• Title/Summary/Keyword: adverse symptom

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A Review of Clinical Researches for Herbal Medicine Treatment on Vitiligo (백반증의 한약 치료에 대한 임상 연구 고찰)

  • Park, Sul Gi;Park, So Hyun;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.34 no.2
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    • pp.57-74
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    • 2020
  • Objectives The purpose of this study is to analyze clinical studies on the efficacy and safety of herbal medicine in vitiligo by analyzing randomized controlled trials (RCTs). Methods Three electronic databases including the PubMed, EMBASE, and Cochrane library were used to search for randomized controlled trials, by using specific key words and criteria up to January 4th, 2020. Data in regards to years of publication, nation, demographic information, disease characteristics, duration of diseases, treatment methods, treatment period, outcome measures, results and adverse events were collected for this study. Results A total of 11 randomized controlled trials were selected and analyzed. The total effective rate of the treatment group treated with herbal medicine was significantly higher than that of the control group. In the other outcome measures, the treatment group also showed statistically significant differences in improving the outcome measures compared to the control group, or showed similar treatment effects to the control group. The most commonly used herbal medicines were Carthami Flos (紅花), Angelicae Gigantis Radix (當歸), Angelica dahurica Bentham et Hooker f. (白芷), Astragali Radix (黃芪), Glycyrrhizae Radix et Rhizoma (甘草), Salviae Miltiorrhizae Radix (丹參), Persicae Semen (桃仁), Araliae Continentalis Radix (獨活), Tribuli Fructus (白蒺藜), Psoraleae Semen (補骨脂) etc. Hardly any severe adverse events were reported from the trials selected. Conclusions Based on the results of the clinical studies, herbal medicine treatment could be an effective and safe option for vitiligo treatment and symptom improvement.

Comparative Assessment of Skin and Subcutaneous Toxicity in Patients of Advanced Colorectal Carcinoma Treated with Different Schedules of FOLFOX

  • Bano, Nusrat;Najam, Rahila;Mateen, Ahmed
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.3
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    • pp.1781-1786
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    • 2013
  • Objective: The study was designed to assess the skin and subcutaneous toxicity in patients with advanced colorectal carcinoma treated with four different schedules of FOLFOX. Methods: The patients with histologically confirmed advanced colorectal carcinoma (CRC) were included in the study as per specified inclusion criteria. Toxicity was graded according to CTC v2.0. The frequency of grade 3 and 4 adverse effects were comparatively assessed in each treatment arm. Results: Very severe toxicity was attributed to the FOLFOX7 schedule. The difference between the incidence rate of grade 4 toxicity with all other grades for all parameters of skin and subcutaneous toxicity was highly significant (p=0.00<0.001). Grade 4 hand and foot syndrome was reported only in the FOLFOX7 treatment arm. The most frequent adverse symptom of skin and subcutaneous toxicity reported in the patients treated with modified schedule of FOLFOX was pruritus (grade 1). Frequency and onset of skin and subcutaneous toxic symptoms like alopecia (p=0.000), nail discoloration (p=0.021) and pruritis (p=0.000) was significantly different in each FOLFOX treatment arm. A few cases of oncholysis were also reported in the FOLFOX7 treatment arm. Hand and foot syndrome was fast progressing in patients with grade 1 toxicity. Conclusion: Higher frequency and severity of hand and foot syndrome and pruritus wasa found in the FOLFOX7 treatment arm. Skin and subcutaneous toxicity was comparatively low in the FOLFOX6 treatment arm.

A Case Report of FOLFOX-induced Adverse Events in a Patient with Recurrent Advanced Gastric Cancer Treated with Korean Medicine (재발 진행성 위암 환자의 FOLFOX 유발 부작용 개선에 대한 한의 치료 1례)

  • Ko, Myung-hyun;Yang, Jae-ho;Jeon, Hyung-joon;Cho, Chong-kwan;Lee, Yeon-weol;Park, So-jung;Yoo, Hwa-seung
    • The Journal of Internal Korean Medicine
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    • v.41 no.1
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    • pp.81-87
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    • 2020
  • Objective: The purpose of this study was to report the clinical effectiveness of Korean medicine treatment on FOLFOX-induced symptoms such as nausea and dizziness in a patient with recurrent advanced gastric adenocarcinoma. Methods: The patient was diagnosed with recurrent advanced gastric cancer and had FOLFOX-induced nausea and dizziness. The patient was treated with Samchulgunbi-tang and Banhasashim-tang for symptom management. The clinical outcomes were measured by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) and a numeral rating scale (NRS). Results: After treatment, the patient's nausea and dizziness were relieved from NRS 9 to 2 and NRS 8 to 2 respectively. During and after treatment, no severe toxicities were detected on laboratory findings. Conclusion: This case study suggests that Samchulgunbi-tang and Banhasashim-tang may relieve symptoms of FOLFOX-induced nausea and dizziness.

