Causes Diagnosis and Treatment Jacque F Noel MD Gastroenterologist Heartburn Diagnosis Heartburn is an occasional condition with mild to moderate symptoms usually of a burning sensation in the chest ID: 731552
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Heartburn, GERD, Barrett’sCauses, Diagnosis and Treatment
Jacque F Noel, MDGastroenterologistSlide2
Heartburn DiagnosisHeartburn is an
occasional condition with mild to moderate symptoms, usually of a burning sensation in the chest.Heartburn is often confused with indigestion.Although the two are related, indigestion is caused by general stomach upset, while heartburn is the burning sensation caused by gastric acid backing up into the esophagus.
Diagnosis is made by frequency and intensity of discomfort, and a history of lifestyle and dietary habits assists in identifying heartburn triggers. Slide3
Common Heartburn Triggers
CoffeeCarbonated drinksAcidic foodsCitrus foodsTomato products
Chocolate, mints
Fried or fatty foods
Onion, garlic and spicy foods
Certain medications, including aspirin or ibuprofen
AlcoholSmokingEating too much or too quicklyLying down soon after eating a large mealPregnancyExcess weight-especially in abdominal areaSlide4
Heartburn TreatmentMost importantly, heartburn is an OCCASIONAL condition with mild to moderate symptoms.
Occasional heartburn should be easily relieved by OTC antacids and moderate lifestyle and dietary changes.Additional tips for minimizing heartburn symptoms include:Wear loose-fitting clothing around waist
Eat smaller, more frequent meals
Raise the head of bed by putting blocks under headboard legs
Limit the food and beverages that worsen symptoms
Stop smoking and/or drinking alcohol
Strive to lose excess weightSlide5
Heartburn Progression
Heartburn symptoms are similar to those of GERD, a more serious condition. Some cardiac problems may also present with similar symptoms.The patient being treated for heartburn should be advised that persistent problems despite treatment signals a more serious condition, and should contact their physician if they experience:
Heartburn that:
Occurs twice a week or more
Increases in intensity/discomfort
Persists after taking antacids
Returns as soon as the antacid wears offWakes individual up at nightDifficulty swallowing Slide6
Gastroesophageal Reflux Disease
GERD DiagnosisGERD occurs when contents in the stomach flow back in the esophagus. This happens when the valve between the stomach and the esophagus-the lower esophageal sphincter (LES)-does not function properlyThe GERD diagnosis is distinguished from Heartburn by frequency and intensity-GERD is suspected when symptoms are occurring frequently versus occasionally and with more intense symptoms; symptoms are not being relieved by OTC antacids and modified lifestyle changes
Slide7
Gastroesophageal Reflux Disease
GERD Diagnosis (continued)Less common symptoms that may also be associated with GERD include unexplained chest pain, wheezing, sore throat, hoarseness and cough. There is also a proven correlation between sleep apnea and increase in GERD.Untreated GERD can allow development of the following:
Ulcerative esophagitis
Esophageal Strictures
Barrett’s Esophagus
Esophageal CancerSlide8
What causes GERD?Gastroesophageal Reflux Disease occurs when there is an imbalance between the normal defense mechanism of the esophagus and the offensive factors of acid and other digestive juices and enzymes in the stomach.
Situations that can contribute to the development of GERD include:LES (lower esophageal sphincter) malfunction
Hiatal Hernia
Excess abdominal fat increasing pressure on stomach
Lifestyle and dietary habits
Sleep apneaSlide9
Complications of GERDThe goal of getting proper treatment for the patient with chronic reflux – GERD – is to promptly diagnosis the condition and attempt to eliminate the condition before inflammatory changes begin to occur in the esophagus from the invasion of acid in the stomach.
Early signs of these changes would be seen during upper endoscopy as redness and irritation of the tissue (esophagitis) which can be mild or severe and be manifested by the presence of ulcers (ulcerative esophagitis).
Strictures commonly form in the esophagus due to the inflammatory process and the patient may have difficulty swallowing or a sensation of food or medicine sticking or “hanging up” in the esophagus.
Treatment with prescription medications and needed esophageal dilatation may be needed in these cases
.
