Higher levels of perceived stress appear to be associated with faster declines in two cognitive domains – episodic memory and visuospatial ability – among older African Americans without dementia, results from a longitudinal study of 467 participants suggest.

“To our knowledge, this is the first study to examine the relationship between perceived stress and cognition in specific cognitive domains in general and in a minority population in particular,” reported Arlener D. Turner, PhD, of the Rush Alzheimer’s Disease Center and the department of behavioral sciences at Rush University, Chicago, and her associates.

©Thinkstock

ghenderson@frontlinemedcom.com

On Twitter @ginahenderson

Higher levels of perceived stress appear to be associated with faster declines in two cognitive domains – episodic memory and visuospatial ability – among older African Americans without dementia, results from a longitudinal study of 467 participants suggest.

“To our knowledge, this is the first study to examine the relationship between perceived stress and cognition in specific cognitive domains in general and in a minority population in particular,” reported Arlener D. Turner, PhD, of the Rush Alzheimer’s Disease Center and the department of behavioral sciences at Rush University, Chicago, and her associates.

©Thinkstock

ghenderson@frontlinemedcom.com

On Twitter @ginahenderson

Higher levels of perceived stress appear to be associated with faster declines in two cognitive domains – episodic memory and visuospatial ability – among older African Americans without dementia, results from a longitudinal study of 467 participants suggest.

“To our knowledge, this is the first study to examine the relationship between perceived stress and cognition in specific cognitive domains in general and in a minority population in particular,” reported Arlener D. Turner, PhD, of the Rush Alzheimer’s Disease Center and the department of behavioral sciences at Rush University, Chicago, and her associates.

©Thinkstock

ghenderson@frontlinemedcom.com

On Twitter @ginahenderson

Women can reduce their risk of dying should they receive a breast cancer diagnosis by following a low-fat diet, suggests an analysis from the phase III multicenter randomized Women’s Health Initiative Dietary Modification trial.

Investigators led by Rowan T. Chlebowski, MD, PhD, formerly of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California, and now at City of Hope National Medical Center, Duarte, California, analyzed data from 48,835 postmenopausal women who had never had breast cancer and had normal mammograms. The women were randomly assigned 2:3 to a diet aimed at reducing fat intake to 20% of energy and increasing intake of fruits, vegetables, and grains or to a usual diet.

Women can reduce their risk of dying should they receive a breast cancer diagnosis by following a low-fat diet, suggests an analysis from the phase III multicenter randomized Women’s Health Initiative Dietary Modification trial.

Investigators led by Rowan T. Chlebowski, MD, PhD, formerly of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California, and now at City of Hope National Medical Center, Duarte, California, analyzed data from 48,835 postmenopausal women who had never had breast cancer and had normal mammograms. The women were randomly assigned 2:3 to a diet aimed at reducing fat intake to 20% of energy and increasing intake of fruits, vegetables, and grains or to a usual diet.

Women can reduce their risk of dying should they receive a breast cancer diagnosis by following a low-fat diet, suggests an analysis from the phase III multicenter randomized Women’s Health Initiative Dietary Modification trial.

Investigators led by Rowan T. Chlebowski, MD, PhD, formerly of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California, and now at City of Hope National Medical Center, Duarte, California, analyzed data from 48,835 postmenopausal women who had never had breast cancer and had normal mammograms. The women were randomly assigned 2:3 to a diet aimed at reducing fat intake to 20% of energy and increasing intake of fruits, vegetables, and grains or to a usual diet.

In this era of biologics for psoriasis with ever-increasing effectiveness and safety as well as patients who have less and less time to visit the physician's office, it would seem that the days of in-office UV treatments would be numbered. However, rumors of the demise of phototherapy may be greatly exaggerated. Phototherapy is still one of the safest and most cost-effective treatments for psoriasis and other dermatoses.1 Its use often is a prerequisite for biologic therapy, and it may be the only therapeutic option for certain subsets of patients, such as children, pregnant women, and immunosuppressed patients. Moreover, narrowband UVB technology has breathed new life into phototherapy, with better efficacy and less long-term risk. Although the utilization of psoralen plus UVA (PUVA) light therapy has indeed decreased over the last 2 decades, the use of UVB therapies continues to increase dramatically.²

Phototherapy Codes

There are 4 chief Current Procedural Terminology (CPT) codes for reporting phototherapy services: (1) 96900: actinotherapy (UV light treatment); (2) 96910: photochemotherapy, tar, and UVB (Goeckerman treatment) or petrolatum and UVB; (3) 96912: photochemotherapy and PUVA; and (4) 96913: photochemotherapy (Goeckerman and/or PUVA) for severe photoresponsive dermatoses requiring at least 4 to 8 hours of care under direct supervision of the physician.³

There is lack of specificity of the CPT code descriptions for phototherapy. Moreover, insurer guidance for documentation for phototherapy is vague to nonexistent, and of course whenever the use of any medical service increases, insurer scrutiny is sure to follow. Therefore, it is not surprising that dermatology practices have reported that private insurers as well as Medicare are auditing medical records for phototherapy treatments.⁴ In fact, recently we have seen a Midwest private insurer demand payment from dermatologists for hundreds of 96910 phototherapy services, which the insurer asserted should have been coded as 96900 because topical therapies were not applied by the dermatology staff. The insurer did not just evaluate medical records but also contacted patients directly and asked how services had been provided. Clearly, more detailed guidance for dermatologists and insurers on documentation and performance standards for each phototherapy service is needed.

Existing coding guidance for phototherapy indicates that actinotherapy (96900) defines the basic service of treating a patient with a UV light unit.⁵ Actinotherapy does not involve application of topical medications while the patient is in the office.

In contrast, photochemotherapy (96910) implies addition of a chemo agent to phototherapy. Despite the somewhat nonspecific nature of the code descriptor, it is apparent that application of photoenhancing agents such as tar, petrolatum, or distillates of petrolatum meet the requirements of 96910. The Coder's Desk Reference for Procedures 2017 describes 96910 as "the physician uses photosensitizing chemicals and light rays to treat skin ailments."⁶ Application of light-enhancing topical products should occur within the office by either staff or the patient. In fact, examination of practice expense data from the Centers for Medicare & Medicaid Services indicated that the 96910 code includes payment for clinical staff time to apply topical products as well as the cost of the topical agent(s).⁷ 

The PUVA code 96912 is defined by the use of photosensitizing psoralen medication, which can be administered topically or orally, followed by UVA treatment. In my experience, PUVA has similar performance standards with in-office application of psoralen, if applicable. If application of topical photoenhancing products occurs outside the office, the requirements of photochemotherapy are not met, and 96900 should be reported. 

The 96913 code defines prolonged phototherapy service with intensive topical therapy requirements and multiple phototherapy sessions per day.³ This code is rarely reported (average of fewer than 100 times in the Medicare population per year), and most insurers do not reimburse this service. 

Protecting Yourself From an Audit

In my experience, review of private insurer audits of phototherapy services has yielded important lessons. First, having a written standard operating procedure in place regarding the performance of phototherapy services and how application of topicals will be handled has been helpful in audit defense. The other key to beating audits for phototherapy services is to have detailed documentation or a flowchart in the medical record regarding the topical agent and the light administration. The medical record should include what topical agent was applied, if any; whether the topical agent was applied in the office; where the topical product was applied; and who applied the topical product. Sometimes topical product application by a physician or staff is not feasible because of patient preference or the site of application. If the patient applied the topical, document that assistance was offered and refused, along with what type of UV light was used and the dosage. Inclusion of these elements in the medical record provides a clear picture of the delivery of the phototherapy service and will aid in responding to medical record audit.

Final Thoughts

Phototherapy is a critical treatment modality that continues to be utilized frequently in the expanding armamentarium of treatments for dermatoses. Phototherapy is performed almost exclusively by dermatologists and allows dermatologists to offer a unique level of care and value in the treatment of skin disease. Careful documentation, a written standard operating procedure, and adherence to proper performance standards will allow dermatologists to be compensated fairly for this important treatment modality and pass audits that are likely to occur.

In this era of biologics for psoriasis with ever-increasing effectiveness and safety as well as patients who have less and less time to visit the physician's office, it would seem that the days of in-office UV treatments would be numbered. However, rumors of the demise of phototherapy may be greatly exaggerated. Phototherapy is still one of the safest and most cost-effective treatments for psoriasis and other dermatoses.1 Its use often is a prerequisite for biologic therapy, and it may be the only therapeutic option for certain subsets of patients, such as children, pregnant women, and immunosuppressed patients. Moreover, narrowband UVB technology has breathed new life into phototherapy, with better efficacy and less long-term risk. Although the utilization of psoralen plus UVA (PUVA) light therapy has indeed decreased over the last 2 decades, the use of UVB therapies continues to increase dramatically.²

Phototherapy Codes

There are 4 chief Current Procedural Terminology (CPT) codes for reporting phototherapy services: (1) 96900: actinotherapy (UV light treatment); (2) 96910: photochemotherapy, tar, and UVB (Goeckerman treatment) or petrolatum and UVB; (3) 96912: photochemotherapy and PUVA; and (4) 96913: photochemotherapy (Goeckerman and/or PUVA) for severe photoresponsive dermatoses requiring at least 4 to 8 hours of care under direct supervision of the physician.³

There is lack of specificity of the CPT code descriptions for phototherapy. Moreover, insurer guidance for documentation for phototherapy is vague to nonexistent, and of course whenever the use of any medical service increases, insurer scrutiny is sure to follow. Therefore, it is not surprising that dermatology practices have reported that private insurers as well as Medicare are auditing medical records for phototherapy treatments.⁴ In fact, recently we have seen a Midwest private insurer demand payment from dermatologists for hundreds of 96910 phototherapy services, which the insurer asserted should have been coded as 96900 because topical therapies were not applied by the dermatology staff. The insurer did not just evaluate medical records but also contacted patients directly and asked how services had been provided. Clearly, more detailed guidance for dermatologists and insurers on documentation and performance standards for each phototherapy service is needed.

Existing coding guidance for phototherapy indicates that actinotherapy (96900) defines the basic service of treating a patient with a UV light unit.⁵ Actinotherapy does not involve application of topical medications while the patient is in the office.

In contrast, photochemotherapy (96910) implies addition of a chemo agent to phototherapy. Despite the somewhat nonspecific nature of the code descriptor, it is apparent that application of photoenhancing agents such as tar, petrolatum, or distillates of petrolatum meet the requirements of 96910. The Coder's Desk Reference for Procedures 2017 describes 96910 as "the physician uses photosensitizing chemicals and light rays to treat skin ailments."⁶ Application of light-enhancing topical products should occur within the office by either staff or the patient. In fact, examination of practice expense data from the Centers for Medicare & Medicaid Services indicated that the 96910 code includes payment for clinical staff time to apply topical products as well as the cost of the topical agent(s).⁷ 

The PUVA code 96912 is defined by the use of photosensitizing psoralen medication, which can be administered topically or orally, followed by UVA treatment. In my experience, PUVA has similar performance standards with in-office application of psoralen, if applicable. If application of topical photoenhancing products occurs outside the office, the requirements of photochemotherapy are not met, and 96900 should be reported. 

