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المؤلفون: Minna Hong, Beom-Joon Lee, Kwan-Il Kim, Yang-Chun Park, Byung Kab Kang, Kitae Kim, Jun-Yong Choi
المصدر: Integrative Medicine Research, Vol 9, Iss 1, Pp 48-53 (2020)
Integrative Medicine Researchمصطلحات موضوعية: medicine.medical_specialty, Eunkyosan, Visual analogue scale, 0211 other engineering and technologies, 02 engineering and technology, Placebo, 03 medical and health sciences, 0302 clinical medicine, Informed consent, Internal medicine, Common cold, 021105 building & construction, Medicine, Adverse effect, Trial registration, lcsh:Miscellaneous systems and treatments, Protocol (science), business.industry, lcsh:RZ409.7-999, medicine.disease, 030205 complementary & alternative medicine, Clinical trial, Complementary and alternative medicine, Original Article, Herbal medicine, Samsoeum, business
الوصف: Background: The common cold is the most frequent acute respiratory illness that places a burden on society, both personally and economically. There is no standard therapy; only symptomatic therapy remains the mainstay of common cold treatment. Thus, interest in herbal medicines is on the rise. Eunkyosan and Samsoeum are used for the common cold in East Asian countries. Although Eunkyosan and Samsoeum are clinically used for the treatment of the common cold, their effectiveness and safety have yet to be studied. Therefore, we aimed to evaluate their effectiveness and safety. Methods: This study is a randomized, patient-assessor blind, controlled, parallel, and multicenter clinical trial. A total of 375 participants diagnosed with the common cold will be enrolled via four hospitals. The common cold patients will take a daily dose of Eunkyosan or Samsoeum or a placebo, three times a day for eight days. The primary outcome is the change in total Wisconsin Upper Respiratory Symptom Scale-21-Korean version (WURSS-21-K) score between baseline and six days. The secondary outcome includes the visual analogue scale (VAS). Safety is evaluated and adverse events are assessed throughout the trial. Written informed consent will be obtained from all study participants before enrollment. Discussion: This results will be published in a peer-reviewed journal and disseminated in related conferences. Trial Registration: ClinicalTrials. gov, registration number: NCT04073511. Keywords: Common cold, Herbal medicine, Eunkyosan, Samsoeum
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المؤلفون: Seon-Eun Baek, Eun-Ji Park, Junhwan Lee, Ojin Kwon, Mikyung Kim, Jeong-Eun Yoo, Ae-Ran Kim, Hyo-Ju Park
المصدر: Integrative Medicine Research, Vol 10, Iss 3, Pp 100715-(2021)
Integrative Medicine Researchمصطلحات موضوعية: medicine.medical_specialty, Danggwijagyaksan, 0211 other engineering and technologies, 02 engineering and technology, Placebo, 03 medical and health sciences, 0302 clinical medicine, Rating scale, Internal medicine, 021105 building & construction, medicine, Climacteric syndrome, Adverse effect, Miscellaneous systems and treatments, business.industry, RZ409.7-999, medicine.disease, 030205 complementary & alternative medicine, Menopause, Clinical research, Complementary and alternative medicine, Lean body mass, Original Article, Herbal medicine, business, Hormone
الوصف: Background Danggwijagyaksan (DJS) has been one of the most widely used herbal medicines for gynecological disorders in traditional East Asian medicine. Several clinical studies about DJS have shown improvement in menopausal symptoms. This pilot study aimed to evaluate the efficacy, safety and feasibility of DJS for treating climacteric syndrome with a blood-deficiency-dominant pattern. Methods This was a randomized, double-blind, placebo-controlled pilot trial. A group of 45-to 60-year-old women with climacteric syndrome were registered for the trial. The participants received treatment over a 4-week period and were then followed for 4 weeks. The primary outcome measure was the mean change in the Menopause Rating Scale (MRS). Secondary outcome measures included the World Health Organization Quality of Life-BREF (WHOQOL-BREF), the Blood-Deficiency Scoring System (BDSS), lean body mass, and serum hormone levels, including follicle-stimulating hormone (FSH) and estradiol (E2) levels. Results The MRS and BDSS scores decreased significantly in both groups, but the differences between two groups were not significant. The WHOQOL-BREF scores increased in the control group. No statistically meaningful differences in serum hormone levels or lean body mass were observed in both groups. There were no serious adverse events, and the laboratory tests were within the normal range. The recruitment rate, completion rate and medication adherence rate were over 90% in both groups, indicating high feasibility. Conclusions DJS showed clinical effectiveness in the treatment of climacteric syndrome with a blood-deficiency-dominant pattern. Additionally, DJS was shown to be safe and feasible for a large-scale study to confirm the efficacy of the treatment. Trial registration: Clinical Research Information Service (CRIS, https://cris.nih.go.kr ): KCT0002387.
