Objectives : The aim of this study was to systematically investigate herbal-drug-associated adverse drug reactions (herbal ADRs) reports submitted by a single oriental hospital and to analyze the general characteristics, causative agents, clinical manifestations, severity and types of herbal medicines which caused herbal ADRs. Methods : This study proceeded with IRB approval. The data on herbal ADR were collected prospectively from January 2008 to February 2012 by EMR of Dongguk University Ilsan Oriental Hospital. The World Health Organization (WHO)-Uppsala Monitoring Center (UMC) criteria was used to determinate causality for each herbal ADR. WHO-Adverse Reaction Terminology (WHO-ART) System Organ Class (SOC) code and WHO severity category were also used in this study. Results : A total of twenty eight cases were reported. Twenty two cases were assessed to have over possible relations with herbal medication. The gender ratio of these cases were 64.6 percent female and 36.4 percent male, demonstrating no statistical significance. Patients aged over 60 were 59.1%. Gastro-intestinal system was reported to be the most frequently affected organ (38.8%), and followed by psychiatric system (22.4%), and integumentary system (22.4%). The most common clinical symptom was headache (12.2%), followed by diarrhea (10.2%), and pruritus (10.2%). The severity of most cases was assessed to be mild (89.8%). The percentage of moderate ones was 10.2%, and there were no severe cases. Conclusions : Progressive study and further analysis on herbal ADRs are warranted for safety in the clinical use of herbal medicines.
Yu, Yun Mi;Choi, Soo An;Lee, Mo Se;Youn, So Jung;Kim, Mi Hye;Choi, Kwang Hoon;Shin, Wan Gyoon
Korean Journal of Clinical Pharmacy
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v.24
no.1
/
pp.45-52
/
2014
Objective: To evaluate the clinical manifestations and causative drugs of the outpatient adverse drug reactions (ADRs) reported by community pharmacy. Methods: From April 2013 to September 2013, all outpatient ADRs reported by community pharmacy to Regional Pharmacovigilance Center of Korean Pharmaceutical Association were included. The causality of ADRs was assessed by the criteria of WHO-Uppsala Monitoring Centre. The clinical features and the offending drugs were analyzed using the WHO-Adverse Reaction Terminology and the classification of American Hospital Formulary Service Drug Information, respectively. Results: 2,826 (97.0%) of the total 2,912 ADRs had causal relationship. The 1,923 patients with mean age of 55.1 years and female fraction of 66.5% were included in the ADRs. Gastrointestinal (33.6%), nervous system (14.9%), and skin (13.5%) symptoms were common in ADRs. Analgesic drugs (19.7%), gastrointestinal drugs (17.7%), and central nervous system drugs (11.0%) were prevalent offending drugs. The leading causative generic drug was the complex of acetaminophen and tramadol. Among 203 ADRs by the nonprescription drugs, the most common clinical features were skin (37.4%) and gastrointestinal (23.6%) symptoms and the most prevalent offending drugs were analgesic drugs (40.0%) and mucocutaneous system drugs (16.3%). The combination of acetaminophen and chlorzoxazone was the leading causative generic in nonprescription drugs. Conclusion: In this study, gastrointestinal symptom was the most common manifestation and analgesic drug was the most common causative drug in outpatient ADRs reported by community pharmacy.
Oseltamivir is an antiviral medication prescribed to prevent and treat influenza A and B. A case from a community pharmacy in Korea was reported for an adverse event associated with oseltamivir administration. A 20-month-old boy had psychiatric symptoms after receiving 2 doses of oseltamivir. Therefore, an evaluation of whether the psychiatric symptoms were caused by oseltamivir was required. To determine whether the adverse event resulted from the administrated medication or other factors, three tools were used: the Naranjo scale, the Korean causality assessment algorithm (Ver.2), and the World Health Organization-Uppsala Monitoring Center (WHO-UMC) criteria. The psychiatric symptoms occurred after oseltamivir administration, and were attenuated after oseltamivir termination. A possible cause of the psychiatric symptoms is high fever, but information on the body temperature of the patient was not sufficient. Therefore, it was unclear whether there were other nonpharmacological causes of adverse drug reaction. For these reasons, in terms of causality, the results evaluated by the three tools represented, "possible", "probable", and "probable/likely", respectively.
