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FDA Approves New Drug Ixekizumab (Talz) for Active Ankylosing Spondylitis

 The US Food and Drug Administration (FDA) has approved the interleukin-17A inhibitor ixekizumab (Taltz, Eli Lilly) for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis, the company has announced.

 This is the third indication for ixekizumab. The drug was first approved for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It was subsequently approved for the treatment of adults with active psoriatic arthritis.

 Roughly 1.6 million people in the United States have AS, which affects the pelvic joints and spine and can cause chronic inflammatory back pain, stiffness, and impaired function and mobility, the company noted in a news release.

 The efficacy of ixekizumab in AS was demonstrated in two randomized, double-blind, placebo-controlled phase 3 studies that included 657 adult patients with active AS.

 The COAST-V trial involved patients who had never used a biologic disease-modifying antirheumatic drug (bDMARD). The COAST-W trial involved patients who previously had an inadequate response to or were intolerant of tumor necrosis factor (TNF) inhibitors.

 In both studies, patients who underwent treatment with ixekizumab achieved “statistically significant and clinically meaningful” improvements in signs and symptoms of AS at 16 weeks, as defined by Assessment of Spondyloarthritis International Society 40 (ASAS40) response, compared to patients who received placebo, the company said.

 In COAST-V, 48% of patients treated with ixekizumab every 4 weeks achieved ASAS40, compared with 18% of patients treated with placebo (P < .0001); corresponding ASAS40 response rates in COAST-W were 25% with ixekizumab vs 13% with placebo (P < .05).

 In both studies, patients who were treated with ixekizumab also showed statistically significant improvements in key secondary endpoints. The proportion of patients who achieved ASAS20 at 16 weeks was higher than that of patients who received placebo (COAST-V: 64% vs 40%; P = .0015; COAST-W: 48% vs 30%; P < .01)

 Results from the phase 3 clinical trial program in AS show that ixekizumab “helped reduce pain and inflammation and improve function in patients who had never been treated with a bDMARD as well as those who previously failed TNF inhibitors,” Philip Mease, MD, Swedish Medical Center/Providence St. Joseph Health and the University of Washington, Seattle, said in the news release. “This approval is an important milestone for patients and physicians who are looking for a much-needed alternative to address symptoms of AS.”

 Ixekizumab is given by injection, either by itself or in combination with a conventional bDMARD, corticosteroids, nonsteroidal anti-inflammatory drugs, and/or analgesics.

 Overall, the safety profile observed in patients with AS who were treated with ixekizumab is consistent with the safety profile seen in patients with psoriasis. Full prescribing information and a medication guide are available online.

Source : Medscape

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Bedside Ultrasound Very Promising in Diagnosing Increased ICP

 Use of bedside optic nerve ultrasonography may hold promise for diagnosing increased intracranial pressure (ICP) in children and adults, a systematic review and meta-analysis published online November 18 in Annals of Internal Medicine has shown.

 “A normal sheath diameter measurement has high sensitivity and a low negative likelihood ratio that may rule out increased intracranial pressure,” write Alex Koziarz, MSc, from the University of Toronto, Ontario, Canada, and colleagues, “whereas an elevated measurement, characterized by a high specificity and positive likelihood ratio, may indicate increased intracranial pressure and the need for additional confirmatory tests.”

 In cases of increased ICP, a patient’s prognosis depends on prompt diagnosis to expedite ICP reduction and reduce associated morbidity and mortality.

 Although various techniques are used to diagnose increased ICP, optic nerve ultrasonography (optic nerve sheath diameter sonography) is emerging as a rapid, noninvasive alternative in these cases.

 However, use of this method remains predominantly limited to clinical research settings.

 Additionally, studies to evaluate this technique have typically focused on specific patient populations and included only small numbers of patients.

 With this in mind, Koziarz and colleagues conducted a systematic review and meta-analysis to examine the accuracy of optic nerve ultrasonography for diagnosing increased ICP in children and adults.

 They analyzed 71 prospective diagnostic test studies (61 of which were conducted in adults) involving 4551 patients (4195 adults).

 Of these 71 studies, 18 included patients with traumatic brain injury, 26 included those with nontraumatic brain injury, and 27 included mixed populations of patients.

