Features analysis on Traditional Chinese Medicine syndromes in patients with diabetic peripheral neuropathy

Objective

To study the features of the distribution and differentiation of Traditional Chinese Medicine (TCM) syndromes in patients with diabetic peripheral neuropathy (DPN).

Methods

We collected clinical data on illness course, age, fasting blood glucose, saccharogenic hemoglobin, TCM syndromes, tongue, and pulse of 238 DPN patients. Differentiated main syndromes (Yin deficiency and exuberant heat, invasion of spleen by damp-heat, deficiency of both Qi and Yin, and deficiency of both Yin and Yang) and accompanying syndromes (blood stasis and phlegm-dampness) of diabetes were also recorded. The features of DPN syndromes were then analyzed.

Results

Among the four main syndromes of diabetes, deficiency of both Yin and Yang was the most common in the 238 DPN patients, of which 89%-96% had blood stasis.

Conclusion

The method of differentiating syndromes of diabetes can be applied to DPN patients. Deficiency of both Yin and Yang, often accompanied by blood stasis, is commonly seen.     

Screening and identification of potential biomarkers and establishment of the diagnostic serum proteomic model for the Traditional Chinese Medicine Syndromes of tuberculosis

Ethnopharmacological relevance

Chemotherapy is the mainstay of modern tuberculosis (TB) control. Traditional Chinese Medicine (TCM) can enhance the effect of anti-TB drug, promote the absorption of the foci in the lung and reduce drug toxicity. In TCM, the determination of treatment is based on ZHENG (also called TCM syndrome). To establish a diagnostic model by using proteomics technology in order to identify potential biomarkers for TCM syndromes of TB.

Materials and methods

The surface-enhanced laser desorption ionization time of flight mass spectrometer (SELDI–TOF MS) combined with weak cation exchange (WCX) magnetic beads was used to screen serum samples from 71 cases of deficiency of lung yin syndrome (DLYS), 64 cases of fire (yang) excess yin deficiency syndrome (FEYDS) and 45 cases of deficiency of both qi and yin syndrome (DQYS). A classification model was established by Biomarker Pattern Software (BPS). Candidate protein biomarkers were purified by reverse phase-high performance liquid chromatograph (RP-HPLC), identified by MALDI–TOF MS, LC–MS/MS and validated by ProteinChip Immunoassays.

Results

A total of 74 discriminating m/z peaks (P<0.001) among three TCM syndromes of TB were detected. A diagnostic model for the TCM syndrome of TB based on the five biomarkers (3961.7, 4679.7, 5646.4, 8891.2 and 9416.7 m/z) was established which could discriminate DLYS, FEYDS and DQYS patients with an accuracy of 74.0%, 72.5%, and 96.7%, respectively. The candidate biomarker with m/z of 9416.7 was identified as a fragment of apolipoprotein C-III (apoC-III) by MALDI–TOF-MS and LC–MS/MS.

Conclusion

The TCM syndrome diagnostic model of TB could successfully distinguish the three TCM syndromes of TB patients. This provided a biological basis for the determination of treatment based on different TCM syndromes of TB. ApoC-III was identified as a potential biomarker for TCM syndromes of TB and revealed the biochemical basis and pathogenesis of TCM syndromes in TB.     

A quantification model of Traditional Chinese Medicine syndromes in children with idiopathic precocious puberty and early puberty

Objective

To establish a quantification model of Traditional Chinese Medicine (TCM) syndromes by sampling patients undergoing idiopathic precocious puberty (IPP) and early puberty.

Methods

A questionnaire for classifying and quantifying TCM syndromes was designed and administered. All the results were analyzed; the relationship between 3 types of syndrome and 47 symptoms were summated. Meanwhile, the frequency distribution of each symptom or sign was aggregated. Fuzzy mathematics was used to develop a quantification model of TCM syndromes.

