Jiyoon Won , Ji-Yeon Han , Yu-jin Ji , Dohyung Ha , Bong Jae Han , Hyangsook Lee
{"title":"Drug trials are more likely to disclose full placebo control information than non-drug trials: A cross-sectional study of participant information leaflets of placebo-controlled trials","authors":"Jiyoon Won , Ji-Yeon Han , Yu-jin Ji , Dohyung Ha , Bong Jae Han , Hyangsook Lee","doi":"10.1016/j.imr.2024.101043","DOIUrl":"10.1016/j.imr.2024.101043","url":null,"abstract":"<div><h3>Background</h3><p>This study aimed to investigate whether placebo control is differently disclosed in drug and non-drug randomised clinical trial (RCT) participant information leaflets (PILs) and how this might affect participant blinding and direction of study outcomes.</p></div><div><h3>Methods</h3><p>PILs were obtained from trials registered in the International Standard Randomised Controlled Trial Number database via email. Placebo descriptions in PILs were categorised as Full Disclosure (FD), Partial Disclosure (PD), or Missing Information (MI). Associations between intervention type (drug or non-drug)/placebo disclosure (FD or PD/MI) and participant blinding success/trial outcome direction (positive or non-positive) were examined using a two-sided Fisher's exact test.</p></div><div><h3>Results</h3><p>Of 116 collected PILs, 56 % were for drug trials and 44 % were for non-drug trials. Among them, 88 PILs had the corresponding publications available and 68 reports specified primary outcomes. Drug trials were more likely to fully disclose placebo information than non-drug trials (92.3 % vs. 74.5 %, <em>p</em> < 0.05). However, the success rate of blinding was only reported in 3 out of 88 trial publications (3.4 %), precluding further analysis. Furthermore, there was no significant association between the direction of trial results and the type of intervention or placebo disclosure.</p></div><div><h3>Conclusion</h3><p>Our study findings suggest that drug and non-drug RCTs might differ in the way they reveal placebo control information. Further research is warranted to understand what leads to more common PD of placebo information in non-drug trials than drug trials and to determine the optimal placebo control disclosure in specific trial context.</p></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"13 2","pages":"Article 101043"},"PeriodicalIF":3.4,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2213422024000234/pdfft?md5=13159ddb3fea15c5dcd0f4fd680e1da0&pid=1-s2.0-S2213422024000234-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140789870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xiaotong Li , Raymond E. Baser , Karolina Bryl , Lindsay Amann , Susan Chimonas , Jun J. Mao
{"title":"How does pretreatment expectancy influence pain outcomes with electroacupuncture and battlefield acupuncture in cancer survivors?","authors":"Xiaotong Li , Raymond E. Baser , Karolina Bryl , Lindsay Amann , Susan Chimonas , Jun J. Mao","doi":"10.1016/j.imr.2024.101040","DOIUrl":"10.1016/j.imr.2024.101040","url":null,"abstract":"<div><h3>Background</h3><p>Outcome expectancy is an important component of non-specific effect that may play an important role in pain research and clinical care. We sought to evaluate whether pretreatment expectancy predicts pain reduction in cancer survivors receiving electroacupuncture (EA) or battlefield acupuncture (BFA).</p></div><div><h3>Methods</h3><p>We analyzed data from a randomized clinical trial that compared EA and BFA versus wait list control (WLC) for chronic musculoskeletal pain in cancer survivors. Expectancy was measured by the Acupuncture Expectancy Scale (AES) at baseline. Pain severity was assessed using the Brief Pain Inventory (BPI) at baseline and week 12. For each treatment arm, multivariable regression models were used to evaluate the association between pretreatment expectancy and week 12 pain severity, controlling for baseline pain severity, age, sex, race, and education.</p></div><div><h3>Results</h3><p>Among 360 participants enrolled, the mean age was 62.1 years (SD 12.7), with 251 (69.7 %) women and 88 (24.4 %) non-white survivors. Pretreatment expectancy was similar for all groups at baseline (EA: 13.9 ± 3.6; BFA: 13.2 ± 3.7, WLC:12.8 ± 3.3, <em>p</em> = 0.14). Greater pretreatment expectancy was not significantly associated with greater pain reduction in any group, after adjusting for co-variates (EA: Coef. = -0.05, 95 % CI = -0.14 – 0.04, <em>p</em> = 0.28; BFA: Coef. = -0.07, 95 % CI = -0.16 – 0.02, <em>p</em> = 0.15; WLC: Coef. = -0.09, 95 % CI = -0.25 – 0.06, <em>p</em> = 0.23).