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Integrating Chiropractic Care and Tai Chi Training for the Treatment of Chronic Nonspecific Neck Pain in Nurses: A Single-Arm Mixed-Methods Pilot Trial. 脊骨神经科护理与太极拳训练相结合治疗护士慢性非特异性颈痛:单臂混合方法试点试验。
IF 1.3 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-12-01 Epub Date: 2024-08-22 DOI: 10.1089/jicm.2024.0043
Wren Burton, Peter M Wayne, Dan Litrownik, Cynthia R Long, Robert Vining, Pamela Rist, Karen Kilgore, Anthony Lisi, Matthew H Kowalski

Objectives: Chronic nonspecific neck pain (CNNP) is prevalent among health care workers, with particularly high rates among nurses. Nurses experiencing CNNP often report decreased job satisfaction, increased absenteeism, and reduced productivity. In recent years, nonpharmacologic approaches have gained attention as effective treatments for the management of CNNP, with exercise and manual therapies representing two of the most common. Early evidence shows that multimodal treatments may be more effective than unimodal strategies. The purpose of this current study was to assess the feasibility and observe the clinical outcomes of combined multimodal chiropractic care (MCC) and Tai Chi (TC) for CNNP in nurses. Methods: A single-arm mixed-methods pilot trial was conducted including 16 weeks of MCC and TC in nurses with self-reported CNNP. Feasibility outcomes were recruitment, retention, and adherence to the interventions. Clinical outcomes of interest included neck pain and related disabilities. Secondary outcomes of interest were functional, affective, and work-related performance. Qualitative interviews were also conducted. Results: Of the 59 screened, 36 met the eligibility criteria, and 21 were enrolled. The retention rate was 71.4%, and adherence rates were 85.3% for MCC and 62.5% for TC classes. Multiple pain and disability-related outcomes exhibited modest improvement from baseline to 16-week follow-up. Qualitative analysis identified six emergent themes: (1) neck pain being an inherent part of nursing, (2) nurses push through their pain, (3) MCC relieves pain and is instructive for preventing pain, (4) TC provides overall relaxation, (5) both interventions increased body awareness and improved posture, and (6) scheduling difficulties were a key obstacle for participating. Conclusions: Observed reductions in neck pain and disability suggest the potential utility of combined MCC and TC interventions for managing CNNP. Along with qualitative feedback regarding facilitators and barriers to participation, the findings support and inform a future randomized trial evaluating the combined benefits of MCC and TC for CNNP in nurses. Clinical Trial Registration #NCT06523036.

目的:慢性非特异性颈痛(CNNP)在医护人员中很普遍,尤其是在护士中发病率很高。患有慢性非特异性颈痛的护士通常会报告工作满意度下降、缺勤率上升和工作效率降低。近年来,非药物疗法作为治疗 CNNP 的有效方法受到关注,其中运动疗法和徒手疗法是最常见的两种疗法。早期证据显示,多模式疗法可能比单模式疗法更有效。本研究的目的是评估多模式整脊疗法(MCC)和太极拳(TC)联合治疗护士 CNNP 的可行性并观察其临床效果。研究方法进行了一项单臂混合方法试点试验,包括对自述有 CNNP 的护士进行为期 16 周的 MCC 和 TC 治疗。可行性结果包括招募、保留和坚持干预。临床结果包括颈部疼痛和相关残疾。次要结果包括功能、情感和工作相关表现。此外,还进行了定性访谈。结果:在筛选出的 59 人中,36 人符合资格标准,21 人被录取。保留率为 71.4%,MCC 课程的坚持率为 85.3%,TC 课程的坚持率为 62.5%。从基线到 16 周的随访,多种疼痛和残疾相关结果均有适度改善。定性分析确定了六个新出现的主题:(1)颈部疼痛是护理工作固有的一部分;(2)护士强忍疼痛;(3)MCC 可缓解疼痛并对预防疼痛有指导作用;(4)TC 可提供整体放松;(5)两种干预措施都可增强身体意识并改善姿势;(6)时间安排困难是参与的主要障碍。最后得出结论:观察到的颈部疼痛和残疾程度的减轻表明,MCC 和 TC 联合干预对控制 CNNP 有潜在的作用。结合有关参与的促进因素和障碍的定性反馈,研究结果支持并指导未来的随机试验,评估 MCC 和 TC 联合治疗护士 CNNP 的益处。临床试验注册 #NCT06523036。
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引用次数: 0
Whole Health Research Thought Further: How Can We Stay Whole in a Reductionist Paradigm? 整体健康研究的进一步思考:如何在还原论范式中保持整体性?
IF 1.3 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-12-01 Epub Date: 2024-11-25 DOI: 10.1089/jicm.2024.0929
Holger Cramer
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引用次数: 0
Effect of Binaural Beats on Anxiety and Tolerance in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation: A Randomized Controlled Trial. 双耳节拍对无镇静上消化道内窥镜检查患者焦虑和耐受性的影响:随机对照试验
IF 1.3 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-12-01 Epub Date: 2024-08-01 DOI: 10.1089/jicm.2023.0804
Selim Demirci, Semih Sezer