Results

We found that precocious puberty had 3 types of syndrome, including hyperactivity of fire due to Yin deficiency (Syndrome I), depressed liver Qi transforming into fire (Syndrome II), and end retention of damp heat (Syndrome III). In the IPP group, Syndrome I was the most common principal syndrome (100%). Forty-six patients (43.81%) were diagnosed with Syndrome I accompanied by Syndrome II and 11 (10.48%) were diagnosed with Syndrome I accompanied by Syndrome III. In the early puberty group, Syndrome I was also the main syndrome (98.39%). The degrees of most symptoms were mild to moderate. Reddened tongue was the most common tongue manifestation (62.86% prevalence) in the IPP group. The most common pulse manifestations were slippery pulse, thread pulse, and taut pulse. The Asymptotic Normalization Coefficient (ANC) method was used to quantify the TCM syndromes in 167 cases. Diagnostic accuracy rate reached 91%, comparable to expert diagnosis.

Conclusion

We find that there are 3 types of syndrome in the IPP group and in the early puberty group. Syndrome I (hyperactivity of fire due to Yin deficiency) is the main syndrome in the two groups. ANC may be an appropriate for quantification model of TCM syndromes.     

Efficacy and safety of Traditional Chinese Medicine for the treatment of acquired immunodeficiency syndrome: a systematic review

Objective

To systematically review the efficacy and safety of Traditional Chinese Medicine (TCM) interventions, compared with control interventions (placebo or conventional Western medical therapy), in the treatment of acquired immunodeficiency syndrome (AIDS).

Methods

Electronic databases including PubMed, the Cochrane Library, China National Knowledge Infrastructure (CNKI), and Wanfang Data were searched to identify relevant randomized controlled trials (RCTs) published as of May 2012. Studies were selected according to the specified inclusion and exclusion criteria and then subjected to methodological quality assessment, data extraction, and meta-analysis according to the Cochrane Handbook for Systematic Reviews of Interventions.

Results

Twelve RCTs involving 881 patients with AIDS were included. Methodological quality assessment showed that two were high-quality, two were moderate-quality, and eight were low-quality. Meta-analysis showed that TCM interventions were associated with significantly reduced plasma viral load compared with placebo [odds ratio OR=2.46, 95% confidence interval CI (1.02, 5.94); P=0.04]. However, the reductions in plasma viral load significantly favored conventional Western medical therapy alone over integrated traditional Chinese and Western medical therapy [OR=0.16, 95% CI (0.05, 0.55); P=0.004]. Patients receiving TCM interventions had significantly higher CD4 + T lymphocyte counts compared with those on placebo [OR=2.54, 95% CI (1.40, 4.60); P=0.002]. In addition, TCM interventions were significantly more likely to have improved clinical symptoms [OR=2.82, 95% CI (1.85, 4.31); P < 0.00001]. TCM interventions conferred a similar risk of adverse events (AEs) compared with control interventions [OR=1.87, 95% CI (0.58, 6.01); P=0.29].

Conclusion

Current evidence suggests that TCM interventions are significantly more effective than placebo in reducing plasma viral load and increasing CD4+ T lymphocyte count in patients with AIDS. When compared with conventional Western medical therapy, TCM interventions were significantly less effective in reducing plasma viral load, although they were associated with a higher percentage of patients with improved symptoms. Patients receiving TCM interventions did not seem to be at an increased risk of AEs.     

Clinical efficacy and safety of Traditional Chinese Medicine combined with Western Medicine in patients with diabetic acute ischemic stroke

Objective

To observe the clinical efficacy and safety of Traditional Chinese Medicine (TCM) combined with Western Medicine (WM) in patients with diabetic acute ischemic stroke.

Methods

Ninety patients with diabetic acute ischemic stroke were randomly divided into a treatment group and a control group. The 45 patients in the treatment group were given standardized treatment with TCM combined with WM. They received corresponding oral Chinese decoctions three times daily, according to their TCM syndromes, along with basic western medical treatment. The 45 patients in the control group were given non-standardized treatment with TCM combined with WM. They received an oral Chinese decoction for promotion of blood circulation to inhibit hemostasis, regardless of their TCM syndromes, along with basic western medical treatment. The treatments lasted for 4 weeks. Scores were evaluated on the National Institutes of Health Stroke Scale (NIHSS) score, activity of daily life (ADL) scores, and TCM symptoms before treatment and 2 and 4 weeks after treatment.

