This presentation is based on the article “How to Read a Clinical Trial Paper: A Lesson in Basic Trial Statistics” published on Gastroenterology and Hepatology in 2012 by Dr Higgins and Dr Govani. Its aim is to help clinicians to incorporate the results of clinical trials into their daily clinical practice.
Nowadays clinical trials, which travel at the rate of 18,000 new studies in the United States alone, make it impossible for gastroenterologists to keep up with the results. Despite the increasing number of clinical trials performed yearly, their results are not always directly applicable to clinical practice.
Basic statistics can help clinicians introduce the results of clinical trial papers in their clinical practice.
A list of ten points can help clinicians to define an easy road map to follow when reading the findings of a new study. Here are presented the first 4.
Are These Subjects Like My Patients?
A well-studied trend demonstrates that patients enrolled in clinical trials usually have conditions worse than the patients a clinician sees in his or her practice. Thus, it is crucial to check if enrolled patients are representative while reading a clinical paper.
The first table of a clinical trial publication usually summarizes not only the population’s age, race, and gender but also the typical disease severity, disease duration, and medication history. The results of a study are applicable only if all these factors are similar to those of the patients seen in clinical practice.
Another aspect to consider is the recruitment method as it can influence the make-up of a study and bring contrasting response rates.
What Happened to the Subjects? Did They Drop Out? Why?
The statistical significance of a study emerges from a dropout rate due to the lack of benefit in the treatment arm lower than in the placebo arm. This information is placed in the Consolidated Standards of Reporting Trials (CONSORT) diagram, usually the first figure in the paper. The CONSORT diagram shows the flow of subjects from recruitment through the end of the study (or early exit from the study). If the reasons for leaving the study are not specified, the exit rate must be compared for each arm. A lower exit rate should be a direct consequence of the more effective treatment arm in a well-tolerated treatment.
Is the Study Design Biased?
Comparator group, allocation of subjects to treatment arms, and blinding are three crucial aspects of study design and need to be checked with special attention.
The comparator is the standard-of-care therapy in disease states with established therapies such as inflammatory bowel disease (IBD).
The placebo effect can affect the results, for this reason, a placebo group and/or a proven effective comparator have to be included.
The allocation of subjects to each treatment arm should be well defined and concealed while investigators cannot anticipate which arm a new subject will enter.
The CONSORT diagram should be easy to follow and similarly detailed for each arm.
Randomization may be at the population level or clustered at the site level; in the latter case, all the subjects at 1 site are in a single arm.
The blinding process can be single- or double-blind. Single-blind means the patient does not know its allocation, double-blind means even investigators do not know the patient’s allocation.
An overestimation of the treatment effect is evident in studies conducted without blinding.
The blinding process can be challenging, but it is crucial, especially in trials involving a procedure. The success of the blinding process was only 2% of 1,599 studies a 2007 analysis says.
Does the Study Include an Intention-to-Treat Analysis?
An analysis that includes all randomized subjects, even if they do not receive the intervention or may drop out of the study, is called an intention-to-treat (ITT) analysis. On the other side, an analysis, in which only subjects who received their assigned intervention are counted, is named a per-protocol analysis (PPA).
As a high rate of early dropout can damage clinical trials, researchers prefer to present the data of a PPA.
Unfortunately, a PPA is reliable only as a secondary endpoint, that is after the presentation of the ITT results.
While reading a clinical paper, clinicians should openly find out if the presented data are part of an ITT analysis or not.
Let’s proceed with the list of ten points that can help clinicians while reading the findings of a new study. Here are presented the other 4.
Is This a Test of Superiority? Equivalence? Non-inferiority?
The intent to prove that one therapy is superior to another is the goal of many clinical trials. An equivalence or non-inferiority to standard treatment study is intended to demonstrate that a new therapy is more convenient or cheaper.
As the definitions of non-inferiority and equivalence can be ambiguous, those studies can lead to difficulties in the results’ interpretation.
The sample size needed to determine non-inferiority or equivalence is always much higher than the size needed to determine superiority.
The reader should be able to replicate the sample size calculation if necessary, and the methods section of a clinical study should reproduce every single step of the calculation.
In an equivalence study, the 95% confidence interval of the difference between the treatments needs to be less than the previously defined acceptable difference. As a direct consequence, the required sample size of an equivalence study is about 4 times larger than the sample size needed for a superiority study.
If initially a study was designed to test for superiority, but the goal was missed, the decision to switch to an equivalence study results inappropriate, because the acceptable difference was not defined in advance, and the sample size is too small.
Does the Measurement Matter? Is It Reproducible? Accurate?
The study’s measurement of success can make the results of a clinical trial difficult to apply to the everyday practice of a clinician.
Considering the three aspects below can facilitate the transferring of those results to clinical practice:
- Reproducibility and accuracy of a measurement.
Many measures are not very reproducible and some instruments, such as the endoscopic grading or the histologic grading of dysplasia, present a high level of disagreement in the middle of the scale. This disagreement produces noise in the data.
- Amount of change seen in the clinical index or score and significant clinical meaning to real-world patients.
The results of a published paper can be statistically significant, but it does not mean that they are also clinically meaningful. Only clinically meaningful results deserve to be translated into clinical practice.
- Validation of the measurements.
The validity fulfils all the below aspects:
- The index is measuring accurately all the important aspects of a disease.
- The measurement is reproducible in subjects whose condition has not changed.
- The instrument is responsive to small but clinically important changes.
How Are Missing Data Addressed?
The 3 common methods for handling missing data are:
- The non-responder imputation considers any subject who has missing data as one who would have failed to meet the endpoint. The success rates (and placebo rates) are smaller, and the results look not so impressive.
- The last-observation-carried-forward approach uses the last observation at which the subject was measured in place of the missing data. It is used in maintenance studies with repeated measurements. The success rates of both the primary intervention and the control arm may inflate.
- The imputation uses other data to estimate what the missing data would have been. The impossibility to check the accuracy of the estimates makes this approach questionable.
Do the Design and Methods Conform to the Prestudy Guidelines?
Clinical trials, registered on the ClinicalTrials.gov website, give to an interested reader the chance to check if the endpoints changed during the study and if the trial was truly prospective.
If it comes out that some of the outcomes mentioned on the initial registration page are not reported in the published paper, it is reasonable to presume that the outcome results were disappointing.
How Good Are the Results?
