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Background. Percutaneous coronary intervention (PCI) is widely used in China, but it does not fundamentally improve exercise endurance or reduce mortality associated with cardiovascular disease. Standardized cardiac rehabilitation (CR) can reduce the mortality associated with coronary heart disease and reduce the need for repeated PCI procedures. Currently, research on CR after PCI is mainly based on traditional exercise prescription, while research on TCM is limited. Often, the combination of traditional Chinese medicine (TCM) and exercise rehabilitation is adopted, from which it is difficult to determine the unique advantages of TCM. Qishen Yiqi dripping pills (QSYQ) can improve myocardial energy metabolism and alleviate myocardial reperfusion injury after PCI. This paper describes the protocol for the clinical assessment of QSYQ on CR. Methods. A randomized, double-blind, placebo-controlled trial will be used to evaluate the efficacy and safety of QSYQ on improving exercise endurance and quality of life. We plan to recruit 66 patients with stable angina pectoris with Qi deficiency and blood stasis syndrome differentiation after PCI from the China-Japan Friendship Hospital. On the basis of conventional drug treatment, QSYQ or placebo will be used for 12 weeks. PeakVO2 will be the main efficacy evaluation index, while Seattle scale and quality of life scale will be the secondary efficacy evaluation indexes. Discussion. CR therapy with integrated traditional Chinese and Western medicine has been developed as a treatment modality in China and has been included in the expert consensus of TCM diagnosis and treatment. A rigorous trial design will ensure objective and scientific evaluation of the efficacy and safety of QSYQ in improving exercise endurance and quality of life in patients with PCI. Trial Registration. This trial is registered with Clinical trial registration in China: ChiCTR2000040838 (registration date: December 11, 2020). [ABSTRACT FROM AUTHOR]

Background. Genital warts are sexually transmitted diseases for which there is no definitive cure. This study aimed to determine the effect of the combination of olive leaf extract and curcumin on the number of lesions and the duration of recovery in patients with external anogenital warts. Methods. This study is a three-blind randomized controlled clinical trial conducted in 2020. In this study, women with external anogenital warts were enrolled by the consecutive nonprobability sampling method and then assigned by stratified block randomization to two groups: placebo (n = 28) and intervention (n = 26). In the intervention group, the combined olive leaf and curcumin extract was applied topically three times a day until recovery and up to 12 weeks. Routine treatment was administered to both groups in addition to the interventions. The number of warts, the duration of recovery, and the severity and duration of treatment side effects were assessed in all participants. Results. The results showed that the mean number of warts was significantly lower in the intervention group (5.65 ± 5.223) than in the placebo group (7.61 ± 5.245) from the fifth day of treatment onwards (p = 0.027). The mean duration of recovery in days in the intervention group (14.73 ± 9.735)) was significantly less than the placebo group (34.25 ± 18.863) (p = 0.001). In addition, there was no significant difference between the two groups in the frequency of drug side effects such as burning (p = 0.083), redness (p = 0.413), and itching (p = 0.706). The intervention group experienced side effects for a shorter duration of time (1.50 ± 1.924) compared to the placebo group (4.93 ± 8.366) (p = 0.043). Conclusion. The combined 10% olive leaf and curcumin extract can be effective in reducing the number of warts, duration of healing, and reducing the duration of complications in patients with external anogenital warts and is recommended as a complementary treatment for these patients. This trail is registered with IRCT20200509047350N1 [ABSTRACT FROM AUTHOR]

The incidence of microbial resistance is growing, and new rescue regimens are needed to treat Helicobacter pylori (H. pylori) infection. This study aimed to evaluate levofloxacin-based quadruple therapies' efficacy, safety, and tolerability in eradicating H. pylori. In a randomized, double-blind clinical trial, 220 patients with dyspepsia and H. pylori infection were randomly assigned to receive either bismuth subcitrate 240 mg, pantoprazole 20 mg, amoxicillin 1000 mg twice a day, and levofloxacin 500 mg daily for seven days (BPAL-7) or ten days (BPAL-10). The eradication of H. pylori was evaluated two months after the end of treatment, and adverse drug reactions (ADRs) were assessed during the intervention. According to intention-to-treat and per-protocol, the eradication rate was significantly lower in the BPAL-7 regimen at 49.1% (95% CI: 39.3–57.8) and 47.6% (95% CI: 39.7–58.4), respectively, compared to the BPAL-10 regimen at 62.7% (95% CI: 53.6–72.8) and 62.4% (95% CI: 55.1–72.8), respectively. The ADR incidence was not statistically significant between the groups of BPAL-7 (33.6%) and BPAL-10 (36.7%). Although the ADRs were negligible in both groups, these regimens could not be an ideal alternative therapy for H. pylori because of their low eradication rates compared to standard regimens. Trial Registration. The study was reviewed and approved by the Iranian Registry of Clinical Trials (IRCT201406141155N19). [ABSTRACT FROM AUTHOR]

Introduction and Objectives. Pressure wound is one of the most common problems in patients with brain and spinal cord lesions leading to complications such as severe pain, infection, and frequent hospitalisation. The present study aimed to determine the restorative and antimicrobial effects of Scrophularia striata hydroalcoholic extract (SHE) on first- and second-grade pressure ulcers in patients with brain and spinal cord lesions. Materials and Methods. This double-blind clinical trial study was performed on grade 1 and 2 pressure wounds in 120 patients with cerebral-spinal cord lesions. The patients were randomly divided into four groups (n = 30). Topical treatments in all groups were performed twice a day. These groups included experiment 1 (SHE + phenytoin), experiment 2 (SHE + SHE), control (phenytoin + phenytoin), and placebo (eucerin + phenytoin). After evaluating the effect of SHE on wound healing, its antibacterial activity was determined by the standard agar well diffusion method. Results. Patients in each group in this study did not significantly differ in demographic and clinical variables. Complete wound healing by the 10th day of the intervention occurred in 63%, 100%, and 27% of patients in experimental 1, experimental 2, and control groups, respectively. In contrast, the placebo group had no complete wound healing until the 10th day. Topical application of SHE, twice a day in the experimental 2 groups, had a higher potency to heal wounds and reduce the duration of complete wound healing in patients compared with other groups. Conclusion. SHE, as a novel treatment option, has good potential to accelerate the healing of first- and second-degree pressure wounds in patients with brain-spinal cord injuries. [ABSTRACT FROM AUTHOR]

Background and Objective. Vulvovaginal candidiasis (VVC) is one of the most troublesome opportunistic infections in women. In recent years, its prevalence has increased significantly because different types of Candida yeast are resistant to common antifungal medications, supplements, and herbs have become common. This research aimed to compare the effects of N. sativa-honey vaginal cream and 1% clotrimazole on VVC. Materials and Methods. This triple-blind, randomized controlled trial was conducted on eighty-four 18 to 49-year-old nonpregnant women from August 2019 to February 2020. The subjects were randomly divided into two groups after confirming the diagnosis of VVC infection through fungal culture. Clinical signs and symptoms and lab tests were recorded at baseline and 6–10 days after treatment. The treatment time for each group was seven nights. Results. There were no significant differences in clinical and laboratory evaluations between the two groups at the beginning of the study (P > 0.05). After treatment, secretion, redness, itching, and fungal culture improved in the two groups (P < 0.001), while pruritus (p = 0.013) and secretion (p = 0.025) in the control group significantly improved. In this trial, no patients showed drug-specific side effects. Conclusion. The results of this study show that the N. sativa-honey significantly improves the symptoms of VVC; thus, the application of N. sativa-honey can be considered as a complementary therapy in the treatment of VVC. This trial is registered with IRCT20190711044176N1. [ABSTRACT FROM AUTHOR]

Background. Medicinal plants have long been used for the treatment of type 2 diabetes mellitus (T2DM). This study aimed to investigate the hypoglycemic efficacy and safety of NW Low-Glu® (contents of one capsule are 300 mg Mas Cotek + 100 mg Cinnamomum cassia L. + 250 mg Nigella sativa L. powdered extracts) in treatment-naïve, newly diagnosed T2DM patients. Methods. This was a 12-week, double-blind, double-dummy, randomized, phase 2 clinical trial. A total of 232 male and female patients aged ≥18 and ≤65 years who were newly diagnosed with T2DM and have not received any antidiabetic drugs before and were equally randomized to receive metformin (2000 mg per day), low-dose NW Low-Glu® (content of four capsules per day), or high-dose NW Low-Glu® (content of five capsules per day). Our primary objective was to measure the mean change in HbA1c between each of the experimental arms and the metformin arm. Results. There was a significant reduction in mean HbA1c at 12 weeks compared to baseline in the low-dose (0.6 (1.4)%; p = 0.002) and high-dose arms (0.8 (1.7)%; p = 0.004). There was also a significant reduction in 2 hr PPG at 12 weeks in the low-dose (35.4 (74.9) mg/dL, p = 0.001) and high-dose arms (24.7 (100.8) mg/dL, p = 0.04). Weight reduction was significantly higher with both high-dose (1.1 (−1.7) Kg; p = 0.005) and low-dose arms (0.9 (−1.5) Kg; p = 0.023) compared to metformin (0.8 (−1.8) Kg). No serious AEs or deaths were reported. Conclusions. After 3 months of treatment, NW Low-Glu® was noninferior to metformin in reducing HbA1c and 2 hr PPG, while leading to significantly higher weight reduction in newly diagnosed T2DM patients. It was also safe and well tolerated. [ABSTRACT FROM AUTHOR]

