Clinical effect of catgut implantation at acupoints for the treatment of simple obesity: A multicentre randomized controlled trial.

BACKGROUND: Catgut implantation at acupoints (CIA) is a subtype of acupuncture that has been widely used to treat simple obesity, but evidence for its effectiveness remains scarce. The aim of this study is to evaluate the efficacy and safety of treating simple obesity with CIA. OBJECTIVE: This clinical trial aims to evaluate the effectiveness and safety of CIA used for treatment of simple obesity. METHODS: This is a multicentre, randomized, parallel, sham-controlled clinical trial. A total of 216 patients with simple obesity will be recruited. They will be randomly assigned in a 1:1 ratio to either the CIA group or the sham control group. All treatments will be given once every 2 weeks. The primary outcome measure is the rate of waistline reduction. Secondary outcome measures are the rates of reduction of body measurements, including weight, body mass index (BMI), hipline, waist-hip-ratio (WHR) and body fat percentage (BFP), the changes in scores on scales, including the Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite), Short Form 36 (SF-36), the Hospital Anxiety and Depression Scale (HAD) and the Self-Esteem Scale (SES), Outcomes will be evaluated at baseline and at weeks 4, 8, 12, 16, 28, and 40, respectively. All adverse events that occur during this study will be recorded. If any participant withdraws from the trial, an intention-to-treat analysis (ITT) will be performed. CONCLUSION: This is a randomized, sham-controlled trial of CIA treatment for simple obesity. The results of this trial will provide more evidence on whether CIA is efficacious and safe for treating obesity. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02936973. Registered on October 18, 2016.

[Comparison between bacteriophage-based assay and BACTEC-960 system in detection of ethambutol resistance in Mycobacterium tuberculosis].

OBJECTIVE: To set up phage amplified biologically assay (PhaB) for rapid detection ethambutol (EMB) resistance and to evaluate the use of PhaB in the detection of EMB resistance. METHODS: To detect the EMB resistance of 138 clinical isolates of Mycobacterium tuberculosis (MTB) by PhaB and compare it with the results of BACTEC-960 system. The minimal inhibitory concentration (MIC) was detected for all the discrepant isolates. RESULTS: Of all the 138 strains of MTB clinical isolates, 114 strains were EMB-susceptible and 24 strains were EMB-resistant with BACTEC-960 system while 118 strains were EMB-susceptible and 20 strains were EMB-resistant with PhaB. 112 of the 138 strains were EMB-susceptible and 18 strains were EMB-resistant with the two methods. The concordant isolates in determination of EMB resistance were 130 strains in the two methods and the concordance rate was 94.2%. The disconcordant isolates were 8 strains and the discrepancy rate was 5.8%. The sensitivity, specificity, positive and negative predictive value as well as overall accuracy for the PhaB assay was 75.0% (18/24), 98.2% (112/114), 90.0% (18/20), 94.9% (112/118) and 94.2% (130/138) respectively if the judgment standard was adopted by BACTEC-960 method. CONCLUSIONS: The PhaB assay can be used for detection of EMB resistance in isolates of MTB easily and quickly in three days. This method do not need special instrument and may be used in rapid screening method for EMB resistance of MTB.

[Comparison of four methods in the detection of isoniazid resistance in clinical isolates of Mycobacterium tuberculosis].

OBJECTIVE: To evaluate the use of phage amplified biologically (PhaB) assay, Bactec-960 system, minimum inhibitory concentration (MIC) method and gene chip in drug susceptibility testing of isoniazid (INH) in clinical isolates of Mycobacterium tuberculosis (MTB). METHODS: INH resistance of 167 clinical isolates of MTB was detected by PhaB assay, Bactec-960 system, MIC and gene-chip methods respectively, and the results of these four methods were compared. RESULTS: 111 INH resistant isolates and 56 INH sensitive isolates were detected by Bactec-960 system. If the result of Bactec-960 system was set as the golden standard, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of PhaB assay were 96.4%, 96.4%, 93.1%, 98.2%, and 96.4% respectively; the sensitivity, specificity, PPV, NPV, and accuracy were 92.9%, 99.1%, 98.1%, 96.5%, and 97.0% for the MIC method, and they were 83.9%, 96.4%, 92.2%, 92.2%, and 92.2% respectively for the gene-chip method. If the result of the MIC method was set as the golden standard, the sensitivity, specificity, PPV, NPV, and accuracy of PhaB assay were 100%, 95.6%, 91.4%, 100%, and 97.0% respectively. The sensitivity, specificity, PPV, NPV, and accuracy were 98.1%, 96.5%, 92.9%, 99.1%, and 97.0% for the Bactec-960 system, and they were 88.7%, 96.5%, 92.2%, 94.8%, and 94.0% respectively for the gene-chip method. CONCLUSIONS: The PhaB assay is highly sensitive and specific, and its result is highly consistent with those of the Bactec-960 system and the MIC method. It is easy to use and took only three days in the detection of drug susceptibility of INH in clinical isolates of MTB. The results indicate that this low-cost assay can be used in rapid screening for INH resistance in MTB isolates. The MIC method proves to be as efficient as the Bactec-960 system, but whether it can be used as the standard method still needs further investigation. The sensitivity of the gene-chip method is lower as compared to the other methods, and therefore can only be used as an ancillary test.