Clinical Evidence

Medically reviewed by Mark Strehlow, MD, Medical Director — October 2026

We practice proactive medicine. We’d rather find a risk early, while there is time to act on it, than wait for symptoms. That’s why we test more broadly than a routine check-up and take the time to go through the results with you. This page shows the research behind that approach, service by service, at Rock Creek Wellness in Leawood, Kansas.

How to read it:

  • Our approach comes first, then the research behind it, then where official guidance or other research differs.
  • Official guidance often answers a different question. A screening recommendation usually asks whether to test everyone in a population, weighing cost and follow-up for millions of people. We make decisions for one patient at a time, with a full history in front of us. Where a guideline disagrees with how we practice, we say what it actually looked at.
  • We note who paid for the research when the funder makes or sells the product studied, whether a drug, device, lab or supplement company. Makers often fund the research because no one else will, and a well-designed study is good evidence whoever pays for it; we judge each study by its design and disclose the interest so you can weigh it too.
  • A study isn’t a promise. Results describe averages in the people studied, and individual results vary.

The year of each source is shown so you can judge how recent it is. This page is educational and is not medical advice.

Hormone therapy

Our approach. We prescribe hormones only after a full evaluation and lab work, and we adjust them to your results over time. For men, we prescribe testosterone when symptoms come with confirmed low levels. For women, hormone therapy, including testosterone, is tailored to symptoms and labs. How we prescribe, and what each form involves, is on our hormone replacement therapy, pellet therapy, women’s and men’s pages.

The research behind it

  • TRAVERSE trial (2023). The largest testosterone trial. In 5,246 men aged 45 to 80 with low testosterone and existing or high heart risk, testosterone gel didn’t increase heart attacks, strokes or cardiovascular deaths compared with placebo over about 33 months. Atrial fibrillation, acute kidney injury and pulmonary embolism were more frequent with testosterone. It didn’t study pellets, injections or women. It was funded by a group of testosterone makers led by AbbVie. N Engl J Med, 2023
  • TRAVERSE prostate substudy (2023). High-grade prostate cancer occurred in 5 of 2,596 men on testosterone and 3 of 2,602 on placebo, not a significant difference, and other prostate events didn’t differ. The men were screened beforehand to exclude a high PSA, and the cases were too few to rule out a difference. JAMA Netw Open, 2023
  • TRAVERSE anemia substudy (2023). Anemia corrected in more men on testosterone than on placebo. JAMA Netw Open, 2023
  • Erectile and sexual function in men. In men with confirmed low testosterone, testosterone improves sexual desire and activity and, on average, erectile function. Pooling individual patients’ data from 17 placebo-controlled trials, the erectile-function score rose about 2 points on a 30-point scale, a change men notice when erectile dysfunction is mild, whatever their age, weight or starting level. In the Testosterone Trials, in men 65 and older, it rose about 2.6 points; those trials were partly funded by AbbVie, which supplied the gel. European urology guidelines recommend testosterone as the first treatment for mild erectile dysfunction in men with low testosterone, adding ED medicine when it’s more severe. Pooled trials, 2023 · Testosterone Trials, 2016 · EAU, 2026
  • Bone density in men. In the Testosterone Trials’ bone study (211 men), spine bone density measured by CT rose about 7% more than with placebo in a year, along with estimated bone strength. A 2-year Australian trial in men with prediabetes or new diabetes found gains at the spine and hip; its funders included Bayer and Eli Lilly. Bone Trial, 2017 · Australian trial, 2021
  • Pooled testosterone trials (2022). Across 35 placebo-controlled trials, cardiovascular events were 7.5% with testosterone and 7.2% with placebo, not a significant difference; the trials were short. Lancet Healthy Longevity, 2022
  • Testosterone levels and heart disease (2024). Studies linking low testosterone with heart disease are mixed. In pooled data from nine cohorts with precise hormone measurements, men with very low testosterone had higher death rates, but levels weren’t linked with new heart attacks or strokes. Funding included donations from a maker of testosterone creams. Ann Intern Med, 2024
  • Testosterone for women, pooled trials (2019). In 36 trials with 8,480 women, testosterone improved sexual desire, arousal, pleasure and satisfaction in postmenopausal women; non-oral forms didn’t raise LDL cholesterol. Effects on bone, muscle and memory weren’t shown, and few women were studied for them. Lancet Diabetes Endocrinol, 2019
  • The Menopause Society, hormone therapy position statement (2022). For women under 60 or within 10 years of menopause without contraindications, it finds the balance favorable for treating bothersome hot flashes and for preventing bone loss, and calls hormone therapy an appropriate way to protect bone in those women; risks vary with type, dose, route and timing. Menopause, 2022
  • Fractures in women (2013). In the two Women’s Health Initiative trials (27,347 women), hip fractures were about a third lower during treatment than with placebo. The trials used one oral estrogen, with or without a synthetic progestin, donated by its maker, not estradiol or pellets. JAMA, 2013
  • FDA label changes for menopausal hormone therapy (2025–2026) and testosterone (2025). FDA revised the benefit and risk information in the labels of approved menopausal hormone products. For testosterone, after TRAVERSE, it removed the boxed-warning language on cardiovascular risk and added a blood-pressure warning. FDA, November 2025 · FDA, February 2026 · FDA, testosterone, 2025
  • Risks by type and route. Estrogen through the skin wasn’t linked to the higher clot risk seen with tablets in a large UK study, and the two Women’s Health Initiative trials found different breast cancer results for estrogen alone and for estrogen with a synthetic progestin. Blood clots, BMJ 2019 · Stroke, BMJ 2010 · Breast cancer, JAMA 2020
  • Older studies of hormone implants. Pellets have been studied less than other forms. These small, older studies measured blood levels, bone density and body composition, and their implants may differ from the compounded pellets prescribed in the US today. Lobo, 1980 · Savvas, BMJ 1988 · Davis, 2000 · Cravioto, 2001