Using only the P-value to determine if a clinically important effect is present leads to misinterpretations.
The underlying assumption of the P-value is that the null hypothesis is true. If the treatment arms are equally effective (Null hypothesis true), the observed differences between the 2 treatment arms will be due to chance alone and the P-value gives this probability.
In other words, the P-value serves to exclude that the observed differences are due to chance alone.
While reading the results of a study, two measurements combined with P-value play an important role in results interpretation: effect size and precision.
The effect size is the difference between two groups, and the precision is the variation of that difference represented by the confidence interval.
Even a small difference between the two groups (effect size) can be statistically significant in a very large study (>500 patients per arm), on the other side a big effect size could scarcely be significant in a small study.
For example, a difference of 2,5 mmHg for blood pressure between treatment A and treatment B in a 500 patients study is statistically significant (P-value 0.0498), on the other side, a difference of 12 mmHg for blood pressure between treatment A and treatment B in a 50 patients study is barely statistically significant (P-value 0.0492). If recruitment had stopped at 40 patients, the difference would not have been statistically significant.
How Big of an Effect Is It?
The number needed to treat (NNT) facilitates judging the impact of a study’s findings. NNT represents the reciprocal of absolute risk reduction and reveals the number of patients that in clinical practice should be treated to see the desired outcome.
Thank you for your attention
There is now time for all your questions!
Reference:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3380258/
Introduction
With more than 760.000 people directly employed, the medical device industry accounts for around 0.3% of total employment in Europe, while the value added per employee is estimated to reach 184,000 euros per employee (1).
The medical technology industry is indeed crucial for Europe’s economy and even more for patients’ health in Europe and the World, as the above indicators clarify.
Medical devices impact the lives of millions of people.
We can divide the medical technologies into three main categories:
1. Medical devices (MDs): are products, services or solutions that prevent, diagnose, monitor, treat and care for human beings by physical means.
2. In vitro diagnostics medical devices (IVDs) are non-invasive tests used on biological samples (for example blood, urine, or tissues) to determine the status of a person’s health.
3. Digital health refers to tools and services that use information and communication technologies (ICTs) to improve prevention, diagnosis, treatment, monitoring and management of health and lifestyle.
The change from an EU Directive (MDD) to an EU Regulation (MDR) was at a certain point the required step to protect patients and ensure that only safe and effective medical devices are available on the market.
On May 5, 2017, the European Commission published a new Regulation for medical devices, which will replace the existing Directives. This article provides an overview of the new Regulation and how it will impact medical device manufacturers.
Why there was a change from an EU Directive to an EU Regulation
There are several reasons why the European Union (EU) is changing its medical device Regulation. One reason is that the current legislation is more than 20 years old and needs to be updated to reflect advances in technology. Since the 1990s technology has advanced, we now have medical apps and 3D printing. This new technology will be covered by the EU Regulation.
Another reason is that the EU wants to align its Regulations with those of other major economies, such as the United States. Finally, the EU wants to make sure that its citizens have access to safe and effective medical devices.
The new Regulation will place greater emphasis on safety and will require manufacturers to provide more data about their products.
Under the new MD Regulation, some changes have been introduced in the risk-based classification system. Classification of medical devices drives many pre- and post-market requirements. Due to the large variety of products, the level of control made by a third party (the “notified body”) before placing them on the market depends on the level of impact on the human body that their use might imply. The same notified body is involved post-market to ensure the continued safety and performance of medical devices.
“Class III” devices are a new category of medical devices which will be subject to the highest level of scrutiny. The class of each de-
vice is linked to the potential risk posed to the health of the public and an individual because of a failure in functioning. All MDs are classified under class I, IIA, IIB or III, with class III being the highest risk class.
The changes will apply to all medical devices sold in the EU.
Structure of the Medical Device Regulation 2017/745
The Medical Device Regulation 2017/745 consists of (2):
- 101 Preamble’s
- 123 Articles in 10 Chapters
- 17 Annexes
- 175 pages
The MDR is divided into chapters: chapter 3 is dedicated to the identification and traceability of devices, registration of devices and of economic operators, a summary of safety and clinical performance, and the European database on medical devices (EUDAMED).
The purposes of EUDAMED are among all to enable the unique identification of devices within the internal market and to facilitate their traceability, the final aim is to inform the public about devices placed on the market and the corresponding clinical investigations carried about to guarantee their safety.
EUDAMED is one of the innovations introduced by the EU MDR 2017/745, where a new term also appears: “Economic operator” and it is defined as “a manufacturer, an authorized representative, an importer, a distributor or a person” that is part of the product supply chain. This includes, for example, manufacturers, importers, distributors, and warehousing facilities.
In the medical device Regulation, there are 8 annexes: the second and third of them introduce the technical documentation and the technical documentation on post-market surveillance.
The technical documentation to prove safety and efficacy is new to Medical Device Regulation.
There are now 22 rules in the MDR compared to the 18 rules in the MDD.
Main changes introduced by the new Regulation
The main changes introduced by the Regulation are:
– A new classification system for medical devices, based on the risks they pose to patients and users;
– New clinical evaluation requirements for all medical devices;
– More stringent post-market surveillance requirements;
– Tighter rules on device manufacturers, importers, and distributors;
– New requirements for notified bodies;
– Strengthened powers for the European Commission and national authorities.
The Medical Device Regulation will bring three major changes:
- Harmonization
- Transparency
- Traceability
Medical Device Regulation 2017/745 EU timelines
It was adopted on the 5th of April 2017 and published in the Official Journal of the European Union on the 5th of May 2017. The Regulation came into force on the 25th of May 2017.
This is the norm, once is published in the Official Journal of the European Union and it comes into force 20 days later.
MDR was to come mandatory on the 25th of May 2020 but on the 23rd of April 2020 the European Commission pushed out the date of the MDR 2017/745 to the 26th of May 2021 due to the Covid pandemic. The application date was postponed by 1 year.
From the 26th of May 2021 on, no medical device can be certified under the old Directives anymore.
The timelines for the transition of the MDR 2017/745
The Medical Devices Directive (93/42/EEC) was introduced in 1993 and was last amended in 2007. The Directive provides a regulatory framework for the marketing of medical devices in the European Union (EU).
As cleared above, the Directive is currently being replaced by the Regulation on Medical Devices (EU) 2017/745, which was published in the Official Journal of the EU on 5 May 2017. The Regulation will come into force on 26 May 2020 and will apply from 26 May 2021.