Results

Analysis of variance for repeated measurements showed that there were significant differences in NIHSS and ADL score before and after treatment in both groups (P<0.05). There were also significant differences between the scores at 2 and 4 weeks after treatment. There were significant differences in TCM syndrome scores before and after treatment in both groups (P<0.05). There were also significant differences between the scores at 2 and 4 weeks after treatment. The χ² test showed no statistically significant difference in the incidence of adverse reactions between the two groups (P>0.05).

Conclusion

Standardized treatment was superior to non-standardized treatment for clinical efficacy of TCM combined with WM in patients with diabetic acute ischemic stroke, and the superiority was more obvious in improving neural dysfunction, ADL score, and TCM symptoms. The adverse reactions were similar in the two treatment groups.     

Discrimination of type 2 diabetes mellitus corresponding to different traditional Chinese medicine syndromes based on plasma fatty acid profiles and chemometric methods

Aims of the study

Traditional Chinese medicine (TCM) has a long history and particular advantages in the diagnosis and treatment of type 2 diabetes mellitus (T2DM). Syndrome differentiation is the foundation and essence of TCM theories. The aims of the study are to discriminate T2DM corresponding to different syndromes (Qi-deficiency, Qi and Yin-deficiency and Damp heat) and discover syndrome-related biomarkers using metabolomics technology.

Materials and methods

Plasma fatty acid profiles of 85 clinical samples were established by high performance liquid chromatography (HPLC). Moreover, some of the lipid parameters, including total cholesterol (TC), triglycerides (TG), high-density lipoprotein (HDL) and low-density lipoprotein (LDL), were obtained through clinical testing methods. Orthogonal signal correction-partial least squares (OSC-PLS) and uncorrelated linear discriminant analysis (ULDA) were employed to establish two-class models for three different syndromes.

Results

Compared with the plasma fatty acid profiles of healthy controls, the characteristic fatty acids of three TCM syndromes were discovered (p<0.01). Totally, the plasma fatty acids of T2DM were up-regulated, while significant differences existed in different syndromes. Results of ULDA indicate that the three TCM syndromes could be effectively separated by the plasma fatty acid profiles and the syndrome-related biomarkers were also screened.

Conclusions

The fact that three TCM syndromes can be separated indicates certain metabolic differences in different TCM syndromes of T2DM really exist and such differences can be manifested by fatty acids and lipid parameters. The results benefit modern biological interpretation of the three TCM syndromes and in a sense the diagnosis and treatment of diabetes.     

Clinical trials of traditional Chinese medicine in the treatment of diabetic nephropathy—A systematic review based on a subgroup analysis

Ethnopharmacological relevance

The purpose of this study is to systematically evaluate the efficacy of traditional Chinese medicine (TCM) decoctions with different ingredients in the treatment of diabetic nephropathy (DN).

Materials and methods

Papers obtained after the retrieval of randomized controlled clinical trials (RCTs) of TCM treatments of diabetic nephropathy through online database (e.g. Medline, CBM, CNKI, VIP, the online database of Chinese medicine, CDFD, CMFD, and CENTRAL FROM Cochrane Library, etc.) as well as research data in our library. They were published between January 2001 and December 2012. According to the categories of the main TCM ingredients, all the cases in the literature were divided into a liver–kidney YIN deficiency group, a QI-BLOOD YIN-and-YANG deficiency group, and a spleen–kidney YANG deficiency group. Stata 11.0 was applied for subgroup analysis.

Results

A total of 21 Chinese RCTs were included in this review. The Q values of the three groups were 13.18, 0.25 and 3.27, respectively, P>0.05, and thus, there was no clinical heterogeneity. The combined relative risk (RR) value and its 95% confidence interval were 1.48 (1.37, 1.60), 1.19 (1.06, 1.34), and 1.33 (1.19, 1.50), respectively, P<0.05.

