With the active encouragement of the Chinese government, all domestic clinical research institutes pay more attention to the human research protect program (HRPP) during the process of clinical trials, and actively follow the regulations of medical ethical practice. We could make fully preparation for the accreditation by the correlated international organizations only by further analyzing the Association for Accreditation of Human Research Protection Program (AAHRPP) from a whole and in each accreditation field at different levels, thus having a clear understanding the difference in acknowledging the difference between China's hospitals and America's hospitals.
Accreditation ; China ; Clinical Trials as Topic ; legislation & jurisprudence ; Humans ; Public Policy ; United States

This study was aimed to observe influence on clinical symptoms of Qing-Fei Pei-Yuan Wei-Wan (QFPY-WW) for pulmonary infection HIV/AIDS cases with the syndrome of phlegm-heat obstructing the lung. A total of 141 pulmonary infection HIV/AIDS cases with the syndrome of phlegm-heat obstructing the lung were randomly divided into the treatment group (94 cases) and the control group (47 cases). The treatment group was given basic western medication combined with QFPYWW. The control group was given basic western medication. After 4 weeks treat-ment, observation was made on changes of main symptoms. The results showed that on the 28th day, compared with the control group, there was improvement on symptoms such as cough, breathing and chest tightness (P< 0.05). Com-parison on coughing up phlegm degree showed that the treatment group was significantly better than the control group (P< 0.05). On the 7th day treatment, the treatment group had better effect on lowering body temperature than the control group (P< 0.05). It was concluded that QFPYWW can improve symptoms such as cough, breathing, chest tightness and cough up phlegm among pulmonary infection HIV/AIDS patients.

This paper summarized the experience of Professor FANG Dingya in staged treatment of Sjögren's syndrome from the perspective of dryness toxin. It is believed that the cause of Sjögren's syndrome is externally-contracted dryness， consumption of essence and fluid， congenital and acquired essence deficiency， depleted essence and insufficient blood， and the core mechanism is internal accumulation of dryness toxin. The treatment can be divided into three stages， that is dryness toxin transforming into fire-heat， damp-heat and phlegm-stasis， from the perspective of dryness metal qi transformation. It is emphasized to dispel pathogen mainly， to clear and moisten with yin-nourishing medicinals in supplementation， and to treat by stages based on syndrome differentiation. For dryness toxin with fire-heat， it is suggested to moisten dryness， resolve toxins and subdue fire， with self-made Runzao Jiedu Decoction （润燥解毒汤） in modification. For dryness toxin with damp-heat， the method of nourishing yin， clearing heat and draining dampness should be used， and Chunze Decoction （春泽汤） in modification is suggested. For dryness toxin with phlegm-stasis， it is recommended to unblock collaterals， disperse phlegm and dissipate stasis， with self-made Sanyu Xiaotan Decoction （散瘀消痰汤） in modification.

ObjectiveTo analyse the current implementation status of Chinese herbal medicine （CHM） placebo and systematically evaluate the placebo effect in randomised controlled trials （RCTs） of traditional Chinese medicine （TCM） for the treatment of functional dyspepsia （FD）. MethodsA combination of medical subject terms and free words was used to search six databases， including PubMed， EMBASE， Cochrane Library， Web of Science， China National Knowledge Infrastructure， and Wanfang， for RCTs with CHM placebo group for FD published from January 31st， 1994 to September 30th， 2023. The dosage forms， composition， and methodological quality were collected and evaluated. The quality of the included articles was evaluated by Cochrane risk of bias assessment tool， and meta-analysis was performed on the CHM placebo response rate of patients with FD， and subgroup analysis and meta-regression was performed according to diagnostic criteria， efficacy criteria， duration of treatment， type of placebo， whether it contained active ingredient， and whether it evaluated placebo effects. ResultsA total of 34 publications were included involving 5046 participants， of which 2221 FD patients received CHM placebo treatment. Granules were the predominant placebo preparation， accounting for 71% （24/34）； 32.35% （11/34） of the studies added real CHM to the placebo， and only 12 （35%） of the studies described appearance， odour， and taste. The placebo response rate in FD patients in the placebo group was 41% （95% CI： 0.35 to 0.47； P＜0.01， I² = 87%）； there was significant difference between groups with different diagnostic criteria and different treatment durations （P＜0.05 or P＜0.01）， but there was no significant difference between the different efficacy evaluation criteria， the different placebo preparation， the presence of a low-dose active ingredient， and the presence or absence of placebo assessment （P＞0.05）. ConclusionThere was a significant CHM placebo effect in patients with FD， with granules as the main preparation of placebop. Different diagnostic criteria and different treatment times may affect the response rate of patients， and the addition of low-dose real medicine to the CHM placebos has not been seen to have an effect on the response rate. Clinical investigators have not paid enough attention to placebos， and there is a lack of uniform standards and norms for the preparation and evaluation of CHM placebos.

