Mentha piperita, better known as peppermint, is used worldwide in many ways. Its use for culinary and medical purposes dates back to the ancient Greek and Roman civilizations. Peppermint is used in numerous forms (i.e., oil, leaf, leaf extract, and leaf water), with the oil as the most versatile (Dermatitis 2010;21:327-9). Peppermint has long been known for its beneficial gastrointestinal effects, and it has a well-established record of antimicrobial, antifungal, and analgesic activity (Mills S., Bone K. Principles and Practice of Phytotherapy: Modern Herbal Medicine. [London: Churchill Livingstone, 2000, pp 507-13]; J. Environ. Biol. 2011;32:23-9).

Courtesy Wikimedia Commons/Vsolymossy/Creative Commons License

Menthol (C10H20O) is a naturally occurring monocyclic terpene alcohol derived from Mentha piperita as well as other mint oils (Skin Therapy Lett. 2010;15:5-9), and has been associated with several health benefits. Recently, anticancer properties have been ascribed to menthol (Biochim. Biophys. Acta 2009;1792:33-8). This column will discuss recent findings regarding the actual or potential cutaneous benefits of peppermint and menthol.

Various Mentha species, including M. piperita, have exhibited significant antioxidant activity (Toxicol. Ind. Health. 2012;28:83-9; Nat. Prod. Commun. 2009;4:1107-12; Nat. Prod. Commun. 2009;4:535-42). In a 2010 study of the antioxidant activity of the essential oils of six popular herbs, including lavender (Lavendular angustifolia), peppermint (M. piperita), rosemary (Rosmarius officinalis), lemon (Citrus limon), grapefruit (C. paradise), and frankincense (Boswellia carteri), investigators found, in testing free radical-scavenging capacity and lipid peroxidation in the linoleic acid system, that peppermint essential oil exhibited the greatest radical-scavenging activity against the 2,2\'-azinobis-(3-ethylbenzothiazoline-6-sulfonic acid) ABTS radical (Nat. Prod. Res. 2010;24:140-51).

In 2010, Baliga and Rao showed that M. piperita and M. arvensis (wild mint) protected mice against gamma-radiation–induced morbidity and mortality. Specifically, M. piperita protected murine testes as well as gastrointestinal and hemopoietic systems (J. Cancer Res. Ther. 2010;6:255-62).

Anticancer activity

Investigations by Jain et al. into the molecular mechanisms supporting the anticarcinogenic potential of M. piperita leaf extracts on six human cancer cell lines (HeLa, MCF-7, Jurkat, T24, HT-29, MIAPaCa-2) in 2011 revealed that chloroform and ethyl acetate extracts dose- and time-dependently displayed anticarcinogenic activity leading to G1 cell cycle arrest and mitochondrial-mediated apoptosis among the cascade of effects. The investigators identified their findings as the first evidence of direct anticarcinogenic activity of Mentha leaf extracts and suggested that future work might focus on isolating active constituents as a foundation for mechanistic and translational studies leading to new anticancer drugs, alone or in combination, to prevent and treat human cancers (Int. J. Toxicol. 2011;30:225-36).

Topical benefits of menthol

In a recent examination of the antibacterial and antifungal properties, as well as speculated anti-inflammatory activity of menthol as a topical treatment for diaper dermatitis, investigators conducted a pilot clinical trial in a hospital setting. The study involved 84 neonates with diagnosed candidal diaper dermatitis who required no critical care or systemic antifungal and anti-inflammatory medications. The menthol group (n = 42) received topical clotrimazole and topically applied menthol drops and the control group (n = 42) received topical clotrimazole and a placebo. Thirty-five infants in each group completed the study. The researchers found that complete healing was shorter in the menthol group, with significant relief of erythema and pustules observed in this group. They concluded that topically-applied menthol may be an effective agent in the treatment of candidal diaper dermatitis (World J. Pediatr. 2011;7:167-70).

In 2011, Qiu et al. showed, through various assays, that menthol, in low concentrations, could significantly suppress the expression of alpha-hemolysin, enterotoxins A and B, and toxic shock syndrome toxin 1 in Staphylococcus aureus. The investigators concluded that menthol may warrant inclusion in the armamentarium against S. aureus when combined with beta-lactam antibiotics, which, at subinhibitory concentrations, can actually augment S. aureus toxin secretion. They added that menthol may also have possible uses in novel anti-virulence drugs (Appl. Microbiol. Biotechnol. 2011;90:705-12). It should be noted that menthol is considered safe and effective, with concentrations up to 16% approved in OTC external products by the Food and Drug Administration (J. Am. Acad. Dermatol. 2007;57:873-8).

Pruritus, TRPM8, and melanoma

Topically applied menthol, in concentrations of 1%-3%, is often used to treat pruritus, particularly in the elderly (Skin Therapy Lett. 2010;15:5-9). In addition, recent evidence suggests that the presence of menthol can facilitate penetration of other agents in topical products (Int. J. Toxicol. 2001;20 Suppl 3:61-73; J. Am. Acad. Dermatol. 2007;57:873-8). Patel and Yosipovitch suggest that elderly patients who report diminished pruritus with cooling may stand to benefit from menthol-containing topical therapies (J. Am. Acad. Dermatol. 2007;57:873-8; Skin Therapy Lett. 2010;15:5-9). Interestingly, menthol, via the transient receptor potential melastatin subfamily 8 (TRPM8) receptor, a member of a family of excitatory ion channels, engenders the same cooling sensation as low temperature, though menthol is not linked to a reduction in skin temperature (J. Am. Acad. Dermatol. 2007;57:873-8; Skin Therapy Lett. 2010;15:5-9).

Although the exact mechanism by which menthol exerts its antipruritic and analgesic effects has yet to be determined, the discovery that the TRPM8 is its underlying receptor is proving to be significant, particularly in understanding the cooling effect of the botanical (J. Am. Acad. Dermatol. 2007;57:873-8). There are also indications that menthol has therapeutic potential for melanoma. Specifically, melanoma expresses TRPM8 receptors, the activation of which inhibits melanoma viability. Menthol appears to mediate this response through an influx of extracellular calcium ions (Am. J. Physiol. Cell Physiol. 2008;295:C296-301; Am. J. Physiol. Cell Physiol. 2008;295:C293-5).

Peppermint oil

In 2003, Schuhmacher et al. investigated the virucidal effect of peppermint oil and found that it had a direct effect against herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) as well as an acyclovir-resistant HSV-1 strain. The investigators concluded, noting the lipophilic nature of peppermint oil, that it might be an appropriate topical treatment for recurrent herpes outbreaks (Phytomedicine 2003;10:504-10).

Because of its flavor, aroma, and cooling qualities, peppermint oil is used in a wide range of products, including cosmeceuticals, personal hygiene products (e.g., bath preparations, mouthwashes, toothpastes, and topical formulations), foods, pharmaceutical products, and aromatherapy. Topical indications include pruritus, irritation, and inflammation. Peppermint oil can act as a skin sensitizer, though, particularly in impaired and sensitive skin (Dermatitis 2010;21:327-9). Although peppermint oil has been reported to be a sensitizer in isolated cases, peppermint oil 8% was not found to be a sensitizer in a recent test using a maximization protocol and the various forms of peppermint (i.e., oil, extract, leaves, and water) are considered to be safe in cosmetic formulations. In rinse-off products, peppermint oil is used in concentrations up to 3% and up to 0.2% in leave-on formulations (Int. J. Toxicol. 2001;20 Suppl 3:61-73).

Conclusion

Peppermint and menthol, its naturally occurring monocyclic terpene alcohol derivative, have long been used for medical purposes. Contemporary practice and continuing research continue to support various uses of M. piperita in the medical armamentarium, with specific and additional uses continually being found in the dermatologic realm.

Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in Miami Beach. She founded the cosmetic dermatology center at the University of Miami in 1997. Dr. Baumann wrote the textbook "Cosmetic Dermatology: Principles and Practice" (McGraw-Hill, April 2002), and a book for consumers, "The Skin Type Solution" (Bantam, 2006). She has contributed to the Cosmeceutical Critique column in Skin & Allergy News since January 2001 and joined the editorial advisory board in 2004. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Galderma, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Stiefel, Topix Pharmaceuticals, and Unilever.

Mentha piperita, better known as peppermint, is used worldwide in many ways. Its use for culinary and medical purposes dates back to the ancient Greek and Roman civilizations. Peppermint is used in numerous forms (i.e., oil, leaf, leaf extract, and leaf water), with the oil as the most versatile (Dermatitis 2010;21:327-9). Peppermint has long been known for its beneficial gastrointestinal effects, and it has a well-established record of antimicrobial, antifungal, and analgesic activity (Mills S., Bone K. Principles and Practice of Phytotherapy: Modern Herbal Medicine. [London: Churchill Livingstone, 2000, pp 507-13]; J. Environ. Biol. 2011;32:23-9).

Courtesy Wikimedia Commons/Vsolymossy/Creative Commons License

Menthol (C10H20O) is a naturally occurring monocyclic terpene alcohol derived from Mentha piperita as well as other mint oils (Skin Therapy Lett. 2010;15:5-9), and has been associated with several health benefits. Recently, anticancer properties have been ascribed to menthol (Biochim. Biophys. Acta 2009;1792:33-8). This column will discuss recent findings regarding the actual or potential cutaneous benefits of peppermint and menthol.

