Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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MBBS, MD (Pathology),
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Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
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Dr. Mamta Gupta
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Aug 2018




Dr. Rajendra Kumar Ghritlaharey

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Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011

Important Notice

Original article / research
Year : 2009 | Month : December | Volume : 3 | Issue : 6 | Page : 1822 - 1826

The Beneficial Effects Of Noni Fruit Juice In Diabetic Patients

SABITHA P*, ADHIKARI PRABHA MR**, SHETTY RUKMINI MS***,HEGDE ANUPAMA****, KAMATH ASHA*****

*(M.D). Pharmacology (Department of Pharmacology),**(M.D). Internal Medicine (Department of Medicine),***M.D. Bio Chemistry Department of Bio Chemistry)****(MD). Bio Chemistry (Department of Bio Chemistry), *****(M.Sc);Biostatistics (Department of Community Medicine *,**,***,**** Kasturba MedicalCollege, Mangalore- 575 001. (India *****Kasturba Medical College,Manipal-576 104. (India)

Correspondence Address :
Dr. Prabha Adhikari M,Behind Sridevi College of Physiotherapy,BallalBagh,Mangalore, Karnataka State,India-575003.Telephone No.: 0988099129,(Mobile)-91-824-2445858 (O);Fax No: 91-824 244320 (O);Email:adhikari_pmr@yahoo.com,sabita_rao1@rediffmail.com

Abstract

Background: There is no scientific evidence to support the beneficial effects of noni fruit juice which is claimed as a “natural health enhancer” and is consumed extensively.
Aim: To evaluate the beneficial effects of noni fruit juice on glycaemic control, lipid profile and antioxidant activity and its safety in diabetic patients.
Settings and Design: A hospital based, randomized, placebo-controlled, double-blind study
Material and Methods: 34 diabetic subjects with normal haematological, serum potassium, renal and liver function test and electrocardiogram readings were enrolled into the study. After collecting venous blood for biochemical efficacy measures, the subjects were randomly allocated to two treatment groups, either to receive noni juice or to get placebo, at a dose of 30 ml/day. The efficacy measures included fasting and postprandial blood glucose, complete lipid profile with fasting, serum fructosamine and endogenous antioxidants like super oxide dismutase and reduced glutathione. The safety and efficacy measures were repeated after 21 days of treatment with placebo or noni juice.
Statistics: The baseline characteristics were compared between the groups using the unpaired t test. Pre-post treatment changes in the efficacy measures within each group and between the groups were analyzed by applying the repeated measures ANOVA test. P<0.05 was considered to be statistically significant.
Results: The efficacy measures were comparable between the two groups at the entry into the study. The influence of the two treatments on blood glucose levels, on the lipid profile and on the endogenous antioxidant activity were similar, without statistical significance. The noni and placebo treated groups came out with decrease and increase in serum fructosamine levels, respectively, both changes being statistically insignificant. Between groups, the comparison of these changes appeared to be statistically significant (p=0.036). The safety measures were within the normal range and no adverse events were reported.
Conclusion: Consumption of noni juice for 21 days yielded elusive results on glycaemic control. It’s beneficial effects on plasma lipid profile and endogenous antioxidant activity were not established. Consumption of the lowest recommended doses of noni fruit juice for a short period of 21 days was found to be safe in diabetic patients. Long term studies with a large population may be needed for evidence of the favourable effects of noni juice on organ functions.

Keywords

antioxidant activity, cholesterol levels, glycaemic control, Morinda citrifolia L, noni.

Introduction
Noni is the common name for Morinda citrifolia L. It’s fruit has a long history of use as a food and the noni fruit juice (NJ) is in high demand as an alternative medicine for different kinds of illnesses including diabetes and atherosclerosis. Noni was one of the herbal remedies used to maintain overall good health. Although NJ is being traditionally used for several ailments, scientific evidence supporting the nutritional and medicinal values of NJ in humans is limited (1). Except for a survey report (1), published data on the anti diabetic value of NJ in humans is lacking. Inhibition of the enzyme involved in cholesterol synthesis by NJ has been reported (2), but no published data substantiating the lipid lowering effects of NJ is available. It was hypothesized that noni juice may protect individuals from free oxygen radicals (1) and this view was supported by it’s chemical analysis (3). This study was conducted to investigate the beneficial effects of NJ on glycaemic control, plasma lipid profile, and endogenous antioxidant activity and its safety in diabetic patients.