Placebo-controlled clinical trials have been more and more emphasized in traditional Chinese medicine (TCM) researches, while the preparation of TCM placebos is still to be improved. For this work, some elements should be taken into consideration comprehensively, including the design of clinical trial, the characteristics of researched disease, the nature of testing drugs, and the way of medication, etc. And the technological process for placebo manufacturing should be selected properly depending upon the basis of the above elements. Un-biased foodstuff is good as excipient for TCM placebos preparation. The placebo should be made in dosage-form similar to that of the testing drug as possible, if there are difficulties for simulating them in appearance and smell completely. However, its potential pharmacological activity meeting to the acceptance of researchers should be ensured.
Clinical Trials as Topic ; Drugs, Chinese Herbal ; administration & dosage ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; methods ; Placebos ; standards

OBJECTIVETo explore the effects of Ronggan Mixture (RGM) on cell apoptosis by observing the expressions of apoptosis-related genes (Fasl and Bcl-2) in transgenic mice with chronic liver immune injury induced by concanavalin A (ConA).

METHODSSeventy-four transgenic mice were divided into 6 groups, the model group, the normal group, and the treated groups treated respectively with biphenyldicarboxylate (DDB), oriental wormwood (OWW), Yinchenhao Decoction (YCHD) and RGM. Pathologic changes of liver tissue were observed by light microscopy, number of apoptotic cells were determined by TUNEL method, and expressions of apoptosis-related genes, Fasl and Bcl-2, in hepatic T lymphocyte were detected by flow cytometer.

RESULTSEvident pathological changes of liver appeared in the model mice, showed severely destroyed structure of hepatic lobules. As compared with the model group, the changes of liver fibrosis and cell necrosis were much lessened in the RGM group and the YCHD group (P < 0.05). The protein expression of apoptotic gene Fasl and the apoptotic index in the model group were higher than those in the normal group (P < 0.05), but that of the apoptotic inhibiting gene, Bcl-2, in model mice was similar to that in normal mice. As compared with the model group, apoptosis index decreased (P < 0.01), levels of Fasl expression was lower and Bcl-2 expression was higher in the RGM group and the YCHD group (P < 0.05, P < 0.01), and the effect of the two was similar, but significantly superior to that of OWW and DDB (P < 0.05 or P < 0.01).

CONCLUSIONThe Chinese compound, RGM and YCHD can not only relieve the hepatic pathological injury, but also reduce the cell apoptosis in chronic liver immune injury mice through regulating the expressions of Fasl and Bcl-2.

Animals ; Apoptosis ; drug effects ; Concanavalin A ; adverse effects ; immunology ; Disease Models, Animal ; Drugs, Chinese Herbal ; administration & dosage ; Fas Ligand Protein ; genetics ; metabolism ; Female ; Gene Expression ; drug effects ; Liver ; cytology ; drug effects ; immunology ; injuries ; Liver Diseases ; drug therapy ; genetics ; immunology ; physiopathology ; Male ; Mice ; Mice, Inbred C57BL ; Mice, Transgenic ; Proto-Oncogene Proteins c-bcl-2 ; genetics ; metabolism ; Random Allocation

OBJECTIVETo observe the clinical efficacy on analgesia and detumescence of Cheezheng Qingpeng ointment in the treatment of rheumatoid arthritis.

METHODSFrom December 2004 to May 2006, 78 patients were divided into the treatment group and the control group randomly using PROC PLAN from SAS software. There were 40 patients in the treatment group, 30 patients were male and 10 patients were female, with an average age of (48.2+/-9.7) years, who were treated with Cheezheng Qingpeng ointment external treatment. Thirty-eight patients were in the control group, 30 patients were male and 8 patients were female, with an average age of (47.7+/-13.7) years, and were treated with Diclofenac diethylamine emugel. All the patients were treated for 2 weeks. The metacarpophalangeal joint with most severe pain and swelling was observed. The indexes including joint pain, tenderness, swelling, joint motion and morning stiffness were detected and the VAS scores were compared between the two groups.

RESULTSAll the patients completed the trial, 35 patients in the treatment group and 33 patients in the control group. At the end of 2 weeks, 1 patient in the treatment group obtained an excellent result, 27 good and 7 bad; in the control group, 2 patients got an excellent result, 20 good and 11 bad. There were no statistically difference of therapeutic effects between the two groups. At the 1st week after treatment, the joint swelling score of the treatment group was (4.0+/-1.4), which was lower than the (5.5+/-1.9) in the control group.

CONCLUSIONThere is no obvious difference of therapeutic effects between Cheezheng Qingpeng ointment and diclofenac diethylamine emugel for the treatment of rheumatoid arthritis, but the relieving of swelling of Cheezheng Qingpeng ointment is better than that of Diclofenac Diethylamine Emugel.

