Effect of transcutaneous electrical stimulation treatment on lower urinary tract symptoms after class III radical hysterectomy in cervical cancer patients: study protocol for a multicentre, randomized controlled trial.

BACKGROUND: Class III radical hysterectomy (RH III)_plus pelvic lymphadenectomy is the standard surgery for early stage cervical cancer (CC) patients, the 5 year survival rate is about 90%, but pelvic floor disorders especially bladder dysfunction are common due to damaged vessels and nerve fibers following surgery. Transcutaneous electrical stimulation (TENS) treatment has been used to treat bladder disorders for many years, but its effect on cervical cancer patients, the best treatment time point and stimulated protocol, had never been assessed. The aim of this study is to investigate the efficacy of TENS treatment on lower urinary tract symptoms (LUTS) after RH III in CC patients. METHODS/DESIGN: The study will be conducted as a clinical, multicentre, randomised controlled trial with balanced randomisation (1:1). The planned sample size is 208 participants (at 1:1 ratio, 104 subjects in each group). At 5-7 days after RH III, patients are screened according to operative and pathological findings. Enrolled participants are randomised into an intervention group (TENS plus conventional clinical care) or control group (conventional clinical care), with stratification by menopausal status (menopause vs. non-menopause) and surgical modality (laparoscopic RH or abdominal RH). Participants in both groups will be followed up at 14 days, 21 days, 28 days, 3 months, 6 months, 12 months, 18 months and 24 months after surgery. The primary endpoint is improvement rate of urination function which is defined as recovery (residual urine ≤50 ml) or improvement (residual urine 50-100 ml). Secondary endpoints include urodynamic parameter, urinary incontinence, anorectal function, pelvic function, quality of life (QOL), disease-free survival and adverse events. Primary endpoint analyses will be carried out by Cochran-Mantel-Haenszel tests taking into center effect. DISCUSSION: To our knowledge this is the first trial to investigate the effect of TENS treatment on bladder function recovery after RH III among CC patients. This study will provide new information on TENS efficacy for bladder function recovery. Once confirmed, it may help to provide a new, non-invisive treatment for those postoperative CC patients with poor pelvic function, which would help improve their quality of life. TRIAL REGISTRATION: The study is registered to Clinical Trials.gov ( NCT02492542 ) on June 25, 2015.

Long-term effects of Xuezhikang on blood pressure in hypertensive patients with previous myocardial infarction: data from the Chinese Coronary Secondary Prevention Study (CCSPS).

Several previous trials from Western population studies have showed that statins may help reduce blood pressure (BP). However, randomized clinical data is limited. Xuezhikang, a partially extract of red yeast rice, contains a family of naturally occurring statins, and has a marked impact on lipids, but it is unknown whether Xuezhikang has any effect on BP during long-term follow-up in the Chinese population. This is a post-hoc subgroup analysis of a randomized, double-blinded, placebo-controlled, parallel group clinical trial, Chinese Coronary Secondary Prevention Study (CCSPS). A total of 2704 hypertensive patients with previous myocardial infarction (MI) were assigned either to placebo (n = 1341) or to Xuezhikang (n = 1363) daily for an average of 4.5 years. The primary outcome was the unadjusted changes in mean arterial pressure (MAP) from baseline to 6 months. We also assessed systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse pressure. Analysis of covariance was used to calculate the adjusted effects of treatment on changes in these outcomes at 6, 12, 24, and 48 months post-randomization, after controlling for potential confounders. This analysis included 2704/4870 (55.5%) hypertensive patients for whom BP was measured at baseline and at least one follow-up visit after randomization. Median duration of the follow-up was 4.5 years (54 months), and 25 patients (0.92%) were lost to the last follow-up because of adverse effects. The results showed that the unadjusted and adjusted changes in MAP, SBP, DBP, or pulse pressure from baseline were not significantly different for Xuezhikang or placebo recipients at 6, 12, 24, and 48 months after randomization. In this post-hoc subgroup analysis, we failed to demonstrate any significant reducing effects of Xuezhikang on BP in Chinese hypertensive patients with previous MI, suggesting that further prospective study on the effects of statins on BP would be needed, especially in high-risk patients.

