Safety Of Nutraceuticals Research Articles

A protocol for systematic review and meta-analysis on the efficacy and safety of nutraceuticals with special reference to Ahara Dravya (food articles) in type 2 diabetes mellitus

Different Aushadi (drugs) are indicated for Prameha (diabetes mellitus) in Ayurveda, with some serving as nutraceuticals. Still, their efficacy and safety need to be investigated. A systematic review will be conducted, including both published and relevant unpublished randomized controlled trials of selected nutraceuticals in diabetes mellitus. For the meta-analysis, only published studies will be considered. Searches will be executed in PubMed, Cochrane Central Register of Controlled Trials, Shodhganga: A reservoir for Indian theses, Digital Helpline for Ayurveda Research Articles, and AYUSH Research Portal, along with dissertation and thesis works in the public domain, unpublished studies from websites of university/institution, as well as other possible sources. Two reviewers will independently select studies, extract data, and synthesize results. A third reviewer will address disagreement. Robinson Risk of Bias 2 tool will be used to evaluate bias. Meta-analysis of extracted data will be performed through Review Manager Web software focusing on fasting blood sugar levels and glycosylated hemoglobin and reported adverse events if any. The strength of the shreds of evidence and reliability will be analyzed using the Grading of Recommendations, Assessment, Development, and Evaluation system. Findings will be presented using appropriate statistical methodology and interpreted accordingly. This study will comprehensively assess the selected nutraceuticals in type 2 diabetes mellitus (T2DM), demonstrating their efficacy and safety in preventing and managing T2DM. The conclusion may be drawn based on the resultant outcome of the impact of selected nutraceuticals on T2DM. PROSPERO registration number: CRD42024529448.

Toxicity Potential of Nutraceuticals.

During the past few decades and especially during and after the COVID-19 pandemic, the use of nutraceuticals has become increasingly popular in both humans and animals due to their easy access, cost-effectiveness, and tolerability with a wide margin of safety. While some nutraceuticals are safe, others have an inherent toxic potential. For a large number of nutraceuticals, no toxicity/safety data are available due to a lack of pharmacological/toxicological studies. The safety of some nutraceuticals can be compromised via contamination with toxic plants, metals, mycotoxins, pesticides, fertilizers, drugs of abuse, etc. Knowledge of pharmacokinetic/toxicokinetic studies and biomarkers of exposure, effect, and susceptibility appears to play a pivotal role in the safety and toxicity assessment of nutraceuticals. Interaction studies are essential to determine efficacy, safety, and toxicity when nutraceuticals and therapeutic drugs are used concomitantly or when polypharmacy is involved. This chapter describes various aspects of nutraceuticals, particularly their toxic potential, and the factors that influence their safety.

Safety and Efficacy of the Consumption of the Nutraceutical "Red Yeast Rice Extract" for the Reduction of Hypercholesterolemia in Humans: A Systematic Review and Meta-Analysis.

Previous studies have shown encouraging results regarding the efficacy and safety of nutraceuticals, such as "red yeast rice (RYR) extract", on reducing hypercholesterolemia in humans. A systematic review and meta-analysis was conducted from January 2012 to May 2022. The search was strictly focused on clinical trials that examined the association between RYR extract consumption and parameters of the lipid profile in humans. Fourteen double-blinded clinical trials were identified. The interventions lasted 4-24 weeks. In most studies, there was one intervention group and one control group. RYR extract consumption statistically significantly reduced total cholesterol (mean absolute reduction: 37.43 mg/dL; 95% confidence interval [CI]: -47.08, -27.79) and low-density lipoprotein cholesterol (LDL-C; mean absolute reduction: 35.82 mg/dL; 95% CI: -43.36, -28.29), but not high-density lipoprotein cholesterol, triglycerides and apolipoproteins A-I and B. As regards the safety, RYR extract was considered a safe choice with neither threatening nor frequent side effects. The consumption of RYR extract by people with hypercholesterolemia was associated with statistically significant reduction in total cholesterol and LDL-C, whereas it was not associated with an increase in life-threatening side effects. Further research on specific subpopulations and outcomes could establish a consensus on determining the clinical benefits and potential risks, if any, of this nutraceutical.

Breaking new frontiers: Assessment and re-evaluation of clinical trial design for nutraceuticals.

