Article

Preliminary assessment of efficacy of Nigella sativa seeds in acute lymphoblastic leukemia in local children

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Abstract

Newly diagnosed acute lymphoblastic leukemia (ALL) patients were randomly divided into Groups I-III; having 21, 20 and 21 patients each, respectively. Ten age, sex and socio-economically matched healthy subjects were included for reference. Blood samples were taken for hematological parameters. In all groups these procedures were repeated after every 0.5 month till 6 months (including first 3 months of completion of induction chemotherapy followed by maintenance therapy. Due to various reasons, 48 subjects (16 in each) completed the study and their data were analyzed. In conventional therapy (Group I), daunorubicin (1.5mg/kg,i/v weekly), vincristine (.4mg/kg i/v twice weekly) and prednisolone (5 mg/kg per day orally in 3 divided doses) were prescribed to patients of ALL as induction therapy for a period of 3 months. In Group II, L-asparaginase was administered in addition to Group I therapy in 100u/kg, i/m twice weekly dose. Powdered Nigella sativa seeds were given to Group III patients in addition to conventional therapy (without L-asparaginase) in 40 mg/kg orally in two equally divided doses. The data showed that prognosis was good in all groups and was similar in male and female. Remission rate (RR) was affected by increasing age and survival was better in younger patients. The prognosis was worse in patients with high (>50000/mm3) initial WBC counts. RR was negatively affected by severe anemia (Hb<8.0g/dl) which showed positive correlation with Hb level. ESR was markedly raised in majority of patients at presentation but remained high even after induction therapy. The RR and survival time were better in patients having blood ESR between 10 t o 100 mm/1st hr.

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... To the best of our knowledge, few clinical studies have been performed with N. sativa [128][129][130]. In children (2-18 years) with acute lymphoblastic leukemia N. saliva seed significantly improved the treatment outcome: the combination of TQ with other cytotoxic drugs, including L-asparaginase, administered at dose 40 mg/kg 2 times orally for 6 months led to a remission rate of 92%; at the same time TQ increased survival rate and exerted non-toxic effects in healthy subjects [128]. ...
... To the best of our knowledge, few clinical studies have been performed with N. sativa [128][129][130]. In children (2-18 years) with acute lymphoblastic leukemia N. saliva seed significantly improved the treatment outcome: the combination of TQ with other cytotoxic drugs, including L-asparaginase, administered at dose 40 mg/kg 2 times orally for 6 months led to a remission rate of 92%; at the same time TQ increased survival rate and exerted non-toxic effects in healthy subjects [128]. Furthermore, in one randomized phase 2 parallel-grouped clinical trial TQ reduced lesion in patients (aged 18-75 years) suffering from oral potential premalignant lesions at dose 100/200 mg for 2 years (ClinicalTrials.gov ...
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In recent times, scientific attention has been paid to different foods and their bioactive components for the ability to inhibit the onset and progress of different types of cancer. Nigella sativa extract, powder and seed oil and its main components, thymoquinone and α-hederin, have showed potent anticancer and chemosensitizing effects against various types of cancer, such as liver, colon, breast, renal, cervical, lung, ovarian, pancreatic, prostate and skin tumors, through the modulation of various molecular signaling pathways. Herein, the purpose of this review was to highlight the anticancer activity of Nigella sativa and it constitutes, focusing on different in vitro, in vivo and clinical studies and projects, in order to underline their antiproliferative, proapoptotic, cytotoxic and antimetastatic effects. Particular attention has been also given to the synergistic effect of Nigella sativa and it constitutes with chemotherapeutic drugs, and to the synthesized analogs of thymoquinone that seem to enhance the chemo-sensitizing potential. This review could be a useful step towards new research on N. sativa and cancer, to include this plant in the dietary treatments in support to conventional therapies, for the best achievement of therapeutic goals.
... The seed extracts have displayed cytotoxicity against breast, lung, and colon cancer cells [123,124]. Also, the essential oil reduced solid tumor volume and cancer metastasis and improved survival rate in mice [125] while reducing the side effects of conventional therapy in patients with acute lymphoblastic leukemia [126]. ...
