• Title/Summary/Keyword: Adverse outcomes

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A Review of Research Trends in Gold Implantation Therapy Focused on Gold Thread, Gold Needle and Gold Bead (금사, 금침, 금주를 중심으로 한 금(金)의 인체 내 매장요법에 대한 연구동향 고찰연구)

  • Jo, Dae Hyun;Baatarkhuyag, Ariunchimeg;Jo, Ye Eun;Lee, Sang Hoon;Lee, Jae Dong
    • Journal of Acupuncture Research
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    • v.33 no.1
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    • pp.79-93
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    • 2016
  • Objectives : The purpose of this study is to explore research trends in gold implantation therapy performed on the animal and human body, through a review of clinical studies focused on gold thread, gold needle and gold bead. Methods : Medical databases, including Pubmed, CENTRAL, MEDLINE, EMBASE, RISS4u, KISTI, OASIS and KTKP, were searched for relevant articles published from their launch to December 31, 2015 using the key word 'gold' with '$thread^*$', '$needle^*$', '$acupuncture^*$', '$wire^*$', '$bead^*$', '$embed^*$', '$implant^*$', or '$insert^*$'. The results were classified into in vivo studies, clinical trials and clinical reports. Analysis of the results was conducted in several research areas, from the identity of studies such as nationality and published year, to the gold preparations-features and implanted locations and to the outcomes that reflect the clinically favorable or adverse effect of gold implantation therapy. Results : A total of 30 studies including 11 in vivo studies, 4 clinical trials and 15 case reports, were found in the search. We observed certain research trends according to the research time, nationality and target indication of the studies. The studies primarily revealed a chronic local inflammatory response which could be a useful mechanism for pain-relief in musculoskeletal diseases and facial rejuvenation. Researches concerning long-term reactions or adverse effects were rare. Conclusion : The results show that the efforts to discover the level of clinical efficacy of gold implantation therapy were steady and worldwide. However, further researches on the longterm effect, and more importantly, the safety of gold implantation therapy are required.

Short term outcomes of topiramate monotherapy as a first-line treatment in newly diagnosed West syndrome

  • Lee, Gyu-Min;Lee, Kyung-Suk;Lee, Eun-Hye;Chung, Sa-Jun
    • Clinical and Experimental Pediatrics
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    • v.54 no.9
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    • pp.380-384
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    • 2011
  • Purpose: To investigate the efficacy of topiramate monotherapy in West syndrome prospectively. Methods: The study population included 28 patients (15 male and 13 female children aged 2 to 18 months) diagnosed with West syndrome. After a 2-week baseline period for documentation of the frequency of spasms, topiramate was initiated at 2 mg/kg/day. The dose was increased by 2 mg/kg every week to a maximum of 12 mg/kg/day. Clinical assessment was based on the parents' report and a neurological examination every 2 weeks for the first 2 months of treatment. The baseline electroencephalograms (EEGs) were compared with the post-treatment EEGs at 2 weeks and 1 month. Results: West syndrome was considered to be cryptogenic in 7 of the 28 patients and symptomatic in 21 patients. After treatment, 11 patients (39%) became spasm-free, 6 (21%) had more than 50% spasms-reduction, 3 (11%) showed less than 50% reduction, and 8 (29%) did not respond. The effective daily dose for achieving more than 50% reduction in spasm frequency, including becoming spasm-free, was found to be $5.8{\pm}1.1$ mg/kg/day. Nine patients (32%) showed complete disappearance of spasms and hypsarrhythmia, and 11 (39%) showed improved EEG results. Despite adverse events (4 instances of irritability, 3 of drowsiness, and 1 of decreased feeding), no patients discontinued the medication. Conclusion: Topiramate monotherapy seems to be effective and well tolerated as a first line therapy for West syndrome and is not associated with serious adverse effects.

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.

