• Title/Summary/Keyword: Randomised controlled trial

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A Randomized trial to investigate the effect of Asparagus racemosus root tablet in Relieving Postmenopausal Hot Flashes

  • K.M. Hina Fatima;Mariyam Roqaiya;Nawazisha
    • CELLMED
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    • v.14 no.10
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    • pp.10.1-10.6
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    • 2024
  • Background and Objectives: As per the available data, 75% peri and postmenopausal women experience hot flashes having negative effect on their quality of life. Using herbal medicines are stepping forward to alleviate hot flashes as the available hormonal medications have been reported the presence of side effects. This study was planned with the intention to investigate the effect of Asparagus racemosus root in the treatment of postmenopausal hot flashes in comparison to the placebo. Methods: This prospective patient blinded clinical trial randomly assigned 40 postmenopausal women with symptoms of hot flashes to receive either test drug (n=20) comprising Asparagus racemosus tablet of 1g in the dosage of 2 tablet thrice in a day for the duration of 60 days continuously or to receive placebo tablet prepared from roasted wheat flour in the same dosage and duration as test drug. The efficacy was determined by reduction in the frequency and intensity of hot flashes assessed by daily diary along with the improvement in quality of life assessed through Hot Flash-Related Daily Interference Scale. Statistical analysis was accomplished by student t test and Chi-square/Fisher Exact test. Results: Test drug significantly (p <0.001) reduced the intensity and frequency of hot flashes as well as improved the quality of life without showing any side effect. Discussion & Conclusion: According to Unani scriptures, the treatment is to treat the underlying cause, such as aberrant temperament and psychological and environmental issues. Unani drugs have emmenagogue, anti-inflammatory, analgesic, and neuroprotective qualities that can help alleviate premenstrual symptoms. Unani herbs such as C. sativus, Vitex, agnus castus, P. vulgare, N. Jatamansi, M. officinalis, and Z. officinalis have been clinically demonstrated to be effective in PMS. Thus, traditional knowledge authentication and conservation are vital for future research and appreciated for application in the modern day. Furthermore, randomised controlled trials, comprehensive reviews, and meta-analyses are suggested.

Electroacupuncture for Women with Overactive Bladder: A Systematic Review and Meta-analysis of Randomized Controlled Trials (여성 과민성 방광 전침 치료의 무작위 대조군 연구에 관한 체계적 문헌 고찰)

  • Ha, Su-Jin;Hwang, Deok-Sang;Lee, Jin-Moo;Lee, Chang-Hoon;Jang, Jun-Bock
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.3
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    • pp.1-19
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    • 2020
  • Objectives: The purpose of this study is to assess the efficacy and safety of electroacupuncture for women with overactive bladder (OAB) comparing with sham- acupuncture, and electroacupuncture plus drugs. Methods: We searched 8 databases upto May 26, 2020. Randomised controlled trials (RCTs) were eligible. The risk of bias was assessed by two independent authors using the Cochrane risk of bias tool. Study outcomes were calculated by standardized mean differences (SMD) with 95% confidence intervals (Cls) and mean differences (MD) with 95% Cls. Results: Of 146 screened, 5 RCTs were included. Number of participants per study ranged from 5 to 57. The combined results showed that electroacupuncture (EA) may be more effective than sham acupuncture or enhance solifenacin succinates in improving Overactive Bladder Symptom Score (OABSS) and urination frequency of 24 h. However, more trials with high quality and larger sample sizes will be needed to provide sufficient evidence. Only 5 of 187 OAB patients from the included studies reported mild adverse reactions related to EA, therefore, electroacupuncture is safe for treating OAB. Conclusions: Electroacupuncture might have effect in decreasing urination frequency of 24 h and OABSS. However, the evidences ins in sufficient to show the effect using electroacupuncture alone or additional effect to drugs in treating OAB.

