Effect of Salvestrol as an Adjunct in the Treatment of Head & Neck, GIT, Ovary, Breast and Lung Malignancies Undergoing Conventional Treatment in an Indian Population

Author(s):  
Bathoju Gayathri

Background: Previous studies have elucidated that Salvestrols are a class of phytonutrients that, function through an extremely targeted mechanism that hinges on their metabolism by the universal cancer marker CYP1B1, causing cell apoptosis. Unfortunately, modern-day cultivation practices have severely limited the obtainability of these specific phytonutrients in the modern food regime. These phytonutrients are all phytoalexins and are not induced in abundance until the plants are exposed to predation or infection as a part of their defense mechanism. Hence this investigation aims to study the effect of Salvestrol as an adjunct to routine cancer therapy on five different types of malignancies and to assess its impact on survival and quality of life has been studied. Patients and Methods: This is a two-arm study comprising of a cohort of 102 patients having cancers of the head and neck, lung, ovary, breast, and GIT. The patients in both the arms were randomized to receiving chemotherapy, radiotherapy, and surgery or in combination. The test group received the above along with Salvestrol (6000 salvestrol units as leader dose for 1 month followed by maintenance 4000 salvestrol units till death or discontinuation). The control arm received the same treatment as the test arm minus the salvestrol. Vitamin C and B complex was given to both groups. Results: The mean overall survival in the head and neck cancer salvestrol arm was 15.91 ±10.73 months and that of the controls was 8.0 ± 5.83 months, which was statistically significant (P=0.0441). The mean overall survival in the lung cancer salvestrol arm was 8.708 ± 9.006 months and in the controls was 2.292 ±1.484 months, which was statistically significant (p=0.0234). The mean overall survival in the GIT salvestrol arm was 10.000 ± 10.317 months and that in the control arm was 3.550 ± 3.700 months which was statistically significant (p=0.0792). The mean survival in the ovary salvestrol arm was 17.63 ± 7.19 months and in the control, the arm was 6.63 ± 7.56, which is very statistically significant (p=0.0099). The mean survival in the breast salvestrol arm was 21.80 ± 6.96 months and that of the control group was 22.10 ± 4.01 months (p=0.9073), which was statistically insignificant. The overall survival among the salvestrol patients was 14.480 ± 10.036 months as compared to 8.333 ± 8.507 months in the control arm (p=0.0012). The mean ECOG score was 1.12 ± 0.773 in the salvestrol arm (n=60) and 1.58 ± 0.8593 in the control arm (n=60), which was statically significant (p=.00591). The HAM-A scores were 2.4314 ± 2.9138 in the salvestrol arm (n=60) and 3.0612 ± 3.4666 in the control arm (n=60), which was statically insignificant (p=0.97). The mean PGSGA scores in the salvestrol arm (n=60) were 6.4688 ± 2.8959 and that in the control arm (n=60) was 7.625 ± 5.7291, which was also statistically insignificant (p=.312209). Conclusion: To date, there have been a case or series of reports on the efficacy of salvestrols in cancer. No randomized control trial has been undertaken with conventional treatment and salvestrol. Hence it was imperative to study the role of salvestrol in a randomized controlled fashion. This study was designed to compare the survival of 102 patients with five types of cancer by adding salvestrol in the prescribed treatment regime to one arm. As the results of the study showed improved overall survival in cancers of the head and neck, lung, GIT, and ovary, it may consider that salvestrols have played a role in survival, as both groups, received the same TNM based treatment. Salvestrols improved ECOG scores but not HAM –A or PGSGA. The use of salvestrol as an adjunct to surgery, radiotherapy and chemotherapy in GIT, lung, Head & neck and ovarian malignancies may prolong the overall survival and improve the ECOG status. CYP1B1 pathways and salvestrol were found to be promising solutions to improve cancer treatment with no added side effects or toxicity. Larger randomized studies are required to further confirm the role of salvestrols.

