Treatment based on syndrome differentiation is an essential feature of traditional Chinese medical diagnosis. The interventions based on changes of syndrome types in randomized controlled trials are complicated, leading to the difficulty of blind method enforcement. This article described a double-blind method. It could be used in randomized controlled trials under the condition of different syndrome types and different medications. It numbered drugs in two stages, and in two phases to achieve double-blind. This method not only guaranteed investigators and subjects to be in blinded conditions, but also achieved using different medications for patients of different syndromes. It also caused no drug waste. It was scientific and feasible.
Double-Blind Method ; Humans ; Medicine, Chinese Traditional ; Randomized Controlled Trials as Topic ; Single-Blind Method

OBJECTIVE: To assess the effects of loupes and microscope on the posture of prosthodontists when preparing the laminate veneer, and to assess the clinical value of loupes and microscope from the ergonomic aspects. METHODS: Twenty young prosthodontists from Department of Prosthodontics, Peking University School and Hospital of Stomatology were recruited into this study, which was a prospective, single blind, self-control trials. The research hypothesis was concealed and the participants were deceived about the precise purpose of the study to counterbalance the lack of direct blinding. The prosthodontists prepared laminate veneers of open window type in the artificial dental model, under routine visual field (control group), 2.5× headwear loupes (loupes group), and 8× operating microscope (microscopic group) by turning. The participants were photographed from profile view and front view. Thereafter, the subjective assessment was performed by themselves using the visual analogue score (VAS). The expert assessment was performed by two professors using modified-dental operator posture assessment instrument on the basis of photographs of the profile view and front view. RESULTS: The subjective assessment scores for the control group, loupes group and microscopic group were 4.55±1.96, 7.90±1.12, and 9.00±0.92, respectively. There was significant difference between the three groups' subjective scores (P < 0.05). The expert assessment scores for the control group, loupes group and microscopic group were 16.38±1.52, 15.15±1.30, and 13.60±0.88, respectively. There was significant difference between the three groups' expert assessment scores (P < 0.05). Specifically, the three groups' expert assessment scores were significantly different (P < 0.05) in trunk position (front to back) (1.33±0.41, 1.03±0.11, 1.00±0.00), head and neck position (front to back) (2.75±0.38, 2.13±0.36, 1.23±0.38), elbows level (1.38±0.43, 1.40±0.45, 1.13±0.22), and shoulders level (1.43±0.41, 1.23±0.34, 1.13±0.28). Thereinto, the microscopic group was better than loupes group in head and neck position (front to back) and elbows level (P < 0.05). CONCLUSION Loupes and microscope improve the posture of the prosthodontist when preparing the laminate veneer, in which the microscope is better than loupes. Therefore, the magnification devices have clinical value from the ergonomic aspects.
Dentists ; Ergonomics ; Humans ; Posture ; Prospective Studies ; Single-Blind Method

OBJECTIVETo study the basic therapeutic function of Tiaokou (ST 38).

METHODSAccording to clinically multi-central randomized controlled and single-blind test principle, 257 cases of periarthritis of shoulder were divided into two groups, a test group (n = 124) treated with oral anti-inflammatory analgesic medicine combined with acupuncture at Tiaokou (ST 38), and a control group (n = 133) treated with oral anti-inflammatory analgesic medicine. Their therapeutic effects were compared.

RESULTSThe total effective rate for stopping pain was 96.0% in the test group and 91.7% in the control group with a very significant difference between the two groups (P< 0.01). And the total effective rate for improvement of shoulder activity was 86.3% in the test group and 59.4% in the control group with a very significant difference between the two groups (P<0.01).

CONCLUSIONOral anti-inflammatory analgesic medicine combined with acupuncture has obvious therapeutic effect on periarthritis of shoulder, which is better than that of simple oral anti-inflammatory analgesic medicine.

OBJECTIVETo probe into clinical value of comprehensive program of acupuncture, moxibustion and massage as main for treatment of cervical spondylopathy of the nerve root type.

METHODSFive centers, single blind, randomized controlled method were used, 660 cases were divided into a treatment group of 317 cases and a control group of 311 cases. They were treated respectively with comprehensive program of acupuncture, moxibustion and massage as main, and comprehensive program of physical therapy as main. Establish syndrome detection scale and multiply dimensional effect assessment indexes, and evaluate the therapeutic effects and safety.

RESULTSThe cured rate, the cured-markedly effective rate were 42.9%, 64.4% in the treatment group, respectively, better than 16.7%, 36.3% in the control group (P<0.01); after treatment of 2 weeks, clinical symptoms improved in the both groups, but the treatment group was better than the control group in the improvement degrees of neck-shoulder-limb pain, neck rigidity, abnormality of cervical anteflexion, etc. (P<0.01 or P<0.05); the treatment group was shorter than the control group in the time of producing the effect and therapeutic course (P<0.01).

CONCLUSIONComprehensive program of acupuncture, moxibustion and massage as main is safe and effective for treatment of cervical spondylopathy, with a better therapeutic effect compared with the comprehensive program of physical therapy.

Controlled Clinical Trials as Topic ; Double-Blind Method ; Drugs, Chinese Herbal ; Humans ; Placebos ; Randomized Controlled Trials as Topic ; Single-Blind Method

BACKGROUND/AIMS: No clear data have been established and validated regarding whether rectal retroflexion has an important and therapeutic impact. The aim of the present study was to evaluate the diagnostic yield and therapeutic impact of rectal retroflexion compared with straight view examination. METHODS: A prospective single-blind study was conducted. Consecutive patients evaluated between October 2011 and April 2012 were included. RESULTS: A total of 934 patients (542 women, 58%) were included. The mean age was 57.4+/-14.8 years. Retroflexion was successful in 917 patients (98.2%). Distinct lesions in the anorectal area were detected in 32 patients (3.4%), of which 10 (1%) were identified only on retroflex view and 22 (2.4%) on both straight and retroflex views. Of the 32 identified lesions, 16 (50%) were polyps, nine (28.1%) were angiodysplasias, six (18.8%) were ulcers, and one (3.1%) was a flat lesion. All 10 patients (1%) in whom lesions were detected only by rectal retroflexion showed a therapeutic impact. CONCLUSIONS: Rectal retroflexion has minimal diagnostic yield and therapeutic impact. However, its low rate of major complications and the possibility of detecting lesions undetectable by straight viewing justify its use.
Angiodysplasia ; Colonoscopy ; Female ; Humans ; Polyps ; Prospective Studies* ; Rectum ; Single-Blind Method* ; Ulcer

BACKGROUND: There have been few studies on the effect of an elevated concentration of lidocaine hydrochloride in the surgical removal of an impacted lower third molar. This study aimed to examine the efficacy of 4% lidocaine along with 1:100,000 epinephrine compared to 2% lidocaine along with 1:100,000 epinephrine as inferior alveolar nerve block for the removal of an impacted lower third molar. METHODS: This single-blind study involved 31 healthy patients (mean age: 23 y; range: 19-33 y) with symmetrically impacted lower third molars as observed on panoramic radiographs. Volunteers required 2 surgical interventions by the same surgeon with a 3-week washout period. The volunteers were assigned either 4% lidocaine with 1:100,000 epinephrine or 2% lidocaine with 1:100,000 epinephrine as local anesthetic during each operation. RESULTS: We recorded the time of administration, need for additional anesthetic administration, total volume of anesthetic used. We found that the patient's preference for either of the 2 types of local anesthetic were significantly different (P < 0.05). However, the extent of pulpal anesthesia, surgical duration, and duration of soft tissue anesthesia were not significantly different. CONCLUSIONS: Our study suggested that inferior alveolar nerve block using 4% lidocaine HCl with 1:100,000 epinephrine as a local anesthetic was clinically more effective than that using 2% lidocaine HCl with 1:100,000 epinephrine; the surgical duration was not affected, and no clinically adverse effects were encountered.
Anesthesia ; Epinephrine ; Humans ; Lidocaine* ; Mandibular Nerve ; Molar, Third* ; Single-Blind Method ; Volunteers

OBJECTIVE: To compare intranasal midazolam and intramuscular phenobarbital sodium for their sedative effect in neonates undergoing magnetic resonance imaging (MRI). METHODS: A total of 70 neonates who underwent cranial MRI from September 2017 to March 2019 were randomized into an observation group and a control group, with 35 cases in each group. The observation group received intranasal drops of midazolam (0.3 mg/kg), and the control group received intramuscular injection of phenobarbital sodium (10 mg/kg). The sedation status of the neonates was evaluated using the Ramsay Sedation Scale. Meanwhile, the two groups were compared for the success rate of MRI procedure and incidence of adverse reactions. RESULTS: In the observation group, the sedation score was the highest at 20 minutes post administration, then was gradually decreasing, and decreased to the lowest level at 70 minutes post administration. In the control group, the sedation score was the lowest at 10 minutes post administration, then was gradually increasing, and increased to the highest level at 40 minutes and 50 minutes post administration, followed by a gradual decrease. Comparison of the sedation score at each time period suggested that the sedation score was significantly higher in the observation group than in the control group within 40 minutes post administration (P<0.05), while there were no significant differences between the two groups in the sedation score after 40 minutes post administration (P>0.05). The success rate of MRI procedure was significantly higher in the observation group than in the control group (89% vs 69%, P<0.05). There was no significant difference between the two groups in the incidence of adverse reactions (P>0.05). CONCLUSIONS Intranasal midazolam is superior to intramuscular phenobarbital sodium in the sedative effect in neonates undergoing MRI, with the benefits of being fast, convenient, safe, and effective.
Humans ; Hypnotics and Sedatives ; pharmacology ; Infant, Newborn ; Magnetic Resonance Spectroscopy ; Midazolam ; Prospective Studies ; Single-Blind Method

OBJECTIVE: To evaluate whether electroacupuncture (EA) would improve gastrointestinal function and clinical prognosis in patients with severe traumatic brain injury (TBI) complicocted by acute gastrointestinal injury (AGI). METHODS: This multicenter, single-blind trial included patients with TBI and AGI admitted to 5 Chinese hospitals from September 2018 to December 2019. A total of 500 patients were randomized to the control or acupuncture groups using a random number table, 250 cases in each group. Patients in the control group received conventional treatment, including mannitol, nutritional support, epilepsy and infection prevention, and maintenance of water, electrolytes, and acid-base balance. While patients in the acupuncture group received EA intervention at bilateral Zusanli (ST 36), Shangjuxu (ST 37), Xiajuxu (ST 39), Tianshu (ST 25), and Zhongwan (RN 12) acupoints in addition to the conventional treatment, 30 min per time, twice daily, for 7 d. The primary endpoint was 28-d mortality. The secondary endpoints were serum levels of D-lactic acid (D-lac), diamine oxidase (DAO), lipopolysaccharide (LPS), motilin (MTL) and gastrin (GAS), intra-abdominal pressure (IAP), bowel sounds, abdominal circumference, AGI grade, scores of gastrointestinal failure (GIF), Glasgow Coma Scale (GCS), Acute Physiology and Chronic Health Evaluation (APACHE II), Sequential Organ Failure Assessment (SOFA), and Multiple Organ Dysfunction Syndrome (MODS), mechanical ventilation time, intense care unit (ICU) stay, and the incidence of hospital-acquired pneumonia. RESULTS: The 28-d mortality in the acupuncture group was lower than that in the control group (22.80% vs. 33.20%, P<0.05). Compared with the control group, the acupuncture group at 7 d showed lower GIF, APACHE II, SOFA, MODS scores, D-lac, DAO, LPS, IAP, and abdominal circumference and higher GCS score, MTL, GAS, and bowel sound frequency (all P<0.05). In addition, the above indices showed simillar changes at 7 d compared with days 1 and 3 (all P<0.05) in the EA group. CONCLUSION Early EA can improve gastrointestinal function and clinical prognosis in patients with severe TBI complicated by AGI. (Registration No. ChiCTR2000032276).
Humans ; Electroacupuncture ; Lipopolysaccharides ; Single-Blind Method ; Acupuncture Therapy ; Brain Injuries, Traumatic/therapy*

Objective: To analyze the effect of psychological suggestion combined with rational food restriction therapy on blood glucose, lipid metabolism and mental resilience in patients with diabetes. Methods: Patients with diabetes admitted to the Third Hospital of Nanchang from January 2020 to August 2020 were divided into the control group and the intervention group with randomized controlled and single blind methods. The control group was treated with routine dietary guidance and health education, and the intervention group was treated with psychological suggestion combined with rational diet therapy on the basis of the control group. Both groups were treated for 3 months. Blood glucose, lipid metabolism, mental resilience and quality of life were compared between the two groups at baseline and after 3-month intervention. Differences between groups and within groups were analyzed by t test and χ² test. Results: 100 patients in the control group and 81 patients in the intervention group completed 3-month intervention. After 3-month intervention, the levels of glycosylated hemoglobin, fasting blood glucose, 2-hour postprandial blood glucose, low-density lipoprotein cholesterol and triglyceride in both groups were lower than those before intervention. The levels of these indicators in intervention group were lower than those in control group (P<0.05). However, the levels of high-density lipoprotein cholesterol and the scores of tenacity, self-reliance, optimism, role function, emotional function, social function, physical function and cognitive function in both groups were higher than those before intervention. These indicators in intervention group were higher than those in control group (P<0.05). Conclusion: Psychological suggestion combined with rational food restriction therapy could effectively improve the glucose and lipid metabolism, mental resilience, and quality of life among patients with diabetes.
Blood Glucose/metabolism* ; Diabetes Mellitus, Type 2 ; Humans ; Lipid Metabolism ; Quality of Life ; Single-Blind Method