Efficacy and Safety of Blood Stasis Based Herbal Medicine for Patients with Traffic Accident : A Prospective Observational Study

Background: Blood stasis (BS) is commonly used for pattern identification in traumatic injuries, including traffic accidents (TAs). Various studies have identified the efficacy of Korean medicine treatments for TA patients, but studies focusing on the BS-based herbal medicine (BSHM), including Tongdo-san (TDS), are rare.<br/>Methods: This was a single-center, prospective observational study, conducted from August 24th, 2018 to December 27th, 2018, which included 40 TA patients. Participants underwent routine Korean medicine treatments including acupuncture, electronic moxibustion, cupping, physical therapy, and herbal medicine. In the herbal medicine treatment, participants took BSHM with more than 3 days including taking TDS. The primary outcome measures were the scores from a 100 mm visual analogue scale (VAS) and numerical rating scale (NRS). Secondary outcome measures included scores from EuroQol-5 dimension (EQ-5D) and EQVAS questionnaires, the BS and cold/heat indices, and safety assessments.<br/>Results: There were significant improvements in the VAS, NRS, EQ-5D, EQ-VAS scores, and BS index after treatment. In the sub-analysis, VAS, NRS, EQ-5D, and EQ-VAS scores were higher in groups with a higher BS index. The moderate and severe BS index groups showed more improvement than the minor BS index group, and there was a significant difference in the EQ-5D scores. There was no significant differences observed in cold/heat index groups scores.<br/>Conclusion: BS is associated with TA-related symptoms. BSHM, including TDS, may significantly reduce BS, pain, and discomfort.

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Reduced physical activity and weight gain are associated with an increase of depressive symptoms during the COVID-19 pandemic. A general practitioners’ prospective observational study

JRSM Cardiovascular Disease ◽

10.1177/20480040211047742 ◽

2021 ◽

Vol 10 ◽

pp. 204800402110477

Author(s):

Simon Wernhart ◽

Eberhard Weihe ◽

Tienush Rassaf

Keyword(s):

Physical Activity ◽

Depressive Symptoms ◽

Weight Gain ◽

Observational Study ◽

General Practitioners ◽

Outcome Measures ◽

Prospective Observational Study ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Reduced Physical Activity

Objectives We aimed to assess associations between depressive symptoms, lifestyle, and somatic symptoms during the COVID-19 pandemic. Design A prospective, observational study using a self-designed questionnaire. Setting Three general practitioners’ (GP) offices in rural Germany. Participants 271 adult patients without manifest cardiovascular or pulmonary disease with (n = 82) and without (n = 189) hypertension reporting to our GP offices. Main outcome measures The reported increase of depressive symptoms (loneliness, sleeplessness, joylessness, listlessness) prior to the first documented case in Germany on 27.01.2020 (t0) as opposed to patients’ health perception during the Corona pandemic (t1) was the primary outcome measure. The secondary outcome measures were changes in physical activity (PA), dyspnea and angina in the two groups. Results Out of 271 patients (50.8 ± 16.8 years, 55.1% females), 1.5% were tested positive for COVID-19. Overall, listlessness (8.5%, p = 0.001), sleeplessness (5.2%, p = 0.001) and joylessness (4.2%, p = 0.003) were increased. Dyspnea significantly increased (9.2%, p < 0.001) and employment status worsened (6.5%, p < 0.001). There were significant associations between the increase of depressive symptoms, weight increase (p = 0.017), and reduction in physical activity (p = 0.046). However, after adjusting for age, hypertensive patients did not show more depressive symptoms (p = 0.704), dyspnea (p = 0.063) or angina (p = 0.432), nor was there any difference in PA (p = 0.906) compared to healthy individuals. Conclusions We demonstrate an association between the deterioration of depressive symptoms, weight gain, and reduced physical activity during COVID-19, both in hypertensives and healthy controls. Hypertension is no driver of symptom deterioration during the pandemic. The trial was registered in the German Clinical Trials Registry (DRKS00022157).