Impact of Xuezhikang on coronary events in hypertensive patients with previous myocardial infarction from the China Coronary Secondary Prevention Study (CCSPS).

BACKGROUND: The lowering of cholesterol concentrations in individuals at high risk for cardiovascular disease improves clinical outcome. Xuezhikang has a marked impact on lipids. METHODS: In this randomized, double-blinded, placebo-controlled, parallel-group clinical trial, a total of 2704 hypertensive patients with previous myocardial infarction (MI) were assigned either to placebo (n = 1341) or to Xuezhikang (0.6 g twice daily, n = 1363) for an average of 4.5 years. The primary end-point was recurrent coronary events; the secondary end-point was all-cause mortality and other clinical events, including adverse effects. RESULTS: There were no differences between the Xuezhikang and placebo group in base-line characteristics. However, Xuezhikang treatment reduced the incidence of coronary events by 43.0% (P = 0.02), deaths from coronary heart disease (CHD) by 30.0% (P < 0.01), and all-cause mortality by 35.8% (P = 0.001). CONCLUSIONS: This study, for the first time, demonstrated that long-term Xuezhikang therapy resulted in significant reduction in cardiovascular events and death in Chinese hypertensive patients with previous MI in a safe manner.

Beneficial impact of Xuezhikang on cardiovascular events and mortality in elderly hypertensive patients with previous myocardial infarction from the China Coronary Secondary Prevention Study (CCSPS).

Coronary heart disease, hypertension, and dyslipidemia are highly prevalent and commonly coexist in people who are middle-aged and older. Previous data suggested that lowering cholesterol concentrations in individuals at high risk of cardiovascular disease improved clinical outcomes. Xuezhikang, a partial extract of red yeast rice containing statin, has a marked impact on lipids. The purpose of this study, therefore, was to evaluate the impact of Xuezhikang on reducing cardiovascular events and mortality in elderly Chinese hypertensive patients with a history of myocardial infarction (MI) enrolled in the Chinese Coronary Secondary Prevention Study. In this randomized trial, 1530 elderly hypertensive patients (> or = 65-years-old) with previous MI were assigned either to placebo (n = 758) or to Xuezhikang (n = 772) daily for an average of 4.5 years. The primary endpoint was recurrent coronary events; the secondary endpoint was all-cause mortality and other clinical events, including adverse effects. There were 68 cases of coronary events (8.8%) detected in the Xuezhikang group and 108 cases (14.3%) in the placebo group (38.2% risk reduction by Xuezhikang therapy). Death from coronary heart disease (CHD) totaled 49 cases in the Xuezhikang group (6.4%) and 68 cases in the placebo group (9.0%), indicating that Xuezhikang significantly decreased the risk of CHD death by 29.2%. Our study demonstrated that Xuezhikang therapy could effectively and safely reduce cardiovascular events and all-cause death in Chinese elderly hypertensive patients with previous MI. This finding may have an important implication for the treatment of elderly hypertensive patients with CHD.

Effect of xuezhikang on cardiovascular events and mortality in elderly patients with a history of myocardial infarction: a subgroup analysis of elderly subjects from the China Coronary Secondary Prevention Study.

