scholarly journals Clinical Efficacy of Prebiotics and Glycosaminoglycans versus Placebo In Dogs with Food Responsive Enteropathy Receiving a Hydrolyzed Diet: A Pilot Study

2021 ◽  
Author(s):  
Karin Allenspach ◽  
Barbara Glanemann ◽  
Yeon-Jung Seo ◽  
Simon L Priestnall ◽  
Oliver A Garden ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Pilot Study ◽  
Relapse Rate ◽  
Dietary Treatment ◽  
Normal Diet ◽  
Power Calculation ◽  
Chronic Enteropathy ◽  
Group 2 ◽  
Group 1

Induction of remission is easily achieved with dietary treatment in dogs diagnosed with Food Responsive Chronic Enteropathy (FRD). Administration of prebiotics and glycosaminoglycans (GAGs) may improve epithelial cell integrity and therefore be useful as adjunct treatment. This study evaluated whether the relapse rate of FRD dogs that are switched back to a normal diet can be influenced using supplemental treatment with prebiotics and GAGs. A randomized, controlled clinical trial (RCCT) was performed in dogs diagnosed with FRD. Dogs were diagnosed based on clinical exclusion diagnosis, endoscopic biopsies showing predominantly lymphoplasmacytic infiltration, and response to dietary treatment. Dogs were randomized to be fed a combination of prebiotics and GAGs (group 1) or placebo (group 2) in addition to a hydrolyzed diet. At week 10, a second endoscopy was performed and dogs were switched back to normal diet. Relapse rate was monitored every 2 weeks after that until week 18. Statistical analysis was performed for each outcome (Canine Chronic Enteropathy Clinical Activity Index (CCECAI), clinicopathological data, endoscopic scoring, mWSAVA histological scoring index (mWSAVA), and number of relapses following switch to normal diet) using a linear mixed effects model for group comparison. Time, group, and their interactions were included as a fixed effect, whereas each dog was treated as a random effect.  Of the 35 dogs enrolled into the clinical trial, 10 in each group reached the point of second endoscopy. A total of 13 dogs (n=8 in group 1 and n=5 in group 2) reached the trial endpoint of 18 weeks. After switching back to normal diet, none of the dogs in either group relapsed. No significant differences were found over time or between groups for CCECAI, endoscopy scoring and histological scoring. Although there was a clinical worsening in the placebo group after switching back to the original diet, this was not statistically significant (CCECAI p=0.58). Post-hoc power calculation revealed that 63 dogs per group would have been needed to detect statistically significant differences in CIBDAI between treatment groups.  Standard dietary treatment induced rapid clinical response in all cases, however, additional supplementation with prebiotics and GAGs did not significantly improve clinical outcome within 4 months after switching back to normal diet. Since there are very few RCCT published in CE in dogs, this pilot study provides important power analyses for planning of further studies.

scholarly journals Clinical efficacy of prebiotics and glycosaminoglycans versus placebo In dogs with food responsive enteropathy receiving a hydrolyzed diet: A pilot study

PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0250681
Author(s):  
Barbara Glanemann ◽  
Yeon-Jung Seo ◽  
Simon L. Priestnall ◽  
Oliver A. Garden ◽  
Logan Kilburn ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Pilot Study ◽  
Relapse Rate ◽  
Random Effect ◽  
Dietary Treatment ◽  
Normal Diet ◽  
Power Calculation ◽  
Group 2 ◽  
Group 1