</p></div><div><h3>Conclusions</h3><p>Pretreatment expectancy did not predict pain reduction for either EA or BFA in cancer survivors. Our study contributes to the interpretation of analgesic effects of EA or BFA, beyond the notion of a mere 'placebo effect'.</p></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"13 2","pages":"Article 101040"},"PeriodicalIF":3.4,"publicationDate":"2024-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2213422024000209/pdfft?md5=a2d025fb5c7b0f24740e5c8f75335613&pid=1-s2.0-S2213422024000209-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140400621","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xiao-ying Chen , Chun-li Lu , Qian-yun Wang , Xing-ru Pan , Yang-yang Zhang , Jia-le Wang , Jun-Ya Liao , Nai-chong Hu , Chen-yang Wang , Bing-jie Duan , Xue-han Liu , Xin-yan Jin , Jennifer Hunter , Jian-ping Liu
{"title":"Traditional, complementary and integrative medicine for fatigue post COVID-19 infection: A systematic review of randomized controlled trials","authors":"Xiao-ying Chen , Chun-li Lu , Qian-yun Wang , Xing-ru Pan , Yang-yang Zhang , Jia-le Wang , Jun-Ya Liao , Nai-chong Hu , Chen-yang Wang , Bing-jie Duan , Xue-han Liu , Xin-yan Jin , Jennifer Hunter , Jian-ping Liu","doi":"10.1016/j.imr.2024.101039","DOIUrl":"https://doi.org/10.1016/j.imr.2024.101039","url":null,"abstract":"<div><h3>Background</h3><p>Chronic fatigue is a predominant symptom of post COVID-19 condition, or long COVID. We aimed to evaluate the efficacy and safety of Traditional, Complementary and Integrative Medicine (TCIM) for fatigue post COVID-19 infection.</p></div><div><h3>Methods</h3><p>Ten English and Chinese language databases and grey literature were searched up to 12 April 2023 for randomized controlled trials (RCTs). Cochrane “Risk of bias” (RoB) tool was applied. Evidence certainty was assessed using Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Effect estimates were presented as risk ratio (RR) or mean difference (MD) with 95% confidence interval (CI).</p></div><div><h3>Results</h3><p>Thirteen RCTs with 1632 participants were included. One RCT showed that Bufei Huoxue herbal capsules reduced fatigue (n=129, MD -14.90, 95%CI -24.53 to -5.27), one RCT reported that Ludangshen herbal liquid lowered fatigue (n=184, MD -1.90, 95%CI -2.38 to -1.42), and the other one RCT shown that fatigue disappearance rate was higher with Ludangshen herbal liquid (n=184, RR 4.19, 95%CI 2.06 to 8.53). Compared to traditional Chinese medicine rehabilitation (TCM-rahab) alone, one RCT showed that fatigue symptoms were lower following Qingjin Yiqi granules plus TCM-rehab (n=388, MD -0.48, 95%CI -0.50 to -0.46). Due to concerns with RoB and/or imprecision, the certainty in this evidence was low to very low. No serious adverse events was reported.</p></div><div><h3>Conclusions</h3><p>Limited evidence suggests that various TCIM interventions might reduce post COVID-19 fatigue. Larger, high quality RCTs of longer duration are required to confirm these preliminary findings.</p></div><div><h3>Study Registration</h3><p>The protocol of this review has been registered at PROSPERO: CRD42022384136.</p></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"13 2","pages":"Article 101039"},"PeriodicalIF":3.4,"publicationDate":"2024-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2213422024000192/pdfft?md5=bc76ea5e2313a749574bd58c0233f6ff&pid=1-s2.0-S2213422024000192-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140879247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Ameliorative effects of Tagetes erecta Linn. flower against desiccation stress-induced dry eye symptoms in the mice model","authors":"Hyesook Lee , Hyun Hwangbo , Jin-Won Hyun , Jung-Hyun Shim , Sun-Hee Leem , Gi-Young Kim , Yung Hyun Choi","doi":"10.1016/j.imr.2024.101038","DOIUrl":"10.1016/j.imr.2024.101038","url":null,"abstract":"<div><h3>Background</h3><p>Tagetes erecta Linn, popularly known as Marigold, has various pharmacological effects. It is used as a dietary supplement, especially for the posterior segment of the eye. However, the effect of T. erecta Linn on ocular disorders is still unknown. The purpose of this study was to investigate the effect of oral administration of ethanol extract of <em>T. erecta</em> Linn flower (TE) for dry eye syndrome (DED) in a murine model.