Where guidance or other research differs

  • Testosterone for women. The 2019 Global Consensus Position Statement and the International Society for the Study of Women’s Sexual Health find evidence only for low sexual desire after menopause. They don’t recommend compounded testosterone unless no approved equivalent is available, and they advise against any form that raises levels above the normal female range, including pellets and injections. We’ll go over every option with you, including the ones that aren’t pellets. Global Consensus, 2019 · ISSWSH, 2021
  • Compounded hormones. The National Academies (2020) and ACOG (2023) advise restricting compounded hormones to specific medical circumstances, citing limited evidence on how they compare with approved products. National Academies, 2020 · ACOG, 2023
  • Erectile function. In TRAVERSE, two years of testosterone gel improved desire and sexual activity but not erectile function, and the American Urological Association (2018) says testosterone alone isn’t an adequate ED treatment. European guidelines find no evidence for testosterone for sexual problems in men whose levels are normal. TRAVERSE, 2024 · AUA, 2018
  • Fractures in men. Higher bone density hasn’t been shown to mean fewer fractures. In TRAVERSE, 3.5% of men on testosterone gel and 2.5% on placebo had a fracture over about three years; the men weren’t chosen for weak bones, and fractures weren’t the trial’s main question. Two pooled analyses found no consistent rise in bone density, and for men at high risk of fracture, European guidelines make a bone medicine the first choice. TRAVERSE fractures, 2024 · Meta-analysis, 2020 · Meta-analysis, 2023
  • Testosterone in men. The Endocrine Society (2018) and the American Urological Association (2018) set lab thresholds for diagnosis, and FDA’s labels keep a limitation for low testosterone due to aging alone. Endocrine Society, 2018 · AUA

Cardiovascular testing

Our approach. No single test tells the whole story about your heart and arteries. We combine advanced blood markers (including apoB, particle number and size, and lipoprotein(a)) with imaging (ultrasound of the heart, carotid arteries and abdominal aorta, plus a coronary calcium score) to build a fuller picture, and we track what matters over time. Your provider decides which tests fit your history. Details are on our advanced cardiovascular screening page.

