scholarly journals The Herbal Formula CBD Improves Sleep Quality Dependent on Oral Microbial Type and Tongue Diagnostic Features in Insomnia

2020 ◽  
Author(s):  
Min-Jee Kim ◽  
Shambhunath Bose ◽  
Na Rae Shin ◽  
Meng Yang ◽  
Ojin Kwon ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Clinical Laboratory ◽  
Heart Function ◽  
Primary Insomnia ◽  
Autonomic Nerve ◽  
Oral Microbiota ◽  
Tongue Coating ◽  
Open Label ◽  
Diagnostic Features ◽  
Tongue Diagnosis

Abstract Background Cheonwangbosim-dan (CBD) is a traditional Korean herb formula that has been widely prescribed for insomnia patients with a heart-yin deficiency (HYD) pattern. Several studies have recently reported that heart function and insomnia are interrelated, and others have explored associations between insomnia, oral microbiota, and tongue diagnosis. This study aimed to evaluate the effects of CBD on primary insomnia, tongue diagnosis, and oral microbiota. We conducted a prospective, open-label clinical trial on primary insomnia. At baseline, 56 patients with primary insomnia were assigned to two groups, a HYD group and a non-HYD (NHYD) group. Members of these groups took CBD for 6 weeks. Primary and secondary outcomes including Pittsburgh Sleep Quality Indices (PSQIs), Insomnia Severity Indices (ISIs), actigraphy results, cardiac function, autonomic nerve function, clinical laboratory results, tongue features, and oral microbiota were collected from all subjects at after 0, 3, or 6 weeks of treatment. Additionally, PSQI and ISI were determined by telephone follow-up 10 weeks after study commencement.Results During the study, PSQIs and ISIs decreased significantly in both groups. However, the PSQI reduction observed in the HYD group was greater than in the NHYD group and sleep times as determined by actigraphy, that is, total bedtimes (TBTs) and total sleep times (TST), increased only in the HYD group. As sleep quality improved, the amount of tongue coating increased at the posterior tongue, where heart function appears. At baseline, the HYD and NHYD group had a specific oral microbiota (Veillonella at genus level), but no significant change was observed after taking CBD. Additionally, subjects were divided into two oral microbiota types (‘orotype’). The genera Prevotella, Veillonella or Neisseria were abundant in each orotype. The reduction in PSQI in the orotype 1 during the 6-week treatment period was greater than in orotype 2.Conclusions Taking together, CBD was effective in primary insomnia patients with a HYD pattern and CBD increased the amount of tongue coating. In addition, oral microbiota distributions were different in patients with a HYD or a NHYD pattern. The study shows CBD could be used to treat primary insomnia in patients with a HYD pattern as determined using tongue diagnosis and oral microbiota distributional patterns.

scholarly journals The Herbal Formula CWBSD Improves Sleep Quality Dependent on Oral Microbial Type and Tongue Diagnostic Features in Insomnia

2021 ◽  
Vol 11 (5) ◽  
pp. 325
Author(s):  
Min-Jee Kim ◽  
Shambhunath Bose ◽  
Na-Rae Shin ◽  
Seohyun Park ◽  
Ojin Kwon ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Heart Function ◽  
Primary Insomnia ◽  
Oral Microbiota ◽  
Quality Indices ◽  
Diagnostic Features ◽  
Tongue Diagnosis ◽  
Yin Deficiency ◽  
Posterior Tongue ◽  
Insomnia Severity

Cheonwangbosim-dan (CWBSD) is a traditional Korean herb formula that has been widely prescribed for insomnia patients with a heart-yin deficiency (HYD) pattern. Several studies have reported that heart function and insomnia are interrelated, and few have explored associations between insomnia, oral microbiota, and tongue diagnosis. This study aimed to evaluate the effects of CWBSD on primary insomnia, tongue diagnosis, and oral microbiota. At baseline, 56 patients with primary insomnia were assigned to two groups, a HYD group and a non-HYD (NHYD) group and they took CWBSD for 6 weeks. During the study, Pittsburgh Sleep Quality Indices (PSQIs) and Insomnia Severity Indices (ISIs) decreased significantly in both groups. However, the PSQI reduction observed in the HYD group was greater than in the NHYD group and sleep times increased only in the HYD group. As sleep quality improved, the amount of tongue coating increased at the posterior tongue, where heart function appears. At baseline, the HYD and NHYD group had a specific oral microbiota (Veillonella at genus level), but no significant change was observed after taking CWBSD. Additionally, subjects were divided into two oral microbiota types (“orotypes”). The genera Prevotella, Veillonella, or Neisseria were abundant in each orotype. The reduction in PSQI in orotype 1 during the 6-week treatment period was greater than in orotype 2. In conclusion, this study shows that CWBSD could be used to treat primary insomnia in patients with a HYD pattern as determined using tongue diagnosis and oral microbiota distributional patterns.