Chia seed (Salvia Hispanica L.) added yogurt reduces short-term food intake and increases satiety: randomised controlled trial

  • Ayaz, Aylin;Akyol, Asli;Inan-Eroglu, Elif;Cetin, Arzu Kabasakal;Samur, Gulhan;Akbiyik, Filiz
    • Nutrition Research and Practice
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    • v.11 no.5
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    • pp.412-418
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    • 2017
  • BACKGROUND/OBJECTIVE: Several studies have reported that consumption of Salvia Hispanica L.,commonly known as chia seed, may exert beneficial effects on health outcomes. The main purpose of this study was to examine the influence of chia seed consumption as a mid-morning snack on short-term satiety. SUBJECTS/METHODS: Subjects (n = 24) were tested using a randomized, cross-over design consisting of three mid-morning snacks. Yogurt with no chia seed, yogurt with 7 g chia seed, and yogurt with 14 g chia seed were given to subjects on different test days. After subjects were asked to report visual analog scale (VAS) scores on sensory outcomes, ad libitum lunch was served, and energy intake of individuals was measured. RESULTS: VAS scores indicated that participants reported significantly lower scores for hunger (P = 0.033), prospective food consumption (P = 0.031), amounts of food that could be consumed (P = 0.017), desire for sugary foods (P = 0.015), and higher scores for satiety (P = 0.031) on the test days with 7 g and 14 g chia seed. Energy intake of individuals during ad libitum lunch was significantly lower when they consumed yogurt with 7 g or 14 g chia seed (P = 0.037). CONCLUSIONS: The study demonstrated that chia seed consumption as a mid-morning snack may induce short-term satiety in healthy individuals.

Smoking Cessation Intervention in Rural Kerala, India: Findings of a Randomised Controlled Trial

  • Jayakrishnan, Radhakrishnan;Uutela, Antti;Mathew, Aleyamma;Auvinen, Anssi;Mathew, Preethi Sara;Sebastian, Paul
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.11
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    • pp.6797-6802
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    • 2013
  • Background: Prevalence of tobacco use is higher in the rural than urban areas of India. Unlike tobacco cessation clinics located in urban areas, community-based smoking cessation intervention has the potential to reach a wider section of the community to assist in smoking cessation in the rural setting. The present study aimed to assess the effectiveness of a cessation intervention in rural Kerala state, India. Materials and Methods: Current daily smoking resident males in the age group 18-60 years from four community development blocks in rural Kerala were randomly allocated to intervention and control groups. The intervention group received multiple approaches in which priority was given to face-to-face interviews and telephone counselling. Initially educational materials on tobacco hazards were distributed. Further, four rounds of counselling sessions were conducted which included a group counselling with a medical camp as well as individual counselling by trained medical social workers. The control group received general awareness training on tobacco hazards along with an anti-tobacco leaflet. Self-reported smoking status was assessed after 6 and 12 months. Factors associated with tobacco cessation were estimated using binomial regression method. Results: Overall prevalence of smoking abstinence was 14.7% in the intervention and 6.8% in the control group (Relative risk: 1.85, 95% CI: 1.05, 3.25). A total of 41.3% subjects in the intervention area and 13.6% in the control area had reduced smoking by 50% or more at the end of 12 months. Lower number of cigarettes/ bidi used, low nicotine dependence and consultation with a doctor for a medical ailment were the statistically significant predictors for smoking cessation. Conclusions: Rigorous approaches for smoking cessation programmes can enhance quit rates in smoking in rural areas of India.

Is the Phone Call the Most Effective Method for Recall in Cervical Cancer Screening? - Results from a Randomised Control Trial

  • Rashid, Rima Marhayu Abdul;Mohamed, Majdah;Hamid, Zaleha Abdul;Dahlui, Maznah
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.10
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    • pp.5901-5904
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    • 2013
  • Objective: To compare the effectiveness of different methods of recall for repeat Pap smear among women who had normal smears in the previous screening. Design: Prospective randomized controlled study. Setting: All community clinics in Klang under the Ministry of Health Malaysia. Participants: Women of Klang who attended cervical screening and had a normal Pap smear in the previous year, and were due for a repeat smear were recruited and randomly assigned to four different methods of recall for repeat smear. Intervention: The recall methods given to the women to remind them for a repeat smear were either by postal letter, registered letter, short message by phone (SMS) or phone call. Main Outcome Measures: Number and percentage of women who responded to the recall within 8 weeks after they had received the recall, irrespective whether they had Pap test conducted. Also the numbers of women in each recall method that came for repeat Pap smear. Results: The rates of recall messages reaching the women when using letter, registered letter, SMS and phone calls were 79%, 87%, 66% and 68%, respectively. However, the positive responses to recall by letter, registered letter, phone messages and telephone call were 23.9%, 23.0%, 32.9% and 50.9%, respectively (p<0.05). Furthermore, more women who received recall by phone call had been screened (p<0.05) compared to those who received recall by postal letter (OR=2.38, CI=1.56-3.62). Conclusion: Both the usual way of sending letters and registered letters had higher chances of reaching patients compared to using phone either for sending messages or calling. The response to the recall method and uptake of repeat smear, however, were highest via phone call, indicating the importance of direct communication.

