OBJECTIVES

This study aimed to identify problems and highlight opportunities for pharmaceutical sciences research in the Philippine pharmaceutical industry's regulatory and clinical research sectors that might have been previously overlooked or underrepresented. It identified current issues that can be addressed by research covering four areas of pharmaceutical sciences: drug design and discovery, pharmacokinetic/pharmacodynamic studies, formulation design and pharmaceutical technology, and regulatory science.

METHODS

A descriptive qualitative approach was used in this study. Data collection was facilitated by key informant interviews (KII) using a standardized interview guide with open-ended questions to identify the pharmaceutical science research needs of the specific sectors. A purposive sampling method was employed, with five key informants (KIs), including the company vice president, director, and top-level managers from different local and multinational pharmaceutical companies. ATLAS.ti software was utilized to facilitate thematic synthesis for qualitative data analysis.

RESULTS

Thirteen common themes were identified from the KIs, such as (1) incomplete development of therapeutic compounds, (2) sustainability of raw materials supply, (3) regulation of herbal medicines versus food supplements, (4) mapping disease priorities through the Philippine pharmaceutical roadmap, (5) government incentives and policies to support research, (6) technical personnel, (7) suboptimal regulatory process, approvals, and implementation, (8) gap in utilization of acquired knowledge on regulations, (9) regulatory governance, (10) passive regulatory action on counterfeit drugs, (11) PIC/S GMP version 14 adaption, (12) formulation optimization, and (13) active pharmaceutical ingredient (API) sourcing and regulation. Based on insights from the International Pharmaceutical Federation regarding anticipated hurdles in pharmaceutical sciences over the next 5-10 years, priority research needs were identified through KIs' input. Relevant action plans were developed, including the creation of research proposals to isolate, purify, and determine chemical structures of natural products, as well as analyzing recent Philippine Health Statistics to help assess the appropriateness of new drug releases for patient needs. Other action plans include forecasting future disease burdens in the country, performing toxicology studies (Health-Based Evaluation Levels/No Observed Adverse Effect Level or HBEL/NOAEL) for common generic drugs, and ensuring that research efforts are directed toward addressing the Philippine pharmaceutical regulatory and clinical research sector's most pressing needs practically and feasibly.

CONCLUSION

This study offers valuable insights into pharmaceutical sciences research and development initiatives within the regulatory and clinical research sectors in the Philippine pharmaceutical industry. These findings have the potential to catalyze transformative advancements in healthcare delivery and outcomes, positioning the Philippines for global excellence and competitiveness.

Occupational Groups ; No-observed-adverse-effect Level ; Social Control, Formal ; Patients ; Pharmaceutical Preparations

OBJECTIVES

Patients undergoing modified radical mastectomy (MRM) often experience significant preoperative anxiety. Effective preoperative education could alleviate anxiety and improve patient outcomes. This research aimed to evaluate whether audiovisual aids during preoperative education correlated with decreased anxiety levels among female MRM patients, and it also aimed to investigate if enhanced preoperative education could lead to reduced anxiety and improved postoperative outcomes.

METHODS

A randomized controlled trial was conducted comparing anxiety levels in MRM patients receiving audiovisual aids versus verbal instructions. Purposive sampling selected female breast cancer patients scheduled for MRM. Data was collected using pre- and post-intervention questionnaires, and statistical analysis was used to test hypotheses.

RESULTS

There was no significant difference in pre-intervention anxiety levels between the control group (mean = 2.77 ± 0.32) and the experimental group (mean = 2.49 ± 0.27; t = 1.49, p = 0.176), indicating comparable baseline anxiety between groups. Following the intervention, the experimental group exhibited a significant reduction in anxiety (mean = 1.83 ± 0.20) compared to the control group (mean = 2.59 ± 0.16; t = 2.79, p = 0.046). Pearson correlation analysis revealed a moderate negative correlation between the use of audiovisual aids and preoperative anxiety levels (r = –0.643, p = 0.017), suggesting that audiovisual education was significantly associated with reduced preoperative anxiety among patients scheduled for MRM.