Material and Methods

This randomized, placebo-controlled, double-blind study enrolled 34 adult patients of type 2 diabetes mellitus with their informed consent. Patients of either gender who did not consume any herbal product /vitamin preparations and who demonstrated stable glycemic control, both for the previous six months, were screened for *normal haematological, liver and renal function test (LFT& RFT), serum potassium and electrocardiogram readings. The subjects who were successful in the screening, underwent clinical examination and venous blood was collected for the measurement of efficacy parameters like- fasting blood glucose (FBS) and lipid profile (LP), two hour postprandial blood glucose (PPBS), serum fructosamine(FA) (4),(5),erythrocyte levels of principal chain-breaking antioxidant enzyme erythrocyte super oxide dismutase (SOD) (6),(7) and antioxidant scavenger like whole blood reduced glutathione (GSH)(8). Then, the participants were randomly allocated into two groups, either to receive NJ or to the group to receive placebo. Group allocation was done by the block-randomization technique (first five blocks with block size six and four in the last block) by a person who was not a part of the investigators’ team. The subjects were asked to drink 15ml of either of the liquid preparations on an empty stomach half an hr before breakfast, and 15ml half an hr before dinner, sipping slowly, making sure that the liquid mixed with the saliva. The subjects were then advised to drink lot of water throughout the day. On day 22, after clinical examination, the laboratory efficacy measures were repeated. Mean changes in the pre- and post study efficacy parameters were estimated in each group and were compared between the groups by applying the statistical test repeated measures ANOVA. P<0.05 was considered to be statistically significant.

The safety of NJ consumption was assessed by looking for any *abnormalities in haematological, LFT, RFT, serum potassium and electrocardiogram readings on day 22 and through the reporting of adverse events. The subjects were asked to continue with the regular medications and the need for a change in any drug or change in the dose of existing drugs was the withdrawal criteria. A commercial preparation marketed as “food supplement” that contained a concentrate of the fruit of Indian Noni was used in the study. The placebo looked like NJ and was dispensed in similar bottles as NJ. Patient compliance to study products was confirmed by collecting the empty bottles on day 22. LFT, RFT, and efficacy measures like FBS, PPBS and LP were estimated using an auto analyzer and the remaining biochemical efficacy measures were estimated manually by using a spectrophotometer (4),(5),(6),(7),(8). The institutional ethics committee had approved this study.

*Abnormal values of safety measures were defined as: Haematological- Haemoglobin <12g/dl (men) and<10g/dl (women), total WBC count beyond 4,000 -11,000 cells/mm3, platelet count <1,00,000 cells/mm3; LFT- AST and ALT >2 X ULN (range 0-40 u/l), total bilirubin 1.5 X ULN (range 0.3-1.0mg/dl); RFT- urea 1.5 X ULN (range10-40mg/dl); creatinine >1.4mg/dl; and serum potassium beyond 3.5-5.0 mM.

Results

Seventeen and 16 subjects in NJ and placebo treated groups respectively, were available for the final analyses of results as one male subject of the latter group absented himself on the day of the end study. Subjects in both groups had a mean age of 63 years (Table/Fig 1) Pre-study efficacy measures were similar between two groups. End study changes in FBS, PPBS and LP measures from the respective pretreatment values were insignificant within each group and these changes were comparable across the two treatment groups. The NJ treatment decreased FA levels and the treatment with placebo resulted in the elevation of FA levels, each change being statistically insignificant by itself, but between groups, the difference was found to be significant. SOD activity was enhanced in both groups without statistical significance. Changes in GSH levels were also insignificant. End study haematological, LFT, RFT,serum potassium and electrocardiogram readings did not reveal any *abnormality and no adverse event was reported during the study period.

