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Safety Evaluation of SH003 and Docetaxel Combination in Patients With Breast and Lung Cancer: A Multi-Center, Open-Label, Dose Escalation Phase I Clinical Trial. SH003和多西他赛联合治疗乳腺癌和肺癌的安全性评价:一项多中心、开放标签、剂量递增的I期临床试验
IF 2.8 3区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2025-08-09 DOI: 10.1177/15347354251363892
Chunhoo Cheon, Hwimun Kim, Seok Yun Kang, Sung Yong Lee, Kyong Hwa Park, Seong-Gyu Ko

Background: Cancer remains one of the leading causes of death worldwide, underscoring the need for novel therapies. SH003, an herbal mixture composed of Astragalus membranaceus, Angelica gigas, and Trichosanthes kirilowii, is a traditional Korean medicine formulation with potential to enhance chemotherapy efficacy and reduce toxicity. This study aimed to assess the safety and determine maximum tolerated dose of SH003 in combination with docetaxel in patients with advanced solid tumors, specifically lung and breast cancer.

Methods: This Phase I, multi-center, open-label, dose-escalation study enrolled patients with advanced lung or breast cancer. Participants received SH003 orally at doses of 2400, 3600, or 4800 mg daily, alongside intravenous docetaxel (75 mg/m²) every 21 days. A 3 + 3 dose-escalation design was employed to determine the maximum tolerated dose. Safety assessments and adverse event monitoring were conducted at each treatment cycle.

Results: Twelve participants were enrolled. SH003 was well tolerated up to 4800 mg/day, with no dose-limiting toxicities attributed to SH003. The most common adverse events were neutropenia, primarily associated with docetaxel, and mild dermatologic reactions such as eczema, rash acneiform, and pruritus. Preliminary evidence of disease stabilization was observed in several participants.

Conclusion: The combination of SH003 and docetaxel demonstrated a favorable safety profile, with 4800 mg/day identified as maximum tolerated dose for SH003. These findings support further investigation in Phase II trials to assess therapeutic efficacy.Trial Registration: Clinical Research Information Service (https://cris.nih.go.kr) KCT0004770.

背景:癌症仍然是世界范围内死亡的主要原因之一,强调了对新疗法的需求。SH003是由黄芪、当归、千里马组成的中药制剂,具有提高化疗效果和降低毒性的作用。本研究旨在评估SH003联合多西他赛治疗晚期实体肿瘤(特别是肺癌和乳腺癌)的安全性,并确定其最大耐受剂量。方法:这项I期、多中心、开放标签、剂量递增的研究纳入了晚期肺癌或乳腺癌患者。参与者每天口服剂量为2400、3600或4800 mg的SH003,同时每21天静脉注射一次多西他赛(75 mg/m²)。采用3 + 3剂量递增设计确定最大耐受剂量。在每个治疗周期进行安全性评估和不良事件监测。结果:12名受试者入组。SH003耐受性良好,高达4800 mg/天,没有归因于SH003的剂量限制性毒性。最常见的不良事件是中性粒细胞减少,主要与多西紫杉醇相关,以及轻微的皮肤反应,如湿疹、痤疮样皮疹和瘙痒。在一些参与者中观察到疾病稳定的初步证据。结论:SH003联合多西他赛具有良好的安全性,SH003的最大耐受剂量为4800 mg/天。这些发现支持在II期试验中进一步研究以评估治疗效果。试验注册:临床研究信息服务(https://cris.nih.go.kr) KCT0004770。
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引用次数: 0
External Application of a Xiaozhen zhiyang Decoction for Facial Rash Related to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Chinese Patients: A Prospective Single-Arm Observational Study. 外敷消贞止阳汤治疗中国患者表皮生长因子受体酪氨酸激酶抑制剂相关的面部皮疹:一项前瞻性单臂观察研究
IF 2.9 3区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2025-05-16 DOI: 10.1177/15347354251335598
Jietao Lin, Lingling Sun, Jing Zhang, Ke Zhu, Hanrui Chen, Xinting Zhen, Yang Cao, Siyu Wang, Lizhu Lin

Background: Evidence regarding Chinese herbal medicine for facial rash related to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) is limited. Therefore, this study aimed to investigate whether ex ternal application of a Xiaozhen zhiyang (XZZY) decoction is effective for EGFR-TKI-related facial rash in Chinese patients.

