scholarly journals Effects of a nine-strain bacterial synbiotic compared to simethicone in colicky babies – an open-label randomised study

2021 ◽  
pp. 1-10
Author(s):  
J. Piątek ◽  
M. Bernatek ◽  
H. Krauss ◽  
M. Wojciechowska ◽  
Z. Chęcińska-Maciejewska ◽  
...  

The aim of the study was to determine effects of administration of simethicone and a multi-strain synbiotic on the crying behaviour of colicky babies. The study design consisted of an open-label, two parallel treatment group study involving 87 infants aged 3-6 weeks with infantile colic (defined as crying episodes lasting 3 or more hours per day and occurring at least 3 days per week within 3 weeks prior to enrolment) randomly, unequally [1:1.5] assigned to receive simethicone (n=33) or a multi-strain synbiotic (n=54) orally for 4 weeks. The multi-strain synbiotic contained Lactobacillus acidophilus LA-14, Lacticaseibacillus casei R0215, Lacticaseibacillus paracasei Lp-115, Lacticaseibacillus rhamnosus GG, Ligilactobacillus salivarius Ls-33, Bifidobacterium lactis Bl-04, Bifidobacterium bifidum R0071, Bifidobacterium longum R0175 and fructooligosaccharides). Primary outcome measures were the responder rates (effect ≥50% reduction from baseline) of the measures ‘crying days last 3 weeks’, ‘average evening crying duration last 3 weeks’ and ‘reduction of average number of crying phases per day last three weeks’ at the end of treatment. The study is registered at ClinicalTrials.gov under NCT 04487834. Significantly higher responder rates (effect ≥50% reduction from baseline) of the multi-strain synbiotic compared to simethicone were found for the measures ‘crying days last 3 weeks’ (72% vs 18%, P<0.0001) and ‘average evening crying duration last 3 weeks’ (85% vs 39%, P=0.0001). No significant difference was found for the measure ‘reduction of average number of crying phases per day last three weeks’ (50% vs 42%, P=0.4852). No adverse effects were reported for the two treatment groups. Based on these results, the multi-strain synbiotic can be considered as an interesting therapeutic possibility for the treatment of infantile colic, worthwhile to be investigated further in non-clinical and clinical studies.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3311-3311 ◽  
Author(s):  
Andres Lopez ◽  
Alberto Fernandez de Sevilla ◽  
Sylvie Castaigne ◽  
Richard Greil ◽  
Jorge Sierra ◽  
...  

Abstract CHOP chemotherapy administered every 21 days has been the standard regimen for treatment of aggressive NHL for many years. Recent studies have shown improvements in both complete remission and survival following addition of Rituximab to CHOP 21 (Coffier et al, NEJM 2002) and following reduction of the cycle length of standard 21 day CHOP to 14 days (Pfreundschuh et al, Blood 2004). Previous studies with CHOP 14 have demonstrated the need for filgrastim to allow for administration of chemotherapy at planned dose and on time in this setting. The primary aim of this study was to explore the feasibility of 14 day CHOP chemotherapy plus Rituximab (CHOP-R 14) with pegfilgrastim and filgrastim. This was an open-label, randomised study of a single administration pegfilgrastim (6mg, day 2) or daily administration filgrastim (5 μg/kg; day 2 until ANC>10x109/L) in subjects with aggressive B-cell NHL being treated with CHOP-R 14 for up to 6 cycles. The endpoints of the study were proportion of cycles given at planned dose on time, proportion of subjects receiving planned dose of chemotherapy on time, and clinical response. A cycle was considered “on time” if it started <17 days after the start of the previous cycle, and at “planned dose” if a dose of >75% was administered for each agent (excluding prednisone and vincristine). This was an exploratory study using descriptive statistics to summarise endpoints therefore no formal comparisons were made between the groups. Twenty-seven subjects were randomised to filgrastim and 33 to pegfilgrastim. Twenty-six (96%) filgrastim and 32 (97%) pegfilgrastim subjects received study drug; 22 (81%) filgrastim and 30 (91%) pegfilgrastim subjects received all 6 cycles of chemotherapy. The treatment groups were generally well balanced at baseline but in the pegfilgrastim group there were more subjects randomised and more subjects completed all 6 cycles. Of the cycles planned, 93% (145/156) in the filgrastim group and 98% (188/192) in the pegfilgrastim group were administered. Of the cycles administered, 94% (137/145) and 93% (175/188) respectively were at planned dose and on time. Across the whole study, the proportion of subjects receiving chemotherapy at planned dose and on time was 81% (21/26) filgrastim and 69% (22/32) pegfilgrastim; with the proportion of subjects decreasing from cycle 2–6 (92% filgrastim and 100% pegfilgrastim in cycle 2 vs. 91% and 83% in cycle 6). The proportion of subjects reporting severe or life threatening adverse events were comparable (9 subjects, 35% filgrastim, 13 subjects, 41% pegfilgrastim). The only events reported by more than 2 subjects in either treatment group were anaemia (4, 15% vs. 4, 13%), febrile neutropenia (1, 4% vs. 3, 9%), and pyrexia (0% vs. 3, 9%). By the end of treatment, the overall response rate was 96% (25/26) for filgrastim and 94% (30/32) for pegfilgrastim subjects. This exploratory study suggests that it is feasible to deliver CHOP-R chemotherapy at planned dose and on time every 14 days, with once per cycle administration of pegfilgrastim or daily administration of filgrastim. Pegfilgrastim is safe and well tolerated with a safety profile similar to daily filgrastim in this subject population.