Objective: Binaural beats, or the perceptual auditory illusions created when simultaneously presenting two similar frequencies to each ear separately, have been used to reduce anxiety in various procedures. Unfortunately, no prior study involved preprocedure binaural music exposure among patients undergoing upper gastrointestinal endoscopy, and this study sought to investigate its effect on anxiety and tolerance among participants undergoing sedation-free upper gastrointestinal endoscopy. Methods: The prospective, controlled, randomized trial included the participation of 96 Turkish patients aged between 18 and 70 years who were scheduled for an upper gastrointestinal endoscopy, regardless of sex or illness, and were divided randomly into two different groups to undergo endoscopy, namely, the binaural beats group (n = 48) and a control group (n = 48). Patients in the binaural beat music group wore headphones, and music was given 15 mins before endoscopy; however, no particular treatment was given for either group. Anxiety levels were assessed by using the State Trait Anxiety Inventory questionnaire, in addition to changes before and after endoscopy to measure patient satisfaction based on the physician's recorded numbers of retches noted by doctors as tolerance was documented and compared among both groups. Results: The results showed that following this procedure, in the music group, state scores remained significantly lower than before them (p = 0.016), compared with the control group (p > 0.05). There was no significant difference regarding changes in diastolic or systolic heart rate or blood pressure (p > 0.05). However, the procedure tolerance and satisfaction scores were significantly higher in the music group than those without music (p < 0.05). Conclusion: For patients undergoing upper gastrointestinal endoscopy, music with binaural beats was found to significantly reduce anxiety levels and increase patient tolerance, providing an alternative option to sedative medications as a potential sedative treatment option.Clinical trials registration number: NCT06114524.

双耳节拍双耳节拍,即同时向每只耳朵分别播放两个相似频率的音乐时产生的知觉听觉幻觉,已被用于减轻各种手术中的焦虑。遗憾的是,之前没有研究涉及接受上消化道内窥镜检查的患者在术前接触双耳音乐的情况,本研究旨在调查双耳音乐对接受无镇静剂上消化道内窥镜检查者的焦虑和耐受性的影响。研究方法这项前瞻性、对照、随机试验包括 96 名年龄在 18 至 70 岁之间、计划接受上消化道内窥镜检查的土耳其患者,他们不分性别和疾病,被随机分为两组接受内窥镜检查,即双耳节拍组(48 人)和对照组(48 人)。双耳节拍音乐组患者佩戴耳机,在内窥镜检查前 15 分钟播放音乐;但两组患者均未接受特殊治疗。焦虑水平通过国家特质焦虑量表问卷进行评估,此外,内窥镜检查前后的变化也是为了衡量患者的满意度,其依据是医生记录下的反胃次数,并对两组患者的耐受性进行了记录和比较。结果显示结果显示,与对照组相比(P > 0.05),音乐组在手术后的状态评分仍明显低于手术前(P = 0.016)。舒张或收缩心率和血压的变化没有明显差异(P > 0.05)。不过,音乐组的手术耐受性和满意度评分明显高于无音乐组(P < 0.05)。结论研究发现,对于接受上消化道内窥镜检查的患者,双耳节拍音乐能明显降低焦虑水平并提高患者的耐受性,为镇静药物提供了一种替代选择,是一种潜在的镇静治疗方案:NCT06114524。
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引用次数: 0
Exploring In-Session Engagement in Equine-Assisted Services for Children and Youth Experiencing Disability: A Scoping Review. 探索为残疾儿童和青少年提供的马术辅助服务中的会期参与:范围审查。
IF 1.3 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-12-01 Epub Date: 2024-07-08 DOI: 10.1089/jicm.2024.0151
Lena M Aewerdieck, Rachelle A Martin, Fiona P Graham, Jean Hay-Smith

