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Journal of Pharmaceutical Negative Results
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  Citation statistics : Table of Contents
   2011| January-June  | Volume 2 | Issue 1  
    Online since July 15, 2011

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Negative intercepts in the Heckel analysis of the crude extract of Vernonia galamensis: A major setback of the equation
Musa Autamashih, Adamu B Isah, Teriyila S Allagh
January-June 2011, 2(1):14-19
Introduction: The dry powdered leaf of Vernonia galamensis (Asteraceae) has been used by traditional herbalists in northern Nigeria to treat diabetes mellitus. However, medicinal plants used in folk medicine have no standard dose or acceptable method of formulation. In this study therefore, the leaves of Vernonia galamensis (Asteraceae) were extracted, evaluated for pharmacological activity and formulated into tablets. Materials and Methods: The extract was found to be highly hygroscopic and deliquescent, therefore the following efflorescent diluents; aerosil® 200 (GmbH, Meggle, Germany), avicel PH 101 (Honey Well and Stein, UK), and anhydrous calcium phosphate (BDH chemicals, England) were used. The wet granulation method was employed for the tablet formulation and the compaction characteristics of the granules were determined using the Heckel equation. Results and Conclusions: Negative intercepts were a setback to the use of the Heckel equation due to the resulting negative values of D A and D B . This makes it difficult to explain the compaction characteristics of the crude extract.
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Quality of reporting of descriptive and inferential statistics in negative studies published in Indian medical journals
Jaykaran , Deepak Saxena, Preeti Yadav, ND Kantharia, Paresh Solanki
January-June 2011, 2(1):39-41
Aims and Objectives : It is observed that negative studies published in medical journals are underpowered to detect the actual difference between the groups, but no data are available on the quality of the statistics reported in these studies. Therefore, this study was carried out with aim of evaluating negative studies published in Indian medical journals for adequacy of reporting of descriptive and inferential statistics. Materials and Methods : All the original articles published in 14 Pubmed-indexed Indian medical journals were analyzed to determine whether the study was negative or positive. All the negative studies were analyzed for correctness of the descriptive statistics and inferential statistics. The types of data and statistical methods were also noted down. Descriptive statistics was used and values were expressed as frequency, percentages and confidence interval. Results : Incorrect descriptive statistics was mentioned in 15 (28.8%, 95% CI 18.3-42.2%) studies. Information related to assumptions of statistical tests were mentioned in only two (3.8%, 95% CI 1.0-12.9%) articles. Inappropriate/incorrect statistical tests was used in 22 (42.3%, 95% CI 29.8-55.8%) studies. The most common reason for inappropriate reporting of descriptive statistics was use of mean and SD for description of ordinal data. The most common reason for incorrect statistical test was use of parametric test for ordinal data. The most common statistical test was the t-test. Conclusion : Negative studies published in prominent Indian medical journals are statistically weak, and readers critically analyze these studies before making any opinion based on them.
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Absence of the antibacterial activity of the crude extracts and compounds isolated from M. rubiginosa against extended-spectrum β-lactamase producing enterobacteria
Geisiany M de Queiroz, Maria Gorete M de Souza, Tatiane C de Carvalho, Luciana A Casemiro, Wilson R Cunha, Carlos H. G. Martins
January-June 2011, 2(1):1-7
Objective: The present study evaluates the antibacterial activity (Minimum Inhibitory Concentration- MIC, Minimum Bactericidal Concentration- MBC) and the Fractional Inhibitory Concentration (FIC) of crude extracts and compounds isolated from Miconia rubiginosa against ten clinical bacterial isolates and one standard bacterial strain Expanded-Spectrum β-lactamase (ESBL)-producing enterobacteria. Materials and Methods: The crude extracts were obtained by maceration and the compounds isolated were purified through different chromatography techniques, and then structures were identified for physical methods of organic analysis. The evaluation of the antibacterial activity for the microdiluition in broth technique. Results: The MIC and MBC result for the ethanolic extract was 2.0 mg/mL. For the dichloromethane extract and ursolic acid and oleanolic acid, MIC was >2.0 mg/mL, but no bactericidal activity (MBC) was observed. The FIC values achieved with the combinatioin of the crude extracts with clavulanic acid were not significantly different. Conclusion: The ethanolic extract from Miconia rubiginosa exhibits better antibacterial activity, but the two isolated compounds are not active against the tested bacterial isolates. The combination of the crude extracts with clavulanic acid does not lead to synergism, and there are no statistical differences between the two crude extracts in this sense.
