Pub Date : 2025-09-01DOI: 10.1016/j.eujim.2025.102542
Isabelle Pagé , Anne Dolbec , Geneviève Côté , Chantale Doucet , David Hayes , Pierre Langevin , Katherine A. Pohlman , Marie-Hélène Vallières , Stéphane Sobczak
Introduction
Though manual therapies are frequently utilized in pediatric care, they carry inherent risks of adverse events. The pediatric iteration of the SafetyNet reporting system encompasses three questionnaires specifically crafted for completion by a child's legal guardian, complemented by one intended for the provider to record treatment details. The objective of this study is to culturally adapt the pediatric SafetyNet reporting system for the French-speaking Canadian demographic.
Methods
A multidisciplinary committee was convened to undertake the translation and cross-cultural adaptation of the four questionnaires comprising the pediatric version of the SafetyNet reporting system. The adaptation process encompassed several stages, including: (1) Forward translation, (2) Synthesis of the translated versions, (3) Cross-cultural adaptation, (4) Review and proposal of the pre-final Canadian French version, and (5) Cognitive debriefing and proposal of the final version. Committee adaptations were subject to review by a developer of the SafetyNet system. Cognitive debriefing involved the participation of French-Canadian legal guardians and clinicians to assess questionnaires’ clarity.
Results
The committee comprised seven researchers and clinicians from diverse backgrounds, including chiropractic, anatomy, and physiotherapy as well as a research associate with a background in linguistics. Upon receiving approval of the cross-cultural adaptations from the developer of the SafetyNet reporting system, all committee members unanimously endorsed the pre-final version. After incorporating improvements based on the cognitive debriefing step, which involved feedback from 13 legal guardians and 10 clinicians, the final version was proposed.
Conclusion
Despite the need for adaptations to existing translation guidelines, the pediatric version of the SafetyNET reporting system was successfully translated and adapted to the Canadian French context.
{"title":"Cross-cultural adaptation of the pediatric version of the SafetyNet reporting system for use in French-speaking Canada","authors":"Isabelle Pagé , Anne Dolbec , Geneviève Côté , Chantale Doucet , David Hayes , Pierre Langevin , Katherine A. Pohlman , Marie-Hélène Vallières , Stéphane Sobczak","doi":"10.1016/j.eujim.2025.102542","DOIUrl":"10.1016/j.eujim.2025.102542","url":null,"abstract":"<div><h3>Introduction</h3><div>Though manual therapies are frequently utilized in pediatric care, they carry inherent risks of adverse events. The pediatric iteration of the SafetyNet reporting system encompasses three questionnaires specifically crafted for completion by a child's legal guardian, complemented by one intended for the provider to record treatment details. The objective of this study is to culturally adapt the pediatric SafetyNet reporting system for the French-speaking Canadian demographic.</div></div><div><h3>Methods</h3><div>A multidisciplinary committee was convened to undertake the translation and cross-cultural adaptation of the four questionnaires comprising the pediatric version of the SafetyNet reporting system. The adaptation process encompassed several stages, including: (1) Forward translation, (2) Synthesis of the translated versions, (3) Cross-cultural adaptation, (4) Review and proposal of the pre-final Canadian French version, and (5) Cognitive debriefing and proposal of the final version. Committee adaptations were subject to review by a developer of the SafetyNet system. Cognitive debriefing involved the participation of French-Canadian legal guardians and clinicians to assess questionnaires’ clarity.</div></div><div><h3>Results</h3><div>The committee comprised seven researchers and clinicians from diverse backgrounds, including chiropractic, anatomy, and physiotherapy as well as a research associate with a background in linguistics. Upon receiving approval of the cross-cultural adaptations from the developer of the SafetyNet reporting system, all committee members unanimously endorsed the pre-final version. After incorporating improvements based on the cognitive debriefing step, which involved feedback from 13 legal guardians and 10 clinicians, the final version was proposed.</div></div><div><h3>Conclusion</h3><div>Despite the need for adaptations to existing translation guidelines, the pediatric version of the SafetyNET reporting system was successfully translated and adapted to the Canadian French context.</div></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"78 ","pages":"Article 102542"},"PeriodicalIF":1.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144996873","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 : 2025-09-01DOI: 10.1016/j.eujim.2025.102550
Louise TC Mulder , Martine Busch , Armelle Demmers , Herman A van Wietmarschen
Introduction
The Dutch health care system needs guidance and implementation of complementary care, of which shared decision making, communication and referral between conventional and complementary care practitioners are major components. A Dutch quality register for complementary healthcare practitioners (RBCZ) was interested in adopting and implementing an improved version of a communication toolkit developed in an earlier project. Therefore, the aim was to further develop a communication toolkit to improve the communication and collaboration between member practitioners of RBCZ and conventional healthcare practitioners.
Methods
Focus group discussions were conducted as part of a co-creation process with conventional and complementary healthcare practitioners to define content and implementation of the toolkit, in three field labs; Utrecht, Amsterdam and the north of the Netherlands. A pragmatic evidence-based decision aid for the respective complementary care modalities was developed based on a literature assessment and Strength Of Recommendation Taxonomy (SORT) criteria.
Results
The final toolkit included seven communication tools: (1) getting acquainted; (2) communication; (3) frame letters; (4) decision aid with evidence-based recommendations for 13 complementary therapies and 6 indications: chronic low back pain, depressive symptoms, medically unexplained physical symptoms, irritable bowel syndrome, burnout, and chronic fatigue syndrome; (5) grading evidence; (6) support for communication of the RBCZ members/professional associations and (7) implementation.
Conclusions
The evidence-based toolkit will be made available to 23 professional associations covering over 9.500 complementary healthcare practitioners in the Netherlands (RBCZ). The regional collaboration amongst complementary healthcare practitioners was strengthened as well as between complementary and conventional healthcare practitioners.