Methods: In this prospective cohort study, 123 participants with EGFR-TKI-related facial rash were recruited from July 18, 2019 to May 20, 2021. The intervention was external application of the XZZY decoction twice daily for 2 weeks using a facial mask. Treatment efficacy, change in the WoMo score, and quality of life were evaluated as endpoints.

Results: The average age of the 123 enrolled participants was 54.83 ± 12.45 years, and 48.78% were female. The total efficiency of treatment was 93.5%, including 12 (10%) cases were cured, 20 (16.26%) cases were markedly improved and 83 (67.48%) cases were improved. The generalized estimating equations showed decreased WoMo scores, itching, and pain, as well as an improved quality of life after the treatment. Only 1 participant reported skin allergies, and no other adverse effects were reported.

Conclusion: This study showed the effectiveness and safety of a XZZY decoction for EGFR-TKI-related rash.

背景:中药治疗与表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKIs)相关的面部皮疹的证据有限。因此,本研究旨在探讨外敷消震止阳汤对中国患者egfr - tki相关性面部皮疹是否有效。方法:在这项前瞻性队列研究中,从2019年7月18日至2021年5月20日招募了123名患有egfr - tki相关面部皮疹的参与者。干预措施为:敷面膜外敷XZZY汤剂,每日2次,连续2周。以治疗疗效、WoMo评分变化和生活质量为终点。结果:123例入组患者的平均年龄为54.83±12.45岁,女性占48.78%。总有效率为93.5%,其中治愈12例(10%),明显好转20例(16.26%),好转83例(67.48%)。广义估计方程显示,治疗后的WoMo评分、瘙痒和疼痛降低,生活质量提高。只有1名参与者报告皮肤过敏,没有其他不良反应报告。结论:本研究显示XZZY汤治疗egfr - tki相关性皮疹的有效性和安全性。
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引用次数: 0
Effectiveness of Shuanghuang Yangxue Decoction for Treating Cancer-Related Anemia With Serum Iron Deficiency in Lung Cancer Patients: A Randomized Clinical Trial. 双黄养血汤治疗肺癌相关性贫血伴血清铁缺乏症的随机临床研究
IF 2.8 3区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2025-11-21 DOI: 10.1177/15347354251396042
Quan-Yao Li, Wen-Xiao Yang, Ying Lu, Dan Lin, Hui Mu, Qin Wang, Jia-Lin Yao, Hui Liu, Li-Qiu Yao, Xi Li, Wen-Chao Qiu, Pei-Pei Xue, Chen Qian, Ling Xu, Jun Shi

Objective: To evaluate the clinical efficacy and safety of Shuanghuang Yangxue Decoction in treating lung cancer patients with cancer-related anemia (CRA) accompanied by serum iron deficiency.

Method: One hundred lung cancer patients with CRA and serum iron deficiency were included in this prospective randomized controlled study and randomly divided into control and treatment groups. The treatment group received Shuanghuang Yangxue Decoction plus ferrous succinate, while the control group received ferrous succinate alone. Related indicators were observed and recorded before and after treatment. Statistical analysis was performed using SPSS 26.0.

Results: The effective correction rate of anemia in the treatment group was significantly higher than that in the control group (64 vs 34%, P < .01). Through stratified analysis of patients with moderate anemia, the effective correction rate in the treatment group was significantly higher than that in the control group (75 vs 45%, P < 0.01). After treatment, the treatment group showed statistically significant differences (P < .05) in peripheral blood routine parameters (hemoglobin, erythrocyte count, and hematocrit), anemia indicators (serum iron, ferritin, transferrin saturation, and erythropoietin [EPO]), immune function markers (cytotoxic T lymphocytes [Tc] and natural killer [NK] lymphocytes), and inflammatory factors (interleukin-1β [IL-1β], IL-6, tumor necrosis factor-α [TNF-α], and interferon-γ [IFN-γ]) compared to baseline values. Between-group comparisons showed that mean hemoglobin in the treatment group increased from 106.60 to 119.86 g/L, which was not significantly different from the control group increase from 110.00 to 116.18 g/L (P > .05). However, mean serum iron in the treatment group increased from 7.03 to 12.33 μmol/L, which was significantly higher than the control group increase from 7.33 to 9.45 μmol/L (P < .01). Throughout the study, no adverse reaction events occurred in either group.

