Pub Date : 2025-01-01Epub Date: 2025-10-14DOI: 10.1159/000548880
Hiroshi Kondo, Erika Matsuda, Shingo Ogawa, Hiroshi Nishimura, Akira Ono
Background: Home healthcare massage is widely used in Japan under insurance coverage, yet scientific evidence on its effectiveness and adverse events remains limited.
Objective: The aims of the study were to examine effectiveness and predictors of improvement in disabled older adults receiving home healthcare massage and to describe adverse events.
Methods: A retrospective cohort study included 469 participants (mean age 80.2 years; 65.7% women) from 10 clinics. Outcomes at baseline and 1 year were the level of nursing care required, the degree of independent living, and 15 basic activities of daily living. Participants were classified as improved, unchanged, or worsened. Logistic regression identified predictors of improvement. Adverse events during 1 year were recorded.
Results: Improvement was associated with a mild level of nursing care required at baseline (OR = 0.865), muscle atrophy (OR = 1.87), and no use of services other than massage (OR = 0.439). Maintenance without deterioration was also considered clinically meaningful. Ninety-six adverse events (20.5%) were reported, most frequently pain, followed by abrasions/contusions/bruises and numbness. Severity, causality, and temporal course were not collected.
Conclusion: Home healthcare massage may contribute to functional improvement under specific conditions, though most participants received combination therapies. These findings reflect real-world practice in Japan and support the need for large-scale prospective studies.
{"title":"Home Healthcare Massage for Disabled Older Adults in Japan: Factors Associated with Improvement and Adverse Events.","authors":"Hiroshi Kondo, Erika Matsuda, Shingo Ogawa, Hiroshi Nishimura, Akira Ono","doi":"10.1159/000548880","DOIUrl":"10.1159/000548880","url":null,"abstract":"<p><strong>Background: </strong>Home healthcare massage is widely used in Japan under insurance coverage, yet scientific evidence on its effectiveness and adverse events remains limited.</p><p><strong>Objective: </strong>The aims of the study were to examine effectiveness and predictors of improvement in disabled older adults receiving home healthcare massage and to describe adverse events.</p><p><strong>Methods: </strong>A retrospective cohort study included 469 participants (mean age 80.2 years; 65.7% women) from 10 clinics. Outcomes at baseline and 1 year were the level of nursing care required, the degree of independent living, and 15 basic activities of daily living. Participants were classified as improved, unchanged, or worsened. Logistic regression identified predictors of improvement. Adverse events during 1 year were recorded.</p><p><strong>Results: </strong>Improvement was associated with a mild level of nursing care required at baseline (OR = 0.865), muscle atrophy (OR = 1.87), and no use of services other than massage (OR = 0.439). Maintenance without deterioration was also considered clinically meaningful. Ninety-six adverse events (20.5%) were reported, most frequently pain, followed by abrasions/contusions/bruises and numbness. Severity, causality, and temporal course were not collected.</p><p><strong>Conclusion: </strong>Home healthcare massage may contribute to functional improvement under specific conditions, though most participants received combination therapies. These findings reflect real-world practice in Japan and support the need for large-scale prospective studies.</p>","PeriodicalId":10541,"journal":{"name":"Complementary Medicine Research","volume":" ","pages":"463-473"},"PeriodicalIF":0.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145291388","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Trigeminal herpetic neuralgia, a common type of Zoster-associated pain (ZAP), affects individuals across all ages groups and poses a significant societal burden all over the world. Electroacupuncture (EA) is increasingly used in the treatment of ZAP due to its affordability, high safety profile, absence of adverse reactions, and high patient acceptance. Consequently, it is essential to conduct randomized controlled trials to evaluate the effectiveness and safety of EA in treating ZAP and to determine if EA can be used as an alternative to pregabalin.
Patients and methods: A total of 102 patients with trigeminal herpetic neuralgia will be enrolled from 2 hospitals and randomly assigned to the EA group, pregabalin group, or EA + pregabalin group in a 1:1:1 ratio using a simple random number table. The study will consist of a 4-week treatment period followed by a 4-week follow-up period. The primary outcome measure will be pain intensity, while secondary outcomes will include mood state, sleep quality, and quality of life. Adverse reactions will be thoroughly evaluated.
Conclusion: This study aims to elucidate the clinical effectiveness of EA combined with pregabalin for trigeminal herpetic neuralgia and to objectively compare the effectiveness and safety of EA versus oral pregabalin in the treatment of trigeminal herpetic neuralgia.