The 96913 code defines prolonged phototherapy service with intensive topical therapy requirements and multiple phototherapy sessions per day.³ This code is rarely reported (average of fewer than 100 times in the Medicare population per year), and most insurers do not reimburse this service. 

Protecting Yourself From an Audit

In my experience, review of private insurer audits of phototherapy services has yielded important lessons. First, having a written standard operating procedure in place regarding the performance of phototherapy services and how application of topicals will be handled has been helpful in audit defense. The other key to beating audits for phototherapy services is to have detailed documentation or a flowchart in the medical record regarding the topical agent and the light administration. The medical record should include what topical agent was applied, if any; whether the topical agent was applied in the office; where the topical product was applied; and who applied the topical product. Sometimes topical product application by a physician or staff is not feasible because of patient preference or the site of application. If the patient applied the topical, document that assistance was offered and refused, along with what type of UV light was used and the dosage. Inclusion of these elements in the medical record provides a clear picture of the delivery of the phototherapy service and will aid in responding to medical record audit.

Final Thoughts

Phototherapy is a critical treatment modality that continues to be utilized frequently in the expanding armamentarium of treatments for dermatoses. Phototherapy is performed almost exclusively by dermatologists and allows dermatologists to offer a unique level of care and value in the treatment of skin disease. Careful documentation, a written standard operating procedure, and adherence to proper performance standards will allow dermatologists to be compensated fairly for this important treatment modality and pass audits that are likely to occur.

In this era of biologics for psoriasis with ever-increasing effectiveness and safety as well as patients who have less and less time to visit the physician's office, it would seem that the days of in-office UV treatments would be numbered. However, rumors of the demise of phototherapy may be greatly exaggerated. Phototherapy is still one of the safest and most cost-effective treatments for psoriasis and other dermatoses.1 Its use often is a prerequisite for biologic therapy, and it may be the only therapeutic option for certain subsets of patients, such as children, pregnant women, and immunosuppressed patients. Moreover, narrowband UVB technology has breathed new life into phototherapy, with better efficacy and less long-term risk. Although the utilization of psoralen plus UVA (PUVA) light therapy has indeed decreased over the last 2 decades, the use of UVB therapies continues to increase dramatically.²

Phototherapy Codes

There are 4 chief Current Procedural Terminology (CPT) codes for reporting phototherapy services: (1) 96900: actinotherapy (UV light treatment); (2) 96910: photochemotherapy, tar, and UVB (Goeckerman treatment) or petrolatum and UVB; (3) 96912: photochemotherapy and PUVA; and (4) 96913: photochemotherapy (Goeckerman and/or PUVA) for severe photoresponsive dermatoses requiring at least 4 to 8 hours of care under direct supervision of the physician.³

There is lack of specificity of the CPT code descriptions for phototherapy. Moreover, insurer guidance for documentation for phototherapy is vague to nonexistent, and of course whenever the use of any medical service increases, insurer scrutiny is sure to follow. Therefore, it is not surprising that dermatology practices have reported that private insurers as well as Medicare are auditing medical records for phototherapy treatments.⁴ In fact, recently we have seen a Midwest private insurer demand payment from dermatologists for hundreds of 96910 phototherapy services, which the insurer asserted should have been coded as 96900 because topical therapies were not applied by the dermatology staff. The insurer did not just evaluate medical records but also contacted patients directly and asked how services had been provided. Clearly, more detailed guidance for dermatologists and insurers on documentation and performance standards for each phototherapy service is needed.

Existing coding guidance for phototherapy indicates that actinotherapy (96900) defines the basic service of treating a patient with a UV light unit.⁵ Actinotherapy does not involve application of topical medications while the patient is in the office.

In contrast, photochemotherapy (96910) implies addition of a chemo agent to phototherapy. Despite the somewhat nonspecific nature of the code descriptor, it is apparent that application of photoenhancing agents such as tar, petrolatum, or distillates of petrolatum meet the requirements of 96910. The Coder's Desk Reference for Procedures 2017 describes 96910 as "the physician uses photosensitizing chemicals and light rays to treat skin ailments."⁶ Application of light-enhancing topical products should occur within the office by either staff or the patient. In fact, examination of practice expense data from the Centers for Medicare & Medicaid Services indicated that the 96910 code includes payment for clinical staff time to apply topical products as well as the cost of the topical agent(s).⁷ 

The PUVA code 96912 is defined by the use of photosensitizing psoralen medication, which can be administered topically or orally, followed by UVA treatment. In my experience, PUVA has similar performance standards with in-office application of psoralen, if applicable. If application of topical photoenhancing products occurs outside the office, the requirements of photochemotherapy are not met, and 96900 should be reported. 

The 96913 code defines prolonged phototherapy service with intensive topical therapy requirements and multiple phototherapy sessions per day.³ This code is rarely reported (average of fewer than 100 times in the Medicare population per year), and most insurers do not reimburse this service. 

Protecting Yourself From an Audit

In my experience, review of private insurer audits of phototherapy services has yielded important lessons. First, having a written standard operating procedure in place regarding the performance of phototherapy services and how application of topicals will be handled has been helpful in audit defense. The other key to beating audits for phototherapy services is to have detailed documentation or a flowchart in the medical record regarding the topical agent and the light administration. The medical record should include what topical agent was applied, if any; whether the topical agent was applied in the office; where the topical product was applied; and who applied the topical product. Sometimes topical product application by a physician or staff is not feasible because of patient preference or the site of application. If the patient applied the topical, document that assistance was offered and refused, along with what type of UV light was used and the dosage. Inclusion of these elements in the medical record provides a clear picture of the delivery of the phototherapy service and will aid in responding to medical record audit.

Final Thoughts

Phototherapy is a critical treatment modality that continues to be utilized frequently in the expanding armamentarium of treatments for dermatoses. Phototherapy is performed almost exclusively by dermatologists and allows dermatologists to offer a unique level of care and value in the treatment of skin disease. Careful documentation, a written standard operating procedure, and adherence to proper performance standards will allow dermatologists to be compensated fairly for this important treatment modality and pass audits that are likely to occur.

Despite widespread availability of the human papillomavirus vaccine over the last 11 years, vaccination rates continue to lag behind national targets and are far behind other vaccines routinely administered in adolescence, such as the meningococcal and tetanus vaccines.

Better collaboration among pediatricians and obstetrician-gynecologists to promote the HPV vaccine may be one answer to turning the tide, said David W. Kimberlin, MD, codirector of the division of pediatric infectious diseases at the University of Alabama at Birmingham and president of the Pediatric Infectious Diseases Society.

Courtesy Steve Wood/University of Alabama, Birmingham

5 steps to increase HPV vaccination

Melissa Kottke, MD, director of the Jane Fonda Center for Adolescent Reproductive Health at Emory University offered her practice steps for increased HPV vaccination rates.

1. Be clear about your recommendation. For example, “I recommend the HPV vaccine. It can help prevent cancer.”

*This story was updated 8/22/2017.
 

agallegos@frontlinemedcom.com

On Twitter @legal_med

Despite widespread availability of the human papillomavirus vaccine over the last 11 years, vaccination rates continue to lag behind national targets and are far behind other vaccines routinely administered in adolescence, such as the meningococcal and tetanus vaccines.

Better collaboration among pediatricians and obstetrician-gynecologists to promote the HPV vaccine may be one answer to turning the tide, said David W. Kimberlin, MD, codirector of the division of pediatric infectious diseases at the University of Alabama at Birmingham and president of the Pediatric Infectious Diseases Society.

Courtesy Steve Wood/University of Alabama, Birmingham

5 steps to increase HPV vaccination

Melissa Kottke, MD, director of the Jane Fonda Center for Adolescent Reproductive Health at Emory University offered her practice steps for increased HPV vaccination rates.

1. Be clear about your recommendation. For example, “I recommend the HPV vaccine. It can help prevent cancer.”

*This story was updated 8/22/2017.
 

agallegos@frontlinemedcom.com

On Twitter @legal_med

Despite widespread availability of the human papillomavirus vaccine over the last 11 years, vaccination rates continue to lag behind national targets and are far behind other vaccines routinely administered in adolescence, such as the meningococcal and tetanus vaccines.

Better collaboration among pediatricians and obstetrician-gynecologists to promote the HPV vaccine may be one answer to turning the tide, said David W. Kimberlin, MD, codirector of the division of pediatric infectious diseases at the University of Alabama at Birmingham and president of the Pediatric Infectious Diseases Society.

Courtesy Steve Wood/University of Alabama, Birmingham

5 steps to increase HPV vaccination

Melissa Kottke, MD, director of the Jane Fonda Center for Adolescent Reproductive Health at Emory University offered her practice steps for increased HPV vaccination rates.

1. Be clear about your recommendation. For example, “I recommend the HPV vaccine. It can help prevent cancer.”

*This story was updated 8/22/2017.
 

agallegos@frontlinemedcom.com

On Twitter @legal_med

MADRID – Infants with perinatal HIV infection are significantly more likely to achieve viral suppression by age 12 months if they start antiretroviral therapy (ART) before age 3 months than if physicians wait until 3-6 months of age, Paolo Palma, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

He presented a study of the factors associated with time to virologic sup

xrender/thinkstockphotos.com

Dr. Palma reported having no relevant financial disclosures.

bjancin@frontlinemedcom.com

MADRID – Infants with perinatal HIV infection are significantly more likely to achieve viral suppression by age 12 months if they start antiretroviral therapy (ART) before age 3 months than if physicians wait until 3-6 months of age, Paolo Palma, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

He presented a study of the factors associated with time to virologic sup

xrender/thinkstockphotos.com

Dr. Palma reported having no relevant financial disclosures.

bjancin@frontlinemedcom.com

MADRID – Infants with perinatal HIV infection are significantly more likely to achieve viral suppression by age 12 months if they start antiretroviral therapy (ART) before age 3 months than if physicians wait until 3-6 months of age, Paolo Palma, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

He presented a study of the factors associated with time to virologic sup

xrender/thinkstockphotos.com

Dr. Palma reported having no relevant financial disclosures.

bjancin@frontlinemedcom.com

Rosacea is a chronic inflammatory skin disease characterized by central facial erythema with or without intermittent papules and pustules (described as the inflammatory lesions of rosacea). Although twice-daily clindamycin 1% solution or gel has been used in the treatment of acne, few studies have investigated the use of clindamycin in rosacea.^1,2 In one study comparing twice-daily clindamycin lotion 1% with oral tetracycline in 43 rosacea patients, clindamycin was found to be superior in the eradication of pustules.³ A combination therapy of clindamycin 1% and benzoyl peroxide 5% was found to be more effective than the vehicle in inflammatory lesions and erythema of rosacea in a 12-week randomized controlled trial; however, a definitive advantage over US Food and Drug Administration-approved topical agents used to treat papulopustular rosacea was not established.^4,5 Two further studies evaluated clindamycin phosphate 1.2%-tretinoin 0.025% combination gel in the treatment of rosacea, but only 1 showed any effect on papulopustular lesions.^6-8 The objective of the studies reported here was to evaluate the efficacy and safety of clindamycin in the treatment of patients with moderate to severe rosacea.