 Overall, optic nerve ultrasound accurately detected increased ICP in children and adults, including among patients with traumatic and nontraumatic causes of the condition.

 For patients presenting with suspected traumatic brain injury, the researchers found a pooled sensitivity of optic nerve ultrasonography for identifying increased ICP of 97% (95% CI, 92% – 99%) and a specificity of 86% (95% CI, 74% – 93%). These patients were 6.93 (95% CI, 3.55 – 13.54) times more likely to have increased ICP after a positive result on optic nerve ultrasonography. And the corresponding negative likelihood ratio was 0.04 (95% CI, 0.02 – 0.10).

 For those with suspected nontraumatic brain injury, sensitivity was 92% (95% CI, 86% – 96%) and specificity was 86% (95% CI, 77% – 92%). Similarly, these patients were 6.39 (95% CI, 3.77 to 10.84) times more likely to have increased ICP after a positive result on ultrasonography. The negative likelihood ratio for this patient population was 0.09 (95% CI, 0.05 – 0.17).

 Estimates of the accuracy of optic nerve ultrasonography were similar among studies stratified according to patient age, clinician specialty and sonography training level, reference standard, sonographer blinding status, and cutoff value.

 As they reviewed the literature for their study, Koziarz and colleagues also compared cutoff values and calculation methods for optic nerve sheath dilation on ultrasonography for identifying increased ICP. As a result, they established that a measurement of 5.0 mm may indicate increased ICP.

 The authors acknowledge the limitations of their study, especially its inclusion of studies that were predominantly small, used different reference standards, and did not assess the effect of optic nerve ultrasonography on clinical outcomes.

 Nevertheless, Koziarz and colleagues conclude that this method is “easy-to-use and can enable healthcare professionals to triage patients with suspected increased intracranial pressure.”

 In an accompanying editorial, Kathleen Y. Ogle, MD, from George Washington University Hospital, Washington, DC, and Resa E. Lewiss, MD, from Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, applaud the careful methods used in the study.

 However, they advise clinicians to use caution when interpreting the cutoff measurement.

 “The measurement of the optic nerve sheath diameter is riddled with greater challenges than other bedside ultrasonography clinical applications,” they stress.

 But because this technique can undoubtedly reduce the time to appropriate management, the editorialists suggest future research should aim to establish a standardized protocol for using optic nerve ultrasonography.

 They also encourage development of a cutoff for an ocular nerve sheath diameter measurement that accounts for sex and intersectional characteristics.

 Anticipating that tele-ultrasound practice will continue to become increasingly available, Ogle and Lewiss also conclude that after an agreed cutoff and protocol are established, “novice sonographer–clinicians could be supported by ultrasound experts for remote integration of bedside ultrasonography.”

Source : Medscape

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Rebranding Palliative Care as Supportive Care May Boost Use

 Palliative care is often underused in cancer care, but a simple name change can dramatically alter that and yield positive and productive results, said Matti S. Aapro, MD, Genolier Cancer Center, Genolier, Switzerland, speaking here at the Advanced Breast Cancer Fifth International Consensus Conference (ABC5).

 “Palliative care should be called ‘supportive treatment’ — it’s not just about the end of life,” said Aapro, who discussed reasons for the change and then presented data from a 2009 study that showed dramatic effects at a major US cancer center.

 He explained that both palliative and supportive care are integral to patient care, but palliation has an image problem: it is often misperceived as the end of the line for patients and their care team — the time where they will part company as patients discontinue active treatment and enter hospice.

 In reality, palliative care, which primarily aims to provide relief from pain and other distressing symptoms, can be offered to all patients with cancer, regardless of their stage, and can greatly improve quality of life, he said.

 Supportive care, on the other hand, is typically thought of as involving treatment management and posttreatment issues, Aapro also explained.

 Traditionally speaking, supportive care alleviates symptoms and complications of cancer; reduces or prevents treatment toxicities; supports communication with patients about their disease and prognosis; and eases patients and their caregivers’ emotional burdens, per the Multinational Association for Supportive Care in Cancer.

