Pub Date : 2025-01-01Epub Date: 2025-03-21DOI: 10.1159/000543959
Giuseppe Di Lorenzo, Carlo Buonerba, Raffaele Baio, Eleonora Monteleone, Francesco Passaro, Antonio Tufano, Vittorino Montanaro, Vittorio Riccio, Ilaria Gallo, Francesca Cappuccio, Oriana Strianese, Roberta Zarrella, Anna Buonocore, Federica Monaco, Antonio Verde, Giovanni Riccio, Valentina Izzo, Federica Fortino, Ferdinando Costabile, Luca Scafuri
Background: The Mediterranean lifestyle is widely recognized for its role in reducing the risk of chronic diseases, including cardiovascular diseases, type 2 diabetes, and cancer. The PREVESMED questionnaire was developed to evaluate adherence to this lifestyle, integrating dietary and non-dietary behaviors. Unlike existing tools, PREVESMED incorporates underexplored elements such as eating pace, herbal tea consumption, and physical activity, providing a multidimensional approach to lifestyle assessment.
Methods: The validation of PREVESMED was carried out as part of a planned interim analysis using data collected from participants in the PREVES-ENERGY survey, a cross-sectional study targeting 1,000 adults aged 18 years and above. To assess the reliability of the PREVESMED scale, internal consistency was evaluated using Cronbach's alpha, ensuring an acceptable level of reliability. To investigate the relationships between lifestyle factors, individual questionnaire items, and adherence to Mediterranean lifestyle according to the PREVESMED scale, a correlation analysis was performed. Additionally, to identify significant predictors of better adherence, a multivariable linear regression model was utilized, highlighting key factors influencing adherence. Finally, an exploratory factor analysis (EFA) was conducted to reveal the underlying structure of the PREVESMED scale, identifying key dimensions and their contributions to the total variance.
Results: The cohort analyzed for the preliminary validation of the PREVESMED questionnaire consisted of 268 participants, in line with the protocol's planned sample size. Internal consistency analysis demonstrated acceptable reliability (Cronbach's alpha = 0.628). In the correlation analysis, the strongest associations with the total PREVESMED score emerged for physical activity, extra virgin olive oil use, and fruit/vegetable consumption, whereas daily alcohol intake showed the weakest correlation. The multivariable linear regression highlighted higher education, lower BMI, nonsmoking status, higher WHO-5 scores, and older age as significant predictors of better adherence. Exploratory factor analysis identified five factors explaining 59.32% of the total variance.
Conclusion: Our findings suggest that the PREVESMED questionnaire is a promising, multidimensional tool for evaluating adherence to a Mediterranean lifestyle, demonstrating acceptable reliability and significant associations with key health indicators. Further refinement and extended validation - encompassing test-retest reliability, weighted scoring, and biomarker correlations - will strengthen its applicability across diverse populations.
{"title":"Development and Validation of the PREVESMED Questionnaire: A Comprehensive Tool for Assessing Adherence to a Mediterranean Lifestyle.","authors":"Giuseppe Di Lorenzo, Carlo Buonerba, Raffaele Baio, Eleonora Monteleone, Francesco Passaro, Antonio Tufano, Vittorino Montanaro, Vittorio Riccio, Ilaria Gallo, Francesca Cappuccio, Oriana Strianese, Roberta Zarrella, Anna Buonocore, Federica Monaco, Antonio Verde, Giovanni Riccio, Valentina Izzo, Federica Fortino, Ferdinando Costabile, Luca Scafuri","doi":"10.1159/000543959","DOIUrl":"10.1159/000543959","url":null,"abstract":"<p><strong>Background: </strong>The Mediterranean lifestyle is widely recognized for its role in reducing the risk of chronic diseases, including cardiovascular diseases, type 2 diabetes, and cancer. The PREVESMED questionnaire was developed to evaluate adherence to this lifestyle, integrating dietary and non-dietary behaviors. Unlike existing tools, PREVESMED incorporates underexplored elements such as eating pace, herbal tea consumption, and physical activity, providing a multidimensional approach to lifestyle assessment.