• Title/Summary/Keyword: Randomized response

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Short-Term Effects of Mahuang on State-Trait Anxiety According to Sasang Constitution Classification : A Double-Blind Randomized Controlled Trial (마황 단기복용이 사상체질인의 불안에 미치는 영향 : 이중맹검 임상시험)

  • Hsing, Li-Chang;Yang, Chang-Sop;Lee, Tae-Ho;Kim, Lak-Hyung;Kwak, Min-Jung;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.28 no.1
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    • pp.106-114
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    • 2007
  • Background : Mahuang (Ephedrae Herba, Ephedra sinica $S_{TAPE}$) has been widely used to treat respiratory disease in Asian over the past thousand years. The main ingredient of Mahuang is ephedrine, whose affects on the autonomic nervous system induce some adverse effects like vasoconstriction, hypertension, tachycardia, miosis, insomnia, dizziness, headache, etc. Although there were lots of reports about adverse effects of Mahuang, there were no clinical studies which evaluated the adverse effects of Mahuang on the autonomic nervous system by objective numerical value in the past decade. Objectives : The purpose of this report was to provide an objective assessment of state-trait anxiety that is caused by Mahuang, and to identify anxiety of Mahuang according to different Sasang constitution classifications. Methods : The study design was a double-blind randomized placebo-controlled trial. The subjects of this study were 79 adults aged between 20 to 40 who agreed to participate. Because 8 adults dropped out, a total of 71 subjects entered the study. They were allocated through randomization to a Mahuang group (N=50) and placebo group (N=21). Each group took three opaque capsules (every opaque capsule containing 2g of Mahuang or none) twice a day. To compare the state and trait anxiety before and after taking Mahuang, we checked the anxiety by using STAI-KYZ. Results : The following results were obtained. Short-term administration of Mahuang significantly increased state-anxiety, but in the placebo group, there were no significant changes in state-anxiety. In the Mahuang group except females, there was more significant increase in state-anxiety of Soeumin than Soyangin and Taeumin in the 2nd measurement. Conclusion : It is suggested that the ingestion of Mahuang can increase sympathetic activity and induce anxiety. There was a significant difference among Sasang constitution classification. Especially, the response is stronger in Soeumin than other constitutions. If we use Mahuang according to the Sasang constitution classification in clinic, we could not only minimize the anxiety but maximize the potential curative value.

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Effects of Feed Processing Methods on Growth Performance and Ileal Digestibility of Amino Acids in Young Pigs

  • Ohh, S.H.;Han, K.N.;Chae, B.J.;Han, In K.;Acda, S.P.
    • Asian-Australasian Journal of Animal Sciences
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    • v.15 no.12
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    • pp.1765-1772
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    • 2002
  • Three experiments were conducted to determine the feed processing method best suited for early and conventionallyweaned pigs, and to investigate the effects of different extrusion temperatures on ileal digestibility of amino acids in diets containing different protein sources. In exp.1, a total of 108 pigs (Landrace${\times}$Yorkshire${\times}$Duroc; 24 d of age and 7.60 kg average body weight) were alloted on the basis of sex, weight and ancestry to three treatments in a randomized complete block design. Feed processing methods used were mash (M), simple pellet (SP), and expanded pellet (EP). In exp. 2, a total of 96 pigs (Landrace${\times}$Yorkshire${\times}$Duroc; 14 d of age) were allotted on the basis of sex, weight, and ancestry to three treatments in a randomized complete block design. Diets were mash (M), expanded pellet (EP), and expanded pellet crumble (EPC). In exp. 3, a study was designed to investigate the effect of different extrusion temperatures (100, 120, and $140^{\circ}C$) over the control (untreated) on the ileal digestibility of amino acids in diets containing protein sources such as spray-dried plasma protein (SDPP), whey protein concentrate (WPC), and fish meal (FM). Results in exp.1 showed that ADG, ADFI and the F/G ratio of pigs fed the SP diet were improved (p<0.05) compared with those fed the M or the EP diets, but the digestibility of nutrients was not different (p>0.05) among the treatments. In exp. 2, pigs fed expanded pellet treatments (EP or EPC) had a significantly improved (p<0.05) F/G ratio compared to the pigs fed the M diet which was primarily attributed to the significant reduction (p<0.05) in ADFI, but the overall growth rate of pigs fed expanded pellet diets was not improved. In exp. 3, there was a significant interaction effect (p<0.05) between the extrusion temperature and protein source on the ileal digestibility of amino acids. With an extrusion temperature of $100^{\circ}C$, the ileal digestibility of Lys, Val, Gly and Ser was significantly lower in the diet containing WPC compared to the diet containing SDPP. Increasing the temperature to $120^{\circ}C$ led to significant differences (p<0.05) in the digestibility of Thr and Tyr between diets containing WPC and SDPP. Regardless of extrusion temperatures, the weaned pigs' diet containing either SDPP or FM had significantly higher Lys, Phe, Thr, Val, and Gly digestibility relative to the WPC diet. Results of the present study suggest that simple pelleting of diets containing protein sources such as whey protein concentrate, spray-dried plasma protein and fish meal would be better than the extruded or expanded pellet diets. Extruder or expander processing of weaned pigs' feed could reduce palatability and ileal digestibility of several amino acids and therefore may be responsible for a negative growth response in weaned pigs.