</p></div><div><h3>Methods</h3><p>Twenty-four mice were subjected to desiccation stress (DS) to induce DED and subcutaneous injection of scopolamine hydrobromide was administered 4 times a day for 21 days. TE and cyclosporine A (CsA) were administered for an additional 14 days under DS conditions. Mice were randomly divided into four groups: control, TE200, TE400, and CsA. Changes in tear production and corneal fluorescein staining were measured at baseline, after 7 days of DS, and after treatment for 7 and 14 days.</p></div><div><h3>Results</h3><p>DS significantly decreased tear production and increased corneal fluorescein score; the parameters were significantly reversed in the TE400 (oral administration of 400 mg TE/kg body weight) group. TE markedly improved DS-induced changes including corneal epithelial detachment and lacrimal gland inflammation. The anti-inflammatory effect of TE 400 supplementation was similar to that of CsA.</p></div><div><h3>Conclusions</h3><p>Our findings suggest that oral administration of TE may protect against DS-induced DED <em>via</em> stabilization of the tear film and suppression of inflammation. This study provides an experimental basis for further studies on the potential clinical use of TE in preventing DED.</p></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"13 2","pages":"Article 101038"},"PeriodicalIF":3.4,"publicationDate":"2024-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2213422024000180/pdfft?md5=0c1067b98ff7ae394de01323ba6a8e26&pid=1-s2.0-S2213422024000180-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140150903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Using the right design controls for acupuncture trials: Methodological rigor and validity in research","authors":"Younbyoung Chae , Jun-Hwan Lee , Myeong Soo Lee","doi":"10.1016/j.imr.2024.101026","DOIUrl":"https://doi.org/10.1016/j.imr.2024.101026","url":null,"abstract":"<div><p>Acupuncture treatment can be defined as a medical procedure with an acupuncture needle at acupoints. Establishing suitable control settings is essential, based on the target elements of the acupuncture therapy. In order to properly design a clinical trial or an experiment, a control group must be established. Here, we overview the significance of the control group and its limitations in acupuncture research. Clinical trials have employed a variety of study designs and controls for acupuncture treatment in order to compare the effects of actual treatments with control groups that include no treatment or treatment as usual, sham acupuncture at true acupoints, real acupuncture at non-acupoints, and sham acupuncture at non-acupoints. In order to determine the point-specificity of acupuncture, real acupuncture at non-acupoints should be taken into consideration, whereas sham acupuncture at the same true acupoints should be used to determine the needling-specific effect of acupuncture. It is crucial to choose the optimum control for acupuncture treatments depending on the study's main goal and to interpret the results in accordance with the research design.</p></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"13 1","pages":"Article 101026"},"PeriodicalIF":3.4,"publicationDate":"2024-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2213422024000064/pdfft?md5=f9cce0036e86b6ddf4f91f1598c56b9f&pid=1-s2.0-S2213422024000064-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139942456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jun-Yong Choi , Bom Choi , Ojin Kwon , Chang-Seob Seo , Ae-Ran Kim , Hyeun-kyoo Shin , Kibong Kim