Untreated GERD over time, allows development of Barrett’s EsophagusSlide10
Treatment of GERDOnce patient presents with symptoms of GERD, not responding to conservative treatment of OTC medications with lifestyle and dietary changes, additional tests prior to initiating a treatment plan are recommended
Diagnostic treatments prior to treatment could include:Upper endoscopy:
Allows physician to visualize esophagus and stomach for structural abnormalities such as a hiatal hernia or open LES and detect an evidence of esophageal damage due to reflux, biopsies and/or brushings can be taken to check for microscopic signs of tissue damage
pH Testing
A small sensor attached to the esophagus during upper endoscopy or a pH probe placed into the esophagus at another time measures acid content in the esophagus for a 24 he period, sowing frequency, time and extent of refluxSlide11
Treatment of GERDAfter definitive diagnosis of GERD has been made, a treatment plan can be determined. Incorporating the dietary and lifestyle changes previously discussed and elevating the head of the bed for sleep are recommended in addition to three central areas of treatment
Medication-commonly proton pump inhibitors (PPIs) alone or in combinationEndoscopic anti-reflux therapy (endoluminal therapy or transoral incisionless fundoplication)
Anti-reflux surgery (laparoscopic or open fundoplication)Slide12
Barrett’s Esophagus
Biopsies may be taken to look for migration of gastric cells into the esophagus. This migration is a protective mechanism that develops due to chronic inflammation resulting from GERD, and the development of this change indicates a condition
called
Barrett’s esophagus.
It becomes visible at he EG junction and then migrates upward in “tongue-like” protrusions resembling the tongues of a
flame
Barrett’s is more common in patients who have long-standing GERD. It is interesting to note that the frequency and intensity of GERD symptoms, such as heartburn, does not affect the likelihood of someone developing Barrett’s. As the gastric cells may replace esophageal cells, the symptoms of reflux actually decrease, although inflammation and damage is still progressing
.
In some patients with Barrett’s esophagus, a precancerous change in the tissue, dysplasia, will develop. Patients with dysplasia are more at risk for developing esophageal cancer. Slide13
Diagnosing Barrett’sAt the current time, a diagnosis of Barrett’s can only be made using endoscopy to detect a change in the lining of the esophagus (Barrett’s tissue has a different appearance than normal esophageal tissue and is visible during endoscopy
) and taking a tissue sample of the abnormal appearing areas by biopsy or brushings.
The
pathology interpretation is required to confirm the Barrett’s diagnosis. Slide14
Who should be screened for Barrett’s?
Barrett’s is twice as common in men as women. It most commonly occurs in middle-aged Caucasian men with a history of heartburn for many years. Current recommendations suggest screening endoscopy for patients older than 50 with a history of significant heartburn or those who have required regular use of medications to control heartburn for several years.
If that first screening is negative, another is not recommended for several years, but aggressive steps should be taken to eliminate GERD in the patient. Slide15
Following diagnosis of Barrett’s
Once a patient has had a confirmed Barrett’s diagnosis, they are put on a repeat endoscopy schedule at set intervals determined by the physician based on the extent of Barrett’s presentMultiple tissue samples are taken at levels of Barrett’s tissue to search for abnormal cells of dysplasia, a precancerous condition that can only be diagnosed by pathology interpretation.
The interpretation will describe any dysplasia seen in the samples as being “high-grade,” low-grade” or “indefinite (or indeterminate) for dysplasia.
High-grade dysplasia
–
indicates that abnormal changes are seen in many of the submitted cells and there is an abnormal growth pattern of the
cellsLow-grade dysplasia – means that there are some abnormal changes seen in the submitted tissue sample, but the changes do not involve most of the cells and the growth pattern of the cells is
normal
Indefinite (or indeterminate) for dysplasia
– means that the pathologist cannot determine whether changes seen in the tissue are caused by dysplasia. Other conditions, such as inflammation, can make cells appear dysplastic when they may not be.Slide16
What is the risk for Esophageal Cancer?
There are two types of esophageal cancer: squamous cell cancer and adenocarcinomaSquamous cell esophageal cancers occur most commonly in individuals who smoke cigarettes, use other tobaccos products or drink alcohol. In addition, African Americans are more at risk for development of this type of esophageal cancer; it is additionally very common in Asia. The frequency of squamous cell cancer of the esophagus in the United States has remained the same for many years; the decline of smoking in the population should show a decrease in the diagnosis
Adenocarcinoma of the esophagus occurs most commonly in patients with long-lasting GERD-again most common in middle aged Caucasian males with excess abdominal girth. Adenocarcinoma of the esophagus is increasing in frequency in the United States in the last 10 years.