 By contrast, Aapro said a newly branded supportive care — one that incorporates the traditional notions about palliative care — breaks down that sequential timing and should proactively be offered to patients. “It should be there at the beginning, when they start treatment,” he said.

Dramatic Results With Experiment in Texas

 Rather than take on the daunting task of educating physicians and patients about the true meaning of palliative care, one well-known institution wondered what would happen if it simply substituted the word “supportive,” said Aapro.

 “The results were remarkable,” he commented.

 As of 2009, palliative care referrals at MD Anderson Cancer Center in Houston, Texas, typically happened late in the course of a patient’s illness.

 Theorizing that prevailing negative assumptions about palliative care posed an obstacle to early patient referral, MD Anderson investigators, led by Nada Fadul, MD, conducted a survey among a random sample of 100 midlevel providers and 100 medical oncologists. A total of 140 (70%) of 200 participants responded (74 midlevel providers and 66 medical oncologists).

 More participants preferred the name “supportive care” (80% midlevel providers, 57% medical oncologists) compared with palliative care (27% midlevel providers, 19% medical oncologists; P < .0001).

 When the investigators combined data from the two groups of professionals, they found that the combined group stated a significantly increased likelihood to refer patients on active primary ([vs not to] — 79% vs 45%, P < .0001) and advanced cancer (89% vs 69%, P < .0001) treatments to a service named “supportive care.” Medical oncologists and midlevel providers heavily preferred the name supportive care and stated more likelihood to refer patients on active primary and advanced cancer treatments to a service named “supportive care.”

 As a follow-up to this study, the team changed the name of the unit and showed dramatic results.

 In a study of records of 4701 consecutive patients with a first palliative care consultation before and after the name change, they found a 41% greater number of palliative care consultations (1950 vs 2751 patients; P < .001), mainly as a result of a rise in inpatient referrals (733 vs 1451 patients; P < .001). And in the outpatient setting, they found a shorter duration from hospital registration to palliative care consultation (median, 9.2 months vs 13.2 months; P < .001) and from advanced cancer diagnosis to palliative care consultation (5.2 months vs 6.9 months; P < .001). They also found a longer overall survival duration from palliative care consultation (median 6.2 months vs 4.7 months; P < .001).

 Beyond the name change, is there anything else clinicians can do to facilitate earlier palliative care referrals?

 “There a lot [of additional options], some of which may require some reorganization,” Aapro told Medscape Medical News.

 He cited a number of situations for advanced breast cancer. “For example, integrating the primary care team if advanced breast cancer tumor boards exist, which is often not the case.” Aapro also said that it is helpful when oncologists see patients along with their primary care team early rather than “when things are dire.”

Source : Medscape

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Treating LDL to Below 70 Reduces Recurrent Stroke

 Treating patients to a lower LDL target after an ischemic stroke of atherosclerotic origin resulted in fewer recurrent strokes or major cardiovascular events compared with a higher LDL goal, even though the international trial was stopped early because of a lack of funding.

 

Dr Pierre Amarenco

 “In the Treat Stroke to Target [TST] trial we showed that the group of patients with an atherosclerotic stroke achieving an LDL cholesterol of less than 70 mg/dL had 22% less recurrent ischemic stroke or other major vascular events than the group achieving an LDL cholesterol between 90 and 110 mg/dL,” lead author Pierre Amarenco, MD, chairman, Department of Neurology and Stroke Centre at Bichat Hospital in Paris, France, told theheart.org | Medscape Cardiology.

 “We avoided more than one recurrence in five,” he added.

 The findings of the investigator-initiated trial were reported here during a late breaking research session at the American Heart Association (AHA) 2019 Scientific Sessions and simultaneously published online November 18 in the New England Journal of Medicine.

 

Dr Mitchell Elkind

 Discussant Mitchell S.V. Elkind, MD, MPhil, president-elect of the American Heart Association, called the TST findings “practice confirming” of a strategy many cardiologists already follow for patients who have suffered a stroke.

 “The TST study is only the second trial that was done in neurology for stroke prevention using statins and lipid-lowering therapy, and that’s what makes it a hopeful and real advance,” he said in an interview.