Various Mentha species, including M. piperita, have exhibited significant antioxidant activity (Toxicol. Ind. Health. 2012;28:83-9; Nat. Prod. Commun. 2009;4:1107-12; Nat. Prod. Commun. 2009;4:535-42). In a 2010 study of the antioxidant activity of the essential oils of six popular herbs, including lavender (Lavendular angustifolia), peppermint (M. piperita), rosemary (Rosmarius officinalis), lemon (Citrus limon), grapefruit (C. paradise), and frankincense (Boswellia carteri), investigators found, in testing free radical-scavenging capacity and lipid peroxidation in the linoleic acid system, that peppermint essential oil exhibited the greatest radical-scavenging activity against the 2,2\'-azinobis-(3-ethylbenzothiazoline-6-sulfonic acid) ABTS radical (Nat. Prod. Res. 2010;24:140-51).

In 2010, Baliga and Rao showed that M. piperita and M. arvensis (wild mint) protected mice against gamma-radiation–induced morbidity and mortality. Specifically, M. piperita protected murine testes as well as gastrointestinal and hemopoietic systems (J. Cancer Res. Ther. 2010;6:255-62).

Anticancer activity

Investigations by Jain et al. into the molecular mechanisms supporting the anticarcinogenic potential of M. piperita leaf extracts on six human cancer cell lines (HeLa, MCF-7, Jurkat, T24, HT-29, MIAPaCa-2) in 2011 revealed that chloroform and ethyl acetate extracts dose- and time-dependently displayed anticarcinogenic activity leading to G1 cell cycle arrest and mitochondrial-mediated apoptosis among the cascade of effects. The investigators identified their findings as the first evidence of direct anticarcinogenic activity of Mentha leaf extracts and suggested that future work might focus on isolating active constituents as a foundation for mechanistic and translational studies leading to new anticancer drugs, alone or in combination, to prevent and treat human cancers (Int. J. Toxicol. 2011;30:225-36).

Topical benefits of menthol

In a recent examination of the antibacterial and antifungal properties, as well as speculated anti-inflammatory activity of menthol as a topical treatment for diaper dermatitis, investigators conducted a pilot clinical trial in a hospital setting. The study involved 84 neonates with diagnosed candidal diaper dermatitis who required no critical care or systemic antifungal and anti-inflammatory medications. The menthol group (n = 42) received topical clotrimazole and topically applied menthol drops and the control group (n = 42) received topical clotrimazole and a placebo. Thirty-five infants in each group completed the study. The researchers found that complete healing was shorter in the menthol group, with significant relief of erythema and pustules observed in this group. They concluded that topically-applied menthol may be an effective agent in the treatment of candidal diaper dermatitis (World J. Pediatr. 2011;7:167-70).

In 2011, Qiu et al. showed, through various assays, that menthol, in low concentrations, could significantly suppress the expression of alpha-hemolysin, enterotoxins A and B, and toxic shock syndrome toxin 1 in Staphylococcus aureus. The investigators concluded that menthol may warrant inclusion in the armamentarium against S. aureus when combined with beta-lactam antibiotics, which, at subinhibitory concentrations, can actually augment S. aureus toxin secretion. They added that menthol may also have possible uses in novel anti-virulence drugs (Appl. Microbiol. Biotechnol. 2011;90:705-12). It should be noted that menthol is considered safe and effective, with concentrations up to 16% approved in OTC external products by the Food and Drug Administration (J. Am. Acad. Dermatol. 2007;57:873-8).

Pruritus, TRPM8, and melanoma

Topically applied menthol, in concentrations of 1%-3%, is often used to treat pruritus, particularly in the elderly (Skin Therapy Lett. 2010;15:5-9). In addition, recent evidence suggests that the presence of menthol can facilitate penetration of other agents in topical products (Int. J. Toxicol. 2001;20 Suppl 3:61-73; J. Am. Acad. Dermatol. 2007;57:873-8). Patel and Yosipovitch suggest that elderly patients who report diminished pruritus with cooling may stand to benefit from menthol-containing topical therapies (J. Am. Acad. Dermatol. 2007;57:873-8; Skin Therapy Lett. 2010;15:5-9). Interestingly, menthol, via the transient receptor potential melastatin subfamily 8 (TRPM8) receptor, a member of a family of excitatory ion channels, engenders the same cooling sensation as low temperature, though menthol is not linked to a reduction in skin temperature (J. Am. Acad. Dermatol. 2007;57:873-8; Skin Therapy Lett. 2010;15:5-9).

Although the exact mechanism by which menthol exerts its antipruritic and analgesic effects has yet to be determined, the discovery that the TRPM8 is its underlying receptor is proving to be significant, particularly in understanding the cooling effect of the botanical (J. Am. Acad. Dermatol. 2007;57:873-8). There are also indications that menthol has therapeutic potential for melanoma. Specifically, melanoma expresses TRPM8 receptors, the activation of which inhibits melanoma viability. Menthol appears to mediate this response through an influx of extracellular calcium ions (Am. J. Physiol. Cell Physiol. 2008;295:C296-301; Am. J. Physiol. Cell Physiol. 2008;295:C293-5).

Peppermint oil

In 2003, Schuhmacher et al. investigated the virucidal effect of peppermint oil and found that it had a direct effect against herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) as well as an acyclovir-resistant HSV-1 strain. The investigators concluded, noting the lipophilic nature of peppermint oil, that it might be an appropriate topical treatment for recurrent herpes outbreaks (Phytomedicine 2003;10:504-10).

Because of its flavor, aroma, and cooling qualities, peppermint oil is used in a wide range of products, including cosmeceuticals, personal hygiene products (e.g., bath preparations, mouthwashes, toothpastes, and topical formulations), foods, pharmaceutical products, and aromatherapy. Topical indications include pruritus, irritation, and inflammation. Peppermint oil can act as a skin sensitizer, though, particularly in impaired and sensitive skin (Dermatitis 2010;21:327-9). Although peppermint oil has been reported to be a sensitizer in isolated cases, peppermint oil 8% was not found to be a sensitizer in a recent test using a maximization protocol and the various forms of peppermint (i.e., oil, extract, leaves, and water) are considered to be safe in cosmetic formulations. In rinse-off products, peppermint oil is used in concentrations up to 3% and up to 0.2% in leave-on formulations (Int. J. Toxicol. 2001;20 Suppl 3:61-73).

Conclusion

Peppermint and menthol, its naturally occurring monocyclic terpene alcohol derivative, have long been used for medical purposes. Contemporary practice and continuing research continue to support various uses of M. piperita in the medical armamentarium, with specific and additional uses continually being found in the dermatologic realm.

Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in Miami Beach. She founded the cosmetic dermatology center at the University of Miami in 1997. Dr. Baumann wrote the textbook "Cosmetic Dermatology: Principles and Practice" (McGraw-Hill, April 2002), and a book for consumers, "The Skin Type Solution" (Bantam, 2006). She has contributed to the Cosmeceutical Critique column in Skin & Allergy News since January 2001 and joined the editorial advisory board in 2004. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Galderma, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Stiefel, Topix Pharmaceuticals, and Unilever.

Mentha piperita, better known as peppermint, is used worldwide in many ways. Its use for culinary and medical purposes dates back to the ancient Greek and Roman civilizations. Peppermint is used in numerous forms (i.e., oil, leaf, leaf extract, and leaf water), with the oil as the most versatile (Dermatitis 2010;21:327-9). Peppermint has long been known for its beneficial gastrointestinal effects, and it has a well-established record of antimicrobial, antifungal, and analgesic activity (Mills S., Bone K. Principles and Practice of Phytotherapy: Modern Herbal Medicine. [London: Churchill Livingstone, 2000, pp 507-13]; J. Environ. Biol. 2011;32:23-9).

Courtesy Wikimedia Commons/Vsolymossy/Creative Commons License

Menthol (C10H20O) is a naturally occurring monocyclic terpene alcohol derived from Mentha piperita as well as other mint oils (Skin Therapy Lett. 2010;15:5-9), and has been associated with several health benefits. Recently, anticancer properties have been ascribed to menthol (Biochim. Biophys. Acta 2009;1792:33-8). This column will discuss recent findings regarding the actual or potential cutaneous benefits of peppermint and menthol.

Various Mentha species, including M. piperita, have exhibited significant antioxidant activity (Toxicol. Ind. Health. 2012;28:83-9; Nat. Prod. Commun. 2009;4:1107-12; Nat. Prod. Commun. 2009;4:535-42). In a 2010 study of the antioxidant activity of the essential oils of six popular herbs, including lavender (Lavendular angustifolia), peppermint (M. piperita), rosemary (Rosmarius officinalis), lemon (Citrus limon), grapefruit (C. paradise), and frankincense (Boswellia carteri), investigators found, in testing free radical-scavenging capacity and lipid peroxidation in the linoleic acid system, that peppermint essential oil exhibited the greatest radical-scavenging activity against the 2,2\'-azinobis-(3-ethylbenzothiazoline-6-sulfonic acid) ABTS radical (Nat. Prod. Res. 2010;24:140-51).

In 2010, Baliga and Rao showed that M. piperita and M. arvensis (wild mint) protected mice against gamma-radiation–induced morbidity and mortality. Specifically, M. piperita protected murine testes as well as gastrointestinal and hemopoietic systems (J. Cancer Res. Ther. 2010;6:255-62).

