Does episiotomy increase perineal laceration length in primiparous women?

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Does episiotomy increase perineal laceration length in primiparous women?

BACKGROUND: Episiotomy was initially used based on theoretical benefit, with little evidence supporting claims that it prevented severe perineal lacerations or pelvic floor dysfunction. As principles of evidence-based medicine have begun to influence obstetrical practice, the utility of routine episiotomy has been called into question. Several observational studies have suggested that episiotomy increases the risk of third- and fourth-degree lacerations. A recent Cochrane review of 6 randomized controlled clinical trials comparing routine versus restricted use of episiotomy showed that episiotomy was associated with more second-degree perineal trauma, without significant differences in dyspareunia, severe perineal trauma, or severe pain. Although all but one of the trials included in the review used mediolateral episiotomy, the one randomized trial conducted in North America (which used midline episiotomy) showed similar results. Despite these data, episiotomy remains a common practice performed in more than 40% of deliveries in the United States.

POPULATION STUDIED: The authors of this study enrolled 80 pregnant women at term who had not had previous vaginal deliveries. The 62 who went on to have vaginal deliveries were included in the analysis. The participants’ mean age was 26.3 years. The majority (92%) had prenatal care, and most (88%) had epidural analgesia during labor. Approximately one fourth of the women (28%) had forceps or vacuum-assisted delivery. A few had malpresentations, with 6% in the occiput posterior position.

STUDY DESIGN AND VALIDITY: This small observational study looked at a range of variables hypothesized to be related to perineal laceration length, including maternal demographics, size of genital hiatus and perineal body, fetal size and presentation, duration of second stage of labor, level of experience of birth attendant, operative vaginal delivery, and episiotomy. After delivery, one of the study authors measured perineal laceration length, and for 10 patients 3 additional observers measured laceration length to assess inter-rater reliability. Observers were blinded to one another’s measurements but not to the other variables included in the analysis. The authors used logistic regression and Mann-Whitney U test to determine which variables were associated with laceration length.

OUTCOMES MEASURED: Perineal laceration length was the primary outcome measured in this study. The authors also assessed laceration severity. The study did not include variables relevant to quality of life, such as healing complications, severity of pain, duration of symptoms, dyspareunia, or incontinence.

RESULTS: Of the 62 patients in the final analysis, 76% had a perineal laceration, with a median length of 4 cm. Five patients (8%) had a third-degree laceration, and one patient (2%) had a fourth-degree laceration. Approximately half (44%) had an episiotomy. The mean laceration length was 3 cm longer for patients who had an episiotomy (4.9 cm vs 1.9 cm; P < 001). Patients who had a forceps- or vacuum-assisted delivery had a longer average length of laceration, but this association was not independent of episiotomy. When assisted deliveries were excluded from the analysis, the association between episiotomy and laceration length remained significant.

RECOMMENDATIONS FOR CLINICAL PRACTICE

This study provides weak evidence that episiotomy increases perineal laceration length in primiparous women. Earlier higher-quality trials provide strong evidence that episiotomy should not be performed routinely. Its use should be restricted to situations in which specific clinical indications exist. In some institutions episiotomy remains common practice despite data that have been available for more than a decade showing that it does not improve outcomes. This suggests the need for further educational interventions on how to attend deliveries in primiparous women without using episiotomy.

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Amy C. Denham, MD, MPH
Valerie J. King, MD, MPH
Department of Family Medicine University of North Carolina at Chapel Hill E-mail: amy_denham@med.unc.edu

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Amy C. Denham, MD, MPH
Valerie J. King, MD, MPH
Department of Family Medicine University of North Carolina at Chapel Hill E-mail: amy_denham@med.unc.edu

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Amy C. Denham, MD, MPH
Valerie J. King, MD, MPH
Department of Family Medicine University of North Carolina at Chapel Hill E-mail: amy_denham@med.unc.edu

BACKGROUND: Episiotomy was initially used based on theoretical benefit, with little evidence supporting claims that it prevented severe perineal lacerations or pelvic floor dysfunction. As principles of evidence-based medicine have begun to influence obstetrical practice, the utility of routine episiotomy has been called into question. Several observational studies have suggested that episiotomy increases the risk of third- and fourth-degree lacerations. A recent Cochrane review of 6 randomized controlled clinical trials comparing routine versus restricted use of episiotomy showed that episiotomy was associated with more second-degree perineal trauma, without significant differences in dyspareunia, severe perineal trauma, or severe pain. Although all but one of the trials included in the review used mediolateral episiotomy, the one randomized trial conducted in North America (which used midline episiotomy) showed similar results. Despite these data, episiotomy remains a common practice performed in more than 40% of deliveries in the United States.

