scholarly journals Traditional Chinese medicine auricular point acupressure for the relief of pain, fatigue, and gastrointestinal adverse reactions after the injection of novel coronavirus-19 vaccines: a structured summary of a study protocol for a multicentre, three-arm, single-blind, prospective randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Qinwei Fu ◽  
Hui Xie ◽  
Li Zhou ◽  
Xinrong Li ◽  
Yang Liu ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Injection Site ◽  
Joint Pain ◽  
Adverse Reactions ◽  
Control Group ◽  
Auricular Point ◽  
Full Protocol ◽  
Novel Coronavirus ◽  
Single Blind

Abstract Objectives To investigate if traditional Chinese medicine (TCM) auricular point acupressure (APA) can alleviate and (or) reduce the pain (including injection site pain, headache, other muscle and joint pain), fatigue, and gastrointestinal adverse reactions (including nausea, vomiting, diarrhea), after the injection of novel coronavirus-19 vaccines (NCVs). Trial design The study is designed as a multicentre, parallel-group, three-arm, single-blind, prospective, randomized (1:1:1 ratio) study. Participants More than 360 participants will be recruited from healthy people who vaccinate NCVs in 5 community healthcare centres in the Sichuan province of China and 1 university hospital (Hospital of Chengdu University of Traditional Chinese Medicine). Inclusion criteria: ①Vaccinators meets the conditions of NCVs injection and have no contraindications to it. The details shall be subject to the instructions of the NCVs used and the statement of medical institutions. The first dose of NCVs injection shall be completed within 24 hours from the time of injection to the time of enrolment; ②No redness, swelling, injury or infection of the skin or soft tissue of both ears, which is not suitable for APA; ③No history of alcohol and adhesive tape contact allergy; ④18-59 years old, regardless of gender; ⑤Those who were able to complete the questionnaire independently at the time of the first and second dose of NCVs and on the 3rd, 7th and 15th day after the first and second dose of NCVs respectively; ⑥Those who agree to participate in the trial and sign the informed consent, and can seriously abide by the precautions after the injection of NCVs and the requirements of traditional Chinese medicine auricular point plasters sticking and acupressure. Exclusion criteria: ①Those who are not suitable to be vaccinated because they belong to the contraindication or cautious population; ②Those who have participated in other clinical trials within 4 weeks before the start of this study; ③No chronic/habitual/persistent headache, Muscle or joint pain, fatigue, diarrhea, nausea, retching or vomiting before the injection of NCVs, and no related diseases present (details of this item is listed in full protocol); ④Those who are in use or have received TCMAPA within 2 weeks before the trial; ⑤Pregnant or lactating women; ⑥Participants with other serious primary diseases and psychosis. Intervention and comparator ①Auricular point acupressure group: participants receive bilateral, symptom-specific TCMAPA in 5 auricular points (per side, 10 points bilateral) for 5 days, 3-4 times (about 1 min each time) of self-acupressure per day, after each NCVs injection (10 days in total). ②Sham auricular point acupressure group: participants receive bilateral, none symptom-specific, sham APA in 5 auricular points (per side, 10 points bilateral) for 5 days, 3-4 times (about 1 min each time) of self-acupressure per day, after each NCVs injection (10 days in total). ③Blank control group: Non-intervention blank control. The Hebei medical device Co. Ltd, Hebei, China manufactured the auricular point sticking plasters. Main outcomes Primary outcomes are all scores of visual analogue scale (VAS) based on subjective judgment of the participants included, including VAS score of pain at injection site, headache, muscle and joint pain, fatigue, nausea, retching, vomiting and diarrhea. Time points for outcomes above are the same: ①Immediately after first and second injection of the vaccine (Baseline assessment); ②Three days after first and second injection of the vaccine; ③Seven days after first and second injection of the vaccine; ④Fifteen days after first and second injection of the vaccine. Randomisation Participants will be randomized in 1:1:1 ratio to each group by computerized random number generator, and independently in each sub-centre. Blinding (masking) Participants, information collectors and statistical evaluators will be blinded between APA group and sham APA group. No blinding in the control group. Numbers to be randomised (sample size) No less than 360 participants will be randomized in 1:1:1 ratio to each group. Trial Status Protocol version 2.0 of February 3rd, 2021. Recruitment is expected to start on February 18th, 2021, and to finish on March 12th, 2021. Trial registration This trial was registered in the China Clinical Trial Registry (ChiCTR) (ChiCTR2100043210) on 8th February, 2021. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals Effect of Traditional Chinese Medicine Combined with Bladder Perfusion with Hydroxycamptothecin on Color Ultrasound and Clinical Efficacy in Patients with Bladder Cancer Surgery