Anticancer activity

Investigations by Jain et al. into the molecular mechanisms supporting the anticarcinogenic potential of M. piperita leaf extracts on six human cancer cell lines (HeLa, MCF-7, Jurkat, T24, HT-29, MIAPaCa-2) in 2011 revealed that chloroform and ethyl acetate extracts dose- and time-dependently displayed anticarcinogenic activity leading to G1 cell cycle arrest and mitochondrial-mediated apoptosis among the cascade of effects. The investigators identified their findings as the first evidence of direct anticarcinogenic activity of Mentha leaf extracts and suggested that future work might focus on isolating active constituents as a foundation for mechanistic and translational studies leading to new anticancer drugs, alone or in combination, to prevent and treat human cancers (Int. J. Toxicol. 2011;30:225-36).

Topical benefits of menthol

In a recent examination of the antibacterial and antifungal properties, as well as speculated anti-inflammatory activity of menthol as a topical treatment for diaper dermatitis, investigators conducted a pilot clinical trial in a hospital setting. The study involved 84 neonates with diagnosed candidal diaper dermatitis who required no critical care or systemic antifungal and anti-inflammatory medications. The menthol group (n = 42) received topical clotrimazole and topically applied menthol drops and the control group (n = 42) received topical clotrimazole and a placebo. Thirty-five infants in each group completed the study. The researchers found that complete healing was shorter in the menthol group, with significant relief of erythema and pustules observed in this group. They concluded that topically-applied menthol may be an effective agent in the treatment of candidal diaper dermatitis (World J. Pediatr. 2011;7:167-70).

In 2011, Qiu et al. showed, through various assays, that menthol, in low concentrations, could significantly suppress the expression of alpha-hemolysin, enterotoxins A and B, and toxic shock syndrome toxin 1 in Staphylococcus aureus. The investigators concluded that menthol may warrant inclusion in the armamentarium against S. aureus when combined with beta-lactam antibiotics, which, at subinhibitory concentrations, can actually augment S. aureus toxin secretion. They added that menthol may also have possible uses in novel anti-virulence drugs (Appl. Microbiol. Biotechnol. 2011;90:705-12). It should be noted that menthol is considered safe and effective, with concentrations up to 16% approved in OTC external products by the Food and Drug Administration (J. Am. Acad. Dermatol. 2007;57:873-8).

Pruritus, TRPM8, and melanoma

Topically applied menthol, in concentrations of 1%-3%, is often used to treat pruritus, particularly in the elderly (Skin Therapy Lett. 2010;15:5-9). In addition, recent evidence suggests that the presence of menthol can facilitate penetration of other agents in topical products (Int. J. Toxicol. 2001;20 Suppl 3:61-73; J. Am. Acad. Dermatol. 2007;57:873-8). Patel and Yosipovitch suggest that elderly patients who report diminished pruritus with cooling may stand to benefit from menthol-containing topical therapies (J. Am. Acad. Dermatol. 2007;57:873-8; Skin Therapy Lett. 2010;15:5-9). Interestingly, menthol, via the transient receptor potential melastatin subfamily 8 (TRPM8) receptor, a member of a family of excitatory ion channels, engenders the same cooling sensation as low temperature, though menthol is not linked to a reduction in skin temperature (J. Am. Acad. Dermatol. 2007;57:873-8; Skin Therapy Lett. 2010;15:5-9).

Although the exact mechanism by which menthol exerts its antipruritic and analgesic effects has yet to be determined, the discovery that the TRPM8 is its underlying receptor is proving to be significant, particularly in understanding the cooling effect of the botanical (J. Am. Acad. Dermatol. 2007;57:873-8). There are also indications that menthol has therapeutic potential for melanoma. Specifically, melanoma expresses TRPM8 receptors, the activation of which inhibits melanoma viability. Menthol appears to mediate this response through an influx of extracellular calcium ions (Am. J. Physiol. Cell Physiol. 2008;295:C296-301; Am. J. Physiol. Cell Physiol. 2008;295:C293-5).

Peppermint oil

In 2003, Schuhmacher et al. investigated the virucidal effect of peppermint oil and found that it had a direct effect against herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) as well as an acyclovir-resistant HSV-1 strain. The investigators concluded, noting the lipophilic nature of peppermint oil, that it might be an appropriate topical treatment for recurrent herpes outbreaks (Phytomedicine 2003;10:504-10).

Because of its flavor, aroma, and cooling qualities, peppermint oil is used in a wide range of products, including cosmeceuticals, personal hygiene products (e.g., bath preparations, mouthwashes, toothpastes, and topical formulations), foods, pharmaceutical products, and aromatherapy. Topical indications include pruritus, irritation, and inflammation. Peppermint oil can act as a skin sensitizer, though, particularly in impaired and sensitive skin (Dermatitis 2010;21:327-9). Although peppermint oil has been reported to be a sensitizer in isolated cases, peppermint oil 8% was not found to be a sensitizer in a recent test using a maximization protocol and the various forms of peppermint (i.e., oil, extract, leaves, and water) are considered to be safe in cosmetic formulations. In rinse-off products, peppermint oil is used in concentrations up to 3% and up to 0.2% in leave-on formulations (Int. J. Toxicol. 2001;20 Suppl 3:61-73).

Conclusion

Peppermint and menthol, its naturally occurring monocyclic terpene alcohol derivative, have long been used for medical purposes. Contemporary practice and continuing research continue to support various uses of M. piperita in the medical armamentarium, with specific and additional uses continually being found in the dermatologic realm.

Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in Miami Beach. She founded the cosmetic dermatology center at the University of Miami in 1997. Dr. Baumann wrote the textbook "Cosmetic Dermatology: Principles and Practice" (McGraw-Hill, April 2002), and a book for consumers, "The Skin Type Solution" (Bantam, 2006). She has contributed to the Cosmeceutical Critique column in Skin & Allergy News since January 2001 and joined the editorial advisory board in 2004. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Galderma, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Stiefel, Topix Pharmaceuticals, and Unilever.

ISTANBUL – Both clinicians and patients gave favorable marks to a novel injectable pharmacologic treatment for removal of unwanted submental fat – the unsightly double chin – in two phase III randomized trials presented at the annual congress of the European Academy of Dermatology and Venereology.

The investigational chin-fat buster, known as ATX-101, is a proprietary purified synthetic form of deoxycholic acid. Upon injection directly into the submental fat, ATX-101 lyses adipocytes by disrupting their cell membranes.

There is an unmet need for a rigorously studied prescription product for nonsurgical treatment of excess submental fat. Not everyone with a double chin is interested in or a good candidate for the established surgical procedures, observed Dr. Berthold Rzany, a dermatologist at Charité University Hospital, Berlin, who presented a 363-patient, randomized, placebo-controlled phase III trial at the meeting. Participants had to have a body mass index no higher than 30 kg/m², dissatisfaction with the appearance of their submental area, and a physician rating of moderate to severe submental fat. Three-quarters of the subjects were women, with a mean age of 46 years and a mean BMI of 25.7 kg/m².

One of the two primary efficacy endpoints required at least a 1-point improvement on the 0- to 4-point Clinician-Reported Submental Fat Rating Scale as assessed 12 weeks after the final treatment. This was achieved in 59% of patients randomized to ATX-101 at a dose of 1mg/cm² and 65% at 2 mg/cm², both significantly higher rates than the 23% in placebo-treated controls.

The other primary endpoint required a high level of patient satisfaction with the appearance of their face and chin after treatment as expressed in a Subject Self-Rating Scale score of 4 or more on the 0-6 scale. This endpoint was achieved in 53% of patients treated with ATX-101 at 1 mg/cm², 66% who received the agent at 2 mg/cm², and 29% of the placebo group.

ATX-101-treated patients were also significantly more likely to report perceived improvement in the visual and psychological impact of their submental fat. For example, 74% of patients who received ATX-101 at 1 mg/cm² and 80% at 2 mg/cm² reported improved definition between their chin and neck, compared with baseline and compared with 28% of placebo-treated controls. In addition, 32% of patients who received the lower dose of ATX-101 and 39% who got the higher dose characterized their submental fat as "a great deal better," compared with baseline, as did a mere 7% of controls.

Also, patients who received ATX-101 reported 12 weeks post treatment that they looked less overweight and were less bothered by and self-conscious about their submental fat, compared with controls.

Treatment-emergent induration, redness, bruising, numbness, and/or swelling variously occurred in one-third to two-thirds of ATX-101 recipients. All of these adverse events were more common than in placebo-treated controls. However, the events were transient and mostly mild or moderate in intensity. The exception was injection site pain, which occurred in roughly 80% of ATX-101-treated patients and was mostly moderate to severe, although it lasted a median of only 1 day, according to Dr. Rzany.

The ATX-101 treatment regimen entails up to 50 2-mL fixed-dose subcutaneous injections 1 cm apart per treatment session. Up to four treatment sessions were permitted, each separated by a minimum of 4 weeks.

In a separate presentation, Dr. Benjamin Ascher reported on 360 randomized patients who participated in the other phase III clinical trial. The two studies had the same design and endpoints.

An improvement of at least 1 point on the Clinician-Reported Submental Fat Rating Scale occurred in 58% of patients randomized to ATX-101 at the 1 mg/cm² dose, 62% of those who received the higher dose, and 35% on placebo. Moreover, 68% of patients who got ATX-101 at 1 mg/cm² were satisfied with their resultant appearance as reflected in a Subject Self-Rating Scale score of at least 4. So were 65% of those who received the higher dose and 29% of placebo-treated controls. As in the previously mentioned study, indices of self-image and psychological well being were also improved following the aesthetic therapy. Treatment-related adverse events were mostly transient and mild to moderate in intensity, according to Dr. Ascher, who is in the private practice of aesthetic surgery in Paris.

