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TECHNICAL NOTES
How to select appropriate statistical test?
Jaykaran
October-December 2010, 1(2):61-63
DOI
:10.4103/0976-9234.75708
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ORIGINAL ARTICLES
No evidence of antiseptic properties and low toxicity of selected
Aloe
species
L Mpala, G Chikowe, IE Cock
July-September 2010, 1(1):10-16
DOI
:10.4103/0976-9234.68869
Background and Aim:
Closely related plant species often share similar secondary metabolites and bioactivities and are therefore good targets for bioactivity testing when one or more species within a genus are known to possess therapeutic properties. The genus
Aloe
has a long history of medicinal usage in many areas of the world. Many species are known to have therapeutic properties, several species of which have well-established antibacterial bioactivities. The current studies examine the toxicity of several
Aloe
species and their ability to inhibit bacterial growth and compare them to the most extensively studied species,
Aloe
barbadensis
, which has well-established antibacterial bioactivities.
Results:
A.
barbadensis
methanolic extract displayed broad spectrum antibacterial activity, inhibiting the growth of 8 of the 14 bacteria tested (57%). It was effective against both Gram-positive and Gram-negative bacteria, inhibiting the growth of 4 of 4 Gram-positive bacteria (100%) and 4 of 10 Gram-negative (40%) bacteria tested, respectively. In contrast,
Aloe
elgonica,
Aloe
pruinosa,
Aloe
chabaudii,
Aloe
daiyana,
Aloe
marlothi and
Aloe
vryheidensis all showed no antibacterial activity toward any of the bacteria tested. All of the
Aloe
species displayed low toxicity similar to that of the
A. barbadensis
control.
A. daiyana
was the most toxic of the
Aloe
species tested with 24, 48 and 72 hours LC50 values of 1018.2, 517.0 and 405.7 ΅g/ml, respectively.
Conclusions:
Despite their close taxonomic relationship,
A. elgonica
,
A. pruinosa
,
A. chabaudii
,
A. daiyana
,
A. marlothi
and
A. vryheidensis
do not have the same antibacterial medicinal potential as
A. barbadensis
, but may still have other similar toxicity-related bioactivities. Testing against protozoa, fungi, virus and tumor cells is required to determine if this is the case.
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Influence of some hydrophilic polymers on dissolution characteristics of furosemide through solid dispersion: An unsatisfied attempt for immediate release formulation
MK Raval, DU Prajapati, SM Varma, MA Khodifad, JM Patel, NR Sheth
October-December 2010, 1(2):29-34
DOI
:10.4103/0976-9234.75702
Background:
The objective of the present investigation was to enhance dissolution characteristics of water insoluble drug, furosemide (FRMD), by solid dispersion in various hydrophilic carriers.
Materials and Methods:
The solid dispersions were prepared by solvent evaporation technique using urea and Hydroxy Propyl Methyl Cellulose (HPMC E50 LV). Physical mixtures of drug with above-mentioned polymers were also prepared. Phase solubility studies were performed for drug in the presence of excipients in different ratios. The formulations were evaluated for drug content, in vitro dissolution, Fourier transform infrared (FT-IR) and differential scanning calorimetry (DSC). Similarity factor (f2) was calculated for comparison between dissolution of pure drug and drug-polymer physical mixtures with solid dispersions.
Results:
Phase solubility studies indicated linear increase in the drug solubility with increase in carrier concentration. In vitro release studies revealed that dissolution characteristic of FRMD was improved by solid dispersion technique. All the preparations of FRMD exhibited significant improvement in its dissolution profiles. Solid dispersion of FRMD with HPMC E50 LV exhibited the highest rate and extent of dissolution. Optimized batches of solid dispersions of both the carriers were characterized by FT-IR and DSC analysis, which indicated absence of major interactions between FRMD and carriers.
Conclusion:
Solid dispersion technique is one of the finest techniques to improve dissolution of poorly soluble drugs.