</p><p><strong>Methods: </strong>The validation of PREVESMED was carried out as part of a planned interim analysis using data collected from participants in the PREVES-ENERGY survey, a cross-sectional study targeting 1,000 adults aged 18 years and above. To assess the reliability of the PREVESMED scale, internal consistency was evaluated using Cronbach's alpha, ensuring an acceptable level of reliability. To investigate the relationships between lifestyle factors, individual questionnaire items, and adherence to Mediterranean lifestyle according to the PREVESMED scale, a correlation analysis was performed. Additionally, to identify significant predictors of better adherence, a multivariable linear regression model was utilized, highlighting key factors influencing adherence. Finally, an exploratory factor analysis (EFA) was conducted to reveal the underlying structure of the PREVESMED scale, identifying key dimensions and their contributions to the total variance.</p><p><strong>Results: </strong>The cohort analyzed for the preliminary validation of the PREVESMED questionnaire consisted of 268 participants, in line with the protocol's planned sample size. Internal consistency analysis demonstrated acceptable reliability (Cronbach's alpha = 0.628). In the correlation analysis, the strongest associations with the total PREVESMED score emerged for physical activity, extra virgin olive oil use, and fruit/vegetable consumption, whereas daily alcohol intake showed the weakest correlation. The multivariable linear regression highlighted higher education, lower BMI, nonsmoking status, higher WHO-5 scores, and older age as significant predictors of better adherence. Exploratory factor analysis identified five factors explaining 59.32% of the total variance.</p><p><strong>Conclusion: </strong>Our findings suggest that the PREVESMED questionnaire is a promising, multidimensional tool for evaluating adherence to a Mediterranean lifestyle, demonstrating acceptable reliability and significant associations with key health indicators. Further refinement and extended validation - encompassing test-retest reliability, weighted scoring, and biomarker correlations - will strengthen its applicability across diverse populations.</p>","PeriodicalId":10541,"journal":{"name":"Complementary Medicine Research","volume":" ","pages":"138-150"},"PeriodicalIF":1.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691204","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 : 2025-01-01Epub Date: 2025-03-24DOI: 10.1159/000544956
Jinjin Yin, Ming Yin, Tianwen Liu, Shumin Qin
Introduction: The role of acupuncture in treating gastroesophageal reflux disease (GERD) has been previously investigated; however, it is unclear whether manual acupuncture is effective for treating GERD. This study aimed to evaluate the effectiveness and safety of manual acupuncture in treating GERD.
Methods: Potentially eligible studies were identified from PubMed, Embase, Cochrane Central Registry for Controlled Trials (CENTRAL), China National Knowledge Infrastructure (CNKI), and the Chinese Biomedical Literature Database (Sinomed). Sensitivity analysis was conducted through excluding low-quality studies. Subgroup analysis was performed according to different proton pump inhibitors (PPIs) and treatment duration. Certainty of evidence was rated using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) framework.
Results: Based on 504 records, 12 relevant studies were included in our meta-analysis. Trial sequential analysis confirmed that manual acupuncture improved symptom scores (mean difference [MD] = -3.43, 95% CI = -5.14 to -1.73, I2 = 88%, p < 0.001, very low evidence) and reduced recurrence rates (risk ratio [RR] = 0.32, 95% confidence interval = 0.16 to 0.64, I2 = 0%, p = 0.001, very low evidence). Although meta-analysis showed no difference in adverse events between manual acupuncture and PPIs (RR = 0.38, 95% CI = 0.09 to 1.58, I2 = 0%, p = 0.18, very low evidence), TSA revealed extremely insufficient statistical power. Furthermore, the global symptom improvement rate was lower with acupuncture compared to PPIs (RR = 1.22, 95% CI = 1.14 to 1.30, I2 = 18%, p < 0.001, low evidence). Sensitivity analysis demonstrated the robustness of the results. Subgroup analysis suggested the therapeutic effects of manual acupuncture alone irrespective of categories of PPIs and treatment duration.
Conclusion: Manual acupuncture has the potential to alleviate the severity of symptoms and decrease the recurrence rate in patients with GERD. However, considering the efficacy of PPI therapy in significantly improving overall symptoms, along with its established safety profile and extensive clinical utilization over the years, we do not recommend manual acupuncture alone as the primary treatment for patients with GERD.