Conclusion: Shuanghuang Yangxue Decoction demonstrates superior efficacy compared to ferrous succinate alone in treating lung cancer CRA with serum iron deficiency. It effectively corrects anemia, increases serum iron levels, reduces inflammation, and is both safe and effective.

目的:评价双黄养血汤治疗肺癌肺癌相关性贫血(CRA)伴血清铁缺乏的临床疗效和安全性。方法:选取100例CRA合并血清缺铁的肺癌患者作为前瞻性随机对照研究,随机分为对照组和治疗组。治疗组给予双黄养血汤加琥珀酸亚铁治疗,对照组单独给予琥珀酸亚铁治疗。观察并记录治疗前后相关指标。采用SPSS 26.0进行统计学分析。结果:治疗组贫血的有效矫正率显著高于对照组(64 vs 34%, P P P P P >.05)。治疗组平均血清铁由7.03 μmol/L升高至12.33 μmol/L,显著高于对照组由7.33 μmol/L升高至9.45 μmol/L (P)。结论:双黄养血汤治疗肺癌CRA伴血清铁缺乏的疗效优于单用琥珀酸亚铁。它有效地纠正贫血,增加血清铁水平,减少炎症,并且是安全有效的。
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引用次数: 0
Expanding Integrative Horizons: Toward a Mechanistic Bridge Between Melatonin and Music Therapy in Radiotherapy-Induced Fatigue and Psychological Distress. 拓展整合视野:探索褪黑素和音乐治疗在放疗引起的疲劳和心理困扰中的机制桥梁。
IF 2.8 3区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2025-11-19 DOI: 10.1177/15347354251398010
Gita Arisara, Oktia Woro Kasmini Handayani, Dini Afriani, Dominikus David Biondi Situmorang
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引用次数: 0
Response to the Editor of the Integrative Cancer Therapies. 对《综合癌症疗法》编辑的回应。
IF 2.8 3区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2025-09-27 DOI: 10.1177/15347354251382557
Aija Klavina
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引用次数: 0
Efficacy of Chinese Herbal Medicine in Managing Hot Flushes in Breast Cancer Patients on Adjuvant Chemotherapy: A Clinical Investigation. 中药治疗乳腺癌辅助化疗患者潮热的临床研究
IF 2.8 3区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2025-11-29 DOI: 10.1177/15347354251398843
Chieh-Ying Chin, Shin-Chung Wu, Hsiang-Yu Wang, Chien-Ting Liu, Yu-Chuen Huang, Ming-Yen Tsai

Background: Chinese herbal medicine (CHM), a commonly used alternative therapy, has been reported to reduce the side effects of cancer treatments and improve the quality of life (QOL) in breast cancer (BC) patients. However, there is limited research on the effects of CHM in BC patients experiencing hot flushes (HFs) during adjuvant chemotherapy. We conducted a non-randomized controlled trial to evaluate the effectiveness of CHM on side effects, QOL, and changes in meridian electrodermal activity.

Methods: Forty-eight patients with stage I-III BC undergoing adjuvant chemotherapy were non-randomly assigned to either a 24-week CHM treatment group or a 24-week non-CHM control group. The CHM intervention involved a combination of Jia Wei Xiao Yao San and Er Zhi Wan in a 3:1 ratio, with a total daily dose of 4 g taken 3 times a day. The primary outcome was the occurrence of 10 or more HFs per week and the severity of symptoms, rated using a visual analog scale (1-10). Secondary outcomes included the Functional Assessment of Cancer Therapy-Breast Cancer questionnaire to assess health-related QOL, and meridian energy analysis to measure skin electrical conductance and sympathetic activity. The difference between the CHM and non-CHM groups in individual changes from baseline to week 24 was evaluated using an independent t-test.

Results: A total of 43 participants completed the study, with 25 in the CHM group and 18 in the control group. The CHM group showed a statistically significant reduction in HF frequency at 12 and 24 weeks and a decrease in HF severity at 12 weeks compared to the control group (P < .05). Physical well-being and specific concerns scores also improved significantly over time in the CHM group compared to the control group (P < .05). While CHM treatment did not lead to significant changes in overall electrical conductance at acupoints (P = .251), it did significantly affect specific meridians, including the heart, liver, and kidney (P = .032, P = .035, and P = .035, respectively). Additionally, sympathetic activity was reduced in the CHM group after completing chemotherapy (P = .045).