Methods

Study Design

Two multicenter (study A, 20 centers; study B, 10 centers), randomized, investigator-blinded, vehicle-controlled studies were conducted in the United States between 1999 and 2002 in accordance with the Declaration of Helsinki, International Conference on Harmonisation Good Clinical Practice guidelines, and local regulatory requirements. The studies were reviewed and approved by the respective institutional review boards, and all participants provided written informed consent.

In study A, moderate to severe rosacea patients with erythema, telangiectasia, and at least 8 inflammatory lesions were randomized to receive clindamycin cream 1% or vehicle cream once (in the evening) or twice daily (in the morning and evening) or clindamycin cream 0.3% once daily (in the evening) for 12 weeks (1:1:1:1:1 ratio). All study treatments were supplied in identical tubes with blinded labels.

In study B, patients with moderate to severe rosacea and at least 8 inflammatory lesions were randomized in a 1:1 ratio with instructions to apply clindamycin gel 1% or vehicle gel to the affected areas twice daily (morning and evening) for 12 weeks.

Efficacy Evaluation

Evaluations were performed at baseline and weeks 2, 4, 8, and 12 on the intention-to-treat population with the last observation carried forward.

Efficacy assessments in both studies included inflammatory lesion counts (papules and pustules) of 5 facial regions--forehead, chin, nose, right cheek, left cheek--counted separately and then combined to give the total inflammatory lesion count (both studies), as well as improvement in the investigator global rosacea severity score (0=none/clear; 1=mild, detectable erythema with ≤7 papules/pustules; 2=moderate, prominent erythema with ≥8 papules/pustules; 3=severe, intense erythema with ≥10 to <50 papules/pustules; 3.5 [study A] or 4 [study B]=very severe, intense erythema with >50 papules/pustules). In study B, the proportion of participants dichotomized to success (a score of 0 [none/clear] or 1 [mild/almost clear]) or failure (a score of ≥2) on the 5-point investigator global rosacea severity scale at week 12 was evaluated. In study A, investigator global improvement assessment at week 12, based on photographs taken at baseline, was graded on a 7-point scale (from -1 [worse], 0 [no change], and 1 [minimal improvement] to 5 [clear]). In both studies, erythema severity was graded on a 7-point scale in increments of 0.5 (from 0=no erythema to 3.5=very severe redness, very intense redness). Skin irritation also was graded as none, mild, moderate, or severe. 

Safety Evaluation

Safety was assessed by the incidence of adverse events (AEs).

Statistical Analysis

Studies were powered assuming 60% reduction in inflammatory lesion counts with active and 40% with vehicle, based on historical data from a prior study with metronidazole cream 0.75% versus vehicle; 64 participants were required in each treatment group to detect this effect using a 2-sided t test (&#945;=.017). Pairwise comparisons (clindamycin vs respective vehicle) were performed using the Cochran-Mantel-Haenszel test for combined lesion count percentage change.

Results

Participant Disposition and Baseline Characteristics

Overall, a total of 629 participants were randomized across both studies. In study A, a total of 416 participants were randomized into 5 treatment arms, with 369 participants (88.7%) completing the study; 47 (11.3%) participants discontinued study A, mainly due to participant request (19/47 [40.4%]) or lost to follow-up (11/47 [23.4%]). In study B, a total of 213 participants were randomized to receive either clindamycin gel 1% (n=109 [51.2%]) twice daily or vehicle gel (n=104 [48.8%]) twice daily, with 193 participants (90.6%) completing the study; 20 (9.4%) participants discontinued study B, mainly due to participant request (6/20 [30%]) or lost to follow-up (4/20 [20%]). Participants in studies A and B were similar in demographics and baseline disease characteristics (Table). The majority of participants were white females. 

Efficacy

No statistically significant difference was observed in all pairwise comparisons (clindamycin cream twice daily vs vehicle twice daily, clindamycin cream once daily vs vehicle once daily, clindamycin gel vs vehicle gel) for the primary end point of mean percentage change from baseline in inflammatory lesion counts at week 12 (Figure 1; P>.5 for all pairwise comparisons). 

At week 12, the proportion of participants in study B deemed as a success (none/clear or mild/almost clear [investigator global rosacea severity score of 0 or 1]) in the clindamycin gel 1% and vehicle gel groups were 45% versus 38%, respectively (P=.347) (Figure 2). 

For the secondary end point of mean investigator global rosacea severity assessment at week 12 (study A), there were no significant differences between the active and vehicle control groups (P>.5 for all pairwise comparisons)(Figure 3). Also, the proportion of participants with at least a moderate investigator global improvement assessment from baseline to week 12 ranged from 45% for clindamycin cream 1% twice daily to 56% for clindamycin cream 0.3% cream once daily and from 45% for vehicle cream once daily to 51% for vehicle cream twice daily (P>.5 for all pairwise comparisons).

There were no significant differences in the mean total erythema severity scores at week 12 for clindamycin cream 1% twice daily versus vehicle cream twice daily (6.3 vs 6.0; P>.5), clindamycin cream 1% once daily versus vehicle cream once daily (6.2 vs 6.0; P>.5), clindamycin cream 0.3% once daily versus vehicle cream once daily (5.9 vs 6.0; P>.5), and clindamycin gel 1% twice daily versus vehicle gel twice daily (6.7 vs 6.2; P>.5). 

There were no relevant differences between any of the clindamycin cream groups and their respective vehicle group at week 12 for skin irritation, including desquamation, edema, dryness, pruritus, and stinging/burning.

Safety

In study A, the majority of AEs in all 5 treatment arms were nondermatologic, mild in intensity, and not considered to be related to the study treatment by the investigator. Overall, 12 participants had AEs considered by the investigator as possibly or probably related to the study treatment: 4.9% in the clindamycin cream 1% twice daily group, 4.6% in the clindamycin cream 1% once daily group, 3.7% in the vehicle cream twice daily group, 1.2% in the clindamycin cream 0.3% once daily group, and 0% in the vehicle cream once daily group. Two treatment-related AEs led to treatment discontinuation, including dermatitis in 1 participant from the clindamycin cream 1% once daily group and contact dermatitis in 1 participant from the clindamycin cream 1% twice daily group.

Comment

No evidence of increased efficacy over the respective vehicles was observed with clindamycin cream or gel, whatever the regimen, in the treatment of rosacea patients in either of these well-designed and well-powered, blinded studies. Slight improvements in the various efficacy criteria were observed, even in the vehicle groups, highlighting the importance of using a good basic skin care regimen in the management of rosacea.⁹ In contrast to our observations of lack of efficacy in the treatment of rosacea, clinical efficacy of clindamycin has been demonstrated in acne,^10-12 albeit with low efficacy for clindamycin monotherapy.¹³ It is noteworthy that oral or topical antibiotics are no longer recommended as monotherapy for acne to prevent and minimize antibiotic resistance and to preserve the therapeutic value of antibiotics.¹⁴

Acne and rosacea are both chronic inflammatory disorders of the skin associated with papules and pustules, and they share some common inflammatory patterns.^15-19 Furthermore, the intrinsic anti-inflammatory activity of clindamycin in addition to its antibiotic effects has been suggested by some authors as the main reason for treating acne with clindamycin.²⁰ However, the relative contributions of antibacterial and/or anti-inflammatory properties remain to be fully elucidated, and evidence for direct anti-inflammatory effects of clindamycin remains heterogeneous.^21,22 Several pathophysiological factors have been implicated in acne, including hormonal effects, abnormal keratinocyte function, increased sebum production, and microbial components (eg, hypercolonization of the skin follicles by Propionibacterium acnes).^23,24 The antibiotic activity of clindamycin against P acnes may be the key factor responsible for the clinical effects in acne.^25,26 Although clindamycin may have anti-inflammatory effects in acne via a different inflammatory pathway not shared by rosacea, a purely antibiotic mechanism of action of clindamycin also could explain why we observed no evidence of efficacy in the treatment of rosacea, as no causative bacterial component has been clearly demonstrated in rosacea.²⁷

Conclusion

In these studies, clindamycin cream 0.3% once daily, clindamycin cream 1% once or twice daily, and clindamycin gel 1% twice daily were all well tolerated; however, they were no more effective than the vehicles in the treatment of moderate to severe rosacea.  

Acknowledgment

The authors would like to thank Helen Simpson, PhD, of Galderma R&D (Sophia Antipolis, France), for editorial and medical writing assistance.

Rosacea is a chronic inflammatory skin disease characterized by central facial erythema with or without intermittent papules and pustules (described as the inflammatory lesions of rosacea). Although twice-daily clindamycin 1% solution or gel has been used in the treatment of acne, few studies have investigated the use of clindamycin in rosacea.^1,2 In one study comparing twice-daily clindamycin lotion 1% with oral tetracycline in 43 rosacea patients, clindamycin was found to be superior in the eradication of pustules.³ A combination therapy of clindamycin 1% and benzoyl peroxide 5% was found to be more effective than the vehicle in inflammatory lesions and erythema of rosacea in a 12-week randomized controlled trial; however, a definitive advantage over US Food and Drug Administration-approved topical agents used to treat papulopustular rosacea was not established.^4,5 Two further studies evaluated clindamycin phosphate 1.2%-tretinoin 0.025% combination gel in the treatment of rosacea, but only 1 showed any effect on papulopustular lesions.^6-8 The objective of the studies reported here was to evaluate the efficacy and safety of clindamycin in the treatment of patients with moderate to severe rosacea.

Methods

Study Design

Two multicenter (study A, 20 centers; study B, 10 centers), randomized, investigator-blinded, vehicle-controlled studies were conducted in the United States between 1999 and 2002 in accordance with the Declaration of Helsinki, International Conference on Harmonisation Good Clinical Practice guidelines, and local regulatory requirements. The studies were reviewed and approved by the respective institutional review boards, and all participants provided written informed consent.

In study A, moderate to severe rosacea patients with erythema, telangiectasia, and at least 8 inflammatory lesions were randomized to receive clindamycin cream 1% or vehicle cream once (in the evening) or twice daily (in the morning and evening) or clindamycin cream 0.3% once daily (in the evening) for 12 weeks (1:1:1:1:1 ratio). All study treatments were supplied in identical tubes with blinded labels.

In study B, patients with moderate to severe rosacea and at least 8 inflammatory lesions were randomized in a 1:1 ratio with instructions to apply clindamycin gel 1% or vehicle gel to the affected areas twice daily (morning and evening) for 12 weeks.

Efficacy Evaluation

Evaluations were performed at baseline and weeks 2, 4, 8, and 12 on the intention-to-treat population with the last observation carried forward.