Study Protocol for the Most Effective Recall Method in a Cervical Cancer Screening Program in Klang, Malaysia

  • Rashid, Rima Marhayu Abdul;Dahlui, Maznah
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.10
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    • pp.5867-5870
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    • 2013
  • Background: Cervical cancer is the second most common cancer among Malaysian women with an ASR of 17.9 and a mortality rate of 5.6 per 100,000 population in 2008 (GLOBOCAN, 2008). The 5 year prevalence was estimated to be 14.5 per 100,000 population. As the second most common cancer affecting productive females, cervical cancer imposes an impact to the socioeconomic aspect of the country. However, the poor uptake of cervical cancer screening is a major problem in detecting early pre-cancerous lesions and thus, delay in initiating treatment for cervical cancer. Realizing the urgency to increase the uptake of PAP smear, besides enhancing the promotion of PAP smear screening for women above 35 years old, the call-recall system for pap smear screening had been piloted in one of the suburban districts which aimed to improve regular participation of women for cervical and breast cancer screening. This is of public health importance as identifying the best feasible option to increase patient's respond to participate in the screening program effectively in our setting will be helpful in implementing an organized regular population based screening program tailored to our setting. The pilot program of cervical cancer screening in Klang was an opportunity to assess different options in recalling patients for a repeat pap smear to increase their participation and adherence to the program. Methods and Results: This was a population based randomized control trial. Women aged 20-65 years in the population that matched the inclusion and exclusion criteria were re-called for a repeat smear. There are four different intervention groups; letter, registered letters, short messages services (SMS) and phone calls where 250 subjects were recruited into each group. Samples were generated randomly from the same population in Klang into four different groups. The first group received a recall letter for a repeat smear similar to the one that has been given during the first invitation. The intervention groups were either be given a registered letter, an SMS or a phone call to re-call them. The socio-demographic data of the patients who came for uptake were collected for further analysis. All the groups were followed up after 8 weeks to assess their compliance to the recall. Conclusions: The study will provide recommendations about the most effective methods for recall in a population based pap smear screening program on two outcomes: i) patients response; ii) uptake for repeat pap smear.

Efficacy and Safety of Neurokinin-1 Receptor Antagonists for Prevention of Chemotherapy-Induced Nausea and Vomiting: Systematic Review and Meta-analysis of Randomized Controlled Trials

  • Yuan, Dong-Mei;Li, Qian;Zhang, Qin;Xiao, Xin-Wu;Yao, Yan-Wen;Zhang, Yan;Lv, Yan-Ling;Liu, Hong-Bin;Lv, Tang-Feng;Song, Yong
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.4
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    • pp.1661-1675
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    • 2016
  • Objectives: Can addition of neurokinin-1 receptor antagonists (NK1-RAs) be considered as an ideal strategy for the prevention of chemotherapy-induced nausea and vomiting (CINV)? Researchers differ on this question. Materials and Methods: Electronic databases were searched for randomized control trials (RCTs) that evaluated the effectiveness and safety of NK1-RAs in preventing CINV. The primary end point was complete response (CR) in the acute, delayed, and overall phases after chemotherapy. Subgroup analyses evaluated the types of NK1-RAs, routines of administration, types of malignancies, regimens used in combination with NK1-RAs, and age of patients included in the studies. The incidences of different types of adverse events were also extracted to estimate the safety of NK1-RAs. Results: A total of 38 RCTs involving 13,923 patients were identified. The CR rate of patients receiving NK-RAs was significantly higher than patients in the control groups during overall phase (70.8% vs 56.0%, P<0.001), acute phase (85.1% vs 79.6%, P<0.001), and delayed phase (71.4% vs 58.2%, P<0.001). There were three studies including patients of children or adolescents, the CR rate was also significantly higher in the treatment group (overall phase: OR=2.807, P<0.001; acute phase: OR=2.863, P =0.012; delayed phase: OR=2.417, P<0.001). For all the other outcomes, patients in the NK1-RAs groups showed improvements compared to the control groups (incidence of nausea: 45.2% vs 45.9%, P<0.001; occurrence of vomiting: 22.6% vs 38.9%, P<0.001; usage of rescue drugs: 23.5% vs 34.1%, P<0.001). The pooled side effects from NK1-RAs did not significantly differ from previous reports and the toxicity rates in patients less than eighteen years old also did not diff between the two groups (P=0.497). However, we found that constipation and insomnia were more common in the patients of control groups, whereas diarrhea and hiccups were more frequently detected in patients receiving NK1-RAs. Conclusions: NK1-RAs improved the CR rate of CINV. They are effective for both adults and children. The use of NK1-RAs might be associated with the appearance of diarrhea and hiccups, while decreasing the possibility of constipation and insomnia.