POPULATION STUDIED: The authors of this study enrolled 80 pregnant women at term who had not had previous vaginal deliveries. The 62 who went on to have vaginal deliveries were included in the analysis. The participants’ mean age was 26.3 years. The majority (92%) had prenatal care, and most (88%) had epidural analgesia during labor. Approximately one fourth of the women (28%) had forceps or vacuum-assisted delivery. A few had malpresentations, with 6% in the occiput posterior position.

STUDY DESIGN AND VALIDITY: This small observational study looked at a range of variables hypothesized to be related to perineal laceration length, including maternal demographics, size of genital hiatus and perineal body, fetal size and presentation, duration of second stage of labor, level of experience of birth attendant, operative vaginal delivery, and episiotomy. After delivery, one of the study authors measured perineal laceration length, and for 10 patients 3 additional observers measured laceration length to assess inter-rater reliability. Observers were blinded to one another’s measurements but not to the other variables included in the analysis. The authors used logistic regression and Mann-Whitney U test to determine which variables were associated with laceration length.

OUTCOMES MEASURED: Perineal laceration length was the primary outcome measured in this study. The authors also assessed laceration severity. The study did not include variables relevant to quality of life, such as healing complications, severity of pain, duration of symptoms, dyspareunia, or incontinence.

RESULTS: Of the 62 patients in the final analysis, 76% had a perineal laceration, with a median length of 4 cm. Five patients (8%) had a third-degree laceration, and one patient (2%) had a fourth-degree laceration. Approximately half (44%) had an episiotomy. The mean laceration length was 3 cm longer for patients who had an episiotomy (4.9 cm vs 1.9 cm; P < 001). Patients who had a forceps- or vacuum-assisted delivery had a longer average length of laceration, but this association was not independent of episiotomy. When assisted deliveries were excluded from the analysis, the association between episiotomy and laceration length remained significant.

RECOMMENDATIONS FOR CLINICAL PRACTICE

This study provides weak evidence that episiotomy increases perineal laceration length in primiparous women. Earlier higher-quality trials provide strong evidence that episiotomy should not be performed routinely. Its use should be restricted to situations in which specific clinical indications exist. In some institutions episiotomy remains common practice despite data that have been available for more than a decade showing that it does not improve outcomes. This suggests the need for further educational interventions on how to attend deliveries in primiparous women without using episiotomy.

BACKGROUND: Episiotomy was initially used based on theoretical benefit, with little evidence supporting claims that it prevented severe perineal lacerations or pelvic floor dysfunction. As principles of evidence-based medicine have begun to influence obstetrical practice, the utility of routine episiotomy has been called into question. Several observational studies have suggested that episiotomy increases the risk of third- and fourth-degree lacerations. A recent Cochrane review of 6 randomized controlled clinical trials comparing routine versus restricted use of episiotomy showed that episiotomy was associated with more second-degree perineal trauma, without significant differences in dyspareunia, severe perineal trauma, or severe pain. Although all but one of the trials included in the review used mediolateral episiotomy, the one randomized trial conducted in North America (which used midline episiotomy) showed similar results. Despite these data, episiotomy remains a common practice performed in more than 40% of deliveries in the United States.

POPULATION STUDIED: The authors of this study enrolled 80 pregnant women at term who had not had previous vaginal deliveries. The 62 who went on to have vaginal deliveries were included in the analysis. The participants’ mean age was 26.3 years. The majority (92%) had prenatal care, and most (88%) had epidural analgesia during labor. Approximately one fourth of the women (28%) had forceps or vacuum-assisted delivery. A few had malpresentations, with 6% in the occiput posterior position.

