BACKGROUND: Many patients with chronic angina experience anginal episodes despite successful recanalization, antianginal and antiischemic medications. Empirical observations suggested that Shenzhu Guanxin Recipe Granules (, SGR), a Chinese herbal compound, exerted potential impacts on increased treadmill exercise performance and angina relieve. However, there has been no systematic study to clarify the impact of SGR on exercise tolerance in patients with stable angina. The SERIES (ShEnzhu guanxin Recipe for Improving Exercise tolerance in patients with Stable angina) trial is designed to determine the effects of SGR on exercise duration, electrocardiographic (ECG) evidence of myocardial ischemia, and incidence of major adverse cardiac events (MACE) in stable anginal patients. METHODS: A total of 184 eligible patients with stable angina will be randomly assigned to receive placebo or SGR (10 g/day for 12 weeks) in a 1:1 ratio. The primary outcome will be the change from baseline in total exercise tolerance duration, time to onset of angina and ECG ischemia during exercise treadmill testing performed over a 12-week study period. The secondary outcome will include ECG measures, the occurrence and composite of MACE and the Seattle Angina Questionnaire score. Moreover, the coronary microcirculation will be evaluated to explore the possible effects in response to treatment of SGR. After the procedure, all participants will be followed up by interview at 3 and 6 months, enquiring about any cardiac events, hospitalizations, cardiac functional level and medication usage. Additionally, the occurrence of adverse events will be evaluated at each follow-up. DISCUSSION This study may provide novel evidence on the efficacy of SGR in improving exercise tolerance and potentially reducing clinical adverse events. (Trial registration No. ChiCTR-TRC-14004504).
Angina, Stable ; drug therapy ; physiopathology ; Coronary Circulation ; Double-Blind Method ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Exercise Test ; Exercise Tolerance ; physiology ; Humans ; Placebos ; Sample Size

Bias (Epidemiology) ; Cognition ; Humans ; Mild Cognitive Impairment ; Neuropsychological Tests ; Pilot Projects ; Placebos ; Prefrontal Cortex ; Sample Size ; Transcranial Magnetic Stimulation ; Treatment Outcome

OBJECTIVE: The role of obsessive-compulsive symptoms (OCS) in patients with acute coronary syndrome (ACS) is not well elucidated. This study investigated the association between OCS and the long-term prognosis of ACS in tandem with depression comorbidity and treatment.METHODS: A cross-sectional baseline study and a nested 24-week double-blind escitalopram-placebo controlled trial were carried out between May 2007 and March 2013, and then a 5–12-year follow-up for major adverse cardiac events (MACE) was conducted. A total of 1,152 patients with ACS were stratified by baseline depression comorbidity and treatment allocation into four groups: no depression (706 patients), depression and taking escitalopram (149 patients), depression and taking a placebo (151 patients), and depression and receiving medical care as usual (CAU; 146 patients). OCS were evaluated using the Symptom Checklist-90-Revised Obsessive-Compulsive symptom domain. During the follow-up, Kaplan-Meier event rates for MACE outcomes were calculated, and hazard ratios were estimated using Cox regression models after adjusting for a range of covariates.RESULTS: A higher OCS score at baseline was associated with a worse ACS prognosis after adjusting for relevant covariates and across MACE outcomes. This association varied according to the depression comorbidity. The association was significant in patients without depression and depressive patients receiving placebos and CAU, but not in depressive patients on escitalopram.CONCLUSION: Evaluating OCS and depression is recommended during the early phase of ACS. Treatment for OCS may improve the long-term cardiac outcomes of patients with ACS.
Acute Coronary Syndrome ; Citalopram ; Comorbidity ; Depression ; Follow-Up Studies ; Humans ; Longitudinal Studies ; Obsessive-Compulsive Disorder ; Placebos ; Prognosis ; Treatment Outcome

OBJECTIVETo verify the efficacy and safety of Quxie Capsule () in patients with metastatic colorectal cancer (mCRC).

METHODSThe present study was a randomized, double-blind, placebo-controlled trial. Sixty patients with mCRC were randomized into two groups at a 1:1 ratio by sealed envelope. The treatment group received conventional therapy combined with Quxie Capsule for 3 months. The control group was treated with conventional therapy combined with placebo for 3 months. Main outcome measures were overall survival (OS) and progression-free survival (PFS). Subgroup analysis was performed according to age, right or left-sided disease, and second-line therapy to determine the differences in PFS and OS between the two groups. Patients were followed up every 3 months until Dec 31st 2016.