Efficacy assessments in both studies included inflammatory lesion counts (papules and pustules) of 5 facial regions--forehead, chin, nose, right cheek, left cheek--counted separately and then combined to give the total inflammatory lesion count (both studies), as well as improvement in the investigator global rosacea severity score (0=none/clear; 1=mild, detectable erythema with ≤7 papules/pustules; 2=moderate, prominent erythema with ≥8 papules/pustules; 3=severe, intense erythema with ≥10 to <50 papules/pustules; 3.5 [study A] or 4 [study B]=very severe, intense erythema with >50 papules/pustules). In study B, the proportion of participants dichotomized to success (a score of 0 [none/clear] or 1 [mild/almost clear]) or failure (a score of ≥2) on the 5-point investigator global rosacea severity scale at week 12 was evaluated. In study A, investigator global improvement assessment at week 12, based on photographs taken at baseline, was graded on a 7-point scale (from -1 [worse], 0 [no change], and 1 [minimal improvement] to 5 [clear]). In both studies, erythema severity was graded on a 7-point scale in increments of 0.5 (from 0=no erythema to 3.5=very severe redness, very intense redness). Skin irritation also was graded as none, mild, moderate, or severe. 

Safety Evaluation

Safety was assessed by the incidence of adverse events (AEs).

Statistical Analysis

Studies were powered assuming 60% reduction in inflammatory lesion counts with active and 40% with vehicle, based on historical data from a prior study with metronidazole cream 0.75% versus vehicle; 64 participants were required in each treatment group to detect this effect using a 2-sided t test (&#945;=.017). Pairwise comparisons (clindamycin vs respective vehicle) were performed using the Cochran-Mantel-Haenszel test for combined lesion count percentage change.

Results

Participant Disposition and Baseline Characteristics

Overall, a total of 629 participants were randomized across both studies. In study A, a total of 416 participants were randomized into 5 treatment arms, with 369 participants (88.7%) completing the study; 47 (11.3%) participants discontinued study A, mainly due to participant request (19/47 [40.4%]) or lost to follow-up (11/47 [23.4%]). In study B, a total of 213 participants were randomized to receive either clindamycin gel 1% (n=109 [51.2%]) twice daily or vehicle gel (n=104 [48.8%]) twice daily, with 193 participants (90.6%) completing the study; 20 (9.4%) participants discontinued study B, mainly due to participant request (6/20 [30%]) or lost to follow-up (4/20 [20%]). Participants in studies A and B were similar in demographics and baseline disease characteristics (Table). The majority of participants were white females. 

Efficacy

No statistically significant difference was observed in all pairwise comparisons (clindamycin cream twice daily vs vehicle twice daily, clindamycin cream once daily vs vehicle once daily, clindamycin gel vs vehicle gel) for the primary end point of mean percentage change from baseline in inflammatory lesion counts at week 12 (Figure 1; P>.5 for all pairwise comparisons). 

At week 12, the proportion of participants in study B deemed as a success (none/clear or mild/almost clear [investigator global rosacea severity score of 0 or 1]) in the clindamycin gel 1% and vehicle gel groups were 45% versus 38%, respectively (P=.347) (Figure 2). 

For the secondary end point of mean investigator global rosacea severity assessment at week 12 (study A), there were no significant differences between the active and vehicle control groups (P>.5 for all pairwise comparisons)(Figure 3). Also, the proportion of participants with at least a moderate investigator global improvement assessment from baseline to week 12 ranged from 45% for clindamycin cream 1% twice daily to 56% for clindamycin cream 0.3% cream once daily and from 45% for vehicle cream once daily to 51% for vehicle cream twice daily (P>.5 for all pairwise comparisons).

There were no significant differences in the mean total erythema severity scores at week 12 for clindamycin cream 1% twice daily versus vehicle cream twice daily (6.3 vs 6.0; P>.5), clindamycin cream 1% once daily versus vehicle cream once daily (6.2 vs 6.0; P>.5), clindamycin cream 0.3% once daily versus vehicle cream once daily (5.9 vs 6.0; P>.5), and clindamycin gel 1% twice daily versus vehicle gel twice daily (6.7 vs 6.2; P>.5). 

There were no relevant differences between any of the clindamycin cream groups and their respective vehicle group at week 12 for skin irritation, including desquamation, edema, dryness, pruritus, and stinging/burning.

Safety

In study A, the majority of AEs in all 5 treatment arms were nondermatologic, mild in intensity, and not considered to be related to the study treatment by the investigator. Overall, 12 participants had AEs considered by the investigator as possibly or probably related to the study treatment: 4.9% in the clindamycin cream 1% twice daily group, 4.6% in the clindamycin cream 1% once daily group, 3.7% in the vehicle cream twice daily group, 1.2% in the clindamycin cream 0.3% once daily group, and 0% in the vehicle cream once daily group. Two treatment-related AEs led to treatment discontinuation, including dermatitis in 1 participant from the clindamycin cream 1% once daily group and contact dermatitis in 1 participant from the clindamycin cream 1% twice daily group.

Comment

No evidence of increased efficacy over the respective vehicles was observed with clindamycin cream or gel, whatever the regimen, in the treatment of rosacea patients in either of these well-designed and well-powered, blinded studies. Slight improvements in the various efficacy criteria were observed, even in the vehicle groups, highlighting the importance of using a good basic skin care regimen in the management of rosacea.⁹ In contrast to our observations of lack of efficacy in the treatment of rosacea, clinical efficacy of clindamycin has been demonstrated in acne,^10-12 albeit with low efficacy for clindamycin monotherapy.¹³ It is noteworthy that oral or topical antibiotics are no longer recommended as monotherapy for acne to prevent and minimize antibiotic resistance and to preserve the therapeutic value of antibiotics.¹⁴

Acne and rosacea are both chronic inflammatory disorders of the skin associated with papules and pustules, and they share some common inflammatory patterns.^15-19 Furthermore, the intrinsic anti-inflammatory activity of clindamycin in addition to its antibiotic effects has been suggested by some authors as the main reason for treating acne with clindamycin.²⁰ However, the relative contributions of antibacterial and/or anti-inflammatory properties remain to be fully elucidated, and evidence for direct anti-inflammatory effects of clindamycin remains heterogeneous.^21,22 Several pathophysiological factors have been implicated in acne, including hormonal effects, abnormal keratinocyte function, increased sebum production, and microbial components (eg, hypercolonization of the skin follicles by Propionibacterium acnes).^23,24 The antibiotic activity of clindamycin against P acnes may be the key factor responsible for the clinical effects in acne.^25,26 Although clindamycin may have anti-inflammatory effects in acne via a different inflammatory pathway not shared by rosacea, a purely antibiotic mechanism of action of clindamycin also could explain why we observed no evidence of efficacy in the treatment of rosacea, as no causative bacterial component has been clearly demonstrated in rosacea.²⁷

Conclusion

In these studies, clindamycin cream 0.3% once daily, clindamycin cream 1% once or twice daily, and clindamycin gel 1% twice daily were all well tolerated; however, they were no more effective than the vehicles in the treatment of moderate to severe rosacea.  

Acknowledgment

The authors would like to thank Helen Simpson, PhD, of Galderma R&D (Sophia Antipolis, France), for editorial and medical writing assistance.

Rosacea is a chronic inflammatory skin disease characterized by central facial erythema with or without intermittent papules and pustules (described as the inflammatory lesions of rosacea). Although twice-daily clindamycin 1% solution or gel has been used in the treatment of acne, few studies have investigated the use of clindamycin in rosacea.^1,2 In one study comparing twice-daily clindamycin lotion 1% with oral tetracycline in 43 rosacea patients, clindamycin was found to be superior in the eradication of pustules.³ A combination therapy of clindamycin 1% and benzoyl peroxide 5% was found to be more effective than the vehicle in inflammatory lesions and erythema of rosacea in a 12-week randomized controlled trial; however, a definitive advantage over US Food and Drug Administration-approved topical agents used to treat papulopustular rosacea was not established.^4,5 Two further studies evaluated clindamycin phosphate 1.2%-tretinoin 0.025% combination gel in the treatment of rosacea, but only 1 showed any effect on papulopustular lesions.^6-8 The objective of the studies reported here was to evaluate the efficacy and safety of clindamycin in the treatment of patients with moderate to severe rosacea.

Methods

Study Design

Two multicenter (study A, 20 centers; study B, 10 centers), randomized, investigator-blinded, vehicle-controlled studies were conducted in the United States between 1999 and 2002 in accordance with the Declaration of Helsinki, International Conference on Harmonisation Good Clinical Practice guidelines, and local regulatory requirements. The studies were reviewed and approved by the respective institutional review boards, and all participants provided written informed consent.

In study A, moderate to severe rosacea patients with erythema, telangiectasia, and at least 8 inflammatory lesions were randomized to receive clindamycin cream 1% or vehicle cream once (in the evening) or twice daily (in the morning and evening) or clindamycin cream 0.3% once daily (in the evening) for 12 weeks (1:1:1:1:1 ratio). All study treatments were supplied in identical tubes with blinded labels.

In study B, patients with moderate to severe rosacea and at least 8 inflammatory lesions were randomized in a 1:1 ratio with instructions to apply clindamycin gel 1% or vehicle gel to the affected areas twice daily (morning and evening) for 12 weeks.

Efficacy Evaluation

Evaluations were performed at baseline and weeks 2, 4, 8, and 12 on the intention-to-treat population with the last observation carried forward.

Efficacy assessments in both studies included inflammatory lesion counts (papules and pustules) of 5 facial regions--forehead, chin, nose, right cheek, left cheek--counted separately and then combined to give the total inflammatory lesion count (both studies), as well as improvement in the investigator global rosacea severity score (0=none/clear; 1=mild, detectable erythema with ≤7 papules/pustules; 2=moderate, prominent erythema with ≥8 papules/pustules; 3=severe, intense erythema with ≥10 to <50 papules/pustules; 3.5 [study A] or 4 [study B]=very severe, intense erythema with >50 papules/pustules). In study B, the proportion of participants dichotomized to success (a score of 0 [none/clear] or 1 [mild/almost clear]) or failure (a score of ≥2) on the 5-point investigator global rosacea severity scale at week 12 was evaluated. In study A, investigator global improvement assessment at week 12, based on photographs taken at baseline, was graded on a 7-point scale (from -1 [worse], 0 [no change], and 1 [minimal improvement] to 5 [clear]). In both studies, erythema severity was graded on a 7-point scale in increments of 0.5 (from 0=no erythema to 3.5=very severe redness, very intense redness). Skin irritation also was graded as none, mild, moderate, or severe. 

Safety Evaluation

Safety was assessed by the incidence of adverse events (AEs).

Statistical Analysis

Studies were powered assuming 60% reduction in inflammatory lesion counts with active and 40% with vehicle, based on historical data from a prior study with metronidazole cream 0.75% versus vehicle; 64 participants were required in each treatment group to detect this effect using a 2-sided t test (&#945;=.017). Pairwise comparisons (clindamycin vs respective vehicle) were performed using the Cochran-Mantel-Haenszel test for combined lesion count percentage change.