OBJECTIVES: To evaluate whether lipid-lowering therapy with xuezhikang reduces the risk of coronary events and total mortality in patients with coronary heart disease (CHD) aged 65 and older. DESIGN: Subgroup analysis of the China Coronary Secondary Prevention Study, a randomized, double-blind, placebo-controlled, clinical trial. SETTING: Sixty-six hospitals in China. PARTICIPANTS: A total of 1,445 patients, aged 65 to 75, were chosen from 4,780 patients with a history of myocardial infarction. INTERVENTION: The patients were randomized to the xuezhikang (n=735) or the placebo (n=710) group and followed for a mean of 4 years. MEASUREMENTS: The primary endpoint was recurrent coronary events; the secondary endpoint was all-cause mortality and other clinical events, including adverse effects. RESULTS: Elderly patients were at greater risk for coronary events, death from coronary events, all-cause mortality, and malignancies than younger patients. Xuezhikang therapy reduced the incidence of coronary events 36.9% (P=.001), death from coronary heart disease 31.0% (P=.04), all-cause mortality 31.9% (P=.01), stroke 44.1% (P=.04), the need for a percutaneous coronary intervention or coronary artery bypass graft 48.6% (P=.07), and malignancies 51.4% (P=.03). Based on the treatment of elderly patients with xuezhikang for an average of 4 years, the number needed to treat (NNT) to prevent one coronary event, one coronary death, and one mortality due to all causes was estimated to be 18, 33, and 23, respectively. In a like manner, the estimated NNT to prevent one coronary event, one coronary death, and one mortality due to all causes in younger patients was 23, 82, and 51, respectively. There was not a significantly greater number of adverse effects in the xuezhikang group than in the placebo group. CONCLUSION: This is the first study demonstrating that treatment with xuezhikang capsules is safe and effective for the secondary prevention of CHD in older Chinese people.

Xuezhikang, an extract of cholestin, reduces cardiovascular events in type 2 diabetes patients with coronary heart disease: subgroup analysis of patients with type 2 diabetes from China coronary secondary prevention study (CCSPS).

Lipid-lowering therapy has been proven to reduce macrovascular complications of type 2 diabetes. Xuezhikang is an extract of cholestin and has a markedly modulating effect on lipids, but the effect of xuezhikang on reducing coronary events in diabetic patients with coronary heart disease (CHD) is less clear. A total of 591 diabetic patients with CHD were randomized to the xuezhikang group (n=306) and the placebo group (n=285). During the average 4 years of follow-up, there were 28 cases of CHD events (9.2%) in the xuezhikang group and 53 cases (18.6%) in the placebo group. Risk reduction for CHD events was 50.8% (P<0.001) by xuezhikang treatment. Xuezhikang decreased the risk of non-fatal MI by 63.8%, fatal MI by 58.5%, CHD sudden death by 26.9%, and other CHD death by 53.4%. CHD death totaled to 21 cases in the xuezhikang group (6.9%) and 35 cases in the placebo group (12.3%), indicating that xuezhikang significantly decreased the risk of CHD death by 44.1% (P<0.05). Seventy-two patients died from various causes, among which there were 27 patients in the xuezhikang group and 45 patients in the placebo group. The risk for all-cause death was 44.1% lower in the xuezhikang group than in the placebo group (P<0.01). This investigation demonstrates that xuezhikang therapy can be effective on reduction of cardiovascular events in diabetic patients with CHD with a reliable safety.

[China coronary secondary prevention study: analysis of patients with different myocardial infarction history].

OBJECTIVE: To assess whether Xuezhikang was effective in the secondary prevention of coronary heart disease (CHD) for patients with different length of myocardial infarction (MI) history. METHODS: 2135 patients with MI history of 28 days to 3 months and 2735 patients with MI history of 3 months to 60 months were recruited separately to receive treatment with Xuezhikang capsule or placebo. The primary end-points were nonfatal myocardial infarction and death from CHD. RESULTS: The occurrence of coronary events were found to be not statistically significantly different for the two groups of patients. For patients with MI history of 28 days to 3 months, Xuezhikang significantly reduced the risk of CHD events by 56.7% (P < 0.0001) and resulted in a 48.6% (P = 0.0002) risk reduction in all-cause mortality as compared with placebo. For patients with MI history of 3 months to 60 months, Xuezhikang significantly decreased the risk of CHD events by 35.3% (P = 0.0008) and led to a 20.0% (P = 0.1181) risk reduction in the all-cause mortality as compared with placebo. Adverse effects and abnormal laboratory parameters did not differ significantly in the two groups of patients. CONCLUSIONS: Xuezhikang is more effective for patients with MI history of 28 days to 3 months as compared with patients with MI history of 3 months to 60 months. Patients with MI history should be treated with Xuezhikang early in order to achieve better prevention of CHD.