Induction of remission is easily achieved with dietary treatment in dogs diagnosed with Food Responsive Chronic Diarrhea (FRD). Administration of prebiotics and glycosaminoglycans (GAGs) may improve epithelial cell integrity and therefore be useful as adjunct treatment. This study evaluated whether the relapse rate of FRD dogs that are switched back to a normal diet can be influenced using supplemental treatment with prebiotics and GAGs. A randomized, controlled clinical trial (RCCT) was performed in dogs diagnosed with FRD. Dogs were diagnosed based on clinical exclusion diagnosis, endoscopic biopsies showing predominantly lymphoplasmacytic infiltration, and response to dietary treatment. Dogs were randomized to be fed a combination of prebiotics and GAGs (group 1) or placebo (group 2) in addition to a hydrolyzed diet. At week 10, a second endoscopy was performed and dogs were switched back to normal diet. Relapse rate was monitored every 2 weeks after that until week 18. Statistical analysis was performed for each outcome (Canine Chronic Enteropathy Clinical Activity Index (CCECAI), clinicopathological data, endoscopic scoring, mWSAVA histological scoring index (mWSAVA), and number of relapses following switch to normal diet) using a linear mixed effects model for group comparison. Time, group, and their interactions were included as a fixed effect, whereas each dog was treated as a random effect. Of the 35 dogs enrolled into the clinical trial, 10 in each group reached the point of second endoscopy. A total of 13 dogs (n = 8 in group 1 and n = 5 in group 2) reached the trial endpoint of 18 weeks. After switching back to normal diet, none of the dogs in either group relapsed. No significant differences were found over time or between groups for CCECAI, endoscopy scoring and histological scoring. Although there was a clinical worsening in the placebo group after switching back to the original diet, this was not statistically significant (CCECAI p = 0.58). Post-hoc power calculation revealed that 63 dogs per group would have been needed to detect statistically significant differences in CIBDAI between treatment groups. Standard dietary treatment induced rapid clinical response in all cases, however, additional supplementation with prebiotics and GAGs did not significantly improve clinical outcome within 4 months after switching back to normal diet. Since there are very few RCCT published in CE in dogs, this pilot study provides important power analyses for planning of further studies.

scholarly journals Association between Rapid Maxillary Expansion and Nocturnal Enuresis in Children: A Pilot Study for a Randomized Controlled Clinical Trial

2020 ◽  
Vol 10 (24) ◽  
pp. 9025
Author(s):  
Xiaowen Niu ◽  
Marie A. Cornelis ◽  
Konstantinos Kamperis ◽  
Paolo M. Cattaneo
Keyword(s):  
Clinical Trial ◽  
Pilot Study ◽  
Nocturnal Enuresis ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Maxillary Expansion ◽  
Randomized Controlled ◽  
Urine Production ◽  
Group 2 ◽  
Group 1

Objectives: This pilot study was conducted to test the protocol of a randomized controlled trial evaluating whether rapid maxillary expansion (RME) can relieve nocturnal enuresis (NE) and improve breathing in children, after ruling out a placebo effect, and investigating whether the effects of RME and NE are related to the morphology of the upper airway. Methods: Seventy 6–15-year-old patients with NE were assessed for eligibility (e.g., constricted maxilla). Enrolled subjects were randomized to immediate treatment with RME (Group 1) or to have the same treatment (RME) delayed for at least six weeks (Group 2). Outcomes comprised the number of wet nights per week, the nocturnal urine production, and the scores of a pediatric sleep questionnaire at baseline, after active treatment (Group 1) or delayed treatment (Group 2), and after 3 months’ retention. Cone beam computed tomographies were taken at baseline and after retention. Results: Six patients were randomized: three in each group. In four of six patients, the number of wet nights per week decreased. Moreover, in responders, nocturnal urine production was reduced following RME. Conclusions: This pilot study suggested that RME might reduce the severity of NE and showed that the protocol of this randomized controlled clinical trial was appropriate.

SO084SILDENAFIL DRUG IN HEMODIALYSIS PATIENTS WITH PULMONARY HYPERTENSION

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Maha Abdelmoneim Behairy Said ◽  
Tamer El Said ◽  
Abdelrahman Elbraky ◽  
Hazem Khorshid ◽  
Waleed Anwar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pulmonary Hypertension ◽  
Placebo Group ◽  
Pulmonary Artery ◽  
Pulmonary Artery Pressure ◽  
Hemodialysis Patients ◽  
Artery Pressure ◽  
Daily Dose ◽  
Group 2 ◽  
Group 1

