Placebo Tablets (placebo + tablet)

Distribution by Scientific Domains
Distribution within Medical Sciences


Selected Abstracts


Postprandial interstitial insulin concentrations in type 2 diabetes relatives

EUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 6 2006
M. Sandqvist
Abstract Background, An endothelial barrier for the insulin transport from the circulation to the target tissues of insulin has previously been suggested to contribute to insulin resistance. The interstitial insulin concentration (I-insulin) and insulin kinetics following a mixed meal have, however, previously not been characterized in human adipose tissue. Subjects and methods, Eight nondiabetic first-degree relatives (FDR) of type 2 diabetes patients were recruited. Their I-insulin was measured by microdialysis after a test meal with or without oral administration of the insulin secretagogue nateglinide (120 mg). In parallel, adipose tissue blood flow and lipolysis were measured by xenon-clearance and microdialysis, respectively. Results, The I-insulin increased after the test meal, and this response was more prominent on the day the subjects received the nateglinide tablet when compared with the day the subjects received the placebo tablet [I-insulin incremental area under the curve (IAUC) nateglinide 7612 ± 3032 vs. Plac 4682 ± 2613 pmol L,1 min; P < 0·05, mean ± SE]. However, the postprandial I-insulinmax/P-insulinmax ratio was similar on the two test days (nateglinide: 213 ± 62 vs. 501 ± 92 pmol L,1, I/P-ratio: 0·38 ± 0·06 and placebo: 159 ± 39 vs. 410 ± 74 pmol L,1, I/P-ratio: 0·36 ± 0·05). There was no difference in time of onset of insulin action in situ, or responsiveness, when comparing placebo and nateglinide. Conclusions, Microdialysis can now be used to measure the I-insulin in human adipose tissue following a mixed meal. The data also showed that the transendothelial delivery of insulin occurs rapidly, supporting the concept that transcapillary insulin transfer is a nonsaturable process in nondiabetic first-degree relatives of type 2 diabetes patients. [source]


Combined therapy of silymarin and desferrioxamine in patients with ,-thalassemia major: a randomized double-blind clinical trial

FUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 3 2009
Marjan Gharagozloo
Abstract Silymarin, a flavonolignan complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective, and iron chelating activities. The present study was designed to investigate the therapeutic activity of orally administered silymarin in patients with thalassemia major under conventional iron chelation therapy. A 3-month randomized, double-blind, clinical trial was conducted in 59 ,-thalassemia major patients in two well-matched groups. Patients were randomized to receive a silymarin tablet (140 mg) three times a day plus conventional desferrioxamine therapy. The second group received the same therapy but a placebo tablet instead of silymarin. Clinical laboratory tests were assessed at the beginning and the end of the trial, except for serum ferritin level that was assessed at the middle of the trial as well. Results of this study revealed that the combined therapy was well tolerated and more effective than desferrioxamine in reducing serum ferritin level. Significant improvement in liver alkaline phosphatase and glutathione levels of red blood cells was also observed in silymarin-treated ,-thalassemia patients. However, no significant difference in serum ferritin levels was detected between silymarin and placebo groups after 1.5 and 3 months treatment, probably because of insufficient sample size to detect subtle changes in ferritin levels between groups. This is the first report showing the beneficial effects of silymarin in thalassemia patients and suggests that silymarin in combination with desferrioxamine can be safely and effectively used in the treatment of iron-loaded patients. [source]


Safety of specific sublingual immunotherapy with SQ standardized grass allergen tablets in children