Conclusions

Compared with the qi-blood yin-and-yang deficiency group and the spleen–kidney yang deficiency group, the liver–kidney yin deficiency group has better prospects in clinical application to ensure renal function during the treatment of DN, and this possibility is worthy of further study.     

Prescription pattern of Chinese herbal products for hypertension in Taiwan: A population-based study

Ethnopharmacological relevance

Traditional Chinese medicine (TCM) has been commonly used in Asia country. The aim of this study is to analyze the utilization of TCM among hypertensive patients in Taiwan.

Materials and methods

The use of TCM for primary hypertensive patients was evaluated using a randomly sampled cohort of 1,000,0s recruited from the National Health Insurance Research Database in 5-year period from 2006 to 2010.

Results

Overall, 49.7% (n=42,586) of primary hypertension utilized TCM and 12.1% (n=5132) of them used TCM for the treatment of hypertension. Among the top 10 most frequently prescribed herbal formulae, Tian-Ma-Gou-Teng-Yin, Gout-Teng-San, Liu-Wei-Di-Huang-Wang and its derivatives were found to be the most common herbal formulae prescribed by TCM doctors for the treatment of hypertension in Taiwan.

Conclusion

This study showed the utilization pattern of Chinese herbal product in patients with hypertension. Further researches and clinical trials are needed to evaluate the efficacy of these Chinese formulae or its ingredients in treating hypertension.     

Therapeutic effect in patients with coronary heart disease based on information analysis from Traditional Chinese Medicine four diagnostic methods

Objective

To study information gained by Traditional Chinese Medicine (TCM) four diagnostic methods and characteristics of syndrome development before and after treatment in patients with coronary heart disease, and to probe into assessment indexes of therapeutic effects with distinctive TCM features.

Methods

Information from the four diagnostic methods before and after treatment in 100 patients with coronary heart disease was collected using the TCM interrogation scale, a pulse condition instrument, a tongue-face diagnosis instrument, and a voice diagnosis information collection system. Changes in the four diagnostic method results from before and after treatment were analyzed with frequency analysis and t-test methods.

Results

Before treatment, deficiency syndrome complicated with hyperactivity of pathogenic factors was most common. After treatment, deficiency syndrome was most common. This change from complex syndromes to single syndromes indicates disease and syndrome alleviation. Frequencies of symptoms gained by interrogation after treatment for syndrome of deficiency of heart-Qi, syndrome of deficiency of heart-Yin, and turbid phlegm syndrome were all less severe than those before treatment. Parameters of face color, color on all sub-regions of tongue, color of tongue fur, septic and greasy fur, and lip color after treatment all had significant changes. After treatment, part of the voice diagnosis parameters in the deficiency of heart-Yin and turbid phlegm syndromes had significant changes, but no significant changes were found in the deficiency of heart-Qi syndrome.

Conclusion

Use of the TCM four diagnostic methods can provide an effective basis for TCM syndrome diagnosis, observation of development of state of illness, and evaluation of clinical therapeutic effects.     

Spleen-Yang-deficiency patients with polycystic ovary syndrome have higher levels of visfatin

Objective

To study serum visfatin levels in women with polycystic ovary syndrome (PCOS) grouped by Traditional Chinese Medicine (TCM) patterns. To study the correlations of serum visfatin levels with homeostatic model assessment insulin resistance (HOMA-IR), fasting plasma glucose (FPG), fasting insulin (FINS), body mass index (BMI), testosterone (T), total cholesterol (TC), and triglycerides (TG).

Methods

Two hundred and twelve PCOS patients were placed into the following TCM pattern subgroups: Kidney-Yang deficiency (KYD) group, Spleen-Yang deficiency (SYD) group, stagnant Liver-Qi transforming into heat (SLQTH) group, and Kidney-Yin deficiency (KYIND) group. The correlations between serum visfatin levels and HOMA-IR, FPG, FINS, BMI, T, TC, and TG were analyzed.