RESULTSThe median OS was 23 months in the treatment group [95% confidence interval (CI): 15-not calculated] vs. 14 months in the control group (95% CI: 11-22, P=0.060). The OS of the treatment group tended to be longer than that of the control group (P>0.05). In the subgroups of patients <65 years old, left-sided colon, and 2nd-line therapy, the treatment group showed a significant survival benefit compared with the control group (P=0.006, 0.038, 0.013, respectively). There were no significant differences between the two groups in PFS (P>0.05). Safety analysis showed no severe hematological toxicity or liver and renal function injury in the treatment group.

CONCLUSIONSQuxie Capsule showed good safety and efficacy, and could prolong the OS of patients with mCRC. (Registration No. ChiCTR-IOR-16009733).

Aged ; Capsules ; Colorectal Neoplasms ; drug therapy ; pathology ; Disease-Free Survival ; Double-Blind Method ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Neoplasm Metastasis ; Placebos

OBJECTIVETo study the efficacy of modified Wuzhuyu Decoction Granule (, MWDG) in the treatment of migraine patients with cold and stasis obstructing meridian syndrome.

METHODSThis study was a randomized, double-blind, placebo-controlled trial. A total of 78 migraine patients with cold and stasis obstructing meridian syndrome were recruited and randomly assigned by a ratio of 2:1 into a treatment group (51 cases) and a placebo group (27 cases). Patients in the treatment group were treated with MWDG while placebo granules were applied in the control group. The treatment course lasted for 12 weeks with a follow-up of 4 weeks. The primary outcome measures included frequency and days of migraine attacks and the secondary outcome measures were analgesics consumption and visual analogue scale (VAS) scores. All outcome assessments were conducted respectively at baseline, the 4th, 8th and 12th week, and the end of follow-up.

RESULTSIn the treatment group, significant decrease in frequency of migraine attacks were observed since the 4th week and that of analgesics consumption since the 8th week (both P<0.05). While, in the placebo group, significant decrease in frequency of migraine attacks were observed since the 8th week and that of analgesics consumption since the 12th week (both P<0.05). No significant decrease in days of migraine attacks and VAS scores of migraine pain were observed in both groups. Between the two groups, there were significant differences in VAS scores and intensity of pain appeared in the 8th week (P<0.05). However, no significant differences were found in days and frequency of migraine attacks and analgesics consumption (P>0.05).

CONCLUSIONSMWDG was probably effective in the treatment of migraine especially for alleviating pain intensity. Furthermore, MWDG could reduce the frequency of migraine attacks and analgesics consumption sooner than the placebo.

Adult ; Analgesics ; therapeutic use ; Demography ; Double-Blind Method ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Female ; Humans ; Male ; Meridians ; Migraine Disorders ; drug therapy ; Pain Measurement ; Patient Dropouts ; Placebos ; Syndrome ; Treatment Outcome

OBJECTIVETo examine the efficacy and safety of bathing therapy with Taohong Siwu Decoction (, TSD) in the treatment of early-stage, mild-moderate diffuse cutaneous systemic sclerosis (dcSSc).

METHODSThis randomized, placebo-controlled trial enrolled 148 men and women (18-60 years) with dcSSc (disease duration 12 months) and baseline modified Rodnan skin score (MRSS) 10. Patients were randomized into a TSD group (71 cases bathing with TSD plus oral prednisone) or control group (71 cases bathing with placebo plus oral prednisone). Bathing (40 °C, 30 min) of the upper and lower limbs was carried out once daily for 12 consecutive weeks. The primary outcome measure was MRSS; secondary outcomes were Raynaud's phenomenon (RP) score, quality of life (QOL), physician visual analogue scale (VAS), patient VAS, percent predicted diffusing capacity for carbon monoxide (DLCO), percent predicted forced vital capacity (FVC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) level and overall treatment effect.

RESULTSThe final analysis included 135 patients (control group, 68 cases; TSD group, 67 cases). Primary and secondary outcome measures after 2 weeks of treatment showed no improvement (versus baseline) in both groups, with no differences between groups. At 12 weeks, QOL, physician VAS, patient VAS, ESR and CRP were improved in both groups, but MRSS and RP score were improved only in the TSD group (all P<0.05). MRSS, RP score, QOL, physician VAS, patient VAS, ESR and CRP differed significantly between groups (all P<0.05). Meanwhile, the overall treatment effect was significantly higher in the TSD group than in the control group (P<0.05). Adverse events in the two groups were similar (P>0.05).

