• Title/Summary/Keyword: randomized clinical trial

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A Review on Treatment of Somatization Disorder in Traditional Chinese Medicine (신체화 장애에 대한 중의학 연구동향)

  • Kim, Hyo-seop;Bae, Jin-soo;Lee, Seung-Hwan;Lim, Jung-Hwa;Seong, Woo-Yong
    • Journal of Oriental Neuropsychiatry
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    • v.28 no.3
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    • pp.217-230
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    • 2017
  • Objectives: This study was conducted to review studies on somatization disorder in traditional Chinese medicine. Methods: We reviewed studies in the China National Knowledge Infrastructure (CNKI) to 2017. Keywords were 軀體化障碍, Somatization disorder, somatic symptom disorder. We included Randomized Controlled Trial (RCT), and excluded non-Randomized Controlled Trial (nRCT), non-related somatization disorder or traditional Chinese medicine, non-clinical trials, dissertations for degrees. Jadad scale and Cochrane Library's Risk of Bias (RoB) were used for assessment of the quality of studies. Results: Twelve studies were selected. The Chinese Classification of Mental Disorders-3 (CCMD-3) was most frequently used as diagnostic criteria for somatization disorder. As for outcome measurement, Hamilton Rating Scale for Depression (HAMD) was used most commonly. Meta-analysis of 10 studies revealed effective rate of Chinese Herbal Medicine groups (CHM) was significantly higher than Western Medicine groups (WM) (RR: 1.14, 95% CI: 1.02 to 1.27, p=0.02, $I^2=40%$). There was no significant difference in effective rate of CHM+WM and WM (RR: 1.12, 95% CI: 0.84 to 1.49, p=0.46, $I^2=83%$). And also, effective rate of Acupuncture group (Acu) revealed no significant difference compared to that of WM (RR: 1.17, 95% CI: 0.95 to 1.44, p=0.13, $I^2=84%$). For HAMD, there was significant difference in CHM vs, WM group and Acu vs. WM group. Quality of selected 12 RCTs was low. Conclusions: Therapies practiced in traditional Chinese medicine may be effective options for somatization disorder. treatment. For further clinical studies in Korean medicine, this study could be groundwork for development of diagnosis and treatment on somatization disorder.

Randomized, Double Blind, Placebo-Controlled Study of Bofu-tsusho-san on Obese Patients (비만환자에 대한 방풍통성산(防風通聖散)의 무작위배정, 이중맹검, 위약-대조군 임상시험)

  • Lee, Ji-Eun;Song, Yun-Kyung;Lim, Hyung-Ho
    • Journal of Korean Medicine for Obesity Research
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    • v.10 no.1
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    • pp.1-16
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    • 2010
  • Objectives The clinical trial was designed to investigate the safety and effects of Bofu-tsusho-san extracts on the change of the weight, body compositions, serum in obese patients. Methods This study was a 4-weeks, double blind, comparative clinical trial. Eligible subjects had a body mass index(BMI) greater than $25\;kg/m^2$ and waist circumference(WC) longer than 85 cm in woman or 90 cm in man. Among 38 subjects, 36 subjects were randomized either to Bofu-tsusho-san or placebo. After 4 weeks of treatment, we measured anthropometric factors(weight, height, WC, BMI etc.), abdominal fat area by CT scanning, serum lipid(total cholesterol(TC), triglyceride(TG), HDL cholesterol, LDL cholesterol), blood level of variety(glucose, adiponectine, leptin, C-reactive protein(CRP) etc.), blood pressure(BP). Adverse events also evaluated. Results BMI, BP, TG, CRP were reduced and weight, WC, score of KOQOL(Korean version of obesity-related QOL scale), SRI(Stress response inventory) were significant changed in Bofu-tsusho-san. But there were no considerable difference between Bofu-tsusho-san and placebo. there were no serious adverse events in either group. Conclusion There were limitations in this study that it conducted within a short period of 4 weeks. but its weight and WC loss effect was significant and it had few adverse events.