Both phase III studies were supported by Bayer HealthCare and KYTHERA Biopharmaceuticals. Dr. Rzany and Dr. Ascher serve as advisers to the companies.

bjancin@frontlinemedcom.com

ISTANBUL – Both clinicians and patients gave favorable marks to a novel injectable pharmacologic treatment for removal of unwanted submental fat – the unsightly double chin – in two phase III randomized trials presented at the annual congress of the European Academy of Dermatology and Venereology.

The investigational chin-fat buster, known as ATX-101, is a proprietary purified synthetic form of deoxycholic acid. Upon injection directly into the submental fat, ATX-101 lyses adipocytes by disrupting their cell membranes.

There is an unmet need for a rigorously studied prescription product for nonsurgical treatment of excess submental fat. Not everyone with a double chin is interested in or a good candidate for the established surgical procedures, observed Dr. Berthold Rzany, a dermatologist at Charité University Hospital, Berlin, who presented a 363-patient, randomized, placebo-controlled phase III trial at the meeting. Participants had to have a body mass index no higher than 30 kg/m², dissatisfaction with the appearance of their submental area, and a physician rating of moderate to severe submental fat. Three-quarters of the subjects were women, with a mean age of 46 years and a mean BMI of 25.7 kg/m².

One of the two primary efficacy endpoints required at least a 1-point improvement on the 0- to 4-point Clinician-Reported Submental Fat Rating Scale as assessed 12 weeks after the final treatment. This was achieved in 59% of patients randomized to ATX-101 at a dose of 1mg/cm² and 65% at 2 mg/cm², both significantly higher rates than the 23% in placebo-treated controls.

The other primary endpoint required a high level of patient satisfaction with the appearance of their face and chin after treatment as expressed in a Subject Self-Rating Scale score of 4 or more on the 0-6 scale. This endpoint was achieved in 53% of patients treated with ATX-101 at 1 mg/cm², 66% who received the agent at 2 mg/cm², and 29% of the placebo group.

ATX-101-treated patients were also significantly more likely to report perceived improvement in the visual and psychological impact of their submental fat. For example, 74% of patients who received ATX-101 at 1 mg/cm² and 80% at 2 mg/cm² reported improved definition between their chin and neck, compared with baseline and compared with 28% of placebo-treated controls. In addition, 32% of patients who received the lower dose of ATX-101 and 39% who got the higher dose characterized their submental fat as "a great deal better," compared with baseline, as did a mere 7% of controls.

Also, patients who received ATX-101 reported 12 weeks post treatment that they looked less overweight and were less bothered by and self-conscious about their submental fat, compared with controls.

Treatment-emergent induration, redness, bruising, numbness, and/or swelling variously occurred in one-third to two-thirds of ATX-101 recipients. All of these adverse events were more common than in placebo-treated controls. However, the events were transient and mostly mild or moderate in intensity. The exception was injection site pain, which occurred in roughly 80% of ATX-101-treated patients and was mostly moderate to severe, although it lasted a median of only 1 day, according to Dr. Rzany.

The ATX-101 treatment regimen entails up to 50 2-mL fixed-dose subcutaneous injections 1 cm apart per treatment session. Up to four treatment sessions were permitted, each separated by a minimum of 4 weeks.

In a separate presentation, Dr. Benjamin Ascher reported on 360 randomized patients who participated in the other phase III clinical trial. The two studies had the same design and endpoints.

An improvement of at least 1 point on the Clinician-Reported Submental Fat Rating Scale occurred in 58% of patients randomized to ATX-101 at the 1 mg/cm² dose, 62% of those who received the higher dose, and 35% on placebo. Moreover, 68% of patients who got ATX-101 at 1 mg/cm² were satisfied with their resultant appearance as reflected in a Subject Self-Rating Scale score of at least 4. So were 65% of those who received the higher dose and 29% of placebo-treated controls. As in the previously mentioned study, indices of self-image and psychological well being were also improved following the aesthetic therapy. Treatment-related adverse events were mostly transient and mild to moderate in intensity, according to Dr. Ascher, who is in the private practice of aesthetic surgery in Paris.

Both phase III studies were supported by Bayer HealthCare and KYTHERA Biopharmaceuticals. Dr. Rzany and Dr. Ascher serve as advisers to the companies.

bjancin@frontlinemedcom.com

ISTANBUL – Both clinicians and patients gave favorable marks to a novel injectable pharmacologic treatment for removal of unwanted submental fat – the unsightly double chin – in two phase III randomized trials presented at the annual congress of the European Academy of Dermatology and Venereology.

The investigational chin-fat buster, known as ATX-101, is a proprietary purified synthetic form of deoxycholic acid. Upon injection directly into the submental fat, ATX-101 lyses adipocytes by disrupting their cell membranes.

There is an unmet need for a rigorously studied prescription product for nonsurgical treatment of excess submental fat. Not everyone with a double chin is interested in or a good candidate for the established surgical procedures, observed Dr. Berthold Rzany, a dermatologist at Charité University Hospital, Berlin, who presented a 363-patient, randomized, placebo-controlled phase III trial at the meeting. Participants had to have a body mass index no higher than 30 kg/m², dissatisfaction with the appearance of their submental area, and a physician rating of moderate to severe submental fat. Three-quarters of the subjects were women, with a mean age of 46 years and a mean BMI of 25.7 kg/m².

One of the two primary efficacy endpoints required at least a 1-point improvement on the 0- to 4-point Clinician-Reported Submental Fat Rating Scale as assessed 12 weeks after the final treatment. This was achieved in 59% of patients randomized to ATX-101 at a dose of 1mg/cm² and 65% at 2 mg/cm², both significantly higher rates than the 23% in placebo-treated controls.

The other primary endpoint required a high level of patient satisfaction with the appearance of their face and chin after treatment as expressed in a Subject Self-Rating Scale score of 4 or more on the 0-6 scale. This endpoint was achieved in 53% of patients treated with ATX-101 at 1 mg/cm², 66% who received the agent at 2 mg/cm², and 29% of the placebo group.

ATX-101-treated patients were also significantly more likely to report perceived improvement in the visual and psychological impact of their submental fat. For example, 74% of patients who received ATX-101 at 1 mg/cm² and 80% at 2 mg/cm² reported improved definition between their chin and neck, compared with baseline and compared with 28% of placebo-treated controls. In addition, 32% of patients who received the lower dose of ATX-101 and 39% who got the higher dose characterized their submental fat as "a great deal better," compared with baseline, as did a mere 7% of controls.

Also, patients who received ATX-101 reported 12 weeks post treatment that they looked less overweight and were less bothered by and self-conscious about their submental fat, compared with controls.

Treatment-emergent induration, redness, bruising, numbness, and/or swelling variously occurred in one-third to two-thirds of ATX-101 recipients. All of these adverse events were more common than in placebo-treated controls. However, the events were transient and mostly mild or moderate in intensity. The exception was injection site pain, which occurred in roughly 80% of ATX-101-treated patients and was mostly moderate to severe, although it lasted a median of only 1 day, according to Dr. Rzany.

The ATX-101 treatment regimen entails up to 50 2-mL fixed-dose subcutaneous injections 1 cm apart per treatment session. Up to four treatment sessions were permitted, each separated by a minimum of 4 weeks.

In a separate presentation, Dr. Benjamin Ascher reported on 360 randomized patients who participated in the other phase III clinical trial. The two studies had the same design and endpoints.

An improvement of at least 1 point on the Clinician-Reported Submental Fat Rating Scale occurred in 58% of patients randomized to ATX-101 at the 1 mg/cm² dose, 62% of those who received the higher dose, and 35% on placebo. Moreover, 68% of patients who got ATX-101 at 1 mg/cm² were satisfied with their resultant appearance as reflected in a Subject Self-Rating Scale score of at least 4. So were 65% of those who received the higher dose and 29% of placebo-treated controls. As in the previously mentioned study, indices of self-image and psychological well being were also improved following the aesthetic therapy. Treatment-related adverse events were mostly transient and mild to moderate in intensity, according to Dr. Ascher, who is in the private practice of aesthetic surgery in Paris.

Both phase III studies were supported by Bayer HealthCare and KYTHERA Biopharmaceuticals. Dr. Rzany and Dr. Ascher serve as advisers to the companies.

bjancin@frontlinemedcom.com

As the date for implementing ICD-10 gets closer, consulting firms send daily offers to help us adapt to the new diagnostic regime. As a service to the profession, Under My Skin will provide periodic updates to save you consulting fees.

In an earlier column, you learned about new codes like injury from burning water skis. We also covered codes for envenomation by Gila monsters, both unintentional and intentional. You should know that these are already available under ICD-9. No need to wait till next year to use them!

ICD-9-CM E905.0: Venomous snakes and lizards causing poisoning and toxic reactions. These include the following: cobra, copperhead snake, coral snake, fer-de-lance snake, Gila monster, krait, mamba, viper, and several others. Do NOT use this code for bites by nonvenomous snakes and lizards. (That may come back to bite you ... Sorry!)

Anyone who can define a fer-de-lance or a krait is gets extra credit (but no extra payment). If you can either identify a mamba, or dance it, good for you!

ICD-10 naturally amplifies this inadequate taxonomy:

• T63.111 – Toxic effect of venom of Gila monster, accidental (unintentional)

• T63.112 – Toxic effect of venom of Gila monster, intentional (self-harm)

• T63.113 – Toxic effect of venom of Gila monster, assault

• T63.114 – Toxic effect of venom of Gila monster, undetermined

Questions: For the new "assault" code, was the Gila monster the assailant or was its owner? Does "undetermined" mean you don’t really know how you got bitten (come on, was that really an accident – weren’t you petting the Gila kind of roughly?) or that you didn’t determine whether it actually was a Gila monster (because it ran away so fast that that it could have been a marmoset).