2005 ◽  
Vol 19 (4) ◽  
pp. 290-294 ◽  
Author(s):  
Juliano Cavagni ◽  
Ana Cristina Soletti ◽  
Eduardo José Gaio ◽  
Cassiano Kuchenbecker Rösing

The aim of this study was to evaluate, in rats, the role of the systemic use of dexamethasone in the pathogenesis of induced alveolar bone loss. In 26 female Wistar rats, ligatures were placed around the second upper molars, and the contralateral ones served as intra-group controls. Two groups were formed. The test group received 0.5 mg/kg of dexamethasone subcutaneously every third day during thirty days. The control group received the same amount of saline solution. After thirty days, the animals were sacrificed and their maxillae were removed. Sodium hypochlorite was used to prepare the specimens, and the cementum-enamel junction was stained with 1% methylene blue. Morphometric analysis of the alveolar bone loss was performed with standardized digital photographs, and the distance between the cementum-enamel junction and the alveolar bone crest was measured with the software ImageTool 3.0. Intra-examiner calibration revealed a Pearson correlation coefficient of 0.99. Statistical analysis was performed by paired or independent samplet tests, as appropriate (alpha = 0.05). Dexamethasone increased the mean alveolar bone loss in ligature-induced periodontitis in relation to the control group (0.77 and 0.61 buccally, and 0.65 and 0.56 palatally, respectively). No significant differences were observed intergroups in the teeth without ligatures. In the animal model used here, the use of dexamethasone increased the progression of ligature-induced alveolar bone loss.


Biology ◽  
2021 ◽  
Vol 10 (5) ◽  
pp. 358
Author(s):  
Javier Aragoneses ◽  
Ana Suárez ◽  
Nansi López-Valverde ◽  
Francisco Martínez-Martínez ◽  
Juan Manuel Aragoneses

The aim of this study was to evaluate the effect of implant surface treatment with carboxyethylphosphonic acid and fibroblast growth factor 2 on the bone–implant interface during the osseointegration period in vivo using an animal model. The present research was carried out in six minipigs, in whose left tibia implants were inserted as follows: eight implants with a standard surface treatment, for the control group, and eight implants with a surface treatment of carboxyethylphosphonic acid and immobilization of FGF-2, for the test group. At 4 weeks after the insertion of the implants, the animals were sacrificed for the histomorphometric analysis of the samples. The means of the results for the implant–bone contact variable (BIC) were 46.39 ± 17.49% for the test group and 34.00 ± 9.92% for the control group; the difference was not statistically significant. For the corrected implant–bone contact variable (BICc), the mean value of the test group was 60.48 ± 18.11%, and that for the control group, 43.08 ± 10.77%; the difference was statistically significant (p-value = 0.035). The new bone formation (BV/TV) showed average results of 27.28 ± 3.88% for the test group and 26.63 ± 7.90% for the control group, meaning that the differences were not statistically significant (p-value = 0.839). Regarding the bone density at the interthread level (BAI/TA), the mean value of the test group was 32.27 ± 6.70%, and that of the control group was 32.91 ± 7.76%, with a p-value of 0.863, while for the peri-implant density (BAP/TA), the mean value of the test group was 44.96 ± 7.55%, and that for the control group was 44.80 ± 8.68%, without a significant difference between the groups. The current research only found a significant difference for the bone–implant contact at the cortical level; therefore, it could be considered that FGF-2 acts on the mineralization of bone tissue. The application of carboxyethylphosphonic acid on the surface of implants can be considered a promising alternative as a biomimetic coating for the immobilization of FGF-2. Despite no differences in the new bone formation around the implants or in the interthread or peri-implant bone density being detected, the biofunctionalization of the implant surface with FGF-2 accelerates the mineralization of the bone–implant interface at the cortical level, thereby reducing the osseointegration period.