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Metabolite profiling of cancer cells presents many opportunities for anticancer drug discovery. The Chinese, Indian, and African flora, in particular, offers a diverse source of anticancer therapeutics as documented in traditional folklores. In-depth scientific information relating to mechanisms of action, quality control, and safety profile will promote their extensive usage in cancer therapy. Metabolomics may be a more holistic strategy to gain valuable insights into the anticancer mechanisms of action of plants but this has remained largely unexplored. This review, therefore, presents the available metabolomics studies on the anticancer effects of herbal medicines commonly used in Africa and Asia. In addition, we present some scientifically understudied ‘candidate plants’ for cancer metabolomics studies and highlight the relevance of metabolomics in addressing other challenges facing the drug development of anticancer herbs. Finally, we discussed the challenges of using metabolomics to uncover the underlying mechanisms of potential anticancer herbs and the progress made in this regard.
... The oral administration of N. sativa (800 mg/kg) increased contractile and vascular functions and reduced oxidative stress in the cardiac tissue. Dogar et al. (2009) confirmed the safe utilization of N. sativa seed flour when children suffering from acute lymphoblastic leukemia (ALL) were fed with N. sativa powder (40 mg/kg) in two doses for a period of 3 months in combination with conventional therapy. It was observed that the side effects produced were lower in comparison with the ones produced by L-asparaginase and medications in the form of daunorubicin, vincristine, and prednisolone. ...
Chapter
The concept of nutraceutical foods has emerged as a result of several research intercessions. Nigella sativa, commonly known as black cumin, a member of the Ranunculaceae family has widespread abundance across the globe especially in Eastern Europe and West Asia. Out of plants of medicinal importance, it has one of the richest histories since it has been used in the form of medicine having herbal origin by several civilizations. The composition of black cumin seed depends on several factors primarily geographic distribution, harvesting time and agronomic patterns adopted as well. The seeds have been reported to exert positive and beneficial effects on lowering serum lipid profile, triglycerides level and enhancing high-density lipoprotein levels. The significance of this seed is also attributed to thymoquinone which is present to a level of 25% in the seed oil. Black cumin is comprising mainly of proteins, carbohydrates, oil in addition to crude fibre and minerals. Iron, phosphorus, and calcium have been reported to be at high levels while calcium, magnesium, zinc, copper, and manganese have been reported in lower amounts. Studies have supported the inclusion of black cumin and its bioac-tive components daily for the overall improvement of health. Nigella sativa seed has been one of the most important antidiabetic plants highly recommended by traditional practitioners. Crude and purified components of Nigella sativa seeds have been known to impart manifold pharmacological effects including antihypertensive,
... Other studies that examined Nigella sativa seeds on patients suffering from seasonal allergic rhinitis reported that use of Nigella sativa was effective in mild and moderate allergic rhinitis symptoms reduction, however adverse effects such as nasal dryness and diarrhea were observed in some patients, which are consider minor effects when compared with conventional drugs used for allergic rhinitis (Akhtar, 2016; A. Mohamed, Abdul, & Ahmed Alobaidi, 2012). In another study by Dogar et al., (2009) side effects such as pancreatitis, hyperbilirubinemia, diabetes mellitus, diarrhea and hypofibrinogenemia appeared when children with acute lymphoblastic leukemia were treated with L-asparaginase, while none of these serious effects were observed in patients who received conventional treatment with Nigella sativa seeds in a powder form. However, the study concluded that low side effects associated with the consumptions Nigella sativa seeds were significantly less when compared to conventional therapy and the use of L-asparaginase, thus Nigella sativa has high beneficial properties as an anti-cancer agent if given in combination with other cytotoxic drugs. ...
Article
The currently available antiviral agents are associated with serious adverse effects, coupled with the increasing rate of viral resistance to the existing antiviral drugs. Hence, the search for alternative natural remedies is gaining momentum across the globe. Nigella sativa Linnen, also called Black seed, is a medicinal plant that is gaining worldwide recognition and has been extensively investigated. The present work is aimed to review the existing literature on the antiviral efficacy of Nigella sativa extracts (oil & bioactive compounds). The findings reveal that numerous articles have been published on Nigella sativa and its beneficial effects against different kinds of diseases. However, the antiviral efficacy of Nigella sativa is yet to be given the proper research attention it deserves.