Abstract Background and Aims Pulmonary hypertension (PH) is not an uncommon progressive condition in prevalent hemodialysis (HD) patients, associated with high morbidity and mortality. Sildenafil drug has limited studies about the efficacy of the drug and optimal dose among prevalent HD patients with PH. Aim of the study to assess the effects of sildenafil drug on estimated Pulmonary Artery pressure value (ePAP) mmHg via transthoracic Doppler Echocardiography and 6-minute walk test ( 6MWT) among hemodialysis patients with pulmonary hypertension. Method Randomized, double-blind, placebo-controlled clinical trial, from December 2018 to May 2019, involving 60 eligible patients on regular adequate HD with PH, estimated Pulmonary Artery Pressure (ePAP) ≥35 mmHg via Doppler echocardiography. HD patients with mean age 52.6±10.8 year divided randomly into 3 groups: Group 1 (20 patients) received 25 mg sildenafil, group 2 (20 patients) received 50 mg sildenafil and group 3 (20 patients) who received placebo as daily dose treatment for 3 months duration. Every patient in the study was subjected to full history taking and clinical examination. Exclusion Criteria: Current treatment of pulmonary hypertension, patient with evident history of cardiac diseases or chronic pulmonary diseases or systemic autoimmune diseases, portal hypertension, HIV, patients with uncontrolled hypertension or severe anaemia or hypersensitivity to sildenafil, treatment with any drugs that may interact with sildenafil all were excluded from the study. Transthoracic echocardiography was done at the begging of the study and after three months in mid-week non-dialysis day for assessment of the change in ePAP, pulmonary artery pressure calculated using the modified Bernoulli equation, and assessment of right ventricular functions . Exercise capacity assessment by 6MWT to assess the clinical response to the drug, was done for every patient at the start of the study and after 3 months of treatment. Clinically meaningful change estimate for the 6MWT considered as increase more than 30 meters. Results Significant increase in mean of 6 MWT in both group 1,2 received 25 mg,50 mg sildenafil respectively after 3 m duration of treatment versus non-significant change in placebo group as basal 6 MWT was (171 ±45, 214 ±58, 175 ±39) meters in group 1,2 and placebo group respectively (p>0.05). Means 6 MWT post-treatment were (205 ±57, 258 ±59, 182 ±49) meters (P<0.001) in group 1, 2&3 respectively, as post Hoc test results, showed significant increase in 6MWT2 in group 2 in comparison to group 1 and placebo group (P<0.01), as shown in figure (1).There was a significant decrease in e PAP in each group of studied groups after treatment (P<0.01). As mean basal ePAP1 measures were (48 ±9, 43.5 ±16, 48.5 ±12) mmHg in group 1,2,3 respectively (P>0.05).There were no significant differences between the studied groups regarding means of ePAP2 post-treatment were ( 42 ±9, 39 ±15, 44.5±8) mmHg in group 1,2,3 respectively (P>0.05). However, the degree of severity of PH was more improved after treatment duration with sildenafil as in group 1 there were 5 patients downgraded from moderate to mild and 2 patients downgraded from severe to moderate after treatment. In group 2 there were 4 patients downgraded from moderate to mild PH and 2 patients downgraded from severe to moderate PH. In 3rd group (placebo group) only one patient downgraded from moderate to mild PH. There were 4 patients dropouts from the study two of them from group 2 (receiving 50mg) due to sildenafil related side effects appeared through the study. Conclusion This a clinical trial confirmed the efficiency of both 50mg and 25mg sildenafil daily dose in reducing e PAP and improving functional exercise capacity in chronic haemodialysis patients with pulmonary hypertension disease.

The influence of continuous local wound infusion on postoperative pain in patients undergoing transfemoral amputation

VASA ◽  
2015 ◽  
Vol 44 (5) ◽  
pp. 381-386 ◽  
Author(s):  
Christian Uhl ◽  
Thomas Betz ◽  
Andrea Rupp ◽  
Markus Steinbauer ◽  
Ingolf Töpel
Keyword(s):  
Pain Management ◽  
Pilot Study ◽  
Local Anaesthetic ◽  
Phantom Pain ◽  
Transfemoral Amputation ◽  
Postoperative Wound ◽  
Stump Pain ◽  
Management Protocol ◽  
Group 2 ◽  
Group 1