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Donepezil for mild cognitive impairment in Parkinson’s disease

Scientific Reports ◽

10.1038/s41598-021-84243-4 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Kyoungwon Baik ◽

Seon Myeong Kim ◽

Jin Ho Jung ◽

Yang Hyun Lee ◽

Seok Jong Chung ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Cognitive Impairment ◽

Mild Cognitive Impairment ◽

Treatment Group ◽

Outcome Measures ◽

Rating Scale ◽

Secondary Outcome ◽

Control Group ◽

Significant Difference

AbstractWe investigated the efficacy of donepezil for mild cognitive impairment in Parkinson’s disease (PD-MCI). This was a prospective, non-randomized, open-label, two-arm study. Eighty PD-MCI patients were assigned to either a treatment or control group. The treatment group received donepezil for 48 weeks. The primary outcome measures were the Korean version of Mini-Mental State Exam and Montreal Cognitive Assessment scores. Secondary outcome measures were the Clinical Dementia Rating, Unified Parkinson’s Disease Rating Scale part III, Clinical Global Impression scores. Progression of dementia was assessed at 48-week. Comprehensive neuropsychological tests and electroencephalography (EEG) were performed at baseline and after 48 weeks. The spectral power ratio of the theta to beta2 band (TB2R) in the electroencephalogram was analyzed. There was no significant difference in the primary and secondary outcome measures between the two groups. However, the treatment group showed a significant decrease in TB2R at bilateral frontotemporoparietal channels compared to the control group. Although we could not demonstrate improvements in the cognitive functions, donepezil treatment had a modulatory effect on the EEG in PD-MCI patients. EEG might be a sensitive biomarker for detecting changes in PD-MCI after donepezil treatment.

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Patient Related Outcome Measures (PROMs) in Morton’s Neuroma: Conservative vs. Surgical Management at One-Year Follow-Up

Foot & Ankle Orthopaedics ◽

10.1177/2473011419s00021 ◽

2019 ◽

Vol 4 (4) ◽

pp. 2473011419S0002

Author(s):

Alastair Faulkner ◽

Alistair Mayne ◽

Fraser Harrold

Keyword(s):

Outcome Measures ◽

Surgical Management ◽

Conservative Management ◽

Morton’S Neuroma ◽

Significant Difference ◽

Morton's Neuroma ◽

One Year ◽

Patient Related Outcome ◽

Eq Vas

Category: Midfoot/Forefoot Introduction/Purpose: Morton’s neuroma is a common condition affecting the foot and is associated with chronic pain and disability. Conservative management including a combination of orthotic input; injection or physiotherapy, and surgical excision are current treatment options. There is a paucity of literature regarding patient related outcome measures (PROMs) data in patients managed conservatively. We sought to compare conservative with surgical management of Morton’s neuroma using PROMs data in patients with follow-up to one year. Methods: Prospective data collection commenced from April 2016. Patients included had to have a confirmed Morton’s neuroma on ultrasound scan. Patient demographics including age, sex and BMI were collected. The primary outcome measures were the Manchester Foot Score for pain (MOX-FQ), EQ time trade off (TTO) and EQ visual analogue scale (VAS) taken pre-operatively; at 26-weeks and at 52-weeks post-operatively. Results: 194 patients were included overall: 79 patients were conservatively managed and 115 surgically managed. 19 patients were converted from conservative to surgical management. MOX-FQ pain scores: pre-op conservative 52.15, surgical 61.56 (p=0.009), 6-months conservative 25.1, surgical 25.39 (p=0.810), 12 months conservative 18.54, surgical 20.52 (p=0.482) EQ-TTO scores: pre-op conservative 0.47, surgical 0.51 (p=0.814), 6-months conservative 0.41, surgical 0.49 (p=0.261), 12 months conservative 0.26, surgical 0.37 (p=0.047) EQ-VAS scores: pre-op conservative 63.84, surgical 71.03 (p=0.172), 6-months conservative 46.10, surgical 52.51 (p=0.337), 12 months conservative 30.77, surgical 37.58 (p=0.227) Satisfaction at 12 months: conservative 17 (21.5%), surgical 32 (27.8%) p=0.327 Conclusion: This is one of the first studies investigating long-term PROMs specifically in conservative management for Morton’s neuroma patients. There was no significant difference in pain score and EQ-VAS between all conservative treatments and surgical management at 12 months There was no significant difference in satisfaction at 12 months between conservative and surgical groups.

