• Title/Summary/Keyword: Randomised Trial

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Acupuncture for Subacute and Chronic Post-thoracotomy Pain in Patients with Traumatic Multiple Rib Fractures: A Study Protocol for a Randomised-controlled, Two-arm, Parallel Design, Pilot Trial

  • Kim, Kun Hyung;Cho, Hyun Min;Lee, Chan Kyu;Seok, JunePill;Kim, Seon Hee;Kim, Jung-Eun;Shin, Yu Kyung;Kim, Min Kyung
    • Journal of Acupuncture Research
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    • v.35 no.2
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    • pp.95-100
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    • 2018
  • Background: The aim of this study is to assess the feasibility of acupuncture treatment for the management of subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures. Methods: A total of 30 participants who have undergone thoracotomy after traumatic multiple rib fractures will be recruited. Participants will be invited and equally randomised into acupuncture plus usual care and usual care alone groups. A computer-generated random number sequence will be used and concealed using opaque, sealed, sequentially numbered envelopes. Twelve sessions of manual and electrical acupuncture performed by Korean medicine doctors will be provided over a span of 3 months to participants allocated to the acupuncture group. Participants in the usual care group will continue pain medication, exercise and physical therapy as required. Study feasibility will be measured based on the proportion of patients who complete the measurement of pain at 12 or 24 weeks after baseline. The clinical outcomes will include; the average pain intensity over the recent week at rest, movement and cough, quality of life, patient's global assessment of recovery, respiratory function measured by the pulmonary function test and use of pain medication at 4, 8, 12 and 24 weeks after enrolment. Adverse events will be recorded for all participants. Written informed consent will be obtained from all participants. The local ethics committee has approved the study. This pilot trial will inform further studies investigating the potential role of acupuncture for subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures.

Omega 3 fatty acids as a host modulator in chronic periodontitis patients: a randomised, double-blind, palcebo-controlled, clinical trial

  • Deore, Girish D.;Gurav, Abhijit N.;Patil, Rahul;Shete, Abhijeet R.;NaikTari, Ritam S.;Inamdar, Saurabh P.
    • Journal of Periodontal and Implant Science
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    • v.44 no.1
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    • pp.25-32
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    • 2014
  • Purpose: Periodontitis is an infectious disease caused predominantly by gram-negative anerobes. The host inflammatory response to these bacteria causes alveolar bone loss that is characterized as periodontitis. Omega-3 fatty acids (${\omega}$-3 FAs) have anti-inflammatory properties, thus have been used to treat some chronic inflammatory diseases such as cardiovascular disease and rheumatoid arthritis. We aimed to evaluate the effect of dietary supplementation with ${\omega}$-3 FAs as a host modulating agent in patients with chronic periodontitis. Methods: Sixty otherwise healthy subjects with moderate and severe chronic periodontitis were enrolled in our randomised, double-blind, placebo-controlled trial. The control group (CG, n=30) was treated with scaling and root planing (SRP) and given a placebo; the treatment group (TG, n=30) was treated with SRP and dietary supplementation of ${\omega}$-3 FAs (one 300 mg tablet daily for 12 weeks). Periodontal clinical parameters and serum C-reactive protein (CRP) levels were evaluated in all patients at baseline, a 6-week and 12-week period after treatment. Results: A significant reduction in the gingival index, sulcus bleeding index, pocket depth, and clinical attachment level was found in the TG compared to the CG at a 12-week period. However, no statistically significant changes in serum CRP levels were found. Conclusions: Our findings suggest that ${\omega}$-3 FAs can successfully reduce gingival inflammation, pocket depth, and attachment level gain. Dietary supplementation with ${\omega}$-3 FAs may have potential benefits as a host modulatory agent in the prevention and/or C management of chronic periodontitis.

A Randomised, Placebo-controlled Trial of the Effects of Preoperative Pregabalin on Pain Intensity and Opioid Consumption following Lumbar Discectomy

  • Hegarty, Dominic A.;Shorten, George D.
    • The Korean Journal of Pain
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    • v.24 no.1
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    • pp.22-30
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    • 2011
  • Background: Pregabalin has been shown to have analgesic effect in acute pain models. The primary objective was to examine the efficacy a single dose of pregabalin, would have on morphine consumption following lumbar discectomy. Methods: With ethical approval a randomized, placebo-controlled prospective trial was undertaken in 32 patients (ASA I-II, 18-65 years) with radicular low back pain for > 3 months undergoing elective lumbar discectomy. Patients received either oral pregabalin 300 mg (PG Group) or placebo (C Group) one hour before surgery. Pain intensity, the accumulative morphine consumption and adverse effects were recorded for 24 hours following surgery. Functional, psychological and quantitative sensory testing were also assessed. Results: Fourteen patients out of the 32 recruited were randomized to receive pregabalin. Morphine consumption was reduced (absolute difference of 42.3%) between groups with medium effect size. (Mann-Whitney; U =52.5, z-score= 2.84, P = 0.004, r = 0.14). This was not associated with a significant difference in the incidence of adverse effects between the two groups. The median pain intensity (VAS) on movement was not significantly different between groups. Conclusions: A single pre-operative dose of pregabalin (300 mg) did not result in a reduction in pain intensity compared to placebo in this patient cohort but the significant reduction in morphine consumption suggests that a fixed peri-operative dosing regime warrants investigation.