2020 ◽  
Vol 09 (03) ◽  
pp. 201-206
Author(s):  
Surabhi Chandra ◽  
Sahil Goel ◽  
Ritika Dawra

AbstractPediatric acute respiratory distress syndrome (PARDS) is a challenging problem with high mortality. Role of neuromuscular blockade in the management of ARDS to date has been controversial, and this study was done to study the role of neuromuscular blockade in children having PARDS and development of associated complications, if any. This was a prospective, case–control study conducted in the pediatric intensive care unit (PICU) of a tertiary care teaching hospital, over a period of 24 months. Patients of age 1 to 18 years who presented with or developed PARDS during their course of hospitalization were included after written informed consent was obtained from their parents and/or guardians. Patients with PARDS requiring invasive mechanical ventilation were partitioned into a case group and a control group. Case group patients were sedated and paralyzed using midazolam (1 µg/kg/min) and vecuronium (1 µg/kg/min), respectively, along with institution of definitive management. Control group patients were given definitive and supportive therapy, but no neuromuscular blocking agents (NMBAs). All patients were followed up for signs and symptoms of myopathy or neuropathy during the entire duration of hospital stay and up to 3 months after discharge. During the study period, 613 patients were admitted to the PICU of which 91 patients qualified as having PARDS. Sepsis was the main etiology in 67 of the 91 patients (73.6%) with PARDS. Fifty-nine patients were included in the study, of which 29 patients were included in the case group and 30 patients were included in the control group. Among the 29 case group patients, 25 patients (86.2%) were successfully extubated. Four patients from the case group expired, while 14 out of 30 control group patients (46.7%) expired. Hypotension was present in 26 case group patients (89.6%), of which all showed resolution within 48 hours of definitive treatment. The mean time to resolution of hypotension was 41.6 hours (standard deviation [SD]: 5.759; range: 24–48) for case group patients, significantly lower (p < 0.0001) than the mean time to resolution of 103 hours (SD: 18.995; range: 90–126) for the 10 control group patients with hypotension that survived. Mean oxygenation index (OI) following 48 hours of vecuronium therapy was significantly lower (p < 0.0001; 95% confidence interval: 5.9129–9.9671) than mean OI at admission for case group patients. None of the patients receiving vecuronium exhibited neuromuscular deficit during their hospital stay, at time of discharge, or at follow-up evaluation up to 3 months after discharge. In this study, pediatric cases diagnosed with PARDS and managed with mechanical ventilation and vecuronium therapy had improved mean OI following 48 hours of NMBA therapy and a lower mortality when compared with matched control group patients. Incidence of NMBA-related weakness was not commonly observed in these patients.


1963 ◽  
Vol 46 (3) ◽  
pp. 406-412
Author(s):  
D F Flick ◽  
James Winbush ◽  
Leo Friedman

Abstract The lower limits of sensitivity of the method by Douglass and Flick for the bioassay of the chick edema factor were more clearly delineated by studies this year in which toxic fatty material (TFM) was fed in duplicate trials at 0.00, 0.25, 0.50, 0.75, and 1.00 g per 16 g cottonseed oil, USP. Nine laboratories collaborated in these studies. Results indicated that the following criteria to establish presence of chick edema factor is valid: "t" value exceeds + 1.3, the mean log (pericardial fluid volume X 100) of the negative control group is 1.1460 or less, and the mean log (pericardial fluid volume X 100) of the test group is 1.1461 or more.


2018 ◽  
Vol 129 (4) ◽  
pp. 1017-1023 ◽  
Author(s):  
Eduardo Vieira ◽  
Thiago C. Guimarães ◽  
Igor V. Faquini ◽  
Jose L. Silva ◽  
Tammy Saboia ◽  
...  