Different Responses to Acupuncture in Electroencephalogram according to Stress Level: A Randomized, Placebo-Controlled, Cross-Over Trial (스트레스 정도에 따라 침 치료가 뇌파(EEG)에 미치는 영향: 무작위배정 플라시보 대조군 교차연구)

  • Kim, Song-Yi;Kim, Sang-Woo;Park, Hi-Joon
    • Korean Journal of Acupuncture
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    • v.31 no.3
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    • pp.136-145
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    • 2014
  • Objectives : The purpose of this randomized, placebo-controlled, cross-over trial was to examine how acupuncture treatment at Shinmun(HT7) affects the brain activity and the autonomic nervous system(ANS), using electroencephalograms(EEG) and heart rate variability(HRV). Methods : Eighteen healthy volunteers participated in two separate experiments: in each experiment, either real acupuncture(RA) or non-penetrating sham acupuncture(SA) was applied at HT7 in random sequences to each person. The EEG and HRV measurements were conducted simultaneously before and during the acupuncture stimulation for 5 minutes, respectively. Resulting EEG and HRV parameters were compared between RA and SA groups. To assess differences according to the stress levels for participants, subgroup analysis was performed based on the results of the stress response index questionnaire. Results : In the results, acupuncture stimulation at HT7 increased ${\alpha}$ band in EEG. In the HRV analysis, heart rate was decreased significantly but HF and RMS-SD were increased in the RA group, compared with those of the SA group. In the subgroup analysis by stress level, participants in the RA group with high stress exhibited an increased in ${\alpha}$ band in their EEG while the low stress participants showed decrease or little increase in the band. For the SA group, ${\alpha}$ band reported relatively moderate changes in all channels. Conclusions : Our results showed that acupuncture induces changes in brain activation and the ANS. Acupuncture was related to the activation of the parasympathetic nervous system. The brain activities of the participants were different depending on the stress level.

Adverse Effects of Ephedra According to Sasang Typology in Healthy Adults : A Double-Blind Randomized Controlled Trial (마황복용 후 사상체질별 이상반응에 관한 임상연구 : 무작위배정 이중맹검시험)

  • Lee, Tae-Ho;Hsing, Li-Chang;Yang, Chang-Sop;Kim, Lak-Hyung;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.30 no.1
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    • pp.144-152
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    • 2009
  • Background : Ephedra (Ephedra sinica) has been widely used to treat respiratory disease in traditional medicine of East Asia for over a hundred years. Despite safety concerns raised by some, the use of ephedra in traditional medicine is documented over more than 1,800 years. It is well established that ephedra is one of the central medicines in Korean 'Seseng constitution' medicine. In Sasang constitution medicine, all humans can be divided into one of four types: Soeumin, Soyangin, Taeumin or Taeyangin, and each constitution type has their own typical characteristics. Accordingly, it is hypothesized that the adverse effects of ephedra differ depending on the Sasang constitution classification. Objectives : The aim of this study was to determine adverse effects of ephedra which is classified as a Taeumin herb, and to observe whether the response differs or not. according to Sasang constitution classification. Methods : The study design was a double-blind randomized controlled trial. The subjects were healthy adults 20 - 50 years old who agreed to participate in this study. They were allocated through randomization to either ephedra group (N=55) or placebo group (N=24). where ephedra extract (6 g of dried ephedra) and placebo with similar opaque capsules were given twice for one day. To compare the adverse events of ephedra according to Sasang constitution classification, we analyzed blood pressure (systolic and diastolic), pulse rate, the morning questionnaire, and patient's global assessment scale score for well known adverse events: palpitation, headache, sweating, tiredness, dyspepsia, and dry mouth. Results : After ingestion of ephedra, the pulse rate had a significant increase in all constitution types. The changes of diastolic pressure in Soeumin and the changes of pulse rate in Soeumin, Soyangin and Taeumin had a significant increase in the ephedra over the control group. In the ephedra group, the palpitation and dyspepsia score of the patients' global assessment scale had a significant increase in Soeumin, with palpitation and sweating score increasing in Soyangin. Others observations were insignificant results. Conclusion : The results of this study may confirm that the physical responses or adverse effects of herbs differ for each type of Sasang constitution. Future studies using other herbs will be required to ascertain the herbal drug reaction of Sasang constitutions.