From that date, all medical devices placed on the market must comply with the provisions of the MDR.
The transition period from the old Directive to the new Regulation will last three years.
From May 2024, all devices placed on the market must be compliant with the MDR.
Transition is explained in article 120 of the MDR 2017/745
Conclusion
As we can see, the Regulation of medical devices is a complex and ever-evolving process. To ensure the safety and efficacy of these products, it is essential that manufacturers work closely with regulatory authorities to ensure compliance. The implementation of the new EU Medical Device Regulation will no doubt bring about some challenges, but by working together we can overcome them and continue to provide safe and effective medical devices to patients across Europe.
References:
(1) https://www.medtecheurope.org/wp-content/uploads/2021/06/medtech-europe-facts-and-figures-2021.pdf
(2) https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
Catch the nutrition tips to increase your performance
In the life of an endurance athlete training and nutrition play a vital role in all the steps of adequate preparation.
Nullifying the efforts made during your training phase with a bad eating strategy is a mistake that an athlete should not allow. Nutrition is the most important aspect of preparation from the first training day to the competition’s day.
Be entirely ready for your race
An adequate nutritional strategy, which is aimed at short trials, or endurance for a Gran Fondo, marathon, and even 24H on mountain bike (MTB), should be traced in advance and represents the first step toward excellent performance.
It is always good to remember that food, in its different forms, can be defined as the fuel for our engine and dramatically affects the well-being of our organism, our balance and, as previously written, plays a fundamental role in performance but also in mental attitude.
Let’s start with the basics of sports nutrition: 3 main meals and 2 snacks
The calorie consumption of an endurance athlete is greater than that of a sedentary person, so the amount of food and calories to be consumed must also be greater and proportionate. The daily diet must be rich in carbohydrates from whole grains, proteins from lean meat or legumes, and fats.
Salmon, olive oil, avocado, and nuts or dried fruit are rich in good fats. As for fruit and vegetables, at least five servings a day, because an athlete consumes more vitamins and produces more free radicals than an inactive person [1], who still needs fruit and vegetables for their content of fiber, vitamins, antioxidants, water, and minerals useful for the body.
General instructions for every phase
On training days, the main meal before the training session should be rich in carbohydrates [2], but the following one requires a correct protein content [3].
On non-training days prefer proteins over carbohydrates [3].
Nutritional instructions for the race preparation
The night before a race, avoid fiber and favor non-whole carbohydrates but in the morning make sure you get a correct amount of them, a typical breakfast could be rusks with jam, porridge, white bread, rump or raw ham, liquids, and, depending on the weather and temperature conditions, a drink added of carbohydrates and mineral salts or one of carbohydrates only, such as maltodextrins or cyclodextrins [4].
Generally used as a thickener in processed food, maltodextrins are also used as a source of immediate energy. They are capable of rapidly increasing blood glucose levels.
Cyclodextrins dissolve more easily in water. Cyclodextrins require little water to dissolve because they are highly soluble. To absorb them, the athlete must therefore ingest less water than other types of carbohydrates and this decreases the gastric emptying time [5].
Slowing gastric emptying helps to make the athlete feel full during performance or training and reduces intestinal problems.
As regards breakfast, it could be useful to eat plain rice or carbohydrates with a low glycemic index at least two and a half / three hours before the competition. A teaspoon of olive oil or a nut of butter will give it a more intense taste and will enrich your meal without making it too heavy. Even if on the morning of the race you have the feeling that you need to increase the amount of fat to have a richer breakfast, remember that fats have a longer digestion time than other nutrients and you risk overloading your body by lengthening the digestion duration [4].
The essential advice in the race
- Drink every 15-20 minutes.
- After the first 90 minutes or so, take a gel or a bar.
- A gel or a bar every hour; if the gel is not isotonic, it should be taken together with water to avoid gastrointestinal discomfort [6].
In MTB races, consumption and caloric needs vary depending on the altitude, so before a demanding climb or halfway through a long test, a gel with the addition of caffeine is useful in terms of perception of fatigue, delaying its onset [6]. Always remember that the nutritional strategy must be studied and tested in advance.
Long-distance circuit races
In the tests lasting 6 or 24 hours, there are various situations to which we must pay particular attention [7]:
- The change of temperature between day and night: during the day it is good to have a solution of mineral salts in your bottle, while at night a solution of carbohydrates with branched amino acids protects the muscles subjected to intense physical exertion.
- Drink plain water with gels (unless it is isotonic gel) and with bars or other solid food.
- Train the intestine at the break with the evening meal, and in any case, alternate gels and bars with normal, easily digestible food; the classic ham sandwich can provide carbohydrates, and proteins and break the continuous intake of sweet foods [8].
- Eat often and avoid ingesting too much food or liquid at one time [9].
- Avoid exhaustion by anticipating the moment when you feel hungry and eating small amounts but constantly: this will also give you continuous energy.
- Evaluate the use of caffeine at night (test the products in training), preferably with resealable vials to divide the dosage [10, 11].
- Extra gel or bar can be useful in case of an emergency.
The recovery phase
All competitions need to set up a sufficient liquid, saline, fast carbohydrate replenishment (simple sugars), and above all to take at least 0.25 g of a high-quality protein per kg of body weight, or an absolute dose of 20-40 g of a high-quality protein to provide all the essential amino acids for restoring the plastic functionality of the stressed muscle [12]. After an hour, eat a solid and easy-to-digest meal, to reduce extra stress for the body. Don’t forget fruit: it contains sugars and antioxidants that also facilitate recovery and reduce damage from free radicals.
References
[1] Powers SK, Deminice R, Ozdemir M, Yoshihara T, Bomkamp MP, Hyatt H. Exercise-induced oxidative stress: Friend or foe? J Sport Health Sci. 2020 Sep;9(5):415-425. doi: 10.1016/j.jshs.2020.04.001. Epub 2020 May 4. PMID: 32380253; PMCID: PMC7498668.
[2] Rothschild JA, Kilding AE, Plews DJ. What Should I Eat Before Exercise? Pre-Exercise Nutrition and the Response to Endurance Exercise: Current Prospective and Future Directions. Nutrients. 2020 Nov 12;12(11):3473. doi: 10.3390/nu12113473. PMID: 33198277; PMCID: PMC7696145.
[3] Kerksick CM, Arent S, Schoenfeld BJ, Stout JR, Campbell B, Wilborn CD, Taylor L, Kalman D, Smith-Ryan AE, Kreider RB, Willoughby D, Arciero PJ, VanDusseldorp TA, Ormsbee MJ, Wildman R, Greenwood M, Ziegenfuss TN, Aragon AA, Antonio J. International society of sports nutrition position stand: nutrient timing. J Int Soc Sports Nutr. 2017 Aug 29;14:33. doi: 10.1186/s12970-017-0189-4. PMID: 28919842; PMCID: PMC5596471.
[4] Tiller NB, Roberts JD, Beasley L, Chapman S, Pinto JM, Smith L, Wiffin M, Russell M, Sparks SA, Duckworth L, O’Hara J, Sutton L, Antonio J, Willoughby DS, Tarpey MD, Smith-Ryan AE, Ormsbee MJ, Astorino TA, Kreider RB, McGinnis GR, Stout JR, Smith JW, Arent SM, Campbell BI, Bannock L. International Society of Sports Nutrition Position Stand: nutritional considerations for single-stage ultra-marathon training and racing. J Int Soc Sports Nutr. 2019 Nov 7;16(1):50. doi: 10.1186/s12970-019-0312-9. PMID: 31699159; PMCID: PMC6839090.
[5] TAKII, Hiroshi & Kometani, Takashi & NISHIMURA, Takahisa & Kuriki, Takashi & FUSHIKI, Tohru. (2004). A Sports Drink Based on Highly Branched Cyclic Dextrin Generates Few Gastrointestinal Disorders in Untrained Men during Bicycle Exercise. Food Science and Technology Research – FOOD SCI TECHNOL RES. 10. 428-431. 10.3136/fstr.10.428.
[6] Costa RJS, Knechtle B, Tarnopolsky M, Hoffman MD. Nutrition for Ultramarathon Running: Trail, Track, and Road. Int J Sport Nutr Exerc Metab. 2019 Mar 1;29(2):130-140. doi: 10.1123/ijsnem.2018-0255. Epub 2019 Apr 3. PMID: 30943823.
[7] Casazza GA, Tovar AP, Richardson CE, Cortez AN, Davis BA. Energy Availability, Macronutrient Intake, and Nutritional Supplementation for Improving Exercise Performance in Endurance Athletes. Curr Sports Med Rep. 2018 Jun;17(6):215-223. doi: 10.1249/JSR.0000000000000494. PMID: 29889151.
[8] Rosset R, Lecoultre V, Egli L, Cros J, Dokumaci AS, Zwygart K, Boesch C, Kreis R, Schneiter P, Tappy L. Postexercise repletion of muscle energy stores with fructose or glucose in mixed meals. Am J Clin Nutr. 2017 Mar;105(3):609-617. doi: 10.3945/ajcn.116.138214. Epub 2017 Jan 18. PMID: 28100512.
[9] Alghannam AF, Ghaith MM, Alhussain MH. Regulation of Energy Substrate Metabolism in Endurance Exercise. Int J Environ Res Public Health. 2021 May 7;18(9):4963. doi: 10.3390/ijerph18094963. PMID: 34066984; PMCID: PMC8124511.
[10] Guest NS, VanDusseldorp TA, Nelson MT, Grgic J, Schoenfeld BJ, Jenkins NDM, Arent SM, Antonio J, Stout JR, Trexler ET, Smith-Ryan AE, Goldstein ER, Kalman DS, Campbell BI. International society of sports nutrition position stand: caffeine and exercise performance. J Int Soc Sports Nutr. 2021 Jan 2;18(1):1. doi: 10.1186/s12970-020-00383-4. PMID: 33388079; PMCID: PMC7777221.
[11] Southward K, Rutherfurd-Markwick KJ, Ali A. The Effect of Acute Caffeine Ingestion on Endurance Performance: A Systematic Review and Meta-Analysis. Sports Med. 2018 Aug;48(8):1913-1928. doi: 10.1007/s40279-018-0939-8. Erratum in: Sports Med. 2018 Aug 9;: PMID: 29876876.
[12] Jäger R, Kerksick CM, Campbell BI, Cribb PJ, Wells SD, Skwiat TM, Purpura M, Ziegenfuss TN, Ferrando AA, Arent SM, Smith-Ryan AE, Stout JR, Arciero PJ, Ormsbee MJ, Taylor LW, Wilborn CD, Kalman DS, Kreider RB, Willoughby DS, Hoffman JR, Krzykowski JL, Antonio J. International Society of Sports Nutrition Position Stand: protein and exercise. J Int Soc Sports Nutr. 2017 Jun 20;14:20. doi: 10.1186/s12970-017-0177-8. PMID: 28642676; PMCID: PMC5477153.
Disclaimer
The information contained herein is not and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Before making any changes to your diet, exercise or treatment, always consult your doctor or a qualified health professional.
The guidance provided may not be appropriate for your specific situation. Never make any decisions about your health based solely on the information provided in this article.
The author and creator of this article are not responsible for any damage or loss resulting from the improper use of the information presented here. Remember that each person is unique and therefore needs a personalized approach to health.
If you have any concerns about your health, please consult a qualified medical professional.
Is Resistance training to be encouraged in adults?
Preserve your muscles and you will preserve your health: here’s how!
Muscle decline and its consequences
Muscle tissue is the primary site of glucose disposal, as it declines at a rate of 3–8% each decade after the age of 30 [1], aging brings a decline in skeletal muscle, increasing the risk of diabetes and changes in glucose tolerance: total diabetes prevalence (undiagnosed and diagnosed) is currently estimated to be 14% of the U.S adult population and is highest in those aged ≥65 years. By the year 2050, diabetes prevalence could be as high as 33%, recent estimates indicate [2]. The improved occurrence of diabetes amongst older adults, coupled with the growing old of our population, suggests a clear need for powerful diabetes prevention strategies [3, 4].
In addition, a decrease in the muscle twitch time and force is experienced, which can be considered a cause or an effect of muscle mass reduction, also named sarcopenia [4]. Other outcomes of this decline in muscles encompass decreased muscle strength, decreased resting metabolic rate, decreased lipid oxidative capacity, and improved adiposity [3, 4].
Are we all becoming diabetic?
The evidence showing that type 2 diabetes can be prevented or delayed by lifestyle interventions including improved nutrition, improved physical activity, and weight reduction of 5% to 7% is robust [5, 6]
However, most of the evidence from clinical trials enrolled primarily middle-aged participants [7]. The exception is the Diabetes Prevention Program (DPP)—the largest clinical trial to date. In the Diabetes Prevention Program, approximately 20% of the participants were aged 60 years or older at enrolment. These seniors experienced a 71% risk reduction for type 2 diabetes compared with a 58% risk reduction in younger participants [8].
Follow-up of the Diabetes Prevention Program participants for 10 years showed the seniors continued to benefit most. Those aged 60 and older had a 49% risk reduction compared with a 34% reduction for all participants. Additional benefits of the lifestyle intervention that might impact older adults, such as reduction in urinary incontinence, improvement in several quality-of-life domains, and improvements in cardiovascular risk factors, also were observed.
The most robust predictor of glucose tolerance
Increasing lean body mass (primarily muscle mass) parallels the improvements in glucose tolerance seen with resistance training among older adults, as many clinical studies have shown [9, 10]. Although lean mass may not be the most robust predictor of glucose tolerance, the results of numerous clinical trials suggest that increases in lean body mass with resistance training are associated with improvements in glucose tolerance [11, 12]. Therefore, increasing lean mass regardless of baseline levels should improve glucose tolerance and insulin resistance, which may be an important strategy to combat the age-related increases in insulin resistance and glucose intolerance.
Can we stop muscle decline?
The Diabetes Prevention Program demonstrated that lifestyle modification reduces the development of diabetes by focusing on weight loss, increased physical activity, and dietary modification. Lifestyle modification decreased the incidence of type 2 diabetes by 58%, as compared to 31% among individuals taking metformin. The physical activity component of the DPP recommended that individuals accumulate 150 minutes/week of moderate physical activity. The DPP stressed brisk walking as the physical activity of choice but also lists aerobic dance, skating, bicycle riding, and swimming as options. In support of the DPP’s recommendations for aerobic training (AT), regular AT improves glucose control and insulin sensitivity [13]. The American Diabetes Association (ADA) recommends that individuals with diabetes perform at least 150 minutes of moderate-intensity AT per week. However, factors such as obesity, arthritis, low back pain, and physical disabilities affecting many older adults may preclude this population from regularly performing AT [14].
Is resistance training safe?
Resistance training is an activity that can be safe and effective for older adults, including the elderly. The ADA encourages individuals with type 2 diabetes to perform resistance exercise three times a week targeting all major muscle groups, progressing to three sets of 8–10 repetitions at high intensity. By using machines that provide external resistance with controlled movements, even those confined to a wheelchair or a walker can perform some types of RT. Though older adults demonstrate reduced overall muscle protein synthesis (MPS) relative to younger adults after a bout of resistance training, clinical trials investigating RT interventions among older adults have shown improvements in insulin resistance and sarcopenia, by increasing lean body mass [15].
High-intensity RT (defined as training loads above 75% one-repetition maximum (RM)) produces greater improvements than RT performed at a moderate or low intensity (training loads between 50%–74% of one RM and below 50% one RM, respectively) [16, 17].
Resistance training? Why not?
Diabetes in the elderly can be prevented or delayed with lifestyle interventions, including improved nutrition, increased physical activity, and weight loss. Physical activity and in particular resistance training has to be clearly encouraged.
References:
[1] Shur NF, Creedon L, Skirrow S, Atherton PJ, MacDonald IA, Lund J, Greenhaff PL. Age-related changes in muscle architecture and metabolism in humans: The likely contribution of physical inactivity to age-related functional decline. Ageing Res Rev. 2021 Jul;68:101344. doi: 10.1016/j.arr.2021.101344. Epub 2021 Apr 16. PMID: 33872778; PMCID: PMC8140403.
[2] “Prevalence of Diagnosed Diabetes | Diabetes | CDC.” https://www.cdc.gov/diabetes/data/statistics-report/diagnosed-diabetes.html
[3] Nishikawa H, Asai A, Fukunishi S, Nishiguchi S, Higuchi K. Metabolic Syndrome and Sarcopenia. Nutrients. 2021 Oct 7;13(10):3519. doi: 10.3390/nu13103519. PMID: 34684520; PMCID: PMC8541622.
[4] Nishikawa H, Fukunishi S, Asai A, Yokohama K, Ohama H, Nishiguchi S, Higuchi K. Sarcopenia, frailty and type 2 diabetes mellitus (Review). Mol Med Rep. 2021 Dec;24(6):854. doi: 10.3892/mmr.2021.12494. Epub 2021 Oct 15. PMID: 34651658.
[5] Ard J, Fitch A, Fruh S, Herman L. Weight Loss and Maintenance Related to the Mechanism of Action of Glucagon-Like Peptide 1 Receptor Agonists. Adv Ther. 2021 Jun;38(6):2821-2839. doi: 10.1007/s12325-021-01710-0. Epub 2021 May 11. PMID: 33977495; PMCID: PMC8189979.
[6] “Diabetes Prevention in Older Adults – Today’s Dietitian Magazine.” https://www.todaysdietitian.com/newarchives/0417p30.shtml.
[7] Grevendonk L, Connell NJ, McCrum C, Fealy CE, Bilet L, Bruls YMH, Mevenkamp J, Schrauwen-Hinderling VB, Jörgensen JA, Moonen-Kornips E, Schaart G, Havekes B, de Vogel-van den Bosch J, Bragt MCE, Meijer K, Schrauwen P, Hoeks J. Impact of aging and exercise on skeletal muscle mitochondrial capacity, energy metabolism, and physical function. Nat Commun. 2021 Aug 6;12(1):4773. doi: 10.1038/s41467-021-24956-2. PMID: 34362885; PMCID: PMC8346468.
[8] Gruss SM, Nhim K, Gregg E, Bell M, Luman E, Albright A. Public Health Approaches to Type 2 Diabetes Prevention: the US National Diabetes Prevention Program and Beyond. Curr Diab Rep. 2019 Aug 5;19(9):78. doi: 10.1007/s11892-019-1200-z. Erratum in: Curr Diab Rep. 2020 Jun 27;20(8):36. PMID: 31385061; PMCID: PMC6682852.
[9] Buchanan A, Villani A. Association of Adherence to a Mediterranean Diet with Excess Body Mass, Muscle Strength and Physical Performance in Overweight or Obese Adults with or without Type 2 Diabetes: Two Cross-Sectional Studies. Healthcare (Basel). 2021 Sep 24;9(10):1255. doi: 10.3390/healthcare9101255. PMID: 34682935; PMCID: PMC8535373.
[10] Barrett M, McClure R, Villani A. Adiposity is inversely associated with strength in older adults with type 2 diabetes mellitus. Eur Geriatr Med. 2020 Jun;11(3):451-458. doi: 10.1007/s41999-020-00309-y. Epub 2020 Mar 19. PMID: 32297268.
[11] Xing Z, Chai X. Changes in fat mass and lean body mass and outcomes in type 2 diabetes mellitus. Intern Emerg Med. 2022 Jun;17(4):1073-1080. doi: 10.1007/s11739-021-02916-4. Epub 2022 Feb 1. PMID: 35106709.
[12] Pan B, Ge L, Xun YQ, Chen YJ, Gao CY, Han X, Zuo LQ, Shan HQ, Yang KH, Ding GW, Tian JH. Exercise training modalities in patients with type 2 diabetes mellitus: a systematic review and network meta-analysis. Int J Behav Nutr Phys Act. 2018 Jul 25;15(1):72. doi: 10.1186/s12966-018-0703-3. PMID: 30045740; PMCID: PMC6060544.
[13] Burd C, Gruss S, Albright A, Zina A, Schumacher P, Alley D. Translating Knowledge into Action to Prevent Type 2 Diabetes: Medicare Expansion of the National Diabetes Prevention Program Lifestyle Intervention. Milbank Q. 2020 Mar;98(1):172-196. doi: 10.1111/1468-0009.12443. Epub 2020 Jan 28. PMID: 31994260; PMCID: PMC7077780.
[14] “Standards of Medical Care in Diabetes—2022 Abridged for Primary Care Providers,” Clin. Diabetes, vol. 40, no. 1, pp. 10–38, Jan. 2022, doi: 10.2337/cd22-as01.
[15] Yamada M, Kimura Y, Ishiyama D, Nishio N, Otobe Y, Tanaka T, Ohji S, Koyama S, Sato A, Suzuki M, Ogawa H, Ichikawa T, Ito D, Arai H. Synergistic effect of bodyweight resistance exercise and protein supplementation on skeletal muscle in sarcopenic or dynapenic older adults. Geriatr Gerontol Int. 2019 May;19(5):429-437. doi: 10.1111/ggi.13643. Epub 2019 Mar 13. PMID: 30864254.
[16] Nilsson MI, Mikhail A, Lan L, Di Carlo A, Hamilton B, Barnard K, Hettinga BP, Hatcher E, Tarnopolsky MG, Nederveen JP, Bujak AL, May L, Tarnopolsky MA. A Five-Ingredient Nutritional Supplement and Home-Based Resistance Exercise Improve Lean Mass and Strength in Free-Living Elderly. Nutrients. 2020 Aug 10;12(8):2391. doi: 10.3390/nu12082391. PMID: 32785021; PMCID: PMC7468764.
[17] Antoniak AE, Greig CA. The effect of combined resistance exercise training and vitamin D3 supplementation on musculoskeletal health and function in older adults: a systematic review and meta-analysis. BMJ Open. 2017 Jul 20;7(7):e014619. doi: 10.1136/bmjopen-2016-014619. PMID: 28729308; PMCID: PMC5541589.
Disclaimer
The information contained herein is not and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Before making any changes to your diet, exercise or treatment, always consult your doctor or a qualified health professional.
The guidance provided may not be appropriate for your specific situation. Never make any decisions about your health based solely on the information provided in this article.
The author and creator of this article are not responsible for any damage or loss resulting from the improper use of the information presented here. Remember that each person is unique and therefore needs a personalized approach to health.
If you have any concerns about your health, please consult a qualified medical professional.
Nutritional neuroscience is an emerging discipline shedding light on the fact that nutritional factors are interlaced with human cognition, behaviour, and emotions [1].
The intersection of mental health and nutrition is still an emerging field of study [2]. Professor Julia Rucklidge is the director of the Mental Health and Nutrition Research Group (University of Canterbury). With her group, she explored the impact of nutritional interventions not only on Attention-Deficit/Hyperactivity [3] but also on a wide range of disorders following a series of earthquakes, insomnia, and premenstrual syndrome [4]. The research was conducted on adults and children.
Nutrition can play a key role in the onset as well as severity and duration of depression [5]. Because of accumulating scientific evidence, nutritional supplementation and treatment are effective therapeutic interventions for depression [6]. Supplementation may be appropriate for controlling and to some extent, preventing depression, bipolar disorder, schizophrenia, eating disorders and anxiety disorders, attention deficit disorder/attention deficit hyperactivity disorder (ADD/ADHD), autism, and addiction [7].
Explaining the relation between nutrition and depression to the public
The number of US adults with MDD increased by 12.9%, from 15.5 to 17.5 million, between 2010 and 2018, whereas the proportion of adults with MDD aged 18-34 years increased from 34.6 to 47.5%. Over this period, the incremental economic burden of adults with MDD increased by 37.9% from $US236.6 billion to 326.2 billion (the year 2020 values) [8]. It is therefore essential to bring this new knowledge to the general public’s attention. Professor Rucklidge created a free educational series for the public in collaboration with Professor Bonnie Kaplan and in 2014 presented a TEDx talk that has had over 1.4 million views.
Can supplements be an alternative to antidepressants?
Most prescription drugs, including common antidepressants, lead to side effects [9,10]. This usually causes the patients to skip taking their medications. Such noncompliant patients are at a higher risk of committing suicide or being institutionalized.
Recent evidence suggests a link between low levels of serotonin and suicide [11, 12]. It is implicated that lower levels of this neurotransmitter can, in part, lead to an overall insensitivity to future consequences.
Supplements containing amino acids have also been found to reduce symptoms, as they are converted to neurotransmitters which in turn alleviate depression and other mental health problems [13].
A notable feature of the diets of patients suffering from mental disorders is the severity of deficiency in essential vitamins, minerals, and omega-3 fatty acids.
Studies have indicated that daily supplements of vital nutrients are often effective in reducing patients’ symptoms [14].
How many supplements, and how many fruits and vegetables do we need to eat to stay healthy?
Although further research needs to be carried out to determine the best-recommended doses of most nutritional supplements in the cases of certain nutrients, psychiatrists can recommend doses of dietary supplements based on previous and current efficacious studies and then adjust the doses based on the results obtained by closely observing the changes in the patient. Deficiencies in neurotransmitters such as serotonin, dopamine, noradrenaline, and γ-aminobutyric acid (GABA) are often associated with depression [15]. The diet is a clear key to producing the chemicals required by the brain [16]. The most common nutritional deficiencies seen in patients with mental disorders are omega–3 fatty acids, B vitamins, minerals, and amino acids that are precursors to neurotransmitters.
Most diets are usually also lacking in fruits and vegetables, which further lead to mineral and vitamin deficiencies. The significance of various nutrients in mental health, with special relevance to depression, is becoming more evident day by day [17].
Nutritional therapy is effective and free of side effects; therefore it represents a valid option in the treatment and prevention of mental diseases that are very common today.
References:
[1] Ortega MA, Fraile-Martínez Ó, García-Montero C, Alvarez-Mon MA, Lahera G, Monserrat J, Llavero-Valero M, Mora F, Rodríguez-Jiménez R, Fernandez-Rojo S, Quintero J, Alvarez De Mon M. Nutrition, Epigenetics, and Major Depressive Disorder: Understanding the Connection. Front Nutr. 2022 May 18;9:867150. doi: 10.3389/fnut.2022.867150. PMID: 35662945; PMCID: PMC9158469.
[2] Sparling TM, Cheng B, Deeney M, Santoso MV, Pfeiffer E, Emerson JA, Amadi FM, Mitu K, Corvalan C, Verdeli H, Araya R, Kadiyala S. Global Mental Health and Nutrition: Moving Toward a Convergent Research Agenda. Front Public Health. 2021 Oct 8;9:722290. doi: 10.3389/fpubh.2021.722290. PMID: 34722437; PMCID: PMC8548935.
[3] Sarris J, Ravindran A, Yatham LN, Marx W, Rucklidge JJ, McIntyre RS, Akhondzadeh S, Benedetti F, Caneo C, Cramer H, Cribb L, de Manincor M, Dean O, Deslandes AC, Freeman MP, Gangadhar B, Harvey BH, Kasper S, Lake J, Lopresti A, Lu L, Metri NJ, Mischoulon D, Ng CH, Nishi D, Rahimi R, Seedat S, Sinclair J, Su KP, Zhang ZJ, Berk M. Clinician guidelines for the treatment of psychiatric disorders with nutraceuticals and phytoceuticals: The World Federation of Societies of Biological Psychiatry (WFSBP) and Canadian Network for Mood and Anxiety Treatments (CANMAT) Taskforce. World J Biol Psychiatry. 2022 Mar 21:1-32. doi: 10.1080/15622975.2021.2013041. Epub ahead of print. PMID: 35311615.
[4] Retallick-Brown H, Blampied N, Rucklidge JJ. A Pilot Randomized Treatment-Controlled Trial Comparing Vitamin B6 with Broad-Spectrum Micronutrients for Premenstrual Syndrome. J Altern Complement Med. 2020 Feb;26(2):88-97. doi: 10.1089/acm.2019.0305. Epub 2020 Jan 10. PMID: 31928364.
[5] Klimova B, Novotny M, Valis M. The Impact of Nutrition and Intestinal Microbiome on Elderly Depression-A Systematic Review. Nutrients. 2020 Mar 7;12(3):710. doi: 10.3390/nu12030710. PMID: 32156003; PMCID: PMC7146624.
[6] Firth J, Gangwisch JE, Borisini A, Wootton RE, Mayer EA. Food and mood: how do diet and nutrition affect mental wellbeing? BMJ. 2020 Jun 29;369:m2382. doi: 10.1136/bmj.m2382. Erratum in: BMJ. 2020 Nov 9;371:m4269. PMID: 32601102; PMCID: PMC7322666.
[7] Kris-Etherton PM, Petersen KS, Hibbeln JR, Hurley D, Kolick V, Peoples S, Rodriguez N, Woodward-Lopez G. Nutrition and behavioral health disorders: depression and anxiety. Nutr Rev. 2021 Feb 11;79(3):247-260. doi: 10.1093/nutrit/nuaa025. PMID: 32447382; PMCID: PMC8453603.
[8] Greenberg PE, Fournier AA, Sisitsky T, Simes M, Berman R, Koenigsberg SH, Kessler RC. The Economic Burden of Adults with Major Depressive Disorder in the United States (2010 and 2018). Pharmacoeconomics. 2021 Jun;39(6):653-665. doi: 10.1007/s40273-021-01019-4. Epub 2021 May 5. PMID: 33950419; PMCID: PMC8097130.
[9] Oliva V, Lippi M, Paci R, Del Fabro L, Delvecchio G, Brambilla P, De Ronchi D, Fanelli G, Serretti A. Gastrointestinal side effects associated with antidepressant treatments in patients with major depressive disorder: A systematic review and meta-analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Jul 13;109:110266. doi: 10.1016/j.pnpbp.2021.110266. Epub 2021 Feb 5. PMID: 33549697.
[10] Anagha K, Shihabudheen P, Uvais NA. Side Effect Profiles of Selective Serotonin Reuptake Inhibitors: A Cross-Sectional Study in a Naturalistic Setting. Prim Care Companion CNS Disord. 2021 Jul 29;23(4):20m02747. doi: 10.4088/PCC.20m02747. PMID: 34324797.
[11] Hengartner MP, Amendola S, Kaminski JA, Kindler S, Bschor T, Plöderl M. Suicide risk with selective serotonin reuptake inhibitors and other new-generation antidepressants in adults: a systematic review and meta-analysis of observational studies. J Epidemiol Community Health. 2021 Mar 8:jech-2020-214611. doi: 10.1136/jech-2020-214611. Epub ahead of print. PMID: 33685964.
[12] Edinoff AN, Akuly HA, Hanna TA, Ochoa CO, Patti SJ, Ghaffar YA, Kaye AD, Viswanath O, Urits I, Boyer AG, Cornett EM, Kaye AM. Selective Serotonin Reuptake Inhibitors and Adverse Effects: A Narrative Review. Neurol Int. 2021 Aug 5;13(3):387-401. doi: 10.3390/neurolint13030038. PMID: 34449705; PMCID: PMC8395812.
[13] Forbes SC, Cordingley DM, Cornish SM, Gualano B, Roschel H, Ostojic SM, Rawson ES, Roy BD, Prokopidis K, Giannos P, Candow DG. Effects of Creatine Supplementation on Brain Function and Health. Nutrients. 2022 Feb 22;14(5):921. doi: 10.3390/nu14050921. PMID: 35267907; PMCID: PMC8912287.
[14] Noah L, Dye L, Bois De Fer B, Mazur A, Pickering G, Pouteau E. Effect of magnesium and vitamin B6 supplementation on mental health and quality of life in stressed healthy adults: Post-hoc analysis of a randomised controlled trial. Stress Health. 2021 Dec;37(5):1000-1009. doi: 10.1002/smi.3051. Epub 2021 May 6. PMID: 33864354.
[15] Della Vecchia A, Arone A, Piccinni A, Mucci F, Marazziti D. GABA System in Depression: Impact on Pathophysiology and Psychopharmacology. Curr Med Chem. 2021 Nov 15. doi: 10.2174/0929867328666211115124149. Epub ahead of print. PMID: 34781862.
[16] Berding K, Vlckova K, Marx W, Schellekens H, Stanton C, Clarke G, Jacka F, Dinan TG, Cryan JF. Diet and the Microbiota-Gut-Brain Axis: Sowing the Seeds of Good Mental Health. Adv Nutr. 2021 Jul 30;12(4):1239-1285. doi: 10.1093/advances/nmaa181. PMID: 33693453; PMCID: PMC8321864.
[17] Hepsomali P, Groeger JA. Diet, Sleep, and Mental Health: Insights from the UK Biobank Study. Nutrients. 2021 Jul 27;13(8):2573. doi: 10.3390/nu13082573. PMID: 34444731; PMCID: PMC8398967.
Disclaimer
The information contained herein is not and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Before making any changes to your diet, exercise or treatment, always consult your doctor or a qualified health professional.
The guidance provided may not be appropriate for your specific situation. Never make any decisions about your health based solely on the information provided in this article.
The author and creator of this article are not responsible for any damage or loss resulting from the improper use of the information presented here. Remember that each person is unique and therefore needs a personalized approach to health.
If you have any concerns about your health, please consult a qualified medical professional.
Learn about the benefits of participating in an organized breast cancer screening program
Screening exams are used to discover cancers earlier than a woman has any symptoms, and that’s why they are so essential and beneficial for all ladies. Diagnostic mammograms are used for women who already have symptoms such as a lump, pain, nipple thickening or discharge, or whose breasts have changed shape or size.
Early detection of breast cancer is extremely important, as it saves lives. The goal of screening is to detect early-stage non-palpable malignant tumours since there are good chances of cure at this stage.
Is mammography always necessary?
Mammography is currently considered the most effective method for the early detection of breast cancer in women aged 50 to 69 years. In general, screening mammograms aren’t endorsed for ladies under the age of forty. However, in cases where there is evidence of genetic mutations, screening can start at 25. In families with women at high risk of breast cancer, i.e. with more family members with breast cancer, screening is frequently initiated 10 years earlier than the primarily affected relative inside the own circle of relatives.
Breast screening is the handiest for women elderly 50 to 74. About 80% of breast cancers occur in women over 50. If you haven’t had a breast screen with us by the time you turn 50, we’ll send you an invitation to start screening. You can also make an appointment if you don’t have an invitation.
The European Guidelines’ principles will help you
European Countries follow and fulfil the European Guidelines, which are based on four principles:
- All women aged 50 to 69 years without any clinical suspicion of breast cancer are invited to attend mammography screening every two years. Together with the letter of invitation, the women receive a standardized medical history information sheet which has to be filled in before examination.
- The mammograms are then taken in the first screening unit where both medical technical staff and mammography system equipment have to meet high-quality standards.
- These mammograms are read independently by two physicians (“double reading”) who both have professional experience of at least 5,000 mammogram readings per year. In the case of discordant findings, the mammograms are evaluated in a consensus review involving the physicians in charge of the programme.
- If further clarification is needed, the first approach involves a clinical and imaging examination. If this assessment gives out a suspicious finding, a “minimally invasive biopsy” is performed, that is, a very tiny tissue string is removed as cautiously as feasible and is examined.
High-quality standards along the entire “screening chain” are ensured, among other things, by:
- recertifying the screening units at fixed intervals
- planned participation in further education training of all employees concerned in screening
- the use of standardized protocols for performing mammograms as well as for any necessary recall of women and subsequent further diagnostics
- regular assessment of the program (program evaluation).
Parameters are specified in the European Guidelines to guarantee the quality and outcome of a Mammography Screening Programme (MSP), including:
- participation rate
- how regularly breast cancers will be detected with the aid of the screening program
- at which stage breast cancers is detected within the screening program:
- Proportion of so-known as non-invasive “ductal carcinoma in situ” (DCIS)
- Proportion of small invasive carcinomas without lymph node involvement
- Proportion of invasive carcinomas in an advanced stage with lymph node involvement.
How many exams will be required to confirm a diagnosis?
To investigate a possible breast cancer diagnosis, your physician will record your medical history, conduct a breast exam, and arrange for you to have three tests:
- X-ray mammography (X-ray examination of the breast)
- sonography (ultrasound scan)
- magnetic resonance imaging (MRI).
X-ray mammography, also called mammography, is the method of choice particularly for older women (after menopause). Mammography is the most common screening test for breast cancer, it might take longer than your routine screening mammogram did, you can usually expect the results of a screening mammogram within two weeks. If you’re having a mammogram as a follow-up test, you may get the results before you leave the appointment.
MRI may be used to screen women who have a high risk of breast cancer. In general, regular mammograms aren’t recommended for women under 40 years of age, in part because breast tissue tends to be dense, making mammograms less effective.
Sonography and MRI are specifically used in younger women or as supplementary diagnostic methods for the clarification of an abnormal mammogram finding.
If your mammogram reveals nothing unusual, your doctor may put the results directly into your record and nobody will call you back. He or she might assume you expect a call only about something abnormal. Make it clear to your doctor that you want to hear any and all results.
Disclaimer
The information contained herein is not and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Before making any changes to your diet, exercise or treatment, always consult your doctor or a qualified health professional.
The guidance provided may not be appropriate for your specific situation. Never make any decisions about your health based solely on the information provided in this article.
The author and creator of this article are not responsible for any damage or loss resulting from the improper use of the information presented here. Remember that each person is unique and therefore needs a personalized approach to health.
If you have any concerns about your health, please consult a qualified medical professional.