The effect of low glycemic index diet on body weight status and blood pressure in overweight adolescent girls: a randomized clinical trial

  • Rouhani, Mohammad Hossein;Kelishadi, Roya;Hashemipour, Mahin;Esmaillzadeh, Ahmad;Azadbakht, Leila
    • Nutrition Research and Practice
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    • v.7 no.5
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    • pp.385-392
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    • 2013
  • Although several studies have assessed the influence of the glycemic index on body weight and blood pressure among adults, limited evidence exists for the pediatric age population. In the current study, we compared the effects of low glycemic index (LGI) diet to the healthy nutritional recommendation (HNR)-based diet on obesity and blood pressure among adolescent girls in pubertal ages. This 10-week parallel randomized clinical trial comprised of 50 overweight or obese and sexually mature girls less than 18 years of age years, who were randomly assigned to LGI or HNR-based diet. Macronutrient distribution was equivalently prescribed in both groups. Blood pressure, weight and waist circumference were measured at baseline and after intervention. Of the 50 participants, 41 subjects (include 82%) completed the study. The GI of the diet in the LGI group was $42.67{\pm}0.067$. A within-group analysis illustrated that in comparison to the baseline values, the body weight and body mass index (not waist circumference and blood pressure) decreased significantly after the intervention in both groups (P = 0.0001). The percent changes of the body weight status, waist circumference and blood pressure were compared between the two groups and the findings did not show any difference between the LGI diet consumers and those in the HNR group. In comparison to the HNR, LGI diet could not change the weight and blood pressure following a 10-week intervention. Further longitudinal studies with a long-term follow up should be conducted in this regard.

Clinical evaluation of efficacy of transcortical anesthesia for the extraction of impacted mandibular third molars: a randomized controlled trial

  • Demir, Esin;Ataoglu, Hanife
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.20 no.1
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    • pp.9-17
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    • 2020
  • Background: This study aimed to compare the pain levels during anesthesia and the efficacy of the QuickSleeper intraosseous (IO) injection system and conventional inferior alveolar nerve block (IANB) in impacted mandibular third molar surgery. Methods: This prospective randomized clinical trial included 30 patients (16 women, 14 men) with bilateral symmetrical impacted mandibular third molars. Thirty subjects randomly received either the IO injection or conventional IANB at two successive appointments. A split-mouth design was used in which each patient underwent treatment of a tooth with one of the techniques and treatment of the homologous contralateral tooth with the other technique. The subjects received 1.8 mL of 2% articaine. Subjects' demographic data, pain levels during anesthesia induction, tooth extractions, and mouth opening on postoperative first, third, and seventh days were recorded. Pain assessment ratings were recorded using the 100-mm visual analog scale. The latency and duration of the anesthetic effect, complications, and operation duration were also analyzed in this study. The duration of anesthetic effect was considered using an electric pulp test and by probing the soft tissue with an explorer. Results: Thirty patients aged between 18 and 47 years (mean age, 25 years) were included in this study. The IO injection was significantly less painful with lesser soft tissue numbness and quicker onset of anesthesia and lingual mucosa anesthesia with single needle penetration than conventional IANB. Moreover, 19 out of 30 patients (63%) preferred transcortical anesthesia. Mouth opening on postoperative first day was significantly better with intraosseous injection than with conventional IANB (P = 0.013). Conclusion: The IO anesthetic system is a good alternative to IANB for extraction of the third molar with less pain during anesthesia induction and sufficient depth of anesthesia for the surgical procedure.

Comparison of lidocaine with articaine buccal injection in reducing complications following impacted mandibular third molar surgery: a split-mouth randomized clinical trial

  • Naghipour, Amin;Esmaeelinejad, Mohammad;Dehnad, Seyed Vahid;Shahi, Anahita;Jarrahi, Alireza
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.20 no.4
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    • pp.213-221
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    • 2020
  • Background: Complications following impacted third molar surgery significantly affect patients' quality of life during the immediate postoperative period. This study aimed to achieve the proper anesthesia method by comparing the effect of the application of lidocaine alone with the application of lidocaine and articaine simultaneously in reducing the complications during and following impacted mandibular third molar surgery. Methods: The study design was a split-mouth double-blind randomized clinical trial. The study was conducted on 13 patients (26 samples) referred for elective surgical removal of bilateral impacted mandibular third molar with similar difficulty on both sides. Each patient underwent similar surgical procedures on two separate appointments. Each patient randomly received 2% lidocaine for conventional inferior alveolar nerve block and 4% articaine for local infiltration before the surgery on one side (group A) and 2% lidocaine alone (for both block anesthesia and infiltration) before the surgery on the other side (group B). Intraoperative and postoperative variables for both groups were established and statistically analyzed. Results: The findings showed that pain on the first day after surgery in group A was significantly lower than that in group B. The patients in group A mentioned experiencing less discomfort following the surgery. The increased horizontal swelling on the first and third days following surgery and oblique swelling on the seventh day in patients in group B were statistically significant. Conclusion: Choosing an appropriate anesthetic drug for oral surgery, specifically impacted third molar surgery, is dependent on the clinician's opinion, however; it seems that the combination of lidocaine and articaine may control the patient's pain significantly better than lidocaine alone.