 To achieve the LDL-lowering goal, two thirds of patients received a high-dose statin therapy while the remainder received both high-dose statin and ezetimibe (Zetia, Merck). There were no significant increases in intracranial hemorrhage observed between lower and higher target groups.

 “Now guidelines should move to recommending a target LDL cholesterol of less than 70 mg/dL in all patients with a proven ischemic stroke of atherosclerotic origin,” said Amarenco, who is also a professor of neurology at Denis Diderot Paris University.

Rare Lipid Study Following Stroke

 American Heart Association/American Stroke Association guidelines recommend intense statin therapy after an atherothrombotic stroke, “but no target level is given to the practitioners,” Amarenco said. “In reality, most patients receive a reduced dose of statin.”

 For example, despite 70% of patients receiving a statin, the average LDL cholesterol level was 92 mg/dL in a real world registry.

 The TST trial is the first major study to evaluate treating to target LDL levels in the ischemic stroke population since the SPARCL trial in 2006. SPARCL was the first randomized controlled clinical trial to evaluate whether daily statin therapy could reduce the risk of stroke in patients who had suffered a stroke or transient ischemic attack (TIA).

 SPARCL demonstrated a 16% risk reduction with atorvastatin 80 mg daily vs placebo, and further risk reduction of 33% among those with carotid stenosis, over 5 years. There was some concern about safety for a time, however, when post-hoc analysis showed what appeared to be an increased risk for intracranial hemorrhage with statin treatment, although subsequent analyses seemed to suggest the finding may have been a chance one.

 For the TST study, Amarenco and colleagues enrolled participants between March 2010 and December 2018 at one of 61 centers in France. In 2015, the study expanded to include 16 sites in South Korea.

 Investigators evaluated participants after an ischemic stroke or a TIA with evidence of atherosclerosis. Blood pressure, smoking cessation, and diabetes were well controlled, Amarenco said.

 Amarenco and colleagues randomly assigned 1430 participants to the low-LDL-cholesterol target group, less than 70 mg/dL, and another 1430 to a high-LDL group with a target of 100 mg/dL.

 Assessments were every 6 months and up to 1 year after the last patient joined the study.

 Treatment with any available statin on the market was allowed. Ezetimibe could be added on top of statin therapy as necessary. A total 55% were statin naïve at study entry.

Study Stopped Early

 The trial was stopped in May of this year after allocated funds ran out. At this point, researchers had 277 events to analyze, although their initial goal was to reach 385.

 The primary endpoint of this event-driven trial was a composite of nonfatal stroke, nonfatal MI, and unstable angina followed by urgent coronary revascularization, TIA followed by urgent carotid revascularization, or cardiovascular death, including sudden deaths.

 The endpoint was experienced by 8.5% of participants in the lower target group vs 10.9% of those in the higher target group. This translated to a 22% relative risk reduction (adjusted hazard ratio, 0.78; 95% confidence interval, 0.61 – 0.98; P = .04).

 A total of 86% of participants had an ischemic stroke confirmed by brain MRI or CT scan. In this group, the relative risk reduction was 33%, “meaning that we could avoid one third of recurrent major vascular events,” Amarenco said.

 Furthermore, targeting the lower LDL levels was associated with a relative risk reduction of 40% among those with diabetes.

Secondary Outcomes Not Significant

 The investigators used hierarchical testing to compare two outcomes at a time in a prespecified order. They planned to continue this strategy until a comparison emerged as nonsignificant.

 This occurred right away when their first composite secondary endpoint comparison between nonfatal MI and urgent revascularization was found to be not significantly different between groups (P = .12).

 The early ending “weakened the results of the trial, and the results should be taken with caution because of that,” Amarenco said.

 In addition, the number of hemorrhagic strokes did not differ significantly between groups. There were 18 of these events in the lower target group and 13 in the higher target cohort.

 That numerical increase in intracranial hemorrhage was “driven by the Korean patients…and that is something we will report soon,” Amarenco said. 

 Interestingly, the researchers also evaluated how much time participants spent within the target LDL cholesterol range, averaged by study site. They found that 53% of the lower LDL target group, for example, was in the therapeutic range on average during the study.

