• Title/Summary/Keyword: Adverse events

Search Result 1,038, Processing Time 0.028 seconds

Randomized Double-Blind Placebo-Controlled Trial of Propolis for Oral Mucositis in Patients Receiving Chemotherapy for Head and Neck Cancer

  • Akhavan-Karbassi, Mohammad Hasan;Yazdi, Mohammad Forat;Ahadian, Hakimeh;Sadr-Abad, Maryam Jalili
    • Asian Pacific Journal of Cancer Prevention
    • /
    • v.17 no.7
    • /
    • pp.3611-3614
    • /
    • 2016
  • Background: Propolis based preparations have a wide range of applications in various specialties of dentistry. The aim of this clinical trial was to test the efficacy of propolis as a mouthwash in the reduction of chemotherapy induced oral mucositis (OM) in a single center. Materials and Methods: In this randomised, controlled study patients undergoing chemotherapy were included consecutively and randomised to an experimental group receiving propolis mouthwash (n = 20) and a control group receiving diluted water (n=20). Oral mucositis, erythema and eating and drink ability were assessed at baseline and after 3 and 7 days using the World Health Organization (WHO) scale and the oral mucositis assessment scale (OMAS). Results: There were significant differences in OM, wound and erythema in propolis group compared to placebo, but no significant difference in eating and drink ability. However, it was interesting that 65% of the patients in the propolis group were completely healed at day 7 of the trial. No significant adverse events were reported by the patients. Conclusions: This study found that oral care with propolis as mouthwash for patients undergoing chemotherapy is an effective intervention to improve oral health. Our findings shouldlencourage health practitioners to apply propolis mouth rinse for the oral care of patients under chemotherapy.

Review of Clinical Research on Effect of Traditional Chinese Medicine for Febrile Seizure (열성 경련에 대한 중의학 임상 연구 동향 - RCT를 중심으로 -)

  • Lee, Bo Ram;Lee, Eun Ju;Lee, Ji Hong;Chang, Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
    • /
    • v.30 no.3
    • /
    • pp.78-96
    • /
    • 2016
  • Objectives The purpose of this study is to provide clinical evidence of Korean medicine for febrile seizure by review of randomized controlled trials on the effect of TCM (traditional Chinese medicine) for febrile seizure. Methods We searched randomized controlled trials about TCM treatment of febrile seizure from the China National Knowledge Infrastructure (CNKI) (January 2008 to June 2016). The selected literatures were assessed by Jadad scale. Results 40 papers were selected from 160 studies. Analyses of selected studies indicated that the TCM treatment group has significantly higher cure rate for febrile seizure than first aid or western medicine group. The most commonly used herbs were Gardeniae Fructus (梔子), Uncariae Ramulus cum Uncis (鉤藤), Cornus Gazeliae (羚羊角), Margarita (珍珠), Scutellariae Radix (黃芩), Glycyrrhizae Radix (甘草). The most commonly used acupoints were GV26 (人中), LI4 (合谷), KI1 (湧泉), GV20 (百會). There were no serious adverse events reported from the TCM treatment group during the treatment period. Conclusions TCM has been shown as not only effective but also safe treatment on febrile seizure. This finding can be widely utilized in clinical practice and can form the basis for development of clinical practice guidelines in future.

Hiwi Knockdown Inhibits the Growth of Lung Cancer in Nude Mice

  • Liang, Dong;Dong, Min;Hu, Lin-Jie;Fang, Ze-Hui;Xu, Xia;Shi, En-Hui;Yang, Yi-Ju
    • Asian Pacific Journal of Cancer Prevention
    • /
    • v.14 no.2
    • /
    • pp.1067-1072
    • /
    • 2013
  • Hiwi, a human homologue of the Piwi family, plays an important role in stem cell self-renewal and is overexpressed in various human tumors. This study aimed to determine whether an RNA interference-based strategy to suppress Hiwi expression could inhibit tumor growth in a xenograft mouse model. A rare population of $SSC^{lo}\;Alde^{br}$ cells was isolated and identified as lung cancer stem cells in our previous study. Plasmids containing U6 promoter-driven shRNAs against Hiwi or control plasmids were successfully established. The xenograft tumor model was generated by subcutaneously inoculating with lung cancer stem cell $SSC^{lo}\;Alde^{br}$ cells. After the tumor size reached about 8 mm in diameter, shRNA plasmids were injected into the mice via the tail vein three times a week for two weeks, then xenograft tumor growth was assessed. In nude mice, intravenously delivery of Hiwi shRNA plasmids significantly inhibited tumor growth compared to treatment with control scrambled shRNA plasmids or the vehicle PBS. No mice died during the experiment and no adverse events were observed in mice administered the plasmids. Moreover, delivery of Hiwi shRNA plasmids resulted in a significant suppressed expression of Hiwi and ALDH-1 in xenograft tumor samples, based on immunohistochemical analysis. Thus, shRNA-mediated Hiwi gene silencing in lung cancer stem cells by an effective in vivo gene delivery strategy appeared to be an effective therapeutic approach for lung cancer, and may provide some useful clues for RNAi gene therapy in solid cancers.