... Other studies that examined Nigella sativa seeds on patients suffering from seasonal allergic rhinitis reported that use of Nigella sativa was effective in mild and moderate allergic rhinitis symptoms reduction, however adverse effects such as nasal dryness and diarrhea were observed in some patients, which are consider minor effects when compared with conventional drugs used for allergic rhinitis (Akhtar, 2016; A. Mohamed, Abdul, & Ahmed Alobaidi, 2012). In another study by Dogar et al., (2009) side effects such as pancreatitis, hyperbilirubinemia, diabetes mellitus, diarrhea and hypofibrinogenemia appeared when children with acute lymphoblastic leukemia were treated with L-asparaginase, while none of these serious effects were observed in patients who received conventional treatment with Nigella sativa seeds in a powder form. However, the study concluded that low side effects associated with the consumptions Nigella sativa seeds were significantly less when compared to conventional therapy and the use of L-asparaginase, thus Nigella sativa has high beneficial properties as an anti-cancer agent if given in combination with other cytotoxic drugs. ...
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The purpose of the study was to examine the consumption practices and perception of ready-to-eat food among university students and employees in Kuala Lumpur, Malaysia. Through random sampling, a total of ninety-three respondents participated by answering questionnaires. The results showed that majority of the respondents (52%) consumed RTE food two to four times a week, and most of them (44%) consumed RTE food during lunch. The biggest motivator for the respondents to purchase RTE food was convenience (46%). It could be highlighted that majority of the respondents felt that fast-food restaurants to be very safe (11.8%), and that street foods to be very risky (34.4%). Most of the respondents were very worried about human spread diseases (such as Hepatitis B) and human spread bacteria (such as E. coli) when buying food (43%). When buying RTE food, consumers were most concerned about the cleanliness of the store they were buying their food from (66.7%). The present study indicated that university students and employees showed food safety awareness and concerns especially regarding RTE food. This study could benefit food marketers, and also public health organizations in their efforts to develop more effective education and dissemination of information to the public.
... One randomized controlled trial of poor quality examined Nigella sativa (black cumin) seeds in ALL in Pakistan. 15 Children were randomized to receive either (1) daunorubicin, vinca alkaloids, and steroids, ...
Article
Traditional and complementary medicine (T&CM) strategies are widely utilized in pediatric oncology, with many families reporting T&CM use with the intention to cure cancer. Study of T&CM agents presents many challenges, as a heterogeneous group of agents and techniques are used for a variety of different purpose in many different oncologic conditions. We present a systematic review of the literature examining published reports in which T&CM agents are used with an intention of cure. Twenty-two reports were identified, with most reports being of poor quality. Novel paradigms are likely needed to further investigate T&CM agents.
... These results were in agreement with Dogar et al., who investigate the efficacy of Nigella sativa seeds in ALL and found that no significant increase in ALT, AST, total serum bilirubin and alkaline phosphatase, in group received Nigella sativa oil in comparison with group not received [33] Ilham and Firas, [34], who investigate the effect of maintenance therapy for childhood ALL on the liver and found that seven of 30 children with ALL receiving daily oral 6-mercaptopurine and weekly methotrexate developed both hepatocellular destruction and intrahepatic cholestasis with abnormally elevated levels of serum aminotransferases enzymes, alkaline phosphatase and total serum bilirubin that mainly indicate biliary tract disorder [34] and El-Gharieb et al., who studied the hepatoprotective effect of NSO and vitamin E on liver of liver of workers exposed to organophosphorus insecticide, there was a significant reduction in serum hepatic transaminases in group received NSO [35] . ...