 When Amarenco and colleagues looked at participants who managed to spend 50% to 100% in the target range, the relative risk reduction was 36%.

 “So we can hypothesize that, if we had used a more potent drug like PCSK9 inhibitors to be closer to 100% in the therapeutic range, we may have had a greater effect size,” Amarenco said.

 “Our results suggest that LDL cholesterol is causally related to atherosclerosis and confirm that the lower the LDL cholesterol the better,” Amarenco said.

 “Future trials should explore the efficacy and safety of lowering LDL cholesterol to very low levels such as less than 55 mg/dL or even 30 mg/dL (as obtained in the FOURIER trial) by using PCSK9 inhibitors or equivalent in patients with an ischemic stroke due to atherosclerotic disease,” Amarenco said.

“Practice-Confirming” Findings

 The findings are also in line with secondary analyses of the WASID and SAMMPRIS trials, which should dispel some concerns that persist about taking LDL to such low levels that it increases risk of intracerebral hemorrhage, Amarenco noted.

 However, the TST trial, he said, didn’t provide clear answers on which specific subgroups of patients with a stroke history would benefit from aggressive lipid lowering.

 “What is stroke without atherosclerotic disease?” he said. “Some people say small-vessel disease is also a form of atherosclerosis, and most patients with atrial fibrillation, which is increasingly recognized as a cause of stroke, are also going to have atherosclerosis of the heart as well as the brain and blood vessels.

 “Many, many stroke patients will fall into this category,” Elkind said, “and the question is, should they be treated more aggressively with lipid lowering?”

 

Dr Donald Lloyd-Jones

 “The results of this study fit pretty nicely into the rubric of the AHA cholesterol guidelines,” said Donald M. Lloyd-Jones, MD, ScM, chairman of the Department of Preventive Medicine at Northwestern University Feinberg School of Medicine, Chicago, Illinois, and chair of the AHA’s 2019 Council on Scientific Sessions Programming. Lloyd-Jones was also a member of the guideline committee.

 Patients who have suffered a stroke are not “garden variety coronary patients,” he said. “The concern about intracerebral hemorrhage continues to be something that we wonder about: Should we be driving our stroke patients as low as our coronary patients? I think these data will certainly help us.”

Consideration for Future Guidelines

 The study would have been more helpful if it provided more detail about the treatment regimens used, Jennifer Robinson, MD, MPH, director, Preventive Intervention Center, Department of Epidemiology, University of Iowa in Iowa City, said in an interview.

 “What was the dose intensity of statins the patients were on?” Robinson said. “Part of our struggle has been to convince people to use high-intensity statins — get the maximum from statins that are generic now and cost-saving in even very low-risk primary prevention patients.”

 She said that one third of patients in TST also taking ezetimibe with the statin “makes sense” because of its generic status.

 Nonetheless, Robinson said TST adds to the evidence that LDL of 100 mg/dL is not good enough, that high-intensity statin therapy is superior to a moderate regimen, and that adding a non-statin — ezetimibe in TST — can derive added benefit.

 The TST findings may give guideline writers direction going forward, she said. “We really need to start thinking about the potential for net benefit from added therapy, whether it’s from intensifying LDL lowering, adding icosapent ethyl (Vascepa, Amarin), which seems to have remarkable benefits, or [an] SGLT2 inhibitor,” she said.

 “There are a lot of options,” Robinson said. “We need to have an outlook beyond just treating to target with what really is the best maximized accepted therapy.”

Source : Medscape

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‘Popcorn Lung’ Type Injury From Vaping

 Researchers in Canada have identified a new kind of vaping-related lung injury they believe is linked to flavorings in conventional vape pens, causing symptoms similar to the “popcorn lung” injury seen in workers exposed to flavorings in microwave popcorn.

 The case, published November 21 in the Canadian Medical Association Journal (CMAJ), involved a 17-year-old male who developed a form of bronchiolitis, a serious and irreversible lung injury caused by chemical exposure.

 The condition has been linked to diacetyl, the chemical that gives microwave popcorn its buttery flavor and a known cause of bronchiolitis. Various studies have also found diacetyl in vaping liquids.