Gemcitabine Alone or in Combination with Cisplatin for Advanced Biliary Tract Carcinomas: an Overview of Clinical Evidence

  • Sun, Tian-Tian;Wang, Ji-Lin;Fang, Jing-Yuan
    • Asian Pacific Journal of Cancer Prevention
    • /
    • v.14 no.2
    • /
    • pp.877-883
    • /
    • 2013
  • Background and Objective: There has been no universally agreed standard chemotherapy regimen for patients with advanced biliary tract carcinomas (BTC). We aimed to fully display and evaluate the clinical evidence for gemcitabine or gemcitabine-cisplatin combination for advanced BTC. Methods: Systematic searches were performed to identify relevant randomized controlled trials (RCTs) and uncontrolled trials. Overall survival (OS), progression-free survival (PFS), overall response rates (ORR), tumor control rates (TCR), and toxicity were evaluated. Evidence levels of the results were evaluated with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results: Results of the eleven gemcitabine-cisplatin trials and ten gemcitabine trials showed both chemotherapy regimens had benefits with reference to mean OS (8.63 vs. 8.79 months), mean PFS (4.86 vs. 4.72 months), pooled ORR (25.3% vs. 19.6%) and TCR (55.2% vs. 53.1%). Two RCTs showed the gemcitabine-cisplatin combination to prolong the mean PFS (mean difference [MD] 2.57, 95%CI 1.69 3.45), substantially increasing the mean OS (MD 3.59, 95% CI 3.48 3.71), and producing a similar effect in ORR (risk ratio [RR] 1.59, 95%CI 1.04 2.43), increasing TCR (RR 1.15, 95%CI 1.02 1.31) compared with gemcitabine alone, with generally manageable grade 3 or 4 adverse events. The evidence level of OS was moderate, and other outcomes (ORR, PFS, TCR, anaemia, neutropenia) were at low evidence levels. Conclusion: Available evidence was limited with low quality, which showed that both gemcitabine-cisplatin and gemcitabine alone had clinical activity with acceptable safety profiles, and gemcitabine-cisplatin appeared to be more useful for advanced BTC patients than gemcitabine alone.

A Review on Clinical Studies of Acupuncture and Moxibustion Therapy for Acute Herpes Zoster (급성기 대상포진의 침구치료에 대한 임상 연구 문헌 고찰)

  • Choi, Yoo Min;Kim, Seok Hee;Kim, Ju Yong;Park, Sang Hun;Yook, Tae Han;Kim, Jong Uk
    • Journal of Acupuncture Research
    • /
    • v.32 no.3
    • /
    • pp.147-161
    • /
    • 2015
  • Objectives : The purpose of this study was to review the effectiveness of acupuncture and moxibustion therapy for the treatment of acute herpes zoster. Methods : Data was collected by two researchers. Clinical trials on PubMed were retrieved using MeSH terms including "herpes zoster" combined with "acupuncture therapy", "moxibustion", "bloodletting", "electroacupuncture", and related keywords. We excluded irrelevant studies and included randomized and non-randomized controlled trials, case series and case reports. Finally, we selected a total of thirteen studies and conducted a literature analysis and an object quality assessment. Results : Twelve of thirteen studies were about acupuncture and moxibustion combined therapy. Only one study suggested that a single acupuncture therapy is expected to be equally as effective as a common western medicine therapy. There was some evidence related to the effectiveness of moxibustion, venesection and electroacupuncture, but it dealt with combining therapy and was insufficient, and with an inclusion of potential risk factors. Only one study was conducted under approval from an institutional review board. No severe treatment-related adverse events were observed. A quality assessment suggested that there was some weakness in the areas of blinding and concealment. Conclusions : There is some evidence that suggests the effectiveness and safety of acupuncture and moxibustion combined therapy as a treatment for acute herpes zoster.