The Effect of Chunggan Plus Extract in Improving Liver Function: A Retrospective Case Series of Eight Patients (청간플러스의 간기능 개선 효과 : 후향적 증례보고 8례)

  • Lee, Ga-young;Park, Chan-ran;Cho, Jung-hyo;Son, Chang-gue;Lee, Nam-hun
    • The Journal of Internal Korean Medicine
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    • v.41 no.3
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    • pp.542-551
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    • 2020
  • Objectives: The purpose of this study was to retrospectively assess the effectiveness of Chunggan plus extract (CGX) in improving liver function in a Korean medical clinic. Methods: We collected the data of inpatients who received CGX to improve abnormal liver function test (LFT) results from March 2016 to February 2020. We analyzed the changes in LFT and adverse events based on subjective symptom changes and creatinine results. Results: The data of eight patients, three male and five female, were selected by inclusion criteria (patients who did LFT before and after the prescription of CGX and who prescribed CGX more than 6 days) and exclusion criteria (patients who administered other herbal medicine for improving liver function except CGX and who are diagnosed with terminal stage of hepatobiliary cancer). As a cause of abnormal LFT, one case was diagnosed with alcoholic liver disease, two cases with non-alcoholic fatty hepatitis, and one case with cholecystitis. Three of the other four were suspected to have drug-induced hepatitis, and one case was determined to have an unknown cause. Most patients showed a decrease in LFT results (Aspartate transaminase 87.5%, Alanine transaminase 87.5%, and Alkaline Phosphatase 100%) without any critical adverse events. Conclusions: CGX may be an efficient and convenient herbal medicine for improving liver function regardless of the chief impression. Further study should be conducted to evaluate the effectiveness of CGX.

Aloe vera Is Effective and Safe in Short-term Treatment of Irritable Bowel Syndrome: A Systematic Review and Meta-analysis

  • Hong, Seung Wook;Chun, Jaeyoung;Park, Sunmin;Lee, Hyun Jung;Im, Jong Pil;Kim, Joo Sung
    • Journal of Neurogastroenterology and Motility
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    • v.24 no.4
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    • pp.528-535
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    • 2018
  • Background/Aims To evaluate the efficacy and safety of Aloe vera (AV) in patients with irritable bowel syndrome (IBS). Methods We searched the MEDLINE, EMBASE, and Cochrane databases for studies dated between 1st January 1960 and 30th December 2017. Eligible randomized controlled trials (RCTs) compared AV to placebo in patients with IBS. The primary outcome was standardized mean difference of the change in severity of IBS symptoms as measured by patient-rated scales. Secondary outcomes included response rate of IBS symptoms and adverse events. Heterogeneity among studies was assessed using Cochrane's Q and $I^2$ statistics. Results Three RCTs with a total of 151 patients with IBS were included. The meta-analysis showed a significant difference for patients with AV compared to those with placebo regarding improvement in IBS symptom score (standardized mean difference, 0.41; 95% CI, 0.07-0.75; P = 0.020). Using intention-to-treat analysis, the AV patients showed significantly better response rates of IBS symptoms compared to placebo (pooled risk ratio, 1.69; 95% CI, 1.05-2.73; P = 0.030). No adverse events related with AV were found in included studies. There was no significant heterogeneity of effects across studies (P = 0.900; $I^2=0%$). Conclusion AV is effective and safe for the treatment of patients with IBS compared to placebo.