{"title":"Effectiveness of Electroacupuncture Combined with Pregabalin in the Treatment of Trigeminal Herpetic Neuralgia: A Multicenter Randomized Controlled Trial Study Protocol.","authors":"Shimin Li, Xilong Yang, Yunfan Xia, Yunyan Shen, Jingfang Li, Chengcheng Kong, Hui Wang, Ruohan Sun, Zhiyuan Bian, Zuyong Zhang, Jianqiao Fang, Ping Lin","doi":"10.1159/000549320","DOIUrl":"10.1159/000549320","url":null,"abstract":"<p><strong>Background: </strong>Trigeminal herpetic neuralgia, a common type of Zoster-associated pain (ZAP), affects individuals across all ages groups and poses a significant societal burden all over the world. Electroacupuncture (EA) is increasingly used in the treatment of ZAP due to its affordability, high safety profile, absence of adverse reactions, and high patient acceptance. Consequently, it is essential to conduct randomized controlled trials to evaluate the effectiveness and safety of EA in treating ZAP and to determine if EA can be used as an alternative to pregabalin.</p><p><strong>Patients and methods: </strong>A total of 102 patients with trigeminal herpetic neuralgia will be enrolled from 2 hospitals and randomly assigned to the EA group, pregabalin group, or EA + pregabalin group in a 1:1:1 ratio using a simple random number table. The study will consist of a 4-week treatment period followed by a 4-week follow-up period. The primary outcome measure will be pain intensity, while secondary outcomes will include mood state, sleep quality, and quality of life. Adverse reactions will be thoroughly evaluated.</p><p><strong>Conclusion: </strong>This study aims to elucidate the clinical effectiveness of EA combined with pregabalin for trigeminal herpetic neuralgia and to objectively compare the effectiveness and safety of EA versus oral pregabalin in the treatment of trigeminal herpetic neuralgia.</p>","PeriodicalId":10541,"journal":{"name":"Complementary Medicine Research","volume":" ","pages":"485-494"},"PeriodicalIF":0.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145421461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: The objective of this study was to examine the efficacy and safety of pestle needle therapy (PNT) across several prevalent conditions, including insomnia, cervical spondylosis, lumbar disc herniation, and other systemic diseases.
Methods: We searched eight databases (SINOMED, China National Knowledge Infrastructure, Wanfang Data, VIP Database, Google Scholar, PubMed, Embase, and Web of Science) from inception to 31 December 2023, using both subject terms and free-text terms related to "pestle needle" and "randomised controlled trial." Eligible randomised controlled trials (RCTs) that investigated PNT alone or in combination with other therapies were included. Primary outcomes included the overall response rate (ORR) and incidence of adverse events.
Results: A total of 29 RCTs involving 2,614 patients were included. Meta-analysis results showed that, compared with controls, PNT significantly improved ORR in insomnia (odds ratio [OR] = 4.07, 95% confidence interval [CI]: 2.33, 7.09), cervical spondylosis (OR = 4.38, 95% CI: 2.41, 7.97), lumbago and leg pain (OR = 3.32, 95% CI: 1.86, 5.91), and lumbar disc herniation (OR = 1.92, 95% CI: 1.12, 3.29). Regarding cervical spondylosis, the intervention of the observation group was significantly better than that of the control group (Z = 4.84, p < 0.001). In terms of low back pain and leg pain, the intervention of the observation group was significantly better than that of the control group (Z = 4.07, p < 0.001). The intervention of the observation group was significantly better than in the control group in improving the total effective rate of the treatment of lumbar disc herniation (Z = 2.37, p = 0.02).
Conclusion: PNT is a safe and effective treatment modality that can complement or substitute conventional interventions. This systematic review and meta-analysis contributes to the evidence base for acupuncture-related therapies, highlighting the potential of PNT to address both musculoskeletal and neurological conditions, thus offering new clinical options and underscoring the need for large-scale, high-quality RCTs to refine treatment protocols.