Discussion

In the present study, consumption of NJ for 21 days did not demonstrate any significant influence on FBS and PPBS which are the short term indicators of glycaemic control. Measurement of FA levels is the medium term indicator of diabetic control that denotes the average blood glucose levels over the preceding two-three weeks (4). Following treatment with NJ, the mean (±SEM) fall in FA levels was 116±55.3. This difference, although not statistically significant, could still be considered clinically significant, taking into account the reference range of serum FA in the non diabetic population (205-285 µM)(9). Fall and rise in FA values were demonstrated following NJ and placebo treatments, respectively and thus, the NJ treatment was found to score better over the placebo treatment (mean difference ± SEM = 176.6±80.6, p=0.036, at 95% CI of 12,341). But the borderline p value and the wide confidence interval associated with the above value are unpromising to claim the superiority of NJ over placebo. With such elusive results, the current study certainly does not totally rule out the possible glucose lowering effects of NJ. Although the traditional use of noni for the treatment of diabetes has been documented (1), there is no clinical trial data to substantiate its glucose lowering efficacy. In experimental diabetic rats, noni juice demonstrated a synergistic action with injected insulin in reducing blood glucose levels (10). A statistical clinical survey, after reviewing the results of more than 10,000 noni juice users, reported that 83% of patients with type 1 and 2 diabetes experienced a noticeable change in their condition (1).

Nine and four subjects in the NJ and placebo groups respectively, received stable doses of the lipid lowering drug atorvastatin for the previous one year and both groups had similar pretreatment lipid profiles. In the current study, NJ consumption for 21 days did not alter the fasting LP significantly in diabetic patients. In an in-vitro bio assay of the 3-hydroxyl-3- methyl glutaryl-CoA reductase enzyme which is involved in the synthesis of cholesterol in humans, NJ inhibited the enzyme activity in a dose dependent manner (2). Published data on the lipid lowering action of NJ in humans is lacking. Of the two endogenous antioxidant levels estimated, SOD activity was enhanced in both the groups without statistical magnitude. The increase of SOD activity with NJ treatment was almost twice than that manifested in the placebo group, but it was not considered to be statistically superior. The data from the in vitro study on the carbon tetra chloride induced liver injury model of rats and current smokers indicate that NJ is a strong antioxidant which can scavenge reactive oxygen free radicals and quench lipid hydro peroxides (1). On chemical analyses, noni juice was demonstrated to contain molecules with antioxidant properties which could have an action on the human body (3),(11). Statistically insignificant results of the current study do not corroborate the above view.

Independent cases of hepatotoxicity and hyperkalaemia have been reported with a suggested causal link to NJ consumption (12),(13). Instead, the safety of NJ has been established in animal and clinical studies and a maximum daily dose of 750ml of NJ was reported to be safe(12). In another preclinical study, NJ exerted effective protection against carbon tetra chloride induced liver injury in rats(14). The current study revealed the safety of NJ on short term use in diabetic individuals when consumed at the lowest dose referred in other safety studies (12).

Conclusions
This randomized, double-blind, placebo- controlled study aimed at investigating the beneficial effects of NJ in diabetic patients, did not contribute substantially to explicate the favourable outcome of NJ on glycaemic control. The lipid lowering potential of NJ and its capacity to enhance endogenous antioxidant activity were not established in the present study. The deleterious effects of NJ on organ functions, on short term use, were ruled out in this study. The duration of NJ consumption (21 days) may be too short for its beneficial effects on the body to become clinically manifest. A small sample size lacking adequate power to detect the statistically significant differences in the efficacy measures, could be a major limitation of the present study. Further studies with prolonged consumption of NJ by a large population need to be carried out to conclude on the beneficial effects of NJ in diabetic patients.