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Influence of solvents on the crystal habit and properties of rofecoxib and celecoxib: No evidence of polymorphism
MK Raval, PR Sathesh Babu, J Thimmasetty, RK Parikh, NR Sheth, C.V.S. Subrahmanyam
October-December 2010, 1(2):40-50
DOI
:10.4103/0976-9234.75704
Background:
In many cases, drugs can exist in more than one crystalline form; the phenomenon is known as "polymorphism." Though the polymorphs are chemically identical, they exhibit different physicochemical properties, viz., melting point, solubility, X-ray diffraction pattern, etc., which further affect the biological properties of drugs. The purpose of this work was to study the effect of solvents on crystallization, solubility and dissolution of rofecoxib and celecoxib.
Materials and Methods:
The crystals were prepared by using different solvents. The melting point, solubility, dissolution, Fourier-transformed infrared (FT-IR), X-ray diffraction (XRD), differential scanning calorimetry (DSC) and scanning electron microscopy (SEM) studies were carried out to confirm the polymorphism in drugs.
Result:
The results indicate that the crystals obtained from different solvents exhibited different physicochemical properties. Though FT-IR and XRD gave an indication of different crystal morphs, DSC proved absence of any polymorphic behavior in the crystals of rofecoxib and celecoxib.
Conclusion:
Crystals having the desired physicochemical properties may be obtained by selecting solvents of specific polarities.
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Negative regulation of glucose uptake by
Costus pictus
in L6 myotube cell line
Anil Pareek, Manish Suthar, Ashok Godavarthi, Manoj Goyal, Vijay Bansal
July-September 2010, 1(1):24-26
DOI
:10.4103/0976-9234.68872
The leaf of
Costus pictus
D. Don is considered as an antidiabetic in folklore medicine and is known to reduce the blood sugar, similar to insulin. The aim of this study is to investigate the effect of ethanolic extract of
C. pictus
leaf on glucose uptake by L6 myotube cell line (skeletal muscle cells) involved in glucose utilization. Ethanolic extract of
C. pictus
leaf was analyzed to study GLUT4 translocation and glucose uptake activity, but it has no direct peripheral action at 300 μg/ml dose comparable with insulin and metformin. The glucose uptake was not enhanced by the extract of
C. pictus
leaf.
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1
Beta vulgaris
: A dearth of antidepressant activity in mice
Ashok Agrawal, Sunil Bavaskar, Pankaj Salunkhe, Nadeem Manyar, Dnyaneshwar Kale, Pravin Kawtikwar
October-December 2010, 1(2):55-57
DOI
:10.4103/0976-9234.75706
The present study was undertaken to investigate antidepressant activity of ethanolic extract of
Beta vulgaris
[BV], by using forced swim test [FST] and tail suspension test [TST] in mice. Imipramine [10 mg/kg, i.p.] used as the standard drug significantly decreased immobility time in both TST and FST, while BV [50 and 100 mg/kg, i.p.] significantly increased immobility time in TST and FST. This suggests that BV has depressant activity and not antidepressant activity.
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LETTER TO EDITOR
Do medicinal plants possess significant activities?
Sanjib Bhattacharya, KK Mueen Ahmed, Vipra Kundoor
July-September 2010, 1(1):27-28
DOI
:10.4103/0976-9234.68873
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400
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ORIGINAL ARTICLES
Failure to detect the anti-mutagenic effect of insulin in experimental type-2 diabetic rats
Syed Imam Rabbani, Kshama Devi, Salma Khanam
July-September 2010, 1(1):17-21
DOI
:10.4103/0976-9234.68870
Background:
The oxidative stress is known to cause mutation-related disorders in diabetic patients.
Materials and Methods:
The present study was designed to investigate the anti-mutagenic effect of insulin in nicotinamide (NA: 230 mg/kg, i.p.) and streptozotocin (STZ: 65 mg/kg, i.p.) induced nuclear defects. Bone marrow micronucleus (MN) test and caudal epididymal sperm abnormalities were detected to find the somatic and germinal cell mutations, respectively. The antioxidant status was determined by estimating serum lipid peroxidation, catalase, superoxide dismutase and glutathione peroxidase levels.
