- Email: [email protected]
Glucose-tolerance testing in acute myocardial infarction
COMMENTARY
Several as yet unpublished sub-studies from the ATAC trial provide additional crucial information. At this year’s ASCO meeting, abstracts were presented showing less abnormal endometrial histopathology in patients on anastrozole compared with tamoxifen.6 In addition, preliminary surveys of quality of life showed no major differences between anastrozole and tamoxifen,7 which was not unexpected but reassuring, since, in a study comparing tamoxifen and placebo, no differences in quality of life were found.8 The ATAC trial also has sub-studies evaluating bone mineral density and lipid profiles. Perhaps the most interesting studies are biological correlates of tumour biomarkers with outcome. Great interest centres on whether patients who are Her2-positive (a population which seems less sensitive to tamoxifen) will benefit from anastrozole.9 The ATAC trial is the initial vanguard of several trials that will examine aromatase inhibitors in breast cancer, including anastrozole, letrozole, and exemestane. With the major probable drawback of a long-term effect of anastrozole being accelerated bone loss, questions about whether all aromatase inhibitors cause this effect, and of how this might be prevented with the concurrent use of bisphosphonates (agents which may have independent antirecurrence effects of their own) are important. Early reporting rules can powerfully affect what information can be gleaned from a trial, particularly if they cause a trial to be reported when many of the patients have not completed therapy, as in ATAC. Early reporting is particularly important when the therapy which is the current standard of care must be given over a long period. In the ATAC trial, patients are to be informed of the early results. It remains to be seen how many of the patients on the two remaining blinded arms will continue to take the therapy that they were randomised to. Peter Ravdin Department of Medical Oncology, University of Texas Health Science Center, San Antonio, TX 98284-7884, USA (e-mail: [email protected]) 1
2
3
4 5
6
7
8
Ravdin PM, Green S, Dorr M et al. Prognostic significance of progesterone receptor levels in estrogen receptor-positive patients with metastatic breast cancer treated with tamoxifen: results of a prospective Southwest Oncology Group Study. J Clin Oncol 1992: 10: 1284–91. Early Breast Cancer Trialists’ Collaborative Group. Tamoxifen for early breast cancer: an overview of the randomised trials. Lancet 1998; 351: 1451–67. Fisher B, Constantino JP, Wickerham DL, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst 1998; 90: 1371–88. Osborne CK. Tamoxifen in the treatment of breast cancer. N Engl J Med 1998; 339: 1609–18. Winer E, Hudis C, Burstein HJ, et al. American Society of Clinical Oncology technology assessment on the use of aromatase inhibitors as adjuvant therapy for women with hormone receptor positive breast cancer: status report 2002. http://www.asco.org/prof/pp/html/guidelines/ai.htm (accessed on June 17). Duffy SR, Jackson TL, et al. The ATAC (‘Arimidex’, tamoxifen, alone or in combination) early breast cancer (EBC) trial in postmenopausal (PM) patients: endometrial sub-protocol results. Proc ASCO 2002; 21: abstr 158. Fallowfield L, Cella CR. Assessing the quality of life (QOL) of postmenopausal (PM) women randomized into the ATAC (‘Arimidex’, tamoxifen, alone or in combination) adjuvant breast cancer (BC) trial. Proc ASCO 2002; 21: abstr 159. Day R, Ganz PA, Costantino JP, Cronin WM, Wickerham DL, Fisher B. Health-related quality of life and tamoxifen in breast cancer prevention: a report from the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Clin Oncol 1999; 17: 2659–69.
THE LANCET • Vol 359 • June 22, 2002 • www.thelancet.com
9
Ellis MJ, Coop A, Singh B, et al. Letrozole is more effective neoadjuvant endocrine therapy than tamoxifen for ErbB-1- and/or ErbB-2-positive, estrogen receptor-positive primary breast cancer: evidence from a phase III randomized trial. J Clin Oncol 2001; 19: 3808–16.
