Therese Borden is the editor of CHEST Physician. After 20 years of research, writing, and editing in the field of international development and economics, she began working in the field of medical editing and has held a variety of editorial positions with the company. She holds a PhD in International Economics from American University, Washington, and a BA in history from the University of Washington, Seattle.

FDA Releases New Sunscreen Label Regulations

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FDA Releases New Sunscreen Label Regulations

The Food and Drug Administration has issued new rules on sunscreen labeling to help consumers select products that prevent sunburn and reduce the risk of skin cancer and early skin aging.

The new labeling will differentiate sunscreen products according to their protective properties. Those products that meet FDA requirements of protection from ultraviolet A (UVA) and ultraviolet B (UVB) will be labeled "Broad Spectrum."

Photo courtesy FDA
    

UVA and UVB radiation are known to contribute to sunburn, skin cancer, and premature skin aging. Under the new rules, only products that qualify as broad spectrum and have SPF values of 15 (or higher) can include labeling that the product helps prevent skin cancer and reduces the risk of early skin aging. Other products with SPF values between 2 and 14 may be labeled broad spectrum if they meet FDA tests for UVA and UVB protection, but will be required to have a warning stating that the product has not been shown to prevent skin cancer or early skin aging.

"FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families."

The new regulations will go into effective in 1 year for most manufacturers. Other sunscreen makers with annual sales of less than $25,000 will have 2 years to comply with the new rules.

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The Food and Drug Administration has issued new rules on sunscreen labeling to help consumers select products that prevent sunburn and reduce the risk of skin cancer and early skin aging.

The new labeling will differentiate sunscreen products according to their protective properties. Those products that meet FDA requirements of protection from ultraviolet A (UVA) and ultraviolet B (UVB) will be labeled "Broad Spectrum."

Photo courtesy FDA
    

UVA and UVB radiation are known to contribute to sunburn, skin cancer, and premature skin aging. Under the new rules, only products that qualify as broad spectrum and have SPF values of 15 (or higher) can include labeling that the product helps prevent skin cancer and reduces the risk of early skin aging. Other products with SPF values between 2 and 14 may be labeled broad spectrum if they meet FDA tests for UVA and UVB protection, but will be required to have a warning stating that the product has not been shown to prevent skin cancer or early skin aging.

"FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families."

The new regulations will go into effective in 1 year for most manufacturers. Other sunscreen makers with annual sales of less than $25,000 will have 2 years to comply with the new rules.

The Food and Drug Administration has issued new rules on sunscreen labeling to help consumers select products that prevent sunburn and reduce the risk of skin cancer and early skin aging.

The new labeling will differentiate sunscreen products according to their protective properties. Those products that meet FDA requirements of protection from ultraviolet A (UVA) and ultraviolet B (UVB) will be labeled "Broad Spectrum."

Photo courtesy FDA
    

UVA and UVB radiation are known to contribute to sunburn, skin cancer, and premature skin aging. Under the new rules, only products that qualify as broad spectrum and have SPF values of 15 (or higher) can include labeling that the product helps prevent skin cancer and reduces the risk of early skin aging. Other products with SPF values between 2 and 14 may be labeled broad spectrum if they meet FDA tests for UVA and UVB protection, but will be required to have a warning stating that the product has not been shown to prevent skin cancer or early skin aging.

"FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families."

The new regulations will go into effective in 1 year for most manufacturers. Other sunscreen makers with annual sales of less than $25,000 will have 2 years to comply with the new rules.

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FDA Releases New Sunscreen Label Regulations

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FDA Releases New Sunscreen Label Regulations

The Food and Drug Administration has issued new rules on sunscreen labeling to help consumers select products that prevent sunburn and reduce the risk of skin cancer and early skin aging.

The new labeling will differentiate sunscreen products according to their protective properties. Those products that meet FDA requirements of protection from ultraviolet A (UVA) and ultraviolet B (UVB) will be labeled "Broad Spectrum."

Photo courtesy FDA
    

UVA and UVB radiation are known to contribute to sunburn, skin cancer, and premature skin aging. Under the new rules, only products that qualify as broad spectrum and have SPF values of 15 (or higher) can include labeling that the product helps prevent skin cancer and reduces the risk of early skin aging. Other products with SPF values between 2 and 14 may be labeled broad spectrum if they meet FDA tests for UVA and UVB protection, but will be required to have a warning stating that the product has not been shown to prevent skin cancer or early skin aging.

"FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families."

The new regulations will go into effective in 1 year for most manufacturers. Other sunscreen makers with annual sales of less than $25,000 will have 2 years to comply with the new rules.

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The Food and Drug Administration has issued new rules on sunscreen labeling to help consumers select products that prevent sunburn and reduce the risk of skin cancer and early skin aging.

The new labeling will differentiate sunscreen products according to their protective properties. Those products that meet FDA requirements of protection from ultraviolet A (UVA) and ultraviolet B (UVB) will be labeled "Broad Spectrum."

Photo courtesy FDA
    

UVA and UVB radiation are known to contribute to sunburn, skin cancer, and premature skin aging. Under the new rules, only products that qualify as broad spectrum and have SPF values of 15 (or higher) can include labeling that the product helps prevent skin cancer and reduces the risk of early skin aging. Other products with SPF values between 2 and 14 may be labeled broad spectrum if they meet FDA tests for UVA and UVB protection, but will be required to have a warning stating that the product has not been shown to prevent skin cancer or early skin aging.

"FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families."

The new regulations will go into effective in 1 year for most manufacturers. Other sunscreen makers with annual sales of less than $25,000 will have 2 years to comply with the new rules.

The Food and Drug Administration has issued new rules on sunscreen labeling to help consumers select products that prevent sunburn and reduce the risk of skin cancer and early skin aging.

The new labeling will differentiate sunscreen products according to their protective properties. Those products that meet FDA requirements of protection from ultraviolet A (UVA) and ultraviolet B (UVB) will be labeled "Broad Spectrum."

Photo courtesy FDA
    

UVA and UVB radiation are known to contribute to sunburn, skin cancer, and premature skin aging. Under the new rules, only products that qualify as broad spectrum and have SPF values of 15 (or higher) can include labeling that the product helps prevent skin cancer and reduces the risk of early skin aging. Other products with SPF values between 2 and 14 may be labeled broad spectrum if they meet FDA tests for UVA and UVB protection, but will be required to have a warning stating that the product has not been shown to prevent skin cancer or early skin aging.

"FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families."

The new regulations will go into effective in 1 year for most manufacturers. Other sunscreen makers with annual sales of less than $25,000 will have 2 years to comply with the new rules.

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DEVELOPING STORY: Abbott Agrees to Pull Obesity Drug Meridia Off the Market

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DEVELOPING STORY: Abbott Agrees to Pull Obesity Drug Meridia Off the Market

The Food and Drug Administration announced today that Meridia (sibutramine), a drug used for treating obesity, will be voluntarily removed from the U.S. market by its maker, Abbott Laboratories. The withdrawal is the result of clinical trial data indicating an association between Meridia use and increased risk of heart attack and stroke.

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The Food and Drug Administration announced today that Meridia (sibutramine), a drug used for treating obesity, will be voluntarily removed from the U.S. market by its maker, Abbott Laboratories. The withdrawal is the result of clinical trial data indicating an association between Meridia use and increased risk of heart attack and stroke.

The Food and Drug Administration announced today that Meridia (sibutramine), a drug used for treating obesity, will be voluntarily removed from the U.S. market by its maker, Abbott Laboratories. The withdrawal is the result of clinical trial data indicating an association between Meridia use and increased risk of heart attack and stroke.

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Octagam Withdrawn From U.S. Market

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Octagam Withdrawn From U.S. Market

The Food and Drug Administration has announced a voluntary manufacturer withdrawal of all lots of Octagam (an intravenous human normal immunoglobulin solution), effective immediately.

The action comes in response to reports of thromboembolic events associated with the use of Octagam (manufactured by Octapharma USA) and follows an Aug. 20 recall of selected lots of the drug.

Octagam is indicated for treatment of primary humoral immunodeficiency (such as congenital agammaglobulinemia), common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Octapharma received no further reports of thromboembolic events since the recall of selected lots but has withdrawn the drug until the cause of the events can be determined and the problem corrected.

Customers are being asked to immediately quarantine their supply of Octagam and to contact Octapharma’s customer service department by telephone at 866-766-4860 or by e-mail at uscustomerservice@octapharma.com to arrange for product return.

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The Food and Drug Administration has announced a voluntary manufacturer withdrawal of all lots of Octagam (an intravenous human normal immunoglobulin solution), effective immediately.