It is estimated that 20% of American adults experience reflux symptoms at least twice a week.
The majority of these people treat themselves for years with antacids, avoiding certain foods and sleeping in a recliner after a large meal, etc.
Most only seek medical attention after no longer being able to tolerate the discomfort or developing a symptom such as difficulty swallowing.
Although these individuals are at increased risk for developing esophageal cancer, the vast majority will not.
In about 10-15% of patients with GERD, esophageal cells will change in response to repeated acid reflux and the Barrett’s condition will develop.
Physicians now know that most cases of adenocarcinoma of the esophagus develop from Barrett’s esophagus
The risk of esophageal cancer developing in Barrett’s patients is about 1 out of 200 per year, with the risk increasing 0.5% per year thereafter without intervention
The risk is high enough that Barrett’s patients are advised to undergo periodic upper endoscopy with random biopsies of Barrett’s tissue to identify any dysplasia at the earliest possible stageSlide17
Barrett’s Surveillance for Dysplasia
Looking for a needle in the haystackInterval surveillance with random forceps biopsies for dysplasia is the clinical standard for the management of patients with Barrett’s esophagus.Since dysplasia as no gross distinctive features, even strict adherence to “Seattle Protocol” for sample collection tests only 2-3% of the epithelium in targeted areas of the esophagus.
Obviously, this leaves the majority of Barrett’s tissue untested, and a source of concern for the physician and patient.
In an effort to overcome the problem of sampling error, specialty labs have developed in the last few years to specifically address this issue of concern.
Last year at our facility, we chose to participate in a study wit EndoCDx® where a “WATS brush biopsy”, which obtains a “wide-area” tissue sample was taken in addition tot eh random forceps biopsy surveillance protocol on patients with Barrett’s
This type of brush tissue collection was also used to obtain samples from GERD patients to test for the presence of Barrett’s, which can be difficult to diagnose from biopsy of small segments of Z-line irregularity
Two things to note as an observation from the collection process—the techs that assist in obtaining the samples were trained in the technique—the brushings are collected in an aggressive “sawing-like” motion covering the entire area in question
Additionally, the brush used has bristles that are much longer and stiffer than a standard cytology brushSlide18
ENDO CDx Sample Analysis
The collection of the “wide-area” tissue sample increases the yield of abnormal findings in the esophagus and significantly reduces the “random” part of the interval surveillance of existing Barrett’s patients.Additionally, the analysis of the WATS tissue samples is aided by a proprietary high speed computer scan, originally developed for the missile defense industry
The computer is able to identify abnormal cells when they pass through the high speed 3-D scan and isolate them – even when the cells are over-lapping.
These specialized computers have routinely shown the ability to identify as few as 2 dysplastic cells in 100,000.
Independent published clinical data has shown that, when used in conjunction with and compared to traditional forceps biopsy, the WATS biopsy detects an additional 39% of Barrett’s cases and 42% more diagnosis of dysplasia.
Although our facility is still in the process of collecting enough data for a valid study comparison, it has been noted that we have seen more confirmed new cases of Barrett’s tissue in GERD patients as well as confirmed dysplasia in surveillance patients with existing Barrett’s. Slide19
ENDO CDx Sample AnalysisSlide20
ENDO CDx Sample Analysis
Limitations of Standard Esophageal Cytology
Unlike Cytology, WATS
3D
Obtains Complete Transepithelial Biopsy of the Entire Thickness of the Esophageal MucosaSlide21
Treatment For Barrett’s Esophagus
Obviously the goal is to have physician intervention early in patients experiencing chronic reflux to prevent progression of Barrett’s disease, dysplasia or esophageal cancer. Medications and anti-reflux procedures/surgery can effectively control the symptoms of GERD, but neither can reverse the presence of Barrett’s esophagus or eliminate the risk of cancer associated with the diagnosis.
Much research is presently being conducted in the area of treatment modalities to destroy Barrett’s tissue and eliminate this risk.
Some methods are currently available, producing good outcomes and gaining favor with physicians and patients, but as of now there is no “Gold Standard” treatment accepted by a vast majority of physicians in the field.