{"title":"Does Manual Acupuncture Improve Gastroesophageal Reflux Disease Symptoms? A Trial Sequential Meta-Analysis.","authors":"Jinjin Yin, Ming Yin, Tianwen Liu, Shumin Qin","doi":"10.1159/000544956","DOIUrl":"10.1159/000544956","url":null,"abstract":"<p><strong>Introduction: </strong>The role of acupuncture in treating gastroesophageal reflux disease (GERD) has been previously investigated; however, it is unclear whether manual acupuncture is effective for treating GERD. This study aimed to evaluate the effectiveness and safety of manual acupuncture in treating GERD.</p><p><strong>Methods: </strong>Potentially eligible studies were identified from PubMed, Embase, Cochrane Central Registry for Controlled Trials (CENTRAL), China National Knowledge Infrastructure (CNKI), and the Chinese Biomedical Literature Database (Sinomed). Sensitivity analysis was conducted through excluding low-quality studies. Subgroup analysis was performed according to different proton pump inhibitors (PPIs) and treatment duration. Certainty of evidence was rated using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) framework.</p><p><strong>Results: </strong>Based on 504 records, 12 relevant studies were included in our meta-analysis. Trial sequential analysis confirmed that manual acupuncture improved symptom scores (mean difference [MD] = -3.43, 95% CI = -5.14 to -1.73, I2 = 88%, p < 0.001, very low evidence) and reduced recurrence rates (risk ratio [RR] = 0.32, 95% confidence interval = 0.16 to 0.64, I2 = 0%, p = 0.001, very low evidence). Although meta-analysis showed no difference in adverse events between manual acupuncture and PPIs (RR = 0.38, 95% CI = 0.09 to 1.58, I2 = 0%, p = 0.18, very low evidence), TSA revealed extremely insufficient statistical power. Furthermore, the global symptom improvement rate was lower with acupuncture compared to PPIs (RR = 1.22, 95% CI = 1.14 to 1.30, I2 = 18%, p < 0.001, low evidence). Sensitivity analysis demonstrated the robustness of the results. Subgroup analysis suggested the therapeutic effects of manual acupuncture alone irrespective of categories of PPIs and treatment duration.</p><p><strong>Conclusion: </strong>Manual acupuncture has the potential to alleviate the severity of symptoms and decrease the recurrence rate in patients with GERD. However, considering the efficacy of PPI therapy in significantly improving overall symptoms, along with its established safety profile and extensive clinical utilization over the years, we do not recommend manual acupuncture alone as the primary treatment for patients with GERD.</p>","PeriodicalId":10541,"journal":{"name":"Complementary Medicine Research","volume":" ","pages":"233-243"},"PeriodicalIF":1.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143699874","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: Aromatherapy has not accrued enough evidence to be integrated into standardized clinical medicine. If high-quality evidence supports the effects of aromatherapy, it will be handled as a parallel option to standardized medical treatment. The aromatherapeutic impact of peppermint (Mentha × piperita L.) essential oil has been researched to a certain extent, such as on pain, anxiety, fatigue, or depression. Considering the rising expenditure on dementia care, the potential effects of peppermint scents on cognition have become increasingly significant. Therefore, we performed a scoping review of the studies on the impact of peppermint scents on cognition and attention.
Methods: We focused on human research, and the effects of peppermint scents were required to be inhaled. According to the inclusion criteria, searching from PubMed, Scopus, and Gale Academic OneFile, we identified a total of 115 studies. Finally, eight references were selected for review. The risk of bias was analyzed according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) criteria.
Results: Each reviewed reference had its own strength in investigating the effects of peppermint scents. However, as most studies have noted, the impact of peppermint scent should be assessed from multiple perspectives, including psychological, physiological, neurological, and pharmacological factors. The risk of bias was not found to be severe (high risk of bias rate: 35.7 ± 3.4%); our critical review elucidated the heterogeneity of the reviewed studies.
Conclusion: In summary, drawing a definitive conclusion at this stage is premature. Therefore, more carefully designed studies are needed to confirm this hypothesis.