Objectives. Conventional approaches for patients with nonerosive gastroesophageal reflux disease (NERD) were not satisfactory. This study aimed to evaluate the effectiveness and mechanisms of Chinese herbal medicine Hewei Jiangni Decoction (HWJND) as a novel and promising regimen for NERD. Methods. A total of 128 patients with NERD were randomly assigned to the Treatment group and Control group. The patients from the Treatment group were administered HWJND (81 g) plus dummy omeprazole (20 mg) daily for 8 weeks, and the others were given dummy HWJND granules (81 g) plus omeprazole (20 mg). The clinical efficacy was assessed using the gastroesophageal reflux disease questionnaire (GERD-Q) scale, patient reported outcomes (PRO) scale, and short form health survey 36 (SF-36) scale at week 4. Moreover, its pharmacological and molecular mechanisms were elucidated based on network pharmacology and molecular docking. Results. Due to case shedding and other reasons, 109 patients, including 56 in the Treatment group and 53 in the Control group completed this study. Our results showed that HWJND significantly improved heartburn, regurgitation, epigastric pain, nausea, and sleep disturbance, which led to a significant reduction of GERD-Q scores in NERD patients. In addition, PRO scores of NERD patients with HWJND administration were improved, and sufficient relief of physical role, body pain, general health, social function, and mental health on the SF-36 scale was also observed in patients after HWJND treatment. We further showed that the curative effect of HWJND was close to that of omeprazole, except for the better improvement of general health and social function. What's more, the main active ingredients of HWJND included quercetin, beta-sitosterol, naringenin, baicalein, and kaempferol were retrieved, and the protective effects of HWJND against NERD may be closely related to targets such as TNF, IL6, IL1B, MMP9, CXCL8, and EGFR, which were mainly enriched in IL-17 signaling pathway and TNF signaling pathway. Conclusion. Our findings demonstrate that HWJND is noninferior to oral omeprazole for the treatment of patients with NERD, plays a therapeutic role through multiple targets and diverse pathways, and holds promise for complementary and alternative therapy for the treatment of NERD. This trial is registered with http://www.chictr.org.cn, Chinese Clinical Trials Registry [ChiCTR2200055960]. [ABSTRACT FROM AUTHOR]

Objective. To investigate the effect of laparoscopic total hysterectomy combined with high hysterosacral ligament suspension on the treatment for uterine prolapse. Methods. A total of 100 patients with uterine prolapse treated in our two hospitals from January 2019 to December 2021 were included in this study, which were divided into two groups through the number double-blind method, with 50 patients in each group. The control group was treated with transvaginal total hysterectomy, and the research group was treated with laparoscopic total hysterectomy combined with high hysterosacral ligament suspension. The surgical effect on patients was evaluated through the pelvic organ prolapse quantification method (POP-Q). The patients' adverse reactions were compared. The quality of sexual life was evaluated with the short form of the pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ-31). And, the patients' quality of life was also evaluated with the pelvic floor distress inventory-short form 20 (PFDl-20). Results. The surgical effect on the control group and the research group was 80.00% and 96.00%, respectively, with statistical significance (X2 = 6.601, P < 0.001). The incidences of adverse reactions of the two groups were 4.00% and 6.00%, respectively, which were comparable (X2 = 0.211, P = 0.646). The total PISQ-31 scores before surgery of the control group (97.07 ± 9.80) and the research group (97.02 ± 9.80) were comparable (t = 0.020, P = 0.984), and those after surgery were 112.55 ± 13.78 in the control group and 130.80 ± 17.42 in the research group, respectively, with statistical significance (t = 4.500, P < 0.001). And, the total PFDl-20 scores before surgery of the control group (72.50 ± 13.58) and the research group (72.50 ± 13.60) were comparable (t = 0.057, P = 0.098), and that after surgery were 56.10 ± 10.51 in the control group and 42.30 ± 8.05 in the research group, respectively, with statistical significance (t = 5.709, P < 0.001). Conclusion. Laparoscopic total hysterectomy combined with high hysterosacral ligament suspension has an ideal effect in patients with uterine prolapse, with few adverse reactions, effectively promoting the improvement of the quality of patients' sexual life and their life. This combination has the significance of active promotion in the clinic. [ABSTRACT FROM AUTHOR]

Background. Heart failure with preserved ejection fraction (HFpEF) is a large subtype of heart failure (HF) characterized by exercise intolerance and reduced quality of life. Studies have shown that traditional Chinese medicine (TCM) combined with conventional Western medicine has a good effect on improving exercise tolerance and quality of life in patients with HFpEF, but the overall quality of evidence is low. This study aimed to determine the safety and efficacy of Yangyin Shuxin (YYSX) decoction in the treatment of HFpEF. Methods. A prospective, single-blind, single-center, randomized controlled clinical study was conducted. 64 patients with HFpEF were randomly assigned to receive oral YYSX decoction (150 ml, twice a day) combined with conventional Western treatment or conventional Western treatment alone at a ratio of 1 : 1. The course of treatment was 2 weeks, and the follow-up was 3 months. The primary outcome was peak oxygen uptake (peak VO2) measured by the cardiopulmonary exercise test (CPET). Furthermore, the safety of YYSX decoction was assessed. Results. 63 patients (31 in the YYSX group and 32 in the control group) were included in the full analysis set. The peak VO2 of the YYSX group was significantly higher than that of the control group (12.04 ± 3.41 vs. 11.02 ± 3.33, P = 0.013) after 2 weeks. The maximum voluntary ventilation (MVV) was significantly higher in the YYSX group compared with the control group (P < 0.05). The YYSX group had a higher EQ-visual analogue scale (EQ-VAS) score (71.13 ± 13.95 vs. 70.94 ± 13.70, P < 0.05) and a lower TCM Four-Dimensional Diagnostic Information Scale (TCMFDIS) score (49.74 ± 24.73 vs. 64.16 ± 27.15, P < 0.05) than the control group. There was no statistical difference between two groups (P = 0.160), although 51.61% of patients in the YYSX group showed a decrease in brain natriuretic peptide (BNP) levels of at least 30%, compared with 37.50% of patients in the control group. No serious adverse events were reported in either group, but systolic and diastolic blood pressure decreased and serum sodium levels increased slightly in the control group. Conclusion. The YYSX decoction combined with conventional Western treatment was superior to the conventional Western treatment alone in improving exercise tolerance, quality of life, and cardiopulmonary function of patients with HFpEF. YYSX decoction is safe and may prevent a drop in blood pressure and sodium retention. Trial Registration. Chinese Clinical Trial Registry (www.chictr.org/cn/, No. ChiCTR-IOR-17014206) [ABSTRACT FROM AUTHOR]

Background. Allergic rhinitis (AR) is a common disease, and conventional medications are often insufficient for treatment. Bojungikgi-tang (BJIGT) is an herbal medicine widely used in traditional medicine and has anti-inflammatory and immunoregulatory effects. We hypothesize that BJIGT would improve nasal symptoms in patients with persistent AR (PAR). Methods. This is a randomized, double-blind, placebo-controlled, phase II trial. A total of 105 patients, identified with perennial allergens, with a history of PAR and a mean total nasal symptom score (TNSS) ≥ 5 during the run-in period will be recruited from Daejeon Korean Medicine Hospital. Participants will be randomly assigned to a high-dose BJIGT group, standard-dose BJIGT group, or control group (placebo) in a 1 : 1 : 1 allocation ratio after a week run-in period. The treatment medication will be taken three times per day for 4 weeks. The primary outcome measure is the mean change in the TNSS before and after medication. The secondary outcome measures include the Korean Allergic Rhinitis-Specific Quality of Life Questionnaire, total IgE and eosinophil count, overall assessment of AR, pattern identification questionnaire for AR, and Sasang constitution. Discussion. The aim of this study is to investigate the efficacy and safety of BJIGT in the treatment of PAR and to determine the suitable dosage of BJIGT. Therefore, we planned a randomized, controlled, phase II trial of two different doses of BJIGT compared with placebo, and the results of this study are expected to provide evidence for the use of BJIGT as a treatment of PAR. Trial Registration. The National Clinical Trial Registry Clinical Research Information Service, CRIS, KCT0006616, https://cris.nih.go.kr/cris/search/detailSearch.do/20706. [ABSTRACT FROM AUTHOR]