OBJECTIVEDecompressive craniectomy (DC) is a widely used procedure in neurosurgery; however, few studies focus on the best surgical technique for the procedure. The authors’ objective was to conduct a prospective randomized controlled trial comparing 2 techniques for performing DC: with watertight duraplasty and without watertight duraplasty (rapid-closure DC).METHODSThe study population comprised patients ranging in age from 18 to 60 years who were admitted to the Neurotrauma Service of the Hospital da Restauração with a clinical indication for unilateral decompressive craniectomy. Patients were randomized by numbered envelopes into 2 groups: with watertight duraplasty (control group) and without watertight duraplasty (test group). After unilateral DC was completed, watertight duraplasty was performed in the control group, while in the test group, no watertight duraplasty was performed and the exposed parenchyma was covered with Surgicel and the remaining dura mater. Patients were then monitored daily from the date of surgery until hospital discharge or death. The primary end point was the incidence of surgical complications (CSF leak, wound infection, brain abscess, or subgaleal fluid collections). The following were analyzed as secondary end points: clinical outcome (analyzed using the Glasgow Outcome Scale [GOS]), surgical time, and hospital costs.RESULTSFifty-eight patients were enrolled, 29 in each group. Three patients were excluded, leaving 27 in the test group and 28 in the control group. There were no significant differences between groups regarding age, Glasgow Coma Scale score at the time of surgery, GOS score, and number of postoperative follow-up days. There were 9 surgical complications (5 in the control group and 4 in the test group), with no significant differences between the groups. The mean surgical time in the control group was 132 minutes, while in the test group the average surgical time was 101 minutes, a difference of 31 minutes (p = 0.001). The mean reduction in total cost was $420.00 USD (a 23.4% reduction) per procedure in the test group.CONCLUSIONSRapid-closure DC without watertight duraplasty is a safe procedure. It is not associated with a higher incidence of surgical complications (CSF leak, wound infection, brain abscess, or subgaleal fluid collections), and it decreased surgical time by 31 minutes on average. There was also a hospital cost reduction of $420.00 USD (23.4% reduction) per procedure.Clinical trial registration no.: NCT02594137 (clinicaltrials.gov)


Author(s):  
G. U. Ezeja ◽  
C. U. Onwudiwe ◽  
O. D. Nwodo ◽  
G. Umahi-Ottah ◽  
N. D. Nwobodo

Background: Ambient air pollution is a serious challenge to human health in most West African countries including Nigeria. Objective: The objective of the study was to determine the effects of dust inhalation on the vital capacity of commercial motorcyclists in Abakaliki metropolis. Methods: 200 subjects participated in this study, 100 commercial motorcyclists (test group) and 100 non-motorcyclists (control group). The mean ± S.D of their age, height and weight were calculated. Vital capacity was measured using a spirometer. A questionnaire and consent form was filled by every participant before the commencement of the study. A handheld laser dust measuring device called air sampler PCE-PCO 1 was used to analyze the quantity, quality and sizes of particulate matters present in the research area. Data were analyzed using descriptive and inferential statistics; Mean and standard deviations were calculated and the Z-test was used to test if the mean were significantly different. Level of significance was set at 95%. Results: The age of participants were within the range of 25 – 30 years. Commercial motorcyclists were exposed to particulate matter 0.5, 1.0 and 2.5 µm. The vital capacity of commercial motorcyclists was significantly lower than that of non-motorcyclists (p =0.01). Furthermore, a significant decrease in the vital capacity of commercial motorcyclists was observed when correlated with the number of years spent in the job (p = 0.03). There was also a significant correlation between vital capacity and hours spent per week among commercial motorcyclists (r = 0.245). Conclusion: Commercial motorcyclists need to be encouraged to adopt respiratory health safety strategies like use of full-face helmets, practice of active cycle of breathing techniques and also, be educated on air pollution hazards by public health workers.


2004 ◽  
Vol 16 (2) ◽  
pp. 207 ◽  
Author(s):  
A. Castro Neto ◽  
B.V. Sanches ◽  
S.H.V. Perri ◽  
M.M. Seneda ◽  
J.F. Garcia