PEDIATRIC ALLERGY AND IMMUNOLOGY, Issue 6 2007
Maria Dolores Ibañez
The aim of the study was to confirm the safety of an orodispersible grass allergen tablet 75,000 SQ-T (Grazax®, ALK-Abelló A/S, Hørsholm, Denmark) in children aged 5,12 yr. The study was randomized, double-blinded and placebo-controlled. Sixty children aged 5,12 yr suffering from grass pollen-induced rhinoconjunctivitis (with or without asthma) from five centres in two countries (three in Germany and two in Spain) participated in the study. They were randomized at the ratio of 3:1 as receiving either Grazax or placebo tablet given sublingually once daily for 28 days outside the grass pollen season. A total of 810 treatment-related adverse events were reported in the Grazax group. The majority of these were local reactions in the mouth or throat and were mostly mild (71%) to moderate (27%) in severity and resolved within days. Thirty-five (78%) subjects treated with Grazax and five (33%) treated with placebo reported at least one treatment-related adverse event. Oral pruritus, throat irritation, mouth oedema and ear pruritus appeared as the most frequently reported treatment-related adverse events. 62% (28 of 45) of the actively treated subjects reported oral pruritus, 36% (16 of 45) throat irritation, 31% (14 of 45) mouth oedema and 22% (10 of 45) ear pruritus. Two actively treated subjects withdrew from the study: one subject due to four adverse events (moderate eye pruritus, moderate pharyngolaryngeal pain, moderate non-cardiac chest pain and moderate dysphagia) and one subject due to a serious adverse event (asthmatic attack). The subjects recovered completely from the events. In conclusion, in the present study, Grazax was in general tolerated in a paediatric population and considered suitable for further clinical investigations in children. [source]


The efficacy of Silybum marianum (L.) Gaertn. (silymarin) in the treatment of type II diabetes: a randomized, double-blind, placebo-controlled, clinical trial

PHYTOTHERAPY RESEARCH, Issue 12 2006
H. Fallah Huseini
Abstract Oxidative stresses are increasingly implicated in the pathogenesis of diabetic complications which may either cause direct pancreatic , -cell damage or lead to metabolic abnormalities that can induce or aggravate diabetes. The valuable effect of antioxidant nutrients on the glycemic control of diabetic patients has been reported in experimental and clinical studies. The present study was designed to investigate the effects of the herbal medicine, Silybum marianum seed extract (silymarin), which is known to have antioxidant properties on the glycemic profile in diabetic patients. A 4-month randomized double-blind clinical trial was conducted in 51 type II diabetic patients in two well-matched groups. The first group (n = 25) received a silymarin (200 mg) tablet 3 times a day plus conventional therapy. The second group (n = 26) received the same therapy but a placebo tablet instead of silymarin. The patients were visited monthly and glycosylated hemoglobin (HbA1c), fasting blood glucose (FBS), insulin, total cholesterol, LDL and HDL, triglyceride, SGOT and SGPT levels were determined at the beginning and the end of the study. The results showed a significant decrease in HbA1c, FBS, total cholesterol, LDL, triglyceride SGOT and SGPT levels in silymarin treated patients compared with placebo as well as with values at the beginning of the study in each group. In conclusion, silymarin treatment in type II diabetic patients for 4 months has a beneficial effect on improving the glycemic profile. Copyright © 2006 John Wiley & Sons, Ltd. [source]


Oral nifepidine versus subcutaneous terbutaline tocolysis for external cephalic version: a double-blind randomised trial

BJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 1 2009
R Collaris
Objective, To evaluate oral nifedipine versus subcutaneous terbutaline tocolysis for external cephalic version (ECV). Design, A double-blind randomised trial. Setting, A university hospital in Malaysia. Population, Non-labouring women with a term singleton fetus in breech presentation or transverse lie suitable for elective ECV. Methods, Participants were randomised to either 10 mg oral nifedipine tablet and subcutaneous saline placebo or oral placebo tablet and 250 microgram bolus terbutaline subcutaneously. Participants and providers were blinded. Ultrasound assessment and cardiotocogram were performed prior to ECV. ECV was commenced 20,30 minutes after treatment. A maximum of two ECV attempts were permitted. Elective caesarean delivery or a repeat ECV attempt at a later date was offered to participants following failed ECV. After successful ECV, management was expectant. Main outcome measures, Primary outcomes were successful ECV (cephalic presentation immediately after ECV) and caesarean delivery. Results, Ninety women were randomised: 44 to nifedipine and 46 to terbutaline. Initial ECV success rate was 15/44 (34.1%) versus 24/46 (52.2%) (relative risk [RR] 0.7, 95% CI 0.4,1.1; P= 0.094), and caesarean delivery rate was 34/44 (77.3%) versus 26/46 (56.5%) (RR 1.4, 95% CI 1.01,1.85; numbers needed to treat to benefit 5, 95% CI 2.5,55; P= 0.046) for nifedipine and terbutaline groups, respectively. Neonatal outcome was not different. Conclusions, Bolus subcutaneous terbutaline tocolysis for ECV compared with oral nifedipine resulted in less caesarean deliveries. ECV success rate was not significantly higher. Larger studies are indicated. [source]