{"title":"Heterogeneity in the Study of Peppermint in Aromatherapy on Cognition and Attention: A Critical Scoping Review.","authors":"Ryusei Nishi, Kenichiro Sagiyama, Takamasa Fukumoto, Haruka Amitani, Akihiro Asakawa","doi":"10.1159/000543974","DOIUrl":"10.1159/000543974","url":null,"abstract":"<p><strong>Introduction: </strong>Aromatherapy has not accrued enough evidence to be integrated into standardized clinical medicine. If high-quality evidence supports the effects of aromatherapy, it will be handled as a parallel option to standardized medical treatment. The aromatherapeutic impact of peppermint (Mentha × piperita L.) essential oil has been researched to a certain extent, such as on pain, anxiety, fatigue, or depression. Considering the rising expenditure on dementia care, the potential effects of peppermint scents on cognition have become increasingly significant. Therefore, we performed a scoping review of the studies on the impact of peppermint scents on cognition and attention.</p><p><strong>Methods: </strong>We focused on human research, and the effects of peppermint scents were required to be inhaled. According to the inclusion criteria, searching from PubMed, Scopus, and Gale Academic OneFile, we identified a total of 115 studies. Finally, eight references were selected for review. The risk of bias was analyzed according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) criteria.</p><p><strong>Results: </strong>Each reviewed reference had its own strength in investigating the effects of peppermint scents. However, as most studies have noted, the impact of peppermint scent should be assessed from multiple perspectives, including psychological, physiological, neurological, and pharmacological factors. The risk of bias was not found to be severe (high risk of bias rate: 35.7 ± 3.4%); our critical review elucidated the heterogeneity of the reviewed studies.</p><p><strong>Conclusion: </strong>In summary, drawing a definitive conclusion at this stage is premature. Therefore, more carefully designed studies are needed to confirm this hypothesis.</p>","PeriodicalId":10541,"journal":{"name":"Complementary Medicine Research","volume":" ","pages":"224-232"},"PeriodicalIF":1.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540422","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 : 2025-01-01Epub Date: 2025-04-04DOI: 10.1159/000545128
Reinhard Saller, Herbert Schwabl, Matthias Rostock, Maja Dal Cero
<p><p>Am Beispiel des in verschiedenen lokalen Traditionen genutzten Blutwurz, auch Tormentill (Potentilla erecta L.), wird exemplarisch eine offensichtliche Kluft zwischen üblichen indikationsgetriebenen Zulassungsverfahren und der empirischen Realität sowie dem Potential vieler Heilpflanzen aufgezeigt. Für Tormentillae rhizoma ist ein breites Spektrum an Inhaltsstoffen und das mit dem Vielstoffgemisch einhergehende Wirkprofil einer u.a. vielfältig antiinflammatorisch wirkenden systemischen Droge experimentell belegt. Die traditionelle Empirie der dämpfenden Effekte im Entzündungsgeschehen wird dadurch plausibilisiert. Die moderne Forschung liefert also Daten für einen sinnvollen Einsatz einer gut verträglichen Heilpflanze mit vielfältigen Anwendungsmöglichkeiten für Haut und Schleimhaut (innerlich und äusserlich). Auf dem Markt gibt es aber, abgesehen von vereinzelten topischen Spezialitäten und Arzneitees, kaum Zubereitungen als zugelassene Arzneispezialität. Denn die derzeitige Praxis der Arzneimittelzulassung bevorzugt die spezifischen und organbezogenen Wirkungen und übersieht dabei das systemische Potential, die Modulationsfähigkeit dieser natürlichen Stoffgemische, wie sie durch traditionelle und empirische Belege angezeigt wird. Systemische Wirkungen zeigen ihre Stärke gerade im Zusammenspiel mit anderen Therapien insbesondere beim additiven Einsatz mit Spezifika, indem sie bestimmte Wirkungen verstärken bzw. abschwächen oder die Verträglichkeit der Spezifika erhöhen bzw. deren Nebenwirkungen abmildern. Die Kombination von spezifisch wirkenden Arzneimitteln mit solchen Systemmitteln (wie z.B. Blutwurz/Tormentill) stellt damit eine weitere Therapieoption dar, die als sinnvolle Ergänzung, wenn nicht sogar als Grundlage bei Prävention, Therapie und Lebensgestaltung zu werten ist.</p><p><p>The example of tormentil (<italic>Potentilla erecta</italic> L.), which is used in various local traditions, is taken to illustrate an obvious gap between the common indication-driven authorization procedures and the empirical reality and potential of many medicinal plants. For <italic>Tormentillae rhizoma</italic>, a broad spectrum of active compounds and the active profile of a systemic drug with multiple anti-inflammatory effects have been experimentally proven. The traditional empiricism of the dampening effects in the inflammatory process is thus made plausible. Modern research, therefore, provides data for the effective use of a well-tolerated medicinal plant with a wide range of possible applications for the skin and mucous membranes (internally and externally). However, apart from a few topical specialties and medicinal teas, there are hardly any preparations on the market as authorized medicinal specialties. This is because the current practice of marketing authorization favors the specific and organ-related effects and overlooks the systemic potential, the modulation capacity of these natural substance mixtures, as indicated by traditional and em