The research behind it

  • ApoB and particle number. ApoB counts the cholesterol-carrying particles that can lodge in artery walls. In the Women’s Health Study (27,533 women, 17 years), apoB disagreed with LDL cholesterol in about 1 in 5 women, and when LDL looked low but apoB was high, risk was underestimated. In 13,015 Danish adults on statins, high apoB with low LDL carried higher risk of heart attack and death. In the UK Biobank, the number of apoB particles tracked coronary risk. Women’s Health Study, 2014 · Copenhagen, 2021 · UK Biobank, 2022
  • Particle size and subclasses. LDL particles come in different sizes, and small, dense ones appear to enter the artery wall faster and bind to it more readily, according to a European Atherosclerosis Society consensus panel. In a pooled analysis of 21 studies (30,628 people), those with mostly small, dense LDL had 36% higher odds of coronary heart disease. In the US ARIC study (11,419 adults), people with the most small, dense LDL cholesterol had 1.51 times the coronary risk of those with the least, and the link held when LDL cholesterol was under 100 mg/dL; the test’s maker supplied the reagents and a research grant. For HDL, women in the Women’s Health Study with larger HDL particles had fewer cardiovascular events; two of its authors had ties to the test’s maker. EAS, 2020 · Meta-analysis, 2020 · ARIC, 2014 · Women’s Health Study, 2009
  • LDL cholesterol. A European Atherosclerosis Society review of genetic studies, cohorts and trials concluded that LDL causes artery disease, which is why we measure it as well. Many of its authors have ties to cholesterol-drug makers. Eur Heart J, 2017
  • Lipoprotein(a). An inherited risk factor that a standard panel doesn’t show. Both the European Atherosclerosis Society and the 2026 US cholesterol guideline advise measuring it at least once in every adult. EAS, 2022 · ACC/AHA, 2026
  • Carotid plaque. In 13,145 adults in the ARIC study, adding carotid plaque to standard risk factors moved about 23% of people into a different risk group. A pooled analysis found plaque predicted heart attacks somewhat better than wall thickness, and the 2026 US guideline encourages cholesterol treatment when plaque is found. ARIC, 2010 · Meta-analysis, 2012
  • Coronary calcium. In the MESA study, a CT calcium score predicted heart events more strongly than carotid plaque, and the 2026 US guideline recommends one when a treatment decision is unclear. MESA, 2017 · MESA ten-year, 2018
  • Abdominal aortic aneurysm. In a trial of 67,800 men aged 65 to 74, inviting men to a single ultrasound lowered aneurysm deaths by 42%, and at 13 years all-cause deaths were 3% lower. MASS, 2002 · MASS 13-year, 2012
  • Echocardiogram. In community studies, greater heart muscle mass and stiff heart filling were linked with later heart disease, heart failure and death, which is why we keep a baseline your provider can compare with later. Framingham, 1990 · Olmsted County, 2011
  • High-sensitivity CRP. In 27,939 women followed for 30 years, a high CRP predicted major heart events, and the 2026 US guideline counts a level of 2 mg/L or more on two tests as a risk enhancer. In JUPITER, people without high LDL but with high CRP had fewer heart events on a statin; the trial was sponsored by the statin’s maker. Women’s Health Study, 2024 · JUPITER, 2008

Where guidance or other research differs

  • Carotid screening. The US Preventive Services Task Force (USPSTF) advises against screening the general population for narrowed neck arteries. That recommendation is about finding narrowing that could lead to surgery, not about plaque used to guide cholesterol treatment. JAMA, 2021
  • Aneurysm, heart rhythm and ECG screening. The USPSTF recommends a one-time aortic ultrasound for men 65 to 75 who have ever smoked and not routinely for women who never smoked, finds too little evidence to recommend for or against screening for atrial fibrillation, and advises against ECG screening in people at low risk. AAA, 2019 · AF, 2022 · ECG, 2018
  • Echocardiogram screening. Cardiology criteria rate a screening echocardiogram in someone without symptoms as inappropriate, and no trial has tested whether screening echoes change outcomes. Appropriate use criteria, 2011
  • Particle size. The 2026 US cholesterol guideline, written with the National Lipid Association, recommends against routine testing of particle size and subclasses to estimate risk and decide whether to start treatment, and says such testing belongs where it would change the treatment plan. Once particles are counted, size adds little: in the UK Biobank (207,368 adults) it added nothing beyond the number of apoB particles, and in a US study of 3,258 adults, small, dense LDL cholesterol, apoB and LDL particle number predicted heart disease about equally. For HDL, genetic studies haven’t shown that larger HDL particles lower risk. ACC/AHA, 2026 · UK Biobank, 2025 · MESA, 2023 · Genetic study, 2021
  • Nontraditional risk factors. The USPSTF (2018) found too little evidence to add CRP, the ankle-brachial index or a calcium score to standard risk assessment for everyone. JAMA, 2018