Current modalities include heat (radiofrequency ablation, thermal ablation with argon plasma coagulation and multipolar agulation), cold energy (cryotherapy) or the use of light and special chemicals (photodynamic therapy). Slide22
Treatment For Barrett’s Esophagus
There has been an increase in the use of endoscopic techniques to locally remove Barrett’s tissue – endoscopic mucosal resection (EMR). The physician’s choice of treatment is based on extent of Barrett’s, pathology reports, availability and effectiveness of treatment and willingness and cooperation of patient in undergoing treatment.
The partners at our facility were very interested in offering a treatment option to our Barrett’s patients.
After evaluating research, published data, outcome statistics and speaking with GI colleagues, the Halo®Radiofrequency Ablation System seemed the best fit for our facility.
The physicians did on-site visits to facilities using the system and then attended training to be certified in the technique. It is now being used in our endoscopy center and partner hospital. Slide23
HALO® Radiofrequency Ablation
Halo ablation technology uses heat to eliminate diseased Barrett’s tissue. By targeting only Barrett’s tissue, the minimally invasive procedure leaves healthy tissue intact.
Halo uses radiofrequency energy to deliver heat through a catheter to eliminate diseased tissue without harming healthy structures underneath it.
While the patient is under conscious sedation, the gastroenterologist will insert an endoscope into the patient’s mouth.
Depending on the extent of the Barrett’s the physician will choose either a balloon mounted Halo -360 catheter or an endoscope –mounted Halo-90 catheter which is plugged into a generator that delivers the radiofrequency energy.
The Halo-360 has a balloon that is covered by a band of radiofrequency electrodes and is used to treat larger areas of Barrett’s. The Halo-90 the electrode is positioned on the smaller area of diseased tissue to deliver the energy.Slide24
HALO® Risks and Benefits
The Halo radiofrequency ablation procedure is considered very safe. Patients may experience minor side effects, such as chest discomfort and swallowing difficulty for several days following the procedure. The physician provides the patient with diet instructions and medications to manage these symptoms, which usually go away in 3-4 days post treatment.
Benefits:
Data
suggests elimination of Barrett’s tissue in 98.4% of patients (some require follow-up applications to smaller residual areas
New, healthy tissue growth occurs 3-4 weeks post-procedure
Quick recovery period with minimal side effects
Minimally invasive, outpatient procedure
No general anesthesia required
Low rate of post-procedure complications
Risks:
Mucosal
laceration
Infection
Narrowing of the esophagus
Minor acute bleedingSlide25
HALO® Risks and BenefitsData has suggested HALO as a treatment option for Barrett’s disease with pathology detecting no dysplasia and few low dysplasia cells.
A pathology finding of high grade dysplasia requires a higher level of aggressive treatment and patients in our practice would be referred for evaluation with EUS and either EMR or surgical intervention, dependent of findings from EUS.Slide26
Proton-Pump Inhibitors
PPIs are the mainstay of anti-reflux treatment. PPIs are prescribed for once or twice daily use for significant reflux and may be reduced to “PRN” use when symptoms are under control.A large number of PPIs are available and frequently individuals respond and/or tolerate one brand over another
When reflux is particularly difficult to control, other types of medications (prokinetics of H2-blockers) may be added to the medication regime to achieve better symptom reduction
For those patients with severe GERD symptoms that can’t be controlled with medication, some type of procedural intervention or surgery may be indicated.
MILD
Severe
GERD
Anatomic
correction
warranted
Lifestyle Changes
Pharmaceuticals
Procedure Intervention
Surgery
Early disease, no correction requiredSlide27
Endoscopic Anti-Reflux Therapy
Stretta ProcedureThe Stretta procedure is a minimally invasive, endoscopic procedure that takes about 60 minutes to perform
It is done on an outpatient basis, and patients typically for home 1-2 hours following procedure
Under sedation, a flexible catheter is inserted through the mouth into the esophagus and is positioned at the lower esophageal sphincter valve at the junction to the stomach.
