Efficacy and Safety of Jiawei Suanzaoren Decoction Combined with Lorazepam for Chronic Insomnia: A Parallel-Group Randomized Controlled Trial

Background. Chronic insomnia is a major public health problem, but there are limited effective therapies. Jiawei Suanzaoren Decoction (JW-SZRD) has been used as an alternative option for treating insomnia. This study aimed to investigate the long-term efficacy and safety of JW-SZRD in combination with lorazepam for chronic insomnia. Methods. A total of 207 participants were analyzed in this study. The treatment group (TG) received JW-SZRD and lorazepam orally, and the control group (CG) received lorazepam alone. The Insomnia Severity Index (ISI), the Self-Rating Depression Scale (SDS), the Self-Rating Anxiety Scale (SAS), and the Somatic Self-rating Scale (SSS) were evaluated at baseline, weeks 4, 8, and 12. The MOS 36-item Short Form Health Survey (SF-36) was assessed at baseline and week 12. Adverse effects (AEs) were evaluated by the Treatment Emergent Symptom Scale (TESS). Results. Both TG and CG showed obvious improvements in the sleep onset latency (SOL) (P=0.001 and 0.005) and total sleep time (TST) (P=0.0001 and 0.001). However, TG was more effective than CG at weeks 8 (P=0.02 for SOL, P=0.008 for TST) and 12 (P=0.03 for SOL, P=0.04 for TST), especially in shortening SOL (Cohen’s d = 1.28). The ISI reduction rate in TG was higher than that in CG at weeks 4, 8, and 12 (P=0.008, 0.001 and 0.001). After treatment, TG had lower SAS scores (P=0.0001, 0.007), less somatic symptoms (P<0.05 or 0.01), higher SF-36 scores (P<0.05 or 0.01), better compliance (P=0.0001), and less adverse effects (P<0.05 or 0.01) than those in CG. Conclusion. The combination of JW-SZRD with lorazepam can significantly improve sleep quality with fewer AEs. It is an effective treatment and superior to lorazepam alone for chronic insomnia.

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The Effect of Electroacupuncture Treatment with Different Intensities for Functional Diarrhea: A Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2022/2564979 ◽

2022 ◽

Vol 2022 ◽

pp. 1-8

Author(s):

Xiaohu Xu ◽

Mingmin Zhang ◽

Xiao Wu ◽

Cuihong Zheng ◽

Guangying Huang

Keyword(s):

Short Form ◽

Current Intensity ◽

Control Group ◽

Gastrointestinal Function ◽

Efficacy And Safety ◽

Self Rating ◽

Functional Diarrhea ◽

Sf 36 ◽

Normal Defecation ◽

The Mean

Background. Electroacupuncture (EA) may have a role in the treatment of diarrhea symptoms. However, the efficacy and safety of EA with different current intensities in improving gastrointestinal function, psychology, and quality of life (QOL) of functional diarrhea (FD) remain unknown. Objective. To investigate the efficacy and safety of EA with different current intensities in improving gastrointestinal function, psychology, and QOL for FD patients. Methods. 73 FD patients were randomly divided into three groups: low current intensity group (LI) of EA, high current intensity group (HI) of EA, and loperamide control group (LC). Four weeks of treatment were provided in the three groups. The primary outcome was the proportion of normal defecation. Additional outcomes included the change from baseline for the weekly spontaneous bowel movements (SBMs) and the change from baseline for the mean Bristol Stool Form Scale (BSFS). QOL was assessed by the 36-item short-form health survey (SF-36). Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) were used to assess the psychology state. Results. Low current intensity of EA significantly improved the proportion of normal defecation during treatment and follow-up period ( P < 0.01 ). EA significantly improves the mean BSFS scores and weekly SBMs, and this efficacy is equivalent to loperamide ( P < 0.05 ). The SF-36 scores of general health in LI and HI groups and vitality and mental health in LI group were significantly increased compared to baseline ( P < 0.05 ). Low current intensity of EA can significantly improve SAS and SDS scores ( P < 0.05 ). Conclusions. EA significantly improved stool consistency and weekly SBMs in FD patients. Compared with loperamide, low current intensity of EA may have a better sustainable effect in restoring normal defecation in patients with FD, and it can also effectively improve QOL, anxiety, and depression. However, larger sample sizes are needed to determine safety and efficacy. Trial registration number: NCT01274793.