 The previously healthy Canadian teen turned up in the emergency  department of a community hospital in Ontario last spring with a severe cough. He was diagnosed with pneumonia and prescribed antibiotics.

 Five days later, he was back with worsening symptoms and was admitted  and given intravenous antibiotics. He continued to decline and was put on a mechanical ventilator, but still failed to improve.

 At that point, he was transferred to London Health Sciences Centre and put on an extracorporeal membrane oxygenation, or ECMO, machine – an extreme treatment that takes over the work of the lungs. That stabilized him, but did not reverse the condition.

 “I was concerned his lungs might never recover enough to get him off the machine,” said Dr. Karen Bosma, a London Health intensive care physician and a study author.

 Fearing he might need a lung transplant, the team transferred the teen to a regional transplant center in Toronto. Since testing had ruled out infection, doctors decided to try high-dose steroids, which helped reduce inflammation.

 The patient had reported using both flavored nicotine vapes and THC – the psychoactive agent in marijuana. Doctors suspected a vaping-related injury, even before the U.S. outbreak had been reported.

 Although the case shares similarities with the more than 2,000 cases of vaping-related illnesses in the United States, the injury is different. Instead of damaged air sacs in the lungs, the teen had damaged airways, which his doctors believe were caused by chemical injury.

 “This is a new finding,” Bosma said.

 Several vaping chemicals could have caused the injury, she said, but the team focused on diacetyl because it has been shown to cause similar illnesses.

 Four months after his discharge, the teen still has trouble breathing. Bosma said it is not clear if his lungs will recover.

 “In patients with popcorn lung, it’s irreversible.”

Source : Medscape 

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Rectal Douching Injury in Men Who Have Sex With Men

 Jamey Scott, RN, was meeting with a patient at the Ryan White clinic where she works in Richmond, Virginia, when he mentioned that he “douched” in preparation for sex.

 The word stopped her, but Scott kept moving. Her training in HIV taught her that “you can’t bat an eye” when patients say things that surprise you. But she did need to know more.

 “I asked, ‘Are you using like a Summer’s Eve–type product or are you using a Fleet [enema]?” she said. “I just put it out there. If they’re going to be bold enough to tell me, I’m going to be bold enough to ask.”

 According to data presented at the Association of Nurses in AIDS Care 2019 Conference, half the gay and bisexual black men in the Deep South have used an enema — or “rectal douche” as it’s called in the community — although what they are using to douche is unclear.

 For men who are receptive partners, it’s even more common. This is despite the conventional wisdom that no one should regularly use an enema unless they have a neurologic condition, such as multiple sclerosis or spinal cord injuries, that necessitates it.

 Data also show that enemas, along with other sexual-hygiene practices, could increase the risk for HIV transmission and other sexually transmitted infections (STIs). But there are formulations that are safer, and research is ongoing into medicated formulations.

Increased HIV and STI Risk

 This is where healthcare providers come in, said Derek Dangerfield, PhD, from the Johns Hopkins School of Nursing in Baltimore. They can help men who are going to douche anyway do so in a way that’s less disruptive to the microbiome and the fragile rectal lining.

 “A lot of guys are learning to do this on their own or they are learning through pornography,” said Dangerfield. “What we need are harm-reduction strategies for this phenomenon.”

 Most clinicians see the rectum as just another part of the colorectal system, but for some patients, it’s much more than that, said Jonathan Baker, PA-C, from the Laser Surgery Center in New York City.

 “A lot of guys are learning to do this on their own or they are learning through pornography.”
 

“More than 30% of the general population sees the anus and rectum as sexual organs. And so does my community,” said Baker, who is gay, citing survey results.

 Baker, who goes by @RectalRockStar on Instagram, treats his patients the way a gynecologist might approach comprehensive sexual health. Patients who report receiving anal sex undergo anal Pap tests to detect high-risk human papillomavirus (HPV), gonorrhea, and chlamydia. The HPV test is especially important for people living with HIV because rates of anal cancer associated with HPV are elevated in that population, he explained.

 In addition, Baker said he counsels his patients on how to care for the delicate rectal mucosa, which is only one layer of cells thick, unlike the vaginal lining, which is multiple layers thick.

