Parallel-group Comparative Study Research Articles

Efficacy and safety of once-yearly zoledronic acid in Japanese patients with primary osteoporosis: two-year results from a randomized placebo-controlled double-blind study (ZOledroNate treatment in Efficacy to osteoporosis; ZONE study)

SummaryIn a 2-year randomized, placebo-controlled study of 665 Japanese patients with primary osteoporosis, once-yearly administration of zoledronic acid (5 mg) reduced the risk of new morphometric vertebral fractures.IntroductionThe purpose of this study was to determine the efficacy and safety of once-yearly intravenous infusion of ZOL in Japanese patients with primary osteoporosis.MethodsThis was a two-year multicenter, randomized, placebo-controlled, double-blind, parallel-group comparative study (ZONE Study). Subjects were 665 Japanese patients between the ages of 65 and 89 years who had prevalent vertebral fracture. Subjects were randomly assigned to receive once-yearly intravenous infusion of 5 mg of ZOL or placebo at baseline and 12 months.ResultsThe 2-year incidence of new morphometric vertebral fracture was 3.0 % (10/330 subjects) in the ZOL group and 8.9 % (29/327) in the placebo group (p = 0.0016). The 24-month cumulative incidence of new morphometric vertebral fracture was 3.3 % in the ZOL group versus 9.7 % in the placebo group (log-rank test: p = 0.0029; hazard ratio: 0.35; 95 % confidence interval: 0.17–0.72). The cumulative incidence of any clinical fracture, clinical vertebral fracture, and non-vertebral fracture was significantly reduced in the ZOL group by 54, 70, and 45 %, respectively, compared to the placebo group. At 24 months, ZOL administration increased bone mineral density in the lumbar spine, femoral neck, and total hip (t test: p < 0.0001). No new adverse events or osteonecrosis of the jaw were observed in this study.ConclusionsOnce-yearly administration of ZOL 5 mg to Japanese patients with primary osteoporosis reduced the risk of new morphometric vertebral fractures and was found to be safe.

Ipragliflozin lowers small, dense low-density lipoprotein cholesterol levels in Japanese patients with type 2 diabetes mellitus

AimsThis preliminary randomized, parallel-group comparative study evaluated the efficacy of ipragliflozin for reduction of small dense low-density lipoprotein cholesterol (sd LDL-C) levels in Japanese patients with type 2 diabetes mellitus (T2DM). MethodsSixty-two patients with T2DM (age, 56 ± 8 years; hemoglobin A1c levels, 8.1 ± 0.9%; BMI, 27.5 ± 3.3 kg/m2) were randomly assigned in a 2:1 ratio to receive ipragliflozin (50 mg/day) (treatment group; n = 40) or continued treatment (control group; n = 22) for 12 weeks.The primary endpoints were changes in sd LDL-C levels detected using the LipoPhor AS® system; the secondary endpoints included changes in the sd LDL-C/large buoyant LDL-C (lb LDL-C) ratio, a surrogate marker for LDL particle size, and percent changes in routine lipid parameters. ResultsThe treatment group exhibited a statistically significant reduction from baseline for LDL-C levels (−0.37 mg/dL vs. 14.4 mg/dL, p = 0.038), sd LDL-C levels (−1.28 mg/dL vs. 2.81 mg/dL, p = 0.012), and sd LDL-C/lb LDL-C ratio (−3.20% vs. 4.58%, p = 0.040) compared with the control group. Multiple regression analysis among all subjects revealed change in TG levels (p = 0.011) and LDL-C levels (p = 0.024) as well as change in body weight (p = 0.006) as independent factors contributing to the reduction in sd LDL-C. ConclusionsIpragliflozin may have a potential for lowering sd LDL-C levels associated with increasing LDL particle size in Japanese patients with T2DM.

