Modified Maimendong decoction in the treatment of patients with idiopathic pulmonary fibrosis: Study protocol for a randomized controlled trial.

INTRODUCTION: With dissatisfaction of western medicine, traditional Chinese medicine becomes alternative treatment for idiopathic pulmonary fibrosis patients. The common syndrome of idiopathic pulmonary fibrosis (IPF) is qi and yin deficiency syndrome. The prescription, Modified Maimendong Decoction (MMD), is usually used for IPF patients with qi and yin deficiency syndrome. However, there is no convinced evidence for the efficacy and safety of MMD to treat IPF. METHODS: A double-blind, placebo-controlled, randomized clinical trial was put forward by us. After a 1-day run-in period, 60 eligible patients will be included in the study. These subjects will be allocated to the experiment group or control group in a 1:1 ratio. Patients in the experiment group will take MMD plus Pirfenidone capsule. At the same time, patients in the control group will receive a matched placebo plus Pirfenidone capsule. All subjects will receive 24 weeks of treatment and follow-up period. The primary outcomes are the mean change from the baseline in forced vital capacity and times of acute exacerbations at week 4, 12, 24. Secondary outcomes are the mean change from baseline in the St. George's respiratory questionnaire total score, forced expiratory volume in 1 second percentage/forced vital capacity, diffusing capacity of Carbon monoxide, brain natriuretic peptide, and curative effect of traditional Chinese medicine syndrome at week 4, 12, and 24. Any side effects of the treatment will be recorded. DISCUSSION: The results of this trial will provide the evidence for the effect of MMD in patients with idiopathic pulmonary fibrosis.

[Changes in symptom patterns and health-related quality of life of cancer patients before and after chemotherapy].

OBJECTIVE: Symptom patterns are an important diagnostic concept in terms of Traditional Chinese Medicine. Although symptom patterns and health related quality of life (HRQOL) are common diagnostic measures for cancer patients, the association between them has not been studied. This study aimed to describe the changes in the pattern of symptoms of Yang-deficiency, Yin-deficiency, blood stasis, and HRQOL before and after chemotherapy, and to examine the association between the patterns and the cancer patients' HRQOL. METHODS: A panel study was undertaken with 123 cancer patients who were about to begin their first course of chemotherapy at four teaching hospitals in Taiwan. A structured questionnaire was used before and after chemotherapy. HRQOL was assessed using the Medical Outcomes Survey Short-Form 36. The Traditional Chinese Medical Constitutional Scale was used to measure Yang-deficiency, Yin-deficiency, and blood stasis patterns, with higher scores indicating a larger deficiency. RESULTS: The patients had significantly worse scores for Yang-deficient pattern, Yin-deficiency pattern, blood stasis pattern, and the physical components of HRQOL after chemotherapy compared with before chemotherapy. The HRQOL scores correlated significantly with Yang-deficiency, Yin-deficiency, and the blood stasis pattern scores. A generalized estimating equation model showed that the HRQOL scores were significantly worse after chemotherapy compared with before chemotherapy for the physical component, but not for the mental component. Blood stasis pattern was significantly associated with a decreased HRQOL in both the physical and mental components. A hemoglobin level < 12 g/dL was associated with a worse physical component of HRQOL. CONCLUSION: The Yang-deficiency, Yin-deficiency, and blood stasis patterns were all associated with lower HRQOL in cancer patients after chemotherapy.

[Experimental study on Qi deficiency and blood stasis induced by muti-factor stimulation in rats].

OBJECTIVE: Animal model of Qi deficiency and blood stasis was established by muti-factor stimulation in rats. METHOD: Healthy SD rats were chronically stimulated randomly by muti-factor methods (chronic sleep deprivation and feed with moderately high lipid and sugar food). Then the indices of hemorheology, plasma total lipids, vasoactive molecules, blood pressure (BP) and ventricular pressure (VP) were measured. RESULT: The results as well as the analysis of etiology and pathology suggested that model rats could objectively reflect the clinical characteristics of Qi deficiency and blood stasis syndrome. Blood viscosity at low level, plasma content of angiotensin II (Ang II) and endothelin (ET) significantly increased in model rats, while BP and VP significantly decreased (P < 0.05). On the other hand, Buyang Huanwu decoction could lower down the level of AngII in serum and blood viscosity at low level in rats induced by some stimulus, whereas BP and VP elevated significantly (P < 0.05). CONCLUSION: Animal model of Qi deficiency and blood stasis induced by muti-factor stimulation including chronic sleep deprivation and feed with moderately high lipid and sugar food could facilitate further study on blood stasis syndrome and screening of Chinese herbal drugs in promoting blood circulation and removing blood stasis.

Comfortable lifestyle-induced imbalance of neuro-endocrine-immunity network: a possible mechanism of vascular endothelial dysfunction.