STUDY DESIGN AND VALIDITY: This small observational study looked at a range of variables hypothesized to be related to perineal laceration length, including maternal demographics, size of genital hiatus and perineal body, fetal size and presentation, duration of second stage of labor, level of experience of birth attendant, operative vaginal delivery, and episiotomy. After delivery, one of the study authors measured perineal laceration length, and for 10 patients 3 additional observers measured laceration length to assess inter-rater reliability. Observers were blinded to one another’s measurements but not to the other variables included in the analysis. The authors used logistic regression and Mann-Whitney U test to determine which variables were associated with laceration length.

OUTCOMES MEASURED: Perineal laceration length was the primary outcome measured in this study. The authors also assessed laceration severity. The study did not include variables relevant to quality of life, such as healing complications, severity of pain, duration of symptoms, dyspareunia, or incontinence.

RESULTS: Of the 62 patients in the final analysis, 76% had a perineal laceration, with a median length of 4 cm. Five patients (8%) had a third-degree laceration, and one patient (2%) had a fourth-degree laceration. Approximately half (44%) had an episiotomy. The mean laceration length was 3 cm longer for patients who had an episiotomy (4.9 cm vs 1.9 cm; P < 001). Patients who had a forceps- or vacuum-assisted delivery had a longer average length of laceration, but this association was not independent of episiotomy. When assisted deliveries were excluded from the analysis, the association between episiotomy and laceration length remained significant.

RECOMMENDATIONS FOR CLINICAL PRACTICE

This study provides weak evidence that episiotomy increases perineal laceration length in primiparous women. Earlier higher-quality trials provide strong evidence that episiotomy should not be performed routinely. Its use should be restricted to situations in which specific clinical indications exist. In some institutions episiotomy remains common practice despite data that have been available for more than a decade showing that it does not improve outcomes. This suggests the need for further educational interventions on how to attend deliveries in primiparous women without using episiotomy.

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Is the sweeping of membranes a useful intervention in conjunction with induction of labor in term pregnancy?

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Is the sweeping of membranes a useful intervention in conjunction with induction of labor in term pregnancy?

BACKGROUND: Routine sweeping or “stripping” of the membranes beginning at 38 to 40 weeks’ gestation is an effective method of reducing the risk of a postdate and post-term pregnancy, as well as the need for more formal induction of labor. However, sweeping has not been shown to decrease the rate of cesarean delivery. This study is the first clinical trial of the effectiveness of membrane sweeping in conjunction with formal induction of labor.

POPULATION STUDIED: Nulliparous (N=130) and multiparous (N=118) women at term (38 to 42 weeks) were recruited into the study if they were admitted for induction of labor and had not had pre-admission sweeping performed. Indications for induction of labor included hypertension, intrauterine growth restriction, post-term, gestational diabetes, and oligohydramnios.

STUDY DESIGN AND VALIDITY: Pairs of eligible women were matched for parity and method of induction, and each was assigned to membrane sweeping or gentle cervical examination to determine Bishop score before induction. Sweeping involved separating the membranes from the lower uterine segment as far as possible with a finger inserted into the internal os. Induction protocols included the use of 3 mg vaginal prostaglandin (PGE2) pessary for women with unfavorable cervices (Bishop score <5) and rupture of membranes at any point when the cervix was favorable. PGE2 was repeated every 6 hours if needed. Oxytocin was started if there were insufficient uterine contractions within 3 hours after rupture of membranes. The oxytocin protocol called for increases of 2.5 mU per minute every half hour to a maximum of 40 mU per minute to achieve 4 to 5 contractions every 10 minutes. Vaginal examinations were routinely done every 3 hours.

OUTCOMES MEASURED: Induction-to-delivery interval, total duration of labor, maximum dose of oxytocin used during induction, and mode of delivery were the primary maternal outcomes reported. The authors also reported meconium-stained amniotic fluid and admission to the neonatal unit but did not report any other patient-based outcomes, such as pain or satisfaction.