{"title":"Co-creation of an evidence-based toolkit to facilitate communication on complementary medicine between conventional and complementary healthcare practitioners in the Netherlands","authors":"Louise TC Mulder , Martine Busch , Armelle Demmers , Herman A van Wietmarschen","doi":"10.1016/j.eujim.2025.102550","DOIUrl":"10.1016/j.eujim.2025.102550","url":null,"abstract":"<div><h3>Introduction</h3><div>The Dutch health care system needs guidance and implementation of complementary care, of which shared decision making, communication and referral between conventional and complementary care practitioners are major components. A Dutch quality register for complementary healthcare practitioners (RBCZ) was interested in adopting and implementing an improved version of a communication toolkit developed in an earlier project. Therefore, the aim was to further develop a communication toolkit to improve the communication and collaboration between member practitioners of RBCZ and conventional healthcare practitioners.</div></div><div><h3>Methods</h3><div>Focus group discussions were conducted as part of a co-creation process with conventional and complementary healthcare practitioners to define content and implementation of the toolkit, in three field labs; Utrecht, Amsterdam and the north of the Netherlands. A pragmatic evidence-based decision aid for the respective complementary care modalities was developed based on a literature assessment and Strength Of Recommendation Taxonomy (SORT) criteria.</div></div><div><h3>Results</h3><div>The final toolkit included seven communication tools: (1) getting acquainted; (2) communication; (3) frame letters; (4) decision aid with evidence-based recommendations for 13 complementary therapies and 6 indications: chronic low back pain, depressive symptoms, medically unexplained physical symptoms, irritable bowel syndrome, burnout, and chronic fatigue syndrome; (5) grading evidence; (6) support for communication of the RBCZ members/professional associations and (7) implementation.</div></div><div><h3>Conclusions</h3><div>The evidence-based toolkit will be made available to 23 professional associations covering over 9.500 complementary healthcare practitioners in the Netherlands (RBCZ). The regional collaboration amongst complementary healthcare practitioners was strengthened as well as between complementary and conventional healthcare practitioners.</div></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"78 ","pages":"Article 102550"},"PeriodicalIF":1.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145003964","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}
Sambucus ebulus, belonging to the Sambucus genus, is important in folk medicine, used to treat stomach pain, rheumatism, eczema, high fever, colds, coughs etc., and also in cancer treatment in Turkish traditional medicine. This study outlines the antioxidant, apoptotic, cytotoxic, antimicrobial activity, and phenolic profile of the water and ethanol extract of S. ebulus and provides its mineral elements.
Methods
The antioxidative capacity of the sample was identified by using radical scavenging (DPPH (2,2-diphenyl-1-picrylhydrazyl radical), ABTS (2,2′-azino-bis (3-ethylbenzothiazoline-6-sulfonic acid)), reducing (CUPRAC (cupric reducing antioxidant capacity), FRAP (ferric ion reducing antioxidant power)), metal chelating, and phosphomolybdenum methods. Cytotoxic effects of the extract were determined by XTT (2,3-Bis-(2-Methoxy-4-nitro-5-sulfophenyl)-2H-tetrazolium-5-carboxanilide, disodium salt) assay. Expression changes of genes related to apoptosis (Bcl-2, Bax, caspase-3,-8,-9) were analysed by real-time PCR (Polymerase Chain Reaction). Antimicrobial activities of the extracts were investigated by disc diffusion assay, and the MIC (minimum inhibitory concentration) values were determined. The phenolics were analysed via HPLC analysis.
Results
The water extract exhibited higher radical scavenging and reducing activities than the ethanol extract. The water extract also exhibited better antimicrobial activity against gram-negative bacteria than gram-positive bacteria. The highest inhibition zone was determined for the water extract against C.albicans. S. ebulus showed apoptotic and cytotoxic effects on the breast cancer cell line. Caffeic acid and epicatechin were the main phenolic compounds identified using HPLC (High performance liquid chromatography).
Conclusion
The results of this study are expected to contribute to ongoing efforts to identify novel plant-derived antioxidants, antibiotics, and anticancer agents. Furthermore, the findings highlight the potential of S. ebulus as a valuable natural antioxidant and suggest its possible use as a beneficial dietary supplement for therapeutic applications.
{"title":"Phytochemical profile, mineral composition, antimicrobial, antioxidant and anti-breast cancer activities of Sambucus ebulus","authors":"Arzu Kaska , Mücahit Seçme , Mehlika Alper , Birsen Atlı , Ramazan Mammadov","doi":"10.1016/j.eujim.2025.102546","DOIUrl":"10.1016/j.eujim.2025.102546","url":null,"abstract":"<div><h3>Introduction</h3><div><em>Sambucus ebulus,</em> belonging to the <em>Sambucus</em> genus, is important in folk medicine, used to treat stomach pain, rheumatism, eczema, high fever, colds, coughs etc., and also in cancer treatment in Turkish traditional medicine. This study outlines the antioxidant, apoptotic, cytotoxic, antimicrobial activity, and phenolic profile of the water and ethanol extract of <em>S. ebulus</em> and provides its mineral elements.</div></div><div><h3>Methods</h3><div>The antioxidative capacity of the sample was identified by using radical scavenging (DPPH (2,2-diphenyl-1-picrylhydrazyl radical), ABTS (2,2′-azino-bis (3-ethylbenzothiazoline-6-sulfonic acid)), reducing (CUPRAC (cupric reducing antioxidant capacity), FRAP (ferric ion reducing antioxidant power)), metal chelating, and phosphomolybdenum methods. Cytotoxic effects of the extract were determined by XTT (2,3-Bis-(2-Methoxy-4-nitro-5-sulfophenyl)-2H-tetrazolium-5-carboxanilide, disodium salt) assay. Expression changes of genes related to apoptosis (Bcl-2, Bax, caspase-3,-8,-9) were analysed by real-time PCR (Polymerase Chain Reaction). Antimicrobial activities of the extracts were investigated by disc diffusion assay, and the MIC (minimum inhibitory concentration) values were determined. The phenolics were analysed via HPLC analysis.</div></div><div><h3>Results</h3><div>The water extract exhibited higher radical scavenging and reducing activities than the ethanol extract. The water extract also exhibited better antimicrobial activity against gram-negative bacteria than gram-positive bacteria. The highest inhibition zone was determined for the water extract against <em>C.albicans. S. ebulus</em> showed apoptotic and cytotoxic effects on the breast cancer cell line. Caffeic acid and epicatechin were the main phenolic compounds identified using HPLC (High performance liquid chromatography).</div></div><div><h3>Conclusion</h3><div>The results of this study are expected to contribute to ongoing efforts to identify novel plant-derived antioxidants, antibiotics, and anticancer agents. Furthermore, the findings highlight the potential of S. ebulus as a valuable natural antioxidant and suggest its possible use as a beneficial dietary supplement for therapeutic applications.</div></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"78 ","pages":"Article 102546"},"PeriodicalIF":1.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144996253","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 : 2025-09-01DOI: 10.1016/j.eujim.2025.102536
