• 셀메드
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• 제13권14호
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• pp.19.1-19.16
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• 2023

Objectives: To compare the efficacy of polyherbal Unani formulations in heavy menstrual bleeding due to endometrial hyperplasia. Methodology: A prospective, randomized comparative trial was conducted at Govt. Nizamia Tibbi College. Group A (n=20) received Itrifal Aftimoon 5g orally BID from menstruation day 3 to day 21 plus suprapubic Marham Dakhilyun application and per vaginally Marham Dakhilyun (5g) and Roghan Gul (10ml) application from menstruation day 5 to day 14. Group B (n=20) received Gulnar Farsi (2g), Phitakri Biryan (0.25g), Dammul Aqwain (0.25g), and Geru (2g), 2.5g powder orally BID, menstruation day 3 for 20 days plus Douche Bargh Sambhalu then Ḥamūl of Safuf Mazu (2g), Kalijiri (2g) and Roghan Gul (10ml) from menstruation day 3 to day 12 for 3 consecutive cycles. The primary outcome was pelvic ultrasound findings of endometrial thickness. The secondary outcome measures were improvement in haemoglobin percentage, change in menstrual flow and menstrual pattern. The level of significance was 5%. Results and conclusion: The intragroup comparison showed that the mean endometrial thickness at baseline and after treatment in groups A and B was extremely significantly different (P<0.0001). The intragroup comparison showed the mean haemoglobin percent at baseline and after treatment in group, A was significantly different (P<0.0001). After treatment, 50% and 60% of participants had normal duration and menstrual blood loss after treatment from baseline in Groups A and B respectively. However, further, phase II and III randomized standard controlled trials in larger samples are recommended to assess the efficacy of these group medicines.

• 셀메드
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• 제13권14호
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• pp.18.1-18.13
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• 2023

Background and objectives: Bacterial vaginosis (BV) is recognized as the most prevalent type of vaginal infection, impacting approximately 19-24% of women in their reproductive years. The recurrence rate of BV is significant, negatively impacting the well-being of affected women. This study aimed to compare the therapeutic effects of a polyherbal Unani formulation and metronidazole in treating bacterial vaginosis. Methodology: In this prospective patient blinded standard controlled trial, a total of 40 individuals with a clinical diagnosis of bacterial vaginosis were randomly assigned to receive either an active control treatment (n = 20) or a test drug (n = 20). In the test drug combination of Acacia catechu, Azadirachta indica and Quercus infectoria in tablet (1g) form in the dose of 2 tablets orally twice daily with water was administered for 3 weeks. In the active control standard drug, metronidazole 400 mg tablet, orally twice daily was given for one week. The primary outcome measure was clinical cure; H. negative Amsel's criteria and a reduction in subjective symptoms, while the secondary outcome measure was an improvement in SF-36 quality of life (QOL). Results and conclusion: Both the experimental treatment and the metronidazole demonstrated a significant clinical cure for bacterial vaginosis as well as an increase in health-related quality of life. Based on these findings, it appears that the test medication is a potent Unani formulation for the treatment of bacterial vaginosis. A well conducted trial with a bigger sample size is required to corroborate these findings.

• Korean Journal of Radiology
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• 제22권12호
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• pp.1974-1984
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• 2021

Objective: This study aimed to compare the efficacy between no-touch (NT) radiofrequency ablation (RFA) and conventional RFA using twin internally cooled wet (TICW) electrodes in the bipolar mode for the treatment of small hepatocellular carcinomas (HCC). Materials and Methods: In this single-center, two-arm, parallel-group, prospective randomized controlled study, we performed a 1:1 random allocation of eligible patients with HCCs to receive NT-RFA or conventional RFA between October 2016 and September 2018. The primary endpoint was the cumulative local tumor progression (LTP) rate after RFA. Secondary endpoints included technical conversion rates of NT-RFA, intrahepatic distance recurrence, extrahepatic metastasis, technical parameters, technical efficacy, and rates of complications. Cumulative LTP rates were analyzed using Kaplan-Meier analysis and the Cox proportional hazard regression model. Considering conversion cases from NT-RFA to conventional RFA, intention-to-treat and as-treated analyses were performed. Results: Enrolled patients were randomly assigned to the NT-RFA group (37 patients with 38 HCCs) or the conventional RFA group (36 patients with 38 HCCs). Among the NT-RFA group patients, conversion to conventional RFA occurred in four patients (10.8%, 4/37). According to intention-to-treat analysis, both 1- and 3-year cumulative LTP rates were 5.6%, in the NT-RFA group, and they were 11.8% and 21.3%, respectively, in the conventional RFA group (p = 0.073, log-rank). In the as-treated analysis, LTP rates at 1 year and 3 years were 0% and 0%, respectively, in the NT-RFA group sand 15.6% and 24.5%, respectively, in the conventional RFA group (p = 0.004, log-rank). In as-treated analysis using multivariable Cox regression analysis, RFA type was the only significant predictive factor for LTP (hazard ratio = 0.061 with conventional RFA as the reference, 95% confidence interval = 0.000-0.497; p = 0.004). There were no significant differences in the procedure characteristics between the two groups. No procedure-related deaths or major complications were observed. Conclusion: NT-RFA using TICW electrodes in bipolar mode demonstrated significantly lower cumulative LTP rates than conventional RFA for small HCCs, which warrants a larger study for further confirmation.