An open-label, randomized, parallel-group comparative study of the efficacy of sorghum bicolor extract in preoperative anemia

ObjectiveAnemia in patients presenting for elective surgery is associated with increased morbidity, allogeneic blood transfusion, and delay of surgery. Extract of sorghum bicolor has been shown to have hemopoietic, immune-stimulating, and antioxidant effects in rats and in patients with HIV. The aim of this study was to determine the effect of the extract in patients with preoperative anemia booked for myomectomy. MethodsConsenting patients (N = 66) were randomly assigned to two groups. The test group (n = 34) was given folic acid 5 mg/d, 200 mg iron tablet three times daily, and 500 mg/d of the extract. The control group (n = 32) was given the same doses of folic acid and iron for a period of 3 wk. Blood samples were taken at baseline and weekly for full blood cell count and liver and kidney function tests. Participants were screened for tuberculosis, HIV, hepatitis, and sickle cell anemia. ResultsIncreases in red blood cell count, hematocrit, and hemoglobin concentration in participants in the test group were highly significant (P < 0.0002, P < 0.0001, and P < 0.0001, respectively). Participants in the control group had a significant increase in the hemoglobin concentration (P > 0.04). The changes in liver enzymes, urea, and creatinine for participants in the test group were within the normal ranges. ConclusionThe addition of the extract of sorghum bicolor to routine hematinics is superior to the use of routine hematinics alone. Although the difference is not statistically significant, the extract will correct preoperative anemia in an additional 15% of the patients.

Efficacy of prolonged ingestion of Lactobacillus acidophilus L-92 in adult patients with atopic dermatitis

To evaluate the safety and efficacy of prolonged ingestion of Lactobacillus acidophilus L-92 (L-92) on skin symptoms in adult atopic dermatitis (AD) patients, a placebo-controlled double-blinded parallel-group comparison study was performed. This included daily administration of heat-killed and dried L-92 or placebo for 24wk in 50 AD patients who were 16yr old or older. The severity of skin symptoms was evaluated at baseline and at 4, 8, 12, 16, 20, and 24wk during the intervention using the investigator global assessment, eczema area and severity index, and scoring atopic dermatitis. Serum cytokine and blood marker levels were also measured at baseline and at 4, 8, 16, and 24wk during the intervention. No adverse events were reported during the study period. Compared with the placebo group, the L-92 group showed significant decreases in investigator global assessment, eczema area and severity index, and scoring atopic dermatitis. Subjective symptoms in adult AD patients were reduced by intake of L-92. Furthermore, it was suggested that sustained ingestion of L-92 resulted in suppression of scratching behavior and maintenance of remission status of skin symptoms. Sixteen weeks after the study commenced, a significant decrease in lactate dehydrogenase and a significant increase in transforming growth factor-β were observed in the L-92 group compared with the placebo group. In the L-92 group, a significant elevation of IL-12 (p70) level at the end of treatment period compared with before the treatment was observed. This study suggested that L-92 suppresses type-2-helper-T-cell-dominant inflammation by activating regulatory T cells and type 1 helper T cells.

Efficacy and safety of leuprorelin acetate 6-month depot, TAP-144-SR (6M), in combination with tamoxifen in postoperative, premenopausal patients with hormone receptor-positive breast cancer: a phase III, randomized, open-label, parallel-group comparative study

BackgroundLeuprorelin acetate, a luteinizing hormone-releasing hormone agonist, is used worldwide in premenopausal women with hormone receptor-positive breast cancer. This study was conducted to assess the non-inferiority of the 6-month depot formulation, TAP-144-SR (6M) 22.5 mg to the 3-month depot formulation, TAP-144-SR (3M) 11.25 mg in postoperative, premenopausal patients with hormone receptor-positive breast cancer.MethodsThis was a 96-week phase III, randomized, open-label, parallel-group comparative study. All patients concomitantly received oral tamoxifen (20 mg daily). The primary endpoint was the suppression rate of serum estradiol (E2) to the menopausal level (≤30 pg/mL) from Week 4 through Week 48.ResultsIn total, 167 patients were randomized to receive TAP-144-SR (6M) (n = 83) or TAP-144-SR (3M) (n = 84) and the E2 suppression rate was 97.6 and 96.4 %, respectively. The estimated between-group difference was 1.2 % (95 % confidence interval −5.2 to 7.8). The non-inferiority of TAP-144-SR (6M) to TAP-144-SR (3M) for E2 suppression was confirmed. As for safety, common adverse events were hot flush and injection site reactions including induration, pain, and erythema in both treatment groups, which were of ≤Grade 2 in severity and not serious. No significant between-group differences in safety profiles and tolerability were observed.ConclusionsTAP-144-SR (6M) was not inferior to TAP-144-SR (3M) for its suppressive effect on serum E2. TAP-144-SR (6M) was also as well tolerated as TAP-144-SR (3M).