{"title":"Systematic Review and Meta-Analysis of Pestle Needle Therapy in Managing Insomnia, Cervical Spondylosis, and Other Systemic Diseases.","authors":"Jiaqi Wang, Yingchao Wang, Shudan Yu, Shujun Li, Ning Liu, Genghui Zhang","doi":"10.1159/000546785","DOIUrl":"10.1159/000546785","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to examine the efficacy and safety of pestle needle therapy (PNT) across several prevalent conditions, including insomnia, cervical spondylosis, lumbar disc herniation, and other systemic diseases.</p><p><strong>Methods: </strong>We searched eight databases (SINOMED, China National Knowledge Infrastructure, Wanfang Data, VIP Database, Google Scholar, PubMed, Embase, and Web of Science) from inception to 31 December 2023, using both subject terms and free-text terms related to \"pestle needle\" and \"randomised controlled trial.\" Eligible randomised controlled trials (RCTs) that investigated PNT alone or in combination with other therapies were included. Primary outcomes included the overall response rate (ORR) and incidence of adverse events.</p><p><strong>Results: </strong>A total of 29 RCTs involving 2,614 patients were included. Meta-analysis results showed that, compared with controls, PNT significantly improved ORR in insomnia (odds ratio [OR] = 4.07, 95% confidence interval [CI]: 2.33, 7.09), cervical spondylosis (OR = 4.38, 95% CI: 2.41, 7.97), lumbago and leg pain (OR = 3.32, 95% CI: 1.86, 5.91), and lumbar disc herniation (OR = 1.92, 95% CI: 1.12, 3.29). Regarding cervical spondylosis, the intervention of the observation group was significantly better than that of the control group (Z = 4.84, p < 0.001). In terms of low back pain and leg pain, the intervention of the observation group was significantly better than that of the control group (Z = 4.07, p < 0.001). The intervention of the observation group was significantly better than in the control group in improving the total effective rate of the treatment of lumbar disc herniation (Z = 2.37, p = 0.02).</p><p><strong>Conclusion: </strong>PNT is a safe and effective treatment modality that can complement or substitute conventional interventions. This systematic review and meta-analysis contributes to the evidence base for acupuncture-related therapies, highlighting the potential of PNT to address both musculoskeletal and neurological conditions, thus offering new clinical options and underscoring the need for large-scale, high-quality RCTs to refine treatment protocols.</p>","PeriodicalId":10541,"journal":{"name":"Complementary Medicine Research","volume":" ","pages":"341-353"},"PeriodicalIF":0.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301277","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction - Hypopharyngeal squamous cell carcinoma has poor prognosis with only 25% chances of 5 years of relative survival in such patients in spite of conventional treatment including radical surgery, radiotherapy and concurrent chemotherapy. Case Presentation - A chronic tobacco - betel nut chewer 62-years-old male patient had dysphagia with hoarseness of voice diagnosed with stage III, grade II malignant pyriform fossa. The patient underwent 9 cycles of neo adjuvant chemotherapy with Inj Paclitaxel 100 mg and Inj Cisplatin 40 mg. He was then referred to our institute for Radical Radiotherapy with Concurrent Chemotherapy with adjunct Ayurvedic treatment. A total dose of 70 Gy of radiation with cobalt 60 source was administered to the bilateral face and neck, in 35 fractions. Patient also received 6 cycles of concurrent weekly chemotherapy with Inj Cisplatin 40 mg. He received well planned adjunct Ayurvedic treatment in the form of Oral Ayurvedic Medicines (OAM) and Detoxifying treatment, Panchakarma. All the measured adverse effects of radiotherapy such as Stomatitis, Xerostomia, Taste Alteration, Dysphagia, Nausea etc. were observed to be remarkably low during and post radiotherapy in this patient. Karnofsky and QoL scores revealed patient's wellbeing throughout the treatment course. After 5 years PET CT scan revealed no FDG avid loco regional recurrence or distant organ involvement implying Disease Free Survival (DFS). Various Chemokines, cytokines and oxidative stress were assessed during the course of treatment to observe tumour microenvironment. Conclusion - Present case of HNC, Stage III and Grade II belonged to high-grade, high-risk hypopharyngeal cancer with poor prognosis. The patient opted for Ayurvedic treatment besides radiotherapy which continued thereafter for 5 years. We therefore emphasize that in this case, minimum side effects of radiotherapy, immunomodulation and reduction in inflammation and oxidative stress along with good quality of life can be attributed to OAM and repeated detoxifying Panchakarma treatment supported with healthy diet and good lifestyle. The highlight of the study is the marked effect on the patient's immune response and reduction in oxidative stress leading to 5 years and beyond of DFS.