Effectiveness and Safety of Korean Medicine for Trigeminal Neuralgia: A Case Report

  • Bae, Ji Min;Kim, Dae Hun;Lee, Byung Ryul;Yang, Gi Young
    • Journal of Acupuncture Research
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    • v.34 no.1
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    • pp.59-66
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    • 2017
  • Objectives : This study aims to report the effectiveness and safety of Korean medicine with thread embedding acupuncture in the treatment of trigeminal neuralgia (TN). Methods : A 73-year-old man who had suffered from severe facial pain for one year and who had had a healthy tooth extracted due to the pain is reported. He could not eat or sleep due to the severe pain. Acupuncture, thread embedding acupuncture, cupping, herbal steam, and herbal medicines were used for the treatment. Numeric Rating Scale (NRS) and adverse events were checked daily, and other outcomes (Baseline Evaluation, Visual Analogue Scale [VAS], Short Form Health Survey 36-Bodily Pain [SF-36 BP], and Patient Global Assessment [PGA]) were measured at hospital admission and discharge. During the follow-up examinations, his pain was evaluated roughly, without using any formal measurements, on the basis of a global assessment. Results : All measured parameters, including pain, quality of life, and patient satisfaction were noted to have improved at the time of discharge compared to admission: VAS from 10 to 1.5, NRS from 7-8 to 1-2, and SF-36 BP from 0 to 22.5, and the patient's global assessment was somewhat improved. He did not take any analgesics after discharge and noted only mild adverse events, like pain where the acupuncture and thread embedding acupuncture needles were inserted. His pain relief was maintained for 6 months. Conclusion : Korean medicine with thread embedding acupuncture might be a safe and effective treatment for TN. In the future, larger sample sizes and high quality randomized clinical trials are warranted to confirm its efficacy and safety.

Pharmacogenomics of Depressive Disorders (우울증의 약물유전체학)

  • Ham, Byung-Joo;Lee, Min-Soo
    • Korean Journal of Biological Psychiatry
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    • v.8 no.2
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    • pp.226-232
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    • 2001
  • The pharmacotherapy of depression has reduced morbidity and improved outcome for many depressive patients. A wide range of classical and new antidepressants are available for their treatment. However, 30-40% of all patients do not respond sufficiently to the initial treatment and present adverse effects. Pharmacogenetics studies the genetic basis of an individual's ability to respond to pharmacotherapy. Recently, some reports on serotonin transporter gene polymorphisms and their influence on the response to antidepressive therapy provide an interesting diagnostic tool in assessing the chances of response to antidepressants. We also investigated the relationship between serotonin transprter polymorphisms(5-HTTLPR) and the long-term effect of the antidepressant treatment. 128 depressive patients were enrolled into 2nd year study. The therapeutic response of each subset was not different at 8th, 16th week, but the subset with homozygote(l/l) of long variant showed a better therapeutic response to antidepressant than the heterozygote(l/s) of long and short variant, which showed a better therapeutic response than the subset with homozygote (s/s) of short variant at 1st year and 2nd year after the antidepressant treatment. This result shows that the serotonin transporter polymorphisms may be related to the long-term effect of antidepressant treatment. The potential for pharmacogenomics, the use of genetic information to guide pharmacotherapy and improve outcome by providing individualized treatment decisions, has gained increasing attention. pharmacogenomics will contribute to individualize drug choice by using genotype to predict positive clinical outcomes, adverse reactions, and levels of drug metabolism. Personalized medicine, the use of marker-assisted diagnosis and targeted therapies derived from an individual molecular profile, will impact the antidepressant therapy and this approach will replace the traditional trial-and-error practice of medicine.