Ji-eun Yu , Hyunmin Kim , Chihyoung Son , Eunji Ahn , Dongsu Kim
{"title":"Corrigendum to “Factors influencing the utilization of traditional Korean medicine and continuity of care among individuals with disabilities in Korea: A cross-sectional analysis using national health insurance data” [European Journal of Integrative Medicine 78 (2025) 102520]","authors":"Ji-eun Yu , Hyunmin Kim , Chihyoung Son , Eunji Ahn , Dongsu Kim","doi":"10.1016/j.eujim.2025.102536","DOIUrl":"10.1016/j.eujim.2025.102536","url":null,"abstract":"","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"78 ","pages":"Article 102536"},"PeriodicalIF":1.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145104477","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 : 2025-09-01DOI: 10.1016/j.eujim.2025.102544
Marcia Edwards , Joanna McParland , Samah Naseem
Introduction
The European Alliance of Associations for Rheumatology (EULAR) in their 2017 paper recommended that an update be conducted after five years to determine whether further trials had been conducted for therapies which had scored low and whether any new therapies had emerged for the management of fibromyalgia. Limbic reflexology is a reflexology approach which targets specific problems that arise from altered function of the limbic brain network and nuclei. The aim of this study was to explore the potential of limbic reflexology as a non-drug treatment for the management of fibromyalgia, through (1) assessing if a person’s experience of living with the fibromyalgia symptoms of pain, fatigue and sleep quality changed after receiving an initial course of six to eight weekly limbic reflexology sessions, and (2) assessing whether any changes in symptoms were maintained with regular maintenance sessions.
Methods
A purposive homogenous sample was used to include participants who were aged 18 and over, had a diagnosis of fibromyalgia and had completed a course of between six to eight weekly limbic reflexology sessions prior to the study. Semi-structured interviews were used for data collection, the interviews were audio recorded, transcribed verbatim, and anonymised. Interpretative phenomenological analysis was then used for the data analysis.
Results
Three women with fibromyalgia were interviewed to gain a detailed account of the impact of six to eight weekly limbic reflexology sessions, plus maintenance sessions on symptoms of fibromyalgia and its impact on their experience of pain, fatigue, and sleep quality. The following themes were identified “The experience of fibromyalgia”, “The experience of limbic reflexology”, and “The holistic impact of limbic reflexology”. Participants reported limbic reflexology improved their symptoms with less pain, reduced fatigue, and more restful sleep. This improvement in symptoms was maintained with regular sessions.
Conclusion
This qualitative study provides new insight into the impact of limbic reflexology on physical and mental function among women living with fibromyalgia. These initial findings provide an invaluable start for further research to determine limbic reflexology’s potential as a non-drug treatment for the management of fibromyalgia symptoms.
{"title":"Limbic reflexology for the management of fibromyalgia: A qualitative investigation of a non-drug treatment","authors":"Marcia Edwards , Joanna McParland , Samah Naseem","doi":"10.1016/j.eujim.2025.102544","DOIUrl":"10.1016/j.eujim.2025.102544","url":null,"abstract":"<div><h3>Introduction</h3><div>The European Alliance of Associations for Rheumatology (EULAR) in their 2017 paper recommended that an update be conducted after five years to determine whether further trials had been conducted for therapies which had scored low and whether any new therapies had emerged for the management of fibromyalgia. Limbic reflexology is a reflexology approach which targets specific problems that arise from altered function of the limbic brain network and nuclei. The aim of this study was to explore the potential of limbic reflexology as a non-drug treatment for the management of fibromyalgia, through (1) assessing if a person’s experience of living with the fibromyalgia symptoms of pain, fatigue and sleep quality changed after receiving an initial course of six to eight weekly limbic reflexology sessions, and (2) assessing whether any changes in symptoms were maintained with regular maintenance sessions.</div></div><div><h3>Methods</h3><div>A purposive homogenous sample was used to include participants who were aged 18 and over, had a diagnosis of fibromyalgia and had completed a course of between six to eight weekly limbic reflexology sessions prior to the study. Semi-structured interviews were used for data collection, the interviews were audio recorded, transcribed verbatim, and anonymised. Interpretative phenomenological analysis was then used for the data analysis.</div></div><div><h3>Results</h3><div>Three women with fibromyalgia were interviewed to gain a detailed account of the impact of six to eight weekly limbic reflexology sessions, plus maintenance sessions on symptoms of fibromyalgia and its impact on their experience of pain, fatigue, and sleep quality. The following themes were identified “The experience of fibromyalgia”, “The experience of limbic reflexology”, and “The holistic impact of limbic reflexology”. Participants reported limbic reflexology improved their symptoms with less pain, reduced fatigue, and more restful sleep. This improvement in symptoms was maintained with regular sessions.</div></div><div><h3>Conclusion</h3><div>This qualitative study provides new insight into the impact of limbic reflexology on physical and mental function among women living with fibromyalgia. These initial findings provide an invaluable start for further research to determine limbic reflexology’s potential as a non-drug treatment for the management of fibromyalgia symptoms.</div></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"78 ","pages":"Article 102544"},"PeriodicalIF":1.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145018765","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 : 2025-09-01DOI: 10.1016/j.eujim.2025.102541
Lihua Wang , Qian Wang , Mingze Sun , Yan Zhang , Xiao Qi
Introduction
Parkinson's disease (PD) is a progressive neurodegenerative disorder, prevalent worldwide, with an unknown etiology and currently no specific treatment. Physical exercise-defined as “planned, structured, and repetitive physical activity aimed at improving or maintaining physical fitness”-has emerged as a non-pharmacological, holistic, and patient-centered intervention for the management of PD. This study aims to evaluate the impact of physical exercise on mental and physical health, and the quality of life in individuals with PD.