[The beneficial effects of lipid-lowering therapy with xuezhikang on cardiac events and total mortality in coronary heart disease patients with or without hypertension: a random, double-blinded, placebo controlled clinical trial].

OBJECTIVE: To evaluate whether lipid-lowering therapy with Xuezhikang can reduce the risk of cardiac events and total mortality in coronary heart disease (CHD) patients with or without hypertension. METHODS: In this random, double-blinded, placebo controlled clinical trial, 2704 patients with hypertension and 2166 patients without hypertension were enrolled and capsule Xuezhikang 0.6 g Bid or placebo on the top of conventional therapy without other lipid-lowering drugs. The mean follow-up period was four years. The primary end-points were nonfatal myocardial infarction and total mortality. RESULTS: Compared to placebo group, the incidence of cardiac events was reduced by 44.0% (P<0.0001) and 47.4% (P<0.0001) respectively in CHD patients with or without hypertension, and the total mortality was lowered by 35.8% (P=0.0012) and 28.6% (P=0.0737) respectively in CHD patients with or without hypertension. There was no significant difference in side effects between study groups. CONCLUSION: Xuezhikang can reduce the cardiac events and mortality in CHD patients with or without hypertension.

[China coronary secondary prevention study (CCSPS): outcomes from analysis of coronary heart disease patients with diabetes].

OBJECTIVE: To elucidate whether lipid-lowering therapy with Xuezhikang can induce a decrease of cardiac events and an attenuation of total mortality in coronary heart disease (CHD) patients with diabetes. METHODS: We designed a random, double-blinded, placebo controlled clinical trial in selected 591 patients. All patients were administrated with capsule Xuezhikang (0.6 g, Bid) or placebo in addition to conventional therapy. The mean follow-up period was four years. The primary end-points were nonfatal myocardial infarction and death from CHD. RESULTS: (1) The incidence of CHD events and that of death from CHD were reduced by 50.8% (P = 0.0008) and by 44.1% (P = 0.0246) in treatment group, respectively; Also, the incidence of nonfatal myocardial infarction was reduced by 63.8% (P = 0.0151). (2) The incidence of stroke, tumor, and PCI/CABG were decreased by 20.2%. (3) The total mortality were lowered by 44.1% in treatment group (P = 0.0097). CONCLUSION: Xuezhikang can effectively reduce the incidence of cardiac events and total mortality in CHD patients with diabetes.

[A study on the association between tea consumption and stroke].

OBJECTIVE: The aim of the study was to investigate the association between tea consumption and stroke. METHODS: A cross sectional study was conducted in autumn, 1998. The subjects were from 12 provinces in China. 15 groups of populations were selected by cluster randomized sampling and each group had about 1000 persons, aged from 35 to 60 years old. 14 212 subjects had complete data for analysis. Data regarding tea drinking would include drinking status, dose and type of teas. Logistic regression was used to analyze the association between tea consumption and stroke. RESULTS: There was a strong inverse correlation between tea drinking and stroke after adjusting other risk factors of stroke (P < 0.05). The odds ratio (OR) of stroke was 0.60 [95% confidence interval (CI): 0.42 - 0.85] for subjects who drank tea compared to those who did not. Increased amount of tea consumption per month was associated with decreased stroke prevalence. The association for tea consumption over 150 gram per month and stroke was statistically significant (P < 0.05) with an OR value of 0.56 (95% CI: 0.36 - 0.89). Analytical results indicated that the OR value was 0.24 (95% CI: 0.06 - 1.01) for black tea and other tea (P = 0.05). The OR value was 0.35 (95% CI: 0.18 - 0.72) for green tea (P < 0.01), and 0.75 (95% CI: 0.51 - 1.11) for jasmine tea (P > 0.05). CONCLUSION: Tea drinking was independently associated with prevalence of stroke which might play a role in the prevention of the disease.