Abstract P5-12-07: Hormone dynamics, pharmacokinetics, safety and efficacy of leuprorelin acetate 6-month depot formulation and tamoxifen adjuvant endocrine therapy combination in premenopausal patients with hormone receptor-positive breast cancer

Abstract Background: Luteinizing hormone-releasing hormone agonist + tamoxifen is standard postoperative adjuvant endocrine therapy for premenopausal patients with hormone receptor-positive breast cancer. Postoperative adjuvant endocrine therapy is now used for a longer period, and the longer-lasting leuprorelin acetate 6-month depot formulation (TAP-144-SR[6M]) is expected to increase patients' quality of life and decrease medical practitioners' burden. Methods: The hormone dynamics, pharmacokinetics (PK), safety, and efficacy of TAP-144-SR(6M) were compared with those of the 3-month depot formulation (TAP-144-SR[3M]) in a 96-week, phase 3 open-label parallel-group comparison study in premenopausal breast cancer patients after surgery (ClinicalTrial.gov ID: NCT01546649). Inclusion criteria were estrogen receptor (ER) and/or progesterone receptor (PgR) positive; TNM classification of T1-T3, any N, M0; and premenopausal (menstruation confirmed within the previous 12 weeks or both follicle-stimulating hormone [FSH] &amp;lt;40 mIU/mL and estradiol [E2] ≥10 pg/mL at enrollment). Patients were randomized to TAP-144-SR(6M) (6M group [6MG]) or TAP-144-SR(3M) (3M group [3MG]) based on number of axillary lymph node metastases, tumor size, age, ER/PgR status, chemotherapy or not, and study site. The primary endpoint was serum E2 suppression rate based on the menopausal level (≤30 pg/mL) from 4 to 48 weeks after the first administration. Secondary endpoints were serum hormone dynamics, efficacy (disease-free survival [DFS] and distance DFS [DDFS]), PK and safety. The planned number of patients was 164 (82 in each group). Results: A total of 180 patients were enrolled from Apr 2012 to Feb 2013 and 167 patients were randomized. We compared 83 patients in 6MG (age: mean 44.2; SD 4.90) and 84 patients in 3MG (44.0; 5.18). There were no significant differences in background factors between the groups. 6MG showed non-inferior suppression of serum E2 levels to 3MG (See Table). Serum LH and FSH levels were also decreased. DFSs and DDFSs at 96 weeks after randomization were similar in both groups. A double-peak PK profile and sustainable release of the study drug for 24 weeks were found with 6MG. All-grade adverse events (AEs) occurred in 98.8% and 97.6% and grade 3 or higher AEs in 18.1% and 21.4% with 6MG and 3MG, respectively. There were no significant differences in lumbar spine bone mineral density change rates in both groups. Table Serum E2 suppression rate based on the menopausal level (≤30 pg/mL) from 4 to 48 weeks after the first administration 6MG (n = 83)3MG (n = 84)Serum E2 suppression rate (%) (95% CI)97.6 (91.565, 99.707)96.4 (89.916, 99.257)6MG − 3MG (95% CI)1.2 (−5.241, 7.806)Note: Noninferiority margin of 10%. Conclusion: This first clinical study of TAP-144-SR(6M) in premenopausal breast cancer patients showed clinically noninferior serum E2 suppression levels to TAP-144-SR(3M), and no significant safety differences between the groups. TAP-144-SR(6M) was confirmed to have excellent usability in premenopausal breast cancer patients after surgery, and is considered valuable for the appropriate treatment of these patients. Citation Format: Kurebayashi J, Toyama T, Sumino S, Fujimoto T. Hormone dynamics, pharmacokinetics, safety and efficacy of leuprorelin acetate 6-month depot formulation and tamoxifen adjuvant endocrine therapy combination in premenopausal patients with hormone receptor-positive breast cancer. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-12-07.