The aim of the present study was to evaluate the effects of uterine double flushing on embryo recovery rates (total structures and viable embryos), after a resting period with the uterus filled with PBS. There were 210 embryo recovery procedures conducted using the uterine double flushing method, and the results were compaired with 432 conventional single flushing procedures. All procedures were conducted with Limousin (n=403) and Guzerá (n=239) cows, following the same superovulation protocol. Cyclic donors received a progestagen implant (CIDR) and 1mL of oestradiol benzoate (Estrogin®) at Day 0. Between Day 5 and Day 9 animals received doses ranging from 200 to 300UI (zebu cows) and 300 to 500UI (taurine cows) of FSH (Pluset® – Serono) in decreasing doses. Between Day 6 and Day 8 PGF2a (Ciosin®) was administered, followed by withdrawal of the progestagen after 24h. Artificial insemination was performed between 14 and 26h after the beginning of treatment. For the double flushing procedure, after the first uterine flushing of both horns with 1L DPBS (Nutricell), a Foley catheter was positioned in the uterine body in order to fill the uterus with the same solution (80 to 150mL). After this procedure the catheter was closed with a disposable 5-mL syringe gasket, and the animals were allowed to rest in the surroundings of the work place for 30min. After this period, a second flush was performed in order to recover the remaning liquid used during manipulation of the uterus. Animals from the control group (group A) were subjected to a single uterine flushing procedure. From 210 double flushing procedures (group B – test), 1409 viable embryos were produced, classified as grades I, II, III and IV (IETS), (average of 6.7 embryos per procedure), whereas, in the 432 single flushing procedure (group A – control), 1993 embryos were produced (average of 4.6). Statistical analysis showed the increase of viable embryo recovery rate. When consecutive double flushing was performed, the average of recovered embryos increased from 8.3 to 12.7 (P&lt;0.05) in Limousin cows, and from 7.9 to 11.5 (P&lt;0.05) in Guzerá cows. Comparing recovery after single flushing with that after double flushing, the mean number of viable embryos increased from 4.7 to 6.9 (P&lt;0.05) in Limousin cows and from 4.5 to 6.4 (P&lt;0.05) in Guzerá cows. In order to assure the nonexistence of negligence effects or operator influence on results, the mean values of total embryo recovery rate after single flushing (control group) was compared to the mean values of the same rate after the first uterine flushing on test group. Results indicated no difference between recovery rates. The present work showed the viability of using the uterine double flushing procedure for improvement of embryo recovery rates in cattle.


2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Shree Ram Lamichhane ◽  
Thanuja Thachil ◽  
Harriet Gee ◽  
Natalie Milic

Background. Circulating microRNAs (miRNAs) are potential molecular biomarkers for cancer detection; however, little is known about their prognostic role in head and neck cancer. This current study is aimed at evaluating the role of novel miRNAs in the survival of head and neck cancer patients. Materials and Methods. We performed a systematic literature search using online databases for articles published between December 2006 and February 2019. A meta-analysis was conducted to assess the correlation between miRNA expressions and overall survival (OS) among the selected head and neck cancer studies. After multilevel screening by reviewers, meta-analysis was performed using hazard ratios (HR) and associated 95% confidence interval (CI) of survival to calculate a pooled effect size. Result. A total of 1577 patients across 13 studies were included in the literature review, with 18 miRNAs upregulated and 4 miRNAs downregulated predicting a poor overall survival. The forest plot generated using cumulated survival data resulted in a pooled HR value of 2.943 (95% CI: 2.394-3.618) indicating a strong association of dysregulated miRNA expression with a poor outcome. Only 2 miRNAs—low levels of miR-9 and high levels of miR-483-5p—were observed in two studies, both showing a significant association with overall cancer survival. Conclusion. To our knowledge, this is the first comprehensive systematic review and meta-analysis that examines the prognostic role of circulating miRNAs from blood in head and neck cancer patients. The combined effect estimates a HR across multiple studies and also supports the previous individual findings that an alteration in miRNA expression is highly associated with poor prognosis. This has the potential to use serum and/or plasma miRNAs as biomarkers and become novel tools for predicting the prognosis of head and neck cancer patients in the near future.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Pei Liu ◽  
Weiye Wen ◽  
Ka Fung Yu ◽  
Xiaoli Gao ◽  
Edward Chin Man Lo ◽  
...  