Background. There is no clear evidence-based medicine that points to the most effective drug treatments for the common cold. In view of its ability to relieve symptoms and shorten the disease course, as well as its minimal side effects, traditional Chinese medicine (TCM) has been widely used to treat the common cold. However, there is a lack of strong evidence to support the clinical efficacy of TCM. This study aimed to evaluate the efficacy and safety of Ganduqing granules in the treatment of the common cold based on the network pharmacology analysis. Methods. In this multicenter, randomized, double-blind, placebo-controlled trial, 60 eligible subjects will be randomly assigned to either the intervention group or the placebo group. The intervention group will be treated with Ganduqing granules, while the placebo group will be treated with placebo. After 5 days of intervention, the efficacy and safety of Ganduqing granules in the treatment of the common cold will be observed. The primary outcome is the time to clearance of all symptoms. The secondary outcomes included the levels of IL-6, TNF-α, SOD, and MDA in the peripheral blood, time to disappearance of primary symptoms and secondary symptoms, clinical symptom remission rate, and change in TCM syndrome score. Results. Sixty participants completed the study. Ganduqing granules showed a greater effect on the time to clearance of all symptoms P < 0.0001 , nasal discharge P = 0.0124 , fatigue and lack of strength P = 0.0138 , dryness of the pharynx P < 0.0001 , pharyngalgia or dysphagia P < 0.0001 , and expectoration P < 0.0431 compared with the placebo group. Participants in the intervention group had a greater decrease of IL-6 levels compared with the placebo group P < 0.007 ; similar results were observed for the SOD P < 0.033 . However, the change in TNF-α and MDA levels in the intervention group was not significantly different from the placebo group. In addition, participants in the intervention group had a greater decrease of TCM syndrome score compared with the placebo group P < 0.040 . Conclusion. Ganduqing granules could improve common cold symptoms, shorten the disease course, attenuated inflammation and oxidative stress, and provided objective evidence for the efficacy and safety of a Chinese herbal medicine in treating the common cold. [ABSTRACT FROM AUTHOR]

The present study was conducted to determine the effect of acupressure on health-related quality of life in patients with polycystic ovary syndrome. This study was a double-blind, randomized clinical trial with a control group. Ninety-six patients with polycystic ovary syndrome from Mofateh gynecological clinic in Yasuj in Iran were enrolled according to the inclusion criteria. Patients were randomly assigned to intervention and control groups. In the intervention group, pressure on the points, Ren3, Ren4, Liv3, Sp6, and Sp10 and in the control group, pressure on sham points were performed for 6 weeks (2 sessions per week). The primary outcome was health-related quality of life, measured by the modified polycystic ovary syndrome health-related quality of life questionnaire (MPCOSQ). The secondary outcomes were total testosterone levels and clinical symptoms in patients with polycystic ovary syndrome. The outcome variables were measured before the intervention at week 0 (baseline) and after the intervention at week 18 (12 weeks after the end of intervention). The results indicated that at week 18, the score of clinical symptoms and the total testosterone level of the intervention group were lower than those of the control group. The health-related quality of life score in the intervention group was higher than that in the control group, which was statistically significant (P < 0 / 05). Therefore, acupressure in these points is recommended as a practical and effective method of treating polycystic ovarian syndrome. [ABSTRACT FROM AUTHOR]

Background and Aims. Diabetes is a leading cause of renal failure. High levels of oxidative stress and inflammation in patients with renal diabetes lead to various disorders and mortality. This study was performed to determine the effect of Nigella sativa (NS) supplementation on superoxide dismutase (SOD), malondialdehyde (MDA), total antioxidant capacity (TAC), high-sensitivity C-reactive protein (hs-CRP), glycosylated hemoglobin (HbA1c), fasting blood sugar (FBS), and insulin (INS) in patients with diabetes mellitus undergoing hemodialysis (HD). Methods. In this randomized, double-blind, placebo-controlled clinical trial, a total of 46 diabetic HD patients were randomly divided into NS (n = 23) and placebo (n = 23) groups. NS group received 2 g/day of NS oil, and the placebo group received paraffin oil for 12 weeks. Serum levels of SOD, MDA, TAC, hs-CRP, HbA1C, FBS, and INS were measured before and after the study. Results. Compared to baseline values, SOD, TAC, and INS levels increased, whereas MDA, hs-CRP, HbA1c, and FBS significantly decreased. After adjusting for covariates using the ANCOVA test, changes in the concentrations of SOD (p =.040), MDA (p =.025), TAC (p=<.001), hs-CRP (p =.017), HbA1c (p =.014), and FBS (p =.027) were statistically significant compared to the placebo group. Intergroup changes in INS were not significant. Additionally, there were no notable side effects during the research. Conclusions. This study found that NS supplementation significantly enhanced the levels of SOD, MDA, TAC, hs-CRP, HbA1c, and FBS in diabetic HD patients. [ABSTRACT FROM AUTHOR]

Introduction. Fluoride plays an important role in the control of dental caries, and currently new dentifrices are being associated with natural products. Objective. This study aimed to evaluate the availability of fluoride in saliva samples after using a dentifrice incorporated with Brazilian red propolis (BRP, INPI Patent no. BR1020170110974) and to compare it to a conventional fluoridated dentifrice in healthy participants. Methods. This study was conducted implementing a double-blind, randomized, controlled, and crossover design. Saliva samples of participants were collected at the following time points: 0 at baseline and 5, 15, 30, 45, and 60 minutes after brushing with each dentifrice. Salivary fluoride concentrations showed no statistically significant difference when comparing the two treatments (p > 0.05). All available fluoride concentrations in saliva decreased after one hour, with no significant difference between BRP and conventional fluoridated dentifrice treatment samples (p > 0.05). Results. The results showed that there was no difference between the analyzed fluoride concentrations 1 hour after brushing with the different dentifrices. Conclusions. The results of this study suggest that the propolis incorporated in the dentifrice did not interfere with the kinetics and bioavailability of the fluoride ion in saliva samples, enabling its integration with the pharmaceutical formula and thereby promoting its anti-inflammatory and antimicrobial benefits without compromising the anticaries activity of the formulation. [ABSTRACT FROM AUTHOR]

Background. Golden plaster is the preferred and most commonly used in China for pain reduction in patients with knee osteoarthritis (OA). However, there was no evidence-based medical evidence about its effect in relieving pain of knee OA patients. Here, a multicenter randomized, double-blind, placebo-controlled trial was performed to evaluate the efficacy and safety of golden plaster for the improvement of pain relief and function's obstacle in patients with knee OA. Methods. 320 patients with knee OA were enrolled at four hospitals and randomly divided into the treatment group and the control group with 160 subjects in each group. Patients in treatment group were treated with golden plaster, and those in control group with placebo plaster. The study cycle in both groups was 21 days. Patient visits were documented before treatment and 7-, 14-, and 21-day follow-ups after treatment. The outcomes included VAS score, WOMAC score, and adverse events. Results. Compared to the control group, the VAS score in the treatment group was significantly decreased after treatment with golden plaster for 7 days, 14 days, and 21 days. Compared to the control group, the WOMAC score in the treatment group was significantly decreased 14 days and 21 days. The incidence rate of adverse events had no statistical difference between both the groups. Conclusions. In conclusion, our study, for the first time by carrying on the double-blind and placebo-controlled randomized trial, showed that golden plaster can effectively alleviate the pain of knee and improve the physical function in the patients with knee OA. This trial is registered with ChiCTR-TRC-13003418. [ABSTRACT FROM AUTHOR]

Purpose. The purpose of this study is to study the effects of heat-clearing Traditional Chinese Medicine (TCM) in the stable stage of bronchiectasis via N-of-1 trials. Methods. The N-of-1 trials in this study were randomized and double-blinded with crossover comparisons consisting of three pairs. Each pair was of two 4-week periods. Each patient took the individualized decoction in the experimental period and the individualized decoction was removed of heat-clearing drugs, mainly including heat-clearing and detoxifying drugs, in the control period for three weeks. After three weeks, the patients stopped taking the decoction for one week. The primary outcome was from patients' self-reporting symptoms scores on a 1–7-point Likert scale. Mixed-effects models were used to conduct statistical analysis on these N-of-1 trials. Results. Of the 21 patients enrolled, 15 completed three pairs of N-of-1 trials (71.43%). (1) Seen from the individual level, no statistical difference between the experimental decoction and the control (P > 0.05) was observed. However, 5 patients found better decoctions according to the clinical criteria. (2) As revealed by the group data of all the N-of-1 trials, the control was better than the individualized decoction in terms of symptom scores on the Likert scale (1.94 ± 0.69 versus 2.08 ± 0.68, P = 0.04, mean difference, and 95% CI: 0.19 (0.01, 0.37)) and on CAT scores (13.66 ± 6.57 versus 13.95 ± 6.97, P = 0.04, mean difference, and 95% CI: 0.86 (0.042, 1.67)), but such differences were not clinically significant. The other outcomes, such as Likert scale score of respiratory symptoms and 24-hour sputum volume, showed no statistical difference. Conclusion. The experimental design of this study can make the TCM individualized treatment fully play its role and can detect the individualized tendencies according to the severity of phlegm and heat in some subjects. With the intermittent use or reduced use of heat-clearing drugs, most of the subjects, at the group level, enrolled in the series of N-of-1 trials may improve the symptoms and quality of life while saving the cost of TCM and reducing the potential side effects of heat-clearing TCM. This trial is registered with clinicaltrials.goc (NCT03147443). [ABSTRACT FROM AUTHOR]