Method
A systematic search was conducted in PubMed, Web of Science (WoS), Embase, and the Cochrane Database for randomized controlled trials (RCTs) from their inception until December 2024. Key data extracted included publication details, sample demographic characteristics, the interventions used for both experimental and control groups, and outcome assessment characteristics at baseline and post-intervention. The Cochrane Risk of Bias tool was utilized to assess the risk of bias, and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied to evaluate the certainty of the evidence.
Result
A total of 35 eligible articles (n = 1620) from 54 studies were included in our systematic review. The results demonstrated that physical exercise interventions had a significant effect on various outcomes, including global cognitive function (SMD 0.43, 95 % CI 0.01 to 0.85, p = 0.04), depression (SMD -0.54, 95 % CI -0.75 to -0.32, p < 0.00001), anxiety (SMD -0.42, 95 % CI -0.69 to -0.15, p = 0.002), physical health (SMD -0.74, 95 % CI -1.01 to -0.48, p = 0.0002), balance (SMD 0.78, 95 % CI 0.36 to 1.19, p < 0.00001), fatigue (SMD -0.65, 95 % CI -1.28 to - 0.01, p = 0.05), and quality of life (SMD -0.51, 95 % CI -0.80 to -0.22, p = 0.0005) in the experimental group (exercise training) compared to the control post-intervention. Most studies were assessed as having a low risk of bias, the quality of the included studies was generally high (median PEDro score = 7, range 5–10). Adverse events were reported in only 5 of 35 trials, with low incidence (3.1–16.1 %) and mild severity (e.g., musculoskeletal discomfort).
Conclusion
This review found moderate certainty evidence that physical exercise can improve depression, physical health, balance and quality of life, and low certainty evidence for improvements in cognitive function, anxiety and fatigue. Further research is indicated to provide clearer insights about the beneficial effects of exercise for PD.
{"title":"Effect of different exercise modalities on health and quality of life in people with Parkinson’s disease: A systematic review and meta-analysis","authors":"Lihua Wang , Qian Wang , Mingze Sun , Yan Zhang , Xiao Qi","doi":"10.1016/j.eujim.2025.102541","DOIUrl":"10.1016/j.eujim.2025.102541","url":null,"abstract":"<div><h3>Introduction</h3><div>Parkinson's disease (PD) is a progressive neurodegenerative disorder, prevalent worldwide, with an unknown etiology and currently no specific treatment. Physical exercise-defined as “planned, structured, and repetitive physical activity aimed at improving or maintaining physical fitness”-has emerged as a non-pharmacological, holistic, and patient-centered intervention for the management of PD. This study aims to evaluate the impact of physical exercise on mental and physical health, and the quality of life in individuals with PD.</div></div><div><h3>Method</h3><div>A systematic search was conducted in PubMed, Web of Science (WoS), Embase, and the Cochrane Database for randomized controlled trials (RCTs) from their inception until December 2024. Key data extracted included publication details, sample demographic characteristics, the interventions used for both experimental and control groups, and outcome assessment characteristics at baseline and post-intervention. The Cochrane Risk of Bias tool was utilized to assess the risk of bias, and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied to evaluate the certainty of the evidence.</div></div><div><h3>Result</h3><div>A total of 35 eligible articles (<em>n</em> = 1620) from 54 studies were included in our systematic review. The results demonstrated that physical exercise interventions had a significant effect on various outcomes, including global cognitive function (SMD 0.43, 95 % CI 0.01 to 0.85, <em>p</em> = 0.04), depression (SMD -0.54, 95 % CI -0.75 to -0.32, <em>p</em> < 0.00001), anxiety (SMD -0.42, 95 % CI -0.69 to -0.15, <em>p</em> = 0.002), physical health (SMD -0.74, 95 % CI -1.01 to -0.48, <em>p</em> = 0.0002), balance (SMD 0.78, 95 % CI 0.36 to 1.19, <em>p</em> < 0.00001), fatigue (SMD -0.65, 95 % CI -1.28 to - 0.01, <em>p</em> = 0.05), and quality of life (SMD -0.51, 95 % CI -0.80 to -0.22, <em>p</em> = 0.0005) in the experimental group (exercise training) compared to the control post-intervention. Most studies were assessed as having a low risk of bias, the quality of the included studies was generally high (median PEDro score = 7, range 5–10). Adverse events were reported in only 5 of 35 trials, with low incidence (3.1–16.1 %) and mild severity (e.g., musculoskeletal discomfort).</div></div><div><h3>Conclusion</h3><div>This review found moderate certainty evidence that physical exercise can improve depression, physical health, balance and quality of life, and low certainty evidence for improvements in cognitive function, anxiety and fatigue. Further research is indicated to provide clearer insights about the beneficial effects of exercise for PD.</div></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"78 ","pages":"Article 102541"},"PeriodicalIF":1.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145003963","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 : 2025-08-31DOI: 10.1016/j.eujim.2025.102548
Huimin Su , Hui Mao , Yangyang Zhang , Heng Yin , Shenlin Chen , Jiayi Hong , Yuxuan Yang , Yifei Song , Shuxuan Chen , Honghao Wang , Landan Xu , Hongjia Li , Manci Zhou , Xun Li
Introduction
This review aims to evaluate the effectiveness and safety of pediatric Tui Na on children’s growth.
Methods
The protocol of this review was registered in INPLASY (10.37766/inplasy2024.2.0116). We searched seven databases and two ongoing trial registers up to June 8, 2024, for randomized controlled trials (RCTs) of pediatric Tui Na, to assess the impact of Tui Na lasting over 3 months on children’s growth. Risk of bias was assessed with the RoB1 tool. Results were presented and synthesized via RevMan 5.4.