Results

Participant Disposition and Baseline Characteristics

Overall, a total of 629 participants were randomized across both studies. In study A, a total of 416 participants were randomized into 5 treatment arms, with 369 participants (88.7%) completing the study; 47 (11.3%) participants discontinued study A, mainly due to participant request (19/47 [40.4%]) or lost to follow-up (11/47 [23.4%]). In study B, a total of 213 participants were randomized to receive either clindamycin gel 1% (n=109 [51.2%]) twice daily or vehicle gel (n=104 [48.8%]) twice daily, with 193 participants (90.6%) completing the study; 20 (9.4%) participants discontinued study B, mainly due to participant request (6/20 [30%]) or lost to follow-up (4/20 [20%]). Participants in studies A and B were similar in demographics and baseline disease characteristics (Table). The majority of participants were white females. 

Efficacy

No statistically significant difference was observed in all pairwise comparisons (clindamycin cream twice daily vs vehicle twice daily, clindamycin cream once daily vs vehicle once daily, clindamycin gel vs vehicle gel) for the primary end point of mean percentage change from baseline in inflammatory lesion counts at week 12 (Figure 1; P>.5 for all pairwise comparisons). 

At week 12, the proportion of participants in study B deemed as a success (none/clear or mild/almost clear [investigator global rosacea severity score of 0 or 1]) in the clindamycin gel 1% and vehicle gel groups were 45% versus 38%, respectively (P=.347) (Figure 2). 

For the secondary end point of mean investigator global rosacea severity assessment at week 12 (study A), there were no significant differences between the active and vehicle control groups (P>.5 for all pairwise comparisons)(Figure 3). Also, the proportion of participants with at least a moderate investigator global improvement assessment from baseline to week 12 ranged from 45% for clindamycin cream 1% twice daily to 56% for clindamycin cream 0.3% cream once daily and from 45% for vehicle cream once daily to 51% for vehicle cream twice daily (P>.5 for all pairwise comparisons).

There were no significant differences in the mean total erythema severity scores at week 12 for clindamycin cream 1% twice daily versus vehicle cream twice daily (6.3 vs 6.0; P>.5), clindamycin cream 1% once daily versus vehicle cream once daily (6.2 vs 6.0; P>.5), clindamycin cream 0.3% once daily versus vehicle cream once daily (5.9 vs 6.0; P>.5), and clindamycin gel 1% twice daily versus vehicle gel twice daily (6.7 vs 6.2; P>.5). 

There were no relevant differences between any of the clindamycin cream groups and their respective vehicle group at week 12 for skin irritation, including desquamation, edema, dryness, pruritus, and stinging/burning.

Safety

In study A, the majority of AEs in all 5 treatment arms were nondermatologic, mild in intensity, and not considered to be related to the study treatment by the investigator. Overall, 12 participants had AEs considered by the investigator as possibly or probably related to the study treatment: 4.9% in the clindamycin cream 1% twice daily group, 4.6% in the clindamycin cream 1% once daily group, 3.7% in the vehicle cream twice daily group, 1.2% in the clindamycin cream 0.3% once daily group, and 0% in the vehicle cream once daily group. Two treatment-related AEs led to treatment discontinuation, including dermatitis in 1 participant from the clindamycin cream 1% once daily group and contact dermatitis in 1 participant from the clindamycin cream 1% twice daily group.

Comment

No evidence of increased efficacy over the respective vehicles was observed with clindamycin cream or gel, whatever the regimen, in the treatment of rosacea patients in either of these well-designed and well-powered, blinded studies. Slight improvements in the various efficacy criteria were observed, even in the vehicle groups, highlighting the importance of using a good basic skin care regimen in the management of rosacea.⁹ In contrast to our observations of lack of efficacy in the treatment of rosacea, clinical efficacy of clindamycin has been demonstrated in acne,^10-12 albeit with low efficacy for clindamycin monotherapy.¹³ It is noteworthy that oral or topical antibiotics are no longer recommended as monotherapy for acne to prevent and minimize antibiotic resistance and to preserve the therapeutic value of antibiotics.¹⁴

Acne and rosacea are both chronic inflammatory disorders of the skin associated with papules and pustules, and they share some common inflammatory patterns.^15-19 Furthermore, the intrinsic anti-inflammatory activity of clindamycin in addition to its antibiotic effects has been suggested by some authors as the main reason for treating acne with clindamycin.²⁰ However, the relative contributions of antibacterial and/or anti-inflammatory properties remain to be fully elucidated, and evidence for direct anti-inflammatory effects of clindamycin remains heterogeneous.^21,22 Several pathophysiological factors have been implicated in acne, including hormonal effects, abnormal keratinocyte function, increased sebum production, and microbial components (eg, hypercolonization of the skin follicles by Propionibacterium acnes).^23,24 The antibiotic activity of clindamycin against P acnes may be the key factor responsible for the clinical effects in acne.^25,26 Although clindamycin may have anti-inflammatory effects in acne via a different inflammatory pathway not shared by rosacea, a purely antibiotic mechanism of action of clindamycin also could explain why we observed no evidence of efficacy in the treatment of rosacea, as no causative bacterial component has been clearly demonstrated in rosacea.²⁷

Conclusion

In these studies, clindamycin cream 0.3% once daily, clindamycin cream 1% once or twice daily, and clindamycin gel 1% twice daily were all well tolerated; however, they were no more effective than the vehicles in the treatment of moderate to severe rosacea.  

Acknowledgment

The authors would like to thank Helen Simpson, PhD, of Galderma R&D (Sophia Antipolis, France), for editorial and medical writing assistance.

The overall prevalence of diabetes increased 35% from 1988-1994 to 2011-2014 among adults aged 20 years and over, according the National Center for Health Statistics.

During 2011-2014, the age-adjusted prevalence of diabetes was 11.9% in adults aged 20 years and over, compared with 8.8% in 1988-1994. That 35% increase came despite a decrease in undiagnosed diabetes from 3.6% to 2.9% over that time period, which was not enough to offset a jump in physician-diagnosed disease from 5.2% to 9%, the NCHS reported in “Health, United States, 2016.”

rfranki@frontlinemedcom.com

The overall prevalence of diabetes increased 35% from 1988-1994 to 2011-2014 among adults aged 20 years and over, according the National Center for Health Statistics.

During 2011-2014, the age-adjusted prevalence of diabetes was 11.9% in adults aged 20 years and over, compared with 8.8% in 1988-1994. That 35% increase came despite a decrease in undiagnosed diabetes from 3.6% to 2.9% over that time period, which was not enough to offset a jump in physician-diagnosed disease from 5.2% to 9%, the NCHS reported in “Health, United States, 2016.”

rfranki@frontlinemedcom.com

The overall prevalence of diabetes increased 35% from 1988-1994 to 2011-2014 among adults aged 20 years and over, according the National Center for Health Statistics.

During 2011-2014, the age-adjusted prevalence of diabetes was 11.9% in adults aged 20 years and over, compared with 8.8% in 1988-1994. That 35% increase came despite a decrease in undiagnosed diabetes from 3.6% to 2.9% over that time period, which was not enough to offset a jump in physician-diagnosed disease from 5.2% to 9%, the NCHS reported in “Health, United States, 2016.”

rfranki@frontlinemedcom.com

To improve patient care and outcomes, leading dermatologists offered their recommendations on redness-reducing products. Consideration must be given to:

• Avène Antirougeurs FORT Relief Concentrate
  Pierre Fabre Dermo-Cosmetique USA
  “This formula has medical-grade ruscus extract to support microcirculation and soothe skin reactivity and redness, as well as soothing Avène Thermal Spring Water.” — Jeannette Graf, MD, New York, New York
   
• Eucerin Redness Relief
  Beiersdorf Inc
  “Eucerin’s Redness Relief product line has worked well for some of my patients.” — Gary Goldenberg, MD, New York, New York
   
• Redness Solutions Daily Protective Base Broad Spectrum SPF 15
  Clinique Laboratories, LLC
  “This oil-free makeup primer has a sheer green tint that camouflages redness while also protecting from UV rays.” — Shari Lipner, MD, PhD, New York, New York

Cutis invites readers to send us their recommendations. Athlete’s foot treatments, cleansing devices, and men’s products will be featured in upcoming editions of Cosmetic Corner. Please email your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on redness-reducing products. Consideration must be given to:

• Avène Antirougeurs FORT Relief Concentrate
  Pierre Fabre Dermo-Cosmetique USA
  “This formula has medical-grade ruscus extract to support microcirculation and soothe skin reactivity and redness, as well as soothing Avène Thermal Spring Water.” — Jeannette Graf, MD, New York, New York
   
• Eucerin Redness Relief
  Beiersdorf Inc
  “Eucerin’s Redness Relief product line has worked well for some of my patients.” — Gary Goldenberg, MD, New York, New York
   
• Redness Solutions Daily Protective Base Broad Spectrum SPF 15
  Clinique Laboratories, LLC
  “This oil-free makeup primer has a sheer green tint that camouflages redness while also protecting from UV rays.” — Shari Lipner, MD, PhD, New York, New York

Cutis invites readers to send us their recommendations. Athlete’s foot treatments, cleansing devices, and men’s products will be featured in upcoming editions of Cosmetic Corner. Please email your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on redness-reducing products. Consideration must be given to:

• Avène Antirougeurs FORT Relief Concentrate
  Pierre Fabre Dermo-Cosmetique USA
  “This formula has medical-grade ruscus extract to support microcirculation and soothe skin reactivity and redness, as well as soothing Avène Thermal Spring Water.” — Jeannette Graf, MD, New York, New York
   
• Eucerin Redness Relief
  Beiersdorf Inc
  “Eucerin’s Redness Relief product line has worked well for some of my patients.” — Gary Goldenberg, MD, New York, New York
   
• Redness Solutions Daily Protective Base Broad Spectrum SPF 15
  Clinique Laboratories, LLC
  “This oil-free makeup primer has a sheer green tint that camouflages redness while also protecting from UV rays.” — Shari Lipner, MD, PhD, New York, New York

Cutis invites readers to send us their recommendations. Athlete’s foot treatments, cleansing devices, and men’s products will be featured in upcoming editions of Cosmetic Corner. Please email your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

Anorectal and urethral foreign body insertions (polyembolokoilamania) are not infrequent presentations to the ED. The motivations behind these insertions vary, ranging from autoeroticism to reckless behavior. These insertions can lead to major complications and even death. Though ED staff members are used to the unpredictability of human behavior, foreign body insertions bring a mixture of responses from the staff, ranging from awe and incredulousness to anger and frustration. A knowledge and comfort in managing these cases includes a nonjudgmental triage assessment, collective professionalism, and self-awareness of the staff’s reaction.