OBJECTIVE: To observe the changes of vascular endothelial functions and general neuro-endocrine-immunity (NEI) network under the state of qi-deficiency syndrome induced by excessive idleness and to approach their internal relevance and illuminate initially the pathophysiological mechanism of vascular lesion induced by excessive idleness. METHODS: A total of 100 male Wistar rats were randomly divided into the control group and the qi-deficiency syndrome model group, 50 rats in each group. The qi-deficiency syndrome model was established by feeding the animals with hyper-alimentation diet in combination with restricting movement for 10 weeks. Changes of common chemical signal molecules related to NEI and vascular endothelial functions were measured by the end of the experiment. Furthermore, their internal relevance was analyzed by the method of canonical correlation analysis. RESULTS: The vascular endothelial structure and function were obviously injured in the model group. Compared with the control group, the chemical signal molecules, such as 5-hydroxytryptamine (5-HT), corticosterone (CORT), triiodothyronine (T3), tetraiodothyronine (T4), angiotensin II (Ang II), interleukin-1 (IL-1), and tumor necrosis factor-alpha (TNF-alpha) in peripheral blood of the model group (n=43) were changed significantly (P<0.05 or P<0.01). Canonical correlation analysis showed that vascular endothelial dysfunction was correlated to the changes of these signal molecules in the NEI network. CONCLUSIONS: Comfort-based lifestyle induced not only vascular endothelial dysfunction but also an imbalance of the NEI network. Vascular endothelial dysfunction and the imbalanced NEI network interacted with each other, and an imbalance of the NEI network may be the pathophysiologic basis for the genesis and development of vascular endothelial dysfunction, even diseases of the blood vessel.

[Exploration on the relationship between pathogenesis for yin-deficiency of acute myocardial infarction and immediate prognosis as well as its mechanism].

OBJECTIVE: To study the relationship between pathogenesis for Yin-deficiency of acute myocardial infarction (AMI) and immediate prognosis as well as its neuro-endocrine mechanism. METHODS: According to the TCM standard of Syndrome Differentiation of Deficiency Syndrome, 194 patients with AMI were classified into the typical Yin-deficiency group (n = 26), the non-typical Yin-deficiency group (n = 61) and the non-Yin-deficiency group (n = 107). Their venous blood samples were collected in the morning while lying on their backs to detect plasma levels of adrenaline, noradrenaline, aldosterone, atrial natriuretic peptide (ANP), corticoid and myocardial enzymes, as well as their hospitalization days and mortality in hospitalized period were calculated and compared in the three groups, with the 30 healthy persons as control. RESULTS: Levels of serum creatine phosphokinase, creatine phosphokinase isozyme, plasma adrenaline, noradrenaline, aldosterone, hospitalization days and mortality were higher in the Yin-deficiency groups than in the non-Yin-deficiency group (P < 0.05, P < 0.01). As compared the indexes between the typical and the non-typical Yin-deficiency groups, significant difference only showed in plasma aldosterone and ANP, which was significantly higher in the former (P < 0.05, P < 0.01). Plasma corticoid level was insignificantly different between the Yin-deficieny groups. CONCLUSION: Patients with AMI of Yin-deficiency type was severer in myocardial damage, with longer hospitalization period and higher mortality, it is probably due to the hyper-activated sympathetic-adrenaline system and strengthened activity of aldosterone in them.

Diagnosis of symptomatic postmenopausal women by traditional Chinese medicine practitioners.

OBJECTIVE: To learn more about the way that practitioners of traditional Chinese medicine (TCM) diagnose women who have menopausal symptoms. DESIGN: We assembled a cohort of 23 postmenopausal women who had hot flushes and were otherwise healthy. Each woman was examined independently by nine practitioners of TCM on the same day. Examination consisted of medical history and physical examination. Diagnoses were recorded and counted. RESULTS: The most frequent diagnosis made by the practitioners of TCM was kidney yin deficiency, which was the diagnosis made after 168 of 207 visits (81%); 23 women seen by nine TCM practitioners. Practitioners showed good agreement regarding presence of kidney yin deficiency: in 12 women (52%), this diagnosis was made by eight of nine practitioners; in 16 women (70%), seven of nine practitioners made this diagnosis; and in all 23 women (100%), at least five of nine practitioners made this diagnosis. CONCLUSIONS: Practitioners of TCM who diagnose postmenopausal women with vasomotor symptoms are likely to make a diagnosis that includes kidney yin deficiency.

Studies on the luminescence of channels in rats and its law of changes with "syndromes" and treatment of acupuncture and moxibustion.

We previously reported the discovery of 14 channels in the human body, which possessed the biophysical property of high emission of light. In this study we found the same property on the Ren and Du channels in healthy rats. Additionally, we discovered that the luminance of the related channels in rat models with different "syndromes" varied greatly. For instance, a markedly low luminance appeared on the Du channel in animals with experimental syndrome of Yang deficiency induced by hydrocortisone; while in animals with experimental syndrome of blood deficiency caused by bleeding, an apparently low luminance occurred on the Ren channel. The intensity of the emitted light on Du and Ren channels increased after acupuncture treatment, but not significantly. This phenomenon conforms to the theory in traditional Chinese medicine that the Du channel is the "sea of Yang channels", while the Ren channel is the "sea of Yin channels".