A new oral delivery system for 5-ASA: Preliminary clinical findings for MMx

INFLAMMATORY BOWEL DISEASES, Issue 5 2005
Cosimo Prantera MD
Abstract Background: Multi-matrix (MMx), a new delivery system for mesalazine, seems to release 5-aminosalicyclic acid (5-ASA) preferentially in the sigmoid colon. This study had 2 objectives: (1) to evaluate the therapeutic response to MMx in patients with active left-sided disease and (2) to gain additional insights as to how the therapy would compare with topical 5-ASA. Methods: Patients received either 1.2 g of 5-ASA MMx three times per day plus placebo enema or 4 g of 5-ASA enema plus placebo tablets for 8 weeks. The primary endpoint was clinical remission (clinical activity index ,4) at 8 weeks. Secondary endpoints were endoscopic and histologic remissions. Results: Seventy-nine patients were enrolled. Clinical remission rates at 4 and 8 weeks were 57.5% and 60.0% for patients treated with MMx and 68.4% and 50.0% for patients randomized to 5-ASA enemas, respectively (95% confidence interval for the difference at 8 weeks, ,12 to +32). Endoscopic remission was achieved by 45.0% of patients on 5-ASA MMx and by 36.8% of those on enema, whereas 15.0% and 8% of patients, respectively, showed histologic remission. Compliance was 97.0% for oral and 87.5% for topical therapy. In the enema group, compliance was 88.0% for the patients in remission and 65.5% for those with active disease. Conclusions: Preliminary studies suggest that similar rates for induction of remission can be expected from 5-ASA enemas and MMx for patients with left-sided ulcerative colitis. [source]