scholarly journals Variations of Tongue Coating Microbiota in Patients with Gastric Cancer

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Jie Hu ◽  
Shuwen Han ◽  
Yan Chen ◽  
Zhaoning Ji
Keyword(s):  
Gastric Cancer ◽  
Microbial Community ◽  
High Throughput Sequencing ◽  
Research Direction ◽  
Community Diversity ◽  
Oral Microbiota ◽  
Healthy Controls ◽  
Tongue Coating ◽  
Tongue Diagnosis ◽  
Tongue Manifestation

The physical status of humans can be estimated by observing the appearance of the tongue coating, known as tongue diagnosis. The goals of this study were to reveal the relationship between tongue coating appearance and the oral microbiota in patients with gastric cancer and to open a novel research direction supporting tongue diagnosis. We used a tongue manifestation acquisition instrument to analyse the thickness of the tongue coating of patients with gastric cancer and that of healthy controls, and high-throughput sequencing was used to describe the microbial community of the tongue coating by sequencing the V2–V4 region of the 16S rDNA. The tongue coatings of 74 patients with gastric cancer were significantly thicker than those of 72 healthy controls (343.11 ± 198.22 versus 98.42 ± 48.25,P<0.001); 51.35% of the patients were assessed as having thick tongue coatings, whereas all healthy controls were assessed as having thin tongue coatings. Thick tongue coatings presented lower microbial community diversity than thin tongue coatings. The tongue coating bacterial community is associated with the appearance of the tongue coating. The tongue coating may be a potential source for diagnosing gastric cancer, but its sensitivity needs to be further improved.

scholarly journals Tasimelteon safely and effectively improves sleep in Smith–Magenis syndrome: a double-blind randomized trial followed by an open-label extension

2021 ◽  
Author(s):  
Christos M. Polymeropoulos ◽  
Justin Brooks ◽  
Emily L. Czeisler ◽  
Michaela A. Fisher ◽  
Mary M. Gibson ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Crossover Study ◽  
Total Sleep Time ◽  
Sleep Time ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Sleep Complaints ◽  
Open Label Extension

Abstract Purpose To assess the efficacy of tasimelteon to improve sleep in Smith–Magenis syndrome (SMS). Methods A 9-week, double-blind, randomized, two-period crossover study was conducted at four US clinical centers. Genetically confirmed patients with SMS, aged 3 to 39, with sleep complaints participated in the study. Patients were assigned to treatment with tasimelteon or placebo in a 4-week crossover study with a 1-week washout between treatments. Eligible patients participated in an open-label study and were followed for >3 months. Results Improvement of sleep quality (DDSQ50) and total sleep time (DDTST50) on the worst 50% of nights were primary endpoints. Secondary measures included actigraphy and behavioral parameters. Over three years, 52 patients were screened, and 25 patients completed the randomized portion of the study. DDSQ50 significantly improved over placebo (0.4, p = 0.0139), and DDTST50 also improved (18.5 minutes, p = 0.0556). Average sleep quality (0.3, p = 0.0155) and actigraphy-based total sleep time (21.1 minutes, p = 0.0134) improved significantly, consistent with the primary outcomes. Patients treated for ≥90 days in the open-label study showed persistent efficacy. Adverse events were similar between placebo and tasimelteon. Conclusion Tasimelteon safely and effectively improved sleep in SMS.

Biology of the Tongue Coating and Its Value in Disease Diagnosis

2017 ◽  
Vol 25 (3) ◽  
pp. 191-197 ◽  
Author(s):  
Shipeng Sun ◽  
Huamin Wei ◽  
Ruili Zhu ◽  
Bo Pang ◽  
Shuming Jia ◽  
...  
Keyword(s):  
Vascular Endothelial Cells ◽  
Disease Diagnosis ◽  
Diagnostic Tools ◽  
Vascular Endothelial ◽  
Tongue Coating ◽  
Tongue Diagnosis ◽  
Material Basis ◽  
Close Relationship ◽  
Fundamental Research ◽  
Diagnosis Tool

Tongue diagnosis is one of the most important diagnostic tools in traditional Chinese medicine and has been verified for thousands of years. However, its subjectivity and repeatability has been disputed continuously. The tongue coating as the primary coverage of tongue diagnosis provides more objectivity and reproducibility due to its relatively clear molecular basis; it also has a close relationship with many system diseases and may be used as a potentially valuable disease diagnostic tool. This article describes the material basis of the tongue coating, including its biology (epithelial cells, blood cells, vascular endothelial cells, and bacteria) and its metabolites; moreover, we summarize the diseases that are most correlated with the tongue coating. This will be valuable not only for fundamental research of tongue diagnosis but also for the diagnosis and differential diagnosis of disease. We suppose that the tongue coating could serve as a valuable auxiliary diagnosis tool in many diseases, and more research should focus on how to colligate the various information about the tongue and provide useful information for disease diagnosis.