{"title":"[Vom Spezifischen zum Systemischen - am Beispiel Tormentill/Blutwurz, der Heilpflanze des Jahres 2024].","authors":"Reinhard Saller, Herbert Schwabl, Matthias Rostock, Maja Dal Cero","doi":"10.1159/000545128","DOIUrl":"10.1159/000545128","url":null,"abstract":"<p><p>Am Beispiel des in verschiedenen lokalen Traditionen genutzten Blutwurz, auch Tormentill (Potentilla erecta L.), wird exemplarisch eine offensichtliche Kluft zwischen üblichen indikationsgetriebenen Zulassungsverfahren und der empirischen Realität sowie dem Potential vieler Heilpflanzen aufgezeigt. Für Tormentillae rhizoma ist ein breites Spektrum an Inhaltsstoffen und das mit dem Vielstoffgemisch einhergehende Wirkprofil einer u.a. vielfältig antiinflammatorisch wirkenden systemischen Droge experimentell belegt. Die traditionelle Empirie der dämpfenden Effekte im Entzündungsgeschehen wird dadurch plausibilisiert. Die moderne Forschung liefert also Daten für einen sinnvollen Einsatz einer gut verträglichen Heilpflanze mit vielfältigen Anwendungsmöglichkeiten für Haut und Schleimhaut (innerlich und äusserlich). Auf dem Markt gibt es aber, abgesehen von vereinzelten topischen Spezialitäten und Arzneitees, kaum Zubereitungen als zugelassene Arzneispezialität. Denn die derzeitige Praxis der Arzneimittelzulassung bevorzugt die spezifischen und organbezogenen Wirkungen und übersieht dabei das systemische Potential, die Modulationsfähigkeit dieser natürlichen Stoffgemische, wie sie durch traditionelle und empirische Belege angezeigt wird. Systemische Wirkungen zeigen ihre Stärke gerade im Zusammenspiel mit anderen Therapien insbesondere beim additiven Einsatz mit Spezifika, indem sie bestimmte Wirkungen verstärken bzw. abschwächen oder die Verträglichkeit der Spezifika erhöhen bzw. deren Nebenwirkungen abmildern. Die Kombination von spezifisch wirkenden Arzneimitteln mit solchen Systemmitteln (wie z.B. Blutwurz/Tormentill) stellt damit eine weitere Therapieoption dar, die als sinnvolle Ergänzung, wenn nicht sogar als Grundlage bei Prävention, Therapie und Lebensgestaltung zu werten ist.</p><p><p>The example of tormentil (<italic>Potentilla erecta</italic> L.), which is used in various local traditions, is taken to illustrate an obvious gap between the common indication-driven authorization procedures and the empirical reality and potential of many medicinal plants. For <italic>Tormentillae rhizoma</italic>, a broad spectrum of active compounds and the active profile of a systemic drug with multiple anti-inflammatory effects have been experimentally proven. The traditional empiricism of the dampening effects in the inflammatory process is thus made plausible. Modern research, therefore, provides data for the effective use of a well-tolerated medicinal plant with a wide range of possible applications for the skin and mucous membranes (internally and externally). However, apart from a few topical specialties and medicinal teas, there are hardly any preparations on the market as authorized medicinal specialties. This is because the current practice of marketing authorization favors the specific and organ-related effects and overlooks the systemic potential, the modulation capacity of these natural substance mixtures, as indicated by traditional and em","PeriodicalId":10541,"journal":{"name":"Complementary Medicine Research","volume":" ","pages":"260-263"},"PeriodicalIF":1.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143794945","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: The escalating prevalence and severity of obesity and its associated comorbidities globally necessitate effective interventions. This randomized open-label clinical study aims to assess the efficacy of amla (Emblica officinalis) extract AMX-160 in adult individuals with obesity.
Trial design: This study is a randomized, open-label clinical study conducted at Rajalakshmi Hospital, Mangalore. The study adhered to the declaration of Helsinki and ICH-GCP guidelines, with protocol approval from institutional ethics committee and registration with the Clinical Trials Registry - India (CTRI/2019/01/017201). All participants provided written, signed, and dated informed consent before any study-related procedures.
Methods: Forty obese patients were enrolled and divided into two groups. AMX-160 capsules, at doses of 500 mg once daily (AMX-M1) and twice daily (AMX-M2), were administered. Patients were monitored as outpatients for 90 days. Efficacy assessments included anthropometric measurements, bioelectric impedance analysis, lipid profile analysis, and the Global Physical Activity Questionnaire (GPAQ) at scheduled visits.
Results: Supplementation with 1 g of AMX-160 (500 mg twice daily) significantly (p < 0.05) reduced visceral fat, increased skeletal muscle mass, and decreased subcutaneous fat. Additionally, it effectively decreased body age and various anthropometric parameters (e.g., waist circumference, waist-to-hip ratio) significantly (p < 0.05), along with reducing BMI, body weight, and improving lipid profile (p < 0.05). The 500 mg once daily dose also significantly (p < 0.05) impacted most parameters. Physical activity levels remained consistent in both groups throughout the study (p > 0.05).