Amoxicillin plus metronidazole in the treatment of adult periodontitis patients

JOURNAL OF CLINICAL PERIODONTOLOGY, Issue 4 2001
A double-blind placebo-controlled study
Abstract Background, aims: The aim of this double-blind, parallel study was to evaluate the adjunctive effects of systemically administered amoxicillin and metronidazole in a group of adult periodontitis patients who also received supra- and subgingival debridement. Methods: 49 patients with a diagnosis of generalised severe periodontitis participated in the study. Random assignment resulted in 26 patients in the placebo (P) group with a mean age of 40 years and 23 patients in the test (T) group which had a mean age of 45 years. Clinical measurements and microbiological assessments were taken at baseline and 3 months after completion of initial periodontal therapy with additional placebo or antibiotic treatment. Patients received coded study medication of either 375 mg amoxicillin in combination with 250 mg metronidazole or identical placebo tablets, every 8 hours for the following 7 days. Results: At baseline, no statistically significant differences between groups were found for any of the clinical parameters. Except for the plaque, there was a significantly larger change in the bleeding, probing pocket depth (PPD) and clinical attachment level (CAL) in the T-group as compared to the P-group after therapy. The greatest reduction in PPD was found at sites with initial PPD of 7 mm, 2.5 mm in the P-group and 3.2 mm in the T-group. The improvement in CAL was most pronounced in the PPD category 7 mm and amounted to 1.5 mm and 2.0 mm in the P- and T-groups, respectively. No significant decrease was found in the number of patients positive for any of the test species in the P-group. The number of patients positive for Porphyromonas gingivalis, Bacteroides forsythus and Prevotella intermedia in the T-group showed a significant decrease. After therapy there was a significant difference between the P- and the T- group in the remaining number of patients positive for P. gingivalis, B. forsythus and Peptostreptococcus micros. 4 subgroups were created on the basis of the initial microbiological status for P. gingivalis positive (Pg-pos) and negative patients (Pg-neg) in the P- and the T-groups. The difference in reduction of PPD between Pg-pos and Pg-neg patients was particularly evident with respect to the changes in % of sites with a probing pocket depth 5 mm. This % decreased from 45% at baseline to 23% after treatment in the Pg-pos placebo subgroup and decreased from 46% to 11% in the Pg-pos test subgroup (p0.005). In contrast, the changes in the proportions of sites with a probing pocket depth 5 mm in the Pg-neg placebo and Pg-neg test subgroup were similar, from 43% at baseline to 18% after treatment versus 40% to 12%, respectively. Conclusions: This study has shown that systemic usage of metronidazole and amoxicillin, when used in conjunction with initial periodontal treatment in adult periodontitis patients, achieves significantly better clinical and microbiological results than initial periodontal treatment alone. Moreover, this research suggests that especially patients diagnosed with P. gingivalis benefit from antibiotic treatment. Zusammenfassung Zielsetzung: Das Ziel dieser placebokontrollierten Doppelblindstudie mit parallelen Gruppen war es, die zusätzlichen Effekte der systemischen Gabe von Amoxicillin und Metronidazol bei Patienten mit Erwachsenenparodontitis zu untersuchen, bei denen auch eine supra- und subgingivale Instrumentierung durchgeführt worden war. Material und Methoden: 49 Patienten mit einer generalisierten schweren Erwachsenenparodontitis nahmen an der Studie teil. Zufällige Zuweisung der Therapien führte zu 26 Patienten in der Placebo-Gruppe (P) mit einem mittleren Alter von 40 und 23 Patienten in der Test-Gruppe (T) mit einem mittleren Alter von 45 Jahren. Klinische Messungen und mikrobiologische Untersuchungen wurden zu Beginn der Therapie sowie 3 Monate nach parodontaler Initialbehandlung mit zusätzlicher Placebo- bzw. Antibiotikagabe durchgeführt. Nachdem alle Zähne mit pathologisch vertieften Taschen subgingival instrumentiert worden waren, erhielten die Patienten eine kodierte Studienmedikation, die entweder aus 375 mg Amoxicillin und 250 mg Metronidazol oder identisch aussehenden Placebotabletten bestand, die die Patienten für 7 Tage alle 8 Stunden einnehmen sollten. Ergebnisse: Zu Beginn der Studie bestand kein statistisch signifikanter Unterschied zwischen den Versuchsgruppen hinsichtlich klinischer Parameter. Nicht für den Plaque Index, aber für Sondierungsblutung, Sondierungstiefen (ST) und klinische Attachmentlevel (PAL) kam es in der T-Gruppe zu signifikant stärkeren Veränderungen im Vergleich zur P-Gruppe. Die stärkste ST-Reduktion bzw. die größten Attachmentgewinne wurden bei Stellen gefunden, die initial ST 7 mm aufgewiesen hatten: P-Gruppe: ST=2.5 mm, PAL=1.5 