Background. A randomized trial suggests that meditation and exercise may prevent acute respiratory infection (ARI). This paper explores potential mediating mechanisms. Methods. Community-recruited adults were randomly assigned to three nonblinded arms: 8-week mindfulness-based stress reduction (N = 51), moderate-intensity exercise (N = 51), or wait-list control (N = 52). Primary outcomes were ARI illness burden (validated Wisconsin Upper Respiratory Symptom Survey). Potential mediators included self-reported psychophysical health and exercise intensity (baseline, 9 weeks, and 3 months). A Baron and Kenny approach-based mediational analysis model, adjusted for group status, age, and gender, evaluated the relationship between the primary outcome and a potential mediator using zero-inflated modeling and Sobel testing. Results. Of 154 randomized, 149 completed the trial (51, 47, and 51 in meditation, exercise, and control groups) and were analyzed (82% female, 94% Caucasian, 59.3 ±SD 6.6 years old). Mediational analyses suggested that improved mindfulness (Mindful Attention Awareness Scale) at 3 months may mediate intervention effects on ARI severity and duration (P < 0.05); 1 point increase in the mindfulness score corresponded to a shortened ARI duration by 7.2-9.6 hours. Conclusions. Meditation and exercise may decrease the ARI illness burden through increased mindfulness. These preliminary findings need confirmation, if confirmed, they would have important policy and clinical implications. [ABSTRACT FROM AUTHOR]

Objective. To evaluate the efficacy and safety of Chuanxiong Qingnao Granule (CQG) to treat migraine. Method. This study was a randomized, double-blind, placebo-controlled trial. All migraineurs were recruited and randomly assigned into a treatment group treated with CQG and a control group treated with a placebo. The whole research process included a 4-week baseline, 12-week intervention, and 12-week follow-up. The primary outcome was responder rate, defined as the percentage of migraineurs with 50% or more reduction in the frequency of migraine attack during treatment and posttreatment period compared with the baseline. The secondary outcomes were the number of migraine days, migraine attack frequency, visual analogue scale (VAS), Fatigue Severity Scale (FSS), Hamilton Depression Scale (HAMD), and Migraine Disability Assessment (MIDAS). Results. A total of 346 migraineurs completed the research and were included in the intention-treatment analyses. The response rates differed significantly between the treatment group and the control group (71.5% vs. 12.1% at week 12 and 83.1% vs. 3.4% at week 24). Attack frequency, days of headache attack, VAS, FSS, HAMD, and MIDAS decreased at week 12 in both groups with more reduction in the treatment group (P < 0.001). No severe adverse events were observed in this trial. Conclusion. Chuanxiong Qingnao Granule can significantly improve headache symptoms in patients with migraine while improving disability, fatigue, and depression with a good safety profile. [ABSTRACT FROM AUTHOR]

Background. Premenstrual disorders involve physical, behavioral, and mood variations that affect women of childbearing age and interfere with family relationships, household responsibilities, professional duties, and social activities. Objectives. Considering the side effects of conventional medications, their use is not recommended except in severe cases of premenstrual disorders. Nowadays, there is a tendency to use traditional and complementary medicine that offers various treatments. The purpose of the current study was to investigate the impacts of garlic as a herbal medicine on the severity of premenstrual symptoms. Methods. This study was a double-blind, randomized, controlled trial. After identification of participants with moderate-to-severe PMS through the premenstrual symptoms screening tools questionnaire (PSST), they were randomly assigned to placebo (n = 64) or garlic (n = 65) groups. Each participant received one tablet daily for three consecutive cycles and logged the severity of their symptoms in the PSST questionnaire during the intervention period. Results. There was no significant difference between the two groups in the baseline level of premenstrual symptoms before the intervention. After treatment with garlic for three consecutive cycles, the total score of the severity of premenstrual symptoms significantly (P < 0.001) reduced from 34.09 ± 7.31 to 11.21 ± 7.17. In the placebo group, this score changed from 33.35 ± 7.96 to 24.28 ± 7.22. The difference between mean changes in the two groups was 13.78, with a 95% Confidence Interval (CI) of 11.23–16.33. No serious side effects were observed in either group. Conclusion. Our findings highlight the potential effect of garlic in reducing the severity of premenstrual symptoms; therefore, the use of garlic can be considered as an alternative therapy in the prevention and treatment of premenstrual disorders. [ABSTRACT FROM AUTHOR]

Introduction. Atopic dermatitis (AD) and diarrhea-predominant irritable bowel syndrome (IBS-D) are two recurrent diseases with limited effective treatments. In Chinese Medicine (CM) theory, they may share dampness pattern as the same dominant pathogenesis at a certain stage and, thus, can be treated with the same method. While Chinese herbal formula Huoxiang Zhengqi (HXZQ) has been reported as an effective dampness-resolving therapy for both AD and IBS-D, further high-quality clinical studies are still needed. In addition, HXZQ lacks accurate clinical positioning based on CM patterns. Therefore, we utilize a master protocol design to evaluate HXZQ for dampness pattern simultaneously in AD and IBS-D, with the aim of identifying the pattern-defined population of HXZQ. Methods and Analysis. This master protocol design includes two randomized controlled trials (RCTs) and a real-world observational study. Based on two registry cohorts of AD and IBS-D, patients with dampness pattern will be enrolled in the RCTs to receive either HXZQ oral liquid or a placebo for 4 weeks and then will be followed up for another 4 weeks, while patients with nondampness pattern will constitute the observational study and experience a 12-week follow-up. A total of 678 AD patients and 322 IBS-D patients will be recruited from 14 hospitals in China over a 3-year period. The eczema area and severity index (EASI) and the proportion of responders for adequate relief (AR) are the primary outcomes in AD and IBS-D, respectively. Analysis will be undertaken separately in each substudy, and then an overall analysis combining multiple subgroups will be performed to comprehensively investigate the effect of HXZQ. Discussion. This study will provide high-quality efficacy evidence of HXZQ for AD and IBS-D patients and give an example of postmarketing evaluation for CM products under the pattern dominating different disease research model. The study is registered with ChiCTR1900026700 and ChiCTR1900026837. [ABSTRACT FROM AUTHOR]

Chronic gastrointestinal symptoms (CGS) negatively affect the quality of life in about 15–30% of the population without effective drugs. Recent studies suggest that dietary supplement may improve CGS, but inconsistent results exist. The goal of this study is to evaluate the effect of a polyherbal-based supplement ColonVita on the gastrointestinal quality of life index (GIQLI) in 100 old adults with CGS (63.1 ± 9.6 years) who were randomly assigned to daily ColonVita or placebo tablets (n = 50/group) for 12 weeks in a double-blind, randomized controlled trial design. No significant fibrdifferences were found between ColonVita and placebo in the baseline total GIQLI score (101.12 ± 16.87 vs. 101.80 ± 16.48) (P > 0.05) or postintervention total GIQLI score (114.78 ± 9.62 vs. 111.74 ± 13.01) (P > 0.05). However, ColonVita significantly improved 16 scores of the 19 core GI symptoms compared with 10 items improved by placebo. The ColonVita group significantly improved the remission rate of 5 core GI symptoms compared to placebo and significantly improved the total GIQLI scores (118.09 ± 7.88 vs. 109.50 ± 16.71) (P < 0.05) and core GI symptom scores (64.61 ± 3.99 vs. 60.00 ± 8.65) (P < 0.05) in people ≥60 years of age (n = 49) but not in those under 60 y (n = 51). ColonVita significantly improved the total GIQLI scores and core GI symptom scores in people without cardiovascular diseases (CVD) (n = 56) (116.74 ± 9.38 vs. 110.10 ± 14.28) (P < 0.05) and (63.11 ± 4.53 vs. 59.93 ± 8.03) (P = 0.07), respectively, but not in those with CVD (n = 44). Thus, ColonVita was beneficial for old adults with CGS, especially those ≥60 years of age and without CVD. Because a heterogenous pathogenesis of CGS-like irritable bowel syndrome (IBS) and inflammatory bowel disease (ISD) is differentially associated with CVD, different comorbidities may have influenced the outcomes of different trials that should be controlled in further studies. [ABSTRACT FROM AUTHOR]

Overweight/obesity is a pressing international health concern, and conventional treatments demonstrate poor long-term efficacy. Several studies have shown that yoga can control risk factors for cardiovascular disease, obesity, and psychosocial stress. The present study aimed to assess the effect of continuous yoga (asanas, pranayama, and Surya Namaskar yoga) on body composition in overweight participants. Forty adolescents with obesity were enrolled in this study. The study was conceived as a prospective, single-center, single-blinded randomized controlled trial. The participants were divided into 2 groups: the intervention group (n = 20), which undertook a continuous yoga practice, and the control group (n = 20). Body composition, including body weight (BW), body mass index (BMI), body fat mass (BFM), and muscle mass, was evaluated using tetrapolar bioelectrical impedance (BIA). Our results showed that the mean BMI and BFM of the yoga intervention group were significantly decreased at week 8 and week 12. The muscle mass of the yoga group continued to improve at a rate of 0.515 per week, which was statistically significant. In conclusion, a continuous yoga practice had a tendency to decrease BMI and BFM and increase muscle mass. These findings demonstrate intervention effectiveness similar to that observed in other clinical research and indicate that continuous yoga practice may be used as an alternative therapy for obesity prevention and health promotion in adolescents with obesity. [ABSTRACT FROM AUTHOR]