Comparative evaluation of glipizide and fenugreek (Trigonella foenum-graecum) seeds as monotherapy and combination therapy on glycaemic control and lipid profile in patients with type 2 diabetes mellitus

Background: Diabetes is commonly associated with dyslipidemia, which is one of the major risk factors of coronary heart disease (CHD), the leading cause of mortality in patients with type 2 diabetic. It is thus desirable that an anti-diabetic drug must provide good glycaemic control and in addition cause correction of dyslipidaemia, at the same time being safe. Fenugreek, a traditional drug has been found to have beneficial effect on glycaemic control as well as lipid profile and may be thus useful in such patients. The study was thus planned to further explore the effect of fenugreek seed on glycaemic control and lipid profile by comparing it with a standard anti-diabetic drug glipizide. Methods: This 12 week, prospective, randomized, open-label, parallel group comparative study was conducted on 60 patients with type 2 diabetes. The patients were randomized to receive either glipizide 5 mg once daily (group A, n=20), fenugreek seed extract 500 mg twice a day (group B, n=20), or a combination of glipizide 2.5 mg and fenugreek seed extract 500 mg once daily (group C, n=20). The primary endpoint were the change in fasting blood glucose (FBG), glycated haemoglobin (HbA1c), and lipid profile from baseline after 12 weeks of treatment. Results: A statistically significant decline in mean FBG levels (group A -33.97%, p<0.001; versus group B -24.62%, p<0.001; versus group C -29.96%, p<0.001), and in HbA1c levels (group A -12.98 %, p<0.0001; group B -9.38%, p<0.0001; and group C -10.62%, p<0.0001) was seen in all three treatment groups. Total cholesterol (TC) reduced non-significantly in group A (-0.98%, p=0.1982), whereas in group B (-5.66%, p<0.001) and group C (-3.87%, p<0.001) it decreased significantly. Non-significant reduction in plasma triglycerides (TG) were seen in group A (-0.74%, p=0.0669), and significant reductions were seen in both group B (-17.23%, p<0.001) and group C (-11.34%, p<0.001). Low density lipoproteins cholesterol (LDL-C) showed non-significant reductions in group A (-0.74%, p=0.5482), and significant reductions in both group B (-4.15%, p<0.001) and group C (-2.68%, p=0.0463). High-density lipoproteins cholesterol (HDL-C) showed non-significant changes in all three groups (group A -0.60%, p =0.1529; group B 0.65%, p=0.2072; and group C 0.76%, p = 0.0543). The adverse drug reactions seen were mild in nature and none of the patients was withdrawn from the study because of serious adverse drug reactions. Conclusions: Monotherapy with fenugreek produced significant improvement in glycaemic control and dyslipidaemia. Glipizide monotherapy was more efficacious in controlling FBG and HbA1c levels than fenugreek monotherapy or in combination with fenugreek; glipizide monotherapy had no effect on lipid profile whereas fenugreek monotherapy was more efficacious in controlling dyslipidaemia than in combination with glipizide. Both drugs as monotherapy or in combination were well-tolerated by the patients.