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Article
Abstract: Background: Acute lymphoblastic leukemia (ALL) is the most common childhood malignancies representing about one third of all pediatric cancers. Adding methotrexate to leukemia treatment protocols has been associated with an increased survival rate in children with ALL. The efficacy of this agent is often limited by its toxicity which can be reduced if supplemented with anti- oxidants. Nigella sativa has antioxidant property through different mechanisms. Objective: The aim of this work was to study the role of Nigella sativa oil in the protection against hepatotoxicity induced by methotrexate therapy in children with ALL and the impact on the treatment outcome. Patients and methods: The present study was conducted in the period between July 2010 and July 2013 on 40 children with newly diagnosed ALL including 28 males and 12 females, with mean age value of 9.17±3.81 years and they were divided into 20 patients of ALL under methotrexate therapy included in ALL treatment protocol, delayed leukovorin rescue (10 mg/m2 orally or IV every 6 hours for five doses beginning 48 hours after start of methotrexate infusion and Nigella sativa oil in form of soft gelatin capsule 450 mg in dose of 80mg/kg/day on three divided doses for one week after each methotrexate dose (Group II) and 20 patients of ALL under methotrexate therapy included in ALL treatment protocol, delayed leukovorin rescue (10 mg/m2 orally or IV every 6 hours for five doses beginning 48 hours after start of methotrexate infusion and placebo for one week after each methotrexate dose (Group III). This study also included 20 healthy children as a control group (11 males and 9 females) with their mean age value of 9.1+ 2.9 (Group I). All patients included in the study were subjected to the following investigations: Complete blood picture, bone marrow aspiration, cytochemistry, immunophenotyping and liver function testes. Results: There were no significant difference in serum bilirubin , alanine aminotransferase, aspartate amino-transferase, alkaline phosphase levels and prothrombin time between group II and group III but there was significant difference between group II and group III compared to controls. There was no significant difference in total protein, albumin, globulin levels, and albumin globulin ratio between studied groups. There were non-significant increase in total, direct and indirect serum bilirubin, serum ALT, AST, and alkaline phosphatase levels and prothrombin time in group II after methotrexate and Nigella sativa oil therapy but there was significant increase in group III after treatment with methotrexate and placebo with significant difference between group II and III after therapy. There were significant difference in overall and disease free survival between group II and group III. Conclusion: Oral administration of Nigella sativa oil in leukemic children can prevent MTX hepatotoxicity and improved survival in patients with ALL. Recommendations: Nigella sativa oil is recommended adjuvant drug as hepatoprotective agent in patients with ALL who received methotrexate therapy.
... These results were in agreement with Dogar et al. 2009 [40], who investigated the efficacy of black seed oil in ALL and found that no significant increase in ALT, AST, total serum bilirubin and alkaline phosphatase, in group received black seed oil in comparison with group not received, Al– Fakhri and Abid, 2005 [41], who investigated the effect of maintenance therapy for childhood ALL on the liver and found that seven of 30 children with ALL receiving daily oral 6–mercaptopurine and weekly methotrexate developed both hepatocellular destruction and intrahepatic cholestasis with abnormally elevated levels of serum aminotransferases, alkaline phosphatase and total serum bilirubin that mainly indicate biliary tract disorder and El-Gharieb et al. 2010 [42] who studied the hepatoprotective effect of black seed oil and vitamin E on the liver of workers exposed to organophosphorus insecticide and they found significant reduction in serum hepatic transaminases in group received black seed oil. ...
Article
'Acute lymphoblastic leukemia is the most common childhood malignancies'. Adding methotrexate to treatment protocols increased survival rate in children with leukemia. Methotrexate efficacy is limited by its hepatotoxicity. 'Aim of the study: To assess' the therapeutic value of Black seed oil in 'methotrexate induced hepatotoxicity in Egyptian children with acute lymphoblastic leukemia '. 'Subjects and methods: This study was conducted on 40 children with acute lymphoblastic leukemia' including 20 patients under methotrexate therapy and Black seeds 80mg/kg/day for one week after each methotrexate dose (Group II) and 20 patients under methotrexate and placebo (Group III).This study included also '20 healthy children as a control group' (Group I). All patients were subjected to complete blood picture, bone marrow aspiration and liver functions. No significant differences in liver functions between group II and III before therapy. There were non-significant increase in liver functions in group II after therapy but there was significant increase in group III with significant difference between group II and III after therapy. There were significant differences in prognosis regarding remission, relapse, death and 'disease free survival but no significant difference in overall survival between group II and III'. Black cumin seeds decreased MTX hepatotoxicity and improved survival in children with ALL and can be recommended as adjuvant drug in patients with ALL under methotrexate therapy.
