• CELLMED
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• v.11 no.4
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• pp.19.1-19.8
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• 2021

Background: Dysmenorrhea is the most common menstrual complaint in young women with a prevalence as high as 90% and is responsible for substantial repeated short-term absenteeism from school and work in young women. The objective of this study was to compare the efficacy of Commiphora myrrha and honey with mefenamic acid in primary dysmenorrhea. Materials and Methods: This prospective standard controlled trial was conducted at Luqman Unani Medical College Hospital and Research Center Vijayapura, India where 40 diagnosed patients of primary dysmenorrhea were randomly assigned to receive test drug (powdered Commiphora myrrha gum resin10g with 30g honey in two divided doses) or active control drug (mefenamic acid 250mg TID) for first 3days of menstruationfor two consecutive cycles. The primary outcome measure was reduction in severity of pain assessed by numerical pain rating scale (NPRS), and secondary outcome measures were improvement in quality of life (QOL) assessed by SF-36 and reduction in perceived stress score (PSS). Results: During first cycle treatment no significant difference was found in NPRS score (p=0.085) between the groups however significant difference in NPRS score (p<0.001) was seen during 2^nd treatment cycle. Significant reduction (p=0.022) in the perceived stress score was noted and overall quality of life was markedly improved after treatment in both the groups. Conclusion: These data suggest that Commiphora myrrha gum resin with honey is an effective herb in reducing symptoms of primary dysmenorrhea. These results need to be confirmed by a properly designed trial with a larger sample size. Trial registration: Clinical Trial Registry India CTRI/2017/09/009596.

• Journal of Pharmacopuncture
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• v.11 no.1
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• pp.21-29
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• 2008

Objectives : To investigate the therapeutic effects of SBVP in the treatment of patients with cancer-related pain. Design : A prospective randomized, double-blind, placebo-controlled study of SBVP. Setting : The study was conducted at the East West Cancer Center of Daejeon University Dunsan Oriental Hospital from March 1, 2007 to June 20, 2007. Patients : 11 patients diagnosed with cancer-related pain of over 3rd degree on the Numeric Rating Scale(NRS)(0, no pain at all, 10, worst pain imaginable) were entered into a double-blind, placebo-controlled trial of SBVP. They were randomized into Groups A and B(SBVP and control group, respectively) using the table of random sampling numbers and never informed of their affiliation by the coordinator. 5 of 6 patients in Group A and 4 of 5 patients in Group B completed the clinical trial. Intervention : SBVP(1ml/day) for group A and Normal Saline Placebo(1ml/day) for group B was injected into the abdomen acupoint, Zhong Wan(CV 12). The treatment was administered daily for five days. Outcome Measures : Degree of cancer-related pain was measured using the Numeric Rating Scale(NRS) before and after each treatment for "Pain right now" and "Average pain in last 24 hours". Statistical Analysis : Analysis regarding variations in NRS was carried out by applying t-tests(independent sample t-test and paired sample t-test) and Wilcoxon signed rank test with level of significance at 5%. Results : Differences in NRS of "Pain right now" for the two groups were statistically significant. The mean improvement point of SBVP was significantly higher than the control group($2.48^{\circ}{\pm}1.52$ vs $0.97^{\circ}{\pm}1.88$, p<0.05). Differences in average pain score before and after treatment in SBVP group were also significant($5.13^{\circ}{\pm}1.77$ vs $2.65^{\circ}{\pm}0.67$, p<0.05) compared with control group. The two groups showed no significant differences for long term effects in "Average pain in last 24 hours." Conclusion : Although further study will be needed on the large scale, SBVP shows potential as an effective treatment for immediate relief of cancer-related pain.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.47 no.3
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• pp.175-182
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• 2021

Objectives: In this prospective randomized controlled trial, we measured the primary and secondary stability of two surface-treated implants placed in the posterior maxilla, applied 3-month loading protocols, and compared and analyzed the short-term outcomes of the implants. Patients and Methods: From June 2018 to June 2019, patients with a residual bone height of 4 mm in the posterior maxilla were enrolled and randomly divided into two groups to place SA implants (Osstem Implants, Korea) in Group A and NH implants (Hiossen, USA) in Group B. Finally, 14 implants placed in 13 patients in Group A and 17 implants placed in 14 patients in Group B were analyzed. The measured primary and secondary stability of each implant was represented by implant stability quotient (ISQ), and treatment outcomes were evaluated. Results: Group A consisted of patients with an average age of 62.2 years (range, 48-80 years), and Group B consisted of patients with an average age of 58.1 years (range, 35-82 years). Primary stability was 73.86±6.40 and 71.24±5.32 in Groups A and B, respectively (P=0.222). Secondary stability was 79.07±5.21 in Group A and 78.29±4.74 in Group B (P=0.667). A steep increase in ISQ during the healing period was observed in Group B, though it was not significant (P=0.265). The mean follow-up period was 378.5±164.6 days in Group A and 385.3±167.9 days in Group B. All implants in each group met the success criteria, and the success rate was 100%. Conclusion: Two surface-treated implants placed in the posterior maxilla with greater than 4 mm alveolar bone height exhibited successful one-year treatment outcomes if a primary stability of 65 or higher ISQ was obtained and a 3-month early loading protocol was applied.