Metabolic syndrome (MetS) represents a cluster of metabolic abnormalities that include hypertension, central obesity, insulin resistance, and dyslipidemia and is strongly associated with an increased risk of diabetes, cardiovascular diseases (CVD), and all-cause mortality. Early diagnosis is important to employ lifestyle and risk factor modification. Existing therapies are limited. Studies report positive effect of omega-3 fatty acids (ω-3FA) on symptoms of metabolic syndrome. The present study was undertaken to evaluate the effect of ω-3FA alone and in combination with proprietary chromium complex (PCC) on endothelial function in subjects with metabolic syndrome. In this randomized, double-blind, parallel-group study, subjects were enrolled into the study after ethics committee (EC) approval and informed consent. Eligible subjects were randomized to receive ω-3FA concentrate 2000 mg (Group A-18 subjects), ω-3FA concentrate 2000 mg + PCC200 mcg (Group B-19 subjects), and ω-3FA concentrate 2000 mg + PCC400 mcg (Group C-21 subjects) daily for 12 weeks. Endothelial dysfunction as measured by reflection index (RI), biomarkers of oxidative stress (NO, MDA, and glutathione), and inflammation (hsCRP, endothelin-1, ICAM-1, and VCAM-1) were evaluated at baseline, 4, and 12 weeks. Lipid-profile and platelet-aggregation tests were performed at baseline and 12 weeks. Adverse drug reactions were recorded. Compliance was assessed by pill count method. GraphPad Prism8 was used for statistical analysis. Significant changes were seen from 4 weeks onwards in all the parameters evaluated. Significant improvement in RI% (mean ± SD = −2.56 ± 0.77 to −3.27 ± 0.67-group A, −2.33 ± 0.76 to 4.72 ± 0.79-group B; −2.39 ± 1.13 to 6.46 ± 1.00-group C) was seen at 12 weeks. Significant improvement in biomarkers of oxidative stress and inflammation was seen with all the treatment groups. Similarly, significant improvement in lipid profile was seen in group B and group C, while group A showed change in HDL, VLDL, and TG. Group C demonstrated the best response in the parameters evaluated. Three patients in group C reported gastrointestinal adverse events, which resolved spontaneously; none stopped the therapy. So, the addition of PCC to ω-3FA may prove to have beneficial effect in reducing cardiovascular morbidity in MetS patients. [ABSTRACT FROM AUTHOR]

Objective. This study aims to evaluate the effects of Plantago major (P. major) seed on liver enzymes and ultrasound patterns in nonalcoholic fatty liver disease (NAFLD). Design. In this randomized double-blind placebo-controlled clinical trial, 74 patients with NAFLD were administered either 2 g P. major or placebo twice daily for 12 weeks. All patients were advised to follow the recommendations for daily exercise and diet modification. Levels of liver enzymes as well as other laboratory indexes were measured at the beginning of the study and after 12 weeks. Indeed, the alteration in ultrasound grade was evaluated in NAFLD patients. Results. Sixty-three participants completed the study in the intervention and control groups. The mean age of participants was 43.3 (±8.927) and 38.7 (±8.48) years in the intervention and control groups, respectively. P. major group showed significant reduction in alanine aminotransferase (ALT) (47.32 ± 21.77 IU/L vs. 50.03 ± 21.19, P = 0.021), aspartate aminotransferase (AST) (28.29 ± 10.49 IU/L vs. 32.03 ± 13.30, P = 0.004), triglyceride (TG) (200.93 ± 106.741 mg/dl vs. 183.75 ± 73.96, P = 0.001), waist circumference (WC) (101.25 ± 9.27 cm vs. 101.18 ± 8.63, P = 0.027), and grade of fatty liver in ultrasonography (P = 0.038), comparing to the placebo group. There was no significant difference between the two groups regarding serum levels of fasting blood sugar (FBS), high-density lipoprotein (HDL), low-density lipoprotein (LDL), cholesterol, and other outcomes. Conclusion. P. major supplementation with a daily dose of 2 g for 12 weeks improved serum levels of ALT, AST, and TG in patients with NAFLD. Further studies with a larger sample size are recommended. [ABSTRACT FROM AUTHOR]

Objectives. This study aimed to evaluate the effect of propolis on cognitive function in elderly Japanese with a placebo-controlled design. Material and Methods. This study was performed on 79 elderly Japanese. Participants orally received either a placebo or dietary supplement containing propolis extract for 24 weeks. Cognitive function assessed by Cognitrax and various blood or urine markers were measured at pre- and postadministration. Results and Conclusion. Eligible data from 68 subjects (placebo: 33, propolis: 35) who completed the study were analyzed. Compared to the placebo group, the propolis group showed significant improvement in verbal memory in Cognitrax (P = 0.028). Total cholesterol, LDL cholesterol, urea nitrogen, creatinine, and uric acid were significantly improved in the propolis group compared to the placebo group (P = 0.011 , P = 0.004 , P = 0.048 , P = 0.045 , and P = 0.005 , respectively). However, urea nitrogen, creatinine, and uric acid fluctuated within the normal level. Furthermore, a subgroup analysis was performed on those with higher than 100 of the standardized score of the neurocognitive index indicated by the overall Cognitrax score. Significant improvements in the propolis group compared to placebo were confirmed in verbal memory (P = 0.007) and processing speed as indications for information processing ability, complex attention, and concentration (P = 0.029). No side effects were observed in any of the groups. This study demonstrates that propolis is effective in improving cognitive functions such as memory, information processing, complex attention, and concentration in elderly Japanese. [ABSTRACT FROM AUTHOR]

Sahastara (SHT) remedy is a Thai traditional medicine described in the Thai National List of Essential Medicine (NLEM) for the relief of muscle pain. The purpose of this study was to investigate the efficacy and safety of SHT remedy extract capsule for treating primary OA. A phase 2, double-blind, randomized, and controlled trial study was used to determine the clinical efficacy and safety of SHT in comparison with diclofenac for the treatment of knee OA. The outcome of reduce pain was measured from VAS, 100 meter time walk, and the WOMAC score of day 14 and day 28 which should reduce significantly when compared with day 0 and should be equal with or better than diclofenac. Blood pressure and blood chemistry values at day 14 and day 28 did not change when compared with day 0. The results found that SHT remedy ethanolic extract capsule can reduce all OA knee scores at day 14 and day 28 significantly when compared with day 0 and also no significant difference with diclofenac (P > 0.05). The SHT also showed safety values on blood pressure and blood chemistry. The SHT was observed that it had no serious side effect. The results of this study are the first report of using the SHT ethanolic extract capsule in the treatment of primary osteoarthritis of the knee. It can be recommended as an anti-inflammatory herbal drug for reducing pain in knee osteoarthritis patients. [ABSTRACT FROM AUTHOR]

To determine if the effect of manipulative acupuncture monitored by laser speckle contrast imaging (LSCI) can improve facial blood perfusion in patients with severe Bell's palsy. This randomized, single-blind, controlled trial included 120 newly diagnosed patients (within 14 days) with severe Bell's palsy (House–Brackmann grading system (HBGS) ≥ grade IV). The patients were randomized (1 : 1) to receive either acupoints acupuncture combined with manipulations of twirling, lifting, and thrusting treatments (manipulative acupuncture) or acupoints acupuncture therapy alone (simple acupuncture). These treatments consisted of a total of 24 sessions, three times per week, and each treatment lasted for 30 min. Following 8 weeks of treatment and 6 months after the initial onset of facial palsy, facial nerve functioning was scored (HBGS) and clinical efficacy was measured. The patients' facial blood perfusion significantly improved following manipulative acupuncture assisted by LSCI compared with that at baseline (P < 0.01). At the conclusion of the 8-week treatment, both groups showed improvement; however, the recovery rate was significantly different (manipulative acupuncture 53.3% vs. simple acupuncture 33.9%, P < 0.05). Follow-up analysis at 6 months after the onset of facial palsy revealed a significantly higher recovery rate (91.7% vs. 78.0%; P < 0.05). In addition, the number of treatments in the observation group was less than that in the simple acupuncture therapy group (P < 0.05). Compared with simple acupuncture therapy, manipulative acupuncture therapy led to a more significant recovery rate in the treatment of severe Bell's palsy and required a shorter course of treatment. This trial was registered with ChiCTR1800019463. [ABSTRACT FROM AUTHOR]

Background. It is generally considered that traditional Chinese medicine (TCM) therapy postpones the progression of some chronic kidney diseases (CKDs). Chinese medicine herbs are widely applied in TCM therapy. We aimed to evaluate clinical efficacy and safety of Chinese herbal formula granules in patients with CKD stage 3 through a prospective randomized controlled study. Methods. A total of 343 participants with CKD stage 3 were recruited from 9 hospitals in Jiangsu Province between April 2014 and October 2016. Participants were randomly assigned to a treatment or control group. Patients in the treatment group orally took Chinese herbal formula granules twice a day, while controls received placebo granules. The duration of intervention was 24 weeks. Primary outcomes were 24-hour proteinuria, serum creatinine, and eGFR, which were measured every 4 weeks. Results. There was no statistical difference in 24-hour proteinuria between the two groups (0.97 ± 1.14 g/d vs. 0.97 ± 1.25 g/d). Patients in the treatment group had significantly lower serum creatinine level (130.78 ± 32.55 μmol/L versus 149.12 ± 41.27 μmol/L) and significantly higher eGFR level (55.74 ± 50.82 ml/min/1.73·m2 versus 44.46 ± 12.60 ml/min/1.73·m2) than those in the control group (P < 0.05). There was no significant difference between two groups in the incidence of adverse events. Conclusion. The treatment adopting Chinese herbal formula granules for 24 weeks improved kidney function of patients with CKD stage 3. [ABSTRACT FROM AUTHOR]