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More than half of Thai patients with cancer take herbal preparations while receiving anticancer therapy. There is no systematic or scoping review on interactions between anticancer drugs and Thai herbs, although several research articles have that Thai herbs inhibit cytochrome P450 (CYP) or efflux transporter. Therefore, we gathered and integrated information related to the interactions between anticancer drugs and Thai herbs. Fifty-two anticancer drugs from the 2020 Thailand National List of Essential Medicines and 75 herbs from the 2020 Thai Herbal Pharmacopoeia were selected to determine potential anticancer drug–herb interactions. The pharmacological profiles of the selected anticancer drugs were reviewed and matched with the herbal pharmacological activities to determine possible interactions. A large number of potential anticancer drug–herb interactions were found; the majority involved CYP inhibition. Efflux transporter inhibition and enzyme induction were also found, which could interfere with the pharmacokinetic profiles of anticancer drugs. However, there is limited knowledge on the pharmacodynamic interactions between anticancer drugs and Thai herbs. Therefore, further research is warranted. Information regarding interactions between anticancer drugs and Thai herbs should provide as a useful resource to healthcare professionals in daily practice. It could enable the prediction of possible anticancer drug–herb interactions and could be used to optimize cancer therapy outcomes.
Chapter
Nigella sativa plant from Ranunculaceae family has been commonly used as traditional remedies by the ancient world such as Greeks, Romans, and Egyptians. The plant is also known black seed or black cumin. The plant is highly valued by Muslims all over the world as it has been mentioned by the Islamic Prophet Muhammad that the black seed has the capability of curing all diseases except death. The purpose of this chapter is to provide updated and categorized information on the traditional uses, chemical composition, biological activities, bioavailability, safety, toxicity, and clinical trials of N. sativa in order to explore their therapeutic potential and evaluate future research opportunities. Every part of this plant contains a valuable medicinal feature. It contains different types of active phytoconstituents like carbohydrates, volatiles, alkaloids, saponins, flavonoids, phenolics, glycoside, coumarins, fixed oils, proteins, vitamins, and minerals are present. The use of its seeds, whole plant, and oil is common for treatment of many diseases like hepatoprotective, antidiabetic, antiasthmatic, cardioprotective, analgesic, neuroprotective, antiinflammatory, antioxidant, antimicrobial, and anticancer effects. N. sativa has potential for the treatment of a wide range of diseases and has been well studied for its phytochemical properties. However, further scientific studies are needed to explore mechanisms of actions, adverse effects of the extracts, the effective therapeutic dose, and the therapeutic effect of major secondary metabolites.
Chapter
Abstract The concept of nutraceutical foods has emerged as a result of several research intercessions. Nigella sativa, commonly known as black cumin, a member of the Ranunculaceae family has widespread abundance across the globe especially in Eastern Europe and West Asia. Out of plants of medicinal importance, it has one of the richest histories since it has been used in the form of medicine having herbal origin by several civilizations. The composition of black cumin seed depends on several factors primarily geographic distribution, harvesting time and agronomic patterns adopted as well. The seeds have been reported to exert positive and beneficial effects on lowering serum lipid profile, triglycerides level and enhancing high-density lipoprotein levels. The significance of this seed is also attributed to thymoquinone which is present to a level of 25% in the seed oil. Black cumin is comprising mainly of proteins, carbohydrates, oil in addition to crude fibre and minerals. Iron, phosphorus, and calcium have been reported to be at high levels while calcium, magnesium, zinc, copper, and manganese have been reported in lower amounts. Studies have supported the inclusion of black cumin and its bioactive components daily for the overall improvement of health. Nigella sativa seed has been one of the most important antidiabetic plants highly recommended by traditional practitioners. Crude and purified components of Nigella sativa seeds have been known to impart manifold pharmacological effects including antihypertensive, hypoglycemic, antifungal, anti-inflammatory, and immune strengthening. Nigella sativa seed components have been also used in the production of functional cosmetic and dietary supplements as well. This chapter reports on the nutraceutical uses and applications of Nigella sativa seed flour. Keywords Acute lymphoblastic leukemia · Blood glucose · HbA1c · HOMA-IR · Nutraceutical importance · Food applications
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Conference Paper
Abstract: Background: ‘Acute lymphoblastic leukemia is the most common childhood malignancy’. Adding methotrexate to treatment protocols increased survival rate in children with leukemia. Methotrexate efficacy is limited by its hepatotoxicity. Aim of the study: To assess the therapeutic value of Black seed oil in ‘methotrexate induced hepatotoxicity in Egyptian children with acute lymphoblastic leukemia’. Subjects and methods: This study was conducted on 40 children with acute lymphoblastic leukemia’ including 20 patients under methotrexate therapy and Black seeds 80mg/kg/day for one week after each methotrexate dose [Group II] and 20 patients under methotrexate therapy and placebo [Group III]. This study included also ‘20 healthy children of matched age and sex as a control group’ [Group I]. All patients were subjected to complete blood picture, bone marrow aspiration and liver functions. Results: No significant differences in liver functions between group II and III before therapy were observed. There were nonsignificant increase in total, direct and indirect serum bilirubin, serum ALT, AST, and alkaline phosphatase levels and prothrombin time in group II after methotrexate and Black seed oil therapy but there was significant increase in group III after treatment with methotrexate and placebo with ‘significant differences between group II and III ʼ after therapy. There were significant differences in prognosis regarding remission, relapse, death and ‘disease free survival but no significant difference in overall survival between group II and III’. Conclusion: Black cumin seeds decreased MTX hepatotoxicity and improved survival in children with ALL and can be recommended as adjuvant drug in patients with ALL under methotrexate therapy. Keywords: Acute lymphoblastic leukemia, black seed oil, hepatotoxicity, methotrexate.