Conclusion: The amla extract AMX-160 (Tri-Low®) demonstrated efficacy in reducing subcutaneous and visceral fat, waist circumference, and body age, while increasing skeletal muscle mass. These findings suggest its potential as a supplement for managing obesity and its associated disorders.
{"title":"Effect of Amla Extract on Body Mass Index, Waist Circumference, Total Body Fat, Visceral Fat, Skeletal Muscle Mass, Body Age, and Related Parameters: A Randomized, Open-Label Clinical Study in Obese Participants.","authors":"Deepa Suhag, Raksha Rathore, Ankia Yadav, Avni Khatkar, Deepa Suhag, Giriraja Kanakapura Vrushabaiah, Suman Govindaraj","doi":"10.1159/000545247","DOIUrl":"10.1159/000545247","url":null,"abstract":"<p><strong>Background: </strong>The escalating prevalence and severity of obesity and its associated comorbidities globally necessitate effective interventions. This randomized open-label clinical study aims to assess the efficacy of amla (Emblica officinalis) extract AMX-160 in adult individuals with obesity.</p><p><strong>Trial design: </strong>This study is a randomized, open-label clinical study conducted at Rajalakshmi Hospital, Mangalore. The study adhered to the declaration of Helsinki and ICH-GCP guidelines, with protocol approval from institutional ethics committee and registration with the Clinical Trials Registry - India (CTRI/2019/01/017201). All participants provided written, signed, and dated informed consent before any study-related procedures.</p><p><strong>Methods: </strong>Forty obese patients were enrolled and divided into two groups. AMX-160 capsules, at doses of 500 mg once daily (AMX-M1) and twice daily (AMX-M2), were administered. Patients were monitored as outpatients for 90 days. Efficacy assessments included anthropometric measurements, bioelectric impedance analysis, lipid profile analysis, and the Global Physical Activity Questionnaire (GPAQ) at scheduled visits.</p><p><strong>Results: </strong>Supplementation with 1 g of AMX-160 (500 mg twice daily) significantly (p < 0.05) reduced visceral fat, increased skeletal muscle mass, and decreased subcutaneous fat. Additionally, it effectively decreased body age and various anthropometric parameters (e.g., waist circumference, waist-to-hip ratio) significantly (p < 0.05), along with reducing BMI, body weight, and improving lipid profile (p < 0.05). The 500 mg once daily dose also significantly (p < 0.05) impacted most parameters. Physical activity levels remained consistent in both groups throughout the study (p > 0.05).</p><p><strong>Conclusion: </strong>The amla extract AMX-160 (Tri-Low®) demonstrated efficacy in reducing subcutaneous and visceral fat, waist circumference, and body age, while increasing skeletal muscle mass. These findings suggest its potential as a supplement for managing obesity and its associated disorders.</p>","PeriodicalId":10541,"journal":{"name":"Complementary Medicine Research","volume":" ","pages":"326-340"},"PeriodicalIF":0.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143969099","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 : 2025-01-01Epub Date: 2025-09-04DOI: 10.1159/000547567
William W N Tsang, Yuen Ting Wong, Joshua S H Tsang
Introduction: The aim of this study was to investigate the effects of 3 months of seated Tai Chi (TC) practice on the eye-hand coordination and sitting balance control of subjects with Parkinson's disease.
Method: A prospective non-randomized study was conducted with 29 subjects practicing TC and 27 subjects as controls according to their preference. The seated TC group underwent 3 months of training with a total of 24 sessions (1 h/session, 2 sessions/week). The outcome measures included a dynamic finger-pointing task (reaction time, movement time, and accuracy), and a sequential weight-shifting balance control test (completion time) while seated.
Results: The TC group showed faster movement time in the dynamic finger-pointing task (p = 0.003). They also achieved a faster completion time of the sequential weight-shifting balance test (p = 0.021). No significant difference was observed in the control group.
Conclusions: The results demonstrate that 3 months of seated TC training could improve movement time in the finger-pointing task and sitting balance control in subjects with Parkinson's disease. A future randomized controlled trial is warranted.