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Shisheng Zhou ◽  
Xia Fan ◽  
Xiaojie Du ◽  
Shuang Liu ◽  
Hongmei Sun ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Chinese Medicine ◽  
Growth Factor ◽  
Traditional Chinese Medicine ◽  
Immune Function ◽  
Adverse Reactions ◽  
Clinical Effect ◽  
Control Group ◽  
Observation Group ◽  
Better Than

Objective. To observe the clinical effect of Xiaozheng Decoction combined with bladder perfusion with hydroxycamptothecin in the treatment of bladder cancer. Methods. A total of 92 bladder cancer patients admitted to our hospital from January to December 2018 were selected and divided into an observation group and a control group according to the random number table method, with 46 cases in each group. The observation group was given Xiaozheng Decoction combined with bladder perfusion with hydroxycamptothecin, and the control group was given hydroxycamptothecin. The levels of serum-related factors (intercellular adhesion molecule-1 (ICAM-1), E-cadherin, cell adhesion molecules (CAM), fibroblast growth factor (FGF), and vascular endothelial growth factor (VEGF)), white blood cell (WBC) level, immune function indexes, short-term total response rate, and incidence of adverse reactions were compared between the two groups before and after treatment. Results. After 2 years of postoperative treatment, the levels of ICAM-1, E-cadherin, CAM-1, FGF, and VEGF (a, b, c) in both groups were improved compared with those before treatment and the observation group was better than the control group p < 0.01 . The number of WBCs was significantly higher than in the control group after Traditional Chinese Medicine (TCM) treatment. The observation group was better than the control group in increasing CD3+ and CD4+ levels and decreasing CD8+ level p < 0.05 , indicating that this prescription could improve the immune function of patients. The recurrence rate in the observation group was 6.52% after 2 years of treatment, lower than 17.39% in the control group. Color ultrasound parameters showed that there were no statistically significant differences in arrive time (AT) and time to peak (TTP) between patients with and without recurrence and peak intensity (PI) and washout time (WT) were higher in patients with recurrence than in patients without recurrence p < 0.01 . The incidence of adverse reactions was significantly lower than that of the control group p < 0.01 . Conclusion. The clinical effect of Xiaozheng Decoction combined with hydroxycamptothecin on the treatment of bladder cancer was clear and superior to that of hydroxycamptothecin, which could effectively improve the serological indicators of patients with a low incidence of adverse reactions and prolong the survival cycle of patients. Therefore, it is worthy of promotion and application.

Interaction between Traditional Chinese Medicine and Anticoagulant/Antiplatelet Drugs

2019 ◽  
Vol 20 (9) ◽  
pp. 701-713 ◽  
Author(s):  
Jiajia Li ◽  
Qing Liang ◽  
GuangChun Sun
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Drug Interactions ◽  
Adverse Reactions ◽  
Bleeding Risk ◽  
Antiplatelet Drugs ◽  
Pharmacokinetic Studies ◽  
Drug Databases ◽  
Concurrent Use ◽  
Anticoagulant Drugs