The red peony root derived from Paeonia lactiflora has been applied to treat human inflammatory diseases. To investigate its therapeutic potential in treating moderately severe acute pancreatitis (MSAP), which has been rarely studied, this study was designed as a double-blinded, placebo-controlled, randomized clinical trial. A total of 60 MSAP patients were enrolled and randomly divided into an experimental (n = 30) group and a control group (n = 30), who received a coloclyster of 15 g of red peony root or placebo granules dissolved in 150 mL of water, respectively. The patients' demographic and clinical characteristics were recorded. The results showed that the experimental group had a shorter remission time of fever (p < 0.05) and abdominal pain (p < 0.01) and faster resumption of self-defecation (p < 0.01) than did the control group. In addition, the coloclyster of red peony root decreased the modified Balthazar CT score as well as the serum interleukin-6 and tumor necrosis factor-alpha levels to a greater extent than did the placebo coloclyster (p < 0.05). The remission times for the normalization of white blood cells and percentage of neutrophils and lymphocytes in the experimental group were also significantly shorter than those in the control group (p < 0.05). In conclusion, a coloclyster of red peony root could help alleviate the clinical symptoms and shorten the course of MSAP by possibly attenuating systematic inflammation. This trial is registered with 14004664. [ABSTRACT FROM AUTHOR]

Objective. To evaluate the efficacy and safety of Tongning Gel (TNG) compared to placebo-controlled (PC) for knee osteoarthritis (KOA). Methods. A multicentre, randomized, double-blinded, parallel, placebo-controlled, clinical trial was performed in 576 patients (432 patients in the TNG group, 144 patients in the PC group), and 1 in the experimental group withdrew due to nonuse of drug. Patients were randomized to receive TNG or PC applied to knee skin at 3g per time, 2 times per day, which lasted for 3 weeks. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score was used to evaluate the primary efficacy of TNG and WOMAC stiffness and physical function and total scores were used to evaluate the secondary efficacy of TNG. All participants who received at least one dose of study drug were included in the safety analysis. This trial has been registered in Chinese Clinical Trial Registry (no. CTR20131276). Results. Primary efficiency outcome: there were significant differences in the decreased value of WOMAC pain score between two groups (P < 0.05), and the decreased value of WOMAC pain score in the TNG group were better than those in the PC group (P < 0.05). Secondary efficiency outcome: the WOMAC total score, WOMAC stiffness score, WOMAC physical function score, and the decrease of the above indexes of the two groups of patients after treatment were statistically significant (P < 0.05), and the improvement of the above indexes in the TNG group was better than that of the PC group (P < 0.05). Safety Evaluation. A total of 42 adverse events were reported by 29 patients: 25 adverse events reported by 16 patients (3.71%) in the experimental group and 17 adverse events were reported by 13 patients (9.03%) in the control group. And 8 adverse reactions were reported by 6 patients including 2 adverse reactions by 2 patients (0.46%) in the experimental group and 6 adverse reactions by 4 patients (2.78%) in the control group. Two cases of significant adverse events occurred in the experimental group. Both groups had one serious adverse event, respectively, which were not relevant to the intervention. Conclusion. These results of the trial demonstrate that TNG is superior to placebo in the treatment of patients with KOA, and TNG can improve other symptoms of KOA, such as stiffness and physical function. TNG is safe for the treatment of knee osteoarthritis as a whole. [ABSTRACT FROM AUTHOR]

Glaucoma is characterized by the degeneration of retinal ganglion cells that cause progressive optic neuropathy, finally resulting in changes to the optic nerve head. Lowering intraocular pressure (IOP) is the only method proven for treating glaucoma. Several studies have discovered that acupuncture can reduce IOP and also increase ocular perfusion and ocular blood flow. Therefore, the present study investigated the effect of acupuncture on IOP in glaucoma patients. We conducted a single-blinded, randomized, controlled trial involving 45 glaucoma patients. The results indicated that the difference between the IOP 60 min after the intervention and IOP immediately before the intervention was greater in the acupuncture group (AG) and electroacupuncture group (EG) than in the sham group (SG) for all four of the interventions performed and in both eyes (all p < 0.05). The IOP difference between immediately before the first intervention and after finishing the final intervention was also greater in the AG and EG than in the SG in both eyes (all p < 0.05). In conclusion, IOP was reduced at 60 min after acupuncture or electroacupuncture was performed at BL1 and EX-HN7. Additionally, IOP was reduced after finishing four acupuncture or electroacupuncture sessions. Therefore, our results suggest that acupuncture and electroacupuncture are beneficial for lowering IOP in glaucoma patients. This trial is registered with NCT04157530. [ABSTRACT FROM AUTHOR]

Objective. The aim of this study was to investigate the clinical efficacy of laser acupuncture for the treatment of women with overactive bladder (OAB) in Taiwan. Methods. A double-blind randomized controlled trial was conducted on female patients with OAB symptoms referred from gynecologists, and subjects were divided into two groups using blocked randomization. LaserPan (RJ-Laser, Germany) was applied to seven selected acupuncture points. The subjects received laser acupuncture 3 times per week for 3 weeks, 9 sessions in total. Basic patient data, Overactive Bladder Symptom Score (OABSS), Incontinence Impact Questionnaire (IIQ-7), and Urogenital Distress Inventory (UDI-6) scores were recorded prior to first treatment and at the end of 3rd, 6th, and 9th treatments. Results. Thirty patients were enrolled, and twenty-seven patients completed all treatments in this study. The OABSS total score of the experimental group decreased significantly by 3.13 (p ≤ 0.001), 4.60 (p ≤ 0.001), and 3.79 (p ≤ 0.001) after 3rd, 6th, and 9th treatments, respectively, compared with that of the control group. The IIQ-7 score declined significantly from baseline by 4.57 (p = 0.003) and 3.63 (p = 0.023) after 3rd and 6th treatments, respectively, compared with that of the control group. Similarly, the UDI-6 score of the experimental group exhibited a significant decrease from baseline by 1.90 (p = 0.042) and 2.25 (p = 0.025) after 6th and 9th interventions, respectively, compared with that of the control group. Conclusions. This study demonstrates that laser acupuncture can alleviate OAB symptoms and improve quality of life. This noninvasive device could be an effective therapy for women with OAB. [ABSTRACT FROM AUTHOR]

Background. One of the most common surgical complications is nausea. Regarding the contradictory findings on the effect of aromatherapy with peppermint on the severity of nausea, in the present study, we aimed at comparing the effect of aromatherapy with 10% and 30% peppermint essential oils on the severity of nausea in surgical patients. Methods. This single-blind randomized controlled trial was conducted at the surgical ward of Imam Reza Hospital in Kermanshah, Iran. A total of 120 patients undergoing abdominal surgery were randomly divided into three groups of 10% peppermint, 30% peppermint, and control (40 patients in each group) using a random number table. In each of the intervention groups, 0.2 ml of 10% and 30% peppermint essential oil was inhaled. In the control group, the same amount of distilled water colored with green food coloring was inhaled. The severity of nausea was measured by nausea visual analog scale (NVAS) before and 10 minutes after the intervention. Results. In the 10% peppermint group, the mean severity of nausea before the intervention was 52.3 ± 13.7 out of 100, which reduced to 40.5 ± 13.5 after the intervention (p < 0.001). In the 30% peppermint group, the mean severity scores of nausea before and after the intervention were 60.2 ± 15.0 and 39.7 ± 12.4, respectively (p < 0.001). In the control group, the mean severity scores of nausea before and after the intervention was not statistically significant. There was no significant difference between the two intervention groups in terms of the mean severity of nausea after the intervention. Conclusions. It can be concluded that 10% and 30% peppermint essential oils are equally effective on the severity of nausea. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the efficacy of electroacupuncture (EA) on Ciliao (BL 32) and Zhongliao (BL 33) acupoints at different depths for the treatment of benign prostatic hyperplasia (BPH) through a single-blind randomized controlled trial. All 120 patients diagnosed with BPH were randomly allocated to an experimental group (deep insertion group, DI group, n = 60) and control group (shallow insertion group, SI group, n = 60) 3 times a week for 4 weeks. The observed results included the International Prostate Symptom Score (IPSS), Quality of Life score (QOL), maximum urine flow rate (Qmax), and postvoid residual urine volume (PVR). After treatment, at both depths, the BPH symptoms of patients were improved by EA. There were significant differences between the IPSS, QOL, and the effective rate of the experimental group and the control group (P < 0.05). Although the observed PVR and Qmax were better than those before treatment, there was no statistical significance between two groups (P > 0.05). Thus, EA with deep insertion can effectively improve the patients' urinary symptoms and quality of life, and it will be suitable for clinical application. [ABSTRACT FROM AUTHOR]