{"title":"Seated Tai Chi Improves Dynamic Finger-Pointing Task and Sitting Balance Control in Subjects with Parkinson's Disease: A Prospective Comparative Observational Study.","authors":"William W N Tsang, Yuen Ting Wong, Joshua S H Tsang","doi":"10.1159/000547567","DOIUrl":"10.1159/000547567","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study was to investigate the effects of 3 months of seated Tai Chi (TC) practice on the eye-hand coordination and sitting balance control of subjects with Parkinson's disease.</p><p><strong>Method: </strong>A prospective non-randomized study was conducted with 29 subjects practicing TC and 27 subjects as controls according to their preference. The seated TC group underwent 3 months of training with a total of 24 sessions (1 h/session, 2 sessions/week). The outcome measures included a dynamic finger-pointing task (reaction time, movement time, and accuracy), and a sequential weight-shifting balance control test (completion time) while seated.</p><p><strong>Results: </strong>The TC group showed faster movement time in the dynamic finger-pointing task (p = 0.003). They also achieved a faster completion time of the sequential weight-shifting balance test (p = 0.021). No significant difference was observed in the control group.</p><p><strong>Conclusions: </strong>The results demonstrate that 3 months of seated TC training could improve movement time in the finger-pointing task and sitting balance control in subjects with Parkinson's disease. A future randomized controlled trial is warranted.</p>","PeriodicalId":10541,"journal":{"name":"Complementary Medicine Research","volume":" ","pages":"273-282"},"PeriodicalIF":0.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144999833","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 : 2025-01-01Epub Date: 2025-07-02DOI: 10.1159/000547181
Jozélio Freire de Carvalho, Aaron Lerner, Carina Benzvi
Background: Garlic and garlic extract (GE) are highly consumed traditional and popular food spices. They are reported to have antioxidant, anti-inflammatory, and infection-protecting properties. The aim of this study was to review the use of GE in various rheumatic diseases.
Summary: PubMed/MEDLINE, Embase, and SciELO were searched for articles on GE and rheumatic diseases between 1966 and May 2024. Four articles were found, including 176 patients. The investigated diseases were rheumatoid arthritis (RA) (n = 3) and osteoarthritis (OA) (n = 1). Age varied from 51.06 ± 13.8 to 58.9 ± 7.5 years old, and female gender was the only one included in all studies. The disease duration was 6.58 ± 7.75 years. The GE dosage ranged from 600 mg to 1,000 mg/day. The follow-up ranged from 4 to 12 weeks. All articles demonstrated improvements in the diverse rheumatic disease parameters (e.g., pain, function, disease activity, tender and swollen joints, stiffness, and WOMAC) and reduced inflammatory biomarkers (C-reactive protein, tumor necrosis factor, malondialdehyde).
Key messages: GE is a safe and well-tolerated therapy for RA and OA. However, studies with more participants are needed to confirm, replicate, and further explore the topic.
{"title":"Garlic Extract in Rheumatological Diseases: A Systematic Review.","authors":"Jozélio Freire de Carvalho, Aaron Lerner, Carina Benzvi","doi":"10.1159/000547181","DOIUrl":"10.1159/000547181","url":null,"abstract":"<p><strong>Background: </strong>Garlic and garlic extract (GE) are highly consumed traditional and popular food spices. They are reported to have antioxidant, anti-inflammatory, and infection-protecting properties. The aim of this study was to review the use of GE in various rheumatic diseases.</p><p><strong>Summary: </strong>PubMed/MEDLINE, Embase, and SciELO were searched for articles on GE and rheumatic diseases between 1966 and May 2024. Four articles were found, including 176 patients. The investigated diseases were rheumatoid arthritis (RA) (n = 3) and osteoarthritis (OA) (n = 1). Age varied from 51.06 ± 13.8 to 58.9 ± 7.5 years old, and female gender was the only one included in all studies. The disease duration was 6.58 ± 7.75 years. The GE dosage ranged from 600 mg to 1,000 mg/day. The follow-up ranged from 4 to 12 weeks. All articles demonstrated improvements in the diverse rheumatic disease parameters (e.g., pain, function, disease activity, tender and swollen joints, stiffness, and WOMAC) and reduced inflammatory biomarkers (C-reactive protein, tumor necrosis factor, malondialdehyde).</p><p><strong>Key messages: </strong>GE is a safe and well-tolerated therapy for RA and OA. However, studies with more participants are needed to confirm, replicate, and further explore the topic.</p>","PeriodicalId":10541,"journal":{"name":"Complementary Medicine Research","volume":" ","pages":"296-300"},"PeriodicalIF":0.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144552517","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}
Pub Date : 2025-01-01Epub Date: 2025-09-01DOI: 10.1159/000547403
Silin Ou, Ming Dong, Ying Wei, Hongmei Huan, Wenqian Wang
Background: With a wide range of clinical needs, evidence-based support for acupuncture therapy through clinical trials is essential for enhancing its scientific value, clinical application, and international influence.