There are other ICD-9 codes you can already use (right now!) I recently got a 6-page EMR from a referring clinic (you get those, don’t you?) listing one of the patient’s 14 diagnoses as E968.2: Assault by striking by blunt or thrown object.

This opened my eyes to:

• E968.5 – Assault by transport vehicle.

• E968.3 – Assault by hot liquid.

• E968.1 – Assault by pushing from a high place. (Questions: How high? How hot? Transporting what?)

While on the subject of injuries in high places, you might consider:

• E840.1 – Accident by powered aircraft at takeoff or landing.

Again, ICD-10 will be more comprehensive.

Looking at injury from burning water skis, we find:

• V91.07 – Burn due to water-skis on fire.

Within which are:

• V91.07XA ... initial encounter.

• V91.07XD ... subsequent encounter.

• V91.07XS ... sequela.

This is not all! V91.07 has many other subcategories:

• V91.0 – Burn due to watercraft on fire.

• V91.01 – Burn due to passenger ship on fire.

• V91.02 – Burn due to fishing boat on fire.

• V91.05 – Burn due to canoe or kayak on fire.

But wait! There is also V91.1 – Crushed between watercraft and other watercraft or other object due to collision. Within which are:

• V91.10 – Crushed between merchant ship and other watercraft or other object due to collision.

• V91.12 – Crushed between fishing boat and other watercraft or other object due to collision.

• V91.15 – Crushed between canoe or kayak and other watercraft or other object due to collision.

Each of these of course includes subcodes for: initial encounter, subsequent encounter, and sequela. (Conversion hysteria caused by paranoid fear of rampaging kayaks?)

The practical advantages to learning all this extend beyond the office. Suppose you’re fishing in a rowboat on a lazy Sunday afternoon when a kayaker waving a flaming blowtorch careens toward you full tilt and you leap overboard. When the Coast Guard pulls you out, you can shout, "V91.05! V91.15!"

In our next installment, we will take up other subsets of external causes of morbidity, including:

• W20 – struck by thrown, projected, or falling object such as:

• W20.0 – Falling object in cave (initial encounter, subsequent encounter, sequela).

• W20.1 – Struck by object due to collapse of building (ditto).

• W28 – Contact with powered lawn mower.

• W60 – Contact with nonvenomous plant thorns and spines and sharp leaves.

Master these. Future columns will cover injuries caused by forces of nature, injuries caused by supernatural means (such as witchcraft, exorcism), assassination (first episode, second episode, sequela), and acute psychosis caused by marauding ICD-10 consultants.

Dr. Rockoff practices dermatology in Brookline, Mass. He is on the clinical faculty at Tufts University School of Medicine, Boston, and has taught senior medical students and other trainees for 30 years. Dr. Rockoff has contributed to the Under My Skin column in Skin & Allergy News since January 2002.

As the date for implementing ICD-10 gets closer, consulting firms send daily offers to help us adapt to the new diagnostic regime. As a service to the profession, Under My Skin will provide periodic updates to save you consulting fees.

In an earlier column, you learned about new codes like injury from burning water skis. We also covered codes for envenomation by Gila monsters, both unintentional and intentional. You should know that these are already available under ICD-9. No need to wait till next year to use them!

ICD-9-CM E905.0: Venomous snakes and lizards causing poisoning and toxic reactions. These include the following: cobra, copperhead snake, coral snake, fer-de-lance snake, Gila monster, krait, mamba, viper, and several others. Do NOT use this code for bites by nonvenomous snakes and lizards. (That may come back to bite you ... Sorry!)

Anyone who can define a fer-de-lance or a krait is gets extra credit (but no extra payment). If you can either identify a mamba, or dance it, good for you!

ICD-10 naturally amplifies this inadequate taxonomy:

• T63.111 – Toxic effect of venom of Gila monster, accidental (unintentional)

• T63.112 – Toxic effect of venom of Gila monster, intentional (self-harm)

• T63.113 – Toxic effect of venom of Gila monster, assault

• T63.114 – Toxic effect of venom of Gila monster, undetermined

Questions: For the new "assault" code, was the Gila monster the assailant or was its owner? Does "undetermined" mean you don’t really know how you got bitten (come on, was that really an accident – weren’t you petting the Gila kind of roughly?) or that you didn’t determine whether it actually was a Gila monster (because it ran away so fast that that it could have been a marmoset).

There are other ICD-9 codes you can already use (right now!) I recently got a 6-page EMR from a referring clinic (you get those, don’t you?) listing one of the patient’s 14 diagnoses as E968.2: Assault by striking by blunt or thrown object.

This opened my eyes to:

• E968.5 – Assault by transport vehicle.

• E968.3 – Assault by hot liquid.

• E968.1 – Assault by pushing from a high place. (Questions: How high? How hot? Transporting what?)

While on the subject of injuries in high places, you might consider:

• E840.1 – Accident by powered aircraft at takeoff or landing.

Again, ICD-10 will be more comprehensive.

Looking at injury from burning water skis, we find:

• V91.07 – Burn due to water-skis on fire.

Within which are:

• V91.07XA ... initial encounter.

• V91.07XD ... subsequent encounter.

• V91.07XS ... sequela.

This is not all! V91.07 has many other subcategories:

• V91.0 – Burn due to watercraft on fire.

• V91.01 – Burn due to passenger ship on fire.

• V91.02 – Burn due to fishing boat on fire.

• V91.05 – Burn due to canoe or kayak on fire.

But wait! There is also V91.1 – Crushed between watercraft and other watercraft or other object due to collision. Within which are:

• V91.10 – Crushed between merchant ship and other watercraft or other object due to collision.

• V91.12 – Crushed between fishing boat and other watercraft or other object due to collision.

• V91.15 – Crushed between canoe or kayak and other watercraft or other object due to collision.

Each of these of course includes subcodes for: initial encounter, subsequent encounter, and sequela. (Conversion hysteria caused by paranoid fear of rampaging kayaks?)

The practical advantages to learning all this extend beyond the office. Suppose you’re fishing in a rowboat on a lazy Sunday afternoon when a kayaker waving a flaming blowtorch careens toward you full tilt and you leap overboard. When the Coast Guard pulls you out, you can shout, "V91.05! V91.15!"

In our next installment, we will take up other subsets of external causes of morbidity, including:

• W20 – struck by thrown, projected, or falling object such as:

• W20.0 – Falling object in cave (initial encounter, subsequent encounter, sequela).

• W20.1 – Struck by object due to collapse of building (ditto).

• W28 – Contact with powered lawn mower.

• W60 – Contact with nonvenomous plant thorns and spines and sharp leaves.

Master these. Future columns will cover injuries caused by forces of nature, injuries caused by supernatural means (such as witchcraft, exorcism), assassination (first episode, second episode, sequela), and acute psychosis caused by marauding ICD-10 consultants.

Dr. Rockoff practices dermatology in Brookline, Mass. He is on the clinical faculty at Tufts University School of Medicine, Boston, and has taught senior medical students and other trainees for 30 years. Dr. Rockoff has contributed to the Under My Skin column in Skin & Allergy News since January 2002.

As the date for implementing ICD-10 gets closer, consulting firms send daily offers to help us adapt to the new diagnostic regime. As a service to the profession, Under My Skin will provide periodic updates to save you consulting fees.

In an earlier column, you learned about new codes like injury from burning water skis. We also covered codes for envenomation by Gila monsters, both unintentional and intentional. You should know that these are already available under ICD-9. No need to wait till next year to use them!

ICD-9-CM E905.0: Venomous snakes and lizards causing poisoning and toxic reactions. These include the following: cobra, copperhead snake, coral snake, fer-de-lance snake, Gila monster, krait, mamba, viper, and several others. Do NOT use this code for bites by nonvenomous snakes and lizards. (That may come back to bite you ... Sorry!)

Anyone who can define a fer-de-lance or a krait is gets extra credit (but no extra payment). If you can either identify a mamba, or dance it, good for you!

ICD-10 naturally amplifies this inadequate taxonomy:

• T63.111 – Toxic effect of venom of Gila monster, accidental (unintentional)

• T63.112 – Toxic effect of venom of Gila monster, intentional (self-harm)

• T63.113 – Toxic effect of venom of Gila monster, assault

• T63.114 – Toxic effect of venom of Gila monster, undetermined

Questions: For the new "assault" code, was the Gila monster the assailant or was its owner? Does "undetermined" mean you don’t really know how you got bitten (come on, was that really an accident – weren’t you petting the Gila kind of roughly?) or that you didn’t determine whether it actually was a Gila monster (because it ran away so fast that that it could have been a marmoset).

There are other ICD-9 codes you can already use (right now!) I recently got a 6-page EMR from a referring clinic (you get those, don’t you?) listing one of the patient’s 14 diagnoses as E968.2: Assault by striking by blunt or thrown object.

This opened my eyes to:

• E968.5 – Assault by transport vehicle.

• E968.3 – Assault by hot liquid.

• E968.1 – Assault by pushing from a high place. (Questions: How high? How hot? Transporting what?)

While on the subject of injuries in high places, you might consider:

• E840.1 – Accident by powered aircraft at takeoff or landing.

Again, ICD-10 will be more comprehensive.

Looking at injury from burning water skis, we find:

• V91.07 – Burn due to water-skis on fire.

Within which are:

• V91.07XA ... initial encounter.

• V91.07XD ... subsequent encounter.