mm; T-Gruppe: ST=3.2 mm, PAL=2.0 mm. Für keines der untersuchten Parodontalpathogene wurde eine signifikante Reduktion in der P-Gruppe beobachtet, während sich in der T-Gruppe eine signifikante Reduktion für Porphyromonas gingivalis, Bacteroides forsythus und Prevotella intermedia ergab. Nach Therapie ergab sich ein statistisch signifikanter Unterschied zwischen T- und P-Gruppe hinsichtlich Persistenz von P. gingivalis, B. forsythus und Peptostreptococcus micros. Entsprechend dem initialen mikrobiologischen Status für P. gingivalis wurden 4 Untergruppen gebildet: P. gingivalis positive (Pg+) oder (Pg,) Patienten in der T-bzw. P-Gruppe. Der Unterschied zwischen Pg+ und Pg, Patienten war besonders groß hinsichtlich der Veränderung des %-Anteils der Stellen mit ST5 mm. Dieser verringerte sich in der Pg+ P-Untergruppe von 45% auf 23% und in der Pg+ T-Untergruppe von 46% auf 11% (p0.005). Im Unterschied dazu war die Reduktion des Anteils der ST 5 mm in der Pg, P- und T-Untergruppen gleich: P-Gruppe: 43% auf 18%; T-Gruppe von 40% auf 12%. Schlußfolgerungen: Die systemische Gabe von Amoxicillin und Metronidazol zusätzlich zu subgingivaler Instrumentierung bei Patienten mit Erwachsenenparodontitis führt zu signifikant günstigeren klinischen und mikrobiologischen Ergebnissen als die konventionelle Therapie allein. Insbesondere Patienten mit P. gingivalis scheinen von dieser unterstützenden antibiotischen Therapie zu profitieren. Résumé Le but de cette étude parallèle en double aveugle était d'évaluer les effets supplémentaires apportés par l'administration d'amoxicilline et de metronidazole dans un groupe de patients atteints de parodontite de l'adulte qui ont reçu également un débridement supra et sous gingival. 49 patients présentant un diagnostic de parodontite généralisée sévère participèrent à l'étude. La composition des groupes sélectionnés au hasard, était de 26 patients dans le groupe placebo (P) avec un âge moyen de 40 ans et 23 patients dans le groupe test (T) avec une moyenne d'âge de 45 ans. Des mesures cliniques et des prélèvements microbiologiques étaient réalisés initialement et 3 mois après la fin de la thérapeutique parodontale initiale complétée par un placebo ou un traitement antibiotique. Les patients recevaient des médicaments codés pour l'étude de 375 mg amoxicilline combiné avec 250 mg de metronidazol ou des comprimés placebo identiques, toutes les 8 heures pendant les 7 jours suivants. Initalement, aucune différence statistiquement significative entre les groupes n'était observée, pour aucun des paramètres cliniques. En dehors de la plaque, il y avait une modification plus élevée significative pour le saignement, la profondeur de poche au sondage (PPD) et le niveau clinique d'attache (CAL) dans le groupe T, par rapport au groupe P, après traitement. La plus grande réduction pour PPD était observée pour les sites ayant une profondeur de poche au sondage intiale>ou égale à 7 mm, 2.5 mm dans le groupe P et 3.2 mm dans le groupe T. L'amélioration du CAL était plus prononcée pour la catégorie >ou égale à 7 mm et allait jusqu'à 1.5 et 2.0 mm dans les groupes P et T, respectivement. Aucune diminution significative n'était trouvée pour le nombre de patients positifs pour n'importe quelle espèce test dans le groupe P. Le nomber de patients positifs pour Porphyromonas gingivalis, Bacteroides forsythus et Prevotella intermedia dans le groupe T présentait une diminution significative. Après thérapeutique, il y avait une différence significative entre les groupe P et T, en ce qui concerne le nombre de patients positifs pour P. gingivalis, B. forsythus et Peptostreptococcus micros. 4-sous groupes furent créés sur la base de l'état microbiologique pour les patients positifs àP. gingivalis (Pg-pos), et négatifs (Pg-neg), dans les groupes P et T. La différence de réduction de PPD entre les patients Pg-pos et Pg-neg était particulièrement évidente en ce qui concernait les changements en % de sites présentant une profondeur de poche au sondage >ou égale à 5 mm. Ce % diminuait de 45% initialement à 23% après traitement dans le sous-groupe Pg-pos placebo et de 46% à 11% dans le sous-groupe Pg-pos test (p<0.005). A l'inverse, les changements observés dans les proportions de sites avec une profondeur de poche au sondage >5 mm dans les sous-groupes Pg-neg placebo et Pg-neg test étaient similaires, de 43% initialement à 18% après traitement contre 40% à 12% respectivement. En conclusion, cette étude a montré que l'utilisation systèmique de metronidazole et d'amoxicilline, lorsqu'elle est utilisée en complément du traitement parodontal initial chez des patients atteints de parodontite de l'adulte, donne, de façon significative, de meilleurs résultats cliniques et microbiologiques qu'un traitement parodontal initial seul. De plus, cette recherche suggère que les patients porteurs du P. gingivalis bénéficient particulièrement d'un traitement antibiotique. [source]