Results

Of all patients with PCOS, there were 82 in the KYD group (38.6%), 67 in the SYD group (31.6%), 37 in the SLQTH group (17.5%), and 26 in the KYIND group (12.3%). Visfatin levels in all PCOS subgroups were higher than those in the control group (P<0.01 or P<0.05). Among these subgroups, the visfatin levels in the SYD group were significantly higher than those in the other three TCM pattern groups (P<0.05). There were no statistical differences among the remaining three pattern groups. The levels of BMI, FINS, HOMA-IR, T, and TG were significantly higher in all subgroups than those in the control group (P<0.05). There were no significant differences in FPG and TC between all PCOS subgroups and the control group (P>0.05). The SYD group had higher levels of FINS and HOMA-IR compared with the KYD, SLQTH, and KYIND groups (P<0.05). In all subgroups, after controlling for BMI, TG, TC, and age, visfatin was positively correlated with FINS (r= 0.197, P=0.015) and HOMA-IR (r=0.173, P=0.033), and was not correlated with T.

Conclusion

KYD and SYD patterns are most common in PCOS patients. Increased visfatin is a common pathophysiologic manifestation in PCOS patients. The SYD group had the highest levels of visfatin, and visfatin was positively correlated with FINS and HOMA-IR.     

Effects of Chinese herbs in children with Henoch-Schonlein purpura nephritis: a randomized controlled trial

Objective

To research the curative effect of Chinese herbs for clearing away heat, promoting diuresis, nourishing the kidney, and consolidating essence in children with Henoch-Schonlein purpura nephritis (HSPN) with internal accumulation of damp-toxin using randomized controlled observations on large samples. To seek the mechanism of the therapy and its scope of indications.

Methods

Overall, 186 children with HSPN were randomly divided into two groups: treatment group (n=126) treated with Chinese herbs for clearing heat and promoting diuresis and a control group (n=60) treated with Western Medicine. The treatment was carried out for three courses of 4 weeks each. We recorded changes in patient urine routines, 24 h urinary protein, blood-coagulating series, immunoglobulin and T-cell subgroups, and improvements in main symptoms. We evaluated the alleviation of clinical symptoms and the improvement of proteinuria, hematuria, and other laboratory test results. Finally, we analyzed the patient population suitable for this therapy according to the relationship between the grouping of patient body weight and curative effect.

Results

Damp-heat syndrome improved in the treatment group, with a significant difference in total effective rate after a 4-week treatment (χ²= 13.5220, P=0.0002) and in curative rate after a 12-week treatment (χ²=6.3410, P=0.0118), compared to those in the control group. The curative effect in the treatment group was greater than that in the control group but there was no statistical difference between the two groups. The curative effect after a 4-week treatment of patients in the treatment group weighing 30 kg or less based on Traditional Chinese Medicine (TCM) signs and urinary protein was significantly greater than that in the control group. However, there was no statistical difference in the curative effect on urinary red cells and various indexes after a 12-week treatment between the two groups.

Conclusion

Therapy for clearing away heat, promoting diuresis, nourishing the kidney, and consolidating essence using TCM is effective in children with HSPN from internal accumulation of damp-toxin. The therapy is especially suitable for patients weighing 30 kg or less. The curative effect may be related to the improvement of immune function and blood-coagulation.     

Correlation between tongue manifestations and glucose,total cholesterol,and high-density lipoprotein cholesterol in patients with acute cerebral infarction

Objective

To analyze the association between tongue manifestations and the levels of glucose (GLU), total cholesterol (TCH), and high-density lipoprotein cholesterol (HDL-C) in subjects with acute cerebral infarction.

Methods

Hospitalized patients with first unilateral cerebral infarction in the Neurological Department of Xuanwu Hospital were included and the correlation between tongue fur color, fur nature, and the levels of GLU, TCH, HDL-C were analyzed.

Results

HDL level in the thin fur group was higher than that in the thick fur group (P=0.02). The difference in the levels of GLU, TCH, and HDL-C among the groups was significant (P<0.05), classified in terms of slippery, moist, and dry fur. Further comparison between the groups by Student-Newman-Keuls test showed that GLU level in the dry fur group was the highest. Moreover, the TCH level in the slippery fur group was higher than the other two groups.