The catheter has 4 small needles which deploy into the muscle of the LES and deliver radiofrequency energy into the muscle. Several areas in the region of the LES and cardia of the stomach are treated to create small thermal lesions
Over time the lesions heal, causing collagen deposition in the area resulting in thickening of the LES area and surrounding muscle tissue
Clinical studies show improvement in GERD symptoms at the 3 to 4 month post-procedure point, with acid exposure and elimination or reduction in the use of reflux medications continuing to improve until the 6 month period before stabilizingSlide28
Endoluminal Therapy: Stretta
Pros:
Minimally invasive-no incisions
Does
not require general anesthesia
Outpatient procedure with minimal recovery
Low risk of complicationsMay be beneficial for gastroparesis
May be repeated if required
Does not limit future treatment options
Cons:
Contraindicated
in patients with large hiatal
hernias, erosive esophagus and severe dysphasia
Small perforation risk
May be minimally effective
Results take time to evaluateSlide29
Endoluminal Gastroplication Surgery (ELGP), EndoCinch, (BARD); ESD, (Wilson-Cook)
In the ELGP procedure, an experienced endoscopist or surgeon uses transoral endoscopic visualization and the suturing delivery system to place a series of adjacent mucosal sutures in opposition below the squamocolumnar junction.
The adjacent sutures are then tied together, forming a plication (or “cinching”) which alters the tension on the valve, thus reducing the acid flow back from the stomach into the patient’s esophagus
Upon first release after FDA approval, technical challenges in the knot tying of the sutures caused a large number of these plications to come undone.
Additionally, the configuration of the plication’s directly affects outcome and results were widely varied based on the suture pattern and dexterity of the operator
It appears, however, that the second-generation device has simplified the suture placement and knotting technique required—resulting in improved and more consistent outcomesSlide30
Endoluminal Gastroplication Surgery (ELGP), EndoCinch, (BARD); ESD, (Wilson-Cook)
Pros:
Minimally invasive-no incision
Does
not require general anesthesia
Outpatient with minimal recovery
Does not limit future treatment options
Low risk of complications
Cons:
Operator-dependent results
Sutures may come undone
May be ineffectiveSlide31
Transoral Incisionless Fundoplication (TIF); Esophyx
TIF is a surgical procedure performed through the mouth without incisionsThe procedure is typically performed in an outpatient setting under general anesthesia
EsophyX is a form of Natural Orifice Surgery (NOS) and the device creates an esophagogastric fundoplication that is up to 270 degrees and 3 cm in length requiring no incisions
In essence, the procedure reconstructs the antireflux valve at the EG junction, preventing reflux
Unlike other endoluminal therapies that are solely focused on the LES, the TIF procedure reconstructs the dynamics of the body’s antireflux barrier similar to the Nissen procedure, with no internal dissection of natural anatomySlide32
TIF Procedurehttp://www.youtube.com/v/vTUNwaZtILYSlide33
TIF;EsophyX
Pros:
Transoral, incisionless procedure
Fast recovery
Few complications
Can be revised if required
Does not limit
future treatment options
Cons:
Small risk of perforation, sore throat, bleeding, N&V, swallowing difficulties
Requires general anesthesiaSlide34
Anti-reflux Surgery (Laparoscopic)
LINX ProcedureThe LINX Reflux Management system is a medical device for use in patients 21 years and older who have been diagnosed with GERD and continue to have problematic symptoms of reflux despite treatment with medication or who have been on long-term medical therapy and are concerned about effects of long-term treatment
The LINX device uses a small flexible band of magnetic beads that is implanted around the LES during a laparoscopic procedure
When placed around the outside of the esophagus at the EG junction, the magnetic attraction between the beads keeps the sphincter stay close to prevent reflux
The force of a swallow, belch or vomiting causes the beads to open, then close when pressure is relievedSlide35
LINX ProcedureSlide36
LINX
Pros:
Minimally
Invasive
Well-tolerated
Removable
Patient able to eat a normal diet after surgery
Few complications
Does not limit future treatment options
Cons:
General anesthesia
Band could migrate or
erode into tissueSlide37
Laparoscopic Nissen Fundoplication
When a surgical fundoplication is performed, the part of the stomach (the fundus) closest to the entry of the esophagus is gathered, and wrapped around the lower end of the esophagus and the LES, where it is sutured into placeThis technique strengthens the LES to prevent the malfunction that is causing GERDIt is usually performed when medical therapy has failed, and is the first-line procedure when the patient also requires repair of a sizeable hiatal hernia