DISCUSSION

The study found that audiovisual aids significantly reduced anxiety levels in the experimental group but had no effect on the control group. This suggested that such interventions could be effective in reducing preoperative anxiety, particularly in females undergoing MRM. However, further research with larger and more diverse samples was needed to confirm these findings and explore influencing factors in clinical settings

CONCLUSION

The study findings suggested that incorporating audiovisual aids in preoperative education for MRM effectively reduced anxiety levels, warranting further research with larger and more diverse participant groups to validate these results

Human ; Female ; Adult: 25-44 Yrs Old ; Middle Aged: 45-64 Yrs Old ; Audiovisual Aids ; Breast Neoplasms ; Control Groups ; Neoplasms ; Mastectomy, Radical ; Mastectomy, Modified Radical ; Volition ; Female ; Breast ; Acquired Immunodeficiency Syndrome

Progressive pulmonary fibrosis (PPF) is a progressive and lethal condition with few effective treatment options. Improvements in quality of life for patients with PPF remain limited even while receiving treatment with approved antifibrotic drugs. Traditional Chinese medicine (TCM) has the potential to improve cough, dyspnea and fatigue symptoms of patients with PPF. TCM treatments are typically diverse and individualized, requiring urgent development of efficient and precise design strategies to identify effective treatment options. We designed an innovative Bayesian adaptive two-stage trial, hoping to provide new ideas for the rapid evaluation of the effectiveness of TCM in PPF. An open-label, two-stage, adaptive Bayesian randomized controlled trial will be conducted in China. Based on Bayesian methods, the trial will employ response-adaptive randomization to allocate patients to study groups based on data collected over the course of the trial. The adaptive Bayesian trial design will employ a Bayesian hierarchical model with "stopping" and "continuation" criteria once a predetermined posterior probability of superiority or futility and a decision threshold are reached. The trial can be implemented more efficiently by sharing the master protocol and organizational management mechanisms of the sub-trial we have implemented. The primary patient-reported outcome is a change in the Leicester Cough Questionnaire score, reflecting an improvement in cough-specific quality of life. The adaptive Bayesian trial design may be a promising method to facilitate the rapid clinical evaluation of TCM effectiveness for PPF, and will provide an example for how to evaluate TCM effectiveness in rare and refractory diseases. However, due to the complexity of the trial implementation, sufficient simulation analysis by professional statistical analysts is required to construct a Bayesian response-adaptive randomization procedure for timely response. Moreover, detailed standard operating procedures need to be developed to ensure the feasibility of the trial implementation. Please cite this article as: Zhang C, Nie YS, Zhang CT, Yang HJ, Zhang HR, Xiao W, Cui GF, Li J, Li SJ, Huang QS, Yan SY. An adaptive Bayesian randomized controlled trial of traditional Chinese medicine in progressive pulmonary fibrosis: Rationale and study design. J Integr Med. 2025; 23(2): 138-145.
Female ; Humans ; Male ; Bayes Theorem ; Disease Progression ; Drugs, Chinese Herbal/therapeutic use* ; Medicine, Chinese Traditional/methods* ; Pulmonary Fibrosis/therapy* ; Quality of Life ; Randomized Controlled Trials as Topic ; Research Design ; Adaptive Clinical Trials as Topic

Acupuncture is an ancient treatment method used in traditional Chinese medicine and has been popularized worldwide. Over the past decade, there has been an increase in the amount of acupuncture research, mostly comprised of randomized controlled trials (RCTs) that aimed to answer the question on the efficacy of acupuncture. However, poor methodology and low replicability in these acupuncture RCTs have resulted in uncertainty about the efficacy of acupuncture. In this review, current advancements and challenges in acupuncture RCTs, regarding the methodological aspects of randomization, blinding, sham acupuncture and quality of reporting, were discussed. While there have been advancements in various aspects, current acupuncture RCTs still face pressing issues such as inadequate randomization and blinding, unviable sham acupuncture controls, and poor reporting quality. Given these limitations, this review seeks to identify the methodological problems that are responsible for these problems and to suggest solutions that could help to overcome them so as to improve the quality of future studies evaluating the efficacy of acupuncture. Please cite this article as: Seetoh WS, Lim RQR, Xu RB, Sun MX, Zhang P, Wang MN. Advancements and challenges of acupuncture randomized controlled trials. J Integr Med. 2025; 23(4): 333-343.
Acupuncture Therapy ; Humans ; Randomized Controlled Trials as Topic/methods* ; Research Design