 “It’s a fragile lining and it does get damaged easily,” he said. “It probably gets damaged from more things than we even realize.”

 The rectum does have its own line of defense, and you only have to look into a microscope to see it, said Craig Hendrix, MD, from the Johns Hopkins School of Medicine in Baltimore.

 There, you’ll find a “lush and rich” lining, a row of protective epithelial cells that also make protective mucin, said Hendrix, who studies pharmacokinetics in drug development and is currently working on a medicated douche to prevent the transmission of HIV.

 The key is to keep that protective lining in place. Some formulations do that, such as the electrolyte-water injection Normosol-R, which Hendrix’s team used to test douche safety.

 But many products used as enemas or anal douches, including some of the most popular, don’t. And with a lining that’s just one layer thick, there is little room for error.

 The process of introducing hyperosmolar fluids into the rectum, for instance, means that fluid is forced through the membrane faster and faster. And the lush epithelial layer “literally disappears,” said Hendrix. “Most of the epithelial cells are gone, and there’s no mucin.”

 The first step in sexual health is to protect that epithelial layer and mucin, he explained. Patients and providers usually don’t know how to do that, said Baker. And that can lead to layers of risk, when patients, unaware of the impact of hyperosmolar preparations, pile one on top of another.

 Take lubricants, for example. Lubricants can reduce friction during sex, preventing tears that could make way for HIV and STI transmission. Recent data suggest that they also reduce the risk of condoms slipping and breaking.

 But many lubricants — such as KY Jelly, Astroglide, and Wet Original — are themselves hyperosmolar, as is the nonoxynol-9 spermicide, according to a 2007 study Hendrix was involved in. That team showed that hyperosmolar lubricants “denuded” the cell lining.

 However, iso-osmolar lubricants do exist, including Good Clean Love and PRÉ, according to one small study. Now add in enemas and rectal douching to the equation. Like lubricants, not all enemas are created equal. And researchers don’t really know what patients mean when they say “douching,” Dangerfield said.

Douching Concoctions

 The people who attended his session confirmed this, reporting the types of douches they knew their patients used, which included commercially available sodium phosphate enemas, like those sold under the brand name Fleet; homemade concoctions of water or soap and water; and mechanical apparatuses that attach to one’s shower and fill the rectum with water.

 There are also “other feminine hygiene products,” like Summer’s Eve, which contains vinegar, said Maureen Scahill, NP, RN, from the University of Rochester in New York. “I’ve never had a patient tell me they use one, but that’s a question worth exploring.”

 And that’s to say nothing of laxatives, suppositories, and the use of multiple approaches at one time, added Baker.

 “I’ve heard of all kinds of behaviors — from laxatives to Imodium, suppositories, enemas, shower attachments, and high-end heated bidets — although I do fully support bidets,” he said. “People sometimes add things like lemon juice or vinegar, which are acidic and may lead to even more mucosal damage.”

 Considerable evidence shows that sodium phosphate enemas, like the kind sold commercially as Fleet, have been associated with the dysregulation of electrolytes in the bowel, hyperphosphatemia, severe metabolic disorders, renal damage, and even death. These kinds of hyperosmolar preparations are as bad for the rectal lining in douche form as they are in lubricant form.

 So it should be no surprise that rectal douching is associated with an elevated risk for HIV transmission and the acquisition of STIs, such as chlamydia and gonorrhea. One study showed that people who used enemas at least once a week were 3.5 times as likely to already have a rectal infection as those who never used enemas (odds ratio [OR], 3.57; P = .001), and nearly four times as likely to acquire a rectal infection during the study (OR, 3.87; P = .001).

 In any case, repeatedly clearing out the rectal cavity increases inflammation, can disrupt the absorption of vitamins, and is associated with increases in the risk for HIV (OR, 2.8) and for STIs (OR, 2.5).

 This is where Dangerfield, a sociologist by training, comes in. His interest started simply: “We know the biology; I’m interested in who these folks are.”

 So Dangerfield partnered with DeMarc Hickson, PhD, principle investigator of the Ecological Study of Sexual Behaviors and HIV/STI Among African American Men Who Have Sex With Men in the Southeastern United States (the MARI study), to figure out who these particular gay and bisexual men are, and how they use anal douching.