Comparison of efficacy, safety and cost-effectiveness of rupatadine and olopatadine in patients of chronic spontaneous urticaria: A randomized, double-blind, comparative, parallel group trial

Objective:To compare efficacy, safety and cost-effectiveness of rupatadine and olopatadine in patients of chronic spontaneous urticaria.Materials and Methods:A 6-week, single-centered, randomized, double blind, parallel group comparative clinical study was conducted on patients with chronic spontaneous urticaria. Following inclusion and exclusion criteria, 60 patients were recruited and were randomized to two treatment groups and received the respective drugs for 6 weeks. At follow-up, parameters assessed were mean total symptom score (MTSS) calculated by adding the mean number of wheals (MNW) and the mean pruritus score (MPS), number of wheals, size of wheal, scale for interference of wheals with sleep (SIWS).Results:Both the drugs significantly reduced the MTSS, number of wheals, size of wheal, scale for interference of wheals with sleep, but olopatadine was found to be superior. In olopatadine group, there was significantly higher reduction in MTSS (p = 0.01), Number of wheals (P < 0.05), Size of wheals (p < 0.05), Scale for intensity of erythema (p < 0.05) and change in eosinopils count (p = 0.015) than that of rupatadine. Incidence of adverse effects was found to be less in olopatadine group when compared with rupatadine group. Cost effectiveness ratio was less in olopatadine group as compared to rupatadine group throughout the treatment.Conclusions:Olopatadine is a better choice in chronic spontaneous urticaria in comparison to rupatadine due to its better efficacy, safety and cost effectiveness profile.

Effect of supplement containing Silybum marianum extract, soy extract, collagen peptide, bifidobacteria and apple extract on skin: A randomized placebo-controlled, double-blind, parallel group comparative clinical study.

Effect of supplement containing Silybum marianum extract, soy extract, collagen peptide, bifidobacteria and apple extract on skin: A randomized placebo-controlled, double-blind, parallel group comparative clinical study.

Switching from atorvastatin to rosuvastatin lowers small, dense low-density lipoprotein cholesterol levels in Japanese hypercholesterolemic patients with type 2 diabetes mellitus

AimsThis open-label, randomized, parallel-group comparative study compared the efficacy of rosuvastatin (5mg/day) and atorvastatin (10mg/day) for reduction of small dense low-density lipoprotein cholesterol (sd LDL-C) levels in Japanese patients with type 2 diabetes mellitus (T2DM). MethodsPatients with T2DM and hypercholesterolemia with detectable sd LDL-C after receiving 10mg/day atorvastatin for ≥24 weeks were randomly assigned to receive rosuvastatin (5mg/day; switched treatment) or atorvastatin (10mg/day; continued treatment) for 12 weeks. The primary endpoints were changes in sd LDL-C levels and sd LDL-C/total LDL-C ratio evaluated using the LipoPhor AS® system. ResultsThere were no significant percent changes from baseline for LDL-C levels between the switched (n=55) and the continued treatment group (n=56). However, the former group exhibited a statistically significant reduction from baseline of sd LDL-C levels, sd LDL-C/total LDL-C ratio compared with the latter group (−3.8mg/dL vs. −1.4mg/dL, p=0.014; −2.3% vs. −0.6%, p=0.004, respectively). Multiple regression analysis among all subjects revealed that independent factors contributing to the reduction in sd LDL-C levels were a change in LDL-C (p=0.003) and triglyceride (TG) levels (p=0.006), treatment group (the switched group=1, the continued group=0; standard coefficient=−1.2, p=0.034) and baseline glycated hemoglobin A1c (HbA1c) (p=0.045), respectively. ConclusionSwitching from 10mg atorvastatin to 5mg rosuvastatin may be a useful therapeutic option to reduce sd LDL-C levels in Japanese hypercholesterolemic patients with T2DM.