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Effects of Cordyceps militaris supplementation on the immune response and upper respiratory infection in healthy adults: a randomized, double-blind, placebo-controlled study (건강한 성인을 대상으로 면역증강 및 상기도 감염 예방에 대한 동충하초주정추출물의 유효성 평가 : 이중맹검 플라세보 대조 연구)

  • Jung, Su Jin;Hwang, Ji Hyun;Oh, Mi Ra;Chae, Soo Wan
    • Journal of Nutrition and Health
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    • v.52 no.3
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    • pp.258-267
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    • 2019
  • Purpose: Upper respiratory tract infections are major causes of the common cold throughout the world. Cordyceps militaris (C. militaris) is a well-known functional food for its anti-fatigue and immunomodulating activities. On the other hand, there are no reports on the protective effect against upper respiratory tract infections (URI). This study was a 12 week randomized, double-blind, and placebo-controlled trial in healthy volunteers. Methods: A total of 100 subjects 20 ~ 70 years of age with a history of at least two colds in the year were enrolled in the study. The participants were required to record any adverse events and rate any cold-related incidents in a diary during the investigation period. The efficacy end point was the symptoms and incidence of URI, and changes in cytokines, IgA and natural killer (NK) cell activity. Results: The Cordyceps militaris group over 12 weeks showed no significant impact on the incidence and symptomatology of URI compared to the placebo group. On the other hand, the experimental group showed significantly higher NK cell activity (p = 0.047) and IgA level (p = 0.035) compared to the placebo group. The NK-cell activity and IgA level were increased significantly by Cordyceps militaris over 12 weeks. Conclusion: The results suggest the possible beneficial immunomodulating effects, but the protective effects on URI could not be demonstrated under these conditions. Additional research will be needed to determine the efficacy and mechanisms of Cordyceps militaris function.

Effects of Neuromuscular Electrical Stimulation on Muscle Wasting with Cancer Patient: A Systematic Review (신경근전기자극치료가 암 환자의 근육 손실에 미치는 영향: 체계적 문헌고찰)

  • Eun Soo Park;Jong Hee Kim;Soo Dam Kim;Dong Hyun Kim;Eun Jung Lee;Min Seok Oh;Hwa Seung Yoo
    • Journal of Korean Medicine Rehabilitation
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    • v.33 no.4
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    • pp.15-29
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    • 2023
  • Objectives The purpose of this study is to systematically review the effects of Neuromuscular Electrical Stimulation treatment on muscle wasting in cancer patients. Methods Randomized controlled trials (RCTs) were searched from seven online databases (PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure, Oriental Medicine Advanced Searching Integrated System, Korean studies Information Service System, Research Information Sharing Service. The selected RCTs were evaluated for methodological quality through the Cochrane RoB. Results A total of 126 articles were identified, and 4 randomized controlled trials were selected for systematic review. In one study, it was found that there were statistically significant improvements in the Health-Related Quality of Life (FACTH&N total score, p<0.001). Additionally, significant effects were observed in measurements that represented the size of the quadriceps muscle (cross-sectional area of Vastus lateralis and Rectus femoris, p=0.004), maximum muscle strength, the twitch response of resistance muscles, and voluntary activation (p<0.001). However, no significant differences were observed between the intervention and control groups in terms of quadriceps muscle strength in two other studies (p>0.05). Lastly, while one study showed no significant differences in muscle fiber characteristics between the two groups, it did report significant improvements in measurements related to mitochondria within muscle tissue and muscle strength in the intervention group (p<0.05). Conclusions Neuromuscular electrical stimulation can be a method used to improve muscle strength in muscle wasting of cancer patients, but it is difficult to see its effects as significant compared to other treatments.