Case 1

A 58-year-old man presented to the ED for evaluation of a foreign body in his rectum. He admitted to placing a beer bottle in his rectum, but was unable to remove it at home. The staff reported that the patient was previously seen in the ED for removal of a vibrator from his rectum.

Radiographic evaluation in the form of an acute abdominal series was obtained and confirmed a beer bottle in the rectum (Figures 1 and 2).

Case 2

A 55-year-old man presented to the ED after he inserted a pen cap into his urethra to aid in obtaining an erection. A pelvic X-ray was obtained and showed a radiolucent structure in the penis (Figure 3).

The patient was admitted to the hospital and taken to the OR by the consulting urologist. Using a rigid cystoscope and flexible graspers, the pen cap was removed from the proximal urethra under monitored anesthesia control. The procedure went without any complications.

A psychiatrist was consulted, and during the encounter, the patient admitted that his behavior was pathological. He revealed that he was a victim of child abuse and reported he had been having mixed emotions of anxiety, guilt, and embarrassment because of his behavior.

Discussion

Foreign body insertions are seen in patients with a wide variety of backgrounds, ages, and lifestyles. Approximately 80,000 cases of foreign body ingestion are seen annually in children under age 20 years. Young males have a higher predilection of swallowing foreign bodies when compared to young females,¹ and rectal foreign body insertions are seen more commonly in males than in females.² In this age group, intentional foreign body insertion may be an initial manifestation of psychiatric illness.

Rectal Insertions

The earliest published report of a rectal foreign body insertion was in 1919 by Smiley.⁶ The typical age at presentation ranges from 20 to 90 years old, with a mean age of 44 years old.² Household objects such as bottles and glasses are the most commonly seen, but a long list of other items have also been reported in the literature, including toothbrushes, knives, deodorant bottles, food articles, sports equipment, cell phones, flashlights, wooden rods, broomsticks, sex toys, light bulbs, construction tools, nails, ornaments, aerosol canisters, cocaine packets, jewelry, batteries, guitar picks, and many other items.^1,2,7

In nearly half of the reported cases, the reasons for rectal insertion was for sexual arousal/stimulation.^1,7 Other reasons include nonsuicidal injurious behavior (eg, borderline personality disorder); suicide attempt; psychosis; depression; factitious disorder; malingering; cognitive disorders, including dementia and delirium; treatment of constipation and hemorrhoids; concealment; attention-seeking behavior; “accidental”; assault; and the consequences of drunken wagers.^1,2 Additionally, abuse should be considered, especially in patients with developmental delay and/or psychiatric illness.

Close to 20% of all traumatic rectal injuries are due to foreign body insertions. In most cases, foreign bodies fail to cause significant anorectal injuries. Complications, however, can result from the process of insertion, removal, or from the contents introduced into the orifice.¹ Any rectal examination should be preceded by an anatomical survey utilizing radiographic modalities to evaluate the integrity and orientation of the object in question. Any sharp object can injure the examining physician if this is not done prior. All examinations should be chaperoned.^2,7 The most obvious and dangerous complication is perforation, and the patient’s care should proceed in the same manner as any other trauma patient. Additionally, resulting sepsis should be managed with the same standards as any other septic patient.⁷

Treatment. The method of object removal is determined by the presence or absence of a surgical abdomen and the need for general anesthesia. The location and shape of the object, however, may not equate with successful retrieval. Objects placed in the sigmoid colon are more than twice as likely to require surgical intervention compared to items placed distally.² Once it is determined that the patient is clinically stable and does not have an acute abdomen, attempts in removing the rectal foreign object can be done in the ED or, if anesthesia is needed, in the OR. Any attempts at transanal removal require optimal patient relaxation, which can be achieved via procedural sedation. The patient should be placed in a lithotomy or left lateral decubitus position to allow palpation of the object in the lower gastrointestinal tract. From here, several methods of removal can be employed. Blunt objects can be grasped and removed by a gloved hand or with a clamp. A Foley catheter can also be passed alongside the object and the balloon inflated above the foreign body to aid in extraction as the Foley is pulled out slowly. Sengstaken-Blakemore tubes, obstetric forceps, and vacuum extractors have also been utilized.⁷

While bedside extraction is advocated by many authors, Cawich et al⁸ recently reported that transanal extraction in the ED failed in 89% of cases. Additionally, these researchers reported that in 63% of the failed extractions, the objects were inadvertently pushed higher into the rectosigmoid region, and therefore recommended early mobilization of the OR team so that exploration under anesthesia can be performed under optimal conditions.⁸

Once the foreign body is successfully removed, follow-up imaging or postextraction endoscopy is warranted. Close observation in the hospital is recommended to facilitate serial abdominal examination.⁷

Urethral Insertions

Sexual exploration, efforts at contraception, transport of illicit drugs, assault or sexual violence, and accidental insertion have all been described as reasons for genitourinary (GU) insertion.¹ The motives, however, mirror those who insert foreign bodies rectally.

Most presentations are due to pain or inability to void. Aggressive treatment should be undertaken because even when the penis appears dark or necrotic, salvage rates have been high. Complications include urinary tract infections, hematuria, urinary retention, urethral tears, abscess, ascending GU infections, and diverticula and fistula formations.^1,3 In women, vaginal insertions can lead to pelvic pain and septic shock.¹ Foreign bodies can also lead to a condition first described in the ancient literature as strangury—the process of slow and painful discharge of urine due to a significant inflammatory component or stricture. The term strangury has been replaced with the more general term bladder spasms.⁹

Treatment. Removal of urethral foreign bodies typically is done in conjunction with a urologist. A cystoscopic procedure is usually successful in removing the foreign body and is an effective method to minimize urethral and bladder injuries. However, more invasive surgical options, including perineal urethrotomy, suprapubic cystostomy, cystolithotomy, and external urethrotomy, have been used in more complicated cases or when the foreign body prevents urethral access of an endoscopic instrument.¹⁰

Patient and Staff Reactions

When patients realize they are unable to remove the inserted object, some present immediately to the ED for evaluation. Interestingly, others may wait up to 2 weeks after insertion before seeking help.² Patients report feelings of being ashamed and report a feeling of being despised, frowned upon, and being talked about during the course of their ED evaluation. As a consequence, these patients may not readily come to the ED or if they do come, may not be open to conversation and hide the true reason of why they came in the first place.^1,4 The amplified paranoia and perceived prejudice may delay diagnosis and lifesaving measures, or worse, lead patients to leave prior to a medical screening examination. Therefore, creating a nonjudgmental environment is essential, even when the presenting story appears to be fabricated.²

Once the patient’s foreign body is removed, and complications are excluded or properly managed, the goal is to understand the motivation behind the insertion, mitigate the consequences of the behavior, and prevent future recurrence. A psychiatric evaluation should be obtained in the ED, or if the patient is admitted, during hospitalization. Psychiatric behavior leading to insertions can be unmasked, treated, and harm-reduction strategies can be taught and instituted.^1,3

Experienced ED staff members are used to the unpredictability of human behavior. However, patients who present with foreign body insertions can elicit a mixture of responses, ranging from awe and incredulousness to anger and frustration. It is not unusual for staff members to not understand or recognize their own reactions. The unique nature of the presentation, along with the astonishing radiographic images, can lead to a breach of privacy and dissemination of the digital photographs by cell phones and into social media sites.¹ Staff members should be encouraged to foster open-mindedness and indifference. Ensuring privacy, professionalism, and empathy can go a long way to helping these patients. Moreover, ED staff members should be educated about countertransference reactions,¹ as these actions are necessary to ensure the singular purpose of optimum patient-staff relationship.

Conclusion

Patients with foreign body insertions challenge the ED staff, as the presenting complaint not only tests the collective technical know-how of the staff, but also their emotional competencies. A nonjudgmental and open-minded approach is crucial, with the tone set during triage. Coordination with surgical specialties should be done early to ensure safe removal and to identify and manage complications. Psychiatric evaluation should be strongly considered prior to disposition in an attempt to prevent future recurrences.

Anorectal and urethral foreign body insertions (polyembolokoilamania) are not infrequent presentations to the ED. The motivations behind these insertions vary, ranging from autoeroticism to reckless behavior. These insertions can lead to major complications and even death. Though ED staff members are used to the unpredictability of human behavior, foreign body insertions bring a mixture of responses from the staff, ranging from awe and incredulousness to anger and frustration. A knowledge and comfort in managing these cases includes a nonjudgmental triage assessment, collective professionalism, and self-awareness of the staff’s reaction.

Case 1

A 58-year-old man presented to the ED for evaluation of a foreign body in his rectum. He admitted to placing a beer bottle in his rectum, but was unable to remove it at home. The staff reported that the patient was previously seen in the ED for removal of a vibrator from his rectum.

Radiographic evaluation in the form of an acute abdominal series was obtained and confirmed a beer bottle in the rectum (Figures 1 and 2).

Case 2

A 55-year-old man presented to the ED after he inserted a pen cap into his urethra to aid in obtaining an erection. A pelvic X-ray was obtained and showed a radiolucent structure in the penis (Figure 3).

The patient was admitted to the hospital and taken to the OR by the consulting urologist. Using a rigid cystoscope and flexible graspers, the pen cap was removed from the proximal urethra under monitored anesthesia control. The procedure went without any complications.

A psychiatrist was consulted, and during the encounter, the patient admitted that his behavior was pathological. He revealed that he was a victim of child abuse and reported he had been having mixed emotions of anxiety, guilt, and embarrassment because of his behavior.

Discussion

Foreign body insertions are seen in patients with a wide variety of backgrounds, ages, and lifestyles. Approximately 80,000 cases of foreign body ingestion are seen annually in children under age 20 years. Young males have a higher predilection of swallowing foreign bodies when compared to young females,¹ and rectal foreign body insertions are seen more commonly in males than in females.² In this age group, intentional foreign body insertion may be an initial manifestation of psychiatric illness.

Rectal Insertions

The earliest published report of a rectal foreign body insertion was in 1919 by Smiley.⁶ The typical age at presentation ranges from 20 to 90 years old, with a mean age of 44 years old.² Household objects such as bottles and glasses are the most commonly seen, but a long list of other items have also been reported in the literature, including toothbrushes, knives, deodorant bottles, food articles, sports equipment, cell phones, flashlights, wooden rods, broomsticks, sex toys, light bulbs, construction tools, nails, ornaments, aerosol canisters, cocaine packets, jewelry, batteries, guitar picks, and many other items.^1,2,7

In nearly half of the reported cases, the reasons for rectal insertion was for sexual arousal/stimulation.^1,7 Other reasons include nonsuicidal injurious behavior (eg, borderline personality disorder); suicide attempt; psychosis; depression; factitious disorder; malingering; cognitive disorders, including dementia and delirium; treatment of constipation and hemorrhoids; concealment; attention-seeking behavior; “accidental”; assault; and the consequences of drunken wagers.^1,2 Additionally, abuse should be considered, especially in patients with developmental delay and/or psychiatric illness.