Author(s):  
Allassane F Ouattara ◽  
Catherine M Bjerum ◽  
Méité Aboulaye ◽  
Olivier Kouadio ◽  
Vanga K Marius ◽  
...  

Abstract Background Ivermectin (IVM) plus albendazole (ALB), or IA, is widely used in mass drug administration (MDA) programs that aim to eliminate lymphatic filariasis (LF) in Africa. However, IVM can cause severe adverse events in persons with heavy Loa loa infections that are common in Central Africa. ALB is safe in loiasis, but more information is needed on its efficacy for LF. This study compared the efficacy and safety of three years of semiannual treatment with ALB to annual IA in persons with bancroftian filariasis. Methods Adults with Wuchereria bancrofti microfilaremia (Mf) were randomized to receive either three annual doses of IA (N=52), six semiannual doses of ALB 400mg (N=45), or six semiannual doses of ALB 800mg (N=47). The primary outcome amicrofilaremia at 36 months. Findings IA was more effective for completely clearing Mf than ALB 400mg or ALB 800mg (79%, CI 67-91; vs. 48%, CI 32-66 and 57%, CI 41-73, respectively). Mean % reductions in Mf counts at 36 months relative to baseline tended to be greater after IA (98%, CI 88-100) than after ALB 400mg (88%, CI 78-98) and ALB 800mg (89%, CI 79-99) (P=0.07 and P=0.06, respectively). Adult worm nest numbers (assessed by ultrasound) were reduced in all treatment groups. Treatments were well tolerated. Interpretation Repeated semiannual treatment with ALB is macrofilaricidal for W. bancrofti and leads to sustained reductions in Mf counts. This is a safe and effective regimen that could be used as MDA to eliminate LF in areas ivermectin cannot be used.


2020 ◽  
Vol 27 (12) ◽  
pp. 2596-2600
Author(s):  
Irfan Ahmad ◽  
Muhammad Israr ul Haq ◽  
Ghulam Abbas

Objectives: To determine efficacy of sofosbuvir and daclatasvir in the treatment of chronic hepatitis C infection. Study Design: Open label uncontrolled interventional study. Setting: Hepatitis Clinic, Sheikh Zayed Medical College/Hospital, Rahim Yar Khan. Period: June to December 2018. Material & Methods: Five hundred treatment naïve chronic hepatitis C patients including those with compensated cirrhosis were included in the study. They were given sofosbuvir 400 mg daily and daclatasvir 60 mg daily. Weight based ribavirin was added if patient has evidence of cirrhosis. Treatment duration was 12 weeks for non-cirrhotic and 24 weeks for cirrhotics. End of treatment response (ETR) was recorded. Results: Mean age of the included patients was 41±11.69 with range from 8 to 82 years, while 217 (43.4 %) patients were male and 283 (56.6 %) were female. Cirrhosis was present in 59 (11.8 %) patients; among these 35.6 % were in Child A and 64.4 % in early Child B. End of treatment response occurred in 491 (98.2 %) patients and there was no significant difference in ETR between male and female patients, and between cirrhotic and non-cirrhotic. Similarly, there was no significant difference in age between those having ETR and those having no ETR. Fatigue was experienced by 13.2 % and headache by 4.2 % patients. Conclusion: The combination of sofosbuvir and daclatasvir has high response rate in chronic hepatitis C patients of our population.