Full-text available
Conference Paper
Abstract Background: Acute Lymphoblastic Leukemia (ALL) is the most common childhood malignancies representing about one third of all pediatric cancers. Adding methotrexate to leukemia treatment protocols has been associated with an increased survival rate in children with ALL. The efficacy of this agent is often limited by its toxicity which can be reduced if supplemented with anti-oxidants. Nigella sativa has antioxidant property through different mechanisms. Objective: The aim of this work was to study the role of Nigella sativa oil in the protection against hepatotoxicity induced by methotrexate therapy in children with ALL and the impact on the treatment outcome. Patients and methods: The present study was conducted in the period between July 2010 and July 2013 on 40 children with newly diagnosed ALL including 28 males and 12 females, with mean age value of 9.17 ± 3.81 years and they were divided into 20 patients of ALL under methotrexate therapy included in ALL treatment protocol, delayed leukovorin rescue (10 mg/m2 orally or IV every 6 hours for five doses beginning 48 hours after start of methotrexate infusion and Nigella sativa oil in form of soft gelatin capsule 450 mg in dose of 80 mg/kg/day on three divided doses for one week after each methotrexate dose (Group II) and 20 patients of ALL under methotrexate therapy included in ALL treatment protocol, delayed leukovorin rescue (10 mg/m2 orally or IV every 6 hours for five doses beginning 48 hours after start of methotrexate infusion and placebo for one week after each methotrexate dose (Group III). This study also included 20 healthy children as a control group (11 males and 9 females) with their mean age value of 9.1+ 2.9 (Group I). All patients included in the study were subjected to the following investigations: Complete blood picture, bone marrow aspiration, cytochemistry, immunophenotyping and liver function testes. Results: There were no significant difference in serum bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphase levels and prothrombin time between group II and group III but there was significant difference between group II and group III compared to controls. There was no significant difference in total protein, albumin, globulin levels, and albumin globulin ratio between studied groups. There were non-significant increase in total, direct and indirect serum bilirubin, serum ALT, AST, and alkaline phosphatase levels and prothrombin time in group II after methotrexate and Nigella sativa oil therapy but there was significant increase in group III after treatment with methotrexate and placebo with significant difference between group II and III after therapy. There were significant differences in overall and disease free survival between group II and group III. Conclusion: Oral administration of Nigella sativa oil in leukemic children can prevent MTX hepatotoxicity and improved survival in patients with ALL. Recommendations: Nigella sativa oil is recommended adjuvant drug as hepatoprotective agent in patients with ALL who received methotrexate therapy.