Conclusions: CHM therapy appears to have a preventive effect on chemotherapy-related HFs in BC patients and is safe, with no severe adverse effects observed.

背景:中药作为一种常用的替代疗法,已被报道可以减少癌症治疗的副作用,提高乳腺癌(BC)患者的生活质量(QOL)。然而,关于CHM在辅助化疗期间经历潮热(HFs)的BC患者中的作用的研究有限。我们进行了一项非随机对照试验,以评估中药在副作用、生活质量和经络皮电活动变化方面的有效性。方法:48例接受辅助化疗的I-III期BC患者非随机分为24周CHM治疗组和24周非CHM对照组。CHM干预包括加味消药散和二致丸以3:1的比例联合使用,每日总剂量为4 g,每天服用3次。主要结局是每周发生10次或10次以上的HFs和症状的严重程度,使用视觉模拟量表(1-10)进行评分。次要结果包括癌症治疗功能评估-乳腺癌问卷评估健康相关的生活质量,经络能量分析测量皮肤电导和交感神经活动。CHM组和非CHM组从基线到第24周的个体变化的差异使用独立t检验进行评估。结果:共有43名参与者完成了研究,其中CHM组25名,对照组18名。与对照组相比,CHM组在12周和24周时HF频率降低,12周时HF严重程度降低,具有统计学意义(P P P =。251),但对特定经络有显著影响,包括心、肝、肾(P =。032, p =。035, P =。035年,分别)。此外,CHM组完成化疗后交感神经活动减少(P = 0.045)。结论:CHM治疗似乎对BC患者化疗相关的HFs有预防作用,并且是安全的,没有观察到严重的不良反应。
{"title":"Efficacy of Chinese Herbal Medicine in Managing Hot Flushes in Breast Cancer Patients on Adjuvant Chemotherapy: A Clinical Investigation.","authors":"Chieh-Ying Chin, Shin-Chung Wu, Hsiang-Yu Wang, Chien-Ting Liu, Yu-Chuen Huang, Ming-Yen Tsai","doi":"10.1177/15347354251398843","DOIUrl":"10.1177/15347354251398843","url":null,"abstract":"<p><strong>Background: </strong>Chinese herbal medicine (CHM), a commonly used alternative therapy, has been reported to reduce the side effects of cancer treatments and improve the quality of life (QOL) in breast cancer (BC) patients. However, there is limited research on the effects of CHM in BC patients experiencing hot flushes (HFs) during adjuvant chemotherapy. We conducted a non-randomized controlled trial to evaluate the effectiveness of CHM on side effects, QOL, and changes in meridian electrodermal activity.</p><p><strong>Methods: </strong>Forty-eight patients with stage I-III BC undergoing adjuvant chemotherapy were non-randomly assigned to either a 24-week CHM treatment group or a 24-week non-CHM control group. The CHM intervention involved a combination of Jia Wei Xiao Yao San and Er Zhi Wan in a 3:1 ratio, with a total daily dose of 4 g taken 3 times a day. The primary outcome was the occurrence of 10 or more HFs per week and the severity of symptoms, rated using a visual analog scale (1-10). Secondary outcomes included the Functional Assessment of Cancer Therapy-Breast Cancer questionnaire to assess health-related QOL, and meridian energy analysis to measure skin electrical conductance and sympathetic activity. The difference between the CHM and non-CHM groups in individual changes from baseline to week 24 was evaluated using an independent <i>t</i>-test.</p><p><strong>Results: </strong>A total of 43 participants completed the study, with 25 in the CHM group and 18 in the control group. The CHM group showed a statistically significant reduction in HF frequency at 12 and 24 weeks and a decrease in HF severity at 12 weeks compared to the control group (<i>P</i> < .05). Physical well-being and specific concerns scores also improved significantly over time in the CHM group compared to the control group (<i>P</i> < .05). While CHM treatment did not lead to significant changes in overall electrical conductance at acupoints (<i>P</i> = .251), it did significantly affect specific meridians, including the heart, liver, and kidney (<i>P</i> = .032, <i>P</i> = .035, and <i>P</i> = .035, respectively). Additionally, sympathetic activity was reduced in the CHM group after completing chemotherapy (<i>P</i> = .045).</p><p><strong>Conclusions: </strong>CHM therapy appears to have a preventive effect on chemotherapy-related HFs in BC patients and is safe, with no severe adverse effects observed.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"24 ","pages":"15347354251398843"},"PeriodicalIF":2.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12665033/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145633162","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Subject: Letter to the Editor regarding "Translation, Cross-cultural Adaptation, and Validation of the Kannada Version of the Exercise Adherence Rating Scale (EARS-Kn) Among Head and Neck Cancer (HNC) Survivors in a Tertiary Care Setup in India" in Integrative Cancer Therapies. 主题:关于“印度三级医疗机构头颈癌(HNC)幸存者运动依从性评定量表(ars - kn)的卡纳达语版本的翻译、跨文化适应和验证”在综合癌症治疗中的致编辑的信。
IF 2.9 3区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2025-03-29 DOI: 10.1177/15347354251331102
Chindhu Shunmuga Sundaram
{"title":"Subject: Letter to the Editor regarding \"Translation, Cross-cultural Adaptation, and Validation of the Kannada Version of the Exercise Adherence Rating Scale (EARS-Kn) Among Head and Neck Cancer (HNC) Survivors in a Tertiary Care Setup in India\" in Integrative Cancer Therapies.","authors":"Chindhu Shunmuga Sundaram","doi":"10.1177/15347354251331102","DOIUrl":"https://doi.org/10.1177/15347354251331102","url":null,"abstract":"","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"24 ","pages":"15347354251331102"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11954529/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742800","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Patients' Expectations and Barriers Toward Reishi Mushroom Use in Cancer Care: A Cross-Sectional Survey. 患者对灵芝用于癌症治疗的期望和障碍:一项横断面调查。
IF 2.8 3区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2025-09-30 DOI: 10.1177/15347354251368419
Xiaotong Li, Anna Ye, Eunbin Kwag, Jerrin Bawa, Lingyun Sun, Susan Qing Li, Yajie Zhou, Jun J Mao, Kevin T Liou