Aims: The purpose of this review was to identify and describe the evidence about children and youth engagement during equine-assisted services (EAS). Methods: Five databases (Scopus, Web of Science, PsycINFO, CINAHL, and MEDLINE) were systematically searched. Included studies reported research about EAS conducted in children and youth and presented findings about in-session engagement or associated concepts such as motivation, involvement, and participation. Extracted data (study type, equine intervention, population, and the studies' key focus) were summarized descriptively, followed by inductive content analysis of the main mechanisms proposed to influence engagement. Results: In total, 30 studies were identified; however, only three centered on rider engagement as the primary focus of research. Other publications addressed in-session engagement within service descriptions or results and discussion sections. Three mechanisms that influence engagement within EAS were derived: (1) the unique EAS landscape, (2) the horse-child relationship and (3) the provider-child relationship. The literature primarily referred to horses as the most important factor influencing child and youth engagement in EAS sessions. Little attention was given to the influence of service providers', parents', or child preferences on engagement. Conclusions: The child/youth-parent-provider relational triad and specific strategies to improve rider engagement within EAS sessions warrants further investigation.

目的:本综述旨在确定和描述有关儿童和青少年在马术辅助服务(EAS)过程中参与的证据。研究方法:系统检索了五个数据库(Scopus、Web of Science、PsycINFO、CINAHL 和 MEDLINE)。收录的研究报告涉及在儿童和青少年中开展的 EAS 研究,并介绍了有关会期参与或相关概念(如动机、介入和参与)的研究结果。我们对提取的数据(研究类型、马术干预、人群和研究重点)进行了描述性总结,然后对所提出的影响参与度的主要机制进行了归纳内容分析。结果:总共确定了 30 项研究,但只有三项研究将骑手的参与作为研究的主要重点。其他出版物则在服务描述或结果与讨论部分讨论了会期参与问题。研究得出了影响参与 EAS 的三个机制:(1)独特的 EAS 环境;(2)马与儿童的关系;(3)提供者与儿童的关系。文献主要提到马匹是影响儿童和青少年参与 EAS 课程的最重要因素。很少有人关注服务提供者、家长或儿童的喜好对参与的影响。结论:儿童/青少年-家长-服务提供者三者之间的关系以及提高骑手参与 EAS 课程的具体策略值得进一步研究。
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引用次数: 0
Integrative Health and Wellness Coaching: A Call to Action to Address a Research Gap for Individuals with Intellectual and Developmental Disabilities. 综合健康与保健辅导:解决智力和发育障碍人士研究缺口的行动呼吁》。
IF 1.3 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-12-01 Epub Date: 2024-11-06 DOI: 10.1089/jicm.2024.0859
Alyssa Morgan Smith, Shelley R Adler, Patricia Prelock, Jeremy Sibold, Karen Westervelt, Ruth Q Wolever
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引用次数: 0
Prenatal Mindfulness Training and Interoceptive Awareness in Pregnant People at Risk for Hypertensive Disorders. 产前正念训练与高血压高危孕妇的互感意识
IF 1.3 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-12-01 Epub Date: 2024-07-08 DOI: 10.1089/jicm.2024.0121
Meghan Sharp, L G Ward, Madison Pomerantz, Ghada Bourjeily, Kate M Guthrie, Elena Salmoirago-Blotcher, Amanda Desmarattes, Margaret H Bublitz