2021 ◽  
Author(s):  
Peter W Horby ◽  
Guilherme Pessoa-Amorim ◽  
Natalie Staplin ◽  
Jonathan R Emberson ◽  
Enti Spata ◽  
...  

Background: Aspirin has been proposed as a treatment for COVID-19 on the basis of its antithrombotic properties. Methods: In this randomised, controlled, open-label trial, several possible treatments were compared with usual care in patients hospitalised with COVID-19. Eligible and consenting adults were randomly allocated in a 1:1 ratio to either usual standard of care alone or usual standard of care plus 150mg aspirin once daily until discharge using web-based simple (unstratified) randomisation with allocation concealment. The primary outcome was 28-day mortality. The trial is registered with ISRCTN (50189673) and clinicaltrials.gov (NCT04381936). Findings: Between 01 November 2020 and 21 March 2021, 7351 patients were randomly allocated to receive aspirin and 7541 patients to receive usual care alone. Overall, 1222 (17%) patients allocated to aspirin and 1299 (17%) patients allocated to usual care died within 28 days (rate ratio 0.96; 95% confidence interval [CI] 0.89-1.04; p=0.35). Consistent results were seen in all pre-specified subgroups of patients. Patients allocated to aspirin had a slightly shorter duration of hospitalisation (median 8 days vs. 9 days) and a higher proportion were discharged from hospital alive within 28 days (75% vs. 74%; rate ratio 1.06; 95% CI 1.02-1.10; p=0.0062). Among those not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (21% vs. 22%; risk ratio 0.96; 95% CI 0.90-1.03; p=0.23). Aspirin use was associated with an absolute reduction in thrombotic events of 0.6% (SE 0.4%) and an absolute increase in clinically significant bleeding of 0.6% (SE 0.2%). Interpretation: In patients hospitalised with COVID-19, aspirin was not associated with reductions in 28-day mortality or in the risk of progressing to invasive mechanical ventilation or death but was associated with a small increase in the rate of being discharged alive.


2019 ◽  
Vol 1 (Supplement_1) ◽  
pp. i17-i17
Author(s):  
Yosef Ellenbogen ◽  
Karanbir Brar ◽  
Nebras Warsi ◽  
Jetan Badhiwala ◽  
Alireza Mansouri

Abstract BACKGROUND: Upwards of 50% of patients with advanced breast cancer are diagnosed with brain metastases (BM). Treatment options for these patients have been rapidly evolving due to increased understanding of the tumor pathophysiology and its genetic underpinnings. This systematic review of randomized controlled trials (RCTs) aims to clarify the evidence guiding the treatment of brain metastases from breast cancer. METHODS: MEDLINE, EMBASE, Cochrane Controlled Register of Trials, ClincialTrials.gov, and Web of Science were searched from inception to October 2018 for RCTs comparing treatments for breast cancer BM. We screened studies, extracted data, and assessed risk of bias independently and in duplicate. Outcomes assessed were overall survival (OS), progression-free survival (PFS), and adverse events (Grade 3+). RESULTS: Among 3188 abstracts, only 3 RCTs (N=412; mean sample size per group N=54.7) meeting inclusion criteria were identified. The studies were phase II or III open-label parallel superiority trials. Inclusion criteria among these trials consisted of age &gt;18 with radiologic evidence of &gt;1 BM. Exclusion criteria consisted of poor-performance functional status (ECOG &gt;2 or KPS &lt; 70). The treatment groups included whole-brain radiation therapy (WBRT) vs WBRT + Temozolomide, WBRT vs WBRT + Efaproxiral, and Afatinib vs Vinorelbine vs investigators’ choice (86% of these patients received WBRT or SRS prior to study enrolment). While two trials found no significant difference in OS, one trial found significant improvement in OS with Efaproxiral in addition to WBRT compared to WBRT alone (HR 0.52; 95%CI 0.332–0.816). No significant differences were found with PFS or rate of adverse events amongst treatment groups. CONCLUSION: Considering the high prevalence of breast cancer BM and our improved understanding of genomic/molecular features of these tumors, a greater number of RCTs dedicated at this disease are needed.