The Effectiveness of Ultrasound-guided Bee Venom Pharmacopuncture Combined with Integrative Korean Medical Treatment for Rotator cuff Diseases : A Retrospective Case Series (초음파 유도하 봉약침치료와 한방복합치료를 병행한 회전근개 질환 환자 4례 : 후향적 증례 연구)

  • Jeong, Jeong Kyo;Park, Gi Nam;Kim, Kyung Min;Kim, So Yun;Kim, Eun Seok;Kim, Jung Ho;Nam, Seung Kyu;Kim, Young Il
    • Journal of Acupuncture Research
    • /
    • v.33 no.4
    • /
    • pp.165-180
    • /
    • 2016
  • Objectives : This study is aimed to report the effectiveness of ultrasound-guided bee venom pharmacopuncture in rotator cuff disease patients. Methods : We treated 4 rotator cuff disease patients with ultrasound-guided bee venom pharmacopuncture and integrative Korean Medical Treatment. The Numeric Rating Scale(NRS), Shoulder Pain And Disability Index(SPADI), and Range Of Motion(ROM) were applied as outcome measures. Results : Comparing before and after treatment, both NRS and SPADI scores were decreased, and ROM was increased in all cases. And adverse events about bee venom pharmacopuncture have not been observed. Conclusion : This study shows ultrasound-guided bee venom pharmacopuncture has a meaningful clinical effect on the improving shoulder pain, disability and ROM.

Remifentanil-Propofol Sedation as an Ambulatory Anesthesia for Carpal Tunnel Release

  • Lee, Jae-Jun;Hwang, Sung-Mi;Jang, Ji-Su;Lim, So-Young;Heo, Dong-Hwa;Cho, Yong-Jun
    • Journal of Korean Neurosurgical Society
    • /
    • v.48 no.5
    • /
    • pp.429-433
    • /
    • 2010
  • Objective : This prospective study evaluated the use of continuous sedation using propofol and remifentanil when carpal tunnel release (CTR) was performed under local anesthesia. Methods : We sedated 60 patients undergoing CTR using local anesthesia with remifentanil at loading and continuous doses of $0.5\;{\mu}g\;kg^{-1}$ and $0.05\;{\mu}g\;kg^{-1}min^{-1}$, respectively, and propofol, using a target controlled infusion (TCI) pump set to a target of $2\;{\mu}g\;mL^{-1}$ (group A), or with the same drug doses except that the continuous remifentanil dose was $0.07\;{\mu}g\;kg^{-1}min^{-1}$ (group B) or $0.1\;{\mu}g\;kg^{-1}min^{-1}$ (group C). Results : In group B, the levels of pain when local anesthetics were administered (p = 0.001), intraoperative pain (p < 0.001) and anxiety (p = 0.001) were significantly lower than those of group A. Furthermore, the incidence of adverse events, including desaturation (p < 0.001) and vomiting (p = 0.043), was significantly lower in group B than in group C. Conclusion : Continuous sedation using an appropriate dose of remifentanil and propofol can be used as safe, efficacious ambulatory anesthesia in cases of CTR under local anesthesia, performed using only 2 mL of local anesthetic, with a high degree of patient satisfaction.

Association between the Weight Gain and Treatment Response to Atypical Antipsychotics in Korean Patients with Schizophrenia (한국인 정신분열병 환자에서 비정형 항정신병 약물의 치료반응과 체중증가의 관련성에 대한 연구)

  • Lee, Jae-Byung;Ham, Byung-Joo;Lee, Hwa-Young;Lee, Min-Soo
    • Korean Journal of Biological Psychiatry
    • /
    • v.18 no.4
    • /
    • pp.225-231
    • /
    • 2011
  • Objectives Atypical antipsychotics show better treatment efficacy, safety and tolerability than typical antipsychotics. Among the adverse events observed during treatment with antipsychotics, extrapyramidal syndrome (EPS) and negative symptoms has been greatly reduced. But still, weight gain is receiving growing attention. The aim of this study was to investigate the association between therapeutic response to atypical antipsychotics and weight gain in admission status. Methods The study was conducted for Korean inpatients with schizophrenia in a university hospital in Seoul, between Jan 2006 and Dec 2010. Data was collected by reviewing the medical record of 39 consecutively hospitalized patients with Schizophrenia (DSM-IV) at a university hospital. Positive and Negative Symptom Scale (PANSS), Body Mass Index (BMI) and body weights were measured. Results No significant difference was observed for sex, age, illness onset age, family history of schizophrenia, numbers of hospitalization before treatment, educational years, marriage status, occupational status and subtype of schizophrenia between weight gainers and non-weight gainers. Regarding treatment response to atypical antipsychotics, weight gainers show significantly more PANSS decrease than non-weight gainers during admission period. Conclusions Our findings suggest that it appears to be more likely to respond to atypical antipsychotics in weight gainers than non-weight gainers (that weght gainers appear to be more likely to respond to atypical antipsychotics than non-weight gainers). These results show that the antipsychotic-induced body weight gain is associated with therapeutic response of antipsychotics in Korean inpatients with schizophrenia.