Glucose-tolerance testing in acute myocardial infarction See page 2140 Type 2 diabetes is associated with an increased incidence of coronary heart disease.1 In some studies, individuals with type 2 diabetes but without previous coronary heart disease have a risk of future myocardial infarction similar to that of non-diabetic patients with coronary heart disease.1 Furthermore, diabetic patients with a myocardial infarction have a worse risk of dying.2 Even milder degrees of glucose intolerance, such as impaired glucose tolerance3 or mild glucose elevations in the non-diabetic range4 are associated with increased coronary heart disease. Indeed, cardiovascular risk factors are higher even before the onset of type 2 diabetes.5 Thus the increased risk of coronary heart disease in type 2 diabetes and even in milder states of glucose intolerance is a public-health problem. The article in today’s Lancet by Anna Norhammar and colleagues helps to clarify just how serious this risk is. In the Norhammar report, of 181 consecutive patients with acute myocardial infarction but without a previous clinical diagnosis of type 2 diabetes, 31% had diabetes and 35% had glucose intolerance. This finding represents a larger proportion of patients with acute myocardial infarction than has been previously recognised. Of interest is that the fasting plasma-glucose criteria suggested by the American Diabetes Association6 identified only about one in three individuals defined as diabetic by the oral glucosetolerance test, clearly an unacceptable performance. Although the investigators develop predicting equations based on fasting glucose and glycosylated haemoglobin, in view of the high risk of future coronary heart disease in patients with diabetes, it is reasonable to suggest an oral glucose-tolerance test at discharge after a myocardial infarction. Although the glucose-tolerance test is burdensome for screening in the general population, it is less so in hospitalised patients. The high frequency of newly discovered diabetes is also important because intensive glycaemic control with insulin during the peri-infarction period followed by improved glycaemic control as outpatients lowers the mortality from acute myocardial infarction.7 Additionally, improved glycaemic control in a predominantly non-diabetic Belgian population, who were intubated in an intensive care unit, showed much lower mortality.8 Thus intensive insulin use may also benefit patients who have an acute myocardial infarction and impaired glucose tolerance. This hypothesis should be tested in trials. One possible objection to the use of an oral glucosetolerance test is that the test has been said to be highly variable. Norhammar and colleagues showed that the overall frequency of impaired glucose tolerance in patients with type 2 diabetes was similar after 3 months to that at discharge. However, whether the same people had impaired glucose tolerance at discharge and 3 months later is unclear. 2127
For personal use. Only reproduce with permission from The Lancet Publishing Group.
COMMENTARY
What might new trials build on the interesting results from Norhammar’s report, in view of the high frequency of impaired glucose tolerance in individuals after a myocardial infarction? It might be possible to design studies to prevent type 2 diabetes just among patients who have had an acute myocardial infarction. These patients will not only have a high risk of developing type 2 diabetes but are also likely to be at high risk of future coronary heart disease. The same study might have adequate power to assess both prevention of type 2 diabetes and cardiovascular disease. Because people with impaired glucose tolerance do not currently require a pharmacological intervention, this setting could prove attractive for testing whether agonists at the peroxisome proliferatoractivated receptor prevent both heart disease and type 2 diabetes. For ethical reasons, all patients would need to be offered a lifestyle intervention, because the American Diabetes Prevention Program has shown that both intensive lifestyle advice, without an active pharmacological agent, and metformin reduce the frequency of type 2 diabetes by 58% and 31%, respectively.9 However, the number of incident cardiovascular events in the American Diabetes Prevention Program was very low in these individuals with impaired glucose tolerance. Randomisation before discharge in patients with myocardial infarction or unstable angina has been used successfully with a statin in the MIRACL trial.10 A similar strategy should be adopted in people with type 2 diabetes or possibly impaired glucose tolerance with use of newer types of diabetic agents. Steven M Haffner Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX 78229–3900, USA (e-mail: [email protected]) 1