• Journal of Gastric Cancer
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• 제22권2호
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• pp.94-106
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• 2022

Purpose: Laparoscopic proximal gastrectomy with double-tract reconstruction (LPG-DTR) is a function-preserving procedure performed for treating upper early gastric cancer (EGC). However, few studies have compared the outcomes of LPG-DTR with those of laparoscopic total gastrectomy (LTG). This study aimed at comparing the short-term outcomes of LPG-DTR between LTG and upper EGC. Materials and Methods: For upper-third EGC, a multicenter, prospective, randomized trial was performed to compare those who underwent LPG-DTR with those who underwent LTG. Short-term outcomes, including clinicopathologic results, morbidity, mortality, and postoperative courses, were evaluated using a full analysis set based on the intention-to-treat principle and the per-protocol set. Results: Of the patients, 138 who fulfilled the criteria were randomized to each group. One patient in the LPG-DTR group withdrew consent. Sixty-eight patients underwent LPG-DTR and 69 underwent LTG. The operative time (LPG-DTR=219.4 minutes; LTG=201.8 minutes; P=0.085), estimated blood loss (LPG-DTR=76.0 mL; LTG=66.1 mL; P=0.413), and the morbidity rate (LPG-DTR=23.5%; LTG=17.4%; P=0.373) between the groups were not significantly different. No mortality occurred in either of the study groups. Two weeks post operation, the Visick scores for postprandial symptoms, including reflux symptoms, were not significantly different between the groups (P=0.749). Laboratory findings on postoperative day 5 were not significantly different between the groups. Conclusions: The short-term outcomes of LPG-DTR for upper EGC were comparable to those of LTG.

• Journal of Gastric Cancer
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• 제17권2호
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• pp.120-131
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• 2017

Purpose: Tumor bleeding is a major complication in inoperable gastric cancer. The study aim was to investigate the effects of proton pump inhibitor (PPI) treatment for the prevention of gastric tumor bleeding. Materials and Methods: This study was a prospective double-blind, randomized, placebo-controlled trial. Patients with inoperable gastric cancer were randomly assigned to receive oral lansoprazole (30 mg) or placebo daily. The primary endpoint was the occurrence of tumor bleeding, and the secondary endpoints were transfusion requirement and overall survival (OS). Results: This study initially planned to enroll 394 patients, but prematurely ended due to low recruitment rate. Overall, 127 patients were included in the analyses: 64 in the lansoprazole group and 63 in the placebo group. During the median follow-up of 6.4 months, tumor bleeding rates were 7.8% and 9.5%, in the lansoprazole and placebo groups, respectively, with the cumulative bleeding incidence not statistically different between the groups (P=0.515, Gray's test). However, during the initial 4 months, 4 placebo-treated patients developed tumor bleeding, whereas there were no bleeding events in the lansoprazole-treated patients (P=0.041, Gray's test). There was no difference in the proportion of patients who required transfusion between the groups. The OS between the lansoprazole (11.7 months) and the placebo (11.0 months) groups was not statistically different (P=0.610). Study drug-related serious adverse event or bleeding-related death did not occur. Conclusions: Treating patients with inoperable gastric cancer with lansoprazole did not significantly reduce the incidence of tumor bleeding. However, further studies are needed to evaluate whether lansoprazole can prevent tumor bleeding during earlier phases of chemotherapy (ClinicalTrial.gov, identifier No. NCT02150447).

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• 제47권6호
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• pp.411-426
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• 2021

Combining different procedures to reduce the number of surgical sessions and patient discomfort in implant placement and sinus floor elevation has been recommended, and evidence supports good outcomes. The aim of this study was to review the results of clinical studies on sinus floor elevation through extraction sockets and simultaneous immediate posterior implant placement. An electronic search was carried out in PubMed, Scopus, and Web of Science to find English articles published in or before August 2020. A manual search was also performed. Titles, abstracts, and the full-text of the retrieved articles were studied. Thirteen studies met our eligibility criteria: 6 retrospective case series, 3 case reports, 2 prospective cohort case-series, 1 prospective case series, and 1 randomized controlled trial. Overall, 306 implants were placed; 2 studies reported implant survival rates of 91.7% and 98.57%. The others either did not report the survival rate or reported 100% survival. Sinus floor elevation through a fresh extraction socket and simultaneous immediate implant placement appears to be a predictable modality with a high success rate. However, proper case selection and the expertise of the clinician play fundamental roles in the success of such complex procedures.