Background: Laundry workers are known to be exposed to organic solvents in various works including dry cleaning. Long-term exposure to organic solvents may cause adverse health effects among laundry workers. Objectives: To investigate the association between exposure to organic solvents and symptom of headache or eyestrain among laundry workers. Methods: The subjects were total 267 laundry workers who participated in the 6th Korean Working Conditions Survey (KWCS). Responses to exposure to 'inhalation of vapor from organic solvent' was categorized into two (non-exposed: rarely or absolutely not exposed during working hours; exposed: ≥1/4 working hours) or three (non-exposed; low exposure: 1/4 of the working hours; high exposure: ≥1/2 working hours) groups. Logistic regression analysis was performed to evaluate the association between exposure to organic solvents and symptom of headache or eyestrain in the last 12 months among laundry workers. Odds ratios (ORs) and the 95% confidence intervals (CIs) were calculated for experience of the symptom of headache or eyestrain with adjustment for age, sex, education, workplace size (by the number of workers), working hours per week, and current working period (year). Results: The proportions of exposure groups, i.e., non-exposed, low exposure, and high exposure, were 80.4%, 11.1%, and 8.5%, respectively. The proportion of those who had symptom of headache or eyestrain in the last 12 months was 18.7%. There was a significant association between exposure to organic solvents and experience of headache or eyestrain (OR=3.2, 95% CI=1.4~7.4). And, the proportion of those who experienced symptom of headache or eyestrain tended to increase significantly as the level of exposure to organic solvents increased (Ptrend=0.002). Conclusions: Our results suggest that exposure to organic solvents are associated with symptom of headache or eystrain among laundry workers in Korea. However, further studies with more relevant design is needed to replicate the association.
Objectives : Despite the increased popularity of highly caffeinated beverages, there is little research examining psychiatric adverse effects. The purpose of this study was to investigate the relationships among pattern of highly caffeinated beverage intake and depressive symptom, suicidal ideation, suicidal plan, suicidal attempt in Korean adolescents. Methods : The data was obtained from the 2014 Korean Youth's Risk Behavior Web-based Study by Korea Centers for Disease Control & Prevention. All participants conducted web-based questionnaire survey. Chisquare test and multiple logistic regression analysis were performed to determine the association among highly caffeinated beverage intake pattern, depressive symptom, suicidal ideation, suicidal plan and suicidal attempt adjusting for differences in age, gender, academic achievement, socioeconomic status. Results : A total of 71,638 participants were enrolled in this study. Depressive symptom, suicidal ideation, suicidal plan and suicidal attempt were significantly more frequent in the group with presence of highly caffeinated beverage intake within 1 week than in non-drinker group(p<0.01). Highly caffeinated beverage intake was significantly associated with suicidal attempt(OR=1.99 ; 95% CI, 1.77-2.22). In addition, depressive symptom, suicidal ideation, suicidal plan and suicidal attempt were significantly more common in the group with heavy-drinker who exceed recommended daily intake dose of caffeine than in the group with light-drinker(p<0.01). Heavy drinking of caffeinated beverage was significantly associated with suicidal attempt(OR=4.05 ; 95% CI, 3.02-5.43). Conclusions : We found that highly caffeinated beverage intake was related to more frequent depressive symptom, suicidal ideation, plan, attempt in adolescents. Also, caffeine intake which exceed recommended daily intake dose identified the predictor of suicidal attempt. Our result suggested that clinicians need to be aware of the possible psychiatric adverse effects of highly caffeinated beverage in vulnerable population including young adolescents.
Objectives The purpose of this study is to review the effectiveness of acupuncture treatment in irritable bowel syndrome (IBS). Methods We reviewed 8 randomized controlled trials (RCT) of acupuncture treatment in IBS which were published from 2008 to 2018 in PubMed. The acupoints, methods of assessment, treatment, results and adverse events were analyzed. Results There were 8 RCT of acupuncture treatment in IBS. The most commonly used acupoints were 天樞 (ST25), and 上巨虛 (ST37). Frequently used assessments in IBS were Bristol scale, visual analogue scale, IBS-symptom severity score, quality of life, and symptom scale. 3 out of 8 studies, the acupuncture treatment group showed significant effectiveness than that of the control group. Conclusions All of the studies have not shown that the acupuncture treatment was effective in relieving IBS symptoms. More clinical studies are needed to prove the effectiveness of the acupuncture treatment in IBS.