Aim: In this secondary analysis of a pilot randomized controlled trial (RCT), we sought to examine whether mindfulness training (MT) is associated with change in interoceptive awareness in pregnant people at risk for hypertension using quantitative and qualitative methods. Interoceptive awareness is the perception, regulation, and integration of bodily sensations. Interoceptive awareness increases following MT and has been proposed as a psychosomatic process underlying hypertension outside of pregnancy. Methods: Twenty-nine participants (mean age 32 ± 4 years; 67% White) with a history of hypertensive disorders of pregnancy (HDP) were enrolled at 16 weeks' gestation (SD = 3) for a RCT assessing the feasibility and acceptability of an 8-week phone-delivered MT intervention. Fifteen participants were randomized to MT, whereas 14 were randomized to usual prenatal care. Before and after the intervention, all participants completed the Multidimensional Assessment of Interoceptive Awareness (MAIA) measure and participated an individual interview, which queried for mind-body changes noticed across the study period. Results: Adjusting for baseline interoceptive awareness and gestational age, participants randomized to MT reported less worry about physical sensations on the MAIA after the intervention compared to those randomized to usual care. Qualitative data corroborated these results; MT participants described improved awareness of body and breath sensations, ability to notice blood pressure changes, non-judgmental observation of thoughts, and improved responses to interpersonal challenges. Conclusions: MT may improve the ability to notice body sensations that arise in pregnancy in a way that promotes healthy responding rather than worry. Results provide support for interoceptive awareness as a potential mechanism through which mindfulness may modulate blood pressure and potentially reduce the prevalence of HDP. Clinical Trial Registration: ClinicalTrials.gov (NCT03679117).

目的:在对一项试点随机对照试验(RCT)进行的二次分析中,我们试图通过定量和定性方法来研究正念训练(MT)是否与高血压高危孕妇的感知间意识变化有关。感知间意识是对身体感觉的感知、调节和整合。在进行正念训练(MT)后,感知间意识会增强,并被认为是妊娠期外高血压的一个心理过程。研究方法29 名参与者(平均年龄 32 ± 4 岁;67% 白人)在妊娠 16 周(SD = 3)时有妊娠高血压疾病(HDP)病史,他们参加了一项 RCT 研究,评估为期 8 周的电话传递 MT 干预的可行性和可接受性。15 名参与者被随机分配到 MT 中,14 名参与者被随机分配到常规产前护理中。在干预前后,所有参与者都完成了 "多维感知意识评估"(MAIA)测量,并参加了个人访谈,询问在整个研究期间注意到的身心变化。研究结果在对基线感知意识和胎龄进行调整后,与随机接受常规护理的参与者相比,随机接受 MT 的参与者在干预后的 MAIA 中对身体感觉的担忧减少了。定性数据证实了这些结果;MT 参与者描述了对身体和呼吸感觉的意识的提高、注意血压变化的能力、对思想的非批判性观察以及对人际挑战的反应的改善。结论:MT 可以提高对孕期身体感觉的觉察能力,从而促进健康的反应而不是担忧。研究结果支持将感知间意识作为一种潜在机制,通过这种机制,正念可以调节血压,并有可能降低 HDP 的患病率。临床试验注册:ClinicalTrials.gov (NCT03679117)。
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引用次数: 0
Bridging the Two Worlds: Worldwide Reflections on the 2024 Hong Kong SAR/PolyU Conference. 连接两个世界:对 2024 年香港特别行政区/理大会议的全球思考。
IF 1.3 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-12-01 Epub Date: 2024-11-11 DOI: 10.1089/jicm.2024.0819
Jerry Wing-Fai Yeung, Afua Bromley, Younbyoung Chae, Denise Shuk Ting Cheung, Lisa Conboy, Sandro Graca, Kate Levett, Kathleen Lumiere, Rosa Schnyer, Kristen Sparrow, Liming Tseng, John Yoo, Yu-Qing Zhang, Claudia Citkovitz
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引用次数: 0
Innovative Statistical Model Uncover Effective Herbal Medicines Among Personalized Treatment Plans in Persian Medicine: A Small-Scale Study in Type 2 Diabetes. 创新统计模型发现波斯医学个性化治疗方案中的有效草药:针对 2 型糖尿病的小规模研究。
IF 1.3 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-12-01 Epub Date: 2024-07-31 DOI: 10.1089/jicm.2024.0180
Samaneh Eftekhari Mahabadi, Reza Khalifeh, Roshanak Ghods, L Susan Wieland, Ricardo Ghelman, Asie Shojaii, Armin Zareian, Nafiseh Hosseini Yekta