• V91.07XS ... sequela.

This is not all! V91.07 has many other subcategories:

• V91.0 – Burn due to watercraft on fire.

• V91.01 – Burn due to passenger ship on fire.

• V91.02 – Burn due to fishing boat on fire.

• V91.05 – Burn due to canoe or kayak on fire.

But wait! There is also V91.1 – Crushed between watercraft and other watercraft or other object due to collision. Within which are:

• V91.10 – Crushed between merchant ship and other watercraft or other object due to collision.

• V91.12 – Crushed between fishing boat and other watercraft or other object due to collision.

• V91.15 – Crushed between canoe or kayak and other watercraft or other object due to collision.

Each of these of course includes subcodes for: initial encounter, subsequent encounter, and sequela. (Conversion hysteria caused by paranoid fear of rampaging kayaks?)

The practical advantages to learning all this extend beyond the office. Suppose you’re fishing in a rowboat on a lazy Sunday afternoon when a kayaker waving a flaming blowtorch careens toward you full tilt and you leap overboard. When the Coast Guard pulls you out, you can shout, "V91.05! V91.15!"

In our next installment, we will take up other subsets of external causes of morbidity, including:

• W20 – struck by thrown, projected, or falling object such as:

• W20.0 – Falling object in cave (initial encounter, subsequent encounter, sequela).

• W20.1 – Struck by object due to collapse of building (ditto).

• W28 – Contact with powered lawn mower.

• W60 – Contact with nonvenomous plant thorns and spines and sharp leaves.

Master these. Future columns will cover injuries caused by forces of nature, injuries caused by supernatural means (such as witchcraft, exorcism), assassination (first episode, second episode, sequela), and acute psychosis caused by marauding ICD-10 consultants.

Dr. Rockoff practices dermatology in Brookline, Mass. He is on the clinical faculty at Tufts University School of Medicine, Boston, and has taught senior medical students and other trainees for 30 years. Dr. Rockoff has contributed to the Under My Skin column in Skin & Allergy News since January 2002.

Medical Education Library

A supplement to Skin & Allergy News. This supplement was sponsored by Medicis, a division of Valeant Pharmaceuticals.

• Herpes Simplex Virus-1: Prevalence and Diagnosis
• HSL Treatment
• XERESE^® (acyclovir and hydrocortisone) Cream 5%/1%
• Summary and Conclusions
• INDICATION
• IMPORTANT SAFETY INFORMATION

Faculty/Faculty Disclosure

Joseph Fowler, MD
University of Louisville
Louisville, Kentucky

Dr. Fowler reported that he is a member of the speakers’ bureau for Valeant Pharmaceuticals and received compensation from Valeant for his assistance in developing the content of this article.

LINKS: Click Here for PDF.

Copyright © by Frontline Medical Communications Inc.

Medical Education Library

A supplement to Skin & Allergy News. This supplement was sponsored by Medicis, a division of Valeant Pharmaceuticals.

• Herpes Simplex Virus-1: Prevalence and Diagnosis
• HSL Treatment
• XERESE^® (acyclovir and hydrocortisone) Cream 5%/1%
• Summary and Conclusions
• INDICATION
• IMPORTANT SAFETY INFORMATION

Faculty/Faculty Disclosure

Joseph Fowler, MD
University of Louisville
Louisville, Kentucky

Dr. Fowler reported that he is a member of the speakers’ bureau for Valeant Pharmaceuticals and received compensation from Valeant for his assistance in developing the content of this article.

LINKS: Click Here for PDF.

Copyright © by Frontline Medical Communications Inc.

Medical Education Library

A supplement to Skin & Allergy News. This supplement was sponsored by Medicis, a division of Valeant Pharmaceuticals.

• Herpes Simplex Virus-1: Prevalence and Diagnosis
• HSL Treatment
• XERESE^® (acyclovir and hydrocortisone) Cream 5%/1%
• Summary and Conclusions
• INDICATION
• IMPORTANT SAFETY INFORMATION

Faculty/Faculty Disclosure

Joseph Fowler, MD
University of Louisville
Louisville, Kentucky

Dr. Fowler reported that he is a member of the speakers’ bureau for Valeant Pharmaceuticals and received compensation from Valeant for his assistance in developing the content of this article.

LINKS: Click Here for PDF.

Copyright © by Frontline Medical Communications Inc.

Pressure ulcers have been the focus of an increasing amount of attention over the past few years, appearing everyplace from the local evening news to the government’s list of potentially preventable conditions, where they can carry a pretty steep financial penalty. When I was in residency, for some reason, they just did not seem to be such a common or important issue ... or perhaps we just didn’t pay them their due respect.

These days, they command the attention of legislators, hospital administrators, and physicians alike, not just the attention of nurses and patients, as in days past. Not long ago, the July 2, 2013, issue of Annals of Internal Medicine devoted a significant portion of an issue to the topic of pressure ulcers.

While I already knew pressure ulcers are a significant cause of morbidity, and, infrequently, mortality, I was shocked to learn the extent of this condition – an estimated 1.3 to 3 million adults in this country are affected – and that the cost to treat a pressure ulcer ranges between $37,800 and $70,000 – yes, each! The yearly cost to the U.S. health care system may be as high as $11 billion! That’s a figure I would expect to see with diabetes complications or advanced heart disease.

The article, titled "Pressure Ulcer Treatment Strategies: A Systematic Comparative Effectiveness Review," summarized evidence comparing the efficacy and safety of various treatment strategies for adults with pressure ulcers. Researchers found that using air-fluidized beds, protein supplementation, electrical stimulation, and radiant heat dressings had moderate-strength evidence for healing (Ann. Intern. Med. 2013 July 2;159:39-50).

Pressure ulcer treatment and prevention are too frequently passed on to nursing staff, probably in part because physicians are busy addressing the primary cause for admission and in part because, quite frankly, the nursing staff treat the ulcers on a day-to-day basis and are more likely to have received an in-service educational session about various treatments, not to mention they are often more up-to-date on the latest formulary alternatives for treating various stages of skin breakdown.

But hospitalists should also have some skin in the game, pardon my pun.

There are simple things we can do to help the surveillance for decubitus ulcers, such as having patients turn on their sides when we listen to their lungs, instead if asking them to sit up in bed or listening anteriorly. That way we can take a quick glance at their bottoms when we auscultate their lungs. We can also reposition some patients ourselves when we see them lying in an awkward position. Asking them or their family members to take part in frequent repositioning is yet another simple task. 

With the profound impact pressure ulcers can have on quality of care, risk of complications, medical costs, and even length of stay, hospitalists are in a unique position to positively influence the rate of pressure ulcer formation by having a heightened sense of awareness of our individual patient’s risk and how we can best play a major role in preventing preventable skin breakdown.

 Dr. Hester is a hospitalist with Baltimore-Washington Medical Center who has a passion for empowering patients to partner in their health care. She is the creator of the Patient Whiz, a patient-engagement app for iOS.

Pressure ulcers have been the focus of an increasing amount of attention over the past few years, appearing everyplace from the local evening news to the government’s list of potentially preventable conditions, where they can carry a pretty steep financial penalty. When I was in residency, for some reason, they just did not seem to be such a common or important issue ... or perhaps we just didn’t pay them their due respect.

These days, they command the attention of legislators, hospital administrators, and physicians alike, not just the attention of nurses and patients, as in days past. Not long ago, the July 2, 2013, issue of Annals of Internal Medicine devoted a significant portion of an issue to the topic of pressure ulcers.

While I already knew pressure ulcers are a significant cause of morbidity, and, infrequently, mortality, I was shocked to learn the extent of this condition – an estimated 1.3 to 3 million adults in this country are affected – and that the cost to treat a pressure ulcer ranges between $37,800 and $70,000 – yes, each! The yearly cost to the U.S. health care system may be as high as $11 billion! That’s a figure I would expect to see with diabetes complications or advanced heart disease.

The article, titled "Pressure Ulcer Treatment Strategies: A Systematic Comparative Effectiveness Review," summarized evidence comparing the efficacy and safety of various treatment strategies for adults with pressure ulcers. Researchers found that using air-fluidized beds, protein supplementation, electrical stimulation, and radiant heat dressings had moderate-strength evidence for healing (Ann. Intern. Med. 2013 July 2;159:39-50).

Pressure ulcer treatment and prevention are too frequently passed on to nursing staff, probably in part because physicians are busy addressing the primary cause for admission and in part because, quite frankly, the nursing staff treat the ulcers on a day-to-day basis and are more likely to have received an in-service educational session about various treatments, not to mention they are often more up-to-date on the latest formulary alternatives for treating various stages of skin breakdown.

But hospitalists should also have some skin in the game, pardon my pun.

There are simple things we can do to help the surveillance for decubitus ulcers, such as having patients turn on their sides when we listen to their lungs, instead if asking them to sit up in bed or listening anteriorly. That way we can take a quick glance at their bottoms when we auscultate their lungs. We can also reposition some patients ourselves when we see them lying in an awkward position. Asking them or their family members to take part in frequent repositioning is yet another simple task. 

With the profound impact pressure ulcers can have on quality of care, risk of complications, medical costs, and even length of stay, hospitalists are in a unique position to positively influence the rate of pressure ulcer formation by having a heightened sense of awareness of our individual patient’s risk and how we can best play a major role in preventing preventable skin breakdown.

 Dr. Hester is a hospitalist with Baltimore-Washington Medical Center who has a passion for empowering patients to partner in their health care. She is the creator of the Patient Whiz, a patient-engagement app for iOS.