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Objectives Nigella sativa (black seed or black cumin), which belongs to the Ranunculacea family, is an annual herb with many pharmacological properties. Among its many active constituents, thymoquinone (TQ) is the most abundant constituent of the volatile oil of Nigella sativa (N. sativa) seeds, and it is the constituent to which most properties of this herb are attributed. Methods PubMed-Medline, Scopus, and Web of Science databases were searched to identify randomized control trials (RCTs) investigating the therapeutic effects of N. sativa and/or TQ. In this review, we investigated the clinical uses of N. sativa and TQ in the prevention and the treatment of different diseases and morbidity conditions in humans. Results Black seed and TQ are shown to possess multiple useful effects for the treatment of patients with several diseases, such as inflammatory and auto-immune disorders, as well as metabolic syndrome. Also, other advantages, including antimicrobial, anti-nociceptive and anti-epileptic properties, have been documented. The side effects of this herbal medicine appear not to be serious, so it can be applied in clinical trials because of its many advantages. Conclusion Some effects of N. sativa, such as its hypoglycemic, hypolipidemic and bronchodilatory effects, have been sufficiently studied and are sufficiently understood to allow for the next phase of clinical trials or drug developments. However, most of its other effects and applications require further clinical and animal studies.
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Background: 'Acute lymphoblastic leukemia is the most common childhood malignancy'. Adding methotrexate to treatment protocols increased survival rate in children with leukemia. Methotrexate efficacy is limited by its hepatotoxicity. Aim of the study: To assess the therapeutic value of Black seed oil in 'methotrexate induced hepatotoxicity in Egyptian children with acute lymphoblastic leukemia'. Subjects and methods: This study was conducted on 40 children with acute lymphoblastic leukemia' including 20 patients under methotrexate therapy and Black seeds 80mg/kg/day for one week after each methotrexate dose [Group II] and 20 patients under methotrexate therapy and placebo [Group III]. This study included also '20 healthy children of matched age and sex as a control group' [Group I]. All patients were subjected to complete blood picture, bone marrow aspiration and liver functions. Results: No significant differences in liver functions between group II and III before therapy were observed. There were non-significant increase in total, direct and indirect serum bilirubin, serum ALT, AST, and alkaline phosphatase levels and prothrombin time in group II after methotrexate and Black seed oil therapy but there was significant increase in group III after treatment with methotrexate and placebo with 'significant differences between group II and III ʼ after therapy. There were significant differences in prognosis regarding remission, relapse, death and 'disease free survival but no significant difference in overall survival between group II and III'. Conclusion: Black cumin seeds decreased MTX hepatotoxicity and improved survival in children with ALL and can be recommended as ad-juvant drug in patients with ALL under methotrexate therapy.
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A standardized, reproducible Ivy bleeding time technic has been described which permits one to obtain accurate bleeding time data in man. The technic was used to standardize an aspirin tolerance test in which 60 normal males had a control bleeding time; were given, on a double blind basis, either placebo or 1 Gm. of aspirin, and had a second bleeding time 2 hours later. The control values were: mean, 5 min.; mean ± 2 st. dev., 2 min., 30 sec. to 10 min. The values after placebo were: mean, 5 min., 30 sec.; mean ± 2 st. dev., 2 min., 30 sec. to 11 min. The values after aspirin were: mean, 9 min., 30 sec.; mean ± 2 st. dev., 4 min. to 21 min. The difference between the mean bleeding time after placebo and after aspirin was highly significant (p < 0.001). The distribution of the bleeding times after aspirin suggested that normal subjects do not respond to aspirin as a single population. The degree of prolongation of the bleeding time and the large size of the drops of blood observed in some subjects suggested to us that small amounts of aspirin may exert a significant effect upon hemostasis in normal individuals.
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Between June 1991 and September 1992, 80 patients with adult acute lymphoblastic leukemia (ALL) (newly diagnosed, n = 68; relapsed or refractory ALL, n = 7; lymphoid blast transformation of Philadelphia chromosome-positive chronic myelogenous leukemia [LT-CML], n = 5) were managed with a combination regimen consisting of idarubicin 36, 20, or 10 mg/m2 plus vincristine, L-asparaginase, and prednisolone (IVAP-1, -2, -3). Three patients with LT-CML and four with relapsing ALL had a complete remission. In the group of newly diagnosed patients aged 15 to 60 years treated with IVAP-1, the complete remission rate was only 44% due to the high incidence of toxic deaths. In contrast, 39 of 44 cases who subsequently received IVAP-2 achieved a complete remission (89%, P = .001), as did 62% of elderly patients who received IVAP-3. Hematologic and nonhematologic toxicity was significantly reduced with IVAP-2 compared with IVAP-1. The use of recombinant human granulocyte colony-stimulating factor in 24 patients was not associated with a reduced duration of granulocytopenia less than 0.5 x 10(9)/L, although there was a lower incidence of documented infections in patients receiving granulocyte colony-stimulating factor than in controls. Post-remission intensification with idarubicin-based courses, high-dose therapy with autologous bone marrow stem cell rescue, and rotational weekly therapy was feasible and its toxicity was manageable. These preliminary findings indicate that IVAP-2 (idarubicin 20 mg/m2) is a highly effective and well-tolerated regimen for remission induction of adult ALL.
