• Journal of Ginseng Research
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• v.42 no.2
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• pp.144-148
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• 2018

Background: Panax ginseng is a well-known immune modulator, and there is concern that its immune-enhancing effects may negatively affect patients with rheumatoid arthritis (RA) by worsening symptoms or increasing the risk of adverse effects from other drugs. In this randomized, crossover clinical trial, we evaluated the impact of Korean Red Ginseng (KRG) on disease activity and safety in RA patients. Methods: A total of 80 female RA patients were randomly assigned to either the KRG (2 g/d, n = 40) treatment or placebo (n = 40) groups for 8 wk, followed by crossover to the other treatment group for an additional 8 wk. The primary outcome was the disease flare rate, defined as worsening disease activity according to the disease activity score 28 joints-erythrocyte sedimentation rate (DAS28-ESR). The secondary outcomes were development of adverse events (AEs) and patient reported outcomes. Outcomes were evaluated at baseline and 8 wk and 16 wk. The outcomes were compared using the Chi-square test. Results: Of the 80 patients, 70 completed the full study. Their mean age was 51.9 yr, and most exhibited low disease activity (mean DAS28-ESR $3.5{\pm}1.0$) at enrollment. After intervention, the flare rate was 3.7% in each group. During KRG treatment, 10 AEs were reported, while five AEs were developed with placebo; however, this difference was not statistically significant (p = 0.16). Gastrointestinal- and nervous system-related symptoms were frequent in the KRG group. Conclusion: KRG is not significantly associated with either disease flare rate or the rate of AE development in RA patients.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.24 no.1
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• pp.96-110
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• 2011

목적 : 본 임상시험을 통하여 혈열(血熱)형으로 변증된 아토피피부염의 한약 치료 후 임상 효능과 안전성을 관찰함으로써 아토피피부염에 대한 한약치료의 유용성을 평가하고자 한다. 방법 : 본 임상시험은 무작위배정, 이중맹검, 양성대조군, 평행 설계로 진행되었다. 자의에 의해 임상시험 동의서에 서명한 대상자 중 선정기준 및 제외기준에 부합된 36명의 대상자들에게 시험약과 양성대조약 과립제를 1일 3회(5.0g* 3회/ 1일) 4주간 복용하도록 하였다. 36명 중 31명의 환자가 4주간의 치료를 종료하였다(시호청간산 복용군: n = 16, 소풍산 복용군: n =15). 아토피피부염 증상을 평가하기 위해 Scoring atopic dermatitis (SCORAD) index와 Eczemaarea and severity index (EASI) 를 사용하여 시험 시작 전과 4주 후 시험 종료일에 환자들의 피부소견을 평가하였다. 아토피 피부염에 대한 한약치료의 안정성을 평가하기 위하여 치료 전후 혈중 AST, ALT, BUN, creatinine 변화를 검토하여 한약치료의 간/신독성 여부에 대해 조사하였다. 결과 및 결론: 두 군 모두에서 유의하게 SCORAD 점수와 EASI 점수가 감소하였으나 두 군 간의 차이는 유의하지 않았다. 부종/구진, 찰상 항목의 점수에는 두 군 간에 유의한 차이가 관찰되었다. 31명의 환자에게서 한약 치료 후 간장과 신장에 미치는 독성이 발견되지 않았으며 한약투여와 관련된 이상반응은 보고되지 않았다. 위의 결과로부터 시호청간산과 소풍산이 혈열형 아토피피부염에 대한 효과적이고 안전한 치료 방법이 될 수 있을 것으로 생각된다.

• Safety and Health at Work
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• v.6 no.3
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• pp.256-262
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• 2015

Background: Heart attack is the most common cause of line-of-duty death in the fire service. Daily aspirin therapy is a preventative measure used to reduce the morbidity of heart attacks but may decrease the ability to dissipate heat by reducing skin blood flow. Methods: In this double-blind, placebo-controlled, crossover study, firefighters were randomized to receive 14 days of therapy (81-mg aspirin or placebo) before performing treadmill exercise in thermal-protective clothing in a hot room [$38.8{\pm}2.1^{\circ}C$, $24.9{\pm}9.1%$ relative humidity (RH)]. Three weeks without therapy was provided before crossing to the other arm. Firefighters completed a baseline skin blood-flow assessment via laser Doppler flowmetry; skin was heated to $44^{\circ}C$ to achieve maximal cutaneous vasodilation. Skin blood flow was measured before and after exercise in a hot room, and at 0 minutes, 10 minutes, 20 minutes, and 30 minutes of recovery under temperature conditions ($25.3{\pm}1.2^{\circ}C$, $40.3{\pm}13.7%\;RH$). Platelet clotting time was assessed before drug administration, and before and after exercise. Results: Fifteen firefighters completed the study. Aspirin increased clotting time before and after exercise compared with placebo (p = 0.003). There were no differences in absolute skin blood flow between groups (p = 0.35). Following exercise, cutaneous vascular conductance (CVC) was $85{\pm}42%$ of maximum in the aspirin and $76{\pm}37%$ in the placebo groups. The percentage of maximal CVC did not differ by treatment before or after recovery. Neither maximal core body temperature nor heart rate responses to exercise differed between trials. Conclusion: There were no differences in skin blood flow during uncompensable heat stress following exercise after aspirin or placebo therapy.