CONCLUSIONSBathing with TSD plus oral prednisone achieves better outcomes than oral prednisone alone in patients with dcSSc and is not associated with serious adverse events.

Adult ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Female ; Humans ; Hygiene ; Intention to Treat Analysis ; Male ; Middle Aged ; Outcome Assessment (Health Care) ; Placebos ; Scleroderma, Diffuse ; drug therapy ; Treatment Outcome

BACKGROUND: Palmar hyperhidrosis is a common disorder of excessive sweating. A number of studies have demonstrated the effectiveness of iontophoresis in the treatment of palmar hyperhidrosis. However, controlled clinical studies on iontophoresis for palmar hyperhidrosis have been limited. OBJECTIVE: To determine the efficacy and safety of iontophoresis in the treatment of palmar hyperhidrosis with a randomized, sham-controlled, single-blind, and parallel-designed study. METHODS: Twenty nine patients with significant palmar hyperhidrosis were enrolled in this study. They received active iontophoresis treatment (group A) or sham treatment (group B). Iontophoresis was performed 20 minutes each time, five times per week, for 2 weeks. Its efficacy was assessed with starch-iodine test, mean sweat secretion rate, and hyperhidrosis disease severity scale. RESULTS: Twenty-seven of the 29 patients completed the 2-week treatment. After completion of 10 times of treatment, results of the starch-iodine test showed clinical improvement in 92.9% of patients in group A and 38.5% of patients in group B (p=0.001). The mean sweat secretion rate was reduced by 91.8% of patients in group A and by 39.1% of patients in group B (p<0.001). Improvement in quality of life was reported by 78.6% of patients in group A and by 30.8% of patients in group B (p=0.028). In group A, one case of localized adverse event was noted, although no adverse event was encountered in group B. CONCLUSION: Tap water iontophoresis could be used as an effective and safe treatment modality for palmar hyperhidrosis.
Humans ; Hyperhidrosis* ; Iontophoresis* ; Placebos ; Quality of Life ; Sweat ; Sweating ; Water*

PURPOSE: Nasal Cellulose Powder (NCP), which can prevent from binding an allergen to nasal mucosa, may reduce allergic rhinitis (AR) symptoms in dust mite-sensitized children. This study was conducted to assess the efficacy of NCP in improving clinical symptoms of a nasal airflow limitation and the response of nasal inflammatory cells. METHODS: Children with dust mite-sensitized AR aged 6–18 years were recruited. After a 4-week run-in period, NCP or a placebo was administered, 1 puff per nostril 3 times daily for 4 weeks. The nasal provocation test (NPT) with Dermatophagoides pteronyssinus (Der p) was performed before and after treatment. The daily symptom scores (DSS), daily medication scores (DMS), the peak nasal inspiratory flows (PNIF), nasal airway resistance (NAR), as well as the maximum tolerated dose of NPT and eosinophil counts in nasal scraping, were evaluated. RESULTS: Sixty children (30 NCP and 30 placebos) were enrolled. Before treatment, there were no significant differences in age, dust mite control measures, DSS, DMS, PNIF, NAR, the maximum tolerated dose of NPT, or nasal eosinophil scores between children receiving NCP and placebos. After treatment, there were no significant differences between the NCP and placebo groups in the median (range) of the outcomes—DSS: 2.06 (0.18–3.77) vs. 1.79 (0.08–7.79), P=0.756; DMS: 1.60 (0–5.13) vs. 0.56 (0–4.84), P=0.239; PNIF (L/min): 110 (60–160) vs. 100 (50–180), P=0.870; NAR (Pa/cm³/s): 0.40 (0.20–0.97) vs. 0.39 (0.24–1.32), P=0.690; the maximum tolerated dose of NPT and the nasal eosinophil scores: 1 (0–4) vs. 1 (0–4), P=0.861. CONCLUSIONS: NCP treatment may not be more effective than placebo treatment in dust mite-sensitized AR children.
Airway Resistance ; Cellulose* ; Child ; Dermatophagoides pteronyssinus ; Dust ; Eosinophils ; Humans ; Maximum Tolerated Dose ; Nasal Mucosa ; Nasal Provocation Tests ; Placebos ; Pyroglyphidae ; Rhinitis, Allergic* ; Tick Control