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Efficacy of Guizhi Fuling Wan for primary dysmenorrhea: protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05834-0 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Yun Du ◽

Yatong Li ◽

Xianyun Fu ◽

Chenjie Li ◽

Lou Yanan

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Blood Stasis ◽

The Self ◽

Blood Stasis Syndrome ◽

Control Group ◽

Primary Dysmenorrhea ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Self Rating

Abstract Background Primary dysmenorrhea (PD) is one of the main gynecological complaints in women of child-bearing age, but limited effective treatments are available. Guizhi Fuling Wan (GFW), one of the most widely known traditional Chinese medicine (TCM) formulations, has been commonly used in clinical practice to treat gynecological disorders in China. In recent years, a growing number of studies have shown that GFW is beneficial for patients with PD. However, the quality of evidence is limited, and there are few studies on specific TCM syndromes of GFW for PD. Therefore, we plan to conduct a randomized controlled trial to explore the efficacy and safety of GFW for PD patients with heat-burning blood-stasis syndrome. Methods and analysis The clinical study is a randomized, double-blinded, placebo-controlled trial. Eligible patients will be randomly assigned to the GFW group (treated with GFW) and the control group (treated with a matching placebo) in a 1:1 ratio for three menstrual cycles with a 3-month follow-up. The primary outcome will be the mean change of pain intensity measured by the visual analog scale (VAS). The secondary outcomes will include the Cox Menstrual Symptom Scale (CMSS), the Self-rating Depression Scale (SDS), the Self-rating Anxiety Scale (SAS), and the TCM syndrome scale. Adverse events will also be reported. Discussion This randomized trial will be the first rigorous study designed to assess the efficacy and safety of GFW in treating PD with heat-burning blood-stasis syndrome. The finding of this study will provide an objective clinical basis for the use of GFW for PD in the future. Trial registration Chinese Clinical Trial Registry ChiCTR2000034118. Registered on 24 June 2020

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Five-Animal Frolics Exercise Improves Anxiety and Depression Outcomes in Patients with Coronary Heart Disease: A Single-Blind Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/6937158 ◽

2020 ◽

Vol 2020 ◽

pp. 1-9

Author(s):

Jun Jiang ◽

Qingbao Chi ◽

Yuting Wang ◽

Xue Jin ◽

Shui Yu

Keyword(s):

Coronary Heart Disease ◽

Heart Disease ◽

Short Form ◽

Depression Scale ◽

Serum Levels ◽

Anxiety Scale ◽

Anxiety And Depression ◽

Control Group ◽

Self Rating ◽

Sf 36

Introduction. The patients with coronary heart disease (CHD) always have emotional implications. As the branch of traditional Chinese medicine, Five-Animal Frolics Exercise (FAE) is a popular mind-body exercise in China and shown to improve emotional wellbeing. Aim. We aimed to explore the effects of FAE on the emotional disorders of CHD patients. Methods. CHD patients were assigned into an experiment group (EG, FAE) and a control group (CG, routine nursing care). We measured serum levels of miR-124 and miR-135 and scores of the Hamilton Depression/Anxiety scale (HAMD/HAMA), Self-Rating Anxiety Scale (SAS), the Self-Rating Depression Scale (SDS), Short Form 36 Health Survey Questionnaire (SF-36), and Pittsburgh Sleep Quality Index (PSQI). Results. After a 3-month FAE intervention, serum levels of miR-124 and miR-135 and the scores of HAMD/HAMA, SAS, SDS, and PSQI in the EG group were lower than those in the CG group, while SF-36 scores in the EG group were higher than those in the CG group (p<0.05). Serum levels of miR-124 and miR-135 had a strong relationship with SAS and SDS scores (p<0.05). Discussion/Implications for Practice. The study suggests that FAE intervention controls anxiety and depression outcomes and improves life quality in CHD patients by affecting serum levels of miR-124 and miR-135.

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Efficacy of Guizhi Fuling Wan for Primary dysmenorrhea: protocol for a randomised controlled trial

10.21203/rs.3.rs-462906/v1 ◽

2021 ◽

Author(s):

Du Yun ◽

Yatong Li ◽

Xianyun Fu ◽

Yanan Luo ◽

Chenjie Li

Keyword(s):