Adult ; Arthritis, Rheumatoid ; drug therapy ; pathology ; Drugs, Chinese Herbal ; therapeutic use ; Edema ; drug therapy ; Female ; Humans ; Male ; Middle Aged ; Ointments ; therapeutic use ; Pain ; drug therapy

OBJECTIVETo evaluate the potential usefulness of a multivariable model, established mainly upon peripheral T-cell subsets, Th1/Th2, T-bet and GATA-3 gene expressions as well as TCM and Western medical diagnostic criteria, in predicting the selection of immunosuppressive therapy (IST) or androgens in treating patients with aplastic anemia (AA).

METHODSPeripheral blood T cell subsets in 85 patients with AA were serially analyzed by flow cytometry before and after treatment, and their T-bet and GATA-3 gene expressions were assessed meantime by Real-time PCR. Then analysis of Logistic regression equation and ROC curves were performed based on the cases responding to IST or androgens.

RESULTS(1) According to the logistic equation and ROC curve of SPSS, setting the false positive rate as 0.10, the P value was 0.832. When P> or =0.832, patients were judged in the immunosuppressive dominant state, IST should be applied; when P<0.832, it means patients in the bone marrow failure dominant state, androgens should be added. (2) A novel theory is raised by the above-mentioned analysis, which indicated that the genesis and development process of AA could be divided in 2 stages, the abnormal immune dominant stage and the bone marrow failure dominant stage. For treatment of patients in the two stages, IST and androgens is the preference respectively.

CONCLUSIONThe multivariable model could be used for indicating which stage the AA patient is in, the abnormal immune stage or the bone marrow failure stage, and thus to guide the proper selection of IST or androgens in clinical practice.

Adult ; Aged ; Androgens ; therapeutic use ; Anemia, Aplastic ; drug therapy ; immunology ; Cyclosporine ; therapeutic use ; Female ; GATA3 Transcription Factor ; metabolism ; Humans ; Immunosuppressive Agents ; therapeutic use ; Logistic Models ; Male ; Middle Aged ; T-Box Domain Proteins ; metabolism ; T-Lymphocyte Subsets ; immunology ; Young Adult

Irritable bowel syndrome (IBS) is a commonly seen disease in clinical practice, and Chinese medicine shows certain preponderance in treating the disease contrasted with modern medicine. However, the clinical effect of Chinese medicine was hardly approved by the world, and the lack of widely accepted clinical assessment indices (CAI) is an important cause. The establishment of Chinese medicine CAI system for studying IBS was discussed in this paper based upon the characteristics of clinical effect and clinical assessment of Chinese medicine.
Drugs, Chinese Herbal ; therapeutic use ; Evaluation Studies as Topic ; Humans ; Irritable Bowel Syndrome ; drug therapy ; Phytotherapy ; Treatment Outcome

OBJECTIVETo observe the clinical efficacy of the needling depth recorded in Lingshu (Miraculous Pivot) for irritable bowel syndrome of diarrhea (IBS-D) in Germany.

METHODSWith the needling technique recorded in Lingshu: Jingshui (Miraculous Pivot: Meridian Water), 21 cases of IBSD were treated with acupuncture at Zhangmen(lR 13), Zhongwan(CV 12), Tianshu (ST 25), Guanyuan(CV 4), Qimen (LR 14), Quchi (LI 11), Hegu (LI 4), Yinlingquan(SP 9), Zusanli (ST 36) and Taichong (LR 3), 0. 1-0. 6 cun (2-12 mm) in depth. Even needling technique was applied. The treatment was given 2-3 times each week, and 8 treatments made one session. The efficacy and the scale for the severity degree of symptom (IBS-SSS) were observed in 1-2 sessions of treatment.

RESULTSThe total effective rate was 52.4% (11/21) in the 1st session and was 90.5% (19/21) in the 2nd session. The efficacy in the 2nd session was superior to that in the 1st session (P < 0.05). IBS-SSS was 143.58 +/- 70.15 in the 1st session and was 115.98 +/- 72.68 in the 2nd session, all reduced obviously as compared with those before treatment (all P < 0.01). The reducing degree in the 2nd session was much remarkable than that in the 1st session (P < 0.05).

CONCLUSIONThe better clinical efficacy has been achieved for IBS-D treated with needling depth recorded in Lingshu (Miraculous Pivot) in Germany. The longer session of treatment is, the better efficacy is obtained.

Acupuncture Points ; Acupuncture Therapy ; instrumentation ; methods ; Adolescent ; Adult ; Diarrhea ; therapy ; Female ; Humans ; Irritable Bowel Syndrome ; therapy ; Male ; Middle Aged ; Treatment Outcome ; Young Adult