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A Case Report of Recurred Hepatocellular Carcinoma Patient Treated with Radio-Frequency Hyperthermia in Conjunction with Sorafenib (고주파 온열치료와 소라페닙을 병용하여 호전된 재발성 간암환자 1례)

  • Kim, Jee-Hye;Lee, Jong-Hoon;Joo, Jong-Cheon;Lee, Jeong-Bok;Cho, Chong-Kwan;Yoo, Hwa-Seung
    • Journal of Korean Traditional Oncology
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    • v.21 no.2
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    • pp.63-74
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    • 2016
  • Objective : The purpose of this study is to report the effects of radio-frequency hyperthermia cancer treatment in conjunction with Sorafenib on hepatocellular carcinoma patient. Method : The patient was diagnosed with hepatocellular carcinoma at S6/7 and treated with right posterior sectionectomy. After 4 months, tumor recurrence was found at S4, 5 and 8. After transarterial chemoembolization, the patient was prescribed Sorafenib (proprietary name $Nexavar^{(R)}$ ) as well as proceeding with radio-frequency hyperthermia. The clinical outcomes were measured by computed tomography, laboratory findings including tumor markers (AFP, PIVKA-II), natural killer (NK) cell activity, and numeric rating scales (NRS). Results : After the treatment, tumor size was decreased accompanying by reducing the level of tumor markers (AFP, PIVKA-II). Major clinical symptoms were improved with increasing NK cell activity. There were no adverse events based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Conclusion : This case suggests that radio-frequency hyperthermia has synergistic effect for the treatment of hepatocellular carcinoma patient in conjunction with Sorafenib.

An 8-wk, randomized, double-blind, placebo-controlled clinical trial for the antidiabetic effects of hydrolyzed ginseng extract

  • Park, Soo-Hyun;Oh, Mi-Ra;Choi, Eun-Kyung;Kim, Min-Gul;Ha, Ki-Chan;Lee, Seung-Kwon;Kim, Young-Gon;Park, Byung-Hyun;Kim, Dal-Sik;Chae, Soo-Wan
    • Journal of Ginseng Research
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    • v.38 no.4
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    • pp.239-243
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    • 2014
  • Background: To investigate the antidiabetic effects of hydrolyzed ginseng extract (HGE) for Korean participants in an 8-wk, randomized, double-blinded, placebo-controlled clinical trial. Methods: Impaired fasting glucose participants [fasting plasma glucose (FPG) ${\geq}5.6mM$ or < 6.9mM who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study. The 23 participants were randomly divided into either the HGE (n = 12, 960 mg/d) or placebo (n = 11) group. Outcomes included measurements of efficacy (FPG, postprandial glucose, fasting plasma insulin, postprandial insulin, homeostatic model assessment-insulin resistance, and homeostatic model assessment-${\beta}$) and safety (adverse events, laboratory tests, electrocardiogram, and vital signs). Results: After 8 wk of HGE supplementation, FPG and postprandial glucose were significantly decreased in the HGE group compared to the placebo group. No clinically significant changes in any safety parameter were observed. Our study revealed that HGE is a potent antidiabetic agent that does not produce noticeable adverse effects. Conclusion: HGE supplementation may be effective for treating impaired fasting glucose individuals.

Current Research Trends in Randomized Controlled Trials Investigating the Combined Effect of Korean Medicine and Western Medicine Treatment

  • Ha, Dohyung;Kim, Seoyeon;Baek, Yong Hyeon;Won, Jiyoon;Nam, Seri;Shin, Jeeyoung;Kwon, Oh-Hoon;Kim, Soo-Yeon;Lee, Hyangsook
    • Journal of Acupuncture Research
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    • v.37 no.1
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    • pp.13-18
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    • 2020
  • This review examined recently published (July 2014 to June 2017), randomized controlled trials (RCTs) which investigated the safety and effectiveness of combined Korean medicine/complementary alternative medicine (CAM) and Western medicine, to indicate the direction for integrative medical practice. The Korean Medicine Convergence Research Information Center evidence-based medicine database (KMCRIC EBM DB) was used to retrieve relevant RCTs indexed in the last 3 years. Study design, country, sample size, disease/condition with the Korean Standard Classification of Diseases code, interventions, direction of outcomes, and adverse events were extracted and summarized. A total of 93 RCTs were included in this review. Acupuncture/moxibustion was the most commonly used intervention (n = 47; 51%), and 19% (n = 18) of the studies treated musculoskeletal disorders, followed by circulatory disorders (n = 16; 17%), and mental and behavioral disorders (n = 9; 10%). Integrative treatment was reported as more effective than monotherapy in approximately 83% of these studies. Adverse events were poorly reported in most studies. This review suggests that integrative treatments are feasible, effective, and safe for various diseases/conditions, based on the evidence from recently published RCTs. Future studies on integrative healthcare are warranted.