Improving Participation in Colorectal Cancer Screening: a Randomised Controlled Trial of Sequential Offers of Faecal then Blood Based Non-Invasive Tests

  • Symonds, Erin L;Pedersen, Susanne;Cole, Stephen R;Massolino, Joseph;Byrne, Daniel;Guy, John;Backhouse, Patricia;Fraser, Robert J;LaPointe, Lawrence;Young, Graeme P
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.18
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    • pp.8455-8460
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    • 2016
  • Background: Poor participation rates are often observed in colorectal cancer (CRC) screening programs utilising faecal occult blood tests. This may be from dislike of faecal sampling, or having benign bleeding conditions that can interfere with test results. These barriers may be circumvented by offering a blood-based DNA test for screening. The aim was to determine if program participation could be increased by offering a blood test following faecal immunochemical test (FIT) non-participation. Materials and Methods: People were invited into a CRC screening study through their General Practice and randomised into control or intervention (n=600/group). Both groups were mailed a FIT (matching conventional screening programs). Participation was defined as FIT completion within 12wk. Intervention group non-participants were offered a screening blood test (methylated BCAT1/IKZF1). Overall participation was compared between the groups. Results: After 12wk, FIT participation was 82% and 81% in the control and intervention groups. In the intervention 96 FIT nonparticipants were offered the blood test - 22 completed this test and 19 completed the FIT instead. Total screening in the intervention group was greater than the control (88% vs 82%, p<0.01). Of 12 invitees who indicated that FIT was inappropriate for them (mainly due to bleeding conditions), 10 completed the blood test (83%). Conclusions: Offering a blood test to FIT non-participants increased overall screening participation compared to a conventional FIT program. Blood test participation was particularly high in invitees who considered FIT to be inappropriate for them. A blood test may be a useful adjunct test within a FIT program.

Research Trend of Traditional Chinese Medicine in the Treatment of Restless Legs Syndrome (하지불안증후군의 중의치료 연구 동향)

  • Kim, Tae-Heon;Jung, Jin-Hyung;Choi, Yun-Hee;Kim, Bo-Kyung
    • Journal of Oriental Neuropsychiatry
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    • v.25 no.2
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    • pp.165-178
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    • 2014
  • Objectives: This study was conducted to assess how Traditional Chinese Medicine treats the medical condition of Restless Legs Syndrome (RLS). Methods: The authors searched for relevant articles through the CNKI (China National Knowledge Infrastructure-www.global.cnki.net) with the following keywords: The main search was for the term 'RLS,' with supportive words added such as 'Acupunture', 'Acupoint', 'Meridian', 'Moxibustion', 'Massage', 'Acupoint injection'. Our search yielded a total of 233 articles; there were a total of 71 articles related to clinical fields. We then analyzed the chosen articles using a number of criteria including the study type used, the treatment method utilized, and the main effect of the treatment. Results: The 71 analyzed articles utilized the following type of study design: 4 were classified as Quasi-randomised trial, 22 as Randomized Controlled Trial, and 45 as a case report. Regarding the treatment used for RLS, 25 studies examined a single treatment modality, while 46 studies examined a complex treatment modality. There were a total of 10 types of acupuncture treatment used in treating RLS; several massage and acupoint injection method were also found. Finally, there were a few studies that used Moxibustion, as well as several supportive treatments like Cupping, Moxibustion, Steam-Washing, TDP (Teding Dancibo Pu) were found. Conclusions: Traditional Chinese Medicine has used a variety of different study designs and treatments vis-a-vis RLS. These treatments are also used to treat the condition in South Korea.

Cost Effective Analysis of Recall Methods for Cervical Cancer Screening in Selangor - Results from a Prospective Randomized Controlled Trial

  • Abdul Rashid, Rima Marhayu;Ramli, Sophia;John, Jennifer;Dahlui, Maznah
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.13
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    • pp.5143-5147
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    • 2014
  • Cervical cancer screening in Malaysia is by opportunistic Pap smear which contributes to the low uptake rate. To overcome this, a pilot project called the SIPPS program (translated as information system of Pap smear program) had been introduced whereby women aged 20-65 years old are invited for Pap smear and receive recall to repeat the test. This study aimed at determining which recall method is most cost-effective in getting women to repeat Pap smear. A randomised control trial was conducted where one thousand women were recalled for repeat smear either by registered letter, phone messages, phone call or the usual postal letter. The total cost applied for cost-effectiveness analysis includes the cost of sending letter for first invitation, cost of the recall method and cost of two Pap smears. Cost-effective analysis (CEA) of Pap smear uptake by each recall method was then performed. The uptake of Pap smear by postal letter, registered letters, SMS and phone calls were 18.8%, 20.0%, 21.6% and 34.4%, respectively (p<0.05). The CER for the recall method was lowest by phone call compared to other interventions; RM 69.18 (SD RM 0.14) compared to RM 106.53 (SD RM 0.13), RM 134.02 (SD RM 0.15) and RM 136.38 (SD RM 0.11) for SMS, registered letter and letter, respectively. ICER showed that it is most cost saving if the usual method of recall by postal letter be changed to recall by phone call. The possibility of letter as a recall for repeat Pap smear to reach the women is higher compared to sending SMS or making phone call. However, getting women to do repeat Pap smear is better with phone call which allows direct communication. Despite the high cost of the phone call as a recall method for repeat Pap smear, it is the most cost-effective method compared to others.