A Randomized Clinical Trial of Local Acupoints Compared with Distal Acupoints in Chronic Neck Pain Patients (만성 경항통 환자에 대한 근위취혈과 원위취혈 침치료 효과 비교연구)

  • Kim, So-Jung;Jang, Jin-Young;Kim, Nam-Sik;Kim, Yong-Suk;Nam, Sang-Soo
    • Journal of Acupuncture Research
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    • v.28 no.5
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    • pp.57-64
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    • 2011
  • Objectives : The purpose of this study is to compare the efficacy after acupuncture on local acupoints group and distal acupoints group for chronic neck pain. Design : A randomized, crossover clinical trial. Methods : From 15st, September 2010 to October 30th, 2010. 20 patients with chronic neck pain were randomly assigned to either group A or group B. Group A received acupuncture at local acupoints then after 1 week washout period acupuncture at distal acupoints. Group B received the treatment in reverse order. To evaluating efficiency and satisfaction, visual analog scale(VAS), neck disability index(NDI), cranio-cervical flextion test(C-CFT) and five-point likert scale were measured before and after each treatment. Results : Patients in local acupoints group experienced greater improvement than distal acupoints group in VAS. Both local acupoints group and distal acupoints group showed significant improvement in NDI but not in C-CFT and the NDI score change comparison between the two groups had no significance. Local acupoints group showed more effective than distal acupoints group on five-point likert scale. Conclusions : Local acupoints is more effective than distal acupoints in controlling pain in chronic neck pain.

Review and Analysis of Sham Acupuncture in Acupuncture Clinical Trials (침 임상연구에 사용된 거짓침의 분석)

  • Jang, Jin-Young;Kim, So-Jung;Kim, Nam-Sik;Nam, Sang-Soo;Kim, Yong-Suk
    • Journal of Acupuncture Research
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    • v.28 no.5
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    • pp.29-38
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    • 2011
  • Objectives : Recent well-designed randomized controlled trials(RCTs) and their meta-analysis have been published on the efficacy of acupuncture in different condition. In most of them, real acupuncture is compared with sham acupuncture including invasive and non-invasive sham methods. But it is not clear how active sham methods are. These results tend to lead the conclusion that acupuncture has no more effective than sham acupuncture. In order to investigate that sham acupuncture is appropriate as a control, we reviewed several acupuncture trials using different sham acupuncture as a control. Methods : We searched Cochrane researches of acupuncture, reviewed and analyzed 25 RCTs in 42 Cochrane reviews. And especially we compared the effect of acupuncture according to the type of sham acupuncture. Results : Invasive sham acupunctures are used in 12 RCTs and non-invasive types are used in the rest. The majority of studies(19 RCTs) fail to show effects beyond a sham acupuncture. Streitberger's sham needle is a validated sham acupuncture of non-invasive type that was used in 8 trials and also no significant group differences are shown except one trial. Conclusions : Acupuncture is a complex intervention. Clinical trials of acupuncture need to be reexamined and redesigned to remove several bias. Especially, sham acupuncture as a control might be investigated for physiological effects as well as validation test including patient-blinding and de qi sensation. Other research need to be investigated and developed for acupuncture trials.

Effects of single-dose, low-level laser therapy on pain associated with the initial stage of fixed orthodontic treatment: A randomized clinical trial

  • Qamruddin, Irfan;Alam, Mohammad Khursheed;Abdullah, Habiba;Kamran, Muhammad Abdullah;Jawaid, Nausheen;Mahroof, Verda
    • The korean journal of orthodontics
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    • v.48 no.2
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    • pp.90-97
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    • 2018
  • Objective: The aim of this study was to assess the analgesic effect of a single application of low-level laser therapy (LLLT) on spontaneous pain and pain on chewing after placement of initial archwires. Methods: Forty-two patients (26 women, 16 men) were randomly recruited for this split-mouth randomized clinical trial. Each patient received super-elastic nickel-titanium (NiTi) initial archwires (0.012, 0.014, 0.016, and 0.018-inch [in]) in the maxilla for leveling and alignment for an interval of 4 weeks between archwires. One side of the mouth was randomly designated as experimental, while the other side served as placebo. After insertion of each archwire, the experimental side was irradiated with a diode laser for 3 seconds each on 5 points facially and palatally per tooth, from the central incisor to first molar. On the placebo side, the laser device was held the same way but without laser application. A numerical rating scale was used to assess the intensity of spontaneous and masticatory pain for the following 7 days. The Mann-Whitney U test was used to compare pain scores between sides. Results: Patients in the LLLT group exhibited significantly lower mean scores for spontaneous pain after insertion of the initial two archwires (0.012-in and 0.014-in NiTi; p < 0.05), while there was no significant difference for 0.016-in and 0.018-in wires between the LLLT and placebo groups. LLLT significantly reduced chewing pain scores (p < 0.05) for all archwires. Conclusions: A single dose of LLLT considerably lessened postoperative pain accompanying the placement of super-elastic NiTi wires for initial alignment and leveling.