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Clinical trials with poor methodological quality and inappropriate statistics: Are they ethical?
Jaykaran , Deepak Saxena
January-June 2011, 2(1):42-43
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Animal research: reporting in vivo experiments: New guideline for reporting animal research
January-June 2011, 2(1):43-44
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Effect of grinding on in vitro floating behaviour of effervescent matrix tablets of ciprofloxacin hydrochloride: Negative impact on initial buoyancy
Jeetendra Singh Negi, Abhinav Trivedi, Vandana Negi, Aadesh Upadhyay, Nikhil Kasliwal
January-June 2011, 2(1):8-13
The purpose of this study was to form dispersion of sodium bicarbonate in hydroxyl-propyl methyl cellulose (HPMC K4M) matrix and investigate its impact on in vitro floating behaviour and drug release. The dispersion of sodium bicarbonate in HPMC K4M was achieved by grinding method using mortar and pestle. The in vitro floating behaviour and drug release of matrix tablets having grinding dispersion (GD) were compared with matrix tablets having physical mixture. The GD matrix tablets were having higher values of buoyancy lag time (BLT) in comparison to PM matrix tablets. However, the floating duration of GD matrix tablets was higher than that for PM matrix tablets. The swelling extent was also found higher for GD matrix tablets. Higher drug release rate was achieved with GD matrix tablets and drug release kinetics was explained by korsemeyer-peppas model. The values of diffusion coefficient (n) were found between 0.45−0.89, which indicates the anomalous type of drug transport.
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Insignificant difference seen on biofilm production among indwelling medical device associated bacterial isolates
Summaiya A Mulla, Sangita B Revdiwala
January-June 2011, 2(1):20-23
Aim of study : Biofilm formation is a developmental process with intercellular signals that regulate growth. Biofilms contaminate catheters, ventilators and medical implants; they act as a source of disease for humans, animals and plants. In this study we have done quantitative assessment of biofilm formation in device-associated clinical bacterial isolates in response to various concentrations of glucose in tryptic soya broth and with different incubation time. Materials and Methods: The study was carried out on 100 positive bacteriological cultures of medical devices which were inserted in hospitalized patients. The bacterial isolates were processed as per microtitre plate method with tryptic soya broth alone and with varying concentrations of glucose and were observed in response to time. Results: The majority of catheter cultures were positive. Out of the total 100 bacterial isolates tested, 88 were biofilm formers. Biofilm production was more in 0.25% than in 0.5% glucose concentration in tryptic soya broth. After 16-h incubation no significant difference was seen in biofilm production. Conclusions: Availability of nutrition in the form of glucose enhances the biofilm formation by bacteria, but further increase in glucose concentration could not enhance biofilm production. Biofilm formation depends on the adherence of bacteria to various surfaces.
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EDTA decreases in vitro transcorneal permeation of fluconazole in phosphate buffer through excised sheep cornea
Sunil Thakral, Munish Ahuja
January-June 2011, 2(1):24-27
Introduction: According to the World Health Organization, corneal diseases are a major cause of vision loss and blindness, second only to cataract in overall importance. Fungal keratitis is a major blinding eye disease in Asia. In epithelia, calcium has been implicated in the maintenance of intercellular matrix and therefore may be a key factor determining the size of potential paracellular routes for drug transport. Although the effects of chelating agents such as EDTA on the permeability of inorganic and organic solutes have been well documented in other epithelia, as well as the corneal endothelium, no definitive studies examining the effects of these compounds upon corneal epithelia have been reported. Materials and Methods: The corneal permeation studies were conducted using freshly excised sheep cornea, mounted between donor and receptor chambers of an all glass-modified Franz diffusion cell, containing 11 ml of ringer bicarbonate (pH 7.4, 34 o±1 o C). At the end of the experiment, each cornea (freed from sclera) was weighed, soaked in 1 ml of methanol, dried overnight at 90΀C and reweighed. From the difference in weights corneal hydration was calculated Results: Fluconazole ophthalmic solutions (0.2% w/v, pH 6.0) containing EDTA shows significant difference in P app 1.51×10 6 (cm/s) as compared to fluconazole ophthalmic solutions (0.2% w/v, pH 6.0) without EDTA showing 2.37×10 6 (cm/s). Conclusions: Use of ethylene diamine tetraacetate as chelating agent in fluconazole ophthalmic solutions significantly decreased the corneal permeability of fluconazole.