A Review of Recent Clinical Researches in Chinese Medical Journal for Efficacy and Safety of Pediatric Herbal Medicine Inhalation Therapy (소아 무화흡입요법의 효과 및 안전성에 대한 최신 중의학 임상 연구 고찰 - 2010년 이후 발표된 임상 연구 논문을 중심으로 -)

  • Park, Sul Gi;Park, So Hyun;Shin, Dong Gil;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.33 no.3
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    • pp.82-102
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    • 2019
  • Objectives The purpose of this study is to investigate clinical studies on the efficacy and safety of herbal medicine inhalation therapy in children by analyzing recent randomized controlled trials conducted in China. Methods We searched the clinical studies from the China Academic Journal (CAJ) in China National Knowledge Infrastructure (CNKI) using a by key word '霧化吸入' and specific criteria from 1st January 2010 to 2nd July 2019. Data regarding years of publication, demographic information, target diseases or symptoms, treatment methods, outcome measure, results and adverse events are collected for this study. Results Total of 44 randomized controlled trials were selected and analyzed. Respiratory diseases and symptoms (84.1%) were the most frequent target diseases that herbal medicine inhalation therapy was used. Acute stomatitis was another disease state that the therapy was used. In most of the studies, the herbal medicine inhalation in children showed significant efficacies. The most commonly used herbal medicines were Ephedrae Herba (麻黃), Lonicera Flos (金銀花), Armeniacae Semen (杏仁), Glycyrrhizae Radix et Rhizoma (甘草), Scutellaria Radix (黃芩), Forsythia Fructus (連翹) etc. Hardly any adverse effects were reported from the trials selected. Conclusions Based on the results of the clinical studies from China, herbal medicine inhalation therapy in children can be an effective and safe option for treatment and symptom improvement.

Antipsychotics for patients with pain

  • Shin, Sang Wook;Lee, Jin Seong;Abdi, Salahadin;Lee, Su Jung;Kim, Kyung Hoon
    • The Korean Journal of Pain
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    • v.32 no.1
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    • pp.3-11
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    • 2019
  • Going back to basics prior to mentioning the use of antipsychotics in patients with pain, the International Association for the Study of Pain (IASP) definition of pain can be summarized as an unpleasant experience, composed of sensory experience caused by actual tissue damage and/or emotional experience caused by potential tissue damage. Less used than antidepressants, antipsychotics have also been used for treating this unpleasant experience as adjuvant analgesics without sufficient evidence from research. Because recently developed atypical antipsychotics reduce the adverse reactions of extrapyramidal symptoms, such as acute dystonia, pseudo-parkinsonism, akathisia, and tardive dyskinesia caused by typical antipsychotics, they are expected to be used more frequently in various painful conditions, while increasing the risk of metabolic syndromes (weight gain, diabetes, and dyslipidemia). Various antipsychotics have different neurotransmitter receptor affinities for dopamine (D), 5-hydroxytryptamine (5-HT), adrenergic (${\alpha}$), histamine (H), and muscarinic (M) receptors. Atypical antipsychotics antagonize transient, weak $D_2$ receptor bindings with strong binding to the $5-HT_{2A}$ receptor, while typical antipsychotics block long-lasting, tight $D_2$ receptor binding. On the contrary, antidepressants in the field of pain management also block the reuptake of similar receptors, mainly on the 5-HT and, next, on the norepinephrine, but rarely on the D receptors. Antipsychotics have been used for treating positive symptoms, such as delusion, hallucination, disorganized thought and behavior, perception disturbance, and inappropriate emotion, rather than the negative, cognitive, and affective symptoms of psychosis. Therefore, an antipsychotic may be prescribed in pain patients with positive symptoms of psychosis during or after controlling all sensory components.

Recent Trends in Clinical Research of Herbal Medicine for Tic Disorder in Children - Focused on Chinese Randomized Controlled Trials - (소아 틱장애의 한약치료에 대한 최신 임상연구 동향 - 중국 무작위 대조군 임상연구를 중심으로 -)

  • Kim, Jae Hyun;Park, Yong Seok;Jeong, Yoon Kyoung;Chang, Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.36 no.1
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    • pp.38-56
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    • 2022
  • Objectives The purpose of this study was to analyze the trend of recent randomized controlled trials (RCTs) that used herbal medicine for the treatment of tic disorders in China and to evaluate the efficacy and safety of the treatment. Methods RCTs published from January 2017 to December 2021 were searched for using the China National Knowledge Infrastructure (CNKI). These were then analyzed using herbal medicine treatment methods and their results. Results A total of 35 randomized controlled trials were selected and analyzed. In most studies, evaluation indicators such as the Yale tic symptom scale and total effective rate were significantly improved in the herbal medicine treatment group compared to the control group. The most commonly used herb for tic disorder was Uncaria Rhynchophylla (釣鉤藤), followed by Glycyrrhizae Radix (甘草), Gastrodiae Rhizoma (天麻), Paeoniae Radix Alba (白芍藥), Batryticatus (白殭蠶), Poria (茯笭), and Bupleuri Radix (柴胡). In all studies that reported adverse events, herbal medicine was identified as a relatively safe treatment with fewer adverse reactions or no significant difference compared with the control group. Conclusions Based on the results of RCTs, herbal medicine has been shown to be safe and effective for the treatment of intellectual disability. However, additional well-designed large-scale clinical trials are needed to confirm these findings.