To improve the consistency of outcome documentation and address the potential for outcome reporting bias in clinical trials involving integrative Chinese and Western medicine (ICWM) for ulcerative colitis (UC), we aim to develop a customized core outcome set (COS) that incorporates input from various stakeholders. The study design of this COS has been informed by the Core Outcome Measures in Effectiveness Trials Initiative Handbook, with adherence to the guidelines from the Core Outcome Set-STAndards for Reporting statement and Core Outcome Set-STAndardised Protocol Items recommendations. Five groups of stakeholders will be invited to participate in the development of COS for clinical trials with ICWM for UC, including healthcare professionals, patients, COS developers, COS users, and methodologists. The process will involve five stages: (1) conducting a systematic review of outcomes reported in clinical trials and protocols to develop a list of potential outcome domains; (2) conducting semi-structured interviews to obtain important outcomes; (3) choosing the most important outcomes by conducting three-round Delphi surveys; (4) achieving a consensus in a face-to-face meeting to discuss the final COS; and (5) publication, dissemination and implementation of COS. Consequently, this specialized COS will be applicable to clinical trials involving both traditional Chinese medicine (TCM) and ICWM interventions. Please cite this article as: Zhang X, Zhang L, Wang J, Lau CT, Wang N, Zhang X, Wang P, Li J, Han F, Bian Z. A protocol for developing, disseminating and implementing a core outcome set for clinical trials of integrative Chinese and Western medicine for ulcerative colitis. J Integr Med. 2025; 23(6):654-659.
Colitis, Ulcerative/therapy* ; Humans ; Medicine, Chinese Traditional ; Clinical Trials as Topic ; Integrative Medicine ; Research Design ; Outcome Assessment, Health Care ; Delphi Technique

OBJECTIVE: Recaticimab (SHR-1209) significantly reduces low-density lipoprotein cholesterol levels. However, its effect on glucose metabolism remains unclear. This study aimed to evaluate its effect on glycemic parameters in a Chinese population. METHODS: Recaticimab versus placebo was administered in a 5:1 ratio to 110 hyperlipidemia patients who were followed up for 24 weeks. Glycated hemoglobin (HbA1c) levels were measured at baseline every 12 weeks. Fasting plasma glucose (FPG) levels were measured at baseline at week 1, 3, 5, 8, 12, 16, 20, and 24. Repeated-measures mixed-effects models were used to determine the longitudinal association between reacticimab and FPG and HbA1c levels. RESULTS: Among the 81 participants with normal glucose metabolism, HbA1c levels significantly decreased ( F = 4.568, P = 0.036). In the 29 participants with abnormal glucose metabolism, a significant time effect was observed for FPG levels ( F = 2.492, P = 0.016). For participants with normal and abnormal glucose metabolism, no significant group × time interaction effects on FPG or HbA1c levels were identified. CONCLUSION Recaticimab showed no adverse glycemic effects in participants with normal or abnormal glucose metabolism, indicating its safety in patients with or without diabetes.
Humans ; Male ; Female ; Blood Glucose/drug effects* ; Middle Aged ; Double-Blind Method ; Hyperlipidemias/blood* ; Antibodies, Monoclonal, Humanized/therapeutic use* ; PCSK9 Inhibitors ; Glycated Hemoglobin ; Aged ; Adult ; Proprotein Convertase 9

Animal experiments are crucial in evaluating the preclinical safety and efficacy of new dental materials, drugs, instruments, and equipment by identifying and eliminating potential health risks to humans. An international team of several dental experts formulated a guideline named Preferred Reporting Items for Animal Studiesin Endodontology (PRIASE) 2021. Consisting of 11 domains, 43 individual items, and a flowchart. PRIASE provides guidance for animal experiments in dentistry and improves the quality of experiment design and reporting. This work introduces the process and basic content of the guideline and interprets the key items of its checklist with specific examples to provide reference for the reporting of animal experiment in dentistry in China.
Animals ; Animal Experimentation/standards* ; Checklist ; China ; Endodontics ; Guidelines as Topic ; Research Design

Bone grafting is a primary method for treating bone defects. Among various graft materials, xenogeneic bone substitutes are widely used in clinical practice due to their abundant sources, convenient processing and storage, and avoidance of secondary surgeries. With the advancement of domestic production and the limitations of imported products, an increasing number of bone filling or grafting substitute materials isentering clinical trials. Relevant experts have drafted this consensus to enhance the management of medical device clinical trials, protect the rights of participants, and ensure the scientific and effective execution of trials. It summarizes clinical experience in aspects, such as design principles, participant inclusion/exclusion criteria, observation periods, efficacy evaluation metrics, safety assessment indicators, and quality control, to provide guidance for professionals in the field.
Humans ; Bone Substitutes/therapeutic use* ; Randomized Controlled Trials as Topic/methods* ; Consensus ; Bone Transplantation ; Research Design