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Transoral Dermoid Cyst Excision: A Multicenter Prospective Observational Study

Otolaryngology ◽

10.1177/0194599818791772 ◽

2018 ◽

Vol 159 (6) ◽

pp. 981-986 ◽

Cited By ~ 5

Author(s):

Jin Pyeong Kim ◽

Dong Kun Lee ◽

Jeong Hwan Moon ◽

Jung Je Park ◽

Seung Hoon Woo

Keyword(s):

Observational Study ◽

Oral Cavity ◽

Dermoid Cyst ◽

Prospective Observational Study ◽

University Hospital ◽

Secondary Outcome ◽

Transoral Surgery ◽

Cyst Excision ◽

Surgery Group ◽

Multicenter Prospective Observational Study

Objective Transoral surgery is becoming a preferred technique because it does not leave any scar after surgery. However, transoral surgery for a dermoid cyst of the oral cavity is not standardized yet, due to the anatomic complexity of this region. The aim of this study was to evaluate the safety and efficacy of a transoral dermoid cyst excision. Study Design Multicenter prospective observational study. Setting University hospital. Subjects and Methods This study was designed as a 4-year prospective multicenter evaluation of dermoid cyst excisions within the floor of mouth. Clinical outcomes and complications related to procedures were evaluated among patients. The primary outcome was the efficacy of the procedure, and the secondary outcome was cosmetic satisfaction of each procedure. Results Twenty-one patients underwent transoral dermoid cyst excisions, and 22 underwent transcervical excisions. In the transoral surgery group, the mean size of the dermoid cyst was 5.35 cm (95% CI, 4.79-5.91), and in the transcervical surgery group, it was 6.19 cm (95% CI, 5.67-6.71). There was no significant differences with respect to overall demographic characteristics between the groups. However, the duration of the operation was shorter with the transoral group than with the transcervical group ( P = .001), and cosmetic satisfaction was much better in the transoral group ( P < .001). Conclusion Transoral dermoid cyst excision is a potentially safe and effective method that can lead to easy and quick removal of an oral cavity dermoid cyst, with excellent cosmetic outcomes.

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Safety and efficacy of herbal medicine for acute intracerebral hemorrhage (CRRICH): a multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-024932 ◽

2019 ◽

Vol 9 (5) ◽

pp. e024932 ◽

Cited By ~ 4

Author(s):

Liling Zeng ◽

Guanghai Tang ◽

Jing Wang ◽

Jianbin Zhong ◽

Zhangyong Xia ◽

...

Keyword(s):