The action comes in response to reports of thromboembolic events associated with the use of Octagam (manufactured by Octapharma USA) and follows an Aug. 20 recall of selected lots of the drug.

Octagam is indicated for treatment of primary humoral immunodeficiency (such as congenital agammaglobulinemia), common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Octapharma received no further reports of thromboembolic events since the recall of selected lots but has withdrawn the drug until the cause of the events can be determined and the problem corrected.

Customers are being asked to immediately quarantine their supply of Octagam and to contact Octapharma’s customer service department by telephone at 866-766-4860 or by e-mail at uscustomerservice@octapharma.com to arrange for product return.

The Food and Drug Administration has announced a voluntary manufacturer withdrawal of all lots of Octagam (an intravenous human normal immunoglobulin solution), effective immediately.

The action comes in response to reports of thromboembolic events associated with the use of Octagam (manufactured by Octapharma USA) and follows an Aug. 20 recall of selected lots of the drug.

Octagam is indicated for treatment of primary humoral immunodeficiency (such as congenital agammaglobulinemia), common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Octapharma received no further reports of thromboembolic events since the recall of selected lots but has withdrawn the drug until the cause of the events can be determined and the problem corrected.

Customers are being asked to immediately quarantine their supply of Octagam and to contact Octapharma’s customer service department by telephone at 866-766-4860 or by e-mail at uscustomerservice@octapharma.com to arrange for product return.

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Octagam Withdrawn From U.S. Market

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Octagam Withdrawn From U.S. Market

The Food and Drug Administration has announced a voluntary manufacturer withdrawal of all lots of Octagam (an intravenous human normal immunoglobulin solution), effective immediately.

The action comes in response to reports of thromboembolic events associated with the use of Octagam (manufactured by Octapharma USA) and follows an Aug. 20 recall of selected lots of the drug.

Octagam is indicated for treatment of primary humoral immunodeficiency (such as congenital agammaglobulinemia), common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Octapharma received no further reports of thromboembolic events since the recall of selected lots but has withdrawn the drug until the cause of the events can be determined and the problem corrected.

Customers are being asked to immediately quarantine their supply of Octagam and to contact Octapharma’s customer service department by telephone at 866-766-4860 or by e-mail at uscustomerservice@octapharma.com to arrange for product return.

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Octagam, humoral immunodeficiency, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies, FDA, Octapharma USA, recall, thromboembolic events
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The Food and Drug Administration has announced a voluntary manufacturer withdrawal of all lots of Octagam (an intravenous human normal immunoglobulin solution), effective immediately.

The action comes in response to reports of thromboembolic events associated with the use of Octagam (manufactured by Octapharma USA) and follows an Aug. 20 recall of selected lots of the drug.

Octagam is indicated for treatment of primary humoral immunodeficiency (such as congenital agammaglobulinemia), common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Octapharma received no further reports of thromboembolic events since the recall of selected lots but has withdrawn the drug until the cause of the events can be determined and the problem corrected.

Customers are being asked to immediately quarantine their supply of Octagam and to contact Octapharma’s customer service department by telephone at 866-766-4860 or by e-mail at uscustomerservice@octapharma.com to arrange for product return.

The Food and Drug Administration has announced a voluntary manufacturer withdrawal of all lots of Octagam (an intravenous human normal immunoglobulin solution), effective immediately.

The action comes in response to reports of thromboembolic events associated with the use of Octagam (manufactured by Octapharma USA) and follows an Aug. 20 recall of selected lots of the drug.

Octagam is indicated for treatment of primary humoral immunodeficiency (such as congenital agammaglobulinemia), common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Octapharma received no further reports of thromboembolic events since the recall of selected lots but has withdrawn the drug until the cause of the events can be determined and the problem corrected.

Customers are being asked to immediately quarantine their supply of Octagam and to contact Octapharma’s customer service department by telephone at 866-766-4860 or by e-mail at uscustomerservice@octapharma.com to arrange for product return.

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Octagam, humoral immunodeficiency, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies, FDA, Octapharma USA, recall, thromboembolic events
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Early Abuse Tied to Later Physical Ailments

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Early Abuse Tied to Later Physical Ailments

Abuse and neglect during childhood appear to be associated with poor physical health just as early abuse affects adult emotional health, a meta-analysis of studies involving more than 40,000 people shows.