Background: Traditional Chinese medicine (TCM) has been used for medical purposes since the ancient time and has gradually gained recognition worldwide. Nowadays, patients with thrombus presiding to anticoagulant/ antiplatelet drugs prefer taking TCM. However, an increasing number of studies on herb–drug interactions have been shown. Nevertheless, findings are frequently conflicting and vague. In this review, we discuss the herb–drug interactions between TCM and anticoagulant/antiplatelet drugs to provide guidance on concomitant ingestion with anticoagulant/antiplatelet drugs. Methods: We undertook a structured search of medicine and drug databases for peer-reviewed literature using focused review questions. Results: Danshen, Ginkgo, Ginger, H. Perforatum, SMY and Puerarin injection had directional regulation effects on the efficacy of anticoagulant drugs by altering the CYPs, pharmacokinetic indexs and hemorheological parameters. H. Perforatum inhibited the efficacy of Clopidogrel by enhancing the CYP3A4 activity and Ginkgo increased the efficacy of Ticlopidine. Additionally, Renshen, the formulae except SMY and injections except Puerarin injection could increase or decrease the efficacy of anticoagulant/antiplatelet drugs via regulating the CYPs, platelet aggregation, hemorheological parameters and others. Conclusion: Some cases have reported that TCMs may increase the bleeding risk or has no effect on coagulation when anticoagulant/antiplatelet drugs are concurrently used. However, pharmacokinetic studies have presented either consistent or slightly varying results. So it is difficult to ascertain whether the concurrent use of TCM may increase or reduce the pharmacologic effects of anticoagulant/antiplatelet drugs with adverse reactions. Therefore, herb–drug interactions of TCM and anticoagulant/antiplatelet drugs should be further explored and defined.

scholarly journals Efficacy of Traditional Chinese Medicine in Treatment and Prophylaxis of Radiation-Induced Oral Mucositis in Patients Receiving Radiotherapy: A Randomized Controlled Trial

2017 ◽  
Vol 17 (2) ◽  
pp. 444-450 ◽  
Author(s):  
Cong Wang ◽  
Peiguo Wang ◽  
Huaqiang Ouyang ◽  
Jing Wang ◽  
Lining Sun ◽  
...  
Keyword(s):  
Body Mass Index ◽  
Chinese Medicine ◽  
Treatment Group ◽  
Traditional Chinese Medicine ◽  
Body Mass ◽  
Oral Mucositis ◽  
Visual Analysis ◽  
Control Group ◽  
Oral Pain ◽  
Radiation Induced

Objective: To estimate the efficacy of traditional Chinese medicine (Chining decoction, CHIN) for radiation-induced oral mucositis in patients with head and neck cancer. Methods: From May 2014 to December 2015, 70 consecutive patients were randomly assigned to receive CHIN (treatment group) or recombinant human epidermal growth factor (rhEGF) spray (control group) at a 1:1 ratio. CHIN was administered to treatment group from the first day of radiotherapy until the completion of radiotherapy. Simultaneously, the rhEGF spray was administered to control group on the oral mucosa of irradiated area. The clinical benefit was determined by gradation of mucositis (Common Terminology Criteria for Adverse Events v4.0), oral pain, and xerostomia (visual analysis scale) for each week during radiotherapy. Body mass index was evaluated before and after radiotherapy. Results: Patients in the treatment group had prominent remission of oral pain and grade of mucositis on each observing point compared with those in control group ( P < .01). Xerostomia was decreased notably in treatment group compared with control group ( P < .01). Body mass index in the treatment group exhibited advantage over control group after radiotherapy, but there was no statistical significance (19.8 ± 3.26 vs 18.8 ± 2.5 kg/m2, P = .153, >.05). Conclusions: CHIN presented an obvious advantage in preventing radiation-induced oral mucositis compared with rhEGF spray.

scholarly journals Traditional Chinese Medicine Use among Emergency Patients in Hong Kong

2007 ◽  
Vol 14 (3) ◽  
pp. 151-153 ◽  
Author(s):  
ML Tse ◽  
FL Lau
Keyword(s):  
Hong Kong ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Topical Treatment ◽  
Adverse Reactions ◽  
Oral Intake ◽  
Prospective Survey ◽  
Emergency Patients ◽  
Number Of Patients ◽  
Christian Hospital