BACKGROUND: Only prospective cohort studies can capture changes in work conditions and their effects on health. Such studies are rare in bus drivers, despite their high rates of injuries and diseases. The three existing cohorts have limited exposure data, collected at baseline and thus uninformative on exposure and exposure-effect dynamics. Therefore, we aimed to develop the Swiss Transport Personnel Health Cohort (TRAPHEAC) and to anticipate and prevent potential bias. METHODS: To set up the study protocol, we first organized the stakeholder consultation and available data inventory. Second, we mapped the exposure-outcomes pairs to list the most prevalent occupational hazards, and conducted exposure measurement campaigns. Third, we built the Swiss Bus-Exposure Matrix for physical-chemical hazards and Bus-Ergonomics Matrix for visual and biomechanical constrains. These matrices contain 705 bus models operated in Switzerland since 1980 and enable assessing current and past exposure when merged with bus drivers' work histories. RESULTS: We opted for an original study design combining prospective cohort part starting at 2024 and a retrospective part with nested case-control studies. Bus drivers will be invited through three complementary channels: unions, companies, and social media. The eligibility screening, information, and consent form signature and registration will be conducted using the study web-site modules. Registered bus drivers will first receive a comprehensive inclusion questionnaire, then a yearly follow-up questionnaire to assess and update the drivers' work histories. Validated self-reported questionnaires will be used for assessing additional health outcomes (e.g., stress, sleep problems, musculoskeletal disorders, burnout) and individual, occupational and live-style related factors (e.g., personality, ICT use, physical activity). Hospital records (with diagnosed diseases, diagnosis dates and treatments) centralized since 2000 by the Swiss Federal Statics Office will be used for assessing disease prevalence, incidence and case-control status. Advanced statistical analysis will be conducted to address etiological and methodological questions (e.g., individual and joint causal effects of multiple exposures and exposure components; time-varying exposure and outcome variables and confounders mixtures). CONCLUSIONS The yearly assessment of both exposure and health outcomes should enable capturing changes in work conditions and their effects on bus drivers' health and well-being over time and facilitate the tailoring, implementation and evaluation of preventive interventions.
Humans ; Switzerland/epidemiology* ; Prospective Studies ; Occupational Exposure/statistics & numerical data* ; Occupational Diseases/epidemiology* ; Cohort Studies ; Motor Vehicles ; Research Design ; Retrospective Studies ; Case-Control Studies ; Occupational Health ; Adult ; Male ; Female

OBJECTIVE: To evaluate the clinical efficacy and safety of Yangxue Qingnao Pills (YXQNP) combined with amlodipine in treating patients with grade 1 hypertension. METHODS: This is a multicenter, randomized, double-blind, and placebo-controlled study. Adult patients with grade 1 hypertension of blood deficiency and Gan (Liver)-yang hyperactivity syndrome were randomly divided into the treatment or the control groups at a 1:1 ratio. The treatment group received YXQNP and amlodipine besylate, while the control group received YXQNP's placebo and amlodipine besylate. The treatment duration lasted for 180 days. Outcomes assessed included changes in blood pressure, Chinese medicine (CM) syndrome scores, symptoms and target organ functions before and after treatment in both groups. Additionally, adverse events, such as nausea, vomiting, rash, itching, and diarrhea, were recorded in both groups. RESULTS: A total of 662 subjects were enrolled, of whom 608 (91.8%) completed the trial (306 in the treatment and 302 in the control groups). After 180 days of treatment, the standard deviations and coefficients of variation of systolic and diastolic blood pressure levels were lower in the treatment group compared with the control group. The improvement rates of dizziness, headache, insomnia, and waist soreness were significantly higher in the treatment group compared with the control group (P<0.05). After 30 days of treatment, the overall therapeutic effects on CM clinical syndromes were significantly increased in the treatment group as compared with the control group (P<0.05). After 180 days of treatment, brachial-ankle pulse wave velocity, ankle brachial index and albumin-to-creatinine ratio were improved in both groups, with no statistically significant differences (P>0.05). No serious treatment-related adverse events occurred during the study period. CONCLUSIONS Combination therapy of YXQNP with amlodipine significantly improved symptoms such as dizziness and headache, reduced blood pressure variability, and showed a trend toward lowering urinary microalbumin in hypertensive patients. These findings suggest that this regimen has good clinical efficacy and safety. (Registration No. ChiCTR1900022470).
Humans ; Amlodipine/adverse effects* ; Drugs, Chinese Herbal/adverse effects* ; Male ; Female ; Hypertension/complications* ; Middle Aged ; Treatment Outcome ; Drug Therapy, Combination ; Adult ; Blood Pressure/drug effects* ; Double-Blind Method ; Aged ; Antihypertensive Agents/adverse effects*