Pressure ulcers have been the focus of an increasing amount of attention over the past few years, appearing everyplace from the local evening news to the government’s list of potentially preventable conditions, where they can carry a pretty steep financial penalty. When I was in residency, for some reason, they just did not seem to be such a common or important issue ... or perhaps we just didn’t pay them their due respect.

These days, they command the attention of legislators, hospital administrators, and physicians alike, not just the attention of nurses and patients, as in days past. Not long ago, the July 2, 2013, issue of Annals of Internal Medicine devoted a significant portion of an issue to the topic of pressure ulcers.

While I already knew pressure ulcers are a significant cause of morbidity, and, infrequently, mortality, I was shocked to learn the extent of this condition – an estimated 1.3 to 3 million adults in this country are affected – and that the cost to treat a pressure ulcer ranges between $37,800 and $70,000 – yes, each! The yearly cost to the U.S. health care system may be as high as $11 billion! That’s a figure I would expect to see with diabetes complications or advanced heart disease.

The article, titled "Pressure Ulcer Treatment Strategies: A Systematic Comparative Effectiveness Review," summarized evidence comparing the efficacy and safety of various treatment strategies for adults with pressure ulcers. Researchers found that using air-fluidized beds, protein supplementation, electrical stimulation, and radiant heat dressings had moderate-strength evidence for healing (Ann. Intern. Med. 2013 July 2;159:39-50).

Pressure ulcer treatment and prevention are too frequently passed on to nursing staff, probably in part because physicians are busy addressing the primary cause for admission and in part because, quite frankly, the nursing staff treat the ulcers on a day-to-day basis and are more likely to have received an in-service educational session about various treatments, not to mention they are often more up-to-date on the latest formulary alternatives for treating various stages of skin breakdown.

But hospitalists should also have some skin in the game, pardon my pun.

There are simple things we can do to help the surveillance for decubitus ulcers, such as having patients turn on their sides when we listen to their lungs, instead if asking them to sit up in bed or listening anteriorly. That way we can take a quick glance at their bottoms when we auscultate their lungs. We can also reposition some patients ourselves when we see them lying in an awkward position. Asking them or their family members to take part in frequent repositioning is yet another simple task. 

With the profound impact pressure ulcers can have on quality of care, risk of complications, medical costs, and even length of stay, hospitalists are in a unique position to positively influence the rate of pressure ulcer formation by having a heightened sense of awareness of our individual patient’s risk and how we can best play a major role in preventing preventable skin breakdown.

 Dr. Hester is a hospitalist with Baltimore-Washington Medical Center who has a passion for empowering patients to partner in their health care. She is the creator of the Patient Whiz, a patient-engagement app for iOS.

ATLANTA – Younger adults with one to three brain metastases survive longer when they are treated with stereotactic radiosurgery alone rather than whole-brain radiation therapy or a combination of both modalities, researchers reported at the annual meeting of the American Society for Radiation Oncology.

Among patients aged 35-50 years, stereotactic radiosurgery (SRS) alone was associated with hazard ratios (HR) for death ranging from 0.46 to 0.64, compared with an age-matched cohort treated with a combination of SRS and whole-brain radiation therapy (WBRT), based on a meta-analysis of data on 389 individual patients in three randomized clinical trials.

For local control, however, the data show a benefit for combined SRS and WBRT. For control of distant brain metastases, the data indicate a benefit for the combined therapies, but only among patients aged 55 years and older, reported Dr. Arjun Sahgal, associate professor of radiation oncology at the University of Toronto.

Courtesy ASTRO

"Our overall survival results favoring radiosurgery alone in younger patients may be explained by the lack of benefit of whole-brain radiation with respect to distant brain control in this cohort, while still exposing them to the harms of whole-brain radiation with respect to memory function and quality of life," he said.

Dr. Sahgal and his colleagues had previously published an aggregate meta-analysis showing that WBRT and SRS improved distant and local brain control but without overall survival benefit compared with SRS alone.

The current study looked at the raw, individual patient data from the three randomized controlled trials included in the original aggregate analysis. The trials included a 2006 study of 132 patients with an endpoint of brain tumor recurrence, a 2009 trial looking at the effect of SRS/WBRT on neurocognitive function in 58 patients, and a 2011 study examining the effect of adjuvant SRS on World Health Organization performance status scores.

The overall median time to local failure in the trials was 6.6 months for SRS alone, compared with 7.7 months for SRS/WBRT. Time to distant failure was also shorter with SRS alone, at a median of 4.7 vs. 7.7 months, respectively. Median time to death, however, was longer with SRS, at 10 vs. 8.2 months.

In a multivariate model for overall survival, the HR was 0.46 for patients at age 35 years, 0.52 at age 40, 0.58 at age 45, and 0.64 at age 50; all hazard ratios had significant confidence intervals. For patients aged 55 years and older, however, the HR for overall survival was not significant.

Patients with only one metastasis had a significantly lower risk of dying, compared with those who had two or three metastases (HR, 0.72).

The risk of local failure was significantly greater with SRS alone for patients aged 45-70.

The risk of new distant metastases was significant with SRS alone for patients aged 55 years and older, and was significantly lower for patients with one metastasis (HR, 0.63) vs. two or more metastases.

Salvage therapy was performed in 28% of patients who underwent SRS alone and 12% of those who received the combined therapies. Distant brain failures occurred in 54% of those in the SRS alone group, compared with 34% of those in the SRS/WBRT group.

Patients who underwent salvage therapy had significantly greater survival rates than those who did not, and this effect did not vary significantly by age, Dr. Sahgal reported.

The authors did not report specific funding sources. Dr. Sahgal reported having no relevant financial disclosures.

ATLANTA – Younger adults with one to three brain metastases survive longer when they are treated with stereotactic radiosurgery alone rather than whole-brain radiation therapy or a combination of both modalities, researchers reported at the annual meeting of the American Society for Radiation Oncology.

Among patients aged 35-50 years, stereotactic radiosurgery (SRS) alone was associated with hazard ratios (HR) for death ranging from 0.46 to 0.64, compared with an age-matched cohort treated with a combination of SRS and whole-brain radiation therapy (WBRT), based on a meta-analysis of data on 389 individual patients in three randomized clinical trials.

For local control, however, the data show a benefit for combined SRS and WBRT. For control of distant brain metastases, the data indicate a benefit for the combined therapies, but only among patients aged 55 years and older, reported Dr. Arjun Sahgal, associate professor of radiation oncology at the University of Toronto.

Courtesy ASTRO

"Our overall survival results favoring radiosurgery alone in younger patients may be explained by the lack of benefit of whole-brain radiation with respect to distant brain control in this cohort, while still exposing them to the harms of whole-brain radiation with respect to memory function and quality of life," he said.

Dr. Sahgal and his colleagues had previously published an aggregate meta-analysis showing that WBRT and SRS improved distant and local brain control but without overall survival benefit compared with SRS alone.

The current study looked at the raw, individual patient data from the three randomized controlled trials included in the original aggregate analysis. The trials included a 2006 study of 132 patients with an endpoint of brain tumor recurrence, a 2009 trial looking at the effect of SRS/WBRT on neurocognitive function in 58 patients, and a 2011 study examining the effect of adjuvant SRS on World Health Organization performance status scores.

The overall median time to local failure in the trials was 6.6 months for SRS alone, compared with 7.7 months for SRS/WBRT. Time to distant failure was also shorter with SRS alone, at a median of 4.7 vs. 7.7 months, respectively. Median time to death, however, was longer with SRS, at 10 vs. 8.2 months.

In a multivariate model for overall survival, the HR was 0.46 for patients at age 35 years, 0.52 at age 40, 0.58 at age 45, and 0.64 at age 50; all hazard ratios had significant confidence intervals. For patients aged 55 years and older, however, the HR for overall survival was not significant.

Patients with only one metastasis had a significantly lower risk of dying, compared with those who had two or three metastases (HR, 0.72).

The risk of local failure was significantly greater with SRS alone for patients aged 45-70.

The risk of new distant metastases was significant with SRS alone for patients aged 55 years and older, and was significantly lower for patients with one metastasis (HR, 0.63) vs. two or more metastases.

Salvage therapy was performed in 28% of patients who underwent SRS alone and 12% of those who received the combined therapies. Distant brain failures occurred in 54% of those in the SRS alone group, compared with 34% of those in the SRS/WBRT group.

Patients who underwent salvage therapy had significantly greater survival rates than those who did not, and this effect did not vary significantly by age, Dr. Sahgal reported.

The authors did not report specific funding sources. Dr. Sahgal reported having no relevant financial disclosures.

ATLANTA – Younger adults with one to three brain metastases survive longer when they are treated with stereotactic radiosurgery alone rather than whole-brain radiation therapy or a combination of both modalities, researchers reported at the annual meeting of the American Society for Radiation Oncology.

Among patients aged 35-50 years, stereotactic radiosurgery (SRS) alone was associated with hazard ratios (HR) for death ranging from 0.46 to 0.64, compared with an age-matched cohort treated with a combination of SRS and whole-brain radiation therapy (WBRT), based on a meta-analysis of data on 389 individual patients in three randomized clinical trials.

For local control, however, the data show a benefit for combined SRS and WBRT. For control of distant brain metastases, the data indicate a benefit for the combined therapies, but only among patients aged 55 years and older, reported Dr. Arjun Sahgal, associate professor of radiation oncology at the University of Toronto.