Placebo Group ◽

Herbal Medicine ◽

Adverse Events ◽

Intracerebral Haemorrhage ◽

Poor Prognosis ◽

Controlled Trial ◽

Blood Stasis ◽

Secondary Outcome ◽

Controlled Study ◽

Safety And Efficacy

ObjectiveTo evaluate the safety and efficacy of removing blood stasis (RBS) herbal medicine for the treatment of acute intracerebral haemorrhage (AICH) within a 6-hour time window.Study designA randomised, multicentre, double-blind, placebo-controlled study performed in 14 hospitals in China.Participants and interventionsPatients with AICH were randomly assigned to receive a placebo, the ICH-1 (Intracerebral Haemorrhage) formula (eight herbs, including the RBS herbs hirudo and tabanus) or the ICH-2 formula (six herbs without the RBS herbs hirudo and tabanus) within 6 hours of ICH onset.OutcomesThe primary safety outcome was the incidence of haematoma enlargement at 24 hours and at 10 days after treatment. The secondary outcome was the incidence of poor prognosis (mortality or modified Rankin Scale score ≥5) assessed at 90 days after symptom onset.ResultsA total of 324 subjects were randomised between October 2013 and May 2016: 105 patients received placebo; 108 patients received the ICH-1 formula; and 111 patients received the ICH-2 formula. The incidence of haematoma enlargement at 24 hours was 7.8% in the placebo group, 12.3% in the ICH-1 group and 7.5% in the ICH-2 group; the incidence of haematoma enlargement on day 10 was 1.1% in the placebo group, 1.1% in the ICH-1 group, and 3.1% in the ICH-2 group, with no significant differences among the groups (P>0.05). The mortality rates were 3.8% in the placebo group, 2.8% in the ICH-1 group, and 0.9% in the ICH-2 group; the incidences of poor prognosis were 7.1% in the placebo group, 6.0% in the ICH-1 group and 4.8% in the ICH-2 group at 3 months, with no significant differences among the groups (p>0.05). However, the overall frequency of treatment-emergent adverse events in the ICH-1 group (12.1%) was higher among the three groups (5.8% and 2.8%, respectively, p<0.05). All three cases of serious adverse events were in the ICH-1 group.ConclusionsUltra-early administration of ICH-1 formula for AICH patients did not exert significant beneficial effects on clinical outcomes but increased the risk of bleeding, which probably resulted from the inclusion of RBS herbal medicines in ICH-1.Trialregistration numberNCT01918722.

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Changes in perioperative hemoglobin and hematocrit in patients undergoing total knee arthroplasty: a prospective observational study of optimal timing of measurement

Journal of International Medical Research ◽

10.1177/0300060520969303 ◽

2020 ◽

Vol 48 (11) ◽

pp. 030006052096930

Author(s):

Chenrong Ke ◽

Naifeng Tian ◽

Xiumeng Zhang ◽

Mochuan Chen

Keyword(s):

Total Knee Arthroplasty ◽

Observational Study ◽

Knee Arthroplasty ◽

Prospective Observational Study ◽

Optimal Timing ◽

Preoperative Period ◽

Hidden Blood Loss ◽

Significant Difference ◽

Total Knee ◽

Hb Concentration

Objective This study was performed to depict the patterns of change in the perioperative hemoglobin (Hb) concentration and hematocrit (Hct) and to identify the optimal timing of Hb and Hct measurement in patients undergoing total knee arthroplasty (TKA). Methods This prospective observational study involved 302 consecutive patients who underwent TKA. The patients were kept in hospital for 1 full week postoperatively. Hb and Hct measurements were performed preoperatively and on days 1 to 7 postoperatively and then during clinic visits at 1, 3, and 6 months postoperatively. Results The Hb concentration and Hct decreased during the first few days postoperatively and reached a nadir on postoperative day 4 and 3, respectively; they then recovered in the following days. Significant differences in the Hb concentration and Hct were detected between the preoperative period and day 1, between days 1 and 2, between days 2 and 3, between day 7 and 1 month, and between 1 and 3 months. A significant difference in the Hct was also detected between 3 and 6 months. Conclusion The optimal timing of Hb and Hct measurement is on postoperative day 3 or 4. This timing accurately reflects ongoing hidden blood loss to better guide blood transfusions.

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Investigation of the demand for a 7-day (extended access) primary care service: an observational study from pilot schemes in England

BMJ Open ◽

10.1136/bmjopen-2018-028138 ◽

2019 ◽

Vol 9 (9) ◽

pp. e028138

Author(s):

William Whittaker ◽

Laura Anselmi ◽

Pauline Nelson ◽

Caroline O'Donnell ◽

Natalie Ross ◽

...