Haffner SM, Lehto S, Rönnemaa T, Pyörälä K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without previous myocardial infarction: implications for treatment of hyperlipidemia in diabetic subjects without prior myocardial infarction. N Engl J Med 1998; 339: 229–34. 2 Miettinen H, Lehto S, Salomaa V, et al. Impact of diabetes on mortality after first myocardial infarction. Diabetes Care 1998; 21: 69–75. 3 Fuller JH, Shipley MJ, Rose G, Jarret RJ, Keen H. Coronary-heartdisease risk and impaired glucose tolerance: the Whitehall study. Lancet 1980; 1: 1373–76. 4 The DECODE study group on behalf of the European diabetes epidemiology group. Glucose tolerance and mortality: comparison of WHO and American Diabetic Association Diagnostic criteria. Lancet 1999; 354: 617–21. 5 Haffner SM, Mykkänen L, Festa A, Burke J, Stern M. Insulin resistant prediabetic subjects have more atherogenic risk factors than insulin sensitive prediabetic subjects: implications for preventing coronary heart disease during the prediabetic state. Circulation 2000; 101: 975–80. 6 The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Report of the expert committee on the diagnosis and classification of diabetes mellitus. Diabetes Care 1997; 20: 1183–97. 7 Malmberg K, Ryden L, Efendic S, et al. Randomized trial of insulinglucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction (DIGAMI study): effects on mortality at 1 year. Am J Coll Cardiol 1995; 26: 57–65. 8 Van den Berghe G, Wouters P, Weekers F, et al. Intensive insulin therapy in critically ill patients. N Engl J Med 2001; 345: 1359–67. 9 Diabetes Prevention Program Writing Group for the DPP Investigators. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002; 346: 393–403. 10 Schwartz GG, Olsson AG, Ezekowitz MD, et al. Effects of
2128
atorvastatin on early recurrent ischemic events in acute coronary syndromes. The MIRACL study: a randomized clinical trial. JAMA 2001; 285: 1711–18.
Responding to fear of childbirth It is common (indeed rational) for women to feel fearful about childbirth. Childbirth is inherently unpredictable and painful, and accompanied by a small risk of serious morbidity or even death for both mother and child. Most women cope with and overcome their fears. A few have extreme fear or anxiety, sometimes expressed as a morbid dread of childbirth (tokophobia)1 or a request for caesarean section without a medical problem. Conversely, some women are unable to consent to a desirable intervention in the face of a compelling indication (eg, refusal of caesarean section because of needle phobia2). Although obstetricians have taken women to court for interventions in the fetal interest,3 they have had less concern about the potential harm to both mother and baby of elective caesarean section “on request”,4,5 and its ethical implications.6 Interventions (instrumental or caesarean) with known and accepted complications are offered when the benefits outweigh risk. Caesarean section rates are rising worldwide and “request” section has been proposed as a prophylactic response to the avoidance of small risks and uncertainties of labour7 and to fulfil women’s informed choices. Others argue that elective caesarean section is not safer than labour, and that the duty of care does not encompass surgery on request.8 Obstetricians are in a dilemma. If they believe surgery requires a medical indication, they must encourage (without proper training) anxious women to address their fear or get into conflict. If they accede to requests, they may have listened to the presented problem but be doing unnecessary surgery, wasting resources, and failing to deal with underlying fear and anxiety. New work on anxiety offers insight into the importance to women of being listened to, and establishing some common ground between the “pro” and “anti” camps about caesarean section. Anxiety has been associated with pregnancy complications,9 emergency caesarean section in labour,10 postnatal depression, and impaired bonding.11 Attention has focused on early identification of anxiety, intervention, and effective treatment. In a recent randomised trial by Terhi Saisto and colleagues,12 178 anxious low-risk women with no contraindication to vaginal delivery were identified, either by request for caesarean section or a specific screening questionnaire. The intervention included three additional 45-min appointments for cognitive therapy with a trained obstetrician, a 90-min appointment with the midwife, and visits to the ward for practical information. Of the 117 women who initially requested caesarean section, 62% chose to deliver vaginally; there was a decrease that was not statistically significant in elective caesarean section for psychosocial reasons in the intensive versus the conventional groups (24% vs 29%). Intention-to-treat analysis showed lower birth concerns, lower pregnancy-anxiety scales, and shorter labours (6·8 vs 8·5 h, p=0·039) in the intensive therapy group. The group of women avoiding the intervention had the highest caesarean section rate. Although this was a small trial it shows that anxiety reduction is associated with shorter labour. A reduction in requests has been shown previously after psychological intervention.13 The need for pain relief, length of labour, and assisted delivery are THE LANCET • Vol 359 • June 22, 2002 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet Publishing Group.