Blood testing

Our approach. We start with a broad baseline of blood and urine tests: roughly 35 individual tests covering more than 100 biomarkers, compared with the handful ordered at a typical annual physical. We go through every result with you in person, and tracking them over time lets us see changes early. Details are on our comprehensive blood testing page, and our testing overview describes each test we offer.

The research behind it

  • Screening that mainstream guidance supports. The USPSTF recommends testing for prediabetes and diabetes in adults 35 to 70 with overweight, and the American Diabetes Association recommends it for all adults from 35. Adults 18 to 79 should be tested for hepatitis C, and all adults for hepatitis B at least once. USPSTF, diabetes, 2021 · ADA, 2026 · USPSTF, hepatitis C, 2020 · CDC, hepatitis B, 2023
  • Why finding prediabetes matters. In the Diabetes Prevention Program (3,234 adults), a lifestyle program cut progression to diabetes by 58% over about three years. N Engl J Med, 2002
  • Thyroid. Our thyroid panel adds free T4, free T3, reverse T3 and two antibodies to the usual TSH. In a US national survey (17,353 people, 1988–1994), 4.6% had an underactive thyroid, mostly mild, and 1.3% an overactive one, and the authors concluded that many people had laboratory signs of thyroid disease without knowing it. In a 20-year follow-up of 2,779 British adults (the Whickham Survey), a raised TSH and thyroid antibodies each predicted later hypothyroidism, and women with both had 38 times the odds. England’s national guideline advises testing when thyroid disease is suspected, and in people with type 1 diabetes, other autoimmune disease or new atrial fibrillation, and considering antibodies when TSH is raised. NHANES III, 2002 · Whickham, 1995 · NICE, updated 2023
  • Both ends of the TSH range. Pooled data on 52,000 to 70,000 adults link a TSH of 10 or higher with about 1.9 times the rate of coronary events, and a low TSH (below 0.45) with more atrial fibrillation and hip fractures, most of all below 0.10. These studies show links, not that treatment changes the outcome. JAMA, 2010 · Arch Intern Med, 2012 · JAMA, 2015
  • Vitamin D. How many people are low depends on the cutoff. In national survey data, about 5% of Americans were at risk of deficiency, about 23% were below 20 ng/mL, and about 65% were below the 30 ng/mL level some guidelines and labs use as the target. Two pooled analyses of trials found 12–13% fewer cancer deaths with vitamin D, mainly with daily dosing, though not fewer cancers. NHANES, 2019 · NHANES 2001–2018, 2022 · Cancer deaths, 2019 · Cancer deaths, 2023
  • Reading results. A result outside the reference range may or may not mean a problem, which is why we look at trends and at the whole panel together. MedlinePlus