Objectives: The purpose of this study is to investigate the frequency of side effects, and the range of the side effects from Korean herb medicine on children. Methods: The study has been carried out from 212 children who took Korean herb medicine in Department of Pediatrics, $\bigcirc\;\bigcirc$ Oriental Medical Hospital from September 2009 to February 2010. The study was completed through patients chart review and telephone survey. Results: 1. There were 6 side effect cases on male, and 3 side effect cases on female out of 212 children. The incidence of side effect was 4.2%. 2. The most common side effect was abdominal pain. The most common related organ was digestive organ. 3. The side effect occurred within one to three days after taking Korean herb medicine, and the symptoms were mostly disappeared after taking the Korean herb medicine into divided dose or less dose. Conclusions: The symptom of side effects on children was not as severe as other adverse drug reactions often seen in Western medication. The most common symptom was abdominal pain. Further studies are needed.
Journal of Physiology & Pathology in Korean Medicine
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v.22
no.1
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pp.234-245
/
2008
Yeonkyopaedok-san(YPS) extract is widely used to treat the common cold. The purpose of this study was to evaluate the efficacy of YPS on the common cold. Two hundred Patients with common colds of recent onset were randomized to the double blind, placebo-controlled study. They received 800 mg YPS extract or placebo in capsules, orally dissolved 3 times a day for 7 days. The total symptom score was assessed by the physician, using a 5-point scale on start and finish. Resolution of cold symptoms based on subjective daily symptoms. Total symptom score was significantly decreased in YPS groups in comparison to that in placebo group (p=0.027). Headache (p=0.012), loss of appetite (p=0.037), eyeball discomfort (p=0.002) were more affected. Time to resolution of cold symptoms did not show significant effect (p=0.592). Adverse effects were less in the YPS group than placebo group (2% vs 3%). In this community-based, randomized controlled trial, YPS were effective in treating cold symptoms in college students.
Kim, Seo-Hee;Lee, Ju-Hyun;Kang, Eun-Jeong;Park, Ji-Won;Hong, Seok-Hoon
The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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v.33
no.2
/
pp.130-139
/
2020
Objectives : The aim of this study is to report the effect of Korean Medicine Treatment for patient with ophthalmoplegia in Miller-Fisher Syndrome. Methods : A patient with ophthalmoplegia treated with herbal medicine, cupping therapy and acupuncture(including pharmacopuncture, electroacupuncture). We used photographs of eye movement to evaluate the changes in symptoms, Scott and Kraft score of left eye, visual field test for measuring peripheral visual field, subjective symptom, and VAS for headache, subjective symptom. Results : After treatment, Scott and Kraft score increase from -4 to -2. Visual field of left side improved from 45° to 80°. Also, other symptoms such as diploma, dizziness, headache, gait disturbance was also improved. There are no adverse effects and no relapse of ophthalmoplegia after 20 days of discharge. Conclusions : This case report suggests that Korean Medicine Treatment can be effective for patient with ophthalmoplegia in Miller-Fisher Syndrome.
The drug reaction with eosinophilia and systemic symptom (DRESS) syndrome is a severe adverse drug-induced reaction which includes a severe skin eruption, fever, hematologic abnormalities (eosinophilia or atypical lymphocytes) and internal organ involvement. The most frequently reported drug was anticonvulsants. The diagnosis of DRESS syndrome is challenging because the pattern of cutaneous eruption and the types of organs involved are various. The treatments for DRESS syndrome are culprit drug withdrawal and corticosteroids. Here we report a 71-year-old man with skin eruption with eosinophilia and hepatic and renal involvement that appeared 4 weeks after he had taken anti-tuberculosis drugs (isoniazid, ethambutol, rifampicin, and pyrazinamide), and resolved after stopping anti-tuberculosis drugs and the administration of systemic corticosteroids. DRESS recurred after re-challenging isoniazid, we identified isoniazid was causative drug.
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