Several as yet unpublished sub-studies from the ATAC trial provide additional crucial information. At this year’s ASCO meeting, abstracts were presented showing less abnormal endometrial histopathology in patients on anastrozole compared with tamoxifen.6 In addition, preliminary surveys of quality of life showed no major differences between anastrozole and tamoxifen,7 which was not unexpected but reassuring, since, in a study comparing tamoxifen and placebo, no differences in quality of life were found.8 The ATAC trial also has sub-studies evaluating bone mineral density and lipid profiles. Perhaps the most interesting studies are biological correlates of tumour biomarkers with outcome. Great interest centres on whether patients who are Her2-positive (a population which seems less sensitive to tamoxifen) will benefit from anastrozole.9 The ATAC trial is the initial vanguard of several trials that will examine aromatase inhibitors in breast cancer, including anastrozole, letrozole, and exemestane. With the major probable drawback of a long-term effect of anastrozole being accelerated bone loss, questions about whether all aromatase inhibitors cause this effect, and of how this might be prevented with the concurrent use of bisphosphonates (agents which may have independent antirecurrence effects of their own) are important. Early reporting rules can powerfully affect what information can be gleaned from a trial, particularly if they cause a trial to be reported when many of the patients have not completed therapy, as in ATAC. Early reporting is particularly important when the therapy which is the current standard of care must be given over a long period. In the ATAC trial, patients are to be informed of the early results. It remains to be seen how many of the patients on the two remaining blinded arms will continue to take the therapy that they were randomised to. Peter Ravdin Department of Medical Oncology, University of Texas Health Science Center, San Antonio, TX 98284-7884, USA (e-mail: [email protected]) 1
2
3
4 5
6
7
8
Ravdin PM, Green S, Dorr M et al. Prognostic significance of progesterone receptor levels in estrogen receptor-positive patients with metastatic breast cancer treated with tamoxifen: results of a prospective Southwest Oncology Group Study. J Clin Oncol 1992: 10: 1284–91. Early Breast Cancer Trialists’ Collaborative Group. Tamoxifen for early breast cancer: an overview of the randomised trials. Lancet 1998; 351: 1451–67. Fisher B, Constantino JP, Wickerham DL, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst 1998; 90: 1371–88. Osborne CK. Tamoxifen in the treatment of breast cancer. N Engl J Med 1998; 339: 1609–18. Winer E, Hudis C, Burstein HJ, et al. American Society of Clinical Oncology technology assessment on the use of aromatase inhibitors as adjuvant therapy for women with hormone receptor positive breast cancer: status report 2002. http://www.asco.org/prof/pp/html/guidelines/ai.htm (accessed on June 17). Duffy SR, Jackson TL, et al. The ATAC (‘Arimidex’, tamoxifen, alone or in combination) early breast cancer (EBC) trial in postmenopausal (PM) patients: endometrial sub-protocol results. Proc ASCO 2002; 21: abstr 158. Fallowfield L, Cella CR. Assessing the quality of life (QOL) of postmenopausal (PM) women randomized into the ATAC (‘Arimidex’, tamoxifen, alone or in combination) adjuvant breast cancer (BC) trial. Proc ASCO 2002; 21: abstr 159. Day R, Ganz PA, Costantino JP, Cronin WM, Wickerham DL, Fisher B. Health-related quality of life and tamoxifen in breast cancer prevention: a report from the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Clin Oncol 1999; 17: 2659–69.
THE LANCET • Vol 359 • June 22, 2002 • www.thelancet.com
9
Ellis MJ, Coop A, Singh B, et al. Letrozole is more effective neoadjuvant endocrine therapy than tamoxifen for ErbB-1- and/or ErbB-2-positive, estrogen receptor-positive primary breast cancer: evidence from a phase III randomized trial. J Clin Oncol 2001; 19: 3808–16.