Courtesy ASTRO

"Our overall survival results favoring radiosurgery alone in younger patients may be explained by the lack of benefit of whole-brain radiation with respect to distant brain control in this cohort, while still exposing them to the harms of whole-brain radiation with respect to memory function and quality of life," he said.

Dr. Sahgal and his colleagues had previously published an aggregate meta-analysis showing that WBRT and SRS improved distant and local brain control but without overall survival benefit compared with SRS alone.

The current study looked at the raw, individual patient data from the three randomized controlled trials included in the original aggregate analysis. The trials included a 2006 study of 132 patients with an endpoint of brain tumor recurrence, a 2009 trial looking at the effect of SRS/WBRT on neurocognitive function in 58 patients, and a 2011 study examining the effect of adjuvant SRS on World Health Organization performance status scores.

The overall median time to local failure in the trials was 6.6 months for SRS alone, compared with 7.7 months for SRS/WBRT. Time to distant failure was also shorter with SRS alone, at a median of 4.7 vs. 7.7 months, respectively. Median time to death, however, was longer with SRS, at 10 vs. 8.2 months.

In a multivariate model for overall survival, the HR was 0.46 for patients at age 35 years, 0.52 at age 40, 0.58 at age 45, and 0.64 at age 50; all hazard ratios had significant confidence intervals. For patients aged 55 years and older, however, the HR for overall survival was not significant.

Patients with only one metastasis had a significantly lower risk of dying, compared with those who had two or three metastases (HR, 0.72).

The risk of local failure was significantly greater with SRS alone for patients aged 45-70.

The risk of new distant metastases was significant with SRS alone for patients aged 55 years and older, and was significantly lower for patients with one metastasis (HR, 0.63) vs. two or more metastases.

Salvage therapy was performed in 28% of patients who underwent SRS alone and 12% of those who received the combined therapies. Distant brain failures occurred in 54% of those in the SRS alone group, compared with 34% of those in the SRS/WBRT group.

Patients who underwent salvage therapy had significantly greater survival rates than those who did not, and this effect did not vary significantly by age, Dr. Sahgal reported.

The authors did not report specific funding sources. Dr. Sahgal reported having no relevant financial disclosures.

ORLANDO – Canadian teenagers with bipolar disorder who reported having headaches also had more severe disease symptoms than did those who did not have headaches, according to an unpublished study.

"We echo previous calls for screening and identification of impairing headaches, such as migraines, among people with mood disorders for two reasons," Dr. Benjamin I. Goldstein, the study’s senior author, said in an interview.

"First, presence of impairing headaches may represent a subtype of bipolar disorder with unique course, characteristics, and perhaps treatment. Second, underrecognition and undertreatment of impairing headaches is well documented among adults with bipolar disorder, and our findings suggest the potential importance of treating these headaches among youth with bipolar disorder as well," said Dr. Goldstein, of Sunnybrook Health Sciences Centre, Toronto, whose poster was presented at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

© Monkey Business Images Ltd./Thinkstockphotos.com

Most of the studies so far have been done on adults, and not much is known about this possible association among teens, noted Dr. Goldstein and his coinvestigators.

They studied 55 outpatients aged between 13 and 19 years, with bipolar disorder I, II, or not otherwise specified (NOS). Roughly 60% of the patients were female.

Thirty-three of the teens, or 60%, reported headaches, and these individuals had significantly higher rates of intake depressions score, intake mania score, and global functioning score, the researchers found.

Also, these teens had significantly greater identity confusion, anger/depression, and disinhibition/persistence.

Meanwhile, nearly half of patients with BP-II reported headaches, compared with 18% of the patients with BP-I, and 36% of those with BP-NOS.

But psychiatric hospitalizations and psychosis rates showed an opposite trend. Teens without headaches had a significantly higher rate in both categories, compared with those who had headaches.

"This was a somewhat counterintuitive finding, given the other findings of increased illness severity among youth with headaches," Dr. Goldstein wrote. "Bipolar disorder shares numerous features with psychotic disorders as well as affective disorders, such as unipolar depression and anxiety. We could speculate that whatever causal factors are implicated in headaches among youth with bipolar disorder may be more closely linked with the depression and anxiety than they are with psychosis, which is a frequent precipitant of hospitalization."

The researchers wrote that there’s a need for longitudinal studies to identify specific BP symptoms most associated with headaches, in addition to identifying biomarkers that might help with understanding the pathophysiology. There’s also a need to "identify the possible need of specific treatments for youth with BP [who] suffer from comorbid headaches."

One of the study’s limitations was its cross-sectional design and lack of a comparison group, according to the authors.

Dr. Goldstein is a consultant for Bristol-Myers Squibb and has received honoraria from Purdue Pharma.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

ORLANDO – Canadian teenagers with bipolar disorder who reported having headaches also had more severe disease symptoms than did those who did not have headaches, according to an unpublished study.

"We echo previous calls for screening and identification of impairing headaches, such as migraines, among people with mood disorders for two reasons," Dr. Benjamin I. Goldstein, the study’s senior author, said in an interview.

"First, presence of impairing headaches may represent a subtype of bipolar disorder with unique course, characteristics, and perhaps treatment. Second, underrecognition and undertreatment of impairing headaches is well documented among adults with bipolar disorder, and our findings suggest the potential importance of treating these headaches among youth with bipolar disorder as well," said Dr. Goldstein, of Sunnybrook Health Sciences Centre, Toronto, whose poster was presented at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

© Monkey Business Images Ltd./Thinkstockphotos.com

Most of the studies so far have been done on adults, and not much is known about this possible association among teens, noted Dr. Goldstein and his coinvestigators.

They studied 55 outpatients aged between 13 and 19 years, with bipolar disorder I, II, or not otherwise specified (NOS). Roughly 60% of the patients were female.

Thirty-three of the teens, or 60%, reported headaches, and these individuals had significantly higher rates of intake depressions score, intake mania score, and global functioning score, the researchers found.

Also, these teens had significantly greater identity confusion, anger/depression, and disinhibition/persistence.

Meanwhile, nearly half of patients with BP-II reported headaches, compared with 18% of the patients with BP-I, and 36% of those with BP-NOS.

But psychiatric hospitalizations and psychosis rates showed an opposite trend. Teens without headaches had a significantly higher rate in both categories, compared with those who had headaches.

"This was a somewhat counterintuitive finding, given the other findings of increased illness severity among youth with headaches," Dr. Goldstein wrote. "Bipolar disorder shares numerous features with psychotic disorders as well as affective disorders, such as unipolar depression and anxiety. We could speculate that whatever causal factors are implicated in headaches among youth with bipolar disorder may be more closely linked with the depression and anxiety than they are with psychosis, which is a frequent precipitant of hospitalization."

The researchers wrote that there’s a need for longitudinal studies to identify specific BP symptoms most associated with headaches, in addition to identifying biomarkers that might help with understanding the pathophysiology. There’s also a need to "identify the possible need of specific treatments for youth with BP [who] suffer from comorbid headaches."

One of the study’s limitations was its cross-sectional design and lack of a comparison group, according to the authors.

Dr. Goldstein is a consultant for Bristol-Myers Squibb and has received honoraria from Purdue Pharma.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

ORLANDO – Canadian teenagers with bipolar disorder who reported having headaches also had more severe disease symptoms than did those who did not have headaches, according to an unpublished study.

"We echo previous calls for screening and identification of impairing headaches, such as migraines, among people with mood disorders for two reasons," Dr. Benjamin I. Goldstein, the study’s senior author, said in an interview.

"First, presence of impairing headaches may represent a subtype of bipolar disorder with unique course, characteristics, and perhaps treatment. Second, underrecognition and undertreatment of impairing headaches is well documented among adults with bipolar disorder, and our findings suggest the potential importance of treating these headaches among youth with bipolar disorder as well," said Dr. Goldstein, of Sunnybrook Health Sciences Centre, Toronto, whose poster was presented at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

© Monkey Business Images Ltd./Thinkstockphotos.com

Most of the studies so far have been done on adults, and not much is known about this possible association among teens, noted Dr. Goldstein and his coinvestigators.

They studied 55 outpatients aged between 13 and 19 years, with bipolar disorder I, II, or not otherwise specified (NOS). Roughly 60% of the patients were female.

Thirty-three of the teens, or 60%, reported headaches, and these individuals had significantly higher rates of intake depressions score, intake mania score, and global functioning score, the researchers found.

Also, these teens had significantly greater identity confusion, anger/depression, and disinhibition/persistence.

Meanwhile, nearly half of patients with BP-II reported headaches, compared with 18% of the patients with BP-I, and 36% of those with BP-NOS.

But psychiatric hospitalizations and psychosis rates showed an opposite trend. Teens without headaches had a significantly higher rate in both categories, compared with those who had headaches.

"This was a somewhat counterintuitive finding, given the other findings of increased illness severity among youth with headaches," Dr. Goldstein wrote. "Bipolar disorder shares numerous features with psychotic disorders as well as affective disorders, such as unipolar depression and anxiety. We could speculate that whatever causal factors are implicated in headaches among youth with bipolar disorder may be more closely linked with the depression and anxiety than they are with psychosis, which is a frequent precipitant of hospitalization."

The researchers wrote that there’s a need for longitudinal studies to identify specific BP symptoms most associated with headaches, in addition to identifying biomarkers that might help with understanding the pathophysiology. There’s also a need to "identify the possible need of specific treatments for youth with BP [who] suffer from comorbid headaches."

One of the study’s limitations was its cross-sectional design and lack of a comparison group, according to the authors.

Dr. Goldstein is a consultant for Bristol-Myers Squibb and has received honoraria from Purdue Pharma.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller