The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. To encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on bmj.com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials.

Curculigo orchioides Gaertn. (family Amarylladaceae) is an endangered rasayana herb which is popularly known as “Kali Musli”. The plant is native to India, and holds a special position as a potent adaptogen and aphrodisiac in Ayurvedic system of medicine. It is an important ingredient of many Ayurvedic preparations and is considered to have aphrodisiac, immunostimulant, hepatoprotective, antioxidant, anticancer and antidiabetic activities. Various chemical constituents like mucilage, phenolic glycosides, saponins and aliphatic compounds from the plant have been reported. The plant is also considered as an important component of various herbal preparations of the Chinese and Kampo medicine. The present review is an attempt to enumerate various biologically tested activities and evaluation of different phytochemicals present in this important medicinal plant.

Background

Radiation pneumonitis is one of the most common complications during radiotherapy of thoracic tumors. It impacts the quality of life of the patients and has life-threatening danger. However, there is a lack of drugs for prevention and treatment of this disease.
Objective

To evaluate the efficacy of Liangxue Jiedu Huoxue Decoction, a compound traditional Chinese herbal medicine, in prevention of radiation pneumonitis.
Design, setting, participants and interventions

A prospective randomized clinical study was conducted. A total of 100 patients diagnosed with lung cancer from Department of Radiotherapy, Chinese PLA General Hospital, who were planning to receive radiotherapy, were randomly assigned into treatment group and control group, with 50 patients in each group. In the treatment group 3 cases were lost to follow-up and one case was excluded, while in the control group 6 cases were lost to follow-up and 2 cases were excluded. Patients in the treatment group were treated with Liangxue Jiedu Huoxue Decoction in addition to radiotherapy, while patients in the control group were treated with radiotherapy alone.
Main outcome measures

The incidence rates of radiation pneumonitis in the two groups were calculated. Acute radiation injury scoring criteria by Radiation Therapy Oncology Group (RTOG), clinical-radiographic-physiologic (CRP) score system, and Karnofsky Performance Status Scale (KPS) were used to evaluate the status of the patients.
Results

The incidence rate of radiation pneumonitis was lower in the treatment group than in the control group (13.04% versus 33.33%, P<0.05). According to the RTOG scale, the extent of lung injury was improved in the treatment group as compared with that in the control group (P<0.05). The CRP score in the treatment group was significantly lower than that in the control group (P<0.05). The KPS score in the treatment group was significantly higher than that in the control group (P<0.05).
Conclusion

Liangxue Jiedu Huoxue Decoction can decrease the incidence rate of radiation pneumonitis, reduce the extent of the lung injury, alleviate the symptoms of radiation pneumonitis, and improve life quality of the patients.

Objective

To explore the relationship between expressions of estrogen (ER) and progesterone (PR) receptors and syndromes of traditional Chinese medicine (TCM) in gastric carcinoma and to establish prognostic indicators for gastric carcinoma.
Methods

 A total of 72 patients with gastric carcinoma were divided into six groups according to TCM syndrome differentiation. Specimens were collected after operation and ER and PR protein expressions were detected by EnVision immunohistochemical method.
Results

The common syndromes in female patients with gastric carcinoma were disharmony between liver and stomach, yin impairment due to stomach heat, and insufficiency of both qi and blood; while in males, interior retention of stagnant toxin, interior retention of phlegm and dampness, and deficiency-cold in spleen and stomach were common. Different TCM syndromes were related with gender (P<0.01), pathology (P<0.01), cell differentiation (P<0.05), infiltration depth (P<0.01), lymphaden metastasis (P<0.05), distant metastasis (P<0.05), and TNM stage (P<0.01). Deficiency and excess syndromes were associated with gender (P<0.05), pathology (P<0.05), tumor location (P<0.01) and TNM stage (P<0.05). The deficiency syndromes were common in female patients. The total positive rates of ER and PR expressions were 8.33% and 37.5% respectively. There was a significant difference in PR expression among different TCM syndromes (P<0.01). PR expression was significantly higher in the syndrome of yin deficiency due to stomach heat than in the other syndromes. The PR expressions in deficiency syndromes were significantly higher than those in excess syndromes (P<0.01). No correlation was found between ER expression and different TCM syndromes.
Conclusion

There is a correlation between PR expression and different TCM syndromes in gastric carcinoma.

Background

There are obvious changes in neuropeptides from plasma and cerebrospinal fluid in patients with vascular dementia (VaD), and regulating the levels of neuropeptides is a key for prevention and treatment of VaD.
Objective

To observe the clinical efficacy of moxibustion at head-points in treatment of vascular dementia (VaD), and assess its effects on memory-related neuropeptides.
Design, setting, participants and interventions

A total of 65 VaD patients from Acupuncture Hospital, Anhui University of Traditional Chinese Medicine, were randomly divided into moxibustion group (33 cases) and Western medicine group (32 cases). Patients in the moxibustion group were treated with indirect moxibustion with common monkshood cake for 20 min. Patients in the Western medicine group were orally administered piracetam tablets, 0.8 g for three times a day. One treatment course was 4 weeks, and they were treated for 4 treatment courses.
ain outcome measures

 The scores of Hasegawa’s Dementia Scale (HDS), Mini-Mental State Examination (MMSE), and Activity of Daily Living Scale (ADL), as well as the levels of learning and memory-related neuropeptides from cerebrospinal fluid such as somatostatin (SS) and arginine vasopressin (AVP) were measured before and after treatment in the two groups.
Results

Total response rate was significantly higher in the moxibustion group than in the Western medicine group (P<0.01). There were significant differences in scores of HDS, MMSE and ADL between before and after treatment in the two groups(P<0.05 or P<0.01). After treatment, the scores of HDS, MMSE and ADL in the moxibustion group were more improved as compared with those in the Western medicine group (P<0.05 or P<0.01). The levels of SS and AVP after treatment were higher than those before treatment in the two groups(P<0.01). After treatment, the increased levels of SS and AVP were higher in the moxibustion group than in the Western medicine group (P<0.01).
Conclusion

Moxibustion is effective in improving the clinical symptom scores and regulating the levels of neuropeptides associated with learning and memory in VaD patients.

Background

Postoperative gastroparesis syndrome (PGS) is a common complication after abdominal surgery in patients with primary liver cancer. However, surgeons usually do not have effective treatment for them.
Objective

To explore the effects of acupuncture applied to Zusanli and other acupoints on PGS in patients after abdominal surgery.
Design, setting, participants and interventions

Sixty-three PGS patients of abdominal surgery, from Eastern Hepatobiliary Surgical Hospital, were randomized into acupuncture group (32 cases) and metoclopramide group (31 cases). The patients in acupuncture group were treated with acupuncture applied to Zusanli and other acupoints once a day, while the patients in metoclopramide group were intramuscularly injected 20 mg metoclopramide three times a day.
Main outcome measures

 Volume of gastric drainage, number of treatment and cure rate in the two groups were measured and evaluated.
Results

Acupuncture and metoclopramide could significantly reduce gastric drainage volume. In acupuncture group, the cure rate was 90.6% and the number of treatment was 6.58±4.26, while in metoclopramide group, the cure rate and the number of treatment were 32.3% and 10.13±3.60 respectively. There were significant differences in gastric drainage volume, cure rate and number of treatment between the two groups (P<0.05, P<0.01).
Conclusion

Acupuncture is a good treatment for PGS, with fewer treatments, high cure rate and rapid effect.

Objective

Anti-cancer potentials of scopoletin (7-hydroxy-6-methoxy coumarin) separated from plant extract (Gelsemium sempervirens) were demonstrated earlier from our in vitro studies. In the present study, its in vivo effects have been evaluated in mice.
Methods

Mice were chronically administered 7,12-dimethylbenz[a]anthracene (DMBA) once a week and croton oil twice a week on their back, which resulted in the development of fully grown finger-like projections (papilloma) after 24 weeks. Two subgroups of mice (drug-treated) were treated with two doses of scopoletin (50 mg and 100 mg/kg body weight) respectively while control received 2% ethyl alcohol (the “vehicle” of scopoletin). After the 24-week drug administration, expressions of several key receptors such as aryl hydrocarbon receptor (AhR) and signal proteins like p53, cytochrome P450 1A1 (CYP1A1), proliferating cell nuclear antigen (PCNA), signal transducer and activator of transcription-3 (Stat-3), survivin, matrix metalloproteinase-2 (MMP-2), cyclin D1, c-myc, tissue inhibitor of matrix metalloproteinase-2 (TIMP-2) and caspase-3, and some anti-oxidant markers were studied. Lipid peroxidation, superoxide dismutase, catalase, glutathione peroxidase and glutathione-s-transferase in supernatant were also detected.
Results

Carcinogens induced toxicity, and over-expression of AhR, CYP1A1, PCNA, Stat-3, survivin, MMP-2, cyclin D1 and c-myc and down-regulation of p53, caspase-3 and TIMP-2. In mice treated with scopoletin, the expressions of these proteins and toxicity biomarkers were reverted.
Conclusion

Since AhR is known to be ligand-activated by DMBA to release signals for several downstream proteins initiating reactive oxygen species generation, the down-regulation of AhR by scopoletin appeared to play a significant role in subsequent down-regulation of some key signal proteins. One possible mechanism of down-regulation of AhR may be through competitive inhibition by scopoletin. Mitogen-activated protein kinases may also have some critical role. This compound can be considered as a possible candidate for chemoprevention.

Objective

To investigate the effects of Qingyi Huaji (QYHJ) decoction, a compound traditional Chinese herbal medicine, on tumor inhibition rate and serum levels of interleukin-6 (IL-6), interleukin-8 (IL-8) and tumor necrosis factor-α (TNF-α) in nude mice with transplanted tumors of human pancreatic cancer.
Methods

The tumor-bearing mice model was established by subcutaneously inoculating with xenografts of pancreatic cancer into the right armpit of 40 BALB/c nude mice. After successful modeling, the mice were randomly divided into untreated group (Arabic gum), capecitabine group, low-dose QYHJ decoction group (36 g/kg) and high-dose QYHJ decoction group (72 g/kg), with 10 mice in each group. Citrate buffer solution (containing 5% Arabic gum), capecitabine suspension and QYHJ decoction were administered to four groups by gavage respectively. After 5-week treatment, the concentrations of serum IL-6, IL-8 and TNF-α were examined by enzyme-linked immunosorbent assay (ELISA) using blood sample from eye socket. Then the mice were euthanized by cervical dislocation. Tumor weight and the tumor inhibition rate were calculated.
Results

Tumor weight in the low-dose QYHJ decoction group decreased significantly as compared with the untreated group (P<0.05). Serum levels of IL-6 and TNF-α in low- and high-dose QYHJ groups were extremely significantly lower than those in the untreated group (P<0.01). Serum level of IL-8 in the low-dose QYHJ group was significantly lower than that in the untreated group (P<0.05). Correlation analysis showed that transplanted tumor weight of the mice was linearly positively correlated with serum levels of IL-6, IL-8 or TNF-α (P<0.01).
Conclusion

Conventional dose of QYHJ decoction is effective in suppressing pancreatic carcinoma in nude mice. The mechanism may be related to down-regulation of serum cytokines such as IL-6, IL-8 and TNF-α.

Objective: To investigate the effects of Wuling Capsule, a compound traditional Chinese herbal medicine, on hippocampal neurogenesis by examining the expressions of brain-derived neurotrophic factor (BDNF) and connexin 43 (Cx43) in rats with depression induced by chronic unpredictable mild stress (CMS), and thereby to explore its antidepressant mechanism.
Methods: Forty-five adult male Sprague-Dawley rats were randomly divided into three groups: control group (n=15), untreated group (n=15) and Wuling group (n=15). All rats except those in the control group were subjected to 3-week CMS to induce depression. At the same time Wuling Capsule was daily added to the diet of the rats in the Wuling group at a dose of 100 mg/kg body weight for 21 days. The degree of depression was determined by sucrose preference test. BDNF expression and neurogenesis were tested by using immunohistochemical staining with BDNF and 5-bromodeoxyuridine (BrdU) antibodies; and the mRNA and protein expression levels of Cx43 in hippocampus were examined by semi-quantitative reverse transcription-polymerase chain reaction and Western blotting.
Results: The numbers of BDNF-positive neurons and BrdU-positive particles in dentate gyrus (DG) were significantly decreased in CMS rats as compared with the normal rats, and the same changes were found in Cx43 mRNA and protein expressions. After Wuling Capsule treatment, the depressed behaviors were improved. Moreover, the reduced expression levels of Cx43 mRNA and protein and fewer newborn neurons induced by CMS were recovered to the normal levels. However, BDNF-positive cells remained low in DG.
Conclusion: Wuling Capsule can improve the low hippocampal neurogenesis in rats subjected to CMS and the antidepressant effects are related to enhancing the Cx43 expression but not through BDNF mediation.

Objective

To observe the effects of acupuncture on synovial pathology, synovial mast cell degranulation and tryptase expression and to investigate the relationship between the functions of mast cells and effects of acupuncture on early adjuvant arthritis in rats.
Methods

Forty-six male Wistar rats were randomly divided into normal control group (n=16), untreated group (n=15) and acupuncture group (n=15). Adjuvant arthritis was induced by injection of 0.1 mL Freund’s complete adjuvant in right hind limb footpad. Normal control group and untreated group received no acupuncture treatment, while rats in the acupuncture group were treated with sterilized disposable stainless steel needles inserted perpendicularly as deep as 2 to 3 mm at Xuanzhong (GB39), 6 mm at Shenshu (BL23) and 7 mm at Zusanli (ST36) for eight times (15 min each time) every two days. Setting the modeling day as the 0 day of the experiment, the body weight and paw volume of the rats were measured every three days from the 0 day. In the end, synovial tissues of the right hind ankles were sampled and made into paraffin sections. Then they were firstly stained with hematoxylin-eosin for observing synovial pathology to evaluate the effects of acupuncture on adjuvant arthritis, then stained with toluidine blue for observing the number and degranulation ratio of synovial mast cells and finally detected by immunohistochemical staining method to investigate the expression of tryptase in synovium.
Results

Compared with the untreated group, the body weight of rats in the acpuncture group was increased significantly (P<0.05), while the paw volume decreased obviously (P<0.01). Hematoxylin-eosin staining showed that acupuncture significantly inhibited inflammatory cell infiltration, synovial cell hyperplasia, and synovial fibroplasia in synovium of rats with adjuvant arthritis as compared with the untreated group (P<0.05). Toluidine blue staining showed that acupuncture could significantly diminish the numbers of total and degranulated mast cells in rats with adjuvant arthritis (P<0.01), which were significantly higher in the untreated group than in the normal control group (P<0.01). Showing by immunohistochemical staining, the expression of tryptase in synovium in the acupuncture group was decreased as compared with the untreated group (P<0.01). Analyzed by Spearman’s bivariate correlation, the number of mast cells and degranulation ratio of mast cells were positively correlated with the pathological scores (r=0.837, P<0.01; r=0.634, P<0.01).
Conclusion

Acupuncture can improve pathological condition of inflammatory synovium in rats with early adjuvant arthritis by inhibiting the function of synovial mast cells, which may play an important underlying role in the immunoregulation of acupuncture on adjuvant arthritis.

Objective

The primary aim of this research is to systematically sort out and analyze available documents for yang deficiency syndrome in traditional Chinese medicine, providing innovative ideas and methods for statistical study of yang deficiency syndrome.
Methods

Based on the China National Knowledge Internet (CNKI) and Chongqing VIP databases, using “yang deficiency”, “deficiency cold”, and “patient” as keywords, we searched literature of clinical researches and used “ratio-comparison” and “accumulation comparison” to analyze objective data after data preprocessing. Relative importance value of physiological and biochemical parameters were reflected by P value calculated by ratio-comparison or Q value by accumulation comparison.
Results

With calculation of relative importance values of clinical indicators among various systems, we got the ranking of relative importance of different indexes. Triiodothyronine and urine 17-hydorxycorticosteroid of endocrine system, immunoglobulin A of immune system, and the ratio of cyclic adenosine monophosphate to cyclic guanosine monophosphate, which had great |P| (or |Q|) values and negative P (or Q) values, had a clearly lower level in yang deficiency patients than in the control; hemorheological indicators such as plasma viscosity, whole blood reduced viscosity and erythrocyte electrophoresis time had small |P| (or |Q|) values. These indicators, however, showed less importance for reflecting yang deficiency.
Conclusion

Ratio-comparison method and accumulation comparison method employed in this study have merits of efficiency and robustness. After detailed compiling and mining of all available data, we have made reasonable advice on the most relevant index of yang deficiency for further study of the essence of this syndrome.