Glucose-tolerance testing in acute myocardial infarction See page 2140 Type 2 diabetes is associated with an increased incidence of coronary heart disease.1 In some studies, individuals with type 2 diabetes but without previous coronary heart disease have a risk of future myocardial infarction similar to that of non-diabetic patients with coronary heart disease.1 Furthermore, diabetic patients with a myocardial infarction have a worse risk of dying.2 Even milder degrees of glucose intolerance, such as impaired glucose tolerance3 or mild glucose elevations in the non-diabetic range4 are associated with increased coronary heart disease. Indeed, cardiovascular risk factors are higher even before the onset of type 2 diabetes.5 Thus the increased risk of coronary heart disease in type 2 diabetes and even in milder states of glucose intolerance is a public-health problem. The article in today’s Lancet by Anna Norhammar and colleagues helps to clarify just how serious this risk is. In the Norhammar report, of 181 consecutive patients with acute myocardial infarction but without a previous clinical diagnosis of type 2 diabetes, 31% had diabetes and 35% had glucose intolerance. This finding represents a larger proportion of patients with acute myocardial infarction than has been previously recognised. Of interest is that the fasting plasma-glucose criteria suggested by the American Diabetes Association6 identified only about one in three individuals defined as diabetic by the oral glucosetolerance test, clearly an unacceptable performance. Although the investigators develop predicting equations based on fasting glucose and glycosylated haemoglobin, in view of the high risk of future coronary heart disease in patients with diabetes, it is reasonable to suggest an oral glucose-tolerance test at discharge after a myocardial infarction. Although the glucose-tolerance test is burdensome for screening in the general population, it is less so in hospitalised patients. The high frequency of newly discovered diabetes is also important because intensive glycaemic control with insulin during the peri-infarction period followed by improved glycaemic control as outpatients lowers the mortality from acute myocardial infarction.7 Additionally, improved glycaemic control in a predominantly non-diabetic Belgian population, who were intubated in an intensive care unit, showed much lower mortality.8 Thus intensive insulin use may also benefit patients who have an acute myocardial infarction and impaired glucose tolerance. This hypothesis should be tested in trials. One possible objection to the use of an oral glucosetolerance test is that the test has been said to be highly variable. Norhammar and colleagues showed that the overall frequency of impaired glucose tolerance in patients with type 2 diabetes was similar after 3 months to that at discharge. However, whether the same people had impaired glucose tolerance at discharge and 3 months later is unclear. 2127
For personal use. Only reproduce with permission from The Lancet Publishing Group.
COMMENTARY
What might new trials build on the interesting results from Norhammar’s report, in view of the high frequency of impaired glucose tolerance in individuals after a myocardial infarction? It might be possible to design studies to prevent type 2 diabetes just among patients who have had an acute myocardial infarction. These patients will not only have a high risk of developing type 2 diabetes but are also likely to be at high risk of future coronary heart disease. The same study might have adequate power to assess both prevention of type 2 diabetes and cardiovascular disease. Because people with impaired glucose tolerance do not currently require a pharmacological intervention, this setting could prove attractive for testing whether agonists at the peroxisome proliferatoractivated receptor prevent both heart disease and type 2 diabetes. For ethical reasons, all patients would need to be offered a lifestyle intervention, because the American Diabetes Prevention Program has shown that both intensive lifestyle advice, without an active pharmacological agent, and metformin reduce the frequency of type 2 diabetes by 58% and 31%, respectively.9 However, the number of incident cardiovascular events in the American Diabetes Prevention Program was very low in these individuals with impaired glucose tolerance. Randomisation before discharge in patients with myocardial infarction or unstable angina has been used successfully with a statin in the MIRACL trial.10 A similar strategy should be adopted in people with type 2 diabetes or possibly impaired glucose tolerance with use of newer types of diabetic agents. Steven M Haffner Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX 78229–3900, USA (e-mail: [email protected]) 1