{"title":"Selective adjuvant Ayurvedic treatment modulates immune response and oxidative stress in patient with carcinoma of pyriform fossa, undergoing radiotherapy: A case study.","authors":"Vineeta Deshmukh,Shubhada Chiplunkar,Sadanand Sardeshmukh,Tushar Patil,Jagdish Shinde,Vidya Gupta,Shweta Gujar,Nilambari Sardeshmukh,Shridevi Pathak,Sandeep Chavan,Trupti Pradhan,Jueelee Godbole","doi":"10.1159/000541254","DOIUrl":"https://doi.org/10.1159/000541254","url":null,"abstract":"Introduction - Hypopharyngeal squamous cell carcinoma has poor prognosis with only 25% chances of 5 years of relative survival in such patients in spite of conventional treatment including radical surgery, radiotherapy and concurrent chemotherapy. Case Presentation - A chronic tobacco - betel nut chewer 62-years-old male patient had dysphagia with hoarseness of voice diagnosed with stage III, grade II malignant pyriform fossa. The patient underwent 9 cycles of neo adjuvant chemotherapy with Inj Paclitaxel 100 mg and Inj Cisplatin 40 mg. He was then referred to our institute for Radical Radiotherapy with Concurrent Chemotherapy with adjunct Ayurvedic treatment. A total dose of 70 Gy of radiation with cobalt 60 source was administered to the bilateral face and neck, in 35 fractions. Patient also received 6 cycles of concurrent weekly chemotherapy with Inj Cisplatin 40 mg. He received well planned adjunct Ayurvedic treatment in the form of Oral Ayurvedic Medicines (OAM) and Detoxifying treatment, Panchakarma. All the measured adverse effects of radiotherapy such as Stomatitis, Xerostomia, Taste Alteration, Dysphagia, Nausea etc. were observed to be remarkably low during and post radiotherapy in this patient. Karnofsky and QoL scores revealed patient's wellbeing throughout the treatment course. After 5 years PET CT scan revealed no FDG avid loco regional recurrence or distant organ involvement implying Disease Free Survival (DFS). Various Chemokines, cytokines and oxidative stress were assessed during the course of treatment to observe tumour microenvironment. Conclusion - Present case of HNC, Stage III and Grade II belonged to high-grade, high-risk hypopharyngeal cancer with poor prognosis. The patient opted for Ayurvedic treatment besides radiotherapy which continued thereafter for 5 years. We therefore emphasize that in this case, minimum side effects of radiotherapy, immunomodulation and reduction in inflammation and oxidative stress along with good quality of life can be attributed to OAM and repeated detoxifying Panchakarma treatment supported with healthy diet and good lifestyle. The highlight of the study is the marked effect on the patient's immune response and reduction in oxidative stress leading to 5 years and beyond of DFS.","PeriodicalId":10541,"journal":{"name":"Complementary Medicine Research","volume":"196 1","pages":"1-23"},"PeriodicalIF":1.8,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142247394","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
INTRODUCTIONThis systematic review examines the efficacy of a combination of Qi benefiting and blood circulation promoting herbs with Dapagliflozin in treating type 2 diabetes mellitus (T2DM) combined with heart failure (HF).METHODSRandomized controlled trials (RCTs) assessing the combination of Qi benefiting and blood circulation promoting herbs with Dapagliflozin for T2DM and CHF was conducted. The search, spanning from the database's establishment to June 2023, included seven databases: China Knowledge Network (CNKI), Wanfang Database, VIP Database, PubMed, Embase, Cochrane Library, and the Chinese Biomedical Literature Database. Two researchers screened and extracted data based on inclusion and exclusion criteria. The Cochrane Handbook version 5.1 guided the quality assessment of studies, and the meta-analysis was performed using RevMan 5.4 software.RESULTSEleven articles, encompassing a sample size of 1192 cases, were included. Meta-analysis results indicated that combining Qi benefiting and blood circulation promoting herbs with Dapagliflozin improved the clinical efficacy rate [OR=4.35, 95% CI (2.98, 6.35), P<0.00001]. It reduced blood glucose levels, evidenced by decreased fasting blood glucose (FBG) [MD=-1.19, 95% CI (-1.30, -1.09), P<0.00001], 2-hour postprandial blood glucose (2hPG) [MD=-1.95, 95% CI (-2.09, -1.80), P<0.00001], and glycosylated haemoglobin (HbA1c) [MD=-1.40, 95% CI (-1.49, -1.31), P<0.00001]. Inflammatory factors also reduced, including C-reactive protein (CRP) [MD=-4.93, 95% CI (-5.38, -4.48), P<0.00001], tumor necrosis factor (TNF-α) [MD=-2.91, 95% CI (-3.32, -2.49), P<0.00001], and interleukin-6 (IL-6) [MD=-11.10, 95% CI (-12.43, -9.43), P<0.00001]. Additionally, left ventricular end-diastolic diameter (LVEDD) [SMD=-1.25, 95% CI (-1.45, -1.05), P<0.00001], left ventricular end-systolic diameter (LVESD) [SMD=-1.34, 95% CI (-1.51, -1.13), P<0.00001], and improved left ventricular ejection fraction (LVEF)[SMD=2.92, 95% CI (2.65, 3.19), P<0.00001], 6-minute walk test (6MWT) [MD=35.59, 95% CI (29.72, 41.47), P<0.00001], and Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores [MD=35.59, 95% CI (29.72, 41.47), P<0.00001] were observed. The incidence of adverse events also decreased [RR=0.25, 95% CI (0.11, 0.56), P=0.0007].CONCLUSIONThe combination of Qi benefiting and blood circulation promoting herbs with Dapagliflozin shows potential in treating patients with T2DM and HF, suggesting its use as adjunctive therapy in clinical practice. However, the limited number and quality of the included studies necessitate further high-quality research to confirm these findings.