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Reports on the outcome of treatment in ALL in Asian (non-Caucasian) adults have been few, and published results compare very unfavourably with results of treatment from 'Western' centres. Seventy-four newly diagnosed Malaysian patients with ALL between the ages of 15 and 69 were treated from 1986 to 1990. The clinical features and prognostic factors were similar to those reported in 'Western' series. The chemotherapy protocol utilized was adapted from the one used by Hoelzer et al in the multicentre German study. The complete remission rate was 73%. The probability of continuous complete remission at 5 years was 29% with a median duration of remission of 15 months. This compares with Hoelzer's initial results of 77% CR rate and 35% CCR at 5 years. Patients with an initial white cell count of less than 30 x 10(9)/l at presentation were found to have a significantly better disease-free survival than those with a count of more than 30 x 10(9)/l (35 vs 22%, P = 0.026, univariate analysis). There was no difference in leukaemia-free survival according to age, sex, ethnic group, or immunophenotype. These results show that the use of moderately intensive chemotherapy protocols in Asian (non-Caucasian) patients achieves similar results to those used in Caucasians. We also showed that the difficulties in 'curing' approximately 70% of adult patient with ALL are universal.
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L-asparaginase is a valuable chemotherapeutic agent used in the induction of remission and improvement of long term survival in patients with acute lymphoblastic leukemia. Hyperglycemia is a well known side effect of L-asparaginase. Fourteen patients developed hyperglycemia during induction therapy of acute lymphoblastic leukemia with L-asparaginase, prednisolone, vincristine and daunorubicin. Hyperglycemia was observed after a mean of five doses of L-asparaginase (range 2-10). Seven of fourteen patients had neutropenic related infective episodes. Hyperglycemia resolved in all patients within 12 days (range 4-25) and two patients died of neutropenic septicemia. During reinduction therapy with the same drugs, only one out of ten patients developed hyperglycemia E-coli-L-asparaginase was replaced by Erwinia asparaginase in two patients one of who had recrudescence on further therapy. Close monitoring during L-asparaginase therapy for hyperglycemia will enable prompt recognition and early correction and prevent delay in therapy of acute lymphoblastic leukemia.
Article
A randomized clinical trial of combination chemotherapy for adult acute lymphoblastic leukemia (ALL) with doxorubicin, vincristine and prednisolone with and without L-asparaginase (AdVP vs L-AdVP) was conducted, involving 58 institutions throughout Japan. After reaching complete remission (CR), patients were treated with the same regimen for more than 2 years. Among 166 evaluable cases of the 198 cases enrolled, CR rates were 63.1% (53/84) with AdVP and 64.6% (53/82) with L-AdVP (P = 0.837). Median survival times and 7-year survival rates were 12.7 months and 21.2% with AdVP, and 16.0 months and 22.3% with L-AdVP (P = 0.955 by generalized Wilcoxon test [GW], P = 0.952 by log-rank test [LR]). Median disease-free survival times and 7-year survival rates were 13.5 months and 23.8% with AdVP and 17.0 months and 30.6% with L-AdVP, showing some increments for L-AdVP but no statistical significance (P = 0.141 by GW, P = 0.300 by LR). Among the cases of extramurally confirmed FAB subtypes, CR rates were 75.9% (63/83) for the L1 subtype and 51.3% (39/76) for the L2 subtype (P = 0.001). As to adverse effects, pancreatitis was complicated more frequently in L-AdVP than in AdVP (P = 0.039). Other side effects such as hyperbilirubinemia, diabetes mellitus, diarrhea and hypofibrinogenemia were observed more frequently with L-AdVP, but with no statistical significance. Thus, addition of a single course of L-asparaginase in the induction phase of combination chemotherapy with doxorubicin, vincristine and prednisolone did not significantly enhance the effect of antileukemic treatment of adult ALL.