Glucosamine-containing supplement improves locomotor functions in subjects with knee pain a randomized, double-blind, placebo-controlled study

BackgroundThe aim of this study was to investigate the ability of a glucosamine-containing supplement to improve locomotor functions in subjects with knee pain.MethodsA randomized, double-blind, placebo-controlled, parallel-group comparative study was conducted for 16 weeks in 100 Japanese subjects (age, 51.8±0.8 years) with knee pain. Subjects were randomly assigned to one of the two supplements containing 1) 1,200 mg of glucosamine hydrochloride, 60 mg of chondroitin sulfate, 45 mg of type II collagen peptides, 90 mg of quercetin glycosides, 10 mg of imidazole peptides, and 5 μg of vitamin D per day (GCQID group, n=50) or 2) a placebo (placebo group, n=50). Japanese Knee Osteoarthritis Measure, visual analog scale score, normal walking speed, and knee-extensor strength were measured to evaluate the effects of the supplement on knee-joint functions and locomotor functions.ResultsIn subjects eligible for efficacy assessment, there was no significant group × time interaction, and there were improvements in knee-joint functions and locomotor functions in both groups, but there was no significant difference between the groups. In subjects with mild-to-severe knee pain at baseline, knee-extensor strength at week 8 (104.6±5.0% body weight vs 92.3±5.5% body weight, P=0.030) and the change in normal walking speed at week 16 (0.11±0.03 m/s vs 0.05±0.02 m/s, P=0.038) were significantly greater in the GCQID group than in the placebo group. Further subgroup analysis based on Kellgren–Lawrence (K–L) grade showed that normal walking speed at week 16 (1.36±0.05 m/s vs 1.21±0.02 m/s, P<0.05) was significantly greater in the GCQID group than in the placebo group in subjects with K–L grade I. No adverse effect of treatment was identified in the safety assessment.ConclusionIn subjects with knee pain, GCQID supplementation was effective for relieving knee pain and improving locomotor functions.

Differences in cortisol profiles and circadian adjustment time between nurses working night shifts and regular day shifts: A prospective longitudinal study.

This study explored the differences in the circadian salivary cortisol profiles between nurses working night shifts and regular day shifts following a slow rotating shift schedule to assess the number of days required for adjusting the circadian rhythm of salivary cortisol levels in nurses working consecutive night shifts and the number of days off required to restore the diurnal circadian rhythm of salivary cortisol levels. This was a prospective, longitudinal, parallel-group comparative study. The participants were randomly assigned to night and day-shift groups, and saliva samples were collected to measure their cortisol levels and circadian secretion patterns. Significant differences were observed in the overall salivary cortisol pattern parameters (cortisol awakening response, changes in cortisol profiles between 6 and 12h after awakening, and changes in cortisol profiles between 30 min and 12 h after awakening) from Days 2 to 4 of the workdays between both groups. However, on Day 2 of the days off, both groups exhibited similar cortisol profiles and the cortisol profiles in the night-shift group were restored. Nurses working night shifts require at least 4 days to adjust their circadian rhythms of cortisol secretions. Moreover, on changing from night shift to other shifts, nurses must be allowed more than 2 days off work.

A randomised, parallel-group comparison study of diquafosol ophthalmic solution in patients with dry eye in China and Singapore

AimsTo compare the efficacy and safety of 3% diquafosol ophthalmic solution with those of 0.1% sodium hyaluronate ophthalmic solution in patients with dry eye in China and Singapore.MethodsA total of...

New Eye Cleansing Product Improves Makeup-Related Ocular Problems.

Purpose. This study evaluated the effects of using a newly developed eye cleansing formulation (Eye Shampoo) to cleanse the eyelids for 4 weeks in a parallel-group comparative study in women with chronic eye discomfort caused by heavy use of eye makeup and poor eye hygiene habits. Methods. Twenty women participants who met the inclusion criteria were randomly allocated to 2 groups comprising 10 participants each. The participants were asked to use either artificial tears alone or artificial tears in conjunction with Eye Shampoo for 4 weeks. The participants answered the questionnaire again and were reexamined, and changes in symptoms within each group and variations of symptoms between the two groups were statistically analyzed. Results. In the group using only artificial tears, improvements in subjective symptoms but not in ophthalmologic examination results were found. In the group using Eye Shampoo together with artificial tears, significant improvements were observed in the subjective symptoms, meibomian orifice obstruction, meibum secretion, tear breakup time, and superficial punctate keratopathy. Conclusion. In patients with chronic eye discomfort thought to be caused by heavy eye makeup, maintaining eyelid hygiene using Eye Shampoo caused a marked improvement in meibomian gland blockage and dry eye symptoms.