Introduction Traditional Chinese Medicine (TCM) use has been believed to be common in Hong Kong but no data existed on its prevalence among emergency patients. We conducted a prospective survey to study the prevalence of its use, the type of TCM use, frequency and nature of associated adverse reactions. Methods All accident & emergency department (AED) attendances at the United Christian Hospital were screened by the triage nurse and attending doctor for TCM use and its type in a consecutive 31 day period. The causal relationships between the TCM and their presenting illness were also assessed and decided by the doctor in-charge. Results 291 out of 21,475 patients (1.4%) reported TCM use within one week. Among them, 117 (40.2%) consumed Chinese herbal medicine, 75 (25.8%) took proprietary Chinese medicine, 1 (0.3%) took both, 96 (33.0%) received topical treatment and 2 (0.7%) were unclassified, with 22 out of the 291 TCM users (7.6%) presented for TCM-related toxicity. Most complications were mild, the commonest ones being dermatitis after topical treatment (68.2%) and allergic reaction after oral intake (22.7%). Conclusion A small number of patients took TCM treatment shortly before AED consultation. Most TCM-related toxicities were mild and the commonest reactions were dermatitis and systemic allergy.

scholarly journals Effects of Shaoyao-Gancao-Fuzi Decoction on the Pharmacokinetics of CYP3A4-Mediated Tofacitinib in Rats

2020 ◽  
Author(s):  
Li Lin ◽  
Yuan Wang ◽  
Sennan Shao ◽  
Wen Lin ◽  
Dan Huang ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Oral Administration ◽  
Western Medicine ◽  
Control Group ◽  
Clinical Use ◽  
Pharmacokinetic Profiles ◽  
Pre Treatment ◽  
Cocktail Approach

Abstract Background: The combination of traditional Chinese medicine and western medicine is commonly accepted in clinics in China. Shaoyao-Gancao-Fuzi decoction (SGFD) has been extensively used to dispel wind, eliminate dampness and treat paralysis. Tofacitinib is approved for the treatment of rheumatoid arthritis. SGFD and tofacitinib could be used together for the treatment of rheumatoid arthritis.Methods: A cocktail approach was employed to assess the effects of SGFD on the activities of CYP450s. After pretreatment for 2 weeks with SGFD, a cocktail solution was given to rats 24 h after the last dose of saline or SGFD. Additionally, the pharmacokinetic profiles of oral administration of tofacitinib in rats, with or without SGFD pre-treatment were investigated.Results: The results showed that SGFD could induce the activity of CYP1A2 and inhibit the activity of CYP3A4. Furthermore, SGFD could significantly affect the pharmacokinetics of tofacitinib. Compared with control group, the AUC0-∞ of tofacitinib was increased from 13669.53 ± 4986.83 to 28706.69 ± 9563.13 ng/mL*h (p < 0.01), and the Cmax was increased from 8359.66 ± 1512.22 to 11332.51 ± 2791.90 ng/mL (p < 0.05).Conclusions: The system exposure of tofacitinib was increased by SGFD. The mechanism might be through inhibiting the activity of CYP3A4 and reducing the metabolism of tofacitinib in rats. The study will provide better guidance for the safe clinical use of SGFD and tofacitinib.

scholarly journals Efficacy and Safety of Ejiao (Asini Corii Colla) in Women With Blood Deficient Symptoms: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Li Zhang ◽  
Zhongju Xu ◽  
Tao Jiang ◽  
Jialu Zhang ◽  
Pinxian Huang ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Blood Cell ◽  
Control Group ◽  
Placebo Control ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Placebo Control Group ◽  
Sf 36

Equus asinus L [Equidae; Asini Corii Colla] (donkey-hide gelatin, Ejiao), a well-known traditional Chinese medicine, has been widely used to nourish the blood, especially for women. The aim of this study was to assess the efficacy and safety of Ejiao in blood-deficient patients. A total of 210 participants were recruited and randomly allocated into the placebo control group and Ejiao-treated group (6 g/day). The primary outcomes on the efficacy of Ejiao included traditional Chinese medicine symptom scores, blood indicators, and SF-36. The secondary outcomes were changes in fireness and safety evaluation. Results showed that Ejiao treatment for 8 weeks had significantly improved dizziness symptoms. Among the tested 24 blood biochemical parameters, the hematocrit and red blood cell numbers decreased in the placebo control group, but decreased significantly less in the Ejiao treatment group. The white blood cell and neutrophil counts increased in the Ejiao group but were within the normal range. In addition, the quality of life improved as the scores in SF-36 domains were significantly higher in the Ejiao group. At the same time, there was no significant change in the fire–heat symptoms score or other safety parameters. Considering all these, our study showed that Ejiao has a promising effect in women suffering from blood deficiency without obvious adverse effects.