Background: Reishi mushroom is one of the most commonly used supplements among cancer patients. However, limited data exists on why patients choose Reishi. This study aimed to explore patients' expectations and barriers to using Reishi.

Methods: We conducted a cross-sectional survey study of a cancer population from Mainland China who reported using Reishi. Participants were recruited using a customer database from Zhongke Health International LLC. Patients' expectations and barriers to Reishi use were assessed using a modified version of the Attitudes and Beliefs Toward Complementary and Alternative Medicine (ABCAM) survey. Multivariable linear regression models were applied to examine whether socio-demographic and clinical factors, as well as Reishi usage patterns, influenced participants' attitudes toward Reishi.

Results: Among 1374 participants, the most common sources of information about Reishi products were friends (49.78%) and family (36.83%). More than half (55.9%) used additional traditional Chinese herbal remedies in combination with Reishi. The most frequently cited expectations for Reishi use were boosting immunity (45% strongly agreed) and improving physical health (41% strongly agreed). 72% identified cost and insurance coverage as the primary barriers to Reishi usage. Approximately 10% considered side effects and limited research evidence as barriers. Stage IV cancer and duration of Reishi use >5 years were significantly associated with higher expectations and lower perceived barriers.

Conclusion: This study identified the most common expectations and barriers to Reishi use in cancer care in Mainland China. These findings can help clinicians better understand patient perspectives and integrate herbal supplements more effectively into supportive cancer care.