Where guidance or other research differs

  • Vitamin D. The Endocrine Society (2024) advises against routine vitamin D testing in healthy people, and the USPSTF (2021) found too little evidence on screening. Both lean on the VITAL trial, in which daily vitamin D didn’t lower cancer, heart events or fractures in adults who mostly weren’t low to begin with; its vitamin D was donated by a supplement maker. Endocrine Society, 2024 · VITAL, 2019
  • Thyroid screening. The USPSTF (2015; a 2024 literature check found no new screening studies) found too little evidence to recommend for or against thyroid screening in adults without symptoms, and Canada’s preventive task force (2019) recommends against it. Both answered a population question for primary care, not what to do for people with symptoms or risk factors. USPSTF, 2015 · Canadian Task Force, 2019
  • Treating a mildly raised TSH. In the TRUST trial (737 adults 65 and over, average TSH 6.4), a year of levothyroxine didn’t change symptoms or tiredness; its maker supplied the tablets. A 2019 BMJ guideline panel advises against thyroid hormone for most adults with a raised TSH and normal T4, and TSH returned to normal without treatment in about 6 in 10 older adults after one raised result, which is why guidelines advise repeating a raised result before acting on it. The European Thyroid Association (2013) advises considering a trial of treatment for adults under 65 with symptoms and a TSH below 10. N Engl J Med, 2017 · BMJ, 2019 · J Clin Endocrinol Metab, 2024 · ETA, 2013
  • Reverse T3 and T3. A 2023 review commissioned by the American Thyroid Association finds no need to measure reverse T3 in routine practice outside rare conditions, and says T3 adds little when an underactive thyroid is suspected; a 2025 family-medicine editorial advises starting with TSH rather than full panels. Thyroid, 2023 · Am Fam Physician, 2025
  • Broad panels. Trials of general health checks in about 233,000 people found no difference in deaths, and every added test raises the chance that a healthy person has a result outside the range. That’s why we interpret results rather than react to single numbers. Cochrane, 2019 · False alarms, 2004

Bone density, body composition, biological age and genetics

Our approach. We use these measurements as data points: a DXA scan for bone density and body composition, a biological age estimate, and genetic results, each read alongside the rest of your picture. See DXA analysis, biological age testing and DNA testing.

The research behind it

  • DXA. The USPSTF (2025) recommends bone density screening for women 65 and older and for younger postmenopausal women at higher fracture risk. DXA uses a very low radiation dose, and follow-up scans belong on the same machine. USPSTF, 2025 · RadiologyInfo
  • Epigenetic clocks. DNA methylation patterns can estimate age, and newer methods narrow the measurement noise that affected earlier clocks. Nat Rev Genet, 2018 · Nat Aging, 2022
  • Genetic results. FDA lists the gene–drug pairs it has evaluated for how people process medicines. FDA

Where guidance or other research differs

  • Body composition. The International Society for Clinical Densitometry recommends whole-body scans only in narrower situations and calls their effect on outcomes uncertain. ISCD, 2023
  • Biological age. Researchers haven’t agreed on how to validate aging clocks, and repeat tests of the same sample have differed by years on some clocks, so a result is an estimate, not a diagnosis. Nat Med, 2024
  • Consumer genetics. Medical genetics and nutrition societies say polygenic scores and diet-gene reports aren’t ready to guide care on their own. ACMG, 2023 · Academy of Nutrition and Dietetics, 2014 · MedlinePlus

Brain health

Our approach. We look at brain-health risk years before memory changes, because the changes behind Alzheimer’s disease start long before symptoms. We work on the risk factors research links to dementia, such as blood pressure, blood sugar, cholesterol and activity. APOE, a one-time genetic test, is one input to that plan. See our Cognitive Health page.

The research behind it

  • Changes start early. In families with inherited Alzheimer’s, amyloid changes in spinal fluid appeared about 25 years before expected symptoms. In a 20-year study of the common form (648 matched pairs), they appeared about 18 years before diagnosis. DIAN, 2012 · N Engl J Med, 2024
  • APOE. In 68,756 people, one copy of APOE ε4 raised the odds of Alzheimer’s about 2 to 4.5 times depending on ancestry, and in an earlier pooled study two copies raised them about 15 times in white clinic samples. In a trial of adults with a parent with Alzheimer’s, learning their result, with structured education, didn’t significantly raise anxiety or depression compared with not learning it. JAMA Neurol, 2023 · JAMA, 1997 · REVEAL, 2009
  • Risk factors. An international commission estimated that 14 modifiable risk factors account for nearly half of dementia risk worldwide if the links are causal. Lancet, 2024
  • Risk-reduction trials. In FINGER (1,260 adults) and US POINTER (2,111 adults), structured programs of diet, exercise, cognitive training and risk-factor care produced slightly better cognitive test scores over two years than general advice or a self-guided program, with similar results in APOE ε4 carriers. Tighter blood-pressure control lowered mild cognitive impairment in SPRINT MIND (dementia itself wasn’t significantly lower), and treating uncontrolled blood pressure lowered dementia in a trial of 33,995 adults in rural China. FINGER, 2015 · FINGER and APOE, 2018 · US POINTER, 2025 · SPRINT MIND, 2019 · Nat Med, 2025