RESULTS: No differences in any outcome measures were found for multiparous women. Nulliparous women assigned to the membrane sweeping group who required cervical ripening with prostaglandins had shorter induction-to-delivery intervals (13.6 vs 17.3 hours, P=.043), required less oxytocin, were more likely to have a spontaneous vaginal delivery (83.3% vs 58.2%, P=.01; number needed to treat [NNT]=4) and were less likely to require a cesarean delivery (6.3% vs 21.8%, P=.01; NNT=7). Nulliparas who had induction with artificial rupture of the membranes plus oxytocin also appeared to have shorter induction-to-delivery intervals and to require lower maximum doses of oxytocin. When these results were analyzed according to Bishop score, however, significant differences persisted only for nulliparous women who had scores of less than 5. There were no significant differences in other outcome measures.

RECOMMENDATIONS FOR CLINICAL PRACTICE

Clinicians should offer membrane sweeping to nulliparous women with Bishop scores less than 5 who require induction of labor. The NNTs to avoid cesarean delivery (7) or operative vaginal delivery (4) are favorable, and the procedure carries little risk to the woman aside from discomfort. There does not appear to be an additional benefit of membrane sweeping in nulliparas with favorable cervices or in multiparous women regardless of their cervical examination results.

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Valerie J. King, MD, MPH
The University of North Carolina, Chapel Hill E-mail: vking@med.unc.edu

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The University of North Carolina, Chapel Hill E-mail: vking@med.unc.edu

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Valerie J. King, MD, MPH
The University of North Carolina, Chapel Hill E-mail: vking@med.unc.edu

BACKGROUND: Routine sweeping or “stripping” of the membranes beginning at 38 to 40 weeks’ gestation is an effective method of reducing the risk of a postdate and post-term pregnancy, as well as the need for more formal induction of labor. However, sweeping has not been shown to decrease the rate of cesarean delivery. This study is the first clinical trial of the effectiveness of membrane sweeping in conjunction with formal induction of labor.

POPULATION STUDIED: Nulliparous (N=130) and multiparous (N=118) women at term (38 to 42 weeks) were recruited into the study if they were admitted for induction of labor and had not had pre-admission sweeping performed. Indications for induction of labor included hypertension, intrauterine growth restriction, post-term, gestational diabetes, and oligohydramnios.

STUDY DESIGN AND VALIDITY: Pairs of eligible women were matched for parity and method of induction, and each was assigned to membrane sweeping or gentle cervical examination to determine Bishop score before induction. Sweeping involved separating the membranes from the lower uterine segment as far as possible with a finger inserted into the internal os. Induction protocols included the use of 3 mg vaginal prostaglandin (PGE2) pessary for women with unfavorable cervices (Bishop score <5) and rupture of membranes at any point when the cervix was favorable. PGE2 was repeated every 6 hours if needed. Oxytocin was started if there were insufficient uterine contractions within 3 hours after rupture of membranes. The oxytocin protocol called for increases of 2.5 mU per minute every half hour to a maximum of 40 mU per minute to achieve 4 to 5 contractions every 10 minutes. Vaginal examinations were routinely done every 3 hours.

OUTCOMES MEASURED: Induction-to-delivery interval, total duration of labor, maximum dose of oxytocin used during induction, and mode of delivery were the primary maternal outcomes reported. The authors also reported meconium-stained amniotic fluid and admission to the neonatal unit but did not report any other patient-based outcomes, such as pain or satisfaction.

RESULTS: No differences in any outcome measures were found for multiparous women. Nulliparous women assigned to the membrane sweeping group who required cervical ripening with prostaglandins had shorter induction-to-delivery intervals (13.6 vs 17.3 hours, P=.043), required less oxytocin, were more likely to have a spontaneous vaginal delivery (83.3% vs 58.2%, P=.01; number needed to treat [NNT]=4) and were less likely to require a cesarean delivery (6.3% vs 21.8%, P=.01; NNT=7). Nulliparas who had induction with artificial rupture of the membranes plus oxytocin also appeared to have shorter induction-to-delivery intervals and to require lower maximum doses of oxytocin. When these results were analyzed according to Bishop score, however, significant differences persisted only for nulliparous women who had scores of less than 5. There were no significant differences in other outcome measures.

RECOMMENDATIONS FOR CLINICAL PRACTICE

Clinicians should offer membrane sweeping to nulliparous women with Bishop scores less than 5 who require induction of labor. The NNTs to avoid cesarean delivery (7) or operative vaginal delivery (4) are favorable, and the procedure carries little risk to the woman aside from discomfort. There does not appear to be an additional benefit of membrane sweeping in nulliparas with favorable cervices or in multiparous women regardless of their cervical examination results.