Objectives: In holistic medicine, developing personalized treatment plans is challenging due to the multitude of possible therapy combinations. This study introduces the use of a statistical approach to identify the most effective herbal medicines prescribed in Persian medicine (PM) in a small-scale sample of patients with type 2 diabetes mellitus (T2DM). Methods: This prospective observational cohort study was conducted with 47 patients with T2DM referred to Behesht Clinic in Tehran, Iran. A physician prescribed individualized PM treatment for T2DM and related systemic issues. The fasting blood sugar (FBS) level of each patient was recorded at initial and two follow-up visits, with visit intervals and treatment modifications determined by patient health status. Patients who completed two follow-up visits were included in the final analysis (n = 27). Data were analyzed using R software. A general linear model was assumed for the mean response, along with an exponential covariance pattern model, to manage irregularly timed measurements. Results: Two fitted models showed that, after adjusting for confounders, the use of the "Diabetes Capsule" significantly reduced the average FBS by 17.14 mmol/L (p = 0.046). For each unit increase in the consumption of "Diabetes Capsule" or "Hab-e-Amber Momiai," the average FBS decreased by 15.22 mmol/L (p = 0.015) and 14.14 mmol/L (p = 0.047), respectively. Conclusion: It is possible to observe which medications are most effective, even when treatments are applied in a holistic and personalized fashion. Preliminary studies such as these may identify promising products for testing in clinical trials conducted under standardized conditions, to inform initial choices for future personalized treatments.

目的:在整体医学中,由于可能的治疗组合众多,因此制定个性化治疗方案具有挑战性。本研究介绍了如何使用统计方法,在小规模抽样调查的 2 型糖尿病(T2DM)患者中确定波斯医学(PM)中最有效的草药处方。研究方法这项前瞻性观察性队列研究的对象是 47 名转诊至伊朗德黑兰 Behesht 诊所的 T2DM 患者。医生针对 T2DM 及相关系统问题开具了个性化的 PM 治疗处方。每位患者的空腹血糖(FBS)水平在初次就诊和两次随访时均有记录,就诊间隔和治疗调整由患者的健康状况决定。完成两次随访的患者纳入最终分析(n = 27)。数据使用 R 软件进行分析。假设平均反应采用一般线性模型,同时采用指数协方差模式模型,以管理不规则的测量时间。结果显示两个拟合模型显示,在对混杂因素进行调整后,使用 "糖尿病胶囊 "可使平均 FBS 显著降低 17.14 mmol/L(p = 0.046)。糖尿病胶囊 "或 "Hab-e-Amber Momiai "的食用量每增加一个单位,平均 FBS 分别降低 15.22 mmol/L (p = 0.015)和 14.14 mmol/L (p = 0.047)。结论即使以整体和个性化的方式进行治疗,也有可能观察到哪些药物最有效。此类初步研究可确定有前景的产品,以便在标准化条件下进行临床试验,为未来个性化治疗的初步选择提供依据。
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引用次数: 0
Barriers and Facilitators to Integrating Acupuncture into the U.S. Health Care System: A Scoping Review. 将针灸纳入美国医疗保健系统的障碍和促进因素:范围综述》。
IF 1.3 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-12-01 Epub Date: 2024-08-02 DOI: 10.1089/jicm.2023.0603
Hongjin Li, Juanita E Darby, Ivy Akpotu, Judith M Schlaeger, Crystal L Patil, Oana Danciu, Andrew D Boyd, Larisa Burke, Miriam O Ezenwa, Mitchell R Knisely, Ta-Ya Lee, Molly W Mandernach, Victoria A de Martelly, Robert E Molokie, Nirmish Shah, Diana J Wilkie, Ardith Z Doorenbos