Objective. To explore a new treatment that can proceed from the whole, control blood pressure smoothly and coordinate the treatment of multiple factors causing blood pressure fluctuations. Method. We conducted a single-center, double-blinded, and randomized controlled clinical trial. 48 patients with acute Type B aortic dissection were randomly assigned into two groups: the experimental group, who received pinggan formula treatment, and the control group, who received placebo treatment. The drug was taken orally after meals three times a day. Only when the patients' blood pressure fluctuated, conventional antihypertensive drugs were given to maintain the blood pressure within the target range and the dosage was recorded to convert the DDD value. Meanwhile, the international standardized score was used to evaluate the defecation, sleep, pain, anxiety, and depression of patients in the two groups during the hospitalization. Result. Univariate analysis was conducted on variables that might affect the assessment results, and it was found that grouping factors had a significant impact on the outcome variables, that is, after the intervention, the mean value of DDDs used in the perioperative period in the control group was 2.19 (0.38, 4.00). (P = 0.0219), defecation score (2.13 (1.59, 2.67); P < 0.0001), sleep score (0.95 (0.40, 1.50); P = 0.0014), pain score (1.77 (0.61, 2.93); P = 0.0045), depression score (4.04 (2.95, 5.12); and P < 0.0001) were significantly higher than that of the experimental group, and the difference was statistically significant. Conclusion. Pinggan formula has a clear therapeutic regulation effect on the overall hemodynamics of acute Stanford type B aortic dissection during the perioperative period and can be recommended as an auxiliary drug for conventional antihypertensive drugs at the current stage. [ABSTRACT FROM AUTHOR]

Background. Various sham acupuncture devices have been developed and used in studies on acupuncture. However, there is controversy on whether these devices act as an appropriate placebo or control. In particular, validation of sham acupuncture has only been performed in studies involving healthy individuals. In this regard, questions on the suitability of various sham acupuncture treatments in studies involving disease treatment remain unanswered. Therefore, in this study, we would like to investigate the most appropriate sham acupuncture in the research on treatment of hemiplegic stroke. Methods. The proposed study is a single-center, prospective, randomized sequence, participant- and assessor-blinded trial with four parallel arms. A total of 90 participants will be randomly assigned to Group 1, Group 2, Group 3, or Group 4 in a 1 : 1 : 1 : 1 ratio. All groups will be treated with Quchi (LI11) for 20 minutes. Group 1 will be treated with verum acupuncture; Group 2, with Park Sham Device; Group 3, with Streitberger's needle; and Group 4, with insertion- and removal-type devices. Participants will undergo one treatment session. The primary outcome is Bang's blinding index. Secondary outcomes are the "Discomfort caused by acupuncture therapy" questionnaire and the Massachusetts General Hospital Acupuncture Sensation Scale index. Immediately after the procedure, all participants will also be monitored for adverse events. Discussion. This study will help identify the optimal sham acupuncture device that can be used for clinical studies on acupuncture treatment in hemiplegic stroke patients. This trial is registered with KCT0002622. [ABSTRACT FROM AUTHOR]

Objectives. Obesity and overweight are chronic disorders of multifactorial origin that are characterized by high oxidative status and by chronic activation of macrophages in peripheral tissues. Effective therapeutic approaches to lower inflammation and oxidative stress are currently of general interest. Royal jelly (RJ) is a functional food with a broad range of pharmacological activities, mainly used by healthy individuals or borderline patients to protect themselves against disease onset. The objective of this randomized, double-blind, placebo-controlled trial was to investigate the effects of RJ supplementation on metabolic profile and oxidative and inflammatory parameters in asymptomatic overweight adults, considered at an early stage of developing metabolic syndrome. Material and Methods. The experimental group (n=30) was given RJ and the control group (n=30) was provided with a placebo for eight weeks. Anthropometric, biochemical parameters, biomarkers of oxidative stress, and inflammation were assessed at baseline, after 4 and 8 weeks of the intervention, and after additional 2 weeks of follow up. Results and Conclusion. Compared with the placebo, RJ supplementation demonstrated a statistically significant decrease in total cholesterol (6.7%; p=0.041) and inflammatory marker C-reactive protein (19%; p=0.027), whereas significant increases were observed in anti-inflammatory marker adiponectin (34%; p=0.011), endogenous antioxidants bilirubin (35%; p=0.002) and uric acid (5%; p=0.018), total antioxidant capacity in serum (54%; p=0.005), and leptin (17%; p=0.025). The present study demonstrated positive effects of RJ administration on lipid profile, satiety, inflammation, and antioxidant capacity in overweight adults. Therefore, our study supports the benefits of RJ supplementation for the improvement of human health. [ABSTRACT FROM AUTHOR]

Study Objectives. This study investigates the therapeutic effect of Low Level Laser Therapy (LLLT) acupuncture for chronic insomnia. Methods. Thirty-seven adult subjects with chronic insomnia were recruited and randomly assigned to three groups, namely, Group A (6 pairs of acupoints: Ex-HN 22, HT 7, SP 6, KI 3, LR 3, and PC 6, bilaterally distributed); Group B (acupoints as for Group A other than PC 6, which was applied only on the left side [i.e., the dominant side of the PC meridian] and the addition of DU 20, which is the main tonic acupoint for integration of all the meridians); and a control group (sham LLLT). The subjects in the treatment groups (i.e., Groups A and B) received LLLT acupuncture and those in the control group received sham LLLT for 15 minutes per session twice a week for five weeks. The sleep quality of all the subjects was evaluated using the Pittsburgh Sleep Quality Index (PSQI), the Epworth Sleepiness Scale (ESS), the Hospital Anxiety and Depression Scale (HADS), and a sleep diary. In addition, the sympathetic activity before and after every treatment sessions was measured using the Heart Rate Variability (HRV). Results. All three groups showed an improved PSQI score. However, only Group A showed a significant reduction in the sleep onset latency and number of awakenings at night and a higher sleep efficiency and ESS score. Furthermore, Group B showed an increased low frequency power and normalized low frequency of the HRV signal and a lower normalized high frequency power, suggesting an increased sympathetic activity and decreased parasympathetic activity. Conclusions. For chronic insomnia insomniacs, LLLT appears to shorten the sleep latency, decrease the number of awakening events at night, and improve the sleep efficiency. [ABSTRACT FROM AUTHOR]

Background. Insomnia is common amongst the elderly. With the adverse effects of prolonged use of hypnotics, the exploration of noninvasive and nonpharmacological complementary methods for insomnia is warranted. Auriculotherapy (AT) is a therapeutic approach where specific points on the auricle are stimulated to manage various physiological disorders. The purpose of this study is to determine the desirable treatment modality using AT to improve the sleep conditions of the elderly. Methods. A three-arm double-blinded randomised trial was conducted on 145 eligible subjects. This study investigated three minimally invasive procedures, namely, laser auriculotherapy (LAT), magneto-auriculotherapy (MAT), and their combination. Seven auricular points were used. Treatment was performed three times a week, for six weeks. Subjects were assessed at baseline, six weeks, and follow-up after six weeks, three months, and six months. Generalised estimating equations were used to evaluate interactions amongst the groups over time based on the Pittsburgh Sleep Quality Index (PSQI), sleep parameters using actigraphic monitoring, health-related quality of life (HRQOL) using SF-12, and PHQ-9 for depression status. Results. The treatment effects of the three procedures were comparable. Significant improvements were found in all of the subjective measures (PSQI, HRQOL, and PHQ-9) for individual groups over time. Improvements in the objective sleep parameters using actigraphic monitoring were detected in subjects who received MAT procedures but not in those who received LAT. The combined MAT and LAT approach did not show any advantage over MAT. Conclusions. The treatment effects of the three procedures were comparable in subjective parameters but not by objective measures using actigraphic monitoring. Longer therapeutic course and more frequent administration of LAT may be considered in future trials to achieve the optimal treatment effect. Trial Registration. This trial is registered with ClinicalTrials.gov: NCT02970695, registered May 2016. [ABSTRACT FROM AUTHOR]

Objective. To evaluate the effectiveness and safety of Qingpeng ointment on eczema-associated pruritus. Trial Design and Method. This single center randomized double-blinded placebo-controlled trial enrolled 60 patients with nonexudative eczema, who were randomized at 1:1 ratio to the Qingpeng ointment and placebo control groups (n=30 in each group). The investigational and control ointment were applied on lesions twice daily for two weeks. Visual analogue scale (VAS) and pruritus symptom scores were used to assess pruritus severity, frequency, and duration. Eczema lesions were evaluated by eczema area and severity index (EASI) and lesion morphology scores. Subjects were evaluated after the first treatment and at the end of the first and second week. Results. The average age and disease duration were 50.1±13.5 years and 30.9±16.0 weeks, respectively. Baseline EASI and VAS scores were similar between the two groups. VAS scores of the Qingpeng ointment group were significantly lower than those of the placebo control group at 10 minutes and 30 minutes after the first treatment and the first and second week follow-up (all P < 0.05). The scores of pruritus severity, frequency, and duration were significantly lower in the Qingpeng ointment group than in the control group at the end of week 1 and week 2 of the study (all P < 0.05). The scores of lesion morphology at the end of week 1 of the study were not significantly different between the two groups, but the Qingpeng ointment group showed significantly lower score than the placebo control group at the end of week 2 of the study. No adverse event was observed in the study. Conclusion. Qingpeng ointment can effectively alleviate pruritus and reduce skin lesions in patients with nonexudative eczema. The antipruritic effects occurred early and at a greater magnitude than the effects on lesion attenuation. [ABSTRACT FROM AUTHOR]