背景:灵芝是癌症患者最常用的补品之一。然而,关于患者为什么选择灵芝的数据有限。本研究旨在探讨患者使用灵芝的期望和障碍。方法:我们对中国大陆报告使用灵芝的癌症人群进行了横断面调查研究。参与者使用中科健康国际有限责任公司的客户数据库招募。患者使用灵芝的期望和障碍使用改进版本的对补充和替代医学的态度和信念(ABCAM)调查进行评估。本研究采用多元线性回归模型,探讨社会人口学、临床因素以及灵芝的使用模式是否会影响受试者对灵芝的态度。结果:在1374名参与者中,最常见的灵芝产品信息来源是朋友(49.78%)和家人(36.83%)。超过一半(55.9%)的人将传统中草药与灵芝结合使用。人们最常提到的对灵芝使用的期望是增强免疫力(45%强烈同意)和改善身体健康(41%强烈同意)。72%的人认为费用和保险是使用灵芝的主要障碍。大约10%的人认为副作用和有限的研究证据是障碍。IV期癌症和灵芝治疗持续时间(≤5年)与更高的期望和更低的感知障碍显著相关。结论:本研究确定了灵芝在中国大陆癌症治疗中最常见的期望和障碍。这些发现可以帮助临床医生更好地了解患者的观点,并更有效地将草药补充剂纳入支持性癌症治疗中。
{"title":"Patients' Expectations and Barriers Toward Reishi Mushroom Use in Cancer Care: A Cross-Sectional Survey.","authors":"Xiaotong Li, Anna Ye, Eunbin Kwag, Jerrin Bawa, Lingyun Sun, Susan Qing Li, Yajie Zhou, Jun J Mao, Kevin T Liou","doi":"10.1177/15347354251368419","DOIUrl":"10.1177/15347354251368419","url":null,"abstract":"<p><strong>Background: </strong>Reishi mushroom is one of the most commonly used supplements among cancer patients. However, limited data exists on why patients choose Reishi. This study aimed to explore patients' expectations and barriers to using Reishi.</p><p><strong>Methods: </strong>We conducted a cross-sectional survey study of a cancer population from Mainland China who reported using Reishi. Participants were recruited using a customer database from Zhongke Health International LLC. Patients' expectations and barriers to Reishi use were assessed using a modified version of the Attitudes and Beliefs Toward Complementary and Alternative Medicine (ABCAM) survey. Multivariable linear regression models were applied to examine whether socio-demographic and clinical factors, as well as Reishi usage patterns, influenced participants' attitudes toward Reishi.</p><p><strong>Results: </strong>Among 1374 participants, the most common sources of information about Reishi products were friends (49.78%) and family (36.83%). More than half (55.9%) used additional traditional Chinese herbal remedies in combination with Reishi. The most frequently cited expectations for Reishi use were boosting immunity (45% strongly agreed) and improving physical health (41% strongly agreed). 72% identified cost and insurance coverage as the primary barriers to Reishi usage. Approximately 10% considered side effects and limited research evidence as barriers. Stage IV cancer and duration of Reishi use >5 years were significantly associated with higher expectations and lower perceived barriers.</p><p><strong>Conclusion: </strong>This study identified the most common expectations and barriers to Reishi use in cancer care in Mainland China. These findings can help clinicians better understand patient perspectives and integrate herbal supplements more effectively into supportive cancer care.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"24 ","pages":"15347354251368419"},"PeriodicalIF":2.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12484901/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145191543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and Safety of Herbal Medicine Bojungikki-Tang in Combination with Pembrolizumab versus Pembrolizumab Monotherapy for Stage IV Non-Small Cell Lung Cancer: Study Protocol for a Randomized, Open-Label, Double-Arm, Multicenter Trial. 中药保正益汤联合派姆单抗与派姆单抗单药治疗IV期非小细胞肺癌的疗效和安全性:一项随机、开放标签、双组、多中心试验的研究方案
IF 2.9 3区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 DOI: 10.1177/15347354251319339
Eunbyul Cho, Jin-Mu Yi, Jaemoo Chun, Ho Jang, Seong Hoon Yoon, Seung Hyeun Lee, Seung Hun Jang, Dong Won Park, Seung Joon Kim, Sang-Won Um, Sung Yong Lee, Mi-Kyung Jeong

Background: Non-small cell lung cancer (NSCLC) exhibits low survival rates. Although immune checkpoint inhibitors (ICIs) have become first-line treatment for NSCLC, their limited response to ICI monotherapy has led to exploration of combination treatments. However, the high incidence of treatment-related adverse events associated with conventional drug combinations has highlighted the need for alternative herbal therapy. Bojungikki-tang (BJIKT), a traditional herbal medicine, has been used to treat gastrointestinal disorders and enhance immune function. Our preclinical studies have demonstrated that BJIKT combined with anti-PD-1 or anti-PD-L1 antibodies exhibits significant efficacy in suppressing tumor growth by modulating the immunosuppressive tumor microenvironment. Building on these preclinical findings, this study aims to evaluate the efficacy and safety of BJIKT with pembrolizumab combination therapy compared to pembrolizumab monotherapy in advanced NSCLC patients.

Methods: 70 individuals with stage IV NSCLC scheduled for first-line pembrolizumab monotherapy will be randomly assigned to intervention or control groups. The primary outcome will be progression-free survival, with secondary outcomes including disease control rate, overall survival, and quality of life assessment. Adverse events will be monitored for safety. This study will explore the synergistic mechanism of combinatorial therapy using immune profiling and multi-omics analysis, and the possibility for personalized integrative therapy based on cold-heat syndrome differentiation (SD) types in East Asian medicine.