方法对益气活血中药联合达帕格列净治疗 2 型糖尿病(T2DM)合并心力衰竭(HF)的随机对照试验(RCT)进行了评估。检索时间跨度为数据库建立至 2023 年 6 月,包括 7 个数据库:中国知网(CNKI)、万方数据库、VIP数据库、PubMed、Embase、Cochrane图书馆和中国生物医学文献数据库。两名研究人员根据纳入和排除标准筛选和提取数据。结果共纳入 7 篇文章,样本量为 1192 例。荟萃分析结果表明,益气活血中药与达帕利洛嗪合用可提高临床有效率[OR=4.35,95% CI (2.98,6.35),P<0.00001]。它降低了血糖水平,表现为空腹血糖(FBG)降低[MD=-1.19,95% CI(-1.30,-1.09),P<0.00001],餐后 2 小时血糖(2hPG)降低[MD=-1.95,95% CI(-2.09,-1.80),P<0.00001]和糖化血红蛋白(HbA1c)[MD=-1.40,95% CI(-1.49,-1.31),P<0.00001]。炎症因子也有所降低,包括C反应蛋白(CRP)[MD=-4.93,95% CI(-5.38,-4.48),P<0.00001]、肿瘤坏死因子(TNF-α)[MD=-2.91,95% CI(-3.32,-2.49),P<0.00001]和白细胞介素-6(IL-6)[MD=-11.10,95% CI(-12.43,-9.43),P<0.00001]。此外,左心室舒张末期直径(LVEDD)[SMD=-1.25,95% CI(-1.45,-1.05),P<0.00001]、左心室收缩末期直径(LVESD)[SMD=-1.34,95% CI(-1.51,-1.13),P<0.00001]和左心室射血分数(LVEF)[SMD=2.92,95% CI (2.65,3.19),P<0.00001]、6分钟步行测试(6MWT)[MD=35.59,95% CI (29.72,41.47),P<0.00001]和明尼苏达心衰患者生活问卷(MLHFQ)评分[MD=35.59,95% CI (29.72,41.47),P<0.00001]均有所改善。结论益气活血中药与达帕利洛嗪联合治疗T2DM合并HF患者显示出潜力,建议在临床实践中作为辅助治疗使用。然而,由于纳入研究的数量和质量有限,有必要进一步开展高质量的研究来证实这些发现。
{"title":"Combination of Qi benefiting and blood circulation promoting herbs with Dapagliflozin in the treatment of type 2 diabetes mellitus combined with heart failure: a systematic evaluation and meta-analysis based on a randomized controlled trial.","authors":"Changxing Liu,Xinyi Guo,He Wang,Yabin Zhou","doi":"10.1159/000541234","DOIUrl":"https://doi.org/10.1159/000541234","url":null,"abstract":"INTRODUCTIONThis systematic review examines the efficacy of a combination of Qi benefiting and blood circulation promoting herbs with Dapagliflozin in treating type 2 diabetes mellitus (T2DM) combined with heart failure (HF).METHODSRandomized controlled trials (RCTs) assessing the combination of Qi benefiting and blood circulation promoting herbs with Dapagliflozin for T2DM and CHF was conducted. The search, spanning from the database's establishment to June 2023, included seven databases: China Knowledge Network (CNKI), Wanfang Database, VIP Database, PubMed, Embase, Cochrane Library, and the Chinese Biomedical Literature Database. Two researchers screened and extracted data based on inclusion and exclusion criteria. The Cochrane Handbook version 5.1 guided the quality assessment of studies, and the meta-analysis was performed using RevMan 5.4 software.RESULTSEleven articles, encompassing a sample size of 1192 cases, were included. Meta-analysis results indicated that combining Qi benefiting and blood circulation promoting herbs with Dapagliflozin improved the clinical efficacy rate [OR=4.35, 95% CI (2.98, 6.35), P<0.00001]. It reduced blood glucose levels, evidenced by decreased fasting blood glucose (FBG) [MD=-1.19, 95% CI (-1.30, -1.09), P<0.00001], 2-hour postprandial blood glucose (2hPG) [MD=-1.95, 95% CI (-2.09, -1.80), P<0.00001], and glycosylated haemoglobin (HbA1c) [MD=-1.40, 95% CI (-1.49, -1.31), P<0.00001]. Inflammatory factors also reduced, including C-reactive protein (CRP) [MD=-4.93, 95% CI (-5.38, -4.48), P<0.00001], tumor necrosis factor (TNF-α) [MD=-2.91, 95% CI (-3.32, -2.49), P<0.00001], and interleukin-6 (IL-6) [MD=-11.10, 95% CI (-12.43, -9.43), P<0.00001]. Additionally, left ventricular end-diastolic diameter (LVEDD) [SMD=-1.25, 95% CI (-1.45, -1.05), P<0.00001], left ventricular end-systolic diameter (LVESD) [SMD=-1.34, 95% CI (-1.51, -1.13), P<0.00001], and improved left ventricular ejection fraction (LVEF)[SMD=2.92, 95% CI (2.65, 3.19), P<0.00001], 6-minute walk test (6MWT) [MD=35.59, 95% CI (29.72, 41.47), P<0.00001], and Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores [MD=35.59, 95% CI (29.72, 41.47), P<0.00001] were observed. The incidence of adverse events also decreased [RR=0.25, 95% CI (0.11, 0.56), P=0.0007].CONCLUSIONThe combination of Qi benefiting and blood circulation promoting herbs with Dapagliflozin shows potential in treating patients with T2DM and HF, suggesting its use as adjunctive therapy in clinical practice. However, the limited number and quality of the included studies necessitate further high-quality research to confirm these findings.","PeriodicalId":10541,"journal":{"name":"Complementary Medicine Research","volume":"64 1","pages":"1-28"},"PeriodicalIF":1.8,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142247391","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-01Epub Date: 2024-03-08DOI: 10.1159/000537979
Karolina Königsberger, Konrad Urech, Marcus Reif, Stephan Baumgartner, David Martin, Wilfried Tröger