Results:
The experimental type diabetes significantly (
P
< 0.001) reduced the antioxidant status and enhanced MN frequency and sperm defects compared to control animals. Although administration of insulin (1, 3, 5 and 7 IU/kg, s.c. for 4 weeks) significantly (
P
< 0.001) reduced hyperglycemia, it did not alter the antioxidant status, and somatic and germinal cell defects in diabetic rats.
Conclusion:
The results suggest that insulin did not have protective effect against the genotoxicity induced by NA-STZ diabetes.
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152
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Lack of analgesic activity of petroleum ether extract of
Bauhinia
racemosa
Lam in rats and mice
KS Chandrashekar, KS Prasanna
July-September 2010, 1(1):22-23
DOI
:10.4103/0976-9234.68871
Objective:
The effect of petroleum ether extract of Bauhinia racemosa was investigated in rats and mice to evaluate the analgesic activity.
Materials and Methods:
Acetic acid induced writhing model and hot plate method were employed to test the analgesic activity.
Results:
The results indicated that the petroleum ether extract had no significant analgesic activity.
Conclusion:
It may be inferred that Bauhinia racemosa do not have analgesic activity and the results are not in agreement with its traditional use.
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219
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Compromising research for publishing thirst: Maladies and remedies
Bhupinder Singh
July-September 2010, 1(1):6-9
DOI
:10.4103/0976-9234.68868
In the current scenario of academic-research, the publication process has become much more demanding and intricate. Every academician and principal investigator of a research project is constrained to publish high quality work in high impact journals. This unquenchable thirst of publishing is evident form the exponentially escalating number of journals and papers in the last one decade. The hallmarks of scientific research and publishing, i.e., ethics and integrity, are consequently getting attenuated. The current article is an endeavor to highlight the major unethical compromises which the authors are tempted to make while publishing their research. Accentuating "Good Publishing Practices", the article serves as a ready-reckoner on various Do's and Don'ts for young scientists and academicians to practice.
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246
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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
DOI
:10.4103/0976-9234.82984
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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199
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Failure of calcium gluconate internal gelation for prolonging drug release from alginate-chitosan-based ocular insert of atenolol
Ritu Mehra Gilhotra, DN Mishra
October-December 2010, 1(2):35-39
DOI
:10.4103/0976-9234.75703
Background:
The aim of the investigation was to develop and evaluate ocular polymeric film of atenolol for the management of glaucoma.
Materials and Methods:
Fixed concentration blends of sodium alginate (NaAlg) and chitosan were combined with the varying concentration of calcium gluconate and the resulting hydrogels were casted as ocular films. Various physicochemical studies and
in vitro
release tests of the prepared films were carried out to study the effect of calcium gluconate addition to alginate-chitosan blend films.
Results:
Cumulative % drug released from the formulations ranged from 95 to 99% within 5- to 12-hour period. The drug release enhanced with incorporation of higher ratios of calcium gluconate. F1 (2% NaAlg and 1% chitosan without calcium gluconate) sustained the drug release for the longest period of time (12 hours). Addition of calcium gluconate to the formulation resulted in faster drug release rather than sustained drug release.
Conclusion:
The results showed that the addition of calcium gluconate leads to a change in the release capacities of the matrices. Despite the presence of calcium ions and thus the possibility of an ionic interaction, the internal gelation of the polymer matrix lead to enhanced drug release and poor sustaining of drug. The sustained release effect of NaAlg-chitosan matrices alone was the best among the formulations studied.
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190
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EDITORIAL
Uncovering negative results: Introducing an open access journal "Journal of Pharmaceutical Negative Results"
Vipra Kundoor, KK Mueen Ahmed
July-September 2010, 1(1):1-3
DOI
:10.4103/0976-9234.68866
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275
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ORIGINAL ARTICLES
Lack of antiglycation activity of fresh juice of whole plant of
Enicostema axillare
(Lam.) Raynal
WD Ratnasooriya, K.I.W.K Somarathna, G.A.S Premakumara, E.R.H.S.S Ediriweera
July-December 2011, 2(2):55-57
DOI
:10.4103/0976-9234.90210
Objective:
To investigate the antiglycation potential of fresh juice of whole plant of
Enicostema axillare
(Lam.) Raynal.
in vitro
.