PURPOSE: It remains unknown whether local inhibition of Nuclear factor-kappa B (NF-κB) could have therapeutic value in the treatment of allergic rhinitis (AR). This study aimed to evaluate the effect of selective NF-κB inhibition using NF-κB decoy oligodeoxynucleotides (ODNs) for the local treatment of AR in ovalbumin (OVA)-sensitized wild-type mice. METHODS: BALB/c mice were sensitized with OVA and alum, and then challenged intranasally with OVA. NF-κB decoy ODNs were given intranasally to the treatment group, and NF-κB scrambled ODNs were given to the sham treatment group. Allergic symptom scores, eosinophil infiltration, cytokine levels in the nasal mucosa, nasal lavage fluid, and spleen cell culture, serum total and OVA-specific immunoglobulins, as well as intercellular adhesion molecure-1 (ICAM-1) in the nasal mucosa, were analyzed. RESULTS: NF-κB decoy ODNs significantly reduced allergic symptoms and eosinophil infiltration in the nasal mucosa. They also suppressed serum levels of total IgE, OVA-specific IgE, and IgG1. IL-5 and TNF-α levels and the expression of ICAM-1 were decreased in the nasal mucosa of the treatment group compared to the positive control and sham treatment groups. In addition, IL-6 levels were significantly decreased in the nasal lavage fluid of the treatment group. Furthermore, NF-κB decoy ODNs significantly reduced expression of the systemic Th2 cytokines, IL-4 and IL-5 in spleen cell culture. CONCLUSIONS: This study demonstrates for the first time that local NF-κB inhibition using NF-κB decoy ODNs suppressed the allergic response in a murine AR model. This shows the therapeutic potential of local NF-κB inhibition in the control of AR.
Animals ; Anti-Allergic Agents ; Cell Culture Techniques ; Cytokines ; Eosinophils ; Immunoglobulin E ; Immunoglobulin G ; Immunoglobulins ; Intercellular Adhesion Molecule-1 ; Interleukin-4 ; Interleukin-5 ; Interleukin-6 ; Mice ; Nasal Lavage Fluid ; Nasal Mucosa ; NF-kappa B ; Oligodeoxyribonucleotides* ; Ovalbumin ; Ovum ; Placebos ; Rhinitis, Allergic* ; Spleen

PURPOSE: Ischemic preconditioning (IPC), including remote IPC (rIPC) and direct IPC (dIPC), is a promising method to decrease ischemia-reperfusion (IR) injury. This study tested the effect of both rIPC and dIPC on the genes for antioxidant enzymes and endoplasmic reticulum (ER) stress-related proteins. MATERIALS AND METHODS: Twenty rats were randomly divided into the control and study groups. In the control group (n=10), the right hind limb was sham-operated. The left hind limb (IscR) of the control group underwent IR injury without IPC. In the study group (n=10), the right hind limb received IR injury after 3 cycles of rIPC. The IscR received IR injury after 3 cycles of dIPC. Gene expression was analyzed by Quantitative real-time polymerase chain reaction from the anterior tibialis muscle. RESULTS: The expression of the antioxidant enzyme genes including glutathione peroxidase (GPx), superoxide dismutase (SOD) 1 and catalase (CAT) were significantly reduced in IscR compared with sham treatment. In comparison with IscR, rIPC enhanced the expression of GPx, SOD2, and CAT genes. dIPC enhanced the expression of SOD2 and CAT genes. The expression of SOD2 genes was consistently higher in rIPC than in dIPC, but the difference was only significant for SOD2. The expression of genes for ER stress-related proteins tended to be reduced in IscR in comparison with sham treatment. However, the difference was only significant for C/EBP homologous protein (CHOP). In comparison with IscR, rIPC significantly up-regulated activating transcription factor 4 and CHOP, whereas dIPC up-regulated CHOP. CONCLUSION: Both rIPC and dIPC enhanced expression of genes for antioxidant enzymes and ER stress-related proteins.
Activating Transcription Factor 4 ; Animals ; Catalase ; Cats ; Endoplasmic Reticulum* ; Extremities ; Gene Expression ; Glutathione Peroxidase ; Ischemic Preconditioning* ; Methods ; Muscle, Skeletal* ; Placebos ; Rats* ; Real-Time Polymerase Chain Reaction ; Reperfusion Injury ; Superoxide Dismutase