Abstract. Summary: Background: This pilot study was set up to examine the effects of a continuous postoperative wound infusion system with a local anaesthetic on perioperative pain and the consumption of analgesics. Patients and methods: We included 42 patients in this prospective observational pilot study. Patients were divided into two groups. One group was treated in accordance with the WHO standard pain management protocol and in addition to that received a continuous local wound infusion treatment (Group 1). Group 2 was treated with analgesics in accordance with the WHO standard pain management protocol, exclusively. Results: The study demonstrated a significantly reduced postoperative VAS score for stump pain in Group 1 for the first 5 days. Furthermore, the intake of opiates was significantly reduced in Group 1 (day 1, Group 1: 42.1 vs. Group 2: 73.5, p = 0.010; day 2, Group 1: 27.7 vs. Group 2: 52.5, p = 0.012; day 3, Group 1: 23.9 vs. Group 2: 53.5, p = 0.002; day 4, Group 1: 15.7 vs. Group 2: 48.3, p = 0.003; day 5, Group 1 13.3 vs. Group 2: 49.9, p = 0.001). There were no significant differences between the two groups, neither in phantom pain intensity at discharge nor postoperative complications and death. Conclusions: Continuous postoperative wound infusion with a local anaesthetic in combination with a standard pain management protocol can reduce both stump pain and opiate intake in patients who have undergone transfemoral amputation. Phantom pain was not significantly affected.

scholarly journals Randomised clinical trial showing the curative effect of bandaging on M2-stage lesions of digital dermatitis in dairy cows

2019 ◽  
Vol 6 (1) ◽  
pp. e000264 ◽  
Author(s):  
Marcus Klawitter ◽  
Dörte Döpfer ◽  
Theo Broderick Braden ◽  
Ermias Amene ◽  
Kerstin Elisabeth Mueller
Keyword(s):  
Clinical Trial ◽  
Dairy Cows ◽  
Dairy Herd ◽  
Randomised Clinical Trial ◽  
Digital Dermatitis ◽  
Group 4 ◽  
Treatment Type ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objectives and designThis trial evaluated the effect of bandaging of acute painful ulcerative bovine digital dermatitis (DD) lesion (stage M2) in dairy cows, tested using two different topical treatments.DesignRandomised clinical trial.SettingThis study was conducted using Holstein-Friesian cows ranging in age from heifers to fourth lactation in a single dairy herd and diagnosed with acute ulcerative DD lesions (stage M2) on the first examination (week 0). Cows were randomly assigned into either a non-bandaged or bandaged group across two treatment conditions: topical chlortetracycline spray (CTC) and Intra Hoof-Fit Gel (IHF). Lesions received standardised bandaging and treatment on a weekly basis. Unhealed lesions could receive up to five repeated treatments, at weekly intervals, within a four-week period. Both M-stage and locomotion were also evaluated and scored weekly. Cows with healthily formed skin (stage M0) were deemed healed and subsequently released from the study.ResultsIn total, 163 M2 lesions were diagnosed at week 0. Bandaged M2 lesions had a significantly higher probability of cure than non-bandaged lesions regardless of treatment type (HR: 4.1; P<0.001; 95 per cent CI: 2.5 to 6.8). Most healing occurred within the first three weeks of trial. Furthermore, bandaged lesions (group 2 and group 4) were significantly less likely to progress into the chronic hyperkeratotic or proliferative stage (M4) than non-bandaged lesions in group 1 and group 3 (HR: 0.10; P<0.001; 95 per cent CI: 0.04 to 0.22). Out of concern for the cow’s wellbeing, this study investigated the effects of bandaging on locomotion. Bandaging had no effect on locomotion for either cows treated with CTC (group 1: median Sprecher score, 2; IQR=1–2; group 2: median Sprecher score, 2; IQR=1–3; P=0.3) or IHF (group 3: median Sprecher score, 2; IQR=1–2; group 4: median Sprecher score, 2; IQR=1–3; P=0.3).

scholarly journals Single versus Multiple Dose Ivermectin Regimen in Onchocerciasis-Infected Persons with Epilepsy Treated with Phenobarbital: A Randomized Clinical Trial in the Democratic Republic of Congo

