confirmed TB (any
form) and DM (Type 1 or Type 2) with complete records
were included. Of 241 patients screened, 131 were included
after exclusions due to incomplete records (29.9%), transfer
(29.9%), loss to follow-up (19.9%), and drug-resistant TB
(2.9%). Data collected included demographics, hemoglobin
A1c (HbA1c) at diagnosis, sputum conversion duration,
treatment duration, type of DM therapy, and clinical
outcomes.
Results:
The cohort had a mean age of 53 years, with 97% having
Type 2 DM.
Mean HbA1c at diagnosis was 10.5%. Poorer glycemic
control was associated with delayed sputum conversion.
Patients who achieved sputum conversion by 8 weeks had
an average HbA1c of 9.6%, compared to 11.8% in those
with delayed conversion. Longer treatment duration was
associated with higher HbA1c (mean 10.5, 8.6, and 11.8%
for 6-, 12-, and 18-month regimens, respectively). Relapse
analysis demonstrated a trend towards higher HbA1c with
increasing relapse episodes (11.2, 13.75, and 14.5% for one, two, and three relapses, respectively). Overall mortality
was 17% (22/131), with markedly higher mean HbA1c in
deceased patients compared to survivors (16.0% vs 10.5%).
Conclusion
Poor glycemic control at TB diagnosis is associated with
delayed sputum conversion, prolonged treatment duration,
and increased mortality. These findings are consistent with
regional evidence, including a South Asian systematic
review (Gautam et al., 2021), demonstrating higher mortality
and treatment failure in patients with TB and DM. Early
and aggressive optimization of glycemic control, alongside
standard anti-TB therapy, is essential to improve outcomes.
Humans
;
Glycemic Control
;
Retrospective Studies
;
Diabetes Mellitus
;
Treatment Outcome
;
Tuberculosis
7.The magnitude of delay in non-metastatic breast cancer treatment in a Tertiary Hospital: An analysis from 2012 to 2018
Rogelio N. Velasco jr. ; Mark M. Ando ; Mark Anthony U. Javelosa ; Rich Ericson C. King ; Karen Anjela M. Mondragon ; Harold Nathan C. Tan ; Corazon A. Ngelangel ; Irisyl O. Real
Acta Medica Philippina 2025;59(8):45-51
BACKGROUND AND OBJECTIVE
The burden of treatment delay in breast cancer is high, especially among developing countries. Despite adversely affecting morbidity and mortality, treatment delay remains unexplored in the Philippines. This study aimed to determine treatment delays among breast cancer patients in a tertiary hospital during surgery, neoadjuvant chemotherapy, and adjuvant chemotherapy, and to identify predictors of delay.
METHODSA cross-sectional study was conducted among breast cancer patients seen between January 1, 2012 to December 31, 2018. The following outcomes were investigated: ≥90 days from initial diagnosis to surgery, ≥8 weeks from diagnosis to initiation of neoadjuvant chemotherapy, and >120 days from diagnosis to initiation of adjuvant chemotherapy. Summary statistics were reported as percent for categorical data and as mean for continuous data. The individual correlations were performed using Chi-square for qualitative data and t-test for quantitative data while predictors were determined through logistic regression.
RESULTSA total of 324 patients were included in this study. The majority of the patients were less than 65 years old living in urban areas. More than half of the patients were overweight or obese, hypertensive, and diabetic. The following delays were observed: 61.1% (n = 198) with any type of delay, 23.8% (n = 53) with delay in surgery, 53.8% (n = 120) with delay in adjuvant chemotherapy, and 74.3% (n = 75) with delay in neoadjuvant chemotherapy. The patients noted to have any type of delay were more likely to be hypertensive (p = 0.046) and residing in urban areas (p = 0.041). There were no differences in the distribution of age, body mass index, and presence of co-morbid conditions such as hypertension, diabetes mellitus, coronary artery disease, and heart failure among those with any form of delay compared with no delay.
CONCLUSIONThe present study shows the presence of treatment delay among breast cancer patients and may be used to enact policy changes to optimize breast cancer care delivery. Further studies may be done to identify other factors affecting these delays and policy changes are recommended to address these gaps in surgery and chemotherapy administration among breast cancer patients.