Keyword(s):

Primary Care ◽

Observational Study ◽

Outcome Measures ◽

Care Service ◽

Primary Care Service ◽

Secondary Outcome ◽

Family Practitioner ◽

Spare Capacity ◽

Patient Demographics ◽

Extended Access

ObjectivesTo understand how the uptake of an extended primary care service in the evenings and weekend varied by day of week and over time. Secondary objectives were to understand patient demographics of users of the service and how these varied by type of appointment and to core hour users.DesignObservational study.SettingPrimary care extended access appointments data in 13 centres in Greater Manchester, England, during 2016.ParticipantsAppointments could be booked by 1 261 326 patients registered with a family practitioner in five Clinical Commissioning Group geographic areas.Main outcome measuresPrimary outcome measure was whether an appointment was used (booked and attended), secondary outcome measures included whether used appointments were prebooked or booked the same day, and delivered by a family or nurse practitioner. Additional analyses compared patient demographics with patients reporting the use of core hour primary care services.Results65.33% of 42 472 appointments were booked and attended (used). Usage of appointments was lowest on a Sunday at 46.73% (18.07 percentage points lower usage than on Mondays (95% CI −32.46 to −3.68)). Prebooked appointments were less likely to be booked among age group 0–9 and to result in patients not attending an appointment. Family practitioner appointments were increasingly less likely to be booked with age in comparison to nurse appointments. Patients attending extended access appointments tended to be younger in comparison to core hour patients.ConclusionsThere is spare capacity in the extended access service, particularly on Sundays, suggesting reconfigurations of the service may be needed to improve efficiency of delivering the service. Patient demographics suggest the service is used by a relatively younger population than core hour services. Patient demographics varied with the types of appointment provided, these findings may help healthcare providers improve usage by tailoring appointment provision to local populations.

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Prospective Observational Study of an Eye-tracking Device for Under 12 Months of Age Infants; the Feasibility of Gazefinder

10.21203/rs.3.rs-149203/v1 ◽

2021 ◽

Author(s):

Tomoo Takahashi ◽

Kazuki Tsukamoto ◽

Misaki Matsumura ◽

Ryo Takigawa ◽

Yasuo Sakai ◽

...

Keyword(s):

Observational Study ◽

Eye Tracking ◽

Prospective Observational Study ◽

Assessment Tool ◽

Positive Association ◽

Autism Spectrum ◽

Fixation Time ◽

Developmental Problems ◽

Significant Difference ◽

The Mean

Abstract Eye-tracking to evaluate gaze patterns has developed as an assessment tool for children with Autism Spectrum Disorder (ASD). Gazefinder is one of Eye-tracking devices and few studies have investigated whether it can measure the gaze data of infants under 12 months of age. We conducted a prospective observational study from April 2019 to March 2020 in a periodic health checkup in Ohchi County, Shimane, Japan. Participants included infants between 4 and 11 months of age who were not suspected the presence of developmental problems. Ninety-three participants’ datapoints were analyzed. The mean age was 6.5 months and mean developmental quotient was 88%. The mean fixation time percentage of all sequences was 81.0% (standard deviation; 4.4), and there was no significant difference in each age group. Infants in all groups showed a significantly higher predilection for eyes than for mouths. There was a positive association of age with human gaze and a negative association with geometric gaze. Moreover, we confirmed that joint attention skills were enhanced in accordance with their growth process. The eye-tracking data were almost corresponding to previous studies’ data of infant with typical development and Gazefinder could be applied to infants starting at 4 months of age.

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Fuchs heterochromic iridocyclitis-associated glaucoma: a retrospective comparison of primary Ahmed glaucoma valve implantation and trabeculectomy with mitomycin C

F1000Research ◽

10.12688/f1000research.15244.2 ◽

2018 ◽

Vol 7 ◽

pp. 876

Author(s):

Hamed Esfandiari ◽

Nils A. Loewen ◽

Kiana Hassanpour ◽

Ali Fatourechi ◽

Shahin Yazdani ◽

...