Abstract Background Poor oral hygiene and high hormone levels during pregnancy can lead to a deterioration in periodontal health. This study assessed the effectiveness of a family-centered behavioral and educational counselling program on improving the periodontal health of women during pregnancy and postpartum. Methods A randomized controlled trial was conducted among pregnant women (10th-22nd gestational week) and their husbands. Participating families were randomized into test and control groups. Intervention in the test group included explanation of oral health education (OHE) pamphlets, oral hygiene instruction, individualized feedback, and proposed solutions to overcome barriers in self-care. Reinforcements were implemented in the 3rd trimester of pregnancy and six months postpartum. In the control group, only OHE pamphlets were distributed. The assessed outcomes were bleeding on probing (BOP), periodontal pocket (Poc), loss of clinical attachment (LoA), and Visible Plaque Index (VPI). The data collection was carried out at baseline (T0), in the 32nd gestational week (T1), and 12 months postpartum (T2). Results Altogether 589 pregnant women were recruited, and 369 attended all three visits (test:188; control:181). In the test group, the mean VPI score at T0 was 0.19, which decreased to 0.14 at T1 and 0.15 at T2. In the control group, the mean VPI decreased from 0.19 at T0 to 0.16 at T1, but increased to 0.22 at T2. A main effect of time and intervention and an interaction between time and intervention were detected (all p < 0.05), indicating that the intervention effect differed between T1 and T2. The test group showed a significantly greater decrease over time than the control group did. Similarly, the mean BOP% decreased more significantly over time in the test group (T0:57%, T1:46%, T2:35%) than in the control group (T0:58%, T1:52%, T2:46%). For Poc and LoA, there were improvements in both study groups at 12 months postpartum, compared with during pregnancy (p < 0.001). Conclusions Providing family-centered, behavioral, and educational counselling to pregnant women at an early stage of pregnancy and with reinforcements can improve their oral hygiene and reduce gingival inflammation. The effect can be sustained over an extended period and is greater than that of distributing oral health leaflets alone. Trial registration Clinicaltrials.gov, #NCT02937194. Registered 18 October 2016. Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02937194?cond=Family-centered+oral+health+promotion+for+new+parents+and+their+infants&draw=2&rank=1


2000 ◽  
Vol 84 (5) ◽  
pp. 775-779 ◽  
Author(s):  
Ramendra N. Mazumder ◽  
Hassan Ashraf ◽  
Syed S. Hoque ◽  
Iqbal Kabir ◽  
Naseha Majid ◽  
...  

To date there have been few reports on the impact of dietary intervention on the clinical course of acute shigellosis. Current management of acute shigellosis is primarily focused on antibiotic therapy with less emphasis on nutritional management. In a randomised clinical trial, we examined the role of an energy-dense diet on the clinical outcome in malnourished children with acute dysentery due to shigellosis. Seventy-five children aged 12–48 months with acute dysentery randomly received either a milk–cereal formula with an energy density of 4960 kJ/l (test group) or a milk–cereal formula with energy of 2480 kJ/l (control group) for 10 d in hospital. In both milk–cereal formulas, protein provided 11 % energy. In addition, the standard hospital diet was offered to all children and all children received an appropriate antibiotic for 5 d. The mean food intakes (g/kg per d) in the test and control groups were: 112 (SE 2·28) AND 116 (se 3·48) (P=0·16) on day 1; 118 (se 2·72) and 107 (se 3·13) (P=0·04) on day 5; 120 (se 2·25) and 100 (se 3·83) (P=0·04) on day 10. The mean energy intakes (kJ/kg per d) in the test and control groups respectively were: 622 (se 13·2) and 315 (se 11·3) (P<0·05) on day 1; 655 (se 15·1) and 311 (se 7·98) (P<0·05) on day 5; 672 (se 14·7) and 294 (se 11·1) (P<0·05) on day 10. The food and energy intakes were mostly from the milk–cereal diet. There was no difference between two groups in resolution of fever, dysenteric (bloody and or mucoid) stools, stool frequency and tenesmus. However, vomiting was more frequently observed among the test-group children during the first 5 d of intervention (67 % v. 41 %, P=0·04). There was an increase in the mean weight-for-age (%) in the test group compared with the control group after the 10 d of dietary intervention (6·2 (se 0·6) v. 2·7 (se 0·4), P<0·01). In addition, resolution of rectal prolapse was better (26 % v. 8 %, P=0·04) in the test group v. control group after 5 d, and 13 % v. 6 %, (P=0·08) after 10 d of dietary intervention. Supplementation with a high-energy diet does not have any adverse effect on clinical course of acute shigellosis and reduces the incidence of rectal prolapse in malnourished children.


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