2020 ◽  
Vol 7 (11) ◽  
Author(s):  
Kerrie Davies ◽  
Damian Mawer ◽  
A Sarah Walker ◽  
Claire Berry ◽  
Timothy Planche ◽  
...  

Abstract Background Lower Clostridium difficile spore counts in feces from C difficile infection (CDI) patients treated with fidaxomicin versus vancomycin have been observed. We aimed to determine whether environmental contamination is lower in patients treated with fidaxomicin compared with those treated with vancomycin/metronidazole. Methods The CDI cases were recruited at 4 UK hospitals (Leeds, Bradford, and London [2 centers]). Environmental samples (5 room sites) were taken pretreatment and at 2–3, 4–5, 6–8, and 9–12 days of treatment, end of treatment (EOT), and post-EOT. Fecal samples were collected at diagnosis and as often as produced thereafter. Swabs/feces were cultured for C difficile; percentage of C difficile-positive samples and C difficile bioburden were compared between different treatment arms at each time point. Results Pre-EOT (n = 244), there was a significant reduction in environmental contamination (≥1 site positive) around fidaxomicin versus vancomycin/metronidazole recipients at days 4–5 (30% vs 50% recipients, P = .04) and at days 9–12 (22% vs 49%, P = .005). This trend was consistently seen at all other timepoints, but it was not statistically significant. No differences were seen between treatment groups post-EOT (n = 76). Fidaxomicin-associated fecal positivity rates and colony counts were consistently lower than those for vancomycin/metronidazole from days 4 to 5 of treatment (including post-EOT); however, the only significant difference was in positivity rate at days 9–12 (15% vs 55%, P = .03). Conclusions There were significant reductions in C difficile recovery from both feces and the environment around fidaxomicin versus vancomycin/metronidazole recipients. Therefore, fidaxomicin treatment may lower the C difficile transmission risk by reducing excretion and environmental contamination.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 18548-18548
Author(s):  
C. F. Pollera ◽  
F. Nelli ◽  
T. Gamucci ◽  
I. Sperduti ◽  
A. M. Giampaolo ◽  
...  

18548 Background: Direct comparison of EA vs EB vs DE has never been performed. In order to define the efficacy, impact on quality of life (QL) and pt’s preference, a prospective observational comparison of erythropoietic agents has been carried out. Methods: Anemic pts (hgb <11 gr/dL) scheduled to receive at least 3 cycles of CT were stratified according to 5 factors (platinum-based CT vs non-platinum; hgb ≤9,5 vs >9,5; PS ≤0–1 vs >1; previous CT vs upfront CT; and previous antianemic therapy vs not) and were autonomously assigned by 15 investigators to EA (3 times a week) or EB (3 times a week and only in pts receiving platinum-based CT) or DE (once a week) therapy. Efficacy by hgb level changes and transfusion needing was evaluated after each cycle of CT, QL by Fact-An questionnaire after 1 and 3 cycles of CT, and pt’s preference for standard vs weekly schedule at least once thereafter. Results: From 09/04 to 12/05 177 pts were recruited: 41%, 39% and 20% were assigned to DE, EA and EB, respectively. Severe anemia at baseline (≤9,5) was reported in 29% of pts, whereas 47% received platinum-based CT. Stratifying categories were well balanced among the treatment groups. Baseline mean hgb values were 9.7, 9.9, and 10 for DE, EA and EB, respectively. As of the general population, DE produced higher subsequent mean hgb increase in respect to EA and EB (Mean increase [gr/dL] for DE: 0.84, 1.58, 2.03; EA: 0.34, 0.84, 1.68; EB: 0.76, 1.54, 1.17). No difference was observed neither among pts receiving platinum-based CT, (mean increase: DE: 0.34, 1.76, 2.8; EA: 0.7, 1.27, 2.14; EB: 0.76, 1.54, 1.71) nor among pts with severe anemia at baseline (DE: 0.98, 2, 2.6; EA: 1.24, 1.94, 3.13; EB: 1.25, 2.25, 2.75). Transfusion needing ranged from 7% for DE to 3% for EB without any significant difference. To date 67% of pts completed at least one subsequent QL valuation, whereas 62% gave their preference for treatment schedule. Conclusions: Early results of our prospective analysis show that antianemic therapy with D is at least as effective as standard schedule of EA or EB. Efficacy of DE seems confirmed in pts with bad prognostic categories for anemia. Major data on QL and pt’s preference will be presented. No significant financial relationships to disclose.