{"title":"Efficacy and safety of herbal medicine Gongjin-Dan and Ssanghwa-Tang in patients with chronic fatigue: A randomized, double-blind, placebo-controlled, clinical trial","authors":"Jun-Yong Choi , Bom Choi , Ojin Kwon , Chang-Seob Seo , Ae-Ran Kim , Hyeun-kyoo Shin , Kibong Kim","doi":"10.1016/j.imr.2024.101025","DOIUrl":"10.1016/j.imr.2024.101025","url":null,"abstract":"<div><h3>Background</h3><p>Gongjin-dan (GJD, also known as Gongchen-dan) and Ssanghwa-tang (SHT, also known as Shuanghe-tang or Souwa-to) are herbal medicines that are widely used in Korea for treating fatigue. However, few studies have evaluated the efficacy and safety of GJD and SHT in the treatment of chronic fatigue.</p></div><div><h3>Methods</h3><p>In this randomized, double-blind, placebo-controlled clinical trial, 90 individuals with persistent (≥6 months) chronic fatigue of unknown cause and a Fatigue Severity Scale (FSS) score of ≥4 were randomly assigned to GJD group, SHT group, and control group in a 1:1:1 ratio. Outcomes were the changes in the self-reported fatigue questionnaire scores, levels of fatigue-related biomarkers and safety assessment.</p></div><div><h3>Results</h3><p>Out of 103 patients recruited, 90 were included in the analysis. A significant improvement in the Social Functioning (SF) score of Short-Form 36 Health Survey (SF-36) at week 4 was observed in the GJD group; similarly, a significant improvement compared with that in the Control group was observed in the Role Emotional (RE) score of SF-36 at weeks 4 and 6 and the Physical Functioning (PF) score of SF-36 at week 6 in the SHT group. Laboratory tests revealed no abnormalities, and serious intervention-related adverse events were not reported.</p></div><div><h3>Conclusions</h3><p>It is suggested that SHT can effectively treat chronic mental and physical fatigue, whereas GJD can effectively treat chronic mental and social fatigue. Furthermore, this study presents evidence supporting the safety of the long-term use of GJD and SHT (up to 4 weeks).</p></div><div><h3>Trial registration</h3><p>This study was registered at Clinical Research Information Service (CRIS) of Korea with the registration number KCT0007515.</p></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"13 1","pages":"Article 101025"},"PeriodicalIF":3.4,"publicationDate":"2024-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2213422024000052/pdfft?md5=0180e2aec9ae7d2e2114f8bded2ad2bb&pid=1-s2.0-S2213422024000052-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139927571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jeremy Y. Ng , Holger Cramer , Myeong Soo Lee , David Moher
{"title":"Traditional, complementary, and integrative medicine and artificial intelligence: Novel opportunities in healthcare","authors":"Jeremy Y. Ng , Holger Cramer , Myeong Soo Lee , David Moher","doi":"10.1016/j.imr.2024.101024","DOIUrl":"https://doi.org/10.1016/j.imr.2024.101024","url":null,"abstract":"<div><p>The convergence of traditional, complementary, and integrative medicine (TCIM) with artificial intelligence (AI) is a promising frontier in healthcare. TCIM is a patient-centric approach that combines conventional medicine with complementary therapies, emphasizing holistic well-being. AI can revolutionize healthcare through data-driven decision-making and personalized treatment plans. This article explores how AI technologies can complement and enhance TCIM, aligning with the shared objectives of researchers from both fields in improving patient outcomes, enhancing care quality, and promoting holistic wellness. This integration of TCIM and AI introduces exciting opportunities but also noteworthy challenges. AI may augment TCIM by assisting in early disease detection, providing personalized treatment plans, predicting health trends, and enhancing patient engagement. Challenges at the intersection of AI and TCIM include data privacy and security, regulatory complexities, maintaining the human touch in patient-provider relationships, and mitigating bias in AI algorithms. Patients' trust, informed consent, and legal accountability are all essential considerations. Future directions in AI-enhanced TCIM include advanced personalized medicine, understanding the efficacy of herbal remedies, and studying patient-provider interactions. Research on bias mitigation, patient acceptance, and trust in AI-driven TCIM healthcare is crucial. In this article, we outlined that the merging of TCIM and AI holds great promise in enhancing healthcare delivery, personalizing treatment plans, preventive care, and patient engagement. Addressing challenges and fostering collaboration between AI experts, TCIM practitioners, and policymakers, however, is vital to harnessing the full potential of this integration.