Haffner SM, Lehto S, Rönnemaa T, Pyörälä K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without previous myocardial infarction: implications for treatment of hyperlipidemia in diabetic subjects without prior myocardial infarction. N Engl J Med 1998; 339: 229–34. 2 Miettinen H, Lehto S, Salomaa V, et al. Impact of diabetes on mortality after first myocardial infarction. Diabetes Care 1998; 21: 69–75. 3 Fuller JH, Shipley MJ, Rose G, Jarret RJ, Keen H. Coronary-heartdisease risk and impaired glucose tolerance: the Whitehall study. Lancet 1980; 1: 1373–76. 4 The DECODE study group on behalf of the European diabetes epidemiology group. Glucose tolerance and mortality: comparison of WHO and American Diabetic Association Diagnostic criteria. Lancet 1999; 354: 617–21. 5 Haffner SM, Mykkänen L, Festa A, Burke J, Stern M. Insulin resistant prediabetic subjects have more atherogenic risk factors than insulin sensitive prediabetic subjects: implications for preventing coronary heart disease during the prediabetic state. Circulation 2000; 101: 975–80. 6 The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Report of the expert committee on the diagnosis and classification of diabetes mellitus. Diabetes Care 1997; 20: 1183–97. 7 Malmberg K, Ryden L, Efendic S, et al. Randomized trial of insulinglucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction (DIGAMI study): effects on mortality at 1 year. Am J Coll Cardiol 1995; 26: 57–65. 8 Van den Berghe G, Wouters P, Weekers F, et al. Intensive insulin therapy in critically ill patients. N Engl J Med 2001; 345: 1359–67. 9 Diabetes Prevention Program Writing Group for the DPP Investigators. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002; 346: 393–403. 10 Schwartz GG, Olsson AG, Ezekowitz MD, et al. Effects of
2128
atorvastatin on early recurrent ischemic events in acute coronary syndromes. The MIRACL study: a randomized clinical trial. JAMA 2001; 285: 1711–18.
Responding to fear of childbirth It is common (indeed rational) for women to feel fearful about childbirth. Childbirth is inherently unpredictable and painful, and accompanied by a small risk of serious morbidity or even death for both mother and child. Most women cope with and overcome their fears. A few have extreme fear or anxiety, sometimes expressed as a morbid dread of childbirth (tokophobia)1 or a request for caesarean section without a medical problem. Conversely, some women are unable to consent to a desirable intervention in the face of a compelling indication (eg, refusal of caesarean section because of needle phobia2). Although obstetricians have taken women to court for interventions in the fetal interest,3 they have had less concern about the potential harm to both mother and baby of elective caesarean section “on request”,4,5 and its ethical implications.6 Interventions (instrumental or caesarean) with known and accepted complications are offered when the benefits outweigh risk. Caesarean section rates are rising worldwide and “request” section has been proposed as a prophylactic response to the avoidance of small risks and uncertainties of labour7 and to fulfil women’s informed choices. Others argue that elective caesarean section is not safer than labour, and that the duty of care does not encompass surgery on request.8 Obstetricians are in a dilemma. If they believe surgery requires a medical indication, they must encourage (without proper training) anxious women to address their fear or get into conflict. If they accede to requests, they may have listened to the presented problem but be doing unnecessary surgery, wasting resources, and failing to deal with underlying fear and anxiety. New work on anxiety offers insight into the importance to women of being listened to, and establishing some common ground between the “pro” and “anti” camps about caesarean section. Anxiety has been associated with pregnancy complications,9 emergency caesarean section in labour,10 postnatal depression, and impaired bonding.11 Attention has focused on early identification of anxiety, intervention, and effective treatment. In a recent randomised trial by Terhi Saisto and colleagues,12 178 anxious low-risk women with no contraindication to vaginal delivery were identified, either by request for caesarean section or a specific screening questionnaire. The intervention included three additional 45-min appointments for cognitive therapy with a trained obstetrician, a 90-min appointment with the midwife, and visits to the ward for practical information. Of the 117 women who initially requested caesarean section, 62% chose to deliver vaginally; there was a decrease that was not statistically significant in elective caesarean section for psychosocial reasons in the intensive versus the conventional groups (24% vs 29%). Intention-to-treat analysis showed lower birth concerns, lower pregnancy-anxiety scales, and shorter labours (6·8 vs 8·5 h, p=0·039) in the intensive therapy group. The group of women avoiding the intervention had the highest caesarean section rate. Although this was a small trial it shows that anxiety reduction is associated with shorter labour. A reduction in requests has been shown previously after psychological intervention.13 The need for pain relief, length of labour, and assisted delivery are THE LANCET • Vol 359 • June 22, 2002 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet Publishing Group.