Results
A total of 46 RCTs involving 11,284 children were included. We found that Tui Na increased height compared to routine health care alone (29 trials, mean 3.68 cm, 95 % CI (confidence interval) [2.92, 4.43], low-certainty evidence) and to touch (2 trials, mean 1.72 cm, 95 % CI [1.22, 2.22], low-certainty evidence). Adding Tui Na to touch resulted in a height increase of 1.99 cm (5 trials, mean 95 % CI [1.04, 2.95], low-certainty evidence). Subgroups of normal children (Tui Na for 3-4 months, 5-6 months, 12 months) and preterm children (Tui Na for 3-4 months, 12 months) both showed significant benefits. Tui Na was also beneficial for the growth of height, weight, head circumference, chest circumference, waist circumference and BMI, as well as parental satisfaction compared to routine health care. Compared to touch, Tui Na was beneficial for growth of height, weight and head circumference. Tui Na also showed additional benefits in growth of height, weight and head circumference added to touch. RevMan 5.4 was used for the meta-analyses and funnel plots.
Conclusion
This evaluation indicates that Tui Na over 3 months can promote children’s growth and appears to be safe, with high parental satisfaction. However, large-sample and high-quality RCTs and real-world observations with long-term follow-up are needed to confirm these findings.
本综述旨在评价小儿推那对儿童生长发育的有效性和安全性。方法本综述方案在INPLASY注册(10.37766/inplasy2024.2.0116)。截至2024年6月8日,我们检索了7个数据库和2个正在进行的试验注册库,以评估持续3个月以上的推那对儿童生长的影响。使用RoB1工具评估偏倚风险。用revman5.4软件对结果进行了分析和合成。结果共纳入46项随机对照试验,涉及11284名儿童。我们发现,与单纯的常规保健相比,推纳组的身高增加(29项试验,平均3.68 cm, 95% CI(可信区间)[2.92,4.43],低确定性证据),与触摸组相比(2项试验,平均1.72 cm, 95% CI[1.22, 2.22],低确定性证据)。将推那添加到触摸中导致身高增加1.99 cm(5项试验,平均95% CI[1.04, 2.95],低确定性证据)。正常儿童(3-4个月,5-6个月,12个月)和早产儿(3-4个月,12个月)的亚组均显示出显着的益处。与常规保健相比,推纳对身高、体重、头围、胸围、腰围、BMI、父母满意度的增长也有好处。与触摸相比,推纳有利于身高、体重和头围的增长。推娜在身高、体重和头围的增长方面也显示出额外的好处。meta分析和漏斗图采用RevMan 5.4。结论3个月以上推那可促进儿童生长发育,安全性好,家长满意度高。然而,需要大样本、高质量的随机对照试验和长期随访的真实世界观察来证实这些发现。
{"title":"Impact of pediatric Tui Na over three months on children’s growth: A systematic review and meta-analysis of randomized controlled trials","authors":"Huimin Su , Hui Mao , Yangyang Zhang , Heng Yin , Shenlin Chen , Jiayi Hong , Yuxuan Yang , Yifei Song , Shuxuan Chen , Honghao Wang , Landan Xu , Hongjia Li , Manci Zhou , Xun Li","doi":"10.1016/j.eujim.2025.102548","DOIUrl":"10.1016/j.eujim.2025.102548","url":null,"abstract":"<div><h3>Introduction</h3><div>This review aims to evaluate the effectiveness and safety of pediatric Tui Na on children’s growth.</div></div><div><h3>Methods</h3><div>The protocol of this review was registered in INPLASY (10.37766/inplasy2024.2.0116). We searched seven databases and two ongoing trial registers up to June 8, 2024, for randomized controlled trials (RCTs) of pediatric Tui Na, to assess the impact of Tui Na lasting over 3 months on children’s growth. Risk of bias was assessed with the RoB1 tool. Results were presented and synthesized via RevMan 5.4.</div></div><div><h3>Results</h3><div>A total of 46 RCTs involving 11,284 children were included. We found that Tui Na increased height compared to routine health care alone (29 trials, mean 3.68 cm, 95 % CI (confidence interval) [2.92, 4.43], low-certainty evidence) and to touch (2 trials, mean 1.72 cm, 95 % CI [1.22, 2.22], low-certainty evidence). Adding Tui Na to touch resulted in a height increase of 1.99 cm (5 trials, mean 95 % CI [1.04, 2.95], low-certainty evidence). Subgroups of normal children (Tui Na for 3-4 months, 5-6 months, 12 months) and preterm children (Tui Na for 3-4 months, 12 months) both showed significant benefits. Tui Na was also beneficial for the growth of height, weight, head circumference, chest circumference, waist circumference and BMI, as well as parental satisfaction compared to routine health care. Compared to touch, Tui Na was beneficial for growth of height, weight and head circumference. Tui Na also showed additional benefits in growth of height, weight and head circumference added to touch. RevMan 5.4 was used for the meta-analyses and funnel plots.</div></div><div><h3>Conclusion</h3><div>This evaluation indicates that Tui Na over 3 months can promote children’s growth and appears to be safe, with high parental satisfaction. However, large-sample and high-quality RCTs and real-world observations with long-term follow-up are needed to confirm these findings.</div></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"79 ","pages":"Article 102548"},"PeriodicalIF":1.7,"publicationDate":"2025-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145104712","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 : 2025-08-26DOI: 10.1016/j.eujim.2025.102543
Chaofan Sun , Guoxing Ling , Chunquan Sun , Xingzhong Feng
Introduction
Diabetic peripheral neuropathy (DPN) is a common complication of type 2 diabetes, characterized by high disability and mortality rates. Pain, the primary symptom of DPN, leads to increased central nervous system responsiveness and decreased pain thresholds, resulting in conditions like hyperalgesia, anxiety, and depression—collectively referred to as "central sensitization." Changes in brain structure and function are closely linked to this phenomenon but remain unclear. While functional magnetic resonance imaging (fMRI) technology can monitor brain function changes, there is limited research on the effects of interventions on these functions in patients with DPN. Yiqi Jiedu (YQJD) Decoction has been used in China to treat DPN for many years, with some studies indicating it may improve symptoms and quality of life, but there is a lack of high-quality clinical evidence, and its central mechanism of action remains unclear.