Clinical Trial ◽

Short Form ◽

Controlled Trial ◽

Blood Stasis ◽

The Self ◽

Blood Stasis Syndrome ◽

Control Group ◽

Self Rating ◽

Double Blinded

Abstract BackgroundPrimary dysmenorrhea (PD) is one of main gynecological complaints in women of child-bearing age, but there are limited effective treatments available. Guizhi Fuling Wan (GFW), one of the most widely known traditional Chinese medicine (TCM) herbal formulas, has been the treatment of choice for gynecological disease in China. A growing number of studies have shown that GFW is beneficial for patients with PD. However, the quality of evidence is limited, and there are few studies on the treatment of PD by GFW with specific TCM syndromes. Therefor we will conduct a randomized controlled trial to explore the efficacy and safety of GFW for PD patients with heat-burning blood-stasis syndrome.Methods and analysisThis study is designed as a randomized, double-blinded, placebo-controlled clinical trial. Eligible patients will be randomly assigned to the GFW group (patients receive GFW) and the control group (patients receive a matching placebo) in a 1:1 ratio. The participants will receive either GFW or placebo, twice daily for 3 menstrual cycles with a 3-month follow-up. The primary outcome is the pain intensity reduction measured by a Visual Analog Scale. The secondary outcomes is the Cox Menstrual Symptom Scale, the Self-rating Depression Scale, the Self-rating Anxiety Scale, the 12-item Short-Form Health Survey and the dysmenorrhea diarymenstrual pain.. All outcomes are assessed at baseline, and the 4th, 8th, and 12th week during the interventions, as well as at the 16th, 20th and 24th week follow-up. Any adverse events will be recorded throughout the study.DiscussionThis is the first double-blinded RCT to assess the effectiveness and safety of GFW in treating PD with the heat-burning blood-stasis syndrome. The scientific and rigorous methodology design of this trial will provide significant evidence regarding the use of GFW to treat PD in future.Trial registrationChinese Clinical Trial Registry, ID: ChiCTR2000034118. Regisrered on 25 June 2020.

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Prospective Randomized Evaluation of Local Injection of Allogeneic Growth Factors in Plantar Fasciitis

Foot & Ankle International ◽

10.1177/1071100720939066 ◽

2020 ◽

Vol 41 (11) ◽

pp. 1335-1341 ◽

Cited By ~ 1

Author(s):

Mahmoud Ibrahim Kandil ◽

Eslam Abdelshafi Tabl ◽

Adel Samy Elhammady

Keyword(s):

Growth Factors ◽

Treatment Group ◽

Adverse Effects ◽

Plantar Fasciitis ◽

Short Form ◽

Case Series ◽

Control Group ◽

Efficacy And Safety ◽

Significant Difference ◽

Level I

Background: The aim of this study was to evaluate the efficacy and safety of injection of allogeneic growth factors in patients with plantar fasciitis. Methods: This study included 150 patients who were randomly divided into 2 equal groups; the patients were locally injected with allogeneic growth factors (GFs) (treatment group) or with saline 0.9% (control group). The patients were assessed using visual analog scale (VAS) and Foot Function Index–Revised short form (FFI-Rs) scores preinjection and 1, 3, 6, and 12 months postinjection. The patients were questioned about their satisfaction. Any adverse effects were recorded. Results: At baseline, there was no significant difference between both groups regarding the mean VAS and FFI-Rs scores. At 3-month follow-up, the reduction in mean VAS score was 87% in the treatment group and 55% in the control group ( P < .001), and the reduction in mean FFI-Rs score was 62% in the treatment group and 40% in the control group ( P < .001). Treatment group and study visit were significant factors affecting both VAS and FFI-Rs scores. Overall, 92% were satisfied in the treatment group, and 78.2% in the control group. Postinjection pain occurred in 5 patients in the treatment group. Conclusion: This study provides Level I evidence regarding the efficacy and safety of allogeneic GF injection in patients with plantar fasciitis. However, additional studies are needed to evaluate their adverse effects, immunogenicity, and microbiological safety. Level of Evidence: Level I, prospective randomized controlled case series.

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Auricular vagal nerve stimulation in peripheral arterial disease patients

VASA ◽

10.1024/0301-1526/a000660 ◽

2017 ◽

Vol 46 (6) ◽

pp. 462-470 ◽

Cited By ~ 3

Author(s):

Gerald Hackl ◽

Andreas Prenner ◽

Philipp Jud ◽

Franz Hafner ◽

Peter Rief ◽

...