• Journal of Gastric Cancer
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• v.5 no.3 s.19
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• pp.139-145
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• 2005

Gastric cancer is the most prevalent cancer in Korea and comprises the second cause of cancer death. Surgery only can provide chance of cure, but most locally advanced cancers recur after a curative resection, even though important advances in the surgical and nonsurgical treatments of gastric cancer have taken place. Preoperative chemotherapy theoretically can provide the advantages of reducing the bulk of tumor, which might improve the R0 resection rate, and of treating micrometastases early. Also, preoperative chemotherapy is expected to render unresectable tumors resectable without increasing postoperative morbidity and mortality. There are many new chemo-therapeutic agents available for the treatment of advanced gastric cancer, but still the most effective agent, the optimal time and number of cycle for administration are still not known. The addition of postoperative chemotherapy through an intraperitoneal route and/or radiotherapy might affect the outcome of surgery favorably, but that hasn't been proved yet. A multicenter prospective randomized phase III trial should be peformed to answer for those questions and to improve the curability of gastric cancer treatment.

• The Korean Journal of Pain
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• v.34 no.3
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• pp.304-314
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• 2021

Background: The study investigated virtual reality (VR) immersion in alleviating procedure-related pain in patients with chronic pain undergoing fluoroscopy-guided minimally-invasive intervention in a prone position at an outpatient clinic. Methods: In this prospective randomized controlled study, 38 patients undergoing lumbar sympathetic ganglion block were randomized into either the VR or the control group. In the VR group, procedure-related pain was controlled via infiltration of local anesthetics while watching a 30-minute VR hypnotic program. In the control group, the skin infiltration alone was used, with the VR device switched off. The primary endpoint was an 11-point score on the numerical rating scale, indicating procedure-related pain. Patients' satisfaction with pain control, anxiety levels, the need for additional local anesthetics during the procedure, hemodynamic stability, and any adverse events were assessed. Results: Procedure-related pain was significantly lower in the VR group (3.7 ± 1.4) than in the control group (5.5 ± 1.7; P = 0.002). Post-procedural anxiety was lower in the VR group than in the control group (P = 0.025), with a significant reduction from pre-procedural anxiety (P < 0.001). Although patients' satisfaction did not differ significantly (P = 0.158) between the groups, a higher number of patients required additional local anesthetics in the control group (n = 13) than in the VR group (n = 4; P = 0.001). No severe adverse events occurred in either group during the study. Conclusions: VR immersion can be safely used as a novel adjunct to reduce procedural pain and anxiety during fluoroscopic pain intervention.

• The Korean Journal of Pain
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• v.34 no.3
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• pp.315-321
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• 2021

Background: Pillar pain may develop after carpal tunnel release surgery (CTRS). This prospective double-blinded randomized trial investigated the effectiveness of extracorporeal shock wave therapy (ESWT) in pillar pain relief and hand function improvement. Methods: The sample consisted of 60 patients with post-CTRS pillar pain, randomized into two groups. The ESWT group (experimental) received three sessions of ESWT, while the control group received three sessions of sham ESWT, one session per week. Participants were evaluated before treatment, and three weeks, three months, and six months after treatment. The pain was assessed using the visual analogue scale (VAS). Hand functions were assessed using the Michigan hand outcomes questionnaire (MHQ). Results: The ESWT group showed significant improvement in VAS and MHQ scores after treatment at all time points compared to the control group (P < 0.001). Before treatment, the ESWT and control groups had a VAS score of 6.8 ± 1.3 and 6.7 ± 1.0, respectively. Three weeks after treatment, they had a VAS score of 2.8 ± 1.1 and 6.1 ± 1.0, respectively. Six months after treatment, the VAS score was reduced to 1.9 ± 0.9 and 5.1 ± 1.0, respectively. The ESWT group had a MHQ score of 54.4 ± 7.7 before treatment and 73.3 ± 6.8 six months after. The control group had a MHQ score of 54.2 ± 7.1 before treatment and 57.8 ± 4.4 six months after. Conclusions: ESWT is an effective and a safe non-invasive treatment option for pain management and hand functionality in pillar pain.

• CELLMED
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• v.13 no.14
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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.

• CELLMED
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• v.13 no.14
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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.

• Journal of Gastric Cancer
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• v.22 no.2
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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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• v.17 no.2
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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).