Methods
This ongoing randomized, double-blind, placebo-controlled trial aims to enroll about 88 patients aged 45–75 with DPN, diagnosed with qi deficiency and blood stasis syndrome. Participants will be randomly assigned in a 1:1 ratio to either receive YQJD Granules or the placebo, with follow-up assessments at weeks 4 and 8. The primary outcomes include the Toronto Clinical Scoring System (TCSS), Michigan Diabetic Neuropathy Score (MDNS), Traditional Chinese Medicine (TCM) syndrome score, nerve conduction velocity, and fMRI changes. Secondary outcomes will assess psychological characteristics in patients and changes in serum cytokines and glucose-lipid metabolism indicators.
Discussion
This study aims to evaluate the efficacy and safety of YQJD Decoction in the treatment of DPN using fMRI technology. It will analyze changes in brain regions before and after treatment, explore the cerebral effects of YQJD, and elucidate the relationship between central sensitization and brain effect patterns in the pathogenesis of DPN. The findings of this study will provide clinical evidence and mechanistic insights for the integration of TCM and Western medicine in the treatment of DPN. It is expected to reveal the central mechanisms involved in the intervention of neuropathic pain through Chinese herbal medicine.
Trial registration
Chinese clinical trial registry, ChiCTR2400084649. Registered on 22 May 2024, https://www.chictr.org.cn/.
{"title":"Evaluation of the efficacy of Yiqi Jiedu decoction on diabetic peripheral neuropathy and related brain function changes: A randomized controlled trial protocol","authors":"Chaofan Sun , Guoxing Ling , Chunquan Sun , Xingzhong Feng","doi":"10.1016/j.eujim.2025.102543","DOIUrl":"10.1016/j.eujim.2025.102543","url":null,"abstract":"<div><h3>Introduction</h3><div>Diabetic peripheral neuropathy (DPN) is a common complication of type 2 diabetes, characterized by high disability and mortality rates. Pain, the primary symptom of DPN, leads to increased central nervous system responsiveness and decreased pain thresholds, resulting in conditions like hyperalgesia, anxiety, and depression—collectively referred to as \"central sensitization.\" Changes in brain structure and function are closely linked to this phenomenon but remain unclear. While functional magnetic resonance imaging (fMRI) technology can monitor brain function changes, there is limited research on the effects of interventions on these functions in patients with DPN. Yiqi Jiedu (YQJD) Decoction has been used in China to treat DPN for many years, with some studies indicating it may improve symptoms and quality of life, but there is a lack of high-quality clinical evidence, and its central mechanism of action remains unclear.</div></div><div><h3>Methods</h3><div>This ongoing randomized, double-blind, placebo-controlled trial aims to enroll about 88 patients aged 45–75 with DPN, diagnosed with qi deficiency and blood stasis syndrome. Participants will be randomly assigned in a 1:1 ratio to either receive YQJD Granules or the placebo, with follow-up assessments at weeks 4 and 8. The primary outcomes include the Toronto Clinical Scoring System (TCSS), Michigan Diabetic Neuropathy Score (MDNS), Traditional Chinese Medicine (TCM) syndrome score, nerve conduction velocity, and fMRI changes. Secondary outcomes will assess psychological characteristics in patients and changes in serum cytokines and glucose-lipid metabolism indicators.</div></div><div><h3>Discussion</h3><div>This study aims to evaluate the efficacy and safety of YQJD Decoction in the treatment of DPN using fMRI technology. It will analyze changes in brain regions before and after treatment, explore the cerebral effects of YQJD, and elucidate the relationship between central sensitization and brain effect patterns in the pathogenesis of DPN. The findings of this study will provide clinical evidence and mechanistic insights for the integration of TCM and Western medicine in the treatment of DPN. It is expected to reveal the central mechanisms involved in the intervention of neuropathic pain through Chinese herbal medicine.</div></div><div><h3>Trial registration</h3><div>Chinese clinical trial registry, ChiCTR2400084649. Registered on 22 May 2024, <span><span>https://www.chictr.org.cn/</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"78 ","pages":"Article 102543"},"PeriodicalIF":1.7,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144912869","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 : 2025-08-10DOI: 10.1016/j.eujim.2025.102540
Zhengyang Mei , Chenyi Cai , Chifong Lam , Tingfeng Wang , Shi Luo
Introduction
Sleep disturbances are increasingly prevalent, with older people particularly vulnerable due to age-related changes and the cumulative impact of psychosocial and health-related stressors. The objective of this systematic review and Bayesian network meta-analysis was to evaluate the comparative efficacy of traditional Chinese exercises (TCEs) for improving sleep disturbances in older people and to identify which intervention is the most effective.
Methods
We searched PubMed, Embase, EBSCOhost, Scopus, Web of Science, APA PsycINFO, the China National Knowledge Infrastructure (CNKI), Wanfang, the Chinese Scientific Journal Database (VIP), and Google Scholar for randomized controlled trials (RCTs) of TCEs in participants aged ≥60 years. We conducted pairwise and network meta-analyses using Stata version 18.0.
Results
The analysis included 17 RCTs involving a total of 1,730 participants. Pairwise meta-analyses indicated that TCEs effectively improved sleep disturbances in older people compared to the control groups (SMD = -0.48, 95 % CI [-0.69, -0.27], p < 0.01). Network meta-analyses indicated that Qigong-Baduanjin exerted the strongest effect on older people’ sleep disturbances (SUCRA: 90.9 %), followed by Tai Chi (SUCRA: 71.8 %) and Qigong-Liuzijue (SUCRA: 46.1 %).
Conclusions
TCEs effectively improved sleep disturbances in older people, and Qigong-Baduanjin exerted the strongest effect, followed by Tai Chi and Qigong-Liuzijue. However, the findings of this review need to be interpreted and applied within specific clinical and patient contexts. When applying the results to clinical practice, careful consideration must be given to the specific circumstances and clinical needs of the patients.