Pathogens ◽  
2020 ◽  
Vol 9 (3) ◽  
pp. 205 ◽  
Author(s):  
Michel Mandro ◽  
Joseph Nelson Siewe Fodjo ◽  
Alfred Dusabimana ◽  
Deby Mukendi ◽  
Steven Haesendonckx ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Seizure Frequency ◽  
Democratic Republic ◽  
Democratic Republic Of Congo ◽  
Analysis Data ◽  
Seizure Freedom ◽  
Republic Of Congo ◽  
Group 2 ◽  
One Year ◽  
Group 1

Background: There is anecdotal evidence that ivermectin may decrease seizure frequency in Onchocerca volvulus-infected persons with epilepsy (PWE). Methods: In October 2017, a 12-month clinical trial was initiated in rural Democratic Republic of Congo. PWE with onchocerciasis-associated epilepsy experiencing ≥2 seizures/month were randomly allocated to receive, over a one-year period, ivermectin once or thrice (group 1), while other onchocerciasis-infected PWE (OIPWE) were randomized to ivermectin twice or thrice (group 2). All participants also received anti-epileptic drugs. Data was analyzed using multiple logistic regression. Results: We enrolled 197 participants. In an intent-to-treat analysis (data from group 1 and 2 combined), seizure freedom was more likely among OIPWE treated with ivermectin thrice (OR: 5.087, 95% CI: 1.378–19.749; p = 0.018) and twice (OR: 2.471, 95% CI: 0.944–6.769; p = 0.075) than in those treated once. Similarly, >50% seizure reduction was more likely among those treated with ivermectin twice (OR: 4.469, 95% CI: 1.250–16.620) and thrice (OR: 2.693, 95% CI: 1.077–6.998). Absence of microfilariae during the last 4 months increased the odds of seizure freedom (p = 0.027). Conclusions: Increasing the number of ivermectin treatments was found to suppress both microfilarial density and seizure frequency in OIPWE, suggesting that O. volvulus infection plays an etiological role in causing seizures.

scholarly journals EFFICACY OF MOUTH RINSE FORMULATION BASED ON CETYLPYRIDINIUM CHLORIDE 0.1% IN THE CONTROL OF DENTAL CALCULUS BUILDUP

2017 ◽  
Vol 9 ◽  
pp. 176 ◽  
Author(s):  
Diah Ayu Maharani ◽  
Alia Ramadhani ◽  
Melissa Adiatman ◽  
Yuniardini Septorini Wimardhani ◽  
Linda Kusdhany ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cetylpyridinium Chloride ◽  
Positive Control ◽  
Negative Control ◽  
Mouth Rinse ◽  
Dental Calculus ◽  
Double Blind ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objective: This study aimed at comparing the antiplaque, anticalculus, and antigingivitis potentials of a mouth rinse containing essential oil, alcohol,zinc, and fluoride with a mouth rinse containing cetylpyridinium chloride (CPC) 0.1% over 1-, 2-, and 3-month periods.Methods: This study was a double-blind, parallel randomized clinical trial with a 3-day run-in phase. Respondents were asked to gargle twice dailywith 15 ml of mouth rinse for 30 seconds after brushing teeth. Respondents were 80 females with a mean age of 21 years, and a single dental examinerwas employed throughout the study to decrease the variance. Prophylaxis was performed for all respondents before the intervention. Three mouthrinses were tested: Group 1 with the mouth rinse containing CPC 0.1%, Group 2 as the negative control, and Group 3 as the positive control with amouth rinse containing alcohol. Evaluations were conducted by plaque index, gingival index, calculus index, and CariScreen examinations.Results: The clinical trial showed that the mouth rinse with alcohol and the mouth rinse containing CPC 0.1% were effective in inhibiting bacterialbuildup (antiplaque) and have anticalculus properties, but with no statistically significant antigingivitis effect.Conclusion: It was found that the mouth rinse containing alcohol has similar effectiveness with CPC 0.1% mouth rinse, but side effects, such as aburning sensation, were reported in the alcohol-containing mouth rinse.

scholarly journals MON-594 The Peculiarity of the Gut Microbiota in Patients with Different Phenotypes of Obesity (Pilot Study)