</p></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"13 1","pages":"Article 101024"},"PeriodicalIF":3.4,"publicationDate":"2024-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2213422024000040/pdfft?md5=b8cbf1adb83572dbee54fa4b37730fde&pid=1-s2.0-S2213422024000040-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139743281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Libin Jia , Michelle Beidelschies , Joel M. Evans , Richard C. Niemtzow , Songxuan Zhou Niemtzow , Jeffery A. Dusek , Yufang Lin , Charles Wu , Yi-Chang Su , C. Jason Wang , Chien-Yu Lin , Peristiwan Ridha Widhi Astana , Danang Ardiyanto , Rusmiyati Hardjoutomo , Khwanchai Visithanon , Jagravudh Puagkong , Julalak Chokpaisarn , Martha Villar Lopez , Hiroshi Yotsuyanagi , Myeong Soo Lee , Cecilia C. Maramba-Lazarte
{"title":"Recommendations and guidelines of integrative medicine for COVID-19 care: The APEC project outcome","authors":"Libin Jia , Michelle Beidelschies , Joel M. Evans , Richard C. Niemtzow , Songxuan Zhou Niemtzow , Jeffery A. Dusek , Yufang Lin , Charles Wu , Yi-Chang Su , C. Jason Wang , Chien-Yu Lin , Peristiwan Ridha Widhi Astana , Danang Ardiyanto , Rusmiyati Hardjoutomo , Khwanchai Visithanon , Jagravudh Puagkong , Julalak Chokpaisarn , Martha Villar Lopez , Hiroshi Yotsuyanagi , Myeong Soo Lee , Cecilia C. Maramba-Lazarte","doi":"10.1016/j.imr.2024.101022","DOIUrl":"https://doi.org/10.1016/j.imr.2024.101022","url":null,"abstract":"<div><p>This article - Recommendations and Guidelines of Integrative Medicine (IM) for COVID-19 Care - was one of the outcomes from an Asia-Pacific Economic Cooperation (APEC) Project (Integrative Medicine (IM) and COVID -19 Care) during the time between May 2022 and March 2023. With the efforts from care providers, researchers, health policy makers and healthcare administrative leaders among APEC economies, the purpose of this file was to provide comprehensive IM systems for COVID-19 care as recommendations and suggestive guidelines including care methods, tools, procedures, symptom conditions and targets selections, and points need to be considered during care applications. All cited COVID-19 care practices have confirmed their efficacy and usefulness either used alone or combined with conventional medicine. This article provides current useful medical information on IM for COVID-19 care which could benefit APEC economies and world health communities on their healthcare system.</p></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"13 1","pages":"Article 101022"},"PeriodicalIF":3.4,"publicationDate":"2024-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2213422024000027/pdfft?md5=810297852db3200d2ed65099f89cf9a7&pid=1-s2.0-S2213422024000027-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139975972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shanze Wang , Chao Yang , Weimei Zeng , Hongfang Tian , Shihao Du , Jiping Zhao
{"title":"Acupuncture treatment for Hashimoto's thyroiditis: An exploratory randomized controlled trial","authors":"Shanze Wang , Chao Yang , Weimei Zeng , Hongfang Tian , Shihao Du , Jiping Zhao","doi":"10.1016/j.imr.2024.101023","DOIUrl":"10.1016/j.imr.2024.101023","url":null,"abstract":"<div><h3>Background</h3><p>Hashimoto's thyroiditis (HT) has a high incidence rate and unresolved clinical symptoms. Although Hand Yangming Meridian Penetrating Acupuncture has been used to treat thyroid diseases in China, there is no randomized controlled trial (RCT) on HT.</p></div><div><h3>Methods</h3><p>This exploratory RCT aims to preliminarily evaluate the efficacy, safety, and feasibility of Hand Yangming Meridian Penetrating Acupuncture in the treatment of HT. Included subjects were randomly assigned to the acupuncture group and the waiting treatment group at a ratio of 1:1. Subjects in the acupuncture group received 16 weeks of acupuncture treatment, followed by a 16-week follow-up observation phase. Subjects in the waiting group received thyroxine supplementation for 16 weeks, followed by 16 weeks of compensation treatment. Serum thyroid peroxidase antibody (TPOab) and thyroglobulin antibody (TGab) levels were the main indicators, and Thyroid-Related Patient-Reported Outcome short form (ThyPRO-39), MOS Item Short Form Health Survey (SF-36), and Hospital Anxiety and Depression Scale (HADS) scores were also recorded.