Keyword(s):

Success Rate ◽

Mitomycin C ◽

Outcome Measures ◽

Rare Complication ◽

Case Series ◽

Secondary Outcome ◽

Final Visit ◽

Cumulative Probability ◽

Ahmed Glaucoma Valve ◽

Significant Difference

Background: The aim of this study was to compare the safety and efficacy of primary trabeculectomy with mitomycin C and Ahmed glaucoma valve (AGV) implantation in patients with Fuchs heterochromic iridocyclitis (FHIC)-related glaucoma, a rare complication of an uncommon form of uveitis. Methods: In this retrospective comparative case series, 26 FHIC-associated glaucoma patients received trabeculectomy (n=12) or an AGV (n=14). Primary outcome measures were surgical success, defined as intraocular pressure (IOP) ≤21 mmHg, decreasing ≥20% from baseline, and no secondary glaucoma surgery. Secondary outcome measures were the number of glaucoma medications, complications, best corrected visual acuity (BCVA), and IOP. Results: The follow-up was 34.0±17.7 months in patients that received trabeculectomy and 33.4±18.6 months in AGV (P= 0.837). The cumulative probability of success rate was 41.7% for trabeculectomy and 85.7% for AGV, with no significant difference in complications (P>0.05). The IOP in patients that received trabeculectomy dropped from 23.4±3.3 mmHg to 21.6±5.2 mmHg at the final visit (P= 0.041). In patients that received AGV, the IOP decreased from 24±7.8 to 17.1±2.6 mmHg (P= 0.003). The number of glaucoma medications at baseline were 3.3±0.5 in those that received trabeculectomy and 3±0.6 in those that received AGV (P=0.233), and decreased to 2.4±1.0 (P=0.008) and 1.7±0.6 (P=0.002), respectively. BCVA was equal in both groups and did not change (P>0.05). Conclusion: Primary AGV had a higher success rate than trabeculectomy, with patients also needing fewer medications for the management of FHIC-associated glaucoma.

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Circumcision in children: postoperative analgesic efficiency of transversus abdominis plan block vs caudal epidural block: a prospective observational study

10.31083/jomh.2021.096 ◽

2021 ◽

pp. 1

Keyword(s):

Postoperative Pain ◽

Observational Study ◽

Postoperative Analgesia ◽

Prospective Observational Study ◽

Transversus Abdominis ◽

Tap Block ◽

Rescue Analgesia ◽

Pain Scores ◽

Significant Difference ◽

Caudal Epidural

Background and objective: Circumcision is one of the most common operations and can cause postoperative pain, fear, and anxiety for children. This study aims to compare the effects of transversus abdominis plane (TAP) block and caudal epidural (CE) anesthesia on postoperative analgesia after circumcision in providing postoperative pain control. Methods: Eighty boys aged 1 to 14 years who underwent elective circumcision surgery under general anesthesia either with USG-guided TAP block or with CE block for postoperative analgesia were enrolled consecutively to this prospective observational study equally in each group. Postoperative pain scores and need for rescue analgesia were recorded and compared between the two groups. Results: There was no statistically significant difference between the groups in mean age and Aldrete scores (p > 0.05). Body mass index (BMI) of the caudal block group was statistically lower than the TAP group (p < 0.05). While there was no statistically significant difference between the groups in 30th-minute VAS values (p > 0.05), the CE block group's 1st, 2nd, 4th, 8th, 12th, 18th, and 24th hour VAS values were statistically lower than the TAP block group's (p < 0.05). Conclusion: USG-guided TAB block under general anesthesia was not associated with lower postoperative pain scores and delayed rescue analgesia need compared with CE block in patients who underwent elective circumcision surgery. CE block provided superior analgesia than the USG-guided TAP block after elective circumcision surgery in this study.

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