• 대한한의학회지
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• 제42권3호
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• pp.99-118
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• 2021

Objectives: The aim of this study is to review and analyze the trends in prospective clinical research (PCR), project, clinical study protocol of Korean medicine (KM) for dementia. Methods: We searched PCRs of KM on dementia in six electronical databases, up to January 28, 2021. Moreover, the clinical research protocol and projects of KM for dementia were searched. Results: Total eight PCRs, nine projects, and three clinical study protocols were included. In the PCRs, there were one randomized controlled trial, five before and after study, and two comparative group before-after studies. Four of them used herbal medicine, two used acupuncture, one study used both herbal medicine and acupuncture, and the other one used moxibustion. Jowiseungchung-tang was the most frequently used herbal medicine. BL62, KI6 were used in electro-acupuncture, auricular-Shenmen in auricular acupuncture, and GV20 in moxibustion. The most frequent outcome was Korean-Dementia Rating Scale (K-DRS). One reported significant increase in K-DRS score, one reported 60% improvement, and the other studies mostly reported no significant difference. In the projects including 20 clinical studies of dementia, herbal medicine, integrative medicine and acupuncture were mainly used. In the protocols, herbal medicine, complex KM intervention, and integrative medicine were used. Conclusions: Currently, the number of PCRs of KM for dementia is very scarce. Therefore, the researcher's interest in this field and national research support should be made more, and the quality of clinical research in the future can be further improved by supplementing the limitations of previously published clinical research.

• Journal of Gastric Cancer
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• 제18권3호
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• pp.209-217
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• 2018

Although the incidence of gastroesophageal junction (GEJ) adenocarcinoma has been increasing worldwide, no standardized surgical strategy for its treatment has been established. This study aimed to provide an update on the surgical treatment of GEJ adenocarcinoma by reviewing previous reports and propose recommended surgical approaches. The Siewert classification is widely used for determining which surgical procedure is used, because previous studies have shown that the pattern of lymph node (LN) metastasis depends on tumor location. In terms of surgical approaches for GEJ adenocarcinoma, a consensus was reached based on two randomized controlled trials. Siewert types I and III are treated as esophageal cancer and gastric cancer, respectively. Although no consensus has been reached regarding the treatment of Siewert type II, several retrospective studies suggested that the optimal treatment strategy includes paraaortic LN dissection. Against this background, a Japanese nationwide prospective trial is being conducted to determine the proportion of LN metastasis in GEJ cancers and to identify the optimal extent of LN dissection in each type.

• Neonatal Medicine
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• 제25권2호
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• pp.72-77
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• 2018

Purpose: Glucose has been recommended as an analgesic for mild to moderately painful procedures in neonates. The goal of this study was to assess the optimal dextrose concentration for pain control in newborns. Methods: This prospective, randomized, blinded clinical trial included 116 healthy full-term newborns. The neonates were randomly assigned to the following four groups by drawing straws: groups receiving sterile water or a 10%, 20%, or 40% dextrose solution orally. Each group was treated with the assigned solution prior to hepatitis B vaccination. The Neonatal Facial Coding System (NFCS) and the Neonatal Infant Pain Scale (NIPS) scores were evaluated before, immediately after, and 2 minutes after the injection in all neonates. Premature Infant Pain Profile (PIPP) scores were evaluated during the injection. All procedures were video-recorded, and pain scores were assessed by two independent observers who were not involved in the care of the newborns studied. The pain scores were compared among the four groups. Results: The 40% dextrose solution significantly reduced the NFCS (P=0.002) and the PIPP scores (P=0.001) compared with sterile water. No hyperglycemic events were noted in the study subjects 2 hours after the injection. Conclusion: The 40% dextrose solution effectively relieved pain due to intramuscular injection in full-term newborns without causing hyperglycemic events. However, the 10% and 20% dextrose solutions did not affect neonatal pain scores.

• Journal of Chest Surgery
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• 제23권2호
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• pp.268-274
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• 1990

Bleeding after cardiopulmonary bypass remains a cause for concern, requiring reexploration of the chest in approximately 3 percent of patients who have had operations on the heart. We examined the possibility that this problem might be alleviated by desmopressin acetate [DDAVP], synthetic vasopressin analogue that lacks vasoconstrictor activity. In a prospective, randomized trial, we studied the effect of intraoperative desmopressin acetate in 20 patients [the treated group 10 patients and the control group 10 patients] undergoing various cardiac operations requiring cardiopulmonary bypass. The result showed that the early postoperative [during first 24hrs] and mean postoperative blood loss [first 3 days] of the treated group were significantly reduced than the control group[447\ulcorner199ml in the treated group versus 746\ulcorner199ml in the treated group versus 746\ulcorner295 ml in the control group, p=0.014; mean\ulcornerstandard deviation and 675\ulcorner276 ml in the treated group versus 1006\ulcorner303 ml in control group, p=0.019]. The mean red-cell transfusion in first 3days were reduced in the treated group than the control group [3.3\ulcorner1.7 units vs 4.9\ulcorner1.7units, P=0.051]. There were no untoward side effects of desmopressin acetate. We conclude that the administration of desmopressin acetate can be recommended to reduce blood loss and blood conservation in patients undergoing cardiac operations.