 Although studies have identified that up to 88% of gay and bisexual men have anally douched, and that up to 64% have done so recently, there are few data on black gay men and black women of trans experience in the Deep South, the people Dangerfield is interested in.

Sex, Sexuality, and Stigma

 “Most studies have majority-white samples or are conducted in a European context,” he said. But “we all know that black men who have sex with men are disproportionately impacted by HIV. And interestingly, over half of trans women living with HIV are black.”

 Hickson found that in a cohort of 386 black participants (5.5% of whom were women of trans experience) from Jackson, Mississippi and Atlanta, 52.9% had used a rectal douche at some point — 30.8% at least six times and 28.3% three to five times.

 For his part, Dangerfield asked all kinds of demographic questions: age, recent history of STIs, HIV status, income, education level, number of sexual partners, and condom use.

 When he analyzed these data for associations with douching, there weren’t any. The only thing that affected the likelihood of douching was the role the person played during sex. In the parlance of the gay community, being “versatile” or a “bottom” during sex means sometimes or always being the receptive partner during sex, and being a “top” means always being the insertive partner.

 People who said they were versatile were 2.46 times as likely to engage in rectal douching as men who identified as tops. And bottoms were 2.36 times as likely to engage in rectal douching as tops.

Compounded Risk

 What emerged was one explanation for the variability in HIV risk in a group that already has a 50-50 chance of acquiring HIV.

 

 There are structural reasons for high rates of HIV in black Americans, like lack of insurance, the inequitable use of HIV pre-exposure prophylaxis, and low rates of viral suppression. Then add in being a bottom or versatile.

 

 Then layer in repeated studies that show that black gay men are more likely to use condoms than their white counterparts and the damage to the rectal lining that can happen from sex without enough lubrication, or the use of the wrong kind of lubricant.

 And then also include the wrong kind of rectal douching, and you have a fertile environment that HIV can exploit. “This is really nuanced and critical,” he said. “This high-risk behavior is going on among folks who are arguably at higher risk. And it creates a high-risk compound factor for STIs and HIV.”

 The point is not to create alarm or tell men that they can’t douche or have anal sex; “that wouldn’t be culturally responsive,” Dangerfield said. And it probably wouldn’t work.

Culturally Responsive Care

 Dangerfield’s study of men who reported douching showed that among the reasons they cite for doing so are that a partner had asked them to, that they believed that it might increase pleasure, and that douching after sex might prevent transmission of STIs.

 More than that, Baker has had patients who have been “blacklisted” from their small, sexual networks for having an accident during sex. “It can be extremely stigmatizing,” he explained. “For some patients, it becomes a necessity. So ignoring it isn’t going to help anyone.”

 In Baker’s office, he starts a sexual history with all of this in mind. He asks about sexual positioning, lube, and douche use. When his patients say they “prepare for sex,” he asks them how, he said.

 

 Although he informs them that rectal douching, especially regularly, isn’t recommended, he sees the conversation as a teaching moment. He recommends against Fleet enemas, and instead suggests simple water enemas using a bulb syringe or an emptied Fleet enema bag.

 If the patient uses a shower attachment to insert water into their rectum, he encourages them to look for an inch — that is, to set the water so it starts to separate and cascade at that point — and then gently insert the nozzle.

 “We are trying to apply the same amount of liquid as we would with a bulb syringe,” he said. More than that and the sheer pressure of the water could cause damage. Baker also recommends water-soluble or silicone lubricants for people who use condoms and oil-based lubricant for people who do not.

 But his favorite thing to talk about, and one that he saves for last, is fiber. He recommends a fiber-rich diet anyway, but also recommends a once- or twice-daily dietary fiber supplement. “In an ideal world, you’d do all this with dietary fiber, but for a lot of patients, that’s probably not realistic,” he said. “It’s all about harm reduction.”

 These kinds of conversations can be done in minutes, Dangerfield said. And they could improve the sexual health of patients. “It’s not a heavy lift,” he said. “Just understanding this component and how it adds to sexual risk in the context of one’s sexuality could be really critical.”

Source : Medscape