Materials and Methods:
Antiglycation activity of fresh juice of whole plant was determined
in vitro
using five concentrations (25, 50, 100, 200, and 400 μg/ml) by determining their ability to inhibit the formation of advanced glycation endproducts in a bovine serum albumin / glucose system using fluorescence spectroscopy.
Results:
There is no antiglycation activity
in vitro
of fresh juice of
E. axillare
plant.
Conclusion:
It is unlikely that impairment of diabetic complications by
E. axillare
whole plant juice as claimed by ayurvedic and traditional physicians is mediated via antiglycation activity.
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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
DOI
:10.4103/0976-9234.82982
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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Anticonvulsant activity of
Passiflora incarnata
: No role of chrysin
Bhupinder Singh, Awanish Mishra, Rajesh Kumar Goel
July-December 2011, 2(2):51-54
DOI
:10.4103/0976-9234.90208
The earlier studies on
Passiflora incarnata
have pointed out the possible role of chrysin for its anticonvulsant activity. But role of chrysin in anticonvulsant property of
P. incarnate
seems to be controversial due to its poor bioavailability reported by different studies. Therefore, this study was designed to investigate the role of chrysin in anticonvulsant property of different extracts of P. incarnata used for medicinal purpose, viz. aqueous (PIAE), hydroethanolic (PIHE), and methanolic extracts (PIME). These extracts were prepared from dried leaves of
P. incarnata
using water, methanol, and 50% ethanol to obtain PIAE, PIME, and PIHE, respectively. The extracts were standardized with reference to chrysin by HPLC-UV method. Different doses (150, 300 and 600 mg/kg; i.p.) of PIAE, PIME, PIHE, and chrysin (1 mg/kg) were administered 30 min before the PTZ injection (75 mg/kg) to evaluate anticonvulsant effect. HPLC estimation has shown the higher amount of chrysin present in PIME followed by PIAE and PIHE. Significant dose-dependent delay in onset of convulsions was observed in PIHE and PIAE treated mice when compared with PTZ convulsive mice, while PIME treatment has not shown delay in onset of convulsions. Chrysin (1 mg/kg, i.p.), as well, did not produce significant increment in onset of convulsions. These results revealed that PIME containing significant amount of chrysin lacks anticonvulsant effect, while PIAE and PIHE, with insignificant chrysin content, have shown significant anticonvulsant effect. Thus, this study suggests that chrysin is not responsible for anticonvulsant effect of
P. incarnata
.
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609
206
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REVIEW ARTICLE
Rimonabant: Boom to ban
Suyog S Jain, Vitthal B Karande, Karuna B Ramteke, Girish T Raparti
July-December 2011, 2(2):45-50
DOI
:10.4103/0976-9234.90207
Rapidly rising prevalence of obesity and health care cost of its complications necessities need for highly efficacious and safe antiobesity drugs. As most old antiobesity drugs had moderate efficacy, severe toxicity and some of them very costly. Rimonabant, CB1 receptor antagonist was introduced with high expectations. Rimonabant has multiple beneficial effects, apart from significant weight loss it increases HDL and reduces triglycerides, Hb A
1C
level, prevalence of metabolic syndrome. This wide spectrum of effects helps in comprehensive management of obesity and associated complications. Cost of rimonabant (generic Rs.5-8 per tablet) is also much lesser than the only other commonly used antiobesity drug orlistat around Rs. 40 per tablet. During trials rimonabant apart from nausea had neuropsychiatric side effects. EMEA approved rimonabant in June 2006 with concern over its psychiatric side effects. In 2007 EMEA contraindicated rimonabant in patients of depression or taking antidepressants. Further analysis in 2008 concluded that the incidence of psychiatric side effects was higher in clinical practice compared to controlled trials also few cases of suicide became a major safety concern, finally leading to suspension of its sale by EMEA in Oct 2008. USFDA never approved rimonabant over safety concerns, while India banned it shortly thereafter as precautionary measure. Present paper deals with the various events during the rapid rise and fall of rimonabant which was widely considered as blockbuster diet pill but was suspended over serious neuropsychiatric side effects.