Comparative Study to Evaluate Efficacy &amp; Cost Effectiveness of Olmesartan Versus Telmisartan, in Patients of Stage I Hypertension

Background: Hypertension is one of the most common diseases in the world. It is an important and independent risk factor for atherosclerosis, heart failure, renal disease, and peripheral arterial disease. It is directly responsible for 57% of all stroke deaths and 42% of coronary heart disease deaths in India. Objectives: To evaluate and compare efficacy and cost effectiveness in hypertensive patients receiving Olmesartan and Telmisartan in Stage I hypertension. Material and methods: The present study was an open, prospective, randomized, parallel group comparative study conducted in 60 patients of stage I hypertension over a period of 16 weeks. Patients were randomly allocated to two, age and sex, matched groups of 30 patients each. Group I patients were started on Olmesartan at a dose of 20 mg&Group II patients were put on Telmisartan at a dose of 40 mg. The BP lowering efficacy and cost effective analysis of Olmesartan versus Telmisartan was calculated&compared. The data was entered in Microsoft excel and compiled. Statistical analysis was done using various tests. Results: Maximum patients in both the groups were in age group of 51-60 years. In group I there were 13 males and 17 females. In group II there were 14 males and 16 females. Both Olmesartan and Telmisartan are effective in lowering systolic&diastolic BP in supine&sitting positions&mean BP is also lowerer, more in Olmesartan group. By cost effective analysis Telmisartan was found more cost effective. Incremental cost effective ratio was found to be 218.35. Conclusion: Both Olmesartan and Telmisartan belong to the same antihypertensive drug class, effectively reduce systolic and diastolic blood pressure at various visits. Taking into account Total cost Telmisartan was more cost effective than Olmesartan. ICER was found to be 218.35.

A placebo-controlled, randomized, single-blind, parallel-group comparative study to evaluate the anti-glycation effect of a functional soymilk beverage supplemented with rice bran/rice bran oil

A placebo-controlled, randomized, single-blind, parallel-group comparative study to evaluate the anti-glycation effect of a functional soymilk beverage supplemented with rice bran/rice bran oil

COMPARATIVE CLINICAL EVALUATION OF JANU VESTANA AND JALAUKAVACHARANA IN JANUSANDHIGATAVATA

Living system has an ability to maintain itself by means of repair and reconstruction. Ageing process leads to a decrease in this efficiency of the body. The autonomous Vayu governs this change and gives rise to various Vatavyadhi as the age advances. Sandhigatavata is one such condition that occurs when provoked Vata enters the asthisandhi owing to gatavata pathology. Pain typically present on joint mobilisation with features like swelling, stiffness, crepitus etc are the clinical manifestations of this condition. It can be well correlated with Osteoarthritis described in modern science. Knee joint is an easy target and the degenerative changes in knees is termed as Janusandhigatavata. Various procedures performed on the knee are in vogue. Local application, intra-articular injections and non pharmacological treatments are some widely used approaches among them. Yet, an additional cavernous review is indispensible to bring out a precise outcome of these procedures. Hence, the particular study was done with Nirgundi taila Janu Vestana and Jalaukavacharana in Janusandhigatavata. It was a parallel group comparative clinical study, conducted and completed on 62 patients suffering from Janusandhigatavata within 70 years of age, irrespective of gender, randomly allocated into 2 groups with 31 patients each subjected to Nirgundi taila Janu Vestana and Jalaukavacharana. The therapeutic effect was assessed based on specific clinical parameters and statistically analysed for test of significance using paired and unpaired‘t’ test. Both groups showed statistically highly significant improvement in the primary outcome parameters with p < 0.001. However the effect of Jalaukavacharana was appreciated instantly when compared to Vestana.