Blood ◽  
1993 ◽  
Vol 81 (6) ◽  
pp. 1428-1434 ◽  
Author(s):  
A Osterborg ◽  
M Bjorkholm ◽  
M Bjoreman ◽  
G Brenning ◽  
K Carlson ◽  
...  

Three hundred thirty-five previously untreated patients with multiple myeloma in clinical stages II and III entered a randomized trial comparing intermittent oral melphalan and prednisone (MP) therapy (n = 171) with MP in combination with natural (leukocyte-derived) alpha- interferon (MP/IFN) (n = 164). The treatment groups were comparable with regard to major prognostic factors. The response frequency was 42% in the MP group and 68% in the MP/IFN group (P < .0001). Eighty-five percent of IgA myelomas and 71% of Bence-Jones myelomas responded to MP/IFN compared with 48% and 27%, respectively, to MP treatment (P = .001). There was no difference in the overall survival between the two treatment groups. However, the survival of 72 patients with IgA or Bence-Jones myeloma randomized to receive MP/IFN was significantly longer (median 32 months) than that of 71 patients treated with MP (median 17 months) (p < .05). No statistically significant difference in response frequency (60% v 46%) or survival was found for patients with IgG myeloma. Hematologic toxicity, WHO grades III and IV, was higher in the MP/IFN group (48%) than in the MP group (33%) (P <.05) during the induction treatment period. Flulike syndrome was observed in 68% of patients receiving MP/IFN. The results show that MP/IFN is a well-tolerated treatment regimen, superior to MP for remission induction, and it improves significantly the overall survival for patients with IgA and Bence-Jones myelomas.


2019 ◽  
Vol 37 (14) ◽  
pp. 1200-1208 ◽  
Author(s):  
Neil Bayman ◽  
Wiebke Appel ◽  
Linda Ashcroft ◽  
David R. Baldwin ◽  
Andrew Bates ◽  
...  

PURPOSE Prophylactic irradiation to the chest wall after diagnostic or therapeutic procedures in patients with malignant pleural mesothelioma (MPM) has been a widespread practice across Europe, although the efficacy of this treatment is uncertain. In this study, we aimed to determine the efficacy of prophylactic radiotherapy in reducing the incidence of chest wall metastases (CWM) after a procedure in MPM. METHODS After undergoing a chest wall procedure, patients with MPM were randomly assigned to receive prophylactic radiotherapy (within 42 days of the procedure) or no radiotherapy. Open thoracotomies, needle biopsies, and indwelling pleural catheters were excluded. Prophylactic radiotherapy was delivered at a dose of 21 Gy in three fractions over three consecutive working days, using a single electron field adapted to maximize coverage of the tract from skin surface to pleura. The primary outcome was the incidence of CWM within 6 months from random assignment, assessed in the intention-to-treat population. Stratification factors included epithelioid histology and intention to give chemotherapy. RESULTS Between July 30, 2012, and December 12, 2015, 375 patients were recruited from 54 centers and randomly assigned to receive prophylactic radiotherapy (n = 186) or no prophylactic radiotherapy (n = 189). Participants were well matched at baseline. No significant difference was seen in the incidence of CWM at 6 months between the prophylactic radiotherapy and no radiotherapy groups (no. [%]: 6 [3.2] v 10 [5.3], respectively; odds ratio, 0.60; 95% CI, 0.17 to 1.86; P = .44). Skin toxicity was the most common radiotherapy-related adverse event in the prophylactic radiotherapy group, with 96 patients (51.6%) receiving grade 1; 19 (10.2%), grade 2; and 1 (0.5%) grade 3 radiation dermatitis (Common Terminology Criteria for Adverse Events, version 4.0). CONCLUSION There is no role for the routine use of prophylactic irradiation to chest wall procedure sites in patients with MPM.


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