Economic Evaluation of Gemcitabine-cisplatin Chemotherapy for Non Small-Cell Lung Cancer Patient in an Outpatient Setting (비용-효과 분석 기법을 이용한 Gemcitabine 외래 항암 치료의 경제성 평가)

  • Min, Su-Hyun;Ko, Su-Kyoung;Lim, Ji-Young
    • Journal of Korean Academy of Nursing
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    • v.38 no.3
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    • pp.363-371
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    • 2008
  • Purpose: This analysis was conducted to evaluate the cost-effectiveness of gemcitabine-cisplatin chemotherapy for non small-cell lung cancer patients in an outpatient setting compared with the traditional inpatient setting. Methods: A cost-effective analysis was conducted from a societal perspective. The effects of treatment, which was measured as an adverse event rate, were abstracted from a published literature search and empirical data from one university hospital. The costs included both direct and indirect costs. Direct costs included hospitalizations, outpatient visits, and lab tests. Pharmaceutical costs were excluded in analysis because they were same for both options. Indirect costs included productivity loss of patients as well as care-givers. In order to determine the robustness of the results, sensitivity analysis on treatment protocol was conducted. Results: Literature search showed no difference in adverse effect rates between inpatient treatment protocol and outpatient treatment protocol. Therefore, this analysis is a cost-minimization analysis. Cost-savings in the outpatient setting was 555,936 won for one treatment cycle. Our sensitivity analysis indicated that the outpatient chemotherapy still showed cost-savings, regardless of changes in treatment protocol. Conclusion: The outpatient gemcitabine-cisplatin chemotherapy for non small-cell lung cancer resulted in cost savings compared to inpatient chemotherapy. More importantly, outpatient chemotherapy could improve the utilization of health service resources in terms of available beds.

Pregabalin and gabapentin in neuropathic pain management after spinal cord injury: a systematic review and meta-analysis

  • Davari, Majid;Amani, Bahman;Amani, Behnam;Khanijahani, Ahmad;Akbarzadeh, Arash;Shabestan, Rouhollah
    • The Korean Journal of Pain
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    • v.33 no.1
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    • pp.3-12
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    • 2020
  • Neuropathic pain after spinal cord injury (SCI) has a significant negative impact on the patients' quality of life. The objective of this systematic review is to examine the safety and efficacy of pregabalin (PGB) and gabapentin (GBP) in the treatment of neuropathic pain due to SCI. PubMed, the Cochrane Library, Embase, Scopus, and the Web of Science were searched up to December 2018. The reference lists of key and review studies were reviewed for additional citations. The quality of the studies was evaluated using the Cochrane Collaboration's tools for assessing the risk of bias. A meta-analysis was performed for primary and secondary outcomes. Eight studies were eligible for inclusion. Meta-analysis of PGB vs. placebo showed that PGB was effective for neuropathic pain (standardized mean difference [SMD] = -0.40; 95% confidence interval [CI]: -0.78, -0.01), anxiety (MD = -0.68; 95% CI: -0.77, -0.59), depression (mean difference [MD] = -0.99; 95% CI: -1.08, -0.89), and sleep interference (MD = -1.08; 95% CI: -1.13, -1.02). Also, GBP was more effective than a placebo for reducing pain. No significant difference was observed between the efficacy of the two drugs (MD = -0.37; 95% CI: -1.67, 0.93). There was no significant difference between the two drugs for discontinuation due to adverse events (risk ratio = 3.00; 95% CI: 0.81, 11.15). PGB and GBP were effective vs. placebos in decreasing neuropathic pain after SCI. Also, there was no significant difference between the two drugs for decreasing pain and adverse events.