Discussion: This study will provide novel evidence regarding survival outcomes, quality of life, and safety profiles of combined ICI and BJIKT therapy for advanced NSCLC. The exploratory data will contribute to tailoring treatments to immune-based SD types in NSCLC patients.

背景:非小细胞肺癌(NSCLC)生存率低。尽管免疫检查点抑制剂(ICI)已成为非小细胞肺癌的一线治疗方法,但其对ICI单药治疗的有限反应导致了对联合治疗的探索。然而,与常规药物组合相关的治疗相关不良事件的高发生率突出了替代草药治疗的必要性。Bojungikki-tang (BJIKT)是一种传统草药,用于治疗胃肠道疾病和增强免疫功能。我们的临床前研究表明,BJIKT联合抗pd -1或抗pd - l1抗体通过调节免疫抑制性肿瘤微环境来抑制肿瘤生长。基于这些临床前研究结果,本研究旨在评估BJIKT与派姆单抗联合治疗在晚期NSCLC患者中的疗效和安全性,并与派姆单抗单药治疗进行比较。方法:70例IV期NSCLC患者计划接受一线派姆单抗单药治疗,随机分为干预组或对照组。主要终点是无进展生存期,次要终点包括疾病控制率、总生存率和生活质量评估。将对不良事件进行安全监测。本研究将通过免疫谱分析和多组学分析探讨联合治疗的协同机制,以及东亚医学基于寒热辨证(SD)类型的个性化综合治疗的可能性。讨论:本研究将为晚期NSCLC联合ICI和BJIKT治疗的生存结局、生活质量和安全性提供新的证据。探索性数据将有助于针对非小细胞肺癌患者的免疫SD类型定制治疗。
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引用次数: 0
Effectiveness of Traditional Chinese Medicine in Psychological Rehabilitation After Lung Cancer Surgery: Systematic Review and Meta-Analysis protocol. 中医在肺癌术后心理康复中的疗效:系统评价和meta分析方案。
IF 2.9 3区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 DOI: 10.1177/15347354251313533
Luchang Cao, Zilin Wang, Xinmiao Wang, Guanghui Zhu, Ying Zhang, Jie Li

Background: The incidence and mortality of lung cancer is the highest among malignant tumors worldwide, and it seriously threatens human life and health. Surgery is the primary radical treatment for lung cancer. However, patients often experience discomfort, changes in social roles, economic pressures, and other postsurgical challenges. These factors frequently cause various psychological disorders such as anxiety and depression, significantly diminishing the quality of life and elevating the risks of recurrence, metastasis, and mortality. Therefore, effective strategies for mental function rehabilitation should be urgently developed. Traditional Chinese medicine can significantly improve psychological function and physical symptoms after lung cancer surgery, and prolong patient survival. However, its effectiveness for mental function rehabilitation after lung cancer surgery remains unclear. This study aimed to investigate the effects of Chinese medicine on mental function recovery after lung cancer surgery through a systematic review and meta-analysis.

Methods: This study will systematically search the following databases: PubMed, Cochrane Library, EMBASE, Web of Science, ClinicalTrials.gov, China National Knowledge Infrastructure, Wanfang database, VIP database, and Chinese BioMedical Literature database. Search for studies published from the inception of each database until April 22, 2024. This study will be limited to clinical randomized controlled trials (RCTs). The primary outcome will be depression or anxiety, as indicated by the scale score. Data analysis will be performed using RevMan 5. The Cochrane Risk of Bias Assessment Tool will be used to evaluate the quality of included studies. Finally, the quality of the evidence will be classified using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) System.

Results: This meta-analysis aims to offer comprehensive evidence of the effectiveness of traditional Chinese medicine in mental function rehabilitation after lung cancer surgery. The study will assess the quality of the reports and conduct a subgroup analysis based on various postoperative stages, intervention measures, intervention duration, and sex to gather more evidence to fill the gap in psychological function rehabilitation after lung cancer surgery. These data can be used to guide clinical practice and inform future studies. More importantly, the results of this study will provide evidence to support the development of expert consensus and clinical guidelines in the field of mental function rehabilitation after lung cancer surgery.