• Maxillofacial Plastic and Reconstructive Surgery
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• v.41
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• pp.29.1-29.10
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• 2019

Background: Reduction in postoperative complications is of vital considerations in impacted third molar teeth surgery. The aim of this study was to compare postoperative complications of impacted third molar surgeries for bone removal using laser, piezoelectric equipment, and conventional rotary instruments. Methods: To address the research purpose, the investigator designed the prospective double-blind clinical trial study. The sample size was determined 20 (40 teeth) by sampling formula in any kind of operation. The data of patients were obtained in the different periods in terms of pain, trismus, swelling, ecchymosis, and patient's satisfaction and then analyzed using SPSS 20 software via paired t test and Wilcoxon and McNemar's tests. Results: The pain immediately after surgery and 2 days and 7 days after surgery was higher in the laser group. The swelling immediately after surgery was more in the laser group but not significant. The amount of mouth opening immediately after surgery and 2 days and 7 days after surgery was significantly lower in the laser group than in the piezosurgery group. The total duration of surgery and duration of osteotomy were significantly longer in the laser group. The patient's satisfaction from surgery with piezosurgery was more than that with laser, but this difference was not significant. Conclusion: Due to the rising demand for impacted wisdom tooth surgery, the present study suggests that hard tissue laser surgery and piezosurgery can clear the future of impacted molar surgery, and these approaches are more efficient in reducing postoperative complications compared to the conventional surgeries.

• Asian Pacific Journal of Cancer Prevention
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• v.17 no.8
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• pp.4125-4129
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• 2016

Background: Chemotherapy-induced nausea and vomiting (CINV) places a significant burden on the patient. Herbal agents are the most commonly complementary therapies used among the public. This study was done to determine the effect of ginger and chamomile capsules on nausea and vomiting in cases undergoing chemotherapy for breast cancer (BC). Materials and Methods: In a randomized, double-blind and clinical trial study, 65 women with BC undergoing chemotherapy were referred to Breast Cancer Research Center, Tehran, Iran, between May 2013 to June 2014. Regimen for ginger group for 5 days before and 5 days after chemotherapy was: 2 times a day and 500 mg capsules of powdered ginger root in addition to a routine antiemetic regimen consisting of dexamethasone, metoclopramide and aprepitant (DMA) capsules. Chamomile group similarly was: 2 times a day and 500 mg capsules of Matricaria chamomilla extract in addition to a routine antiemetic regimen consisting of DMA capsules. Control group, routine antiemetic regimen consisting of DMA capsules. Results: There were no significant differences between the ginger, chamomile and control groups regarding age. Drugs used for chemotherapy were identical and duration of disease was also matched (1-4 months). Ginger and chamomile were both significantly effective for reducing the frequency of vomiting, there being no significant difference between the ginger and chamomile groups. Moreover, unlike the chamomile, ginger significantly influenced the frequency of nausea. Conclusions: According to the findings of this study, it should be declared that taking ginger capsules (1 g/day) might relieve CINV safely. Nurses dealing directly with cancer patients should be responsible for providing educational programs for patients and their families about how to deal with their drug regimens and associated side effects.

• Tuberculosis and Respiratory Diseases
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• v.80 no.3
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• pp.265-269
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• 2017

Background: The first line of anti-tuberculosis (TB) drugs are the most effective standard of drugs for TB. However, the use of these drugs is associated with hepatotoxicity. Silymarin has protective effects against hepatotoxicity of anti-TB drugs in animal models. This study aims to investigate the protective effect of silymarin on hepatotoxicity caused by anti-TB drugs. Methods: This is a prospective, randomized, double-blind and placebo-controlled study. Patients were eligible if they were 20 years of age or order and started the first-line anti-tuberculosis drugs. Eligible patients were randomized for receiving silymarin or a placebo for the first 4 weeks. The primary outcome was the proportion of patients who showed elevated serum liver enzymes more than 3 times the upper normal limit (UNL) or total bilirubin (TBil) > $2{\times}UNL$ within the first 8 weeks of anti-TB treatment. Results: We enrolled a total of 121 patients who silymarin or a placebo to start their anti-TB treatment, for the first 8 weeks. The proportions of elevated serum liver enzymes more than 3 times of UNL at week 2, week 4, and week 8 did not show any significant difference between the silymarin and placebo groups, at 0% versus 3.6% (p>0.999); 4.4% versus 3.6% (p>0.999); and 8.7% versus 10.8% (p=0.630), respectively. However, patients with TBil >$2{\times}UNL$ at week 8 were significantly low in the silymarin group (0% versus 8.7%, p=0.043). Conclusion: Our findings did not show silymarin had any significant preventive effect on the hepatotoxicity of anti-TB drugs.