The object of the meta-analysis was to assess the evidence on the relationship between abuse in childhood and physical health outcomes, and to examine the role of variables such as specific health outcomes, gender, and type of abuse.

“Although the consequences of childhood sexual abuse have been explored extensively in the psychiatric literature, other forms of abuse such as physical abuse, emotional abuse, or neglect have important effects on well-being in adulthood, although their unique effect is just beginning to be understood,” wrote Holly L. Wegman, of Wake Forest University, Winston-Salem, N.C., and Cinnamon Stetler, Ph.D., of Furman University, Greenville, S.C. (Psychosomatic Med. 2009;71:805-12).

The researchers conducted a systematic review of 24 studies involving 48,801 individuals. From each study, data were coded for the following variables: health outcome, sex, average age of sample, type of abuse (physical, sexual, emotional, neglect), method used to assess abuse (self-report or objective method), and method used to assess health outcome (self-report or objective method). The meta-analysis yielded a small to medium weighted mean effect size (Cohen's d = 0.42, 95% confidence interval 0.39-0.45) for the association between childhood abuse and physical disorders in adulthood.

Neurologic and musculoskeletal disease showed the strongest association with childhood abuse, followed by respiratory, cardiovascular, and gastrointestinal disorders.

Nineteen of the 24 studies used self-report methods, which the researchers said “are subject to reporting biases that could introduce unreliability and adult magnitude of the relationship between child abuse and adult health.” Despite the potential for bias, no significant difference was found between the two groups in the strength of the association between early abuse and adult health outcomes.

Another potential source of bias is the overrepresentation of females in the study; 16 of the studies had an entirely female sample. The association between abuse and later physical disorders was stronger among the female-only studies (d = 0.66) than among the mixed-gender samples (0.49), but this finding may reflect the male underrepresentation.

The researchers noted that the association between childhood maltreatment and later health problems appeared to be comparable to the child abuse and psychological disorders correlation found in previous studies (Child Maltreat. 1996;1:6-16; J. Psychol. 2001;135:17-36; Clin. J. Pain 2005;21:398-405).

Ms. Wegman and Dr. Stetler speculated that neurologic and musculoskeletal problems might have the largest effects because “these are the types of conditions that persist as direct effects of the physical abuse in childhood.” Child abuse victims might be at a greater risk for respiratory, cardiovascular, and gastrointestinal problems because they are more likely than their nonabused counterparts to engage in dangerous health behaviors, such as smoking and excessive alcohol consumption, they said.

The meta-analysis contributes to the research on the relationship between childhood maltreatment and adult health problems, but it also highlights gaps in the literature. Studies that are more representative in terms of gender and age groups, more objective in methodogy, and more specific about types of abuse are needed to pinpoint the relationship between abuse and health outcomes.

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Abuse and neglect during childhood appear to be associated with poor physical health just as early abuse affects adult emotional health, a meta-analysis of studies involving more than 40,000 people shows.

The object of the meta-analysis was to assess the evidence on the relationship between abuse in childhood and physical health outcomes, and to examine the role of variables such as specific health outcomes, gender, and type of abuse.

“Although the consequences of childhood sexual abuse have been explored extensively in the psychiatric literature, other forms of abuse such as physical abuse, emotional abuse, or neglect have important effects on well-being in adulthood, although their unique effect is just beginning to be understood,” wrote Holly L. Wegman, of Wake Forest University, Winston-Salem, N.C., and Cinnamon Stetler, Ph.D., of Furman University, Greenville, S.C. (Psychosomatic Med. 2009;71:805-12).

The researchers conducted a systematic review of 24 studies involving 48,801 individuals. From each study, data were coded for the following variables: health outcome, sex, average age of sample, type of abuse (physical, sexual, emotional, neglect), method used to assess abuse (self-report or objective method), and method used to assess health outcome (self-report or objective method). The meta-analysis yielded a small to medium weighted mean effect size (Cohen's d = 0.42, 95% confidence interval 0.39-0.45) for the association between childhood abuse and physical disorders in adulthood.

Neurologic and musculoskeletal disease showed the strongest association with childhood abuse, followed by respiratory, cardiovascular, and gastrointestinal disorders.