Close to 20% of all traumatic rectal injuries are due to foreign body insertions. In most cases, foreign bodies fail to cause significant anorectal injuries. Complications, however, can result from the process of insertion, removal, or from the contents introduced into the orifice.¹ Any rectal examination should be preceded by an anatomical survey utilizing radiographic modalities to evaluate the integrity and orientation of the object in question. Any sharp object can injure the examining physician if this is not done prior. All examinations should be chaperoned.^2,7 The most obvious and dangerous complication is perforation, and the patient’s care should proceed in the same manner as any other trauma patient. Additionally, resulting sepsis should be managed with the same standards as any other septic patient.⁷

Treatment. The method of object removal is determined by the presence or absence of a surgical abdomen and the need for general anesthesia. The location and shape of the object, however, may not equate with successful retrieval. Objects placed in the sigmoid colon are more than twice as likely to require surgical intervention compared to items placed distally.² Once it is determined that the patient is clinically stable and does not have an acute abdomen, attempts in removing the rectal foreign object can be done in the ED or, if anesthesia is needed, in the OR. Any attempts at transanal removal require optimal patient relaxation, which can be achieved via procedural sedation. The patient should be placed in a lithotomy or left lateral decubitus position to allow palpation of the object in the lower gastrointestinal tract. From here, several methods of removal can be employed. Blunt objects can be grasped and removed by a gloved hand or with a clamp. A Foley catheter can also be passed alongside the object and the balloon inflated above the foreign body to aid in extraction as the Foley is pulled out slowly. Sengstaken-Blakemore tubes, obstetric forceps, and vacuum extractors have also been utilized.⁷

While bedside extraction is advocated by many authors, Cawich et al⁸ recently reported that transanal extraction in the ED failed in 89% of cases. Additionally, these researchers reported that in 63% of the failed extractions, the objects were inadvertently pushed higher into the rectosigmoid region, and therefore recommended early mobilization of the OR team so that exploration under anesthesia can be performed under optimal conditions.⁸

Once the foreign body is successfully removed, follow-up imaging or postextraction endoscopy is warranted. Close observation in the hospital is recommended to facilitate serial abdominal examination.⁷

Urethral Insertions

Sexual exploration, efforts at contraception, transport of illicit drugs, assault or sexual violence, and accidental insertion have all been described as reasons for genitourinary (GU) insertion.¹ The motives, however, mirror those who insert foreign bodies rectally.

Most presentations are due to pain or inability to void. Aggressive treatment should be undertaken because even when the penis appears dark or necrotic, salvage rates have been high. Complications include urinary tract infections, hematuria, urinary retention, urethral tears, abscess, ascending GU infections, and diverticula and fistula formations.^1,3 In women, vaginal insertions can lead to pelvic pain and septic shock.¹ Foreign bodies can also lead to a condition first described in the ancient literature as strangury—the process of slow and painful discharge of urine due to a significant inflammatory component or stricture. The term strangury has been replaced with the more general term bladder spasms.⁹

Treatment. Removal of urethral foreign bodies typically is done in conjunction with a urologist. A cystoscopic procedure is usually successful in removing the foreign body and is an effective method to minimize urethral and bladder injuries. However, more invasive surgical options, including perineal urethrotomy, suprapubic cystostomy, cystolithotomy, and external urethrotomy, have been used in more complicated cases or when the foreign body prevents urethral access of an endoscopic instrument.¹⁰

Patient and Staff Reactions

When patients realize they are unable to remove the inserted object, some present immediately to the ED for evaluation. Interestingly, others may wait up to 2 weeks after insertion before seeking help.² Patients report feelings of being ashamed and report a feeling of being despised, frowned upon, and being talked about during the course of their ED evaluation. As a consequence, these patients may not readily come to the ED or if they do come, may not be open to conversation and hide the true reason of why they came in the first place.^1,4 The amplified paranoia and perceived prejudice may delay diagnosis and lifesaving measures, or worse, lead patients to leave prior to a medical screening examination. Therefore, creating a nonjudgmental environment is essential, even when the presenting story appears to be fabricated.²

Once the patient’s foreign body is removed, and complications are excluded or properly managed, the goal is to understand the motivation behind the insertion, mitigate the consequences of the behavior, and prevent future recurrence. A psychiatric evaluation should be obtained in the ED, or if the patient is admitted, during hospitalization. Psychiatric behavior leading to insertions can be unmasked, treated, and harm-reduction strategies can be taught and instituted.^1,3

Experienced ED staff members are used to the unpredictability of human behavior. However, patients who present with foreign body insertions can elicit a mixture of responses, ranging from awe and incredulousness to anger and frustration. It is not unusual for staff members to not understand or recognize their own reactions. The unique nature of the presentation, along with the astonishing radiographic images, can lead to a breach of privacy and dissemination of the digital photographs by cell phones and into social media sites.¹ Staff members should be encouraged to foster open-mindedness and indifference. Ensuring privacy, professionalism, and empathy can go a long way to helping these patients. Moreover, ED staff members should be educated about countertransference reactions,¹ as these actions are necessary to ensure the singular purpose of optimum patient-staff relationship.

Conclusion

Patients with foreign body insertions challenge the ED staff, as the presenting complaint not only tests the collective technical know-how of the staff, but also their emotional competencies. A nonjudgmental and open-minded approach is crucial, with the tone set during triage. Coordination with surgical specialties should be done early to ensure safe removal and to identify and manage complications. Psychiatric evaluation should be strongly considered prior to disposition in an attempt to prevent future recurrences.

Anorectal and urethral foreign body insertions (polyembolokoilamania) are not infrequent presentations to the ED. The motivations behind these insertions vary, ranging from autoeroticism to reckless behavior. These insertions can lead to major complications and even death. Though ED staff members are used to the unpredictability of human behavior, foreign body insertions bring a mixture of responses from the staff, ranging from awe and incredulousness to anger and frustration. A knowledge and comfort in managing these cases includes a nonjudgmental triage assessment, collective professionalism, and self-awareness of the staff’s reaction.

Case 1

A 58-year-old man presented to the ED for evaluation of a foreign body in his rectum. He admitted to placing a beer bottle in his rectum, but was unable to remove it at home. The staff reported that the patient was previously seen in the ED for removal of a vibrator from his rectum.

Radiographic evaluation in the form of an acute abdominal series was obtained and confirmed a beer bottle in the rectum (Figures 1 and 2).

Case 2

A 55-year-old man presented to the ED after he inserted a pen cap into his urethra to aid in obtaining an erection. A pelvic X-ray was obtained and showed a radiolucent structure in the penis (Figure 3).

The patient was admitted to the hospital and taken to the OR by the consulting urologist. Using a rigid cystoscope and flexible graspers, the pen cap was removed from the proximal urethra under monitored anesthesia control. The procedure went without any complications.

A psychiatrist was consulted, and during the encounter, the patient admitted that his behavior was pathological. He revealed that he was a victim of child abuse and reported he had been having mixed emotions of anxiety, guilt, and embarrassment because of his behavior.

Discussion

Foreign body insertions are seen in patients with a wide variety of backgrounds, ages, and lifestyles. Approximately 80,000 cases of foreign body ingestion are seen annually in children under age 20 years. Young males have a higher predilection of swallowing foreign bodies when compared to young females,¹ and rectal foreign body insertions are seen more commonly in males than in females.² In this age group, intentional foreign body insertion may be an initial manifestation of psychiatric illness.

Rectal Insertions

The earliest published report of a rectal foreign body insertion was in 1919 by Smiley.⁶ The typical age at presentation ranges from 20 to 90 years old, with a mean age of 44 years old.² Household objects such as bottles and glasses are the most commonly seen, but a long list of other items have also been reported in the literature, including toothbrushes, knives, deodorant bottles, food articles, sports equipment, cell phones, flashlights, wooden rods, broomsticks, sex toys, light bulbs, construction tools, nails, ornaments, aerosol canisters, cocaine packets, jewelry, batteries, guitar picks, and many other items.^1,2,7

In nearly half of the reported cases, the reasons for rectal insertion was for sexual arousal/stimulation.^1,7 Other reasons include nonsuicidal injurious behavior (eg, borderline personality disorder); suicide attempt; psychosis; depression; factitious disorder; malingering; cognitive disorders, including dementia and delirium; treatment of constipation and hemorrhoids; concealment; attention-seeking behavior; “accidental”; assault; and the consequences of drunken wagers.^1,2 Additionally, abuse should be considered, especially in patients with developmental delay and/or psychiatric illness.

Close to 20% of all traumatic rectal injuries are due to foreign body insertions. In most cases, foreign bodies fail to cause significant anorectal injuries. Complications, however, can result from the process of insertion, removal, or from the contents introduced into the orifice.¹ Any rectal examination should be preceded by an anatomical survey utilizing radiographic modalities to evaluate the integrity and orientation of the object in question. Any sharp object can injure the examining physician if this is not done prior. All examinations should be chaperoned.^2,7 The most obvious and dangerous complication is perforation, and the patient’s care should proceed in the same manner as any other trauma patient. Additionally, resulting sepsis should be managed with the same standards as any other septic patient.⁷

Treatment. The method of object removal is determined by the presence or absence of a surgical abdomen and the need for general anesthesia. The location and shape of the object, however, may not equate with successful retrieval. Objects placed in the sigmoid colon are more than twice as likely to require surgical intervention compared to items placed distally.² Once it is determined that the patient is clinically stable and does not have an acute abdomen, attempts in removing the rectal foreign object can be done in the ED or, if anesthesia is needed, in the OR. Any attempts at transanal removal require optimal patient relaxation, which can be achieved via procedural sedation. The patient should be placed in a lithotomy or left lateral decubitus position to allow palpation of the object in the lower gastrointestinal tract. From here, several methods of removal can be employed. Blunt objects can be grasped and removed by a gloved hand or with a clamp. A Foley catheter can also be passed alongside the object and the balloon inflated above the foreign body to aid in extraction as the Foley is pulled out slowly. Sengstaken-Blakemore tubes, obstetric forceps, and vacuum extractors have also been utilized.⁷

While bedside extraction is advocated by many authors, Cawich et al⁸ recently reported that transanal extraction in the ED failed in 89% of cases. Additionally, these researchers reported that in 63% of the failed extractions, the objects were inadvertently pushed higher into the rectosigmoid region, and therefore recommended early mobilization of the OR team so that exploration under anesthesia can be performed under optimal conditions.⁸

Once the foreign body is successfully removed, follow-up imaging or postextraction endoscopy is warranted. Close observation in the hospital is recommended to facilitate serial abdominal examination.⁷

Urethral Insertions

Sexual exploration, efforts at contraception, transport of illicit drugs, assault or sexual violence, and accidental insertion have all been described as reasons for genitourinary (GU) insertion.¹ The motives, however, mirror those who insert foreign bodies rectally.

Most presentations are due to pain or inability to void. Aggressive treatment should be undertaken because even when the penis appears dark or necrotic, salvage rates have been high. Complications include urinary tract infections, hematuria, urinary retention, urethral tears, abscess, ascending GU infections, and diverticula and fistula formations.^1,3 In women, vaginal insertions can lead to pelvic pain and septic shock.¹ Foreign bodies can also lead to a condition first described in the ancient literature as strangury—the process of slow and painful discharge of urine due to a significant inflammatory component or stricture. The term strangury has been replaced with the more general term bladder spasms.⁹

Treatment. Removal of urethral foreign bodies typically is done in conjunction with a urologist. A cystoscopic procedure is usually successful in removing the foreign body and is an effective method to minimize urethral and bladder injuries. However, more invasive surgical options, including perineal urethrotomy, suprapubic cystostomy, cystolithotomy, and external urethrotomy, have been used in more complicated cases or when the foreign body prevents urethral access of an endoscopic instrument.¹⁰

Patient and Staff Reactions

When patients realize they are unable to remove the inserted object, some present immediately to the ED for evaluation. Interestingly, others may wait up to 2 weeks after insertion before seeking help.² Patients report feelings of being ashamed and report a feeling of being despised, frowned upon, and being talked about during the course of their ED evaluation. As a consequence, these patients may not readily come to the ED or if they do come, may not be open to conversation and hide the true reason of why they came in the first place.^1,4 The amplified paranoia and perceived prejudice may delay diagnosis and lifesaving measures, or worse, lead patients to leave prior to a medical screening examination. Therefore, creating a nonjudgmental environment is essential, even when the presenting story appears to be fabricated.²

Once the patient’s foreign body is removed, and complications are excluded or properly managed, the goal is to understand the motivation behind the insertion, mitigate the consequences of the behavior, and prevent future recurrence. A psychiatric evaluation should be obtained in the ED, or if the patient is admitted, during hospitalization. Psychiatric behavior leading to insertions can be unmasked, treated, and harm-reduction strategies can be taught and instituted.^1,3

Experienced ED staff members are used to the unpredictability of human behavior. However, patients who present with foreign body insertions can elicit a mixture of responses, ranging from awe and incredulousness to anger and frustration. It is not unusual for staff members to not understand or recognize their own reactions. The unique nature of the presentation, along with the astonishing radiographic images, can lead to a breach of privacy and dissemination of the digital photographs by cell phones and into social media sites.¹ Staff members should be encouraged to foster open-mindedness and indifference. Ensuring privacy, professionalism, and empathy can go a long way to helping these patients. Moreover, ED staff members should be educated about countertransference reactions,¹ as these actions are necessary to ensure the singular purpose of optimum patient-staff relationship.

Conclusion

Patients with foreign body insertions challenge the ED staff, as the presenting complaint not only tests the collective technical know-how of the staff, but also their emotional competencies. A nonjudgmental and open-minded approach is crucial, with the tone set during triage. Coordination with surgical specialties should be done early to ensure safe removal and to identify and manage complications. Psychiatric evaluation should be strongly considered prior to disposition in an attempt to prevent future recurrences.

NEW YORK – Telomere length reliably predicts response to fludarabine-cyclophosphamide-rituximab (FCR) treatment in patients with chronic lymphocytic leukemia, according to an analysis of 278 samples from the ARCTIC and ADMIRE clinical trials of FCR in previously untreated CLL.

The findings were particularly pronounced in the immunoglobulin heavy-chain variable region gene (IGHV)–mutated patients and suggest a role for telomere measurement as a predictive tool in risk-adapted clinical trials, Kevin Norris reported in a poster at the annual International Workshop on Chronic Lymphocytic Leukemia.

Short telomere length was associated with quicker time to progression (median of 3.9 years vs. 5.5 years; hazard ratio[HR], 2.04) and reduced overall survival (OS) (median of 5.5 years vs. OS not reached; HR, 2.1), compared with long telomere length. IGHV-mutated patients with short telomeres were more than five times more likely to relapse (median progression-free survival 2.97 vs. PFS not reached; HR, 5.1), and more than four times more likely to die than were patients with long telomere length (median OS, 4.15 years vs. OS not reached; HR, 4.16), said Mr. Norris, a research associate at Cardiff (Wales) University.

The association between telomere length and FCR response was less pronounced among IGHV-unmutated patients, but those with short telomeres in this group still had an inferior response and shorter survival, compared with those with long telomeres (HR, 1.6 and 1.6, respectively), he noted.

Mr. Norris also noted that in contrast to the telomere length findings, CD38 expression and b2-microglobulin were not predictive of time to progression or OS.

“In multivariate analysis, telomere length was the dominant covariable for both PFS (HR, 2.58) and OS (HR, 2.84); when telomere length was entered into the model no other variable retained independent prognostic significance,” he and his colleagues wrote.

Telomere length in this analysis was assessed by use of the high throughput single telomere length analysis (HT-STELA) assay.

It has recently been shown that a proportion of IGHV-mutated CLL patients treated with FCR can achieve long-term remissions. The current findings demonstrate that these patients can be accurately identified by measuring telomere length, the investigators said, noting that they saw a similar pattern in patients in the UK CLL4 trial who were treated with fludarabine and cyclophosphamide

“Our results demonstrate that telomere length is the major determinant of response and survival following treatment with FCR,” they wrote. “IGHV-mutated patients with longer telomeres have a high probability of achieving a long-term remission following treatment with FCR (greater than 81% survival after 5 years). Equally, IGHV-mutated patients with short dysfunctional telomeres show a markedly inferior response to FCR and should be considered for alternative treatment options in the frontline setting.”

Patient material for this study was obtained from the UK CLL Trials Biobank, University of Liverpool, which is funded by Bloodwise. The authors reported having no other disclosures.

sworcester@frontlinemedcom.com

NEW YORK – Telomere length reliably predicts response to fludarabine-cyclophosphamide-rituximab (FCR) treatment in patients with chronic lymphocytic leukemia, according to an analysis of 278 samples from the ARCTIC and ADMIRE clinical trials of FCR in previously untreated CLL.

The findings were particularly pronounced in the immunoglobulin heavy-chain variable region gene (IGHV)–mutated patients and suggest a role for telomere measurement as a predictive tool in risk-adapted clinical trials, Kevin Norris reported in a poster at the annual International Workshop on Chronic Lymphocytic Leukemia.

Short telomere length was associated with quicker time to progression (median of 3.9 years vs. 5.5 years; hazard ratio[HR], 2.04) and reduced overall survival (OS) (median of 5.5 years vs. OS not reached; HR, 2.1), compared with long telomere length. IGHV-mutated patients with short telomeres were more than five times more likely to relapse (median progression-free survival 2.97 vs. PFS not reached; HR, 5.1), and more than four times more likely to die than were patients with long telomere length (median OS, 4.15 years vs. OS not reached; HR, 4.16), said Mr. Norris, a research associate at Cardiff (Wales) University.

The association between telomere length and FCR response was less pronounced among IGHV-unmutated patients, but those with short telomeres in this group still had an inferior response and shorter survival, compared with those with long telomeres (HR, 1.6 and 1.6, respectively), he noted.

Mr. Norris also noted that in contrast to the telomere length findings, CD38 expression and b2-microglobulin were not predictive of time to progression or OS.

“In multivariate analysis, telomere length was the dominant covariable for both PFS (HR, 2.58) and OS (HR, 2.84); when telomere length was entered into the model no other variable retained independent prognostic significance,” he and his colleagues wrote.

Telomere length in this analysis was assessed by use of the high throughput single telomere length analysis (HT-STELA) assay.

It has recently been shown that a proportion of IGHV-mutated CLL patients treated with FCR can achieve long-term remissions. The current findings demonstrate that these patients can be accurately identified by measuring telomere length, the investigators said, noting that they saw a similar pattern in patients in the UK CLL4 trial who were treated with fludarabine and cyclophosphamide

“Our results demonstrate that telomere length is the major determinant of response and survival following treatment with FCR,” they wrote. “IGHV-mutated patients with longer telomeres have a high probability of achieving a long-term remission following treatment with FCR (greater than 81% survival after 5 years). Equally, IGHV-mutated patients with short dysfunctional telomeres show a markedly inferior response to FCR and should be considered for alternative treatment options in the frontline setting.”

Patient material for this study was obtained from the UK CLL Trials Biobank, University of Liverpool, which is funded by Bloodwise. The authors reported having no other disclosures.

sworcester@frontlinemedcom.com

NEW YORK – Telomere length reliably predicts response to fludarabine-cyclophosphamide-rituximab (FCR) treatment in patients with chronic lymphocytic leukemia, according to an analysis of 278 samples from the ARCTIC and ADMIRE clinical trials of FCR in previously untreated CLL.

The findings were particularly pronounced in the immunoglobulin heavy-chain variable region gene (IGHV)–mutated patients and suggest a role for telomere measurement as a predictive tool in risk-adapted clinical trials, Kevin Norris reported in a poster at the annual International Workshop on Chronic Lymphocytic Leukemia.

Short telomere length was associated with quicker time to progression (median of 3.9 years vs. 5.5 years; hazard ratio[HR], 2.04) and reduced overall survival (OS) (median of 5.5 years vs. OS not reached; HR, 2.1), compared with long telomere length. IGHV-mutated patients with short telomeres were more than five times more likely to relapse (median progression-free survival 2.97 vs. PFS not reached; HR, 5.1), and more than four times more likely to die than were patients with long telomere length (median OS, 4.15 years vs. OS not reached; HR, 4.16), said Mr. Norris, a research associate at Cardiff (Wales) University.

The association between telomere length and FCR response was less pronounced among IGHV-unmutated patients, but those with short telomeres in this group still had an inferior response and shorter survival, compared with those with long telomeres (HR, 1.6 and 1.6, respectively), he noted.

Mr. Norris also noted that in contrast to the telomere length findings, CD38 expression and b2-microglobulin were not predictive of time to progression or OS.

“In multivariate analysis, telomere length was the dominant covariable for both PFS (HR, 2.58) and OS (HR, 2.84); when telomere length was entered into the model no other variable retained independent prognostic significance,” he and his colleagues wrote.

Telomere length in this analysis was assessed by use of the high throughput single telomere length analysis (HT-STELA) assay.

It has recently been shown that a proportion of IGHV-mutated CLL patients treated with FCR can achieve long-term remissions. The current findings demonstrate that these patients can be accurately identified by measuring telomere length, the investigators said, noting that they saw a similar pattern in patients in the UK CLL4 trial who were treated with fludarabine and cyclophosphamide

“Our results demonstrate that telomere length is the major determinant of response and survival following treatment with FCR,” they wrote. “IGHV-mutated patients with longer telomeres have a high probability of achieving a long-term remission following treatment with FCR (greater than 81% survival after 5 years). Equally, IGHV-mutated patients with short dysfunctional telomeres show a markedly inferior response to FCR and should be considered for alternative treatment options in the frontline setting.”

Patient material for this study was obtained from the UK CLL Trials Biobank, University of Liverpool, which is funded by Bloodwise. The authors reported having no other disclosures.

sworcester@frontlinemedcom.com