The
Nissen
procedure is the most common fundoplication and involves a total 360 degree wrap used for GERD treatment
A
Dor or Toupet, in contrast, are partial fundoplication's used to correct achalasiaIf a patient has a hiatal hernia, it is repaired in conjunction with the fundoplication by pulling the herniated segment of the stomach from the chest and anchoring it with suture so that it is secured in the abdominal cavitySlide38
Laparoscopic Nissen Fundoplication
The opening in the diaphragm through which the esophagus passes from the chest into the abdomen is also tightened The laparoscopic Nissen procedure is performed under general anesthesia and requires only 5 small holes in the abdomen where instruments and illumination enter into the operative siteThe advantage of the laparoscopic surgery is a speedier recovery and less post-operative pain
The procedure usually takes somewhat longer that the open method and is harder for the surgeon to judge precisely how tight the wrap is around the esophagus
Occasionally, a laparoscopic procedure will be switched to an open procedure by the surgeon if difficulty or complications are encounteredSlide39
Open Nissen Fundoplication
The open surgery Nissen Fundoplication requires a 4-8 inch upper abdominal incisionThe open method of Nissen has been greatly outnumbered by the laparoscopic version of the surgery due to the patient benefits
Some surgeons prefer the open procedures, especially in obese patients and that that require hiatal hernia repair
During open cases, surgeons may place a mesh to repair the enlarged diaphragm opening that allows the stomach access to the chest cavity
Additionally, the surgeon can make a better determination of how tight or loose the wrap is around the LESSlide40
In ReviewHeartburn
Occasional condition with mild to moderate symptoms of burning sensation in chestSuccessfully treated with OTC medications, dietary and lifestyle changesDoes not increase in frequency or intensity of discomfortSlide41
In ReviewGERD
Occurs frequently-twice a week or moreModerate to severe increase in intensity/discomfortNon-cardiac origin confirmedPersists after taking antacids or returns as soon as antacid wears off
Wakes individual up at night
Causes swallowing difficulty
Common causes include: LES malfunction, Excess abdominal fat, Lifestyle and Dietary habits, sleep apnea
Physician evaluation of cause and treatment to prevent GERD critical in preventing esophageal damage from reflux, such as esophagitis, ulcers, strictures, Barrett’sSlide42
In ReviewGERD
Diagnostic testing may include: upper endoscopy, PH TestingDietary and lifestyle modifications important in treatment planAdditional therapies include three central areas of treatment:
Medication (PPIs or combinations)
Endoscopic anti-reflux therapy (Stretta, Endoluminal Gastroplication-ELGP)
Anti-reflux surgery (Transoral Incisionless Fundoplication –TIF, Linx Procedure, Laparoscopic and Open Nissen Fundoplication)
Failure to control GERD increases risk of developing Barrett’s esophagus, and possible risk of esophageal cancerSlide43
In Review
Barrett’s EsophagusDevelops due to chronic inflammation from esophageal exposure to acid. Gastric cells migrate into esophagus causing cellular changes resulting in Barrett’s.Diagnosed by upper endoscopy with tissue samples for pathology evaluation
More common in middle aged Caucasian men with abdominal fat and long-standing history of GERD symptoms
Once diagnosis of Barrett’s is confirmed by pathology, patients are placed on a scheduled surveillance timeline for repeat endoscopy with random biopsies to screen for development of dysplasia, a precancerous condition
Diagnosis of Barrett’s increases risk of esophageal cancer development
Specialty pathology (ENDO CDx) collection and analysis techniques can be utilized to increase confirmation of first-time Barrett’s and presence of dysphasia in existing Barrett’s cases
Current available treatment methods to destroy Barrett’s tissue: Heat (radiofrequency ablation, thermal ablation, argon plasma coagulation, multipolar agulation), Cold energy (cryotherapy), or the use of light and special chemicals (photodynamic therapy)
Discussion of use of Halo therapy – a method of destroying Barrett’s tissue in use at presenter's facility Slide44
Questions?
Comments?
The End!Slide45
Disclaimer
Presenter declares that he has no actual, potential or perceived vested interest in relation to this program. He further declares that he has no vested interest or arrangement with any organization, manufacturer or company that could be considered a real or apparent conflict of interest.Products, manufacturers or companies mentioned in this presentation are offered as a personal observation only, with opinions about said products based on person use and experience or personal research of publications and/or studies of product efficacy and outcomes. Comments should not be considered advertisement or endorsement of any specific product.