<p><strong>Introduction: </strong>Cutaneous squamous cell carcinoma (cSCC) and basal cell carcinoma (BCC) belong to the group of keratinocyte carcinomas (KC). Actinic keratosis (AK) is a precursor lesion of cSCC. The incidences of cSCC, BCC, and AK are currently strongly increasing. Different standard therapies exist for these conditions but are not always applicable or successful. Hydrophilic Viscum album extracts have been used in anthroposophic cancer therapy since 1917. Viscum album lipophilic extract (VALE) is prepared by means of supercritical CO2 extraction. This retrospective case series assessed the safety and clinical effects of a topical application of 10% VALE in individual cases of cSCC, BCC, and AK.</p><p><strong>Methods: </strong>For this retrospective case series, a positive vote was obtained from the Ethics Committee of the University of Witten/Herdecke (No. 146/2020). Eligible patients signed a declaration of consent prior to inclusion in the study. The main outcome parameters were the clinical response to treatment with VALE and adverse drug reactions. Risk factors, concomitant therapies and diseases, further diagnostic and therapeutic information were documented where available. Data analysis was performed on the level of patients and of individual lesions.</p><p><strong>Results: </strong>The study population consisted of 55 patients with 74 skin lesions. Individual case analysis accompanied by photographic documentation revealed typical and promising treatment courses. Clinical response rates (complete + partial remissions) for individual lesions were 78% for cSCC, 70% for BCC, and 71% for AK. Complete remission rates for individual lesions were 56% for cSCC, 35% for BCC, and 15% for AK. In cSCC and BCC, shorter times to best clinical response were observed. Adverse drug reactions were reported in 5 patients including erythema and inflammatory reactions of mostly moderate severity that resolved completely. In one case, therapy was temporarily paused, in four cases it was continued without interruption.</p><p><strong>Discussion/conclusion: </strong>The results of this study suggest that VALE is a safe and tolerable extract under whose application complete and partial remissions of KC could be observed. To improve and assess the efficacy of VALE, prospective investigations are necessary.</p><p><p><title>Einleitung</title>Das kutane Plattenepithelkarzinom (cSCC) und das Basalzellkarzinom (BCC) gehören zur Gruppe der Keratinozytenkarzinome (KC). Die aktinische Keratose (AK) ist eine Vorstufe des cSCC. Die Häufigkeit von cSCC, BCC und AK ist derzeit stark im Steigen begriffen. Es gibt verschiedene Standardtherapien für diese Erkrankungen, die jedoch nicht immer anwendbar oder erfolgreich sind. Hydrophile <italic>Viscum album</italic>-Extrakte werden seit 1917 in der anthroposophischen Krebstherapie eingesetzt. <italic>Viscum album</italic> Lipophilic Extract (VALE) wird mittels überkritischer CO2-Extraktion hergestellt. In dieser
{"title":"Viscum Album Lipophilic Extract in Actinic Keratosis, Cutaneous Squamous Cell Carcinoma, and Basal Cell Carcinoma: A Retrospective Case Series.","authors":"Karolina Königsberger, Konrad Urech, Marcus Reif, Stephan Baumgartner, David Martin, Wilfried Tröger","doi":"10.1159/000537979","DOIUrl":"10.1159/000537979","url":null,"abstract":"<p><strong>Introduction: </strong>Cutaneous squamous cell carcinoma (cSCC) and basal cell carcinoma (BCC) belong to the group of keratinocyte carcinomas (KC). Actinic keratosis (AK) is a precursor lesion of cSCC. The incidences of cSCC, BCC, and AK are currently strongly increasing. Different standard therapies exist for these conditions but are not always applicable or successful. Hydrophilic Viscum album extracts have been used in anthroposophic cancer therapy since 1917. Viscum album lipophilic extract (VALE) is prepared by means of supercritical CO2 extraction. This retrospective case series assessed the safety and clinical effects of a topical application of 10% VALE in individual cases of cSCC, BCC, and AK.</p><p><strong>Methods: </strong>For this retrospective case series, a positive vote was obtained from the Ethics Committee of the University of Witten/Herdecke (No. 146/2020). Eligible patients signed a declaration of consent prior to inclusion in the study. The main outcome parameters were the clinical response to treatment with VALE and adverse drug reactions. Risk factors, concomitant therapies and diseases, further diagnostic and therapeutic information were documented where available. Data analysis was performed on the level of patients and of individual lesions.