Conclusion

A correlation between tongue manifestations and GLU, TCH, HDL-C was identified in the patients with acute cerebral infarction.     

Traditional Chinese Medicine syndrome patterns and Qi-regulating,chest-relaxing and blood-activating therapy on cardiac syndrome X

Objective

To master the syndrome patterns characteristics and explore the effective therapy methods of Traditional Chinese Medicine (TCM) for cardiac syndrome X (CSX).

Methods

The TCM syndrome characteristics were mastered and the TCM intervention programs were determined by clinical investigations for TCM syndrome patterns characteristics of CSX patients. Then, the clinical efficacy studies on TCM intervention for CSX were carried out through randomized controlled trials.

Results

CSX is a clinical syndrome with the main manifestations of chest pain and chest stuffiness, and Qi stagnation, phlegm retention and blood stasis are the basic symptoms of CSX. As a result, the Qi-regulating, chest-relaxing and blood-activating therapy integrated with some Western Medicines was adopted for treatment. The effect of Qi-regulating, chest-relaxing and blood-activating therapy can reduce the frequency and degree of angina, improve the symptoms and exercise the tolerance of patients, inhibit the inflammatory response of vascular walls and protect the function of vascular endothelial cells, which is better than that of the simple and conventional Western Medicine alone.

Conclusion

A good effect was achieved in the integration of Chinese and Western Medicines for CSX. The therapy is worthy to be applied further in clinical practice. On the other hand, more long-term and randomised controlled studies with large samples are still required to further determine the clinical efficacy and safety of the therapy.     

Correlation between acne and Northwest dryness syndrome in Xinjiang autonomous region of China

Objective

To analyze the correlation between acne and Northwest dryness syndrome in the Xinjiang region to provide an epidemiological foundation for the prevention and treatment of acne in the region.

Methods

The correlations among acne, clinical syndromes of Northwest dryness syndrome, and Northwest dryness syndrome were evaluated using the syndrome fitness index and canonical correlation analysis.

Results

The acne group had a Northwest dryness syndrome rate of 24.13%, and the control group 10.34% (χ²=7.733, P<0.01). There was no significant difference in the fitness index for acne and for the sub-syndromes of Northwest dryness syndrome (P> 0.05). The first canonical correlation coefficient was 0.5656 (P<0.01). The acne-dependent variable group had the largest damp-heat syndrome load (0.8709), and the independent variable had the largest lung-heart-spleen pyretic dryness load (0.6766).

Conclusion

Northwest dryness syndrome is a risk factor for acne in the Xinjiang region. Exogenous dryness and endogenous damp are frequently seen as subsyndromes in Northwest dryness syndrome in acne patients in the region. Acne was correlated with the damp-heat and lung-heart-spleen pyretic dryness sub-syndromes of Northwest dryness syndrome.     

Randomized controlled multicenter clinical trial for integrated treatment of community-acquired pneumonia based on Traditional Chinese Medicine syndrome differentiation

Objective

To evaluate the efficacy and safety of treatment based on syndrome differentiation of Traditional Chinese Medicine (TCM) for community-acquired pneumonia (CAP).

Methods

A total of 240 CAP patients were randomly divided into the following two groups: the control group was treated by anti-infection plus conventional medicine treatment; and the trial group was treated by TCM plus the above-mentioned treatment given to the controls. The course of treatment was 14 days, and the patients were followed up for 7 days.

Results

Of the 240 patients, 235 accomplished the whole process of treatment. The five patients who withdrew from the study were brought into an intent-to-treat analysis. The therapeutic effects of the trial group were superior to those of the control group (P<0.01). The trial group took less time to become clinically stable, with a higher score in the quality of life (P<0.01). There were no significant differences in mortality rate (P>0.05), white blood cell count (P>0.05), bacterial clearance rate (P>0.05), and adverse reactions between the two integrated groups.

Conclusion

Treatment based on TCM syndrome differentiation for CAP has the advantages of resulting in less time to achieve a stable clinical condition, improvement of clinical symptoms and quality of life, and is comparatively safe.     

