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  1. Article ; Online: Developing Placebos for Clinical Research in Traditional Chinese Medicine

    Mengli Xiao / Jiake Ying / Yang Zhao / Qingna Li / Yingpan Zhao / Rui Gao / Fang Lu

    Frontiers in Pharmacology, Vol

    Assessing Organoleptic Properties of Three Dosage Forms (Oral Liquid, Capsule and Granule)

    2021  Volume 12

    Abstract: Background: The successful application of randomized, double-blind placebo-controlled studies requires maximum blinding. Organoleptic properties of the placebo should be similar to the drug, making it difficult to distinguish between the two. The ... ...

    Abstract Background: The successful application of randomized, double-blind placebo-controlled studies requires maximum blinding. Organoleptic properties of the placebo should be similar to the drug, making it difficult to distinguish between the two. The uniqueness of traditional Chinese medicine (TCM) preparations makes it challenging to prepare placebo. Evaluation of the TCM placebo simulation effect can determine whether the preparation of placebo can be genuinely blind in clinical trials. There is still a lack of well-established methods to evaluate TCM placebos. Hence, this study aimed to explore the evaluation methodology of TCM placebo simulation.Methods: An independent evaluation method and three comparative evaluation methods were proposed, and three dosage forms (oral liquid, capsule, and granule) were tested. The independent evaluation, in which each person was given an experimental drug or a placebo, gave an overall assessment of organoleptic properties in a blind state. We comparatively evaluated the similarity in organoleptic properties between the experimental drug and placebo. According to different distribution methods, we divided comparative evaluation methods into three. In method 1, the evaluator was given the experimental drug and placebo and was told that there must be a placebo among them. In method 2, each evaluator was randomly assigned to the combination group or two investigational drugs group. In method 3, the evaluator was assigned to a set of three coded samples, numbered by random three-digit numbers, each different, two of which were identical, and the two samples were equally frequent.Results: In the independent evaluation, there was no difference between TCM placebo and experimental drugs in a blind state at the level of p = 0.05. Even though the comparative evaluation methods enabled identification of potential differences between the two samples, methods 2 and 3 were better than method 1 in eliminating psychological factors. Also, in method 3, the completely random method combined ...
    Keywords traditional Chinese medicine ; placebo ; simulation effect ; evaluation ; organoleptic properties ; Therapeutics. Pharmacology ; RM1-950
    Subject code 610
    Language English
    Publishing date 2021-06-01T00:00:00Z
    Publisher Frontiers Media S.A.
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: Developing a Scale for the Evaluation of People With Post-prandial Distress Syndrome

    Mengli Xiao / Jiake Ying / Yingpan Zhao / Yang Zhao / Ying Liu / Fang Lu

    Frontiers in Public Health, Vol

    2021  Volume 9

    Abstract: Background: Functional dyspepsia (FD) is one of the most critical health problems worldwide. Although there has been an increased intervention to improve FD symptoms, it is difficult to compare the effect of intervention measures with the existing ... ...