</p><p><strong>Results: </strong>The study population consisted of 55 patients with 74 skin lesions. Individual case analysis accompanied by photographic documentation revealed typical and promising treatment courses. Clinical response rates (complete + partial remissions) for individual lesions were 78% for cSCC, 70% for BCC, and 71% for AK. Complete remission rates for individual lesions were 56% for cSCC, 35% for BCC, and 15% for AK. In cSCC and BCC, shorter times to best clinical response were observed. Adverse drug reactions were reported in 5 patients including erythema and inflammatory reactions of mostly moderate severity that resolved completely. In one case, therapy was temporarily paused, in four cases it was continued without interruption.</p><p><strong>Discussion/conclusion: </strong>The results of this study suggest that VALE is a safe and tolerable extract under whose application complete and partial remissions of KC could be observed. To improve and assess the efficacy of VALE, prospective investigations are necessary.</p><p><p><title>Einleitung</title>Das kutane Plattenepithelkarzinom (cSCC) und das Basalzellkarzinom (BCC) gehören zur Gruppe der Keratinozytenkarzinome (KC). Die aktinische Keratose (AK) ist eine Vorstufe des cSCC. Die Häufigkeit von cSCC, BCC und AK ist derzeit stark im Steigen begriffen. Es gibt verschiedene Standardtherapien für diese Erkrankungen, die jedoch nicht immer anwendbar oder erfolgreich sind. Hydrophile <italic>Viscum album</italic>-Extrakte werden seit 1917 in der anthroposophischen Krebstherapie eingesetzt. <italic>Viscum album</italic> Lipophilic Extract (VALE) wird mittels überkritischer CO2-Extraktion hergestellt. In dieser ","PeriodicalId":10541,"journal":{"name":"Complementary Medicine Research","volume":" ","pages":"241-252"},"PeriodicalIF":1.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140048914","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<p><strong>Introduction: </strong>The coronavirus disease 2019 (COVID-19) is leading to unknown and unusual health conditions that are challenging to manage. Post-COVID-19 fatigue is one of those challenges, becoming increasingly common as the pandemic evolves, as it impairs the quality of life of an individual. This trial attempts to identify the preliminary evidence of the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of post-COVID-19 fatigue in adults.</p><p><strong>Methods: </strong>A 3-month, single-blind, randomized, placebo-controlled, parallel-arm trial was conducted at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital, India. Sixty participants were randomized in a 1:1 ratio to receive either IHMs (n = 30) or identical-looking placebos (n = 30). The primary and secondary outcome measures were the Fatigue Assessment Scale (FAS) and Outcome in Relation to Impact on Daily Living (ORIDL), respectively, measured every month, for up to 3 months. Comparative analysis was carried out on the intention-to-treat sample to detect group differences.</p><p><strong>Results: </strong>Group differences in both the primary (FAS total: F1, 58 = 14.356, p < 0.001) and secondary outcomes (ORIDL: F1, 58 = 210.986, p < 0.001) after 3 months favored IHMs against placebos. Lycopodium clavatum (11.7%), sulfur (11.7%), Arsenicum album (10%), and Thuja occidentalis (10%) were the most frequently indicated medicines. No harm, unintended effects, homeopathic aggravations, or any serious adverse events were reported from either of the groups.</p><p><strong>Conclusion: </strong>IHMs produced significantly better effects than placebos in the treatment of post-COVID-19 fatigue in adults. Definitive robust trials may be undertaken to confirm the findings.</p><p><p><title>Einleitung</title>Die Coronainfektion (COVID-19) zieht unbekannte und ungewöhnliche gesundheitliche Probleme nach sich, deren Management oft eine Herausforderung darstellt. Das gilt unter anderem für Ermüdung nach einer COVID-19-Erkrankung, die mit zunehmender Dauer der Pandemie immer häufiger auftritt und die Lebensqualität der Betroffenen beeinträchtigt. In dieser Studie wird versucht, vorläufige Belege für die Wirksamkeit individualisierter homöopathischer Mittel (IHM) im Vergleich zu Placebo zur Behandlung von Ermüdung nach COVID-19 bei Erwachsenen zu identifizieren.<title>Methoden</title>Eine einfach verblindete, randomisierte, placebokontrollierte Parallelgruppenstudie von 3 Monaten Dauer wurde im ambulanten Bereich des Calcutta Homoeopathic Medical College and Hospital in Indien durchgeführt. 60 Teilnehmer erhielten nach Randomisierung im Verhältnis 1:1 entweder IHM (<italic>n</italic> = 30) oder identisch aussehendes Placebo (<italic>n</italic> = 30). Die primäre und die sekundäre Zielgröße waren die Fatigue Assessment Scale (FAS) und das Outcome in Relation to Impact on Daily Living (ORIDL) für bis zu 3 Monate, je