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Natalia Volkova ◽  
Julia Naboka ◽  
Lilia Ganenko ◽  
Oksana Oksenuk ◽  
Ilia Davidenko ◽  
...  
Keyword(s):  
Pilot Study ◽  
Gut Microbiota ◽  
Nutrition Education ◽  
Control Group ◽  
Metabolically Healthy Obesity ◽  
Detection Frequency ◽  
Group 3 ◽  
Metabolically Healthy ◽  
Group 2 ◽  
Group 1

Abstract Recent studies have shown that obesity is not a homogeneous condition and that there is a subgroup of people with obesity, but without metabolic disturbance. This phenotype of obesity is called “metabolically healthy obesity” (MHO) [1]. More and more data are appearing in the scientific literature, indicating that quantitative and qualitative changes in the gut microbiota (GM) can be a trigger in the development of obesity and metabolic disorders [2]. In order to study the role of GM in the development of various types of obesity, 37 patients were examined, divided into 3 groups: group 1 (n = 11) - healthy people without obesity and overweight (control), group 2 (n = 13) - patients with MHO, group 3 (n = 13) - patients with metabolically unhealthy obesity (MUHO). The basic metabolic parameters were determined for all of them and a quantitative assessment of the condition of the GM was performed using the Real-time PCR method. Results: 1. In people from the control group (group 1) in the GM, compared with formal normative indicators, the number of Lactobacillus spp., Bifidobacterium spp., B. thetaiotaomicron was reduced (p&lt;0.05) and indicators of the total bacterial mass and Enterobacter spp./Citrobacter spp. were increased (p&lt;0.05). 2. In subjects with MHO (group 2), GM changes similar to group 1 were observed. However, in comparison to group 1, Klebsiella spp. and Proteus spp. were recorded in feces in quantities exceeding the formal regulatory. In patients with MUHO (group 3), in addition to changes detected in group 2, C. difficile was found in feces, as well as a significant (p &lt;0.05) decrease in F. prausnitzii and an increase (p &lt;0.05) in the detection frequency of banal E.coli, as well as the more diverse composition of the microbiota. Thus, the data obtained as a result of a pilot study certainly indicate changes in the GM in people with different phenotypes of obesity and in healthy ones. Further study of the GM in patients with various types of obesity, but in a larger groups, is required. Reference: 1) Phillips C.M. Metabolically healthy obesity across the life course: epidemiology, determinants and implications. Ann N.Y. Acad Sci 2017 Mar;139(1):85-100.doi:10.1111/nyas.13230. 2). Giovanna Muscogiuri, Elena Cantone, Sara Cassarano, Dario Tuccinardi, Luigi Barrea, Silvia Savastano, Annamaria Colao & on behalf of the Obesity Programs of nutrition, Education, Research and Assessment (OPERA) group. Gut microbiota: a new path to treat obesity. International Journal of Obesity Supplements 2019 Apr;9(1):10-19. doi: 10.1038/s41367-019-0011-7

Efficacy of Raloxifene Hydrochloride for the Prevention of Health Care Problems in Patients Who Undergo Surgery for Endometrial Cancer: A Multicenter Randomized Clinical Trial

2015 ◽  
Vol 25 (2) ◽  
pp. 288-295 ◽  
Author(s):  
Koji Nakamura ◽  
Kenjiro Sawada ◽  
Michiyo Sugiyama ◽  
Seiji Mabuchi ◽  
Takeshi Hisamatsu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Endometrial Cancer ◽  
Lumbar Spine ◽  
Femoral Neck ◽  
Lipid Profile ◽  
Bone Metabolism ◽  
Randomized Clinical Trial ◽  
Group 2 ◽  
Raloxifene Hydrochloride ◽  
Group 1