    Abstract Background: Functional dyspepsia (FD) is one of the most critical health problems worldwide. Although there has been an increased intervention to improve FD symptoms, it is difficult to compare the effect of intervention measures with the existing methods of reporting the outcome, and it is a lack of clinical evaluation tools that can be used to evaluate patients' symptoms and treatment. One way of potentially addressing this way is to offer a patient-reported symptom scoring scales, which can be self-reported by patients to highlight interventions' authenticity and reliability. Nevertheless, there is still a lack of validated patient-reported outcome instruments for post-prandial distress syndrome (PDS). This study aims to establish a symptom scoring scale to evaluate the effectiveness of interventions for PDS.Methods: The study consists of two steps. The first step was to formulate the scale. Through a systematic literature review and group discussion, an item pool and scale framework were formed. Then, through the expert consultation and pre-investigation, the formal version of the scale was formed. The second step is to test the reliability and validity of the scale. The scale is tested in the target population to determine whether the reliability and validity of the scale.Discussion: The improvement in patients' self-reported symptoms had a significant impact on the researchers' evaluation of the intervention's authenticity. Therefore, we develop a symptom scoring scale for reporting studies evaluating the effectiveness of PDS interventions. The scale will be used for a more significant comparison to evaluate PDS interventions' effectiveness. The scale also improves trial reporting, reducing research waste by prioritizing the collection and reporting of critical results for all relevant stakeholders.Clinical Trial Registration: ChiCTR, ChiCTR2100044489. Registered on March 22, 2021.
    Keywords scale ; post-prandial distress syndrome ; curative effect evaluation ; scale development ; scale evaluation ; Public aspects of medicine ; RA1-1270
    Subject code 360
    Language English
    Publishing date 2021-06-01T00:00:00Z
    Publisher Frontiers Media S.A.
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Efficacy of Fufang E’jiao Jiang in the Treatment of Patients with Qi and Blood Deficiency Syndrome

    Mengjie Zhao / Mengli Xiao / Jiake Ying / Panbo Qiu / Hongxian Wu / Qin Tan / Shiliang Chen / Lulu Zhang / Sanfei Shi / Guida Li / Yang Zhao / Fang Lu

    Evidence-Based Complementary and Alternative Medicine, Vol

    A Real-World Prospective Multicenter Study with a Patient Registry

    2023  Volume 2023

    Abstract: Objective. This nationwide, multicenter prospective observational study with a patient registry was designed to evaluate the efficacy of Fufang E’jiao Jiang (FEJ) in Chinese patients with Qi and blood deficiency syndrome (QBDS). Methods. QBDS patients ... ...

    Abstract Objective. This nationwide, multicenter prospective observational study with a patient registry was designed to evaluate the efficacy of Fufang E’jiao Jiang (FEJ) in Chinese patients with Qi and blood deficiency syndrome (QBDS). Methods. QBDS patients were consecutively recruited from 81 investigational sites in China from July, 2019, to December, 2020. Patients who met the eligibility criteria were enrolled in a prospective registry database. Baseline characteristics and changes in scores on the traditional Chinese medicine (TCM) symptom evaluation scale for Qi and blood deficiency, the clinical global impression (CGI) scale, the fatigue scale-14 (FS-14), and the Pittsburgh sleep quality index (PSQI) were analyzed to determine the clinical efficacy of FEJ. Results. A total of 3,203 patients were recruited. The average remission rate (i.e., the sum of the cure rate and improvement rate) of the 20 symptoms of QBDS was 92.49% after 4 weeks of FEJ treatment, which was higher than at baseline; the rate increased to 94.69% at 8 weeks. The CGI scale revealed that the number of total remissions at 4 and 8 weeks was 3,120 (97.41%) and 415 (100%), respectively. The total FS-14 scores decreased by 1.67 ± 4.11 (p<0.001) at 4 weeks and 1.72 ± 3.09 (p<0.001) at 8 weeks of treatment. The PSQI scores were 6.6 ± 4.7 and 6.52 ± 3.07 at 4 and 8 weeks, respectively, which were significantly lower than the baseline scores (p<0.001; p=0.0033). Both the subhealth fatigue (SF) and iron deficiency anemia (IDA) groups showed significantly improved clinical symptoms of QBDS (p<0.01). Between-group comparisons revealed significantly greater improvements in FS-14 and PSQI scores in the SF group than in the IDA group (p<0.05). A multivariate logistic regression analysis showed that disease course, FS-14 score at baseline, and four-week FEJ doses were independent risk factors for the degree of symptom relief in QBDS patients (p<0.05). Conclusion. In real-world settings, FEJ has a promising effect in treating QBDS and can ...
    Keywords Other systems of medicine ; RZ201-999
    Subject code 610
    Language English
    Publishing date 2023-01-01T00:00:00Z
    Publisher Hindawi Limited
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

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