睡眠障碍越来越普遍,由于与年龄有关的变化以及社会心理和健康相关压力因素的累积影响,老年人特别容易受到影响。本系统综述和贝叶斯网络荟萃分析的目的是评估中国传统运动(TCEs)改善老年人睡眠障碍的比较功效,并确定哪种干预措施最有效。方法检索PubMed、Embase、EBSCOhost、Scopus、Web of Science、APA PsycINFO、中国知网(CNKI)、万方、中国科学期刊数据库(VIP)和谷歌Scholar,检索年龄≥60岁受试者的TCEs随机对照试验(RCTs)。我们使用Stata 18.0版本进行了配对和网络荟萃分析。结果纳入17项随机对照试验,共1730名受试者。两两荟萃分析显示,与对照组相比,tce有效改善了老年人的睡眠障碍(SMD = -0.48, 95% CI [-0.69, -0.27], p <;0.01)。网络荟萃分析显示,气功-八段锦对老年人睡眠障碍的影响最大(supra: 90.9%),其次是太极拳(supra: 71.8%)和气功-六子觉(supra: 46.1%)。结论stce能有效改善老年人睡眠障碍,其中气功八段锦效果最强,太极拳、气功六子觉效果次之。然而,本综述的发现需要在特定的临床和患者背景下进行解释和应用。在将结果应用于临床实践时,必须仔细考虑患者的具体情况和临床需求。
{"title":"Comparative efficacy of traditional Chinese exercises for sleep disturbances in older people: A systematic review and Bayesian network meta‐analysis","authors":"Zhengyang Mei , Chenyi Cai , Chifong Lam , Tingfeng Wang , Shi Luo","doi":"10.1016/j.eujim.2025.102540","DOIUrl":"10.1016/j.eujim.2025.102540","url":null,"abstract":"<div><h3>Introduction</h3><div>Sleep disturbances are increasingly prevalent, with older people particularly vulnerable due to age-related changes and the cumulative impact of psychosocial and health-related stressors. The objective of this systematic review and Bayesian network meta-analysis was to evaluate the comparative efficacy of traditional Chinese exercises (TCEs) for improving sleep disturbances in older people and to identify which intervention is the most effective.</div></div><div><h3>Methods</h3><div>We searched PubMed, Embase, EBSCOhost, Scopus, Web of Science, APA PsycINFO, the China National Knowledge Infrastructure (CNKI), Wanfang, the Chinese Scientific Journal Database (VIP), and Google Scholar for randomized controlled trials (RCTs) of TCEs in participants aged ≥60 years. We conducted pairwise and network meta-analyses using Stata version 18.0.</div></div><div><h3>Results</h3><div>The analysis included 17 RCTs involving a total of 1,730 participants. Pairwise meta-analyses indicated that TCEs effectively improved sleep disturbances in older people compared to the control groups (SMD = -0.48, 95 % CI [-0.69, -0.27], <em>p</em> < 0.01). Network meta-analyses indicated that Qigong-Baduanjin exerted the strongest effect on older people’ sleep disturbances (SUCRA: 90.9 %), followed by Tai Chi (SUCRA: 71.8 %) and Qigong-Liuzijue (SUCRA: 46.1 %).</div></div><div><h3>Conclusions</h3><div>TCEs effectively improved sleep disturbances in older people, and Qigong-Baduanjin exerted the strongest effect, followed by Tai Chi and Qigong-Liuzijue. However, the findings of this review need to be interpreted and applied within specific clinical and patient contexts. When applying the results to clinical practice, careful consideration must be given to the specific circumstances and clinical needs of the patients.</div></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"78 ","pages":"Article 102540"},"PeriodicalIF":1.7,"publicationDate":"2025-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144829572","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 : 2025-08-07DOI: 10.1016/j.eujim.2025.102537
Yifan Yang , Qinghao Cai , Jiayu Huang , Runru Mai , Yuanyuan Hu , Lijun Ouyang , Zhimin Yang , Biyun Xu
Introduction
: Bailemian capsule is a Chinese patent medicine widely used for insomnia. Recently, numerous new randomized controlled trials (RCTs) have been published. Our objective was to evaluate the efficacy and safety of Bailemian capsule.
Methods
: Seven databases (EMBASE, PubMed, the Cochrane library, Web of Science, Chinese National Knowledge Infrastructure, Wanfang database and China Biomedical Literature database) were searched for RCTs of Bailemian capsule as of 24 February 2024. Primary outcomes were assessed with the Pittsburgh Sleep Quality Index (PSQI). The risk of bias was assessed by the Cochrane Collaboration's tool, and meta- analysis was performed using Review Manager 5.3. The review was registered in PROSPERO (CRD42024507706).
Results
: A total of 15 RCTs involving 1547 participants were included. Compared with monotherapy, combining Bailemian capsules with sedating psychotropic drugs (MD = -3.74, 95 % CI [-4.99, -2.48], Z = 5.85, P < 0.00001, I2= 87 %) or non-sedating psychotropic drugs (MD = -2.84, 95 % CI [-4.61, -1.08], Z = 3.16, P = 0.002, I2= 95 %) significantly reduced PSQI scores in patients with insomnia. The combination with non-sedating psychotropic drugs also significantly improved PSQI scores in patients with anxiety insomnia (MD = -1.28, 95 % CI [-1.85, -0.72], Z = 3.16, P < 0.00001, I2 = 0 %) and depressive/anxiety insomnia (MD = -4.34, 95 % CI [-4.91, -3.77], Z = 4.49, P < 0.00001, I2 = 0 %). Compared with sedating psychotropic drugs, the combination with Bailemian capsules led to greater reductions in PSQI scores in patients with insomnia disorder (MD = -3.55, 95 % CI: [-5.09, -2.00]; Z = 4.49, P = 0.0002, I2=92.9 %). Furthermore, the combination significantly reduced the incidence of adverse events compared with sedating (RR = 0.29, 95 % CI 0.17–0.50, Z = 4.47, P < 0.00001, I2 = 0 %) and non-sedating psychotropic drugs alone (RR = 0.42, 95 % CI 0.25–0.69, Z = 3.42, P = 0.0006, I2 = 0 %).