Nineteen of the 24 studies used self-report methods, which the researchers said “are subject to reporting biases that could introduce unreliability and adult magnitude of the relationship between child abuse and adult health.” Despite the potential for bias, no significant difference was found between the two groups in the strength of the association between early abuse and adult health outcomes.

Another potential source of bias is the overrepresentation of females in the study; 16 of the studies had an entirely female sample. The association between abuse and later physical disorders was stronger among the female-only studies (d = 0.66) than among the mixed-gender samples (0.49), but this finding may reflect the male underrepresentation.

The researchers noted that the association between childhood maltreatment and later health problems appeared to be comparable to the child abuse and psychological disorders correlation found in previous studies (Child Maltreat. 1996;1:6-16; J. Psychol. 2001;135:17-36; Clin. J. Pain 2005;21:398-405).

Ms. Wegman and Dr. Stetler speculated that neurologic and musculoskeletal problems might have the largest effects because “these are the types of conditions that persist as direct effects of the physical abuse in childhood.” Child abuse victims might be at a greater risk for respiratory, cardiovascular, and gastrointestinal problems because they are more likely than their nonabused counterparts to engage in dangerous health behaviors, such as smoking and excessive alcohol consumption, they said.

The meta-analysis contributes to the research on the relationship between childhood maltreatment and adult health problems, but it also highlights gaps in the literature. Studies that are more representative in terms of gender and age groups, more objective in methodogy, and more specific about types of abuse are needed to pinpoint the relationship between abuse and health outcomes.

Abuse and neglect during childhood appear to be associated with poor physical health just as early abuse affects adult emotional health, a meta-analysis of studies involving more than 40,000 people shows.

The object of the meta-analysis was to assess the evidence on the relationship between abuse in childhood and physical health outcomes, and to examine the role of variables such as specific health outcomes, gender, and type of abuse.

“Although the consequences of childhood sexual abuse have been explored extensively in the psychiatric literature, other forms of abuse such as physical abuse, emotional abuse, or neglect have important effects on well-being in adulthood, although their unique effect is just beginning to be understood,” wrote Holly L. Wegman, of Wake Forest University, Winston-Salem, N.C., and Cinnamon Stetler, Ph.D., of Furman University, Greenville, S.C. (Psychosomatic Med. 2009;71:805-12).

The researchers conducted a systematic review of 24 studies involving 48,801 individuals. From each study, data were coded for the following variables: health outcome, sex, average age of sample, type of abuse (physical, sexual, emotional, neglect), method used to assess abuse (self-report or objective method), and method used to assess health outcome (self-report or objective method). The meta-analysis yielded a small to medium weighted mean effect size (Cohen's d = 0.42, 95% confidence interval 0.39-0.45) for the association between childhood abuse and physical disorders in adulthood.

Neurologic and musculoskeletal disease showed the strongest association with childhood abuse, followed by respiratory, cardiovascular, and gastrointestinal disorders.

Nineteen of the 24 studies used self-report methods, which the researchers said “are subject to reporting biases that could introduce unreliability and adult magnitude of the relationship between child abuse and adult health.” Despite the potential for bias, no significant difference was found between the two groups in the strength of the association between early abuse and adult health outcomes.

Another potential source of bias is the overrepresentation of females in the study; 16 of the studies had an entirely female sample. The association between abuse and later physical disorders was stronger among the female-only studies (d = 0.66) than among the mixed-gender samples (0.49), but this finding may reflect the male underrepresentation.

The researchers noted that the association between childhood maltreatment and later health problems appeared to be comparable to the child abuse and psychological disorders correlation found in previous studies (Child Maltreat. 1996;1:6-16; J. Psychol. 2001;135:17-36; Clin. J. Pain 2005;21:398-405).

Ms. Wegman and Dr. Stetler speculated that neurologic and musculoskeletal problems might have the largest effects because “these are the types of conditions that persist as direct effects of the physical abuse in childhood.” Child abuse victims might be at a greater risk for respiratory, cardiovascular, and gastrointestinal problems because they are more likely than their nonabused counterparts to engage in dangerous health behaviors, such as smoking and excessive alcohol consumption, they said.

The meta-analysis contributes to the research on the relationship between childhood maltreatment and adult health problems, but it also highlights gaps in the literature. Studies that are more representative in terms of gender and age groups, more objective in methodogy, and more specific about types of abuse are needed to pinpoint the relationship between abuse and health outcomes.

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