Background: Acupuncture is a widely practiced complementary and integrative health modality that has multiple clinical applications. The use of acupuncture in the United States is rapidly increasing. Although studies have shown the efficacy and effectiveness of acupuncture for various ailments, the integration of acupuncture into the U.S. health care system remains a challenge. Little is known about the factors affecting this integration. Objective: To provide a systematic review of the barriers and facilitators affecting the integration of acupuncture into the U.S. health care system. Methods: Four electronic databases were searched. Three independent reviewers were involved in the screening and data charting processes. Findings were synthesized and categorized into four levels based on the Social Ecological Model. Results: A total of 22 studies were included in the final review. The barriers and facilitators affecting the integration of acupuncture were mapped into four levels (individual, interpersonal, organizational, and policy). The most frequently reported barriers and facilitators were mapped into the Social Ecological Model constructs within the "Individual" level (i.e., beliefs and attitudes of acupuncture, and practical issues) and the "Organizational" level (i.e., credentialing, space and facility, referral system). Conclusion: This review has identified and synthesized the breadth of evidence on the barriers and facilitators to the integration of acupuncture into the U.S. health care system. Results of this review will guide future implementation studies to develop and test implementation strategies to integrate acupuncture into the U.S. health care system.

背景:针灸是一种广泛使用的补充和综合保健方式,具有多种临床应用价值。在美国,针灸的使用正在迅速增加。尽管研究表明针灸对各种疾病都有疗效,但如何将针灸融入美国的医疗保健体系仍是一项挑战。人们对影响这种整合的因素知之甚少。目的对影响针灸融入美国医疗体系的障碍和促进因素进行系统综述。方法:检索了四个电子数据库:检索了四个电子数据库。三位独立审稿人参与了筛选和数据制表过程。根据社会生态模型将研究结果综合归类为四个层次。结果共有 22 项研究被纳入最终审查。影响针灸整合的障碍和促进因素被划分为四个层次(个人、人际、组织和政策)。在 "个人 "层面(即对针灸的信仰和态度以及实际问题)和 "组织 "层面(即资格认证、空间和设施、转诊系统),最常报告的障碍和促进因素被映射到社会生态模型的构建中。结论:本综述对针灸融入美国医疗保健系统的障碍和促进因素进行了广泛的论证和综合。本综述的结果将指导未来的实施研究,以制定和测试将针灸纳入美国医疗体系的实施策略。
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引用次数: 0
Treatment of Menstrual Irregularities with Individualized Homeopathic Medicinal Products in Early Reproductive Females: A Double-Blind, Randomized, Placebo-Controlled Trial. 用个性化顺势疗法药品治疗生殖早期女性的月经不调:双盲、随机、安慰剂对照试验。
IF 1.3 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-12-01 Epub Date: 2024-07-31 DOI: 10.1089/jicm.2024.0050
Usashi Nag, Rajat Kumar Pal, Subhranil Saha, Sk Monsur Alam, Tahira Parvin, Raghubir Gole, Pintu Debnath, Sumana Sengupta, Mousumi Koley, Urmi Roy, Junayed Akram, Abdur Rahaman Shaikh, Munmun Koley, Shyamal Kumar Mukherjee