背景:肺癌是世界范围内发病率和死亡率最高的恶性肿瘤,严重威胁着人类的生命和健康。手术是肺癌的主要根治方法。然而,患者经常会经历不适、社会角色的变化、经济压力和其他术后挑战。这些因素经常引起各种心理障碍,如焦虑和抑郁,显著降低生活质量,增加复发、转移和死亡率的风险。因此,迫切需要制定有效的心理功能康复策略。中药能显著改善肺癌术后的心理功能和躯体症状,延长患者生存期。然而,其对肺癌手术后心理功能康复的效果尚不清楚。本研究旨在通过系统综述和荟萃分析,探讨中药对肺癌术后心理功能恢复的影响。方法:系统检索PubMed、Cochrane Library、EMBASE、Web of Science、ClinicalTrials.gov、中国国家知识基础设施、万方数据库、VIP数据库、中国生物医学文献数据库。检索从每个数据库建立到2024年4月22日发表的研究。本研究仅限于临床随机对照试验(RCTs)。主要结果将是抑郁或焦虑,如量表得分所示。数据分析将使用RevMan 5进行。Cochrane偏倚风险评估工具将用于评估纳入研究的质量。最后,证据的质量将使用分级建议评估、发展和评估(GRADE)系统进行分类。结果:本荟萃分析旨在为中医在肺癌术后心理功能康复中的有效性提供综合证据。本研究将对报告的质量进行评估,并根据术后各阶段、干预措施、干预时间、性别进行亚组分析,以收集更多证据,填补肺癌手术后心理功能康复的空白。这些数据可用于指导临床实践并为未来的研究提供信息。更重要的是,本研究结果将为肺癌术后心理功能康复领域的专家共识和临床指南的制定提供证据支持。
{"title":"Effectiveness of Traditional Chinese Medicine in Psychological Rehabilitation After Lung Cancer Surgery: Systematic Review and Meta-Analysis protocol.","authors":"Luchang Cao, Zilin Wang, Xinmiao Wang, Guanghui Zhu, Ying Zhang, Jie Li","doi":"10.1177/15347354251313533","DOIUrl":"10.1177/15347354251313533","url":null,"abstract":"<p><strong>Background: </strong>The incidence and mortality of lung cancer is the highest among malignant tumors worldwide, and it seriously threatens human life and health. Surgery is the primary radical treatment for lung cancer. However, patients often experience discomfort, changes in social roles, economic pressures, and other postsurgical challenges. These factors frequently cause various psychological disorders such as anxiety and depression, significantly diminishing the quality of life and elevating the risks of recurrence, metastasis, and mortality. Therefore, effective strategies for mental function rehabilitation should be urgently developed. Traditional Chinese medicine can significantly improve psychological function and physical symptoms after lung cancer surgery, and prolong patient survival. However, its effectiveness for mental function rehabilitation after lung cancer surgery remains unclear. This study aimed to investigate the effects of Chinese medicine on mental function recovery after lung cancer surgery through a systematic review and meta-analysis.</p><p><strong>Methods: </strong>This study will systematically search the following databases: PubMed, Cochrane Library, EMBASE, Web of Science, ClinicalTrials.gov, China National Knowledge Infrastructure, <i>Wanfang</i> database, VIP database, and Chinese BioMedical Literature database. Search for studies published from the inception of each database until April 22, 2024. This study will be limited to clinical randomized controlled trials (RCTs). The primary outcome will be depression or anxiety, as indicated by the scale score. Data analysis will be performed using RevMan 5. The Cochrane Risk of Bias Assessment Tool will be used to evaluate the quality of included studies. Finally, the quality of the evidence will be classified using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) System.</p><p><strong>Results: </strong>This meta-analysis aims to offer comprehensive evidence of the effectiveness of traditional Chinese medicine in mental function rehabilitation after lung cancer surgery. The study will assess the quality of the reports and conduct a subgroup analysis based on various postoperative stages, intervention measures, intervention duration, and sex to gather more evidence to fill the gap in psychological function rehabilitation after lung cancer surgery. These data can be used to guide clinical practice and inform future studies. More importantly, the results of this study will provide evidence to support the development of expert consensus and clinical guidelines in the field of mental function rehabilitation after lung cancer surgery.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"24 ","pages":"15347354251313533"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11726522/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142970687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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Integrative Cancer Therapies
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