</p></div><div><h3>Results</h3><p>In total, 58 subjects were included. After 16 weeks of treatment, there was no statistical difference in the changes in TPOab levels between the two groups, but the TGab level in the acupuncture group was significantly lower than in the waiting group (difference: −141.97 [95 % CI: −222.4 to −61.5]<em>, P</em> = 0.011). Moreover, the total ThyPRO-39 and SF-36 scores were statistically different between the two groups (<em>P</em><sub>ThyPRO-39</sub> < 0.001, <em>P</em><sub>SF-36</sub> = 0.005). There was no statistical difference in HADS between the two groups.</p></div><div><h3>Conclusions</h3><p>Hand Yangming Meridian Penetrating Acupuncture may be safe and feasible for HT hypothyroidism to improve symptoms and reduce TGab levels.</p></div><div><h3>Trial registration number</h3><p>This trial was registered at Acupuncture-Moxibustion Clinical Trial Registry: AMCTR-IOR-19000308 (ChiCTR1900026830, <span>https://www.chictr.org.cn/searchprojEN.html</span><svg><path></path></svg>).</p></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"13 1","pages":"Article 101023"},"PeriodicalIF":3.4,"publicationDate":"2024-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2213422024000039/pdfft?md5=46d85862d2dae13130ef55fe03b3b5ba&pid=1-s2.0-S2213422024000039-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139754365","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xue-Zhou Wang , Cun-Zhi Liu , Li-Qiong Wang , Zhi-Cheng Qu , Ying Cao , Shi-Yan Yan , Jing-Wen Yang , Jian-Feng Tu
{"title":"Acupuncture for response and complete pain relief time of acute renal colic: Secondary analysis of a randomized controlled trial","authors":"Xue-Zhou Wang , Cun-Zhi Liu , Li-Qiong Wang , Zhi-Cheng Qu , Ying Cao , Shi-Yan Yan , Jing-Wen Yang , Jian-Feng Tu","doi":"10.1016/j.imr.2024.101021","DOIUrl":"10.1016/j.imr.2024.101021","url":null,"abstract":"<div><h3>Background</h3><p>The integration of acupuncture with intramuscular injection of diclofenac sodium can expedite the onset of analgesia in treating acute renal colic caused by urolithiasis. However, it remains unclear whether acupuncture can accelerate pain relief constantly until complete remission. This study aimed to explore the extent to which acupuncture can expedite the onset time of response or complete pain relief in treating acute renal colic, and the predictive value of patient characteristics for treatment efficacy.</p></div><div><h3>Methods</h3><p>This secondary analysis utilized data from a prior randomized controlled trial. Eighty patients with acute renal colic were randomly assigned 1:1 to the acupuncture group or the sham acupuncture group. After intramuscular injection of diclofenac sodium, acupuncture or sham acupuncture was delivered to patients. The outcomes included time to response (at least a 50 % reduction in pain) and complete pain relief. Between-group comparison under the 2 events was estimated by Kaplan-Meier methodology. Subgroup analysis was performed utilizing the Cox proportional hazards model.</p></div><div><h3>Results</h3><p>The median response time and complete pain relief time in the acupuncture group were lower than those in the sham acupuncture group (5 vs 30 min, Log Rank <em>P</em> < 0.001; 20 min vs not observed, Log Rank <em>P</em> < 0.001, respectively). Hazard Ratios (HRs) for response across all subgroups favored the acupuncture group. All HRs for complete pain relief favored acupuncture, expect large stone and moderate pain at baseline. No interaction was found in either event.</p></div><div><h3>Conclusion</h3><p>Acupuncture can accelerate the response time and complete pain relief time for patients with acute renal colic, with the efficacy universally.</p></div><div><h3>Trial registration</h3><p>This study has been registered at Chinese Clinical Trial Registry: ChiCTR1900025202.</p></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"13 1","pages":"Article 101021"},"PeriodicalIF":3.4,"publicationDate":"2024-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2213422024000015/pdfft?md5=ee00c056134e72095dbd3da8043d8b0c&pid=1-s2.0-S2213422024000015-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139507269","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}