Despite sophisticated study designs and measurement tools, we have yet to create an innovative space for diet and dietary supplements in the health care system. The path is challenging due to current hierarchies of scientific evidence and regulatory affairs. The role of the randomized, double-blind, placebo-controlled clinical trial (RCT) as a research approach functions well to characterize the benefits and risks of drugs but lacks the sensitivity to capture the efficacy and safety of nutraceuticals. While some facets of RCTs can be relevant and useful when applied to nutraceuticals, other aspects are limiting and potentially misleading when taken in their entirety. A differentiation between guidelines for evidence-based medicine and the evidence required for nutrition spotlight the need to reconceptualize constituents of the RCT and their applicability with relevance to health promotion. This perspective identifies the limitations of the traditional RCT to capture the complexities of nutraceuticals and proposes the N-of-1 as Level 1 evidence better suited for the proof of efficacy of nutraceuticals.

Knowledge, Attitude and Practice Related to the Use of Nutraceuticals for Prophylaxis against COVID-19 among Undergraduate Medical and Nursing Students in a Tertiary Care Teaching Hospital, Bihar, India

Introduction: Nutritional supplements modify immune response and protect against viral infections. Health related behaviour of medical and nursing students governs their attitude towards counselling patients. This study assessed the differences in the Knowledge, Attitude, and Practice (KAP) between undergraduate medical and nursing students regarding the role of nutraceuticals in Coronavirus Disease-2019 (COVID-19). Aim: To assess the differences in the KAP between undergraduate medical and nursing students regarding the role of nutraceuticals in COVID-19. Materials and Methods: An analytical cross-sectional study was conducted in a tertiary care teaching hospital, Patna, Bihar, India in September 2020. A questionnaire was administered to assess the KAP of 265 medical and 150 nursing undergraduates regarding nutraceuticals. The total knowledge score varied between 0 and 12. The score of the attitude was based on 5 points Likert scale. The data was collected through self-administered google forms. Chi-square test and Fisher’s exact test was used to compare the difference in categorical data. Results: There were total 273 (65.8%) participants with good knowledge and only 47 (11.3%) with positive attitude. About 68.7% medical students and 82.7% nursing students felt that regular intake of nutraceuticals has a positive role in protecting against COVID-19 (p=0.007). Out of 415, 264 participants (63.6%) had used nutraceuticals. About 156 (58.9%) medical students and 103 (68.7%) nursing students felt that the safety of nutraceuticals is a grave concern. Two- fifth of the participants (202, 48.7%) had consumed a dietary supplement to maintain good health. Conclusion: Although the knowledge score was good, but positive attitude was lacking. Thus, Health Care Personnels (HCP)s should be trained regarding proper usage and recommendations of nutraceuticals.

Efficacy and Safety of Nutraceutical on Menopausal Symptoms in Post-Menopausal Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Background Menopausal symptoms severely reduce the quality of life of post-menopausal women worldwide. Nutraceuticals are widely prescribed as a viable and safer alternative and complementary approach to standard therapies. The aim of this study was to evaluate the clinical efficacy and safety of a nutraceutical in post-menopausal women. Methods The study was designed as a randomized, double-blinded, placebo-controlled clinical trial. Post-menopausal women aged 45–60 years old were enrolled and randomly assigned to either treatment (n = 50) or placebo group (n = 51). The intervention, a proprietary combination of soy isoflavone, black cohosh, chasteberry and evening primrose oil extracts, and the placebo, were administered to each group for total of 12 weeks. Menopausal symptoms, endocrine profiles, and blood chemistry were evaluated at baseline, 6 weeks, and 12 weeks of the study. Results Nutraceutical supplementation demonstrated a statistically significant reduction in hot flushes and sweating (p < 0.0001), sleep problems (p < 0.0005), depressed mood (p = 0.0004) and irritability symptoms (p < 0.0003) compared with the placebo group. There were no significant differences in hormonal levels between the test and placebo groups, however levels of C-reactive protein were significantly decreased. Moreover, serum LDL-C and triglyceride levels were significantly lower than baseline levels in the treatment group at 6- and 12-week timepoints. No adverse effects were reported during the treatment. Conclusion These data indicate that a nutraceutical containing a combination of four medicinal herbs effectively and safely improved menopausal symptoms, as well as general health indicators, in post-menopausal women.