Conclusion
: This meta-analysis provides evidence for the efficacy and safety of Bailemian capsule in treating insomnia. However, with high heterogeneity and high risk of bias of the included studies, the recommendation of this conclusion remains cautious and requires further validation by high-quality clinical studies.
介绍:百乐眠胶囊是一种广泛用于治疗失眠的中成药。最近,许多新的随机对照试验(rct)被发表。我们的目的是评价百乐眠胶囊的有效性和安全性。方法:检索截至2024年2月24日的7个数据库(EMBASE、PubMed、Cochrane图书馆、Web of Science、中国国家知识基础设施、万方数据库和中国生物医学文献数据库),检索白莲面胶囊的rct。主要结果用匹兹堡睡眠质量指数(PSQI)进行评估。偏倚风险由Cochrane协作工具评估,meta分析使用Review Manager 5.3进行。该综述已在PROSPERO注册(CRD42024507706)。结果:共纳入15项rct, 1547名受试者。与单药治疗相比,百乐眠胶囊与镇静精神药物合用(MD = -3.74, 95% CI [-4.99, -2.48], Z = 5.85, P <;0.00001, I2= 87%)或非镇静性精神药物(MD = -2.84, 95% CI [-4.61, -1.08], Z = 3.16, P = 0.002, I2= 95%)显著降低失眠患者的PSQI评分。联用非镇静性精神药物也能显著改善焦虑性失眠患者的PSQI评分(MD = -1.28, 95% CI [-1.85, -0.72], Z = 3.16, P <;0.00001, I2 = 0%)和抑郁/焦虑性失眠(MD = -4.34, 95% CI [-4.91, -3.77], Z = 4.49, P <;0.00001, i2 = 0%)。与镇静精神药物相比,百乐眠胶囊对失眠患者PSQI评分的降低更大(MD = -3.55, 95% CI: [-5.09, - 2.50];Z = 4.49, p = 0.0002, i2 = 92.9%)。此外,与镇静相比,联合用药显著降低了不良事件的发生率(RR = 0.29, 95% CI 0.17-0.50, Z = 4.47, P <;0.00001, I2 = 0%)和单独使用非镇静性精神药物(RR = 0.42, 95% CI 0.25 ~ 0.69, Z = 3.42, P = 0.0006, I2 = 0%)。结论:本荟萃分析为百乐眠胶囊治疗失眠症的有效性和安全性提供了证据。然而,由于纳入的研究具有高异质性和高偏倚风险,该结论的推荐仍然是谨慎的,需要通过高质量的临床研究进一步验证。
{"title":"Bailemian capsule for insomnia: a systematic review with meta-analysis","authors":"Yifan Yang , Qinghao Cai , Jiayu Huang , Runru Mai , Yuanyuan Hu , Lijun Ouyang , Zhimin Yang , Biyun Xu","doi":"10.1016/j.eujim.2025.102537","DOIUrl":"10.1016/j.eujim.2025.102537","url":null,"abstract":"<div><h3>Introduction</h3><div><strong>:</strong> Bailemian capsule is a Chinese patent medicine widely used for insomnia. Recently, numerous new randomized controlled trials (RCTs) have been published. Our objective was to evaluate the efficacy and safety of Bailemian capsule.</div></div><div><h3>Methods</h3><div><strong>:</strong> Seven databases (EMBASE, PubMed, the Cochrane library, Web of Science, Chinese National Knowledge Infrastructure, Wanfang database and China Biomedical Literature database) were searched for RCTs of Bailemian capsule as of 24 February 2024. Primary outcomes were assessed with the Pittsburgh Sleep Quality Index (PSQI). The risk of bias was assessed by the Cochrane Collaboration's tool, and meta- analysis was performed using Review Manager 5.3. The review was registered in PROSPERO (CRD42024507706).</div></div><div><h3>Results</h3><div><strong>:</strong> A total of 15 RCTs involving 1547 participants were included. Compared with monotherapy, combining Bailemian capsules with sedating psychotropic drugs (MD = -3.74, 95 % CI [-4.99, -2.48], <em>Z</em> = 5.85, <em>P</em> < 0.00001, I<sup>2</sup>= 87 %) or non-sedating psychotropic drugs (MD = -2.84, 95 % CI [-4.61, -1.08], <em>Z</em> = 3.16, <em>P</em> = 0.002, I<sup>2</sup>= 95 %) significantly reduced PSQI scores in patients with insomnia. The combination with non-sedating psychotropic drugs also significantly improved PSQI scores in patients with anxiety insomnia (MD = -1.28, 95 % CI [-1.85, -0.72], <em>Z</em> = 3.16, <em>P</em> < 0.00001, I<sup>2</sup> = 0 %) and depressive/anxiety insomnia (MD = -4.34, 95 % CI [-4.91, -3.77], <em>Z</em> = 4.49, <em>P</em> < 0.00001, I<sup>2</sup> = 0 %). Compared with sedating psychotropic drugs, the combination with Bailemian capsules led to greater reductions in PSQI scores in patients with insomnia disorder (MD = -3.55, 95 % CI: [-5.09, -2.00]; <em>Z</em> = 4.49, <em>P</em> = 0.0002, I2=92.9 %). Furthermore, the combination significantly reduced the incidence of adverse events compared with sedating (RR = 0.29, 95 % CI 0.17–0.50, <em>Z</em> = 4.47, <em>P</em> < 0.00001, I<sup>2</sup> = 0 %) and non-sedating psychotropic drugs alone (RR = 0.42, 95 % CI 0.25–0.69, <em>Z</em> = 3.42, <em>P</em> = 0.0006, I<sup>2</sup> = 0 %).</div></div><div><h3>Conclusion</h3><div><strong>:</strong> This meta-analysis provides evidence for the efficacy and safety of Bailemian capsule in treating insomnia. However, with high heterogeneity and high risk of bias of the included studies, the recommendation of this conclusion remains cautious and requires further validation by high-quality clinical studies.</div></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"78 ","pages":"Article 102537"},"PeriodicalIF":1.7,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144828282","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}