A population-based study of breast implant illness

  • Magno-Padron, David A.;Luo, Jessica;Jessop, Terry C.;Garlick, Jared W.;Manum, Joanna S.;Carter, Gentry C.;Agarwal, Jayant P.;Kwok, Alvin C.
    • Archives of Plastic Surgery
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    • v.48 no.4
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    • pp.353-360
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    • 2021
  • Background Despite evidence supporting the safety of breast implants, some women associate their implants with adverse health effects and have called this syndrome "breast implant illness." We sought to characterize breast implant illness symptoms and to report how implant removal affects their symptoms. Methods An anonymous 20 question survey was administered to the Facebook group: "UTAH Breast Implant Illness" to characterize the symptoms these women attributed to their breast implants. Several questions allowed us to evaluate how implant removal affected women's symptoms. Results Of the 182 respondents, 97% report that implants negatively affect their health and 95% identify these symptoms with breast implant illness. Ninety-six percent of respondents had implants placed for cosmetic reasons and 51% had silicone implants. The most common symptoms associated with breast implant illness are brain fog (95%), fatigue (92%), joint pain (80%), and hair loss (74%). Sixty percent of respondents learned about breast implant illness from family/friends and/or social media platforms (56%), 40% of respondents had their implants removed, and 97% report relief of their symptoms post-removal (23% complete, 74% partial). Following explantation, there was a significant improvement in all but one reported symptom. An association was found between the number of symptoms reported prior to explantation and the number of symptoms resolving following explantation. Conclusions Breast implant illness is a syndrome characterized by fatigue, decreased focus, hair loss, and joint pain after the placement of breast implants. Nearly all patients report improvement of symptoms after implant removal. Significant efforts should be made to better understand breast implant illness and its etiology.

Efficacy and Safety of Codonopsis lanceolata (S. et Z.) Trautv. Extract on the Improvement of the Hypersensitivity Reaction in Allergic Rhinitis Patients (알레르기 비염 질환자를 대상으로 한 더덕(Codonopsis lanceolata (S. et Z.) Trautv.) 추출물의 과민면역반응 개선에 대한 유효성 및 안전성 평가)

  • Ahn, Ha-Young;Boo, Hee-Ock;Kim, Hyeong-Jun
    • The Korea Journal of Herbology
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    • v.34 no.1
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    • pp.13-21
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    • 2019
  • Objectives : This clinical trial is performed to investigate the effect of improving the hypersensitivity reaction and the safety of powdered ethanol extract Codonopsis lanceolata (S. et Z.) Trautv. for allergic patients. Methods : This study was randomized, double blinded, placebo-controlled clinical trial. 60 allergic rhinitis subjects were randomly assigned to Treatment group(n=30) and Control group(n=30). They were received the test substance or placebo in their $1^{st}$ and $2^{nd}$ visit, and took it once a day, 1 powder bag per 1 time, for 8 weeks. The freeze dried powder of Codonopsis lanceolata (S. et Z.) Trautv. was mixed with 30% ethanol and the filtrate was collected thrice with constant stirring of the mixture. The placebo was prepared in the same form as the test substance by replacing with corn starch. Total Nasal Symptom Score(TNSS) questionnaires and laboratory tests were performed at the screening and last visit to evaluate the efficacy. And to assess safety, vital signs and adverse events were confirmed at every visit. Statistical analysis about the result was performed using SAS 9.4. Results : In treatment group, there was a significant decrease in B cell after taking the test substance(p<0.005). And there was a statistically significant difference between groups(p<0.005). Changes in nasal symptoms were not statistically significant between groups, and both groups showed statistically significant differences before and after the test(p<0.0001). Also there were no adverse events associated with the clinical trial product. Conclusions : This clinical trial showed that Codonopsis lanceolata (S. et Z.) Trautv. extract was helpful in improving the hypersensitivity reaction in allergic patients without significant side effects.