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Non-beneficial effects of rosiglitazone in oxaliplatin-induced cold hyperalgesia in rats
Vivek Jain, Amteshwar Singh Jaggi, Nirmal Singh
January-June 2011, 2(1):28-34
Background: Studies have suggested the ameliorative potential of PPAR g agonist in attenuating the nerve injury-induced neuropathic pain. However, their role in chemotherapy-induced neuropathic pain is not explored yet. Aims: To investigate the potential of rosiglitazone, a PPAR g agonist, in oxaliplatin-induced cold hyperalgesia in rats. Settings and Design: All animals were divided in nine groups and single administration of oxaliplatin (6 mg/kg ip) used for induction of neuropathy. Material and Methods : The pinprick, cold immersion, hot plate and hot immersion tests were performed to assess the degree of mechanical hyperalgesia, cold hyperalgesia, heat hyperalgesia, and heat allodynia, respectively. The levels of thiobarbituric acid reactive species (TBARS) and reduced glutathione (GSH) were measured as an index of oxidative stress. The myeloperoxidase (MPO) activity (a specific marker of inflammation) and calcium levels were also determined. Statistical analysis: Two-way analysis of variance (ANOVA) followed by Bonferroni's post test for behavioral assessment and one-way ANOVA followed by Tukey's multiple range tests for biochemical assessment were performed. Results: Single administration of oxaliplatin resulted in significant development of cold hyperalgesia without altering the nociceptive threshold for mechanical and heat stimuli. Furthermore, oxaliplatin increased the oxidative stress and decreased calcium levels without affecting inflammation. Treatment with rosiglitazone (2.5, 5, and 10 mg/kg po) for 11 days did not modulate oxaliplatin-induced cold hyperalgesia. Moreover, rosiglitazone did not modulate oxaliplatin-induced biochemical changes. Conclusions: PPAR g agonists are ineffective in attenuating the state of cold hyperalgesia during oxaliplatin administration.
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Study design and statistical methods in Indian medical journals
Jaykaran , Paresh Solanki, Deepak Saxena, ND Kantharia
January-June 2011, 2(1):35-38
Aims and Objectives: Types of study designs and statistical method utilized by authors for articles published in foreign journals has been widely documented. Few such attempts are also done for articles published in Chinese and Pakistani Journals but no such attempt has been documented for articles published in Indian Medical Journals. This manuscript is an attempt to appraising articles published in Indian Medical Journals in terms of study designs and statistical methods used. Materials and Methods: All the original articles published in 2009 from 14 PubMed indexed Indian Medical Journals were analyzed for study designs and statistical methods. These journals were Annals of Indian Academy of Neurology (AIAN), Indian Journal of Orthopedics (IJOrtho), Indian Journal of Critical Care Medicine (IJCCM), Indian Journal of Dermatology, Venereology and Leprology (IJDVL), Indian Journal of Nephrology (IJN), Indian Journal of Dermatology (IJD), Indian Journal of Ophthalmology (IJO), Indian Journal of Urology (IJU), Indian Journal of Anesthesia (IJA), Indian Journal of Psychiatry (IJPsy), Indian Pediatrics (IP), Indian Journal of Medical Research (IJMR), Indian Journal of Medical Science (IJMS) and Indian Journal of Community Medicine (IJCM). Values are shown as frequency and percentages. Results: Majority of the published articles were based on prospective study designs (60.8%). Clinical trials were as method of study was documented in 12.5% articles. Three most common tests were t test (23.2%), Chi-square test (21.9%) and analysis of variance (ANOVA) (10.5%). However, statistical methods were not at all used by 26.2% articles. Conclusions: Knowledge regarding prospective studies and statistical methods related to contingency table, t test and ANOVA needs to be updated to the Undergraduate and Postgraduate students.
  - 3,023 411