scholarly journals FC 022AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF INTRAVENOUS DIFELIKEFALIN IN PATIENTS WITH MODERATE-TO-SEVERE CKD–ASSOCIATED PRURITUS UNDERGOING HEMODIALYSIS

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Daniel Weiner ◽  
Frederique Menzaghi ◽  
Warren Wen ◽  
Jenny Qian ◽  
Catherine Munera ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Safety Profile ◽  
Complete Resolution ◽  
Skin Irritation ◽  
Quality Score ◽  
Open Label ◽  
Phase 3 ◽  
Open Label Study ◽  
Label Study ◽  
Self Confidence

Abstract Background and Aims Chronic kidney disease–associated pruritus (CKD-aP) is a common and highly distressing condition in patients undergoing hemodialysis (HD). CKD-aP is associated with sleep disturbances, significant quality-of-life (QoL) impairment, and increased morbidity and mortality. Difelikefalin (DFK) is a selective kappa opioid receptor agonist in development for CKD-aP that has minimal central nervous system penetration. In placebo-controlled phase 3 trials of patients with moderate to severe CKD-aP undergoing HD, intravenous (IV) DFK had an acceptable safety profile and demonstrated significant reductions vs placebo in itch intensity. We report safety and effectiveness outcomes, including itch-related QoL and sleep measures, from a phase 3 open-label study of DFK in patients with moderate to severe CKD-aP. Method This multicenter, open-label study conducted in the United States and Europe enrolled patients with moderate to severe CKD-aP (mean baseline 24-hour Worst Itching Intensity Numerical Rating Scale [WI-NRS] score ≥5) undergoing HD for ≥3 months. Patients received IV DFK 0.5 mcg/kg 3 times/week at the end of each HD session for up to 12 weeks. Predefined effectiveness endpoints at week 12 included ≥3-point and ≥4-point improvement in the weekly mean of the 24-hour WI-NRS score (range from 0 [no itching] to 10 [worst itching imaginable]). Change from baseline in QoL at week 12 was assessed using the 5-D itch and Skindex-10, multidimensional itch-related questionnaires validated in CKD-aP (higher scores indicate worse QoL). The proportion of patients with no problems (score of 1) on the skin irritation and self-confidence domains of the EQ-PSO questionnaire was evaluated. Post hoc endpoints included complete resolution in WI-NRS (≥75% of week 12 scores 0 or 1) and Sleep Quality Questionnaire total score assessments (range of possible scores, 0 [did not interfere] to 10 [completely interfered]), including ≥3-point and ≥4-point improvement in weekly mean score and complete resolution (all scores of 0) at week 12. Safety assessments and adverse events (AEs) were evaluated. Data were summarized descriptively. Results Among 222 patients who received DFK, 197 (88.7%) completed the study. At baseline, mean ±SD age was 58.1 ±12.8 years and 54.5% of patients were male. Baseline mean ±SD WI-NRS score was 7.6 ±1.3, Sleep Quality score was 6.6 ±2.2, 5-D itch score was 17.1 ±3.5, and Skindex-10 score was 32.9 ±14.3. At week 12, the majority of patients achieved ≥3-point and ≥4-point improvement in WI-NRS (73.7% and 59.3%) and Sleep Quality score (66.0% and 56.7%). Complete resolution of WI-NRS and Sleep Quality score was observed in 29.4% and 19.1% of patients, respectively (Figure). DFK was associated with improvements in mean 5-D itch (−7.1 ±4.3) and Skindex-10 (−21.0 ±15.6) scores at week 12. The proportion of patients reporting no problems in the skin irritation EQ-PSO domain increased from 1.4% at baseline to 28.9% at week 12, and self-confidence EQ-PSO domain scores increased from 63.5% at baseline to 73.2% at week 12. Overall, 64.4% (143/222) of patients reported ≥1 treatment-emergent AE (TEAE). The most commonly reported TEAEs (≥4% of patients) were diarrhea (5.0% [11/222]), nausea (4.5% [10/222]), and hyperkalemia (4.1% [9/222]). Serious TEAEs were reported by 20.3% (45/222) of patients; no serious TEAEs were related to study drug. Conclusion In this phase 3 open-label study in patients with moderate to severe CKD-aP undergoing HD, DFK was generally well tolerated with an acceptable safety profile. DFK demonstrated effectiveness based on reduction of itch intensity, and improvements in sleep quality and itch-related QoL at week 12. The majority of patients reported ≥3-point or ≥4-point improvement in WI-NRS and Sleep Quality scores, with some reporting complete resolution. Findings from this open-label study provide insight into the potential real-world effectiveness of DFK in moderate to severe CKD-aP.