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209
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COMMENTARY
Negative results as part of quality research: An insight
Javed Ali
July-September 2010, 1(1):4-5
DOI
:10.4103/0976-9234.68867
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260
1
ORIGINAL ARTICLES
Absence of central activity in
Wrightia tinctoria
bark ethanolic extract
P Bigoniya, AC Rana
October-December 2010, 1(2):51-54
DOI
:10.4103/0976-9234.75705
Objective:
The objective of the present study was to investigate the central activity profile of
Wrightia tinctoria
(Roxb) R.Br. Linn. (Family: Apocynaceae) in mice and rats using various models.
Materials and Methods:
The effects of ethanolic extract were observed in 3 different dose levels 300, 500, and 1000 mg/kg as the extract did not show any signs of toxicity up to 5000 mg/kg (p.o.) dose. Investigations were carried out for assessing the activity on pentobarbitone-induced hypnosis and maximum electro-shock (MES)- and leptazole-induced convulsions.
Results:
W. tinctoria
ethanolic extract did not have any significant effect on pentobarbitone-induced hypnosis. The extract is devoid of any protective effect against leptazole- or MES-induced convulsions at any of the tested doses.
Conclusion:
W. tinctoria
bark ethanolic extract had no central nervous system depressant or anticonvulsant activity.
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Insignificant antidiabetic activity of rhizome of
Zingiber zerumbet
VK Lal, A Pandey, P Tripathi, RD Pandey
October-December 2010, 1(2):58-60
DOI
:10.4103/0976-9234.75707
Objective:
To investigate the antidiabetic activity of
Z. zerumbet
in streptozotocin (STZ)-induced diabetic rats.
Materials and Methods:
The diabetic rats were given aqueous extract of
Z. zerumbet
(200 mg/kg) and glibenclamide (10 mg/kg) for 21 days, and their hypoglycemic activity and effect on body weight were assessed.
Result:
The treatment with aqueous extract of
Z. zerumbet
and glibenclamide both showed hypoglycemic activity but efficacy of
Z. zerumbet
is not as significant as glibenclamide. Glibenclamide maintain the body weight of rats throughout the study period, whereas the body weight of
Z. zerumbet
-treated rats significantly falls.
Conclusion:
This study suggests that aqueous extract of
Z. zerumbet
shows no significant activity in STZ-induced diabetic rats.
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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
DOI
:10.4103/0976-9234.82987
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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522
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LETTER TO EDITOR
Some commonly observed statistical errors in clinical trials published in Indian Medical Journals
Jaykaran
October-December 2010, 1(2):64-65
DOI
:10.4103/0976-9234.75709
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ORIGINAL ARTICLES
Absence of antimicrobial activity in alcoholic extract of
Santalum album
Linn
Vaishali Patil, GP Vadnere, Neeraj Patel
July-December 2011, 2(2):107-109
DOI
:10.4103/0976-9234.90224
Objective:
The objective of the present study was to investigate the antimicrobial activity of seed of
Santalum album
Linn. (Family: Santalaceae) in various microbial strains.
Materials and Methods:
The effects of ethanolic extract of seed of
S. album
were analyzed in different microorganisms at a concentration of 5 mg/ml per disk.
Results:
The result indicated that the ethanolic extract of seed of
S.
album
did not show any zone of inhibition against the tested microorganisms.
Conclusion:
The ethanolic extract of seed of
S. album
has no significant antimicrobial activity.
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82
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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
DOI
:10.4103/0976-9234.82981
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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76
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LETTERS TO EDITOR
Clinical trials with poor methodological quality and inappropriate statistics: Are they ethical?
Jaykaran , Deepak Saxena
January-June 2011, 2(1):42-43
DOI
:10.4103/0976-9234.82979
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© Journal of Pharmaceutical Negative Results | Published by
Medknow
Online since 15
th
June, 2010