scholarly journals Clinical Observation on the Effect of Chinese Medicine Five-Color Therapy on the Treatment of Children with Chronic Urticaria

2020 ◽  
Vol 4 (3) ◽  
Author(s):  
Yu Zhu ◽  
Lu Shi
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Chronic Urticaria ◽  
Statistical Significance ◽  
Effective Rate ◽  
Control Group ◽  
Color Treatment ◽  
Income Data ◽  
Grouping Method ◽  
Experimental Group

Objective: To analyze the clinical treatment effect of traditional Chinese medicine five-color therapy on chronic urticaria in children. Methods: The income data target of this article is 80 children with chronic urticaria. The grouping method is a randomized method with 40 children in each group. The experimental group was treated with five-color treatment of traditional Chinese medicine, and the control group was treated with western medicine. The incidence, treatment and recurrence of adverse reactions in children with chronic urticaria were compared between the two groups. Results: Showed total effective rate of children with chronic urticaria in the experimental group was compared with the control group, P<0.05, the data showed statistical significance. Conclusion: Stated use of TCM five-color therapy in the treatment of children with chronic urticaria can significantly improve safety.

scholarly journals Therapeutic Effect of Oral Administration and External Therapy of Traditional Chinese Medicine on Cervical Tuberculous

2019 ◽  
Vol 3 (3) ◽  
Author(s):  
Guoqiang Yang ◽  
Jin Zhang
Keyword(s):  
Statistical Analysis ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Oral Administration ◽  
Total Effective Rate ◽  
Statistical Significance ◽  
Effective Rate ◽  
Control Group ◽  
Treatment Data ◽  
Experimental Group

Objective: To analyze the clinical effect and value of oral administration and external therapy of traditional Chinese medicine for treatment of cervical tuberculous lymphadenopathy. Methods: A total of 56 patients with cervical tuberculous lymphadenopathy admitted to our hospital from January 1 to January 2018 were recruited. By using double-blind method, the patients were divided into control group (n=28) and experimental group (n=28). Control group comprised of patients with conventional anti-tuberculosis treatment, while the experimental group comprised of patients treated with oral administration and external therapy of traditional Chinese medicine. Total effective rate, incidence of complication and level of T lymphocyte subsets were compared between the two groups of cervical tuberculous lymphadenopathy patients. Results: Post-treatment data of total effective rate, complication rate, CD3+, CD4+, CD8+, CD4+/CD8+ of the experimental group were compared with the control group. P<0.05; statistical analysis showed statistical significance. Post-treatment data of CD3+, CD4+, CD8+, CD4+/CD8+ of both control and experimental groups were compared with pre-treatment data. P<0.05; statistical analysis showed statistical significance. Conclusion: Oral administration and external therapy of traditional Chinese medicine possesses significant effect in treatment of cervical tuberculous lymphadenopathy.

scholarly journals Research Progress on Treatment of Abnormal Uterine Bleeding during Puberty with Traditional Chinese and Western Medicine

2021 ◽  
Vol 5 (4) ◽  
pp. 144-147
Author(s):  
Dan Zhang ◽  
Jing Cai ◽  
Xiaoping Cui ◽  
Xinchun Xiao
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Recurrence Rate ◽  
Western Medicine ◽  
Adverse Reactions ◽  
Abnormal Uterine Bleeding ◽  
Uterine Bleeding ◽  
Research Progress ◽  
Related Literature ◽  
Sudden Collapse

In recent years, the frequency of clinical occurrence of abnormal uterine bleeding in adolescence has gradually increased. In order to fully understand the research progress in the treatment of abnormal uterine bleeding in adolescence, various studies and clinical experience have been reviewed by consulting related literature reports. The results found that currently Western medicine mainly uses hormone drugs in clinical treatment, but there are risks such as more clinical adverse reactions and higher recurrence rate; traditional Chinese medicine (TCM) treatment has achieved satisfactory results, but the advantages of sudden collapse and hemostasis are not obvious. Combined TCM and Western medicine treatment, it can learn from each other and has become a research hotspot in recent years, which is worthy of an in-depth discussion.

Sign in / Sign up

Export Citation Format

Share Document