Keyword(s):

Primary Endpoint ◽

Nerve Stimulation ◽

Short Form ◽

Therapeutic Option ◽

Arterial Disease ◽

Walking Distance ◽

Control Group ◽

Sf 36 ◽

Peripheral Arterial ◽

Double Blinded

Abstract. Background: Auricular nerve stimulation has been proven effective in different diseases. We investigated if a conservative therapeutic alternative for claudication in peripheral arterial occlusive disease (PAD) via electroacupuncture of the outer ear can be established. Patients and methods: In this prospective, double-blinded trial an ear acupuncture using an electroacupuncture device was carried out in 40 PAD patients in Fontaine stage IIb. Twenty patients were randomized to the verum group using a fully functional electroacupuncture device, the other 20 patients received a sham device (control group). Per patient, eight cycles (1 cycle = 1 week) of electroacupuncture were performed. The primary endpoint was defined as a significantly more frequent doubling of the absolute walking distance after eight cycles in the verum group compared to controls in a standardized treadmill testing. Secondary endpoints were a significant improvement of the total score of the Walking Impairment Questionnaire (WIQ) as well as improvements in health related quality of life using the Short Form 36 Health Survey (SF-36). Results: There were no differences in baseline characteristics between the two groups. The initial walking distance significantly increased in both groups (verum group [means]: 182 [95 % CI 128–236] meters to 345 [95 % CI 227–463] meters [+ 90 %], p < 0.01; control group [means]: 159 [95 % CI 109–210] meters to 268 [95 % CI 182–366] meters [+ 69 %], p = 0.01). Twelve patients (60 %) in the verum group and five patients (25 %) in controls reached the primary endpoint of doubling walking distance (p = 0.05). The total score of WIQ significantly improved in the verum group (+ 22 %, p = 0.01) but not in controls (+ 8 %, p = 0.56). SF-36 showed significantly improvements in six out of eight categories in the verum group and only in one of eight in controls. Conclusions: Electroacupuncture of the outer ear seems to be an easy-to-use therapeutic option in an age of increasingly invasive and mechanically complex treatments for PAD patients.

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Effects of Self RehAbilitation Video Exercises (SAVE) on Functional Restorations in Patients with Subacute Stroke

Healthcare ◽

10.3390/healthcare9050565 ◽

2021 ◽

Vol 9 (5) ◽

pp. 565

Author(s):

Seung-Hwan Jung ◽

Eunhee Park ◽

Ju-Hyun Kim ◽

Bi-Ang Park ◽

Ja-Won Yu ◽

...

Keyword(s):

Acute Stroke ◽

Short Form ◽

Intervention Group ◽

Exercise Program ◽

Berg Balance Scale ◽

Control Group ◽

Early Recovery ◽

Subacute Stroke ◽

Sf 36 ◽

State Examination

Background: Additional exercise therapy has been shown to positively affect acute stroke rehabilitation, which requires an effective method to deliver increased exercise. In this study, we designed a 4-week caregiver-supervised self-exercise program with videos, named “Self rehAbilitation Video Exercises (SAVE)”, to improve the functional outcomes and facilitate early recovery by increasing the continuity of rehabilitation therapy after acute stroke. Methods: This study is a non-randomized trial. Eighty-eight patients were included in an intervention group (SAVE group), who received conventional rehabilitation therapies and an additional self-rehabilitation session by watching bedside exercise videos and continued their own exercises in their rooms for 60 min every day for 4 weeks. Ninety-six patients were included in a control group, who received only conventional rehabilitation therapies. After 4 weeks of hospitalization, both groups assessed several outcome measurements, including the Berg Balance Scale (BBS), Modified Barthel Index (MBI), physical component summary (PCS) and the mental component summary of the Short-Form Survey 36 (SF-36), Mini-Mental State Examination, and Beck Depression Inventory. Results: Differences in BBS, MBI, and PCS components in SF-36 were more statistically significant in the SAVE group than that in the control group (p < 0.05). Patients in the SAVE group showed more significant improvement in BBS, MBI, and PCS components in SF-36 as compared to that in the control group. Conclusions: This evidence-based SAVE intervention can optimize patient recovery after a subacute stroke while keeping the available resources in mind.

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Quality of life in patients with Charcot-Marie-Tooth disease type 1A

Arquivos de Neuro-Psiquiatria ◽

10.1590/0004-282x20130045 ◽

2013 ◽

Vol 71 (6) ◽

pp. 392-396 ◽

Cited By ~ 2

Author(s):

Juliana B. Taniguchi ◽

Valeria M.C. Elui ◽

Flavia L. Osorio ◽

Jaime E.C. Hallak ◽

Jose A.S. Crippa ◽

...