Cognitive Function Effects of Acupuncture Treatment for Mild Cognitive Impairment : Systematic Literature Review and Meta-Analysis (경도인지장애 침치료 인지기능효과 : 체계적 문헌고찰 메타분석)

  • Won Soon Kim
    • Journal of Society of Preventive Korean Medicine
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    • v.28 no.2
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    • pp.151-164
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    • 2024
  • Objectives : Using MMSE and MoCA cognitive tools, this study tried to measure the effect of acupuncture differing by cognitive types. Through the method of PRISMA literature review, this study aimed to understand and improve the acupuncture's effectiveness in its application. Methods : The research method was a literature review and Cochrane meta-analysis of papers on the effectiveness of acupuncture treatments for mild cognitive impairment conducted from 2012 to 2023. The Cochrane risk of bias (RoB) tool was used as a quality analysis tool, and the meta-analysis tool was Cochrane RevMan V5.4.1 software. Results : As a result of the study, a total of 967 subjects were used for analysis, and 16 papers on randomized acupuncture trials were analyzed. The results are as follows: As a result of meta-analysis of acupuncture intervention for mild cognitive impairment, the MMSE score had an average of 1.61 with a 95% confidence interval ranging from 0.14 to 3.07, and a statistically significant result with p<0.001. The Z-score was 2.15, which corresponded to a p-value of 0.03. The MoCA score had an average range between 0.39 and 2.49, also showing statistical significance with p<0.001, and a Z-score of 2.70 (p=0.007). The effect of acupuncture in subjects with mild cognitive impairment was significant. Conclusion : The suggestions and conclusion indicate that acupuncture intervention has a significant effect on mild cognitive impairment. This study propose future experimental research on various types of acupuncture interventions for mild cognitive impairment. The significance of this study is that it presented basic data for the development of a preventive convergence cognitive intervention program for patients with mild cognitive impairment in the community.

Effectiveness of Aromatherapy with Light Thai Massage for Cellular Immunity Improvement in Colorectal Cancer Patients Receiving Chemotherapy

  • Khiewkhern, Santisith;Promthet, Supannee;Sukprasert, Aemkhea;Eunhpinitpong, Wichai;Bradshaw, Peter
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.6
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    • pp.3903-3907
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    • 2013
  • Background: Patients with colorectal cancer are usually treated with chemotherapy, which reduces the number of blood cells, especially white blood cells, and consequently increases the risk of infections. Some research studies have reported that aromatherapy massage affects the immune system and improves immune function by, for example, increasing the numbers of natural killer cells and peripheral blood lymphocytes. However, there has been no report of any study which provided good evidence as to whether aromatherapy with Thai massage could improve the immune system in patients with colorectal cancer. The objectives of this study were to determine whether the use of aromatherapy with light Thai massage in patients with colorectal cancer, who have received chemotherapy, can result in improvement of the cellular immunity and reduce the severity of the common symptoms of side effects. Materials and Methods: Sixty-six patients with colorectal cancer in Phichit Hospital, Thailand, were enrolled in a single-blind, randomised-controlled trial. The intervention consisted of three massage sessions with ginger and coconut oil over a 1-week period. The control group received standard supportive care only. Assessments were conducted at pre-assessment and at the end of one week of massage or standard care. Changes from pre-assessment to the end of treatment were measured in terms of white blood cells, neutrophils, lymphocytes, CD4 and CD8 cells and the CD4/CD8 ratio and also the severity of self-rated symptom scores. Results: The main finding was that after adjusting for pre-assessment values the mean lymphocyte count at the post-assessment was significantly higher (P=0.04) in the treatment group than in the controls. The size of this difference suggested that aromatherapy with Thai massage could boost lymphocyte numbers by 11%. The secondary outcomes were that at the post assessment the symptom severity scores for fatigue, presenting symptom, pain and stress were significantly lower in the massage group than in the standard care controls. Conclusions: Aromatherapy with light Thai massage can be beneficial for the immune systems of cancer patients who are undergoing chemotherapy by increasing the number of lymphocytes and can help to reduce the severity of common symptoms.