Key Message

1. Noni fruit juice may possess glucose lowering actions in diabetic subjects.
2. The current study did not establish the beneficial effects of noni fruit juice on plasma lipid profile.
3. The endogenous antioxidant activity was not enhanced by noni fruit juice in the current study.
4. Safety of the short term use of noni fruit juice was proved in diabetic individuals.

References

1.
Wang MY, West BJ, Jenson CJ, Diane N, Chen SU, Palu AK, et al. Morinda citrifolia (Noni): a literature review and recent advances in Noni research. Acta Pharmacol Sin 2002; 23: 1127-41.
2.
Palu FK, West BJ, Jensen CJ, Zhou BN. Morinda citrifolia L. Noni has Cholesterol Lowering Potential. Proceedings of the 47th Annual Meeting of Society for Economic Botany; 2006 June 5-9; Chiang Mai,Thailand. Honululu: The Society for Economic Botany, Inc; 2006. (Abstract) Availablefrom:www.econbot.org/_organization_/07_annual_meetings/meetings_by_year/2006/pdfs/SEB2006%20Program.pdf. (Accessed on 7th March 2009).
3.
Chunhieng T, Hay L, Montet D. Detailed study of the juice composition of noni (Morinda citrifolia) fruits from Cambodia. Fruits 2005; 60:13-24.
4.
Johnson RN, Metcalf PA, Baker JR. Fructosamine: A new approach to the estimation of serum glycosylprotein. An index of diabetic control. Clin Chim Acta 1983; 127: 87-95.
5.
Schleicher ED, Voght BW. Standardization of serum fructosamine assays. Clin Chim Acta 1990; 36: 136-9.
6.
McCord Fridovich IM. Superoxide dismutase on enzymatic function for erythrocumei. J Biol Chem 1969 ; 24:6049-55.
7.
Marklund S, Marklund E (modified by Nandi et al 1988). Assay of SOD Activity in animal tissue. J Biochem 1988; 13: 305 -15.
8.
Beutler E, Duron O, Kelly BM. Improved method for the determination of blood glutathione. J Lab Clin Med 1963; 61:883-7.
9.
Sacks DB. Carbohydrates. In: Burtis CA, Ashwood ER, Bruns DE, editors. Tietz Text book of Clinical Chemistry and Molecular Diagnostics. 4th ed. New Delhi: Elsevier; 2006. p. 837-901.
10.
Horsfall AU, Olabiyi O, Aiyegbusi A, Noronha CC, Okanlawon AO. Morinda citrifolia fruit juice augments insulin action in Sprague-Dawley rats with experimentally induced diabetes. Nig Q J Hosp Med 2008; 18:162-5. (Abstract)
11.
Su BN, Pawlus AD, Jung HA, Keller WJ, McLaughlin JL, Kinghorn AD. Chemical constituents of the fruits of Morinda citrifolia (Noni) and their antioxidant activity. J Nat Prod. 2005; 68: 592-5.
12.
West BJ, Jenson CJ, Westendorf J, White LD. A safety review of Noni fruit juice. J Food Sci 2006; 71:101-6.
13.
Hepatitis induced by Noni juice from Morinda citrifolia: a rare cause of hepatotoxicity or the tip of the iceberg? Digestion. 2006; 73:167-70.
14.
Wang MY, Nowicki D, Anderson G, Jensen J, West B. Liver Protective Effects of Morinda citrifolia (Noni). Plant Foods Hum Nutr 2008; 63:59-63.

Tables and Figures
[Table / Fig - 1]
JCDR is now Monthly and more widely Indexed .
  • Emerging Sources Citation Index (Web of Science, thomsonreuters)
  • Index Copernicus ICV 2017: 134.54
  • Academic Search Complete Database
  • Directory of Open Access Journals (DOAJ)
  • EBSCOhost
  • Google Scholar
  • HINARI Access to Research in Health Programme
  • Indian Science Abstracts (ISA)
  • Journal seek Database
  • Google
  • Popline (reproductive health literature)
  • www.omnimedicalsearch.com