Keyword(s):

Quality Of Life ◽

Short Form ◽

Control Group ◽

Life Questionnaire ◽

Charcot Marie Tooth ◽

Social And Emotional ◽

Charcot Marie Tooth Disease ◽

Sf 36 ◽

And Gender

We assessed the functional impairment in Charcot-Marie-Tooth resulting from 17p11.2-p12 duplication (CMT1A) patients using the Short-Form Health Survey (SF-36), which is a quality of life questionnaire. Twenty-five patients of both genders aged ≥10 years with a positive molecular diagnosis of CMT1A were selected. Age- and gender-matched Control Group (without family history of neuropathy), and the sociodemographic and professional conditions similar to the patients' group were selected to compare the SF-36 results between them. The results showed that the majority quality of life impairments in CMT1A patients occurred in the social and emotional domains. Functional capacity also tended to be significantly affected; other indicators of physical impairment were preserved. In conclusion, social and emotional aspects are mostly neglected in the assistance provided to CMT1A Brazilian patients, and they should be better understood in order to offer global health assistance with adequate quality of life as a result.

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Quality of Sleep and Quality of Life during Pregnancy

Journal of the Korean Neurological Association ◽

10.17340/jkna.2020.3.4 ◽

2020 ◽

Vol 38 (3) ◽

pp. 188-193

Author(s):

Keun Tae Kim ◽

Hyoeun Bae ◽

Jin Gon Bae ◽

Yong Won Cho

Keyword(s):

Sleep Quality ◽

Pregnant Women ◽

Short Form ◽

Life Quality ◽

Control Group ◽

Quality Of Sleep ◽

Third Trimester ◽

Cross Sectional ◽

Sf 36

Background: The prevalence of sleep disorders increases as pregnancy progresses, which affects the health of pregnant women, fetal health, and the outcomes of pregnancy. The aim of this study is to evaluate the quality of sleep and life in pregnant women in Korea.Methods: This study is a prospective cross-sectional, case-control study of pregnant women and age-matched controls. From July to September 2019, all participants completed Korean-language versions of the sleep questionnaires including Pittsburgh sleep quality index (K-PSQI), Insomnia severity index, Epworth sleepiness scale, Back’s depression inventory-2(K-BDI), STOP (Snoring, Tiredness, Observed apneas, and high blood Pressure), and short-form 36 (K-SF-36).Results: A total of 422 participants consisted of 385 pregnant women and 137 controls. Second and third trimester were 200 and 185, respectively. K-PSQI scores were higher in pregnant women compared with the controls (7.87±3.49 and 8.50±3.55 vs. 5.79±2.76, <i>p</i><0.001). Total score of K-SF-36 was lowest in third trimester (62.07±17.72) and highest in the control group(79.41±13.36). There was no statistical difference between groups in K-BDI.Conclusions: This study demonstrated worsening of sleep quality as well as life quality during pregnancy. More attention to sleep of pregnant women is needed.

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Efficacy and Safety of Ejiao (Asini Corii Colla) in Women With Blood Deficient Symptoms: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

Frontiers in Pharmacology ◽

10.3389/fphar.2021.718154 ◽

2021 ◽

Vol 12 ◽

Author(s):

Li Zhang ◽

Zhongju Xu ◽

Tao Jiang ◽

Jialu Zhang ◽

Pinxian Huang ◽

...

Keyword(s):

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Blood Cell ◽

Control Group ◽

Placebo Control ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Double Blind ◽

Placebo Control Group ◽

Sf 36

Equus asinus L [Equidae; Asini Corii Colla] (donkey-hide gelatin, Ejiao), a well-known traditional Chinese medicine, has been widely used to nourish the blood, especially for women. The aim of this study was to assess the efficacy and safety of Ejiao in blood-deficient patients. A total of 210 participants were recruited and randomly allocated into the placebo control group and Ejiao-treated group (6 g/day). The primary outcomes on the efficacy of Ejiao included traditional Chinese medicine symptom scores, blood indicators, and SF-36. The secondary outcomes were changes in fireness and safety evaluation. Results showed that Ejiao treatment for 8 weeks had significantly improved dizziness symptoms. Among the tested 24 blood biochemical parameters, the hematocrit and red blood cell numbers decreased in the placebo control group, but decreased significantly less in the Ejiao treatment group. The white blood cell and neutrophil counts increased in the Ejiao group but were within the normal range. In addition, the quality of life improved as the scores in SF-36 domains were significantly higher in the Ejiao group. At the same time, there was no significant change in the fire–heat symptoms score or other safety parameters. Considering all these, our study showed that Ejiao has a promising effect in women suffering from blood deficiency without obvious adverse effects.

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