Intrapleural Fibrinolysis with Urokinase versus Alteplase in Complicated Pleural Effusions and Empyema: A Prospective Randomized Controlled Trial

  • Sudipt Adhikari;Vikas Marwah;Robin Choudhary;Indermani Pandey;Tentu Ajai Kumar;Virender Malik;Arpita Pemmaraju;Shrinath Vasudevan;Suraj Kapoor
    • Tuberculosis and Respiratory Diseases
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    • v.87 no.3
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    • pp.378-385
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    • 2024
  • Background: Intrapleural fibrinolytic therapy (IPFT) has been used as an effective agent since 1949 for managing complicated pleural effusion and empyema. Several agents, such as streptokinase, urokinase (UK), and recombinant tissue plasminogen activator (rt-PA), have been found to be effective with variable effectiveness. However, a head-tohead controlled trial comparing the efficacy of the most frequently used agents, i.e., UK and rt-PA (alteplase) for managing complicated pleural effusion has rarely been reported. Methods: A total of 50 patients were randomized in two intervention groups, i.e., UK and rt-PA. The dose of rt-PA was 10 mg, and that of UK was 1.0 lac units. UK was given thrice daily for 2 days, followed by clamping to allow the retainment of drugs in the pleural space for 2 hours. rt-PA was instilled into the pleural space twice daily for 2 days, and intercostal drainage was clamped for 1 hour. Results: A total of 50 patients were enrolled into the study, of which 84% (n=42) were males and 16% (n=8) were females. Among them, 30 (60%) patients received UK, and 20 (40%) patients received alteplase as IPFT agents. The percentage of mean±standard deviation changes in pleural opacity was -33.0%±9.9% in the UK group and -41.0%±14.9% in the alteplase group, respectively (p=0.014). Pain was the most common adverse side effect, occurring in 60% (n=18) of the patients in the UK group and in 40% (n=8) of the patients in the alteplase group (p=0.24), while fever was the second most common side effect. Patients who reported early (within 6 weeks of onset of symptoms) showed a greater response than those who reported late for the intervention. Conclusion: IPFT is a safe and effective option for managing complicated pleural effusion or empyema, and newer agents, such as alteplase, have greater efficacy and a similar adverse effect profile when compared with conventional agents, such as UK.

Cisplatin Plus Gemcitabine for Treatment of Breast Cancer Patients with Brain Metastases: a Preferential Option for Triple Negative Patients?

  • Erten, Cigdem;Demir, Lutfiye;Somali, Isil;Alacacioglu, Ahmet;Kucukzeybek, Yuksel;Akyol, Murat;Can, Alper;Dirican, Ahmet;Bayoglu, Vedat;Tarhan, Mustafa Oktay
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.6
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    • pp.3711-3717
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    • 2013
  • Background: To assess the efficacy and tolerability of Cisplatin plus Gemcitabine combination in patients with brain metastases (BM) from breast cancer (BC). Materials and Methods: Eighteen BC patients with BM who were treated with Cisplatin plus Gemcitabine regimen between 2003-2011 were evaluated. Results: A median of 6 cycles of this regimen were received, in fifteen patients (83.3%) as first-line chemotherapy, in 2 as second-line and in 1 as third-line after diagnosis of BM. Dose reduction was performed in 11 (61.1%) patients; major reasons were neutropenia and leukopenia. Grade III neutropenia and Grade II trombocytopenia rates were 33.3% and 16.7% respectively. Overall response rate (ORR; complete+partial response rate) was 33.4% (n=6) for the entire study population; triple negative patients achieved an 66.6% ORR while hormone receptor (HR) positive patients had 25% and HER2 positive patients 12.5%. Median progression-free survival was 5.6 months (2.4-8.8 months, 95%CI) and longer in patients with triple negative breast cancer (TNBC) (median 7.4 months, 95%CI, 2.4-12.3 months) than the patients with other subtypes (median 5 months for HER2 positive and 3.6 months for HR positive patients). Median PFS of the patients with TNBC who received this regimen as first-line was 9.2 months (5.2-13.2 months, 95%CI). Conclusions: Cisplatin plus Gemcitabine may be a treatment option for patients with BM from breast cancer. Longer PFS and higher response rates are results that support the usage of this regimen especially for the triple negative subtype. However, further prospective and randomized trials are clearly required to provide more exact information.