ObjectiveRemoval of the ovaries is common during surgery for endometrial cancer. However, because loss of the ovaries can cause several health problems in patients, strategies for the prevention of such problems need to be established. Hence, we decided to conduct a multicenter randomized clinical trial to assess the effect of raloxifene on bone mineral density (BMD), bone metabolism, and the lipid profile of patients who had undergone surgery for patients with endometrial cancer.Materials and MethodsPatients with endometrial cancer were enrolled after treatment. The participants were randomized into 2 groups: group 1 included 39 women who received alfacalcidol (1 μg/d) alone and group 2 included 37 women who received alfacalcidol and the test drug, raloxifene hydrochloride, at a dose of 60 mg/d. The BMD of lumbar spine and femoral neck, serum bone markers, as well as lipid profile parameters were evaluated at enrollment as well as 6, 12, and 24 months after the enrollment. The primary efficacy end point was the percentage change from baseline to 24 months in lumbar spine (L2-L4) and femoral neck BMD.ResultsSixty-four women completed the 24-month study. At 24 months, the lumbar and femoral neck BMDs were significantly increased in group 2 compared with group 1 (3.5% vs −0.8% and 2.3% vs −2.8%, respectively). In group 2, low-density lipoprotein-cholesterol levels were significantly reduced by 13.6% and serum N-terminal telopeptide of type I collagen as well as bone-specific alkaline phosphatase values were significantly reduced by 16.7% and 25.7%, respectively. The patients who received adjuvant therapy for endometrial cancer showed a significantly higher response to raloxifene (5.8% vs 1.9%). Recurrence was detected in 2 (2.6%) patients in group 1. No severe adverse events were noted in any patient during the study period.ConclusionsRaloxifene exerts positive effects on BMD, bone metabolism, and lipid profile parameters and could provide an improved therapeutic option for patients with endometrial cancer.

Does Upfront Therapy with Fludarabine Increase the Risk of Histological Transformation In Patients with Follicular Lymphoma?

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4885-4885
Author(s):  
Sobia Yaqub ◽  
Todd W. Gress ◽  
Oscar Ballester
Keyword(s):  
Follicular Lymphoma ◽  
Relapse Rate ◽  
Group 4 ◽  
Number Of Patients ◽  
Histological Transformation ◽  
Group 3 ◽  
Group 2 ◽  
Time To Relapse ◽  
Group 1

Abstract Abstract 4885 Introduction: Fludarabine has been reported to increase the incidence of relapse and histological transformation in chronic lymphocytic leukemia (Thornton PD, Leukemia research, 2005) and Waldenstrom macroglobulinemia (Leleu X, J Clincal Oncology, 2009). The purpose of our study was to investigate the role of Fludarabine and the risk of transformation and relapse in follicular lymphoma (FL). Patients and Methods: This is a retrospective single institution study. We included 50 patients consecutively diagnosed with FL Grade I and II based on WHO classification of lymphoid malignancies. Grade III patients were excluded from the study. Median follow up is 2.86 years. Patients were grouped according to the initial therapy chosen by their treating physicians: Group 1(n=14) included patients on observation and radiation therapy, Group 2 (n=6) included patients on Fludarabine based regimens, Group 3(n=13) included CVP-R and other rituximab regimens and Group 4(n=17) included R-CHOP. Data collected included time to the onset of biopsy proven transformation, time to relapse, mortality and overall survival. Level of significance was set at <0.05. Results: Median age of the patients was 56.5 and it was not significantly different for the various groups. High risk FLIPI score was seen in 66% of patients treated with Fludarabine regimens as compared to 61% of R-CHOP treated patients. Overall, relapse occurred in 38% patients and transformation occurred in 16% patients during the follow up period. Fludarabine treated patients had the highest relapse rate: 50% (p=0.03). R-CHOP group has lowest relapse rate: 11%. Transformation rate was highest in the Fludarabine group: 33%, as compared to 13% to 17% in other groups (p=0.10). Mortality rate was 7% in group 1, 16% in group 2, 23% for group 3 and 5% in group 4 (p=0.44). Time to relapse/progression in group 1 was 2.9 years; in group 2 was 2.1 years; in group 3 was 2.7 years and in group 4 was 5.8 years. Conclusions: In our study, Fludarabine treated patients appear to be at higher risk for relapse and transformation compared to patients treated with R-CHOP. The differences can not be explained on the basis of known prognostic factors such as age or FLIPI score. The retrospective nature of the study and the small numbers of patients preclude more definitive conclusions. Further research is needed with large number of patients. Disclosures: No relevant conflicts of interest to declare.

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