趾爪白癬患者におけるランダム化二重盲検並行群間比較試験によるイトラコナゾール（ITCZ）パルス療法至適用量・サイクル試験―1年間のフォローアップを含めて―

趾爪白癬患者におけるランダム化二重盲検並行群間比較試験によるイトラコナゾール（ITCZ）パルス療法至適用量・サイクル試験―1年間のフォローアップを含めて―

A parallel-group comparison study of celecoxib with loxoprofen sodium in third mandibular molar extraction patients

Non-steroidal anti-inflammatory drugs (NSAIDs) are used widely, but they may damage the upper gastrointestinal mucosa owing to their mechanism of action. Selective cyclooxygenase 2 (COX-2) inhibitors are known to have a reduced risk for such damage. In this comparative study, the efficacy and safety of the selective COX-2 inhibitor celecoxib for pain after third mandibular molar extraction were compared with those of loxoprofen sodium. This was a parallel-group comparison study; 107 patients who had undergone third mandibular molar extraction were given celecoxib and 102 were given loxoprofen. The level of pain on a visual analogue scale (VAS) 15min and 30min after taking the experimental drug decreased over time, with no significant difference between the two groups. The percentage of patients taking a second dose was 64.5% for celecoxib and 80.4% for loxoprofen. The time to second dose was significantly longer for celecoxib (533.5min) than for loxoprofen (387.4min). There was no significant difference in the patients’ impression of efficacy between the two groups, with ratings of ‘excellent’ and ‘good’ for 77.4% in the loxoprofen group and 74.5% in the celecoxib group. These results demonstrate that celecoxib is of equal clinical value to loxoprofen for acute pain after third mandibular molar extraction.

Safety test of a supplement, 5-aminolevulinic acid phosphate with sodium ferrous citrate, in diabetic patients treated with oral hypoglycemic agents

Objective: This study aimed to examine the safety of 5-aminolevulinic acid phosphate (5-ALA) with sodium ferrous citrate (SFC) in diabetic patients treated with one or more oral hypoglycemic agents (OHAs).Background: Recent intervention studies performed in the USA and Japan have shown that a nutritional supplement of 5-ALA with SFC efficiently reduced blood glucose levels in pre-diabetic population without any adverse events. Thus, it was anticipated that 5-ALA with SFC may potentially be taken as a beneficial supplement by diabetic patients who were being treated with OHA therapy. Nevertheless, it is important to examine its safety and efficacy in diabetic population.Methods: This study was a prospective single-blinded, randomized, placebo-controlled and parallel-group comparison study. Medically treated diabetic patients between the ages of 30 and 75 were recruited from the Tokyo metropolitan area of Japan and 45 subjects were selected after screening. These subjects were randomly assigned to three groups: daily intake of 15mg 5-ALA, 50mg 5-ALA, and a placebo (n=15, respectively). The supplement or placebo was administered for 12 weeks followed by a four week washout period. The primary endpoint was safety and occurrence of hypoglycemic attack, while the secondary endpoint was changes of fasting blood glucose (FBG) and hemoglobin A1c (HbA1c). Results: Adverse events related to 5-ALA with SFC were not observed in all the groups. Abnormalities in blood and urine tests were not observed either. Significant decrease in FBG was not detected in all the groups. However, there was a small but significant decrease in HbA1c at 4 and 8 week in the 15 mg 5-ALA group. Significant decrease in HbA1c was not observed in the 50 mg 5-ALA group, although a tendency to decrease after 4 weeks was apparent.Conclusion: 5-ALA with SFC is a safe and potentially beneficial supplement if taken by diabetic patients treated with OHAs.Trial registration: UMIN 000008038Key words: type 2 diabetes, 5-aminolevulinic acid (5-ALA), sodium ferrous citrate (SFC), oral hypoglycemic agent (OHA), hemoglobin A1c (HbA1c), fasting blood glucose (FBG)