Factors affecting consumers’ decisions on the use of nutraceuticals: a systematic review

There is a high and increasing global prevalence of nutraceuticals use. This study aims to systematically review and critically appraise all available evidence to identify the factors affecting consumers’ decisions in taking nutraceuticals. Questionnaire, interview or focus group studies which directly reported factors affecting consumers’ decisions in using nutraceuticals were included. A thematic synthesis method was employed to synthesis the findings from the included studies. Out of the 76 studies included, the key factors identified as the most important factors motivating consumers to take nutraceuticals were the perceived health benefits and safety of nutraceuticals, as well as the advice from healthcare professionals, friends and family. The identified barriers to take nutraceuticals were a lack of belief in the health benefit of nutraceuticals, the high cost of nutraceuticals and consumers’ lack of knowledge about nutraceuticals. As a chief course of recommendation for the use of nutraceuticals, healthcare professionals should strive to utilise reliable information from clinical evidence to help consumers in making an informed decision in using nutraceuticals. Future studies should explore the possible ways to improve channelling clinical evidence information of nutraceuticals to the public.

Nutraceuticals in the Management of Osteoarthritis

Osteoarthritis (OA) is a chronic, highly prevalent and disabling disease that is expected to increase in prevalence secondary to longer life expectancy and a disproportionately aging population. Treatment of OA is only marginally effective and has been focused primarily on symptom control using weight loss, physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, intra-articular steroids or viscosupplementation, topical NSAIDs and analgesics, diacerein (an oral interleukin-1β inhibitor) and finally joint replacement surgery. The use of nutraceuticals in the treatment of OA is common, and scientific studies examining the effects of nutraceuticals on the pathogenesis and treatment of OA are increasing. This review examines the efficacy and safety of select nutraceuticals for the treatment of OA. The reviewed nutraceuticals include glucosamine, chondroitin, collagen hydrolysates (CHs) and avocado-soybean unsaponifiables (ASUs). There have been several clinical trials examining the efficacy of these products and the results demonstrate significant heterogeneity. Significant improvements in pain, function and structural outcomes have been shown for some of the treatment arms or subgroups of patients, but the effects are not consistent across the studies. Glucosamine, chondroitin and the two in combination have been the most extensively studied. Significant improvement in pain and functional indices and a decrease in the loss of joint space width were demonstrated in some but not all studies. CHs showed significant improvement in pain and functional indices for several subgroups of patients, but these findings were not pervasive amongst the treatment arms. ASU has demonstrated positive results with respect to decreased NSAID use in several studies and functional and pain end points in most of the reviewed studies; however, in the two studies examining structural end points, the results were mixed. The safety of these nutraceuticals has been demonstrated across all of the reviewed trials, and there were no significant issues with tolerance. Given the good safety profile of nutraceuticals, the marginal efficacy of conventional treatments, the high prevalence and rate of disability from OA and the possible benefit of nutraceuticals to patients with OA, use of nutraceuticals in select patients is appropriate. An overall recommendation to use nutraceuticals in the treatment of all patients with OA is not strongly supported by the available data. Future studies should focus on standardization of symptomatic and structural outcome measures, be of longer duration and pay careful attention to the content of the investigational product.

Nutraceuticals, a Call for Quality Control of Delivery Systems

The nutraceutical revolution which has become an integral part of the medical discovery process, marked the entry of nutraceuticals into the mainstream of clinical practice and scientific medical research. This has given rise to an increasingly urgent need to rationalize the scientific development, standardization, commercial availability and communications of these products to a dual audience of consumers and physicians. Standardization is often based on the concentration of a major active constituent and ensures consistency in identification of the active ingredient, consistency in strength and content in the delivery system and consistency in dosing and thus, optimization of intended therapy. Critical quality control measures ensure that these standards are met. Nutraceuticals are not regulated by the existing legislation, i.e., the Nutrition Labeling Health and Education Act of 1990 (NLEA) and the Dietary Supplement and Health Education Act of 1994 (DSHEA). The objective of this report is to highlight how the lack of standardization influences the quality of commercial nutraceutical dosage forms. The dosage form evaluation focused on products containing the potential antiarthritic nutraceuticals chondroitin sulfate and glucosamine. The dosage form evaluation carried out in terms of content uniformity illustrated that not all supplements containing glucosamine or chondroitin sulfate or both, contain the stated amount which appears on the label. Research and regulation focusing on quality control standards are required so as to ensure consistency, efficacy and safety of nutraceuticals.