Korean Clinic Based Outcome Measure Studies (한방 병-의원에서 하는 임상지표 연구)

  • Park, Jong-Bae
    • Journal of Pharmacopuncture
    • /
    • v.6 no.1
    • /
    • pp.35-36
    • /
    • 2003
  • Background: Evidence based medicine has become main tools for medical practice. However, conducting a highly ranked in the evidence hierarchy pyramid is not easy or feasible at all times and places. There remains a room for descriptive clinical outcome measure studies with admitting the limit of the intepretation. Aims: Presents three Korean clinic based outcome measure studies with a view to encouraging Korean clinicians to conduct similar studies. Methods: Three studies are presented briefly here in치uding 1) Quality of Life of liver cancer patients after 8 Constitutional acupuncture; 2) Developing a Korean version of Measuring yourself Medical Outcome profile (MYMOP); and 3) Survey on 5 Shu points: a pilot In the first study, we have included 4 primary or secondary liver cancer patients collecting their diagnostic X-ray film and clinical data f개m their hospital, and asked them to fill in the European Organization Research and Treatment of Cancer, Quality of Life Questionnaire before the commencement of the treatment. The acupuncture treatment is set up format but not disclosed yet. The translation and developing a Korean version of outcome measures that is Korean clinician friendly has been sought for MYMOP is one of the most appropriate one. The permission was granted, the translation into Korean was done, then back translated into English only based on the Korean translation by the researcher who is bilingual in both languages. The back translation was compared by the original developer of MYMOP and confirmed usable. In order to test the existence of acupoints and meridians through popular forms of Korean acupuncture regimes, we aim at collecting opinions from 101 Korean clinicians that have used those forms. The questions asked include most effective symptoms, 5 Shu points, points those are least likely to use due to either adverse events or the lack of effectiveness, theoretical reasons for the above proposals, proposing outcome measures, and the time from insertion to be effective. The questionnaire is posted on the virtual notice board of the homepage of the communication KOMA (The official tool of Association of Korean Oriental Medicine).

Long-Term Exposure of Sildenafil Citrate on Sperm Parameters in Rat

  • Suresh, Sekar;Prithiviraj, Elumali;Venkatalakshmi, Nagella;Ganesh, Mohanraj Karthik;Ganesh, Lakshmanan;Lee, Hyun-Jeong;Prakash, Seppan
    • Reproductive and Developmental Biology
    • /
    • v.35 no.4
    • /
    • pp.435-439
    • /
    • 2011
  • Sildenafil citrate (SIL) a phosphodiesterase 5 inhibitor (PDE5I) has been used for long time as a first line oral drug for erectile dysfunction. Though it has beneficial effects on erectile organ it also has some adverse effects in other cells and/or tissues related to reproductive system when exposed to longer duration. The objective of the present study is to evaluate the long term effect of SIL on sperm parameters in Wistar albino rat. The animals are divided into two groups, for group I - rats were treated with saline (vehicle alone) and group - II oral administration of 5 mg/kg b.w. of SIL was administrated orally once in a day for 120 days. At the end of the trial period animals were sacrificed and epididymal sperm were subjected to various analysis. Results showed significant reduction in sperm count, motility, viability and morphologically intact sperm in long term PDE5I exposed animals when compared to control. Acrosomal status and fertility test also showed significant reduction in long term PDE5I exposed animals. The present study clearly indicated that long term SIL has shown to induce alteration in sperm quality and quantity, leading to decline in fertility rate. Indicate that SIL impinge on spermatogenesis as well as epididymal function. Understanding the molecular down-stream events involved in long-term exposure to PDE5 inhibitor can be valuable to supervise on related infertility issues and to suggest corrective measures.