Review of the Large-Scale Clinical Researches on Acupuncture in Germany: ASH, ART, ARC, and GERAC (2000년부터 독일에서 수행된 대규모 침 임상연구들에 대한 고찰: ASH, ART, ARC, GERAC)

  • Yoon, Juyeon;Han, Kuk-In;Jeong, Jinsu;Lee, Seungho;Jang, Insoo
    • Korean Journal of Acupuncture
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    • v.30 no.1
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    • pp.21-26
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    • 2013
  • Objectives : The purpose is to introduce the recent large-scale clinical researches for safety, efficacy and effectiveness of acupuncture in Germany. Results : In 2000, the German Federal Committee of Physicians and Health insurer proposed that large research initiatives on acupuncture, Acupuncture Model Projects(Modellvorhaben Akupunktur), could be conducted by health insurance companies for several pain that acupuncture is syndromes to justify the insurance-based reimbursement. Accordingly, 4 clinical researches were carried out; the Acupuncture Safety and Health economics studies(ASH), the Acupuncture Randomised Trial(ART), the Acupuncture in Routine Care studies(ARC), and the German Acupuncture trial(GERAC). Meanwhile, ASH is a prospective observational study for safety and costs. ART and GERAC are composed of RCTs for efficacy. ARC includes 6 pragmatic RCTs with additional non-randomized cohort study for effectiveness. We investigated the papers related to them and discussed about the outcomes. The researches showed that acupuncture is effective in practice for several chronic conditions such as migraine, tension-type headache, chronic low back pain, osteoarthritis of knee, dysmenorrhea, and allergic rhinitis. Based in part on them, the German health authorities decided that acupuncture would be included into routine reimbursement by social health insurance funds for chronic low back pain and chronic osteoarthritis of the knee in 2006. Conclusions : The German clinical researches may suggest the clues for establishing the evidence of acupuncture treatment.

The Effect of Comfrey on Enoxaparin-Induced Bruise in Patients with Acute Coronary Syndrome: A Randomised Clinical Trial

  • Bagheri, Zahra;Azizi, Azim;Oshvandi, Khodayar;Mohammadi, Younes;Larki-Harchegani, Amir
    • Journal of Pharmacopuncture
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    • v.24 no.4
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    • pp.196-205
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    • 2021
  • Objectives: Bruising is an important side effect of enoxaparin injection. Comfrey (Symphytum officinale) is used to treat different types of wounds, bone fractures, and bruising in traditional medicine in many countries for centuries. This study aimed to determine the effects of the Comfrey ointment on the bruise size and color following enoxaparin injection. Methods: This double-blind randomized clinical trial was conducted on 80 patients with acute coronary syndrome (ACS). The participants were randomly divided into two groups of 40, namely Comfrey and Placebo. Changes in bruise size and color in both groups were assessed daily before and after the intervention. Results: The Comfrey and Placebo groups were homogeneous in demographic and clinical variables. A downward trend was observed in the bruise size in both groups throughout the study. However, the bruise size was smaller in the Comfrey group than the Placebo group on day 2-5 of the intervention. Moreover, there was a significant difference in bruise color between the groups, with a shorter healing course in the Comfrey group. Conclusion: The Comfrey ointment accelerated the healing process of enoxaparin injection-induced bruising in patients with ACS. It is recommended as a safe and simple approach for these patients.

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.

Comparison of Two Different Educational Methods for Teachers' Mammography Based on the Health Belief Model

  • Heydari, Esmat;Noroozi, Azita
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.16
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    • pp.6981-6986
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    • 2015
  • Background: Breast cancer is the most common cancer in women. One way to decrease the burden of this cancer is early detection through mammography. This study compared the effectiveness of two different educational methods for teachers' uptake of mammography based on the Health Belief Model. Materials and Methods: The current study was a randomised trial of 120 teachers over 40 years old in two groups receiving multimedia or group education, both based on the Health Belief Model. Participants completed questionnaires before, immediately and three months after educational intervention. Mammography was evaluated before and after educational intervention. Results: The participants in the two groups were demographically similar. Comparison showed no difference noted in the scores of knowledge, perceived barriers, susceptibility, and severity constructs between two groups (p > 0.05). Health motivation and benefit were perceived to be higher in the group education compared to the multimedia group. There was a significant difference in mammography between two groups after the intervention (p= 0.003). Conclusions: Planning and implementation of educational program based on the Health Belief Model can raise knowledge and increase participation in mammography especially with group education.