Where guidance or other research differs

  • APOE testing. The medical genetics societies’ 2011 statement, reaffirmed in 2018 and now classed as a practice resource rather than a guideline, advises against APOE testing to predict Alzheimer’s, citing limited predictive value, and says any testing should come with counseling. Since then, FDA’s label for the anti-amyloid drug lecanemab says APOE ε4 status should be tested before treatment. Know too that federal genetic-privacy law doesn’t cover long-term care, life or disability insurance. ACMG and NSGC · Lecanemab label · NHGRI
  • Early biomarkers. Most older adults with amyloid never develop dementia (for a 65-year-old woman with amyloid alone, the estimated lifetime risk is about 29%), and an international working group advises calling this stage “at risk” rather than Alzheimer’s. An antibody trial at this stage (A4, funded in part by the drug’s maker) didn’t slow decline. Lifetime risk, 2018 · IWG, 2024 · A4, 2023
  • Prevention programs. In preDIVA (3,526 adults over about seven years), nurse-led vascular care didn’t lower dementia, and a National Academies review (2017) found the evidence for these steps encouraging but inconclusive. preDIVA, 2016 · National Academies, 2017
  • Screening tests. The USPSTF found too little evidence on screening adults 65 and older without symptoms, and the Alzheimer’s blood tests are cleared and recommended for people who already have memory or thinking problems. USPSTF, 2020 · Alzheimer’s Association, 2025 · FDA, 2025

The TB006 Expanded Access Program (TB006 program). TB006 is investigational. It is not approved by the FDA, and its safety and effectiveness have not been established. ClinicalTrials.gov, NCT05959239 · FDA, expanded access

IV therapy

Our approach. Every IV is prescribed by one of our providers after an evaluation, and we tell you plainly what the research does and doesn’t show. Our IV therapy page has the menu, the risks and how IV vitamins compare with taking them by mouth.

The research behind it

  • Blood levels by IV. The same 1.25-gram dose of vitamin C produced much higher blood levels by IV than by mouth, and the levels fell back within hours. Ann Intern Med, 2004
  • Niagen IV and NAD+ IV. A small pilot study, not yet peer reviewed and funded by the manufacturer, measured blood NAD+, side effects and infusion time, and a review of 14 clinic records compared infusion time and side effects; neither measured health outcomes. See our Niagen IV page. medRxiv preprint, 2024 · Front Aging, 2026

Where guidance or other research differs

  • Wellness drips. The American College of Clinical Pharmacology (2024) found little to no evidence that the gains from these infusions outweigh their risks in healthy people, and a 2025 review found reported results come mostly from anecdotes and self-reports. In a placebo-controlled pilot trial of the Myers’ Cocktail in 34 adults with fibromyalgia, people improved with both the drip and a placebo; see our Myers’ Cocktail page. J Clin Pharmacol, 2024 · Cureus, 2025 · Myers’ Cocktail, 2009
  • Oral B12. In people low in B12, high oral doses raised blood levels about as much as injections. Cochrane, 2018
  • How Kansas regulates IV therapy. The state’s medical and pharmacy boards set out what they expect of anyone offering it. KSBHA and Board of Pharmacy, 2026

Sexual wellness

Our approach. We offer shockwave therapy for erectile dysfunction and for Peyronie’s disease, and ThermiVa for women, and we explain what the research shows before you decide. See shockwave therapy and ThermiVa.