Effects of Fresh Yellow Onion Consumption on CEA, CA125 and Hepatic Enzymes in Breast Cancer Patients: A Double-Blind Randomized Controlled Clinical Trial

  • Jafarpour-Sadegh, Farnaz;Montazeri, Vahid;Adili, Ali;Esfehani, Ali;Rashidi, Mohammad-Reza;Mesgari, Mehran;Pirouzpanah, Saeed
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.17
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    • pp.7517-7522
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    • 2015
  • Onion (Allium cepa) consumption has been remarked in folk medicine which has not been noted to be administered so far as an adjunct to conventional doxorubicin-based chemotherapy in breast cancer patients. To our knowledge, this is the first study aimed to investigate the effects of consuming fresh yellow onions on hepatic enzymes and cancer specific antigens compared with a low-onion containing diet among breast cancer (BC) participants treated with doxorubicin. This parallel design randomized controlled clinical trial was conducted on 56 BC patients whose malignancy was confirmed with histopathological examination. Subjects were assigned in a stratified-random allocation into either group received body mass index dependent 100-160 g/d of onion as high onion group (HO; n=28) or 30-40 g/d small onion in low onion group (LO; n=28) for eight weeks intervention. Participants, care givers and laboratory assessor were blinded to the assignments (IRCT registry no: IRCT2012103111335N1). The compliance of participants in the analysis was appropriate (87.9%). Comparing changes throughout pre- and post-dose treatments indicated significant controls on carcinoembryonic antigen, cancer antigen-125 and alkaline phosphatase levels in the HO group (P<0.05). Our findings for the first time showed that regular onion administration could be effective for hepatic enzyme conveying adjuvant chemotherapy relevant toxicity and reducing the tumor markers in BC during doxorubicin-based chemotherapy.

Effects of vitamin D supplementation on metabolic indices and hs-CRP levels in gestational diabetes mellitus patients: a randomized, double-blinded, placebo-controlled clinical trial

  • Yazdchi, Roya;Gargari, Bahram Pourghassem;Asghari-Jafarabadi, Mohammad;Sahhaf, Farnaz
    • Nutrition Research and Practice
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    • v.10 no.3
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    • pp.328-335
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    • 2016
  • BACKGROUND/OBJECTIVES: Vitamin D plays an important role in the etiology of gestational diabetes mellitus (GDM). This study evaluated the effect of vitamin D supplementation on metabolic indices and hs-C-reactive protein (CRP) levels in GDM patients. SUBJECTS/METHODS: The study was a randomized, placebo-controlled, double-blinded clinical trial. Seventy-six pregnant women with GDM and gestational age between 24-28 weeks were assigned to receive four oral treatments consisting of 50,000 IU of vitamin $D_3$ (n = 38) or placebo (n = 38) once every 2 weeks for 2 months. Fasting blood glucose (FG), insulin, HbA1c, 25-hydroxyvitamin D, lipid profile, hs-CRP, and homeostasis model assessment-insulin resistance (HOMA-IR) were measured before and after treatment. Independent and paired t-tests were used to determine intra- and intergroup differences, respectively. ANCOVA was used to assess the effects of vitamin D supplementation on biochemical parameters. RESULTS: Compared with the placebo group, in the vitamin D group, the serum level of 25-hydroxyvitamin D increased (19.15 vs. -0.40 ng/ml; P < 0.01) and that of FG (-4.72 vs. 5.27 mg/dl; P = 0.01) as well as HbA1c (-0.18% vs. 0.17%; P = 0.02) decreased. Improvements in the lipid profiles were observed in the vitamin D group, but without statistical significance. Significant increases in concentrations of hs-CRP, FG, HbA1c, total cholesterol, and LDL cholesterol were observed in the placebo group. No significant change in fasting insulin and HOMA-IR was observed in either group. CONCLUSIONS: In GDM patients, vitamin D supplementation improved FG and HbA1c but had no significant effects on lipid profile or hs-CRP.