• Journal of Dental Anesthesia and Pain Medicine
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• v.17 no.1
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• pp.47-53
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• 2017

Background: Every patient who undergoes mandibular third molar surgery is concerned about post-operative pain. Indeed, previous researchers have used various methods to treat such pain. This study aimed to assess the effectiveness of sublingual injection of dexamethasone (8 mg) to treat post-operative pain after mandibular third molar surgery. Method: This was a randomized, double-blind, split-mouth, clinical trial, involving 48 healthy patients who required surgical removal of two mandibular third molars with similar bilateral positions. All operations were performed by the same experienced surgeon. The patients were randomized into a study group (8 mg dexamethasone injection) and a placebo group (normal saline injection). Both interventions were injected into the sublingual space immediately after local anesthesia, 30 min before the first incision. The study group received an 8 mg dexamethasone injection, while the placebo group received a normal saline injection. The wash period between the patients' two operations was 3 to 4 weeks. Pain was assessed by recording the number of analgesic tablets (rescue drug) consumed, as well as by noting the patients' responses to the visual analog scale (VAS) on the first, second, and third days after surgery. Results: The study group differed significantly from the placebo group in terms of VAS score and analgesic consumption. Conclusion: Dexamethasone (8 mg), injected sublingually, significantly eased post-operative pain after surgical removal of the mandibular third molar.

• Journal of Dental Anesthesia and Pain Medicine
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• v.20 no.4
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• pp.233-240
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• 2020

Background: Palatal injection of local anesthetics is the most painful injection. To obviate the need for palatal injections, local anesthetic agents with diffusibility are being investigated. Hence the present study was designed to analyze the anesthetic efficacy of 2% lidocaine hydrochloride (HCl) with 1:100,000 adrenaline and 4% articaine hydrochloride (HCl) with 1:100,000 adrenaline using single buccal infiltration for the extraction of maxillary premolars. Methods: A prospective, double-blind, crossover, randomized clinical study was performed on 60 consecutive systemically healthy patients with an age range of 15-30 years, requiring extraction of asymptomatic bilateral maxillary premolars for orthodontic purposes. They received 1ml buccal infiltration of 4% articaine HCl with 1:100,000 adrenaline on one side and 2% lidocaine HCl with 1:100,000 adrenaline on the other side. The extraction procedure on either side was scheduled 14 days apart. Parameters assessed were the time of onset of anesthesia, intraoperative discomfort, hemodynamic parameters, and the duration of analgesia. Analysis of the data was done using the Mann-Whitney test, the Wilcoxon test, the Kruskal-Wallis ANOVA test, and the chi-square test. Statistical significance was established at P < 0.05. Results: Articaine showed a faster time of onset and longer duration of analgesia than lidocaine. However, the difference in the intraoperative discomfort and hemodynamic parameters was statistically insignificant. Conclusion: Within the limitations of the study, it can be concluded that the extraction of maxillary premolars can be performed with a single buccal infiltration of 2% lidocaine HCl with 1:100,000 adrenaline, which is one of the most commonly used local anesthetic agent.

• 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.

• Journal of Dental Anesthesia and Pain Medicine
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• v.20 no.4
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• pp.223-231
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• 2020

Background: The most frequent complication of nasotracheal intubation (NTI) is epistaxis. Epinephrine nasal gauze packing has been used conventionally as a pre-treatment for reducing epistaxis, but it carries a disadvantage of pain and anxiety in patients. However, xylometazoline drops are easier to administer and more convenient for patients. We aimed at comparing the effectiveness of xylometazoline drops and epinephrine merocele packing in reducing bleeding and postoperative complications in our population. Methods: Our study enrolled 120 patients in a double-blind randomized controlled trial. We randomly allocated ASA1 or 2 adult patients into 2 groups: Group X and Group E. Group X received 0.1% xylometazoline nasal drops, and epinephrine (1:10,000) merocele nasal packing was used in Group E. The primary outcome was the incidence of bleeding during NTI; the severity of bleeding, navigability, bleeding during extubation, and postoperative complications were secondary outcomes. We used IBM SPSS and Minitab software for statistical analysis, and P < 0.05 was considered statistically significant. Results: We analyzed the data of 110 patients: 55 in Group X and 55 in Group E. The two groups did not have different bleeding incidence (56.4% vs 60.0%; P = 0.70); however, the incidence of severe bleeding was less with xylometazoline than with epinephrine (3.63% vs 14.54%; P < 0.05). We also observed less bleeding during extubation (38.2% vs 68.5%; P < 0.05) with xylometazoline. Other secondary outcomes were akin to both groups. Conclusion: The incidence of severe and post-extubation bleeding was significantly less with xylometazoline. Hence, it may be an effective alternative for reducing the incidence and severity of epistaxis during NTI.