The efficacy of folk medicines in the management of type 2 diabetes mellitus: results of a randomized controlled trial of Syzygium cumini (L.) Skeels

JOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 1 2006
C. C. Teixeira MD
Summary Objective:, To investigate whether a tea prepared from leaves of jambolan, Syzygium cumini (L.) Skeels, has an antihyperglycaemic effect in patients with type 2 diabetes mellitus. Research design and methods:, Patients with type 2 diabetes mellitus were enrolled in a double-blind, double-dummy, randomized clinical trial. The three experimental groups received a tea prepared from leaves of S. cumini plus placebo tablets, placebo tea plus glyburide tablets or placebo tea plus placebo tablets. Results:, In total, 27 patients were allocated to one of the treatment groups and followed for 28 days. Fasting blood glucose levels decreased significantly with glyburide and did not change with S. cumini tea or placebo. Body mass index, creatinine, , -glutamyl transferase, alkaline phosphatase, aspartate aminotransferase (SGOT), alanine aminotransferase (SGPT), 24-h glicosuria, 24-h proteinuria, triglycerides, total, low-density lipoprotein and high-density lipoprotein cholesterol did not vary significantly between the different groups. Conclusions:, Tea prepared from leaves of S. cumini has no hypoglycaemic effect. [source]


Five-year follow-up study after Helicobacter pylori eradication: Reinfection and peptic ulcer status

JOURNAL OF DIGESTIVE DISEASES, Issue 1 2003
Li Ya ZHOU
OBJECTIVE: To investigate the prevalence of peptic ulcers and Helicobactor pylori reinfection 5 years after H. pylori eradication. METHODS: One thousand and six adults were randomly sampled from the general population in a high-incidence region of gastric cancer. Of these, 552 subjects were confirmed to be H. pylori -positive by using both the rapid urease test and the Warthin,Starry stain. All H. pylori -positive subjects were randomly divided into two groups: (i) the eradication group, who received 1 week of omeprazole-based triple therapy; and (ii) the control group, who received placebo tablets. Four weeks after the cessation of treatment, 13C-urea breath tests demonstrated that H. pylori had been successfully eradicated in 88.9% of patients in the eradication group, whereas 96.4% of patients remained H. pylori positive in the control group. Subjects in both groups were followed up using endoscopy at the end of the first and fifth year after treatment. The H. pylori infection status was determined by using the rapid urease test and Warthin,Starry staining. RESULTS: The response rates to endoscopy at the end of the first and fifth year were 89.3 and 83.11%, respectively. The prevalence of peptic ulcers in the eradication group and control group were 9.87 and 7.61% before treatment, 3.70 and 12.58% 1 year after treatment (P < 0.05), and 5.86 and 14.93% 5 years after treatment (P < 0.05), respectively. The recurrence rates of peptic ulcers in the eradication group and the control group were 3.70 and 38.10% 1 year after treatment, and 14.81 and 42.86% 5 years after treatment, respectively. The rates of H. pylori infection 1 and 5 years after treatment in the eradication group were 13.58, and 19.82%, respectively. In the control group, the rates of H. pylori infection were 91.97 and 83.26% 1 and 5 years after treatment, respectively. CONCLUSIONS: The prevalence of peptic ulcers decreased significantly after the eradication of H. pylori. The reinfection rate after H. pylori eradication was 4,5% per year. Helicobacter pylori infection status remained constant in almost 85% of cases. [source]


Assessment of diffuse transmission mode in near-infrared quantification,part I: The press effect on low-dose pharmaceutical tablets