AB0510 INFLIXIMAB IS AN EFFECTIVE GLUCOCORTICOID-SPARING TREATMENT FOR TAKAYASU ARTERITIS: RESULTS OF A MULTICENTER OPEN-LABEL PROSPECTIVE STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1552.1-1553
Author(s):  
P. Mertz ◽  
J. F. Kleinmann ◽  
M. Lambert ◽  
X. Puéchal ◽  
T. Martin ◽  
...  
Keyword(s):  
Cohort Study ◽  
Takayasu Arteritis ◽  
Conventional Therapy ◽  
Clinical Laboratory ◽  
Immunosuppressive Treatment ◽  
Median Dose ◽  
Open Label ◽  
National Drug ◽  
Sparing Effect

Background:Approximately half of patients with Takayasu Arteritis (TA) have glucocorticoid (GC)-dependency and require the addition of a second-line immunosuppressive treatment.Objectives:Here, we conducted a multicenter open-label prospective cohort study to assess the efficacy and safety of infliximab originator as a GC-sparing agent in TA.Methods:A temporary recommendation for use for infliximab in refractory TA was approved by the French National Drug Authorities (April 2014). Infliximab was administered to patients in case of disease activity with a NIH score ≥2 despite conventional therapy. Data regarding patient’s clinical, laboratory, imaging and treatments were obtained at baseline, and at each following visit until last visit (October 2017). TA activity was evaluated according to NIH criteria and GC requirement throughout the study.Results:Twenty-three patients were enrolled, including 19 female. The median age at inclusion was 33 years (Interquartile range, IQR: 23-44 years). At baseline, 17 (74%) patients were treated with GCs, at a median dose of 10 mg/day (IQR: 0-21) of prednisone-equivalent. After a median follow-up of 36.9 months (IQR: 10-58.7), improvement of ≥1 NIH criterion of TA activity was achieved for 14/22 (64%) patients. The median GC dose was 8 mg/day (IQR: 7-10) at 6 months; 5 mg/day (IQR: 0-8) at 12 months and 0 mg/day (IQR: 0-5) at 36 months of follow-up. Overall, infliximab originator had a significant GC-sparing effect between baseline and last follow-up (p=0.009).Conclusion:This multicenter open-label cohort study suggests that infliximab originator is an effective GC-sparing treatment for TA refractory to conventional therapy.Disclosure of Interests:None declared

scholarly journals 0515 Durability of Effects of Forehead Cooling on EEG Sleep Measures in Insomnia Patients from 2- to 30-Nights Use and 6-Month Safety Results

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A197-A197
Author(s):  
D Rippole ◽  
J Schirm ◽  
E Nofzinger
Keyword(s):  
Sleep Quality ◽  
Open Label ◽  
Safety Study ◽  
Subjective Sleep Quality ◽  
Sleep Study ◽  
Subjective Sleep ◽  
Sleep Studies ◽  
Open Label Trial ◽  
Study Participants ◽  
Over Time

Abstract Introduction Forehead cooling has previously been shown to improve EEG sleep measures in insomnia patients when applied for 2 nights. The current study assessed the durability of these effects after 30 days in home use as well as safety over 6 months in home use. Methods This was a prospective, open label trial involving 32 adults meeting diagnostic criteria for primary insomnia who previously had participated in a 2 night in lab EEG sleep study. In the current study, participants received an additional 30 nights in home treatment, then had repeat EEG sleep studies performed to determine if effects noted at 2 nights remained durable after 30 days. Subjects also participated in an open label 6-month in-home use safety study. Results Baseline, 2-night and 30-night EEG sleep measures for sleep latency were 80.7 ± 73.8, 25.3 ± 22.6, 26.2 ±25.8 minutes (2- to 30-night difference p=0.81, NS) and for sleep efficiency were 67.4 ± 15.7, 81.4 ± 11.2, 83.2 ± 13.6 (2- to 30-night difference p=0.18, NS). Subjective sleep quality (0-100 scale with 100=best) at baseline, 2-night and 30-nights were 29.8 ± 15.2, 48.3 ± 20.2, 57.2 ± 21.1 (linear improvements significant over time p&lt;0.001). No adverse effects were seen across 6-months use. Conclusion Forehead cooling demonstrated durability of effects on EEG sleep measures from 2- to 30-nights use. Continuing improvements in subjective sleep quality when measured over time from baseline assessments to the end of the 30-night in-home use period were noted. Forehead cooling was safe over 6 months use in the home as evidenced by no serious device related adverse events. Support Ebb Therapeutics, Pittsburgh, PA 15222

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