Anti-inflammatory activity of roots of Ecbolium viride (Forsk) Merrill

Ethnopharmacological relevance

Traditionally the aqueous extracts of dried roots of the plant Ecbolium viride are used for menorrhagia, rheumatism and jaundice.

Aim of the study

The aim was to evaluate the anti-inflammatory activity of Ecbolium viride extract in an in vivo model.

Materials and methods

The ethyl acetate fraction of Ecbolium viride root extract was prepared and administered orally to rats. The anti-inflammatory activity of Ecbolium viride was determined by carrageenan-induced paw edema and cotton pellet granuloma models.

Results

Oral administration of Ecbolium viride extract reduced inflammation significantly (P < 0.01) in both the carageenan paw edema and the cotton pellet granuloma models.

Conclusions

The results of the study supported the traditional use of Ecbolium viride in the treatment for inflammatory disease.     

Association among lifestyle,clinical examination,polymorphisms in CDH1 gene and Traditional Chinese Medicine syndrome differentiation of gastric cancer

Objective

To explore the association among lifestyle, clinical examination, polymorphisms in CDH1 gene and Traditional Chinese Medicine (TCM) syndrome differentiation of gastric cancer (GC).

Methods

A hospital-based population of 387 GC patients was investigated in Jiangsu province. Relevant information regarding lifestyle and clinical examination were collected by a standard questionnaire. Four known single nucleotide polymorphisms (SNPs) in CDH1 were investigated by polymerase chain reaction-ligation detection reaction methods. Statistical analysis was conducted by SPSS 16.0 software.

Results

The results showed that meal duration and the status of glutamic pyruvic transaminase were significantly associated with TCM syndrome differentiation of GC (both P<0.05). None of the four SNPs in the E-cadherin (CDH1) gene achieved significant differences in their distributions among the nine syndrome types of GC (both P>0.05). However, significant differences were observed in rs13689 genotype distributions between several pairs of syndrome types of GC, suggesting that rs13689 is correlated with the syndrome differentiation of GC.

Conclusion

Integrated analysis of lifestyle, clinical examination and CDH1 gene polymorphisms can contribute to a better understanding of the GC syndrome types and may improve the efficacy of interventions by stratifying disease according to TCM criteria.     

Risk factors of gastrointestinal and hepatic adverse drug reactions in the treatment of rheumatoid arthritis with biomedical combination therapy and Chinese medicine

Ethnopharmacological relevance

The exploration of risk factors on the gastrointestinal adverse drug reactions (GI ADRs) and hepatic ADRs in the treatment of rheumatoid arthritis (RA) with traditional Chinese medicien (CM) and convertional Western Medicien (WM) therapy will benifit the clincial drug administration.

Methods

A multi-center, randomized-clinical trial was conducted on RA patients in China. After 12 and 24 weeks of treatment, the efficacy and safety of WM therapy and CM therapy were evaluated. The Chi-square and logistic regression were conducted to analyze the correlations between the biological parameters, CM symptoms and the ADRs.

Results

505 patients were recruited from 9 centers and randomly assigned into WM therapy group (n = 251) or CM group (n = 254). 397 of them completed the 24 week treatment (194 in WM and 203 in CM group). Total ADRs incidence and withdrawal rates were similar in two groups. For the patients treated with WM, logistic regression analysis showed that CRP level was negatively related to GI ADRs (p < 0.05), dizziness was positively related to GI ADRs (p < 0.05); and IgG level and chills were positively related to hepatic ADRs (p < 0.01, p < 0.05). In the patients treated with CM, no laboratory measurements were found related with GI ADRs and hepatic ADRs, lassitude and nocturia were risk factors for GI ADRs, cold extremities for hepatic ADRs, respectively (p < 0.05).

Conclusion

CRP in normal scale and dizziness were the risk factors for GI ADRs, higher IgG level and chills were the risk factors for hepatic ADRs in the RA patients treated with conventional WM therapy. Lassitude and nocturia were the risk factors for GI ADRs, and cold extremities were the risk factors for hepatic ADRs in the RA patients treated with CM therapy.