Objectives: Prevalence of irregular menstrual cycle ranges from 81.7% to 96.3%. Recent research suggested that homeopathy is one of the most popular choices for women with various gynecological disorders. This trial was aimed at differentiating individualized homeopathic medicinal products (IHMPs) from identical-looking placebos in the treatment of menstrual irregularities in early reproductive women. Design: Double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: D. N. De Homoeopathic Medical College & Hospital, Kolkata, West Bengal, India. Subjects: Ninety-two females with menstrual irregularities. Interventions: Group verum (n = 46; IHMPs plus concomitant care) versus group control (n = 46; placebos plus concomitant care). Outcome Measures: Primary-The proportion of early reproductive females in whom menstrual irregularities can be corrected for consecutive three cycles; Secondary-Menstrual Distress Questionnaire (MDQ) total score; all of them were measured at baseline and every month, up to 4 months. Results: Intention-to-treat sample (n = 92) was analyzed. Group differences were examined by chi-squared tests with categorical outcomes, two-way repeated measure analysis of variance accounting for the time-effect interactions, and unpaired t-tests comparing the mean estimates obtained individually every month. The level of significance was set at p < 0.05 two-tailed. After 4 months of intervention, the group difference in the primary outcome was nonsignificant statistically-IHMPs: 22/46 v/s placebo: 24/46, chi-square (Yates corrected) = 0.043, p = 0.835. The improvement observed in the MDQ total score (F1,90 = 0.054, p = 0.816) and subscales scores were higher in the IHMPs group than in placebos, however statistically nonsignificant in most of the occasions, except for the behavioral change subscale (F1,90 = 0.029, p < 0.001). Pulsatilla nigricans was the most frequently prescribed medicine. Kent's Repertory and Zandvoort's Complete Repertory were the most frequently used repertories. No harm or serious adverse events were reported from either group. Conclusions: The analysis failed to demonstrate clearly that IHMPs were effective beyond placebos in all but one of the outcomes. More appropriate outcome measures may be sought for future trials. Clinical Trial Registration Number: CTRI/2022/04/041659.

目的:月经周期不规律的发病率为 81.7%至 96.3%。最近的研究表明,顺势疗法是治疗女性各种妇科疾病的最受欢迎的选择之一。本试验旨在区分个体化顺势疗法药物产品(IHMPs)和外观相同的安慰剂在治疗早期生育妇女月经不调方面的作用。设计:双盲、随机(1:1)、两组平行、安慰剂对照试验。试验地点印度西孟加拉邦加尔各答 D. N. De 顺势疗法医学院和医院。受试者92 名月经不调的女性。干预措施:治疗组(n = 46;IHMPs 加辅助护理)与对照组(n = 46;安慰剂加辅助护理)。结果测量主要指标-连续三个周期月经不调得到纠正的早育女性比例;次要指标-月经困扰问卷(MDQ)总分;所有指标均在基线和每个月进行测量,直至4个月。结果对意向治疗样本(n = 92)进行了分析。通过分类结果的卡方检验、考虑时间效应交互作用的双向重复测量方差分析,以及比较每个月单独获得的平均估计值的非配对 t 检验来检验组间差异。显著性水平设定为 p < 0.05(双尾)。经过 4 个月的干预后,主要结果的组间差异在统计学上并不显著--HHMPs:22/46 对安慰剂:24/46,秩方(耶茨校正)= 0.043,P = 0.835。IHMPs 组的 MDQ 总分(F1,90 = 0.054,p = 0.816)和分量表得分均高于安慰剂组,但除了行为改变分量表(F1,90 = 0.029,p < 0.001)外,其他大部分分量表得分的改善在统计学上并不显著。白头翁是最常用的处方药。Kent's Repertory 和 Zandvoort's Complete Repertory 是最常用的药方。两组患者均未出现任何伤害或严重不良反应。结论除一项结果外,分析未能清楚地证明 IHMP 在所有结果中的有效性均优于安慰剂。在未来的试验中,可能会寻求更合适的结果测量方法。临床试验注册号:CTRI/2022/04/041659.
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Journal of Integrative and Complementary Medicine
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