{"title":"Individualized Homeopathic Medicines in the Treatment of Post-COVID-19 Fatigue in Adults: Single-Blind, Randomized, Placebo-Controlled Trial.","authors":"Sangita Saha, Rakesh Singh, Ishika Mani, Kalyan Chakraborty, Paulami Sarkar, Subhranil Saha, Abhijit Rana, Rajat Chattopadhyay","doi":"10.1159/000535279","DOIUrl":"10.1159/000535279","url":null,"abstract":"<p><strong>Introduction: </strong>The coronavirus disease 2019 (COVID-19) is leading to unknown and unusual health conditions that are challenging to manage. Post-COVID-19 fatigue is one of those challenges, becoming increasingly common as the pandemic evolves, as it impairs the quality of life of an individual. This trial attempts to identify the preliminary evidence of the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of post-COVID-19 fatigue in adults.</p><p><strong>Methods: </strong>A 3-month, single-blind, randomized, placebo-controlled, parallel-arm trial was conducted at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital, India. Sixty participants were randomized in a 1:1 ratio to receive either IHMs (n = 30) or identical-looking placebos (n = 30). The primary and secondary outcome measures were the Fatigue Assessment Scale (FAS) and Outcome in Relation to Impact on Daily Living (ORIDL), respectively, measured every month, for up to 3 months. Comparative analysis was carried out on the intention-to-treat sample to detect group differences.</p><p><strong>Results: </strong>Group differences in both the primary (FAS total: F1, 58 = 14.356, p < 0.001) and secondary outcomes (ORIDL: F1, 58 = 210.986, p < 0.001) after 3 months favored IHMs against placebos. Lycopodium clavatum (11.7%), sulfur (11.7%), Arsenicum album (10%), and Thuja occidentalis (10%) were the most frequently indicated medicines. No harm, unintended effects, homeopathic aggravations, or any serious adverse events were reported from either of the groups.</p><p><strong>Conclusion: </strong>IHMs produced significantly better effects than placebos in the treatment of post-COVID-19 fatigue in adults. Definitive robust trials may be undertaken to confirm the findings.</p><p><p><title>Einleitung</title>Die Coronainfektion (COVID-19) zieht unbekannte und ungewöhnliche gesundheitliche Probleme nach sich, deren Management oft eine Herausforderung darstellt. Das gilt unter anderem für Ermüdung nach einer COVID-19-Erkrankung, die mit zunehmender Dauer der Pandemie immer häufiger auftritt und die Lebensqualität der Betroffenen beeinträchtigt. In dieser Studie wird versucht, vorläufige Belege für die Wirksamkeit individualisierter homöopathischer Mittel (IHM) im Vergleich zu Placebo zur Behandlung von Ermüdung nach COVID-19 bei Erwachsenen zu identifizieren.<title>Methoden</title>Eine einfach verblindete, randomisierte, placebokontrollierte Parallelgruppenstudie von 3 Monaten Dauer wurde im ambulanten Bereich des Calcutta Homoeopathic Medical College and Hospital in Indien durchgeführt. 60 Teilnehmer erhielten nach Randomisierung im Verhältnis 1:1 entweder IHM (<italic>n</italic> = 30) oder identisch aussehendes Placebo (<italic>n</italic> = 30). Die primäre und die sekundäre Zielgröße waren die Fatigue Assessment Scale (FAS) und das Outcome in Relation to Impact on Daily Living (ORIDL) für bis zu 3 Monate, je","PeriodicalId":10541,"journal":{"name":"Complementary Medicine Research","volume":" ","pages":"1-9"},"PeriodicalIF":1.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138440346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-01Epub Date: 2024-07-19DOI: 10.1159/000540335
{"title":"Erratum.","authors":"","doi":"10.1159/000540335","DOIUrl":"10.1159/000540335","url":null,"abstract":"","PeriodicalId":10541,"journal":{"name":"Complementary Medicine Research","volume":" ","pages":"399"},"PeriodicalIF":1.1,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141733725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}