The research behind it

  • Shockwave for erectile dysfunction. Across 21 sham-controlled trials with 1,357 men, erectile-function scores were slightly higher than with sham treatment in the short term. In the first sham-controlled trial (67 men, supported by the device maker), scores rose more with active treatment a month later. Cochrane, 2025 · Vardi, 2012 · Olsen, 2015
  • Shockwave for Peyronie’s disease. US and European urology guidelines allow shockwave therapy for penile pain from Peyronie’s disease (the European one in its early, active phase). Two pooled analyses of the trials disagree on whether pain eases more than with placebo, and neither found a clear change in curvature. AUA, 2015 · EAU, 2026 · Meta-analysis, 2021 · Meta-analysis, 2024

Where guidance or other research differs

  • Shockwave for erectile dysfunction. The American Urological Association (2018) calls it investigational, and the European Association of Urology gives it a weak recommendation for mild ED. Most studies used focused devices; the device we use delivers radial waves, and a sham-controlled trial of radial waves in 80 men found no difference at 6 weeks. No shockwave device is FDA-cleared to treat erectile dysfunction; ours is cleared as a vibration massage system. AUA, 2018 · EAU · Radial waves, 2022 · FDA 510(k) K173692
  • Shockwave for Peyronie’s disease. Both urology guidelines advise against using it to reduce curvature or plaque, because the trials they reviewed showed no change in either. Those trials used focused devices; radial waves like ours haven’t been tested for Peyronie’s, and our device isn’t FDA-cleared for it.
  • ThermiVa. In 2018 FDA warned that energy-based devices used for vaginal “rejuvenation” or for symptoms of menopause, incontinence or sexual function can cause serious harm, and said it had not cleared any device for those uses; ThermiVa is cleared for electrocoagulation and stopping bleeding in surgery. The American Urogynecologic Society’s panel found no evidence that radiofrequency helps stress incontinence. FDA, archived copy · FDA 510(k) K130689 · AUGS, 2022

Cosmetic injectables

Our approach. We use FDA-approved products: BOTOX Cosmetic and the Juvéderm family of fillers. See our Botox and Juvéderm pages.

  • BOTOX Cosmetic label. Approved for the temporary improvement of frown lines, crow’s feet, forehead lines and vertical neck bands in adults. Its boxed warning says the effect of any botulinum toxin may spread beyond the injection site; the label notes that no definitive serious cases have been linked to the labeled cosmetic doses. DailyMed
  • Dermal fillers. FDA approves fillers for specific areas; the most serious risk is injection into a blood vessel, and fillers bought online may be counterfeit. FDA · JUVÉDERM VOLUMA XC · JUVÉDERM VOLBELLA XC

Mild hyperbaric sessions

Our approach. Our sessions use a 1.3 ATA soft-shelled chamber. It is a wellness service, not the hospital hyperbaric oxygen therapy given in hard chambers, and we don’t claim it treats any condition. See our hyperbaric page.

The research behind it

  • What has been studied. The aging and memory studies most often cited used hard chambers at 2.0 ATA with 100% oxygen by mask for 60 sessions. Neither had a sham group, and their authors worked for or held shares in a commercial hyperbaric company. Hachmo, 2020 · Hadanny, 2020
  • Mild pressures. Controlled studies at 1.2 to 1.5 ATA are few and small. A trial in children with autism at 1.3 ATA, funded by a chamber-industry group, reported better clinician ratings than normal pressure; a Cochrane review excluded it because its slightly enriched air isn’t hyperbaric oxygen. A study of 16 healthy young adults exercising at 1.41 ATA found no difference in cognitive performance compared with normal air. In military trials of concussion symptoms, people breathing air at 1.2 to 1.3 ATA, the comparison group, improved about as much as those given oxygen at higher pressures; the authors read this as a placebo effect. Autism trial, 2009 · Healthy adults, 2026 · Military trial, 2012 · Military trial, 2015

Where guidance or other research differs

  • Definitions and clearance. The Undersea and Hyperbaric Medical Society defines hyperbaric oxygen therapy as at least 1.4 ATA with near-100% oxygen and knows of no reliable evidence of effect below 1.4 ATA. FDA cleared soft chambers for altitude sickness. UHMS, 2018 · FDA, archived copy · FDA, safe use, 2025

Questions about the research

Ask your provider at your visit, or call us at (913) 727-7700. To start, request an appointment or a free consultation.

This page is educational and is not medical advice. Individual results vary.