JOURNAL OF PHARMACEUTICAL SCIENCES, Issue 12 2009
M. Saeed
Abstract Quantitative applications for pharmaceutical solid dosage forms using near-infrared (NIR) spectroscopy are central to process analytical technology (PAT) manufacturing designs. A series of studies were conducted to evaluate the use of NIR transmission mode under various pharmaceutical settings. The spectral variability in relation to tablet physical parameters were investigated using placebo tablets with different thickness and porosity steps and both variables showed an exponential relationship with the detected transmittance signal drop. The drug content of 2.5% m/m folic acid tablets produced under extremely different compaction conditions was predicted and found to agree with UV assay results after inclusion of extreme physical outliers to the training sets. NIR transmission was also shown to traverse a wide section of the tablet by comparing relative blocking intensities from different regions of the tablet surface and >90% of the signal was detected through a central area of 7 mm diameters of the tablet surface. NIR Quantification of both film thickness and active ingredient for film-coated tablets are examined in part II of this study. © 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:4877,4886, 2009 [source]


Efficacy of methotrexate treatment in patients with probable rheumatoid arthritis: A double-blind, randomized, placebo-controlled trial

ARTHRITIS & RHEUMATISM, Issue 5 2007
Henrike van Dongen
Objective To determine whether patients with undifferentiated arthritis (UA; inflammatory, nontraumatic arthritis that cannot be diagnosed using current classification criteria) benefit from treatment with methotrexate (MTX). Methods The PRObable rheumatoid arthritis: Methotrexate versus Placebo Treatment (PROMPT) study was a double-blind, placebo-controlled, randomized, multicenter trial involving 110 patients with UA who fulfilled the American College of Rheumatology (ACR) 1958 criteria for probable RA. Treatment started with MTX (15 mg/week) or placebo tablets, and every 3 months the dosage was increased if the Disease Activity Score was >2.4. After 12 months, the study medication was tapered and discontinued. Patients were followed up for 30 months. When a patient fulfilled the ACR criteria for RA (primary end point), the study medication was changed to MTX. Joint damage was scored on radiographs of the hands and feet. Results In 22 of the 55 patients (40%) in the MTX group, UA progressed to RA compared with 29 of 55 patients (53%) in the placebo group. However, in the MTX group, patients fulfilled the ACR criteria for RA at a later time point than in the placebo group (P = 0.04), and fewer patients showed radiographic progression over 18 months (P = 0.046). Conclusion This study provides evidence for the efficacy of MTX treatment in postponing the diagnosis of RA, as defined by the ACR 1987 criteria, and retarding radiographic joint damage in UA patients. [source]


SOY ISOFLAVONE TABLETS REDUCE OSTEOPOROSIS RISK FACTORS AND OBESITY IN MIDDLE-AGED JAPANESE WOMEN

CLINICAL AND EXPERIMENTAL PHARMACOLOGY AND PHYSIOLOGY, Issue 2004
Mari Mori
Summary 1.,This study examines whether the supplementation of isoflavones (ISO) exerts beneficial effects on the bone mineral density (BMD) measured by dual energy X-ray absorptiometry (DEXA). 2.,Eighty-one healthy Japanese pre- and postmenopausal women were randomly assigned to the following two groups taking either ISO (100 mg) tablets (ISO group) or placebo tablets (P group) containing vitamins C (25 mg) and E (5 mg) daily for 24 weeks in a double-blind placebo controlled parallel design. 3.,Seventy women completed the intervention study (34 on ISO, 36 on P), only ISO group was proven to increase significantly BMD (P < 0.05 vs before) and to significantly decrease body fat measured by the DEXA (P < 0.0001 vs before and P < 0.05 vs P group), while BMI was maintained in ISO group despite significant BMI increase in P group. Thus, percent changes in BMI were significantly different between ISO and P groups (P < 0.05) 24 weeks after the intervention. 4.,This prospective DEXA study confirmed a long-term ISO supplementation, 100 mg/day could not only prevent menopausal bone resorption but also increase BMD and decrease body fat concomitantly with BMI reduction. Enough ISO supplementation may contribute to the risk reduction of osteoporosis and obesity and, thus to overall health promotion in menopausal women. [source]