Breast Neoplasms ; Breast Cancer ; Quality Of Health Care ; Treatment Delay
8.Systematic review and Meta-analysis of efficacy and safety of Wumei Pills in treatment of type 2 diabetes mellitus.
Wei-Jin HUANG ; Yun-Yi YANG ; Jia-Yuan CAI ; Xiao-Xiao QU ; Yan-Ming HE ; Hong-Jie YANG
China Journal of Chinese Materia Medica 2025;50(12):3441-3451
Wumei Pills, a classic traditional Chinese medicine(TCM) formula, are widely used in the treatment of biliary ascariasis and diarrhea. In recent years, studies have shown that Wumei Pills have advantages in the treatment of type 2 diabetes mellitus(T2DM), while there are no relevant reports that systematically evaluate the efficacy of Wumei Pills in the treatment of T2DM. This study addresses this issue by systematically evaluating the efficacy and safety of Wumei Pills, aiming to provide an evidence-based basis for clinical practice. PubMed, Cochrane Library, EMbase, Web of Science, CNKI, Wanfang, and VIP were researched for the randomized controlled trial(RCT) involving Wumei Pills for the treatment of T2DM that were published from inception to September 2024. RevMan 5.3 was used for the Meta-analysis of the data. A total of 18 RCTs were included, with a total of 1 437 patients. Meta-analysis produced the following results.(1)Treatment group outperformed control group in terms of overall response rate(RR=1.28, 95%CI[1.14, 1.43], P<0.000 1), fasting blood glucose(FPG)(WMD=-0.69, 95%CI[-0.93,-0.46], P<0.000 01), two-hour postprandial plasma glucose(2hPG)(WMD=-0.74, 95%CI[-1.17,-0.31], P<0.000 7), glycated hemoglobin(HbA1c)(WMD=-0.39, 95%CI[-0.60,-0.18], P=0.000 3), high-density lipoprotein(HDL)(WMD=0.38, 95%CI[0.28, 0.48], P<0.000 01), and body mass index(BMI)(WMD=-1.41, 95%CI[-2.40,-0.42], P=0.005).(2)The two groups had comparable effects regarding total cholesterol(TC)(WMD=-0.53, 95%CI[-1.13, 0.08], P=0.09) and low-density lipoprotein(LDL)(WMD=-0.25, 95%CI[-0.56, 0.06], P=0.12).(3)Triglycerides(TG)(WMD=-0.28,95%CI [-0.59,0.03],P=0.08), sensitivity analysis showed potential reduction effect(WMD=-0.20,95%CI[-0.36,-0.04],P=0.01). Occurrence of adverse drug reaction(RR=0.43,95%CI [0.23,0.80],P=0.007), sensitivity analysis showed significant disappearance(RR=0.56,95%CI[0.26,1.22],P=0.14), suggesting that the efficacy of treatment group was not better than that of control group. The results indicate that the treatment of T2DM with Wumei Pills is greatly related to the improvement of glucose metabolism, lipid metabolism, and clinical efficacy. The findings provide a basis for clinical application of Wumei Pills in treating T2DM, while the conclusion remains to be verified by clinical studies with higher quality.
Humans
;
Diabetes Mellitus, Type 2/blood*
;
Drugs, Chinese Herbal/administration & dosage*
;
Randomized Controlled Trials as Topic
;
Blood Glucose/metabolism*
;
Hypoglycemic Agents/therapeutic use*
;
Treatment Outcome
;
Glycated Hemoglobin/metabolism*
;
Female
9.Construction of core outcome set for clinical research on traditional Chinese medicine treatment of simple obesity.