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المؤلفون: Bowen Yu, Xiaohua Pei, Shi-Bing Liang, Bao-Yong Lai, Huijuan Cao, Jianping Liu, Li-Yan Jia, Ai-Jing Chu
المصدر: Integrative Medicine Research, Vol 10, Iss 2, Pp 100491-(2021)
Integrative Medicine Researchمصطلحات موضوعية: medicine.medical_specialty, 0211 other engineering and technologies, Breast pain, Review Article, 02 engineering and technology, Breast Disorder, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, 021105 building & construction, Medicine, Miscellaneous systems and treatments, Adverse effect, business.industry, Incidence (epidemiology), RZ409.7-999, 030205 complementary & alternative medicine, Complementary and alternative medicine, Meta-analysis, Systematic review, Herbal medicine, medicine.symptom, business, Tamoxifen, Meta-Analysis, medicine.drug
الوصف: Background Breast pain is one of the most common breast disorders, affecting 41%–69% women in the clinical populations. Chinese herbal medicine (Rupi Sanjie, RPSJ) capsule has been recommended to be commonly used for breast pain in China. This review aimed to systematically collect latest evidence and critically evaluate the eff ;ectiveness and safety of RPSJ capsule for breast pain. Methods We searched 6 databases from their inception to June 1, 2020 for randomized clinical trials (RCTs) comparing RPSJ capsule with conventional drug therapies, placebo or no treatment. Primary outcomes were breast pain relief, reduction of breast mass and clinical cure rate. Results Seventeen RCTs were included in total, involving 2899 participants with breast pain. RPSJ capsule showed a significant effects in shortening duration of the breast pain (MD-6.51 days, 95%CI [-8.57, -4.45], n = 82, 1 trial), shortening the duration of breast mass (MD-5.17 days, 95%CI [-7.56, -2.78], n = 82, 1 trial), improving clinical cure rate (RR 1.55, 95% CI [1.21, 2.00], I² = 64%, n = 1398, 10 trials) and total effective rate (RR 1.08, 95% CI [1.03, 1.14], I² = 71%, n = 2170, 14 trials) compared to Tamoxifen (TAM). The meta-analysis showed that the incidence of total adverse events was higher in TAM group than the RPSJ capsule group (RR 0.30, 95%CI [0.21, 0.42], I² = 49%, n = 2122, 13 trials). Conclusions RPSJ capsule appears to be a potentially effective in treating breast pain and seems generally safe for clinical application. However, this potential benefit is inconclusive due to generally weak evidence, and the findings should be further confirmed in large and rigorous trials.
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المؤلفون: Seungwon Shin, Soo Jung Park, Min-Woo Hwang
المصدر: Integrative Medicine Research, Vol 10, Iss 2, Pp 100664-(2021)
مصطلحات موضوعية: medicine.medical_specialty, Visual analogue scale, 0211 other engineering and technologies, Placebo-controlled study, 02 engineering and technology, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Randomized controlled trial, law, Internal medicine, 021105 building & construction, Chronic fatigue syndrome, medicine, Miscellaneous systems and treatments, Adverse effect, business.industry, RZ409.7-999, medicine.disease, Complementary therapies, Confidence interval, 030205 complementary & alternative medicine, Complementary and alternative medicine, Herbal medicine, business
الوصف: Background Sipjeondaebo-tang (SJDBT, Shi-quan-da-bu-tang in Chinese) is a widely prescribed herbal medicine in traditional Korean medicine. This study aimed to evaluate the effectiveness and safety of SJDBT for treating chronic fatigue syndrome (CFS). Methods Ninety-six eligible participants were randomly allocated to either the SJDBT or placebo groups in a 1:1 ratio. Nine grams of SJDBT or placebo granules were administered to the patients for 8 weeks. The primary outcome was the response rate, defined as the proportion of participants with a score of 76 or higher in the Checklist Individual Strength assessment. Other measurements for fatigue severity, quality of life, and qi/blood/yin/yang deficiency were included. Safety was assessed throughout the trial. Results At week 8, the response rate did not significantly differ between the groups (SJDBT: 35.4%; placebo: 54.2%; P = 0.101, effect size [95% confidence interval] = 0.021 [-0.177, 0.218]). However, the scores of the visual analogue scale (P = 0.001, -0.327 [-0.506, -0.128]), Fatigue Severity Scale (P = 0.020, 0.480 [0.066, 0.889]), and Chalder fatigue scale (P = 0.004, -0.292 [-0.479, -0.101]) for the SJDBT group showed significant improvements in fatigue severity at the endpoint. Quality of life was not significantly different. Furthermore, SJDBT significantly ameliorated the severity of qi deficiency compared to that in the placebo group. No serious adverse events were observed. Conclusion This trial failed to show a significant improvement in fatigue severity, as assessed by the CIS-deprived response rate. It merely showed that SJDBT could alleviate the severity of fatigue and qi deficiency in patients with CFS. However, the further study is needed to confirm the details.