Objective: The aim of this study was to provide design ideas and specific methodology references for acupuncturists and researchers for the design, implementation, and publication of high-level acupuncture clinical research.
Data sources: The data came from PubMed, Web of Science, and EBSCO databases since its inception until February 28, 2024. A total of 89 articles were retrieved, and the primary interventions were manual acupuncture, electroacupuncture, auricular acupuncture, and laser acupuncture. Eighty-five clinical trials on manual acupuncture and electroacupuncture as primary interventions were included.
Results: All of the high-quality clinical trial publications on acupuncture included in the review adhered to the Consolidated Standards of Reporting Trials (CONSORT) statement and the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). They demonstrated rigor and accuracy in trial design selection, inclusion criteria development, sample size calculations, and statistical methodology, and provided clear, concise details of acupuncture interventions and control settings.
Conclusion: These trials have elevated the overall quality of the research and provided invaluable insights and methodological frameworks for designing randomized controlled trials (RCTs) in acupuncture. Despite these advancements, several limitations remain that warrant attention in future endeavors. Addressing these shortcomings is crucial for enhancing the methodological rigor and reliability of acupuncture trials and advancing evidence-based practice in this field.
背景:针灸治疗具有广泛的临床需求,通过临床试验为针灸疗法提供循证支持是提高其科学价值、临床应用和国际影响力的必要条件。目的:为针灸师和科研人员设计、实施和发表高水平针灸临床研究提供设计思路和具体方法论参考。数据来源:数据来自Pubmed, Web of Science和EBSCO数据库,从成立到2024年2月28日。共检索到91篇文献,主要干预措施为手针、电针、耳针和激光针。纳入85项以手针和电针为主要干预措施的临床试验。结果:纳入本综述的所有高质量的针灸临床试验出版物均遵守试验综合报告标准(CONSORT)声明和针灸临床试验干预措施报告标准(STRICTA)。他们在试验设计选择、纳入标准制定、样本量计算、统计方法方面表现出严谨性和准确性,并提供了针灸干预和对照设置的清晰、简明的细节。结论:这些试验提高了研究的整体质量,并为设计针灸随机对照试验(rct)提供了宝贵的见解和方法框架。尽管取得了这些进步,但仍存在一些限制,值得在未来的努力中加以注意。解决这些缺点对于提高针灸试验方法的严谨性和可靠性以及推进该领域的循证实践至关重要。
{"title":"Commonality Analysis of High-Quality Acupuncture Clinical Trial Articles.","authors":"Silin Ou, Ming Dong, Ying Wei, Hongmei Huan, Wenqian Wang","doi":"10.1159/000547403","DOIUrl":"10.1159/000547403","url":null,"abstract":"<p><strong>Background: </strong>With a wide range of clinical needs, evidence-based support for acupuncture therapy through clinical trials is essential for enhancing its scientific value, clinical application, and international influence.</p><p><strong>Objective: </strong>The aim of this study was to provide design ideas and specific methodology references for acupuncturists and researchers for the design, implementation, and publication of high-level acupuncture clinical research.</p><p><strong>Data sources: </strong>The data came from PubMed, Web of Science, and EBSCO databases since its inception until February 28, 2024. A total of 89 articles were retrieved, and the primary interventions were manual acupuncture, electroacupuncture, auricular acupuncture, and laser acupuncture. Eighty-five clinical trials on manual acupuncture and electroacupuncture as primary interventions were included.</p><p><strong>Results: </strong>All of the high-quality clinical trial publications on acupuncture included in the review adhered to the Consolidated Standards of Reporting Trials (CONSORT) statement and the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). They demonstrated rigor and accuracy in trial design selection, inclusion criteria development, sample size calculations, and statistical methodology, and provided clear, concise details of acupuncture interventions and control settings.</p><p><strong>Conclusion: </strong>These trials have elevated the overall quality of the research and provided invaluable insights and methodological frameworks for designing randomized controlled trials (RCTs) in acupuncture. Despite these advancements, several limitations remain that warrant attention in future endeavors. Addressing these shortcomings is crucial for enhancing the methodological rigor and reliability of acupuncture trials and advancing evidence-based practice in this field.</p>","PeriodicalId":10541,"journal":{"name":"Complementary Medicine Research","volume":" ","pages":"314-325"},"PeriodicalIF":0.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945755","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 : 2025-01-01Epub 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}