Tong-Tong WU ; Yan YU ; Qian HUANG ; Xue-Yin CHEN ; Fu-Ming-Xiang LIU ; Li-Hong YANG ; Chang-Cai XIE ; Shao-Nan LIU ; Yu CHEN ; Xin-Feng GUO
China Journal of Chinese Materia Medica 2025;50(12):3423-3430
Following the core outcome set standards for development(COS-STAD), this study aims to construct core outcome set(COS) for clinical research on traditional Chinese medicine(TCM) treatment of simple obesity. Firstly, a comprehensive review was conducted on the randomized controlled trial(RCT) and systematic review(SR) about TCM treatment of simple obesity that were published in Chinese and English databases to collect reported outcomes. Additional outcomes were obtained through semi-structured interviews with patients and open-ended questionnaire surveys for clinicians. All the collected outcomes were then merged and organized as an initial outcome pool, and then a preliminary list of outcomes was formed after discussion by the working group. Subsequently, two rounds of Delphi surveys were conducted with clinicians, methodology experts, and patients to score the importance of outcomes in the list. Finally, a consensus meeting was held to establish the COS for clinical research on TCM treatment of simple obesity. A total of 221 RCTs and 12 SRs were included, and after integration of supplementary outcomes, an initial outcome pool of 141 outcomes were formed. Following discussions in the steering advisory group meeting, a preliminary list of 33 outcomes was finalized, encompassing 9 domains. Through two rounds of Delphi surveys and a consensus meeting, the final COS for clinical research on TCM treatment of simple obesity was determined to include 8 outcomes: TCM symptom scores, body mass index(BMI), waist-hip ratio, waist circumference, visceral fat index, body fat rate, quality of life, and safety, which were classified into 4 domains: TCM-related outcomes, anthropometric measurements, quality of life, and safety. This study has preliminarily established a COS for clinical research on TCM treatment of simple obesity. It helps reduce the heterogeneity in the selection and reporting of outcomes in similar clinical studies, thereby improving the comparability of research results and the feasibility of meta-analysis and providing higher-level evidence support for clinical practice.
Humans
;
Obesity/therapy*
;
Medicine, Chinese Traditional
;
Randomized Controlled Trials as Topic
;
Treatment Outcome
;
Drugs, Chinese Herbal/therapeutic use*
10.Modified Sini Powder in treating mild to moderate generalized anxiety disorder in patients with syndrome of liver depression transforming into fire: a single-center, randomized, double-blind, dose-controlled trial.
Jia-Xin XU ; Hong-Jun YANG ; Hong-Wei WU ; Li-Jun MAO ; Jian-Xin WANG ; Zong-Liang YU ; Yang ZHAO ; Xiao-Nan HAO ; Rui GAO
China Journal of Chinese Materia Medica 2025;50(14):4063-4070
A single-center, randomized, double-blind, dose-controlled trial of modified Sini Powder in treating mild to moderate generalized anxiety disorder(GAD) in the patients with syndrome of liver depression transforming into fire was conducted at Xiyuan Hospital, China Academy of Chinese Medical Sciences. A total of 80 patients with mild to moderate GAD and the syndrome of liver depression transforming into fire were included. Patients were assigned by the central randomization system at a ratio of 3∶1 into an observation group(n=60, receiving a conventional-dose of granules of modified Sini Powder) and a control group(n=20, receiving low-dose granules with the active ingredients being 50% of that in observation group). Assessments were conducted before treatment(baseline), after 2 weeks of introduction, after 2/4/8 weeks of treatment, and after 4 weeks of follow-up. The results were summarized as follows. In terms of primary outcome indicators, the observation group(62.2%) showed higher total response rate than the control group(26.6%)(P<0.05), and greater Hamilton anxiety scale(HAMA) score reduction after 8 weeks of treatment(P<0.05). In terms of secondary outcome indicators, the HAMA score(somatic anxiety score), traditional Chinese medicine(TCM) syndrome scores, Pittsburgh sleep quality index(PSQI) scale, and clinical global impression(CGI) scale score in the observation group showed a significant compared to the control group at each visit points(P<0.05). Adverse events occurred in 10 cases, including 9(16.9%) cases in the observation group and 1(6.6%) case in the control group. No adverse reaction was observed. In conclusion, conventional-dose modified Sini Powder demonstrated superior efficacy and favorable safety for mild and moderate GAD in the patients with the syndrome of liver depression transforming into fire over low-dose treatment.
Humans
;
Male
;
Female
;
Adult
;
Middle Aged
;
Double-Blind Method
;
Drugs, Chinese Herbal/administration & dosage*
;
Anxiety Disorders/drug therapy*
;
Treatment Outcome
;
Young Adult
;
Powders
;
Aged
;
Liver/drug effects*
;
Generalized Anxiety Disorder


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