Allergic rhinitis (AR) is one of the common allergic diseases in clinical practice and significantly impairs the quality of life (QoL) of patients. The conventional treatments are not satisfactory because of various reasons. Tian Jiu (TJ) therapy is a characteristic external intervention of complementary and alternative medicine (CAM) and has been widely utilized in the management of AR. However, the evidences resulted from current studies were generally poor due to high risk of bias. Therefore, we conducted this rigorous designed, single-blinded, three-arm, randomized controlled study to evaluate the efficacy and safety of TJ therapy on AR. Totally 138 AR patients were enrolled. The TJ group and placebo group received 4-week treatment with either TJ or placebo patches for 2 hours each time applied to Dazhui (GV 14), bilateral Feishu (UB 13), and bilateral Shenshu (UB 23) one session per week and then underwent a 4-week follow-up. The waitlist group received no treatment during the corresponding treatment period, but would be given compensatory TJ treatment in the next 4 weeks. The primary outcome was the change of the Total Nasal Symptom Score (TNSS) after treatment. The secondary outcomes included the changes of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and rescue medication score (RMS). After treatment, the total TNSS in TJ group was significantly reduced compared with baseline, but showed no statistical meaning compared with placebo. Among the four domains of TNSS, the change of nasal obstruction exhibited statistical difference compared with placebo group. The total RQLQ score in TJ group was significantly reduced compared with both placebo and waitlist groups. The needs of rescue medications were no distinct difference between two groups. In summary, this study showed potential effectiveness of TJ therapy in improving nasal obstruction symptoms and QoL of AR patients. [ABSTRACT FROM AUTHOR]

Background. Shenfu injection (SFI) has shown a remarkable therapeutic effect in patients with chronic heart failure (CHF) during the acute phase of symptom aggravation since it became commercially available in 1987. However, the therapeutic effect of SFI has not been validated in a standard clinical study. As a pilot clinical trial, this study aimed to evaluate the safety and efficacy of SFI for treatment of CHF patients during the acute phase. Methods. A total of 160 patients experiencing acute phase CHF were enrolled in this study and randomly assigned to receive the placebo (placebo group, 150 ml glucose (GS)) or SFI (SFI group, 50 ml SFI + 100 ml GS) in addition to their standard medications for CHF treatment. The treatment lasted for 7 ± 1 days, and the follow-up continued for 28 ± 3 days after treatment. The primary endpoints were New York Heart Association (NYHA) classification and Traditional Chinese Medicine (TCM) syndrome scores. Results. After 7±1 days of treatment, the efficacy of SFI according to improvements in NYHA and TCM syndrome scores in the SFI group (78.38% and 89.19%, respectively) was significantly higher than that in the placebo group (61.43% and 60.00%, respectively; P<0.05). The SFI group had a longer increase in amplitude than the placebo group (113.00 m versus 82.99 m, P<0.05). The incidence of adverse events and other safety indices showed no significant differences between the two groups. Conclusion. SFI combined with conventional therapy for treatment of CHF during acute symptom aggravation ameliorated the cardiac dysfunction and clinical symptoms and improved the patients' quality of life without any significant AEs compared with the conventional therapy alone. [ABSTRACT FROM AUTHOR]

Aim. To examine the efficacy and safety of the toothpaste containing Rhizoma Chuanxiong and Rhizoma Imperatae extracts in reducing gingivitis. Method. A double-blind clinical trial was conducted, in which 120 volunteers were randomly assigned to the test group (N = 60) or the control group (N = 60). Tetramethylpyrazine, senkyunolide A, ferulic acid, and ligustilide are the main effective components of Rhizoma Chuanxiong and Rhizoma Imperatae contains the main components of cylindrin, carotene, 5-hydroxytryptamine, potassium, and calcium. The control group used placebo toothpaste containing neither Rhizoma Chuanxiong extract nor Rhizoma Imperatae extract. Plaque, gingivitis, and bleeding were assessed at the baseline, prior to the supragingival scaling, and at 4, 8, and 12 weeks. Results. During the trial, both test and control groups showed a decreasing trend compared to the baseline. At the end of 12 weeks, with respect to Gingival Index (GI), Bleeding Index (BI), and Bleeding on Probing percentage (BOP%) scores, there were significant differences between test and control groups (GI, P<0.001, BI, P<0.001, and BOP%, P<0.001, resp.). After 4 weeks of usage, there were no statistically significant differences in all of GI, BI, and BOP% scores between the two groups. However, the decrease became statistically significant at next two intervals (GI, P<0.001, BI, P<0.001, and BOP%, P<0.001, resp.) in the efficiency of GI, BI, and BOP% which was 8.04%, 11.02%, and 37.16%, respectively. There were no treatment-related adverse events reported. Conclusion. The toothpaste containing Rhizoma Chuanxiong and Rhizoma Imperatae extracts was well tolerated and significantly reduced gingivitis and bleeding after usage for 12 weeks. There was better improvement at molars, and the more serious the baseline status was, the better the efficacy was. [ABSTRACT FROM AUTHOR]

Previous studies have reported that visceral disturbances can lead to increased musculoskeletal tension and pain in structures innervated from the corresponding spinal level through viscerosomatic reflexes. We designed a pilot randomised placebo-controlled study using placebo visceral manipulation as the control to evaluate the effect of osteopathic visceral manipulation (OVM) of the stomach and liver on pain, cervical mobility, and electromyographic activity of the upper trapezius (UT) muscle in individuals with nonspecific neck pain (NS-NP) and functional dyspepsia. Twenty-eight NS-NP patients were randomly assigned into two groups: treated with OVM (OVMG; n = 14) and treated with placebo visceral manipulation (PVMG; n = 14). The effects were evaluated immediately and 7 days after treatment through pain, cervical range, and electromyographic activity of the UT muscle. Significant effects were confirmed immediately after treatment (OVMG and PVMG) for numeric rating scale scores (p < 0.001) and pain area (p < 0.001). Significant increases in EMG amplitude were identified immediately and 7 days after treatment for the OVMG (p < 0.001). No differences were identified between the OVMG and the PVMG for cervical range of motion (p > 0.05). This study demonstrated that a single visceral mobilisation session for the stomach and liver reduces cervical pain and increases the amplitude of the EMG signal of the UT muscle immediately and 7 days after treatment in patients with nonspecific neck pain and functional dyspepsia. [ABSTRACT FROM AUTHOR]

Introduction. Functional dyspepsia (FD) is a functional gastrointestinal disorder characterized by persistent upper dyspeptic symptoms without organic lesions. There is no standard therapy for FD. Yukgunja-tang (YGJT) is an herbal medicine used for treating upper gastrointestinal symptoms in Asia. Studies on the effect of YGJT on FD have been conducted. However, the results were inconsistent. In Hyungsang medicine, traditional Korean medicine, FD patients are classified into bladder body (BB) or gallbladder body (GB) subtypes by the shape and angle of their faces. Each subtype may have different characteristics, physiology, and pathology of the same disease. YGJT is more effective for patients with BB subtype. The three-dimensional facial shape diagnostic system (3-FSDS) was shown to be effective in diagnosing BB or GB subtypes. This study aimed to investigate the effect of YGJT on FD patients classified using the 3-FSDS. Materials and Methods. The current study was a placebo-controlled, double-blinded, randomized, two-center trial. Eligible patients were diagnosed with either BB or GB FD subtype using the 3-FSDS. Ninety-six participants (48 BB and 48 GB subtypes) were randomly allocated to treatment or control groups in a 2:1 ratio. YGJT or placebo was administered for eight weeks. The primary outcome was assessed using the total dyspepsia symptom scale (TDS), while the secondary outcomes were assessed using the single dyspepsia symptom scale (SDS), proportion of responders, visual analog scale, Nepean dyspepsia index, functional dyspepsia-related quality of life, and spleen qi deficiency questionnaire. Results and Discussion. The result of TDS showed the superior effect of YGJT on BB over GB subtype. The subgroup analysis of TDS and SDS scores showed the superior effect of YGJT over placebo. Other outcome variables did not show any significant differences between groups. Conclusion. YGJT may be considered for FD patients diagnosed with BB subtype using 3-FSDS. [ABSTRACT FROM AUTHOR]

The primary objective of the study was to evaluate the effect of a hydrolyzed polysaccharide, Rice Bran Arabinoxylan Compound (RBAC), on biomarkers in adults with nonalcoholic fatty liver disease (NAFLD). A 90-day randomized double-blind placebo-controlled trial examined the effect of RBAC on complete blood count, liver enzymes, lipids, oxidative stress markers, cytokines, and growth factors. Twenty-three adults with NAFLD were enrolled and randomly assigned to one of the two study conditions (n=12 RBAC and n=11 placebo) and consumed 1 gram/day of either compound for 90 days. Subjects were assessed at baseline and 45 and 90 days. No adverse effects were reported. Alkaline phosphatase significantly decreased (−3.1%; SD = 19.9; F[1,19]=5.1, p=0.03) in the RBAC group compared to placebo. Percent monocytes (17.9%; SD = 18.3; F[1,19]=5.9, p=0.02) and percent eosinophils (30.6%; SD = 30.5; F[1,19]=12.3, p<0.01) increased in the RBAC group. IFN-γ (156%; SD = 131.8; F[1,19]=4.2, p=0.06) and IL-18 (29.1%; SD = 64; F[1,19]=5.3, p=0.03) increased in the RBAC group compared to placebo. Other improvements were noted for platelets, neutrophils, neutrophil-lymphocyte ratio, γ-glutamyl transferase, and 4-hydroxynonenal. RBAC had beneficial effects on several biomarkers that add to the known immunomodulatory activities of RBAC, which may be promising for people with NAFLD. [ABSTRACT FROM AUTHOR]