BACKGROUND: Routine sweeping or “stripping” of the membranes beginning at 38 to 40 weeks’ gestation is an effective method of reducing the risk of a postdate and post-term pregnancy, as well as the need for more formal induction of labor. However, sweeping has not been shown to decrease the rate of cesarean delivery. This study is the first clinical trial of the effectiveness of membrane sweeping in conjunction with formal induction of labor.

POPULATION STUDIED: Nulliparous (N=130) and multiparous (N=118) women at term (38 to 42 weeks) were recruited into the study if they were admitted for induction of labor and had not had pre-admission sweeping performed. Indications for induction of labor included hypertension, intrauterine growth restriction, post-term, gestational diabetes, and oligohydramnios.

STUDY DESIGN AND VALIDITY: Pairs of eligible women were matched for parity and method of induction, and each was assigned to membrane sweeping or gentle cervical examination to determine Bishop score before induction. Sweeping involved separating the membranes from the lower uterine segment as far as possible with a finger inserted into the internal os. Induction protocols included the use of 3 mg vaginal prostaglandin (PGE2) pessary for women with unfavorable cervices (Bishop score <5) and rupture of membranes at any point when the cervix was favorable. PGE2 was repeated every 6 hours if needed. Oxytocin was started if there were insufficient uterine contractions within 3 hours after rupture of membranes. The oxytocin protocol called for increases of 2.5 mU per minute every half hour to a maximum of 40 mU per minute to achieve 4 to 5 contractions every 10 minutes. Vaginal examinations were routinely done every 3 hours.

OUTCOMES MEASURED: Induction-to-delivery interval, total duration of labor, maximum dose of oxytocin used during induction, and mode of delivery were the primary maternal outcomes reported. The authors also reported meconium-stained amniotic fluid and admission to the neonatal unit but did not report any other patient-based outcomes, such as pain or satisfaction.

RESULTS: No differences in any outcome measures were found for multiparous women. Nulliparous women assigned to the membrane sweeping group who required cervical ripening with prostaglandins had shorter induction-to-delivery intervals (13.6 vs 17.3 hours, P=.043), required less oxytocin, were more likely to have a spontaneous vaginal delivery (83.3% vs 58.2%, P=.01; number needed to treat [NNT]=4) and were less likely to require a cesarean delivery (6.3% vs 21.8%, P=.01; NNT=7). Nulliparas who had induction with artificial rupture of the membranes plus oxytocin also appeared to have shorter induction-to-delivery intervals and to require lower maximum doses of oxytocin. When these results were analyzed according to Bishop score, however, significant differences persisted only for nulliparous women who had scores of less than 5. There were no significant differences in other outcome measures.

RECOMMENDATIONS FOR CLINICAL PRACTICE

Clinicians should offer membrane sweeping to nulliparous women with Bishop scores less than 5 who require induction of labor. The NNTs to avoid cesarean delivery (7) or operative vaginal delivery (4) are favorable, and the procedure carries little risk to the woman aside from discomfort. There does not appear to be an additional benefit of membrane sweeping in nulliparas with favorable cervices or in multiparous women regardless of their cervical examination results.

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Is test-and-eradicate or prompt endoscopy more effective for treatment of dyspepsia in Helicobacter pylori–positive patients?

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Is test-and-eradicate or prompt endoscopy more effective for treatment of dyspepsia in Helicobacter pylori–positive patients?

BACKGROUND: A recent Cochrane review found that early endoscopy was not more effective than initial acid suppressive therapy, but the 3 available studies lacked statistical power to confirm a clear difference. No eligible trials of treatment guided by the results of H pylori testing versus treatment guided by initial endoscopy were found.1

POPULATION STUDIED: A total of 576 dyspeptic patients with a median age of approximately 45 years were recruited from Danish general practitioners. After exclusion for significant comorbidities or complicating factors, such as such as upper gastrointestinal bleeding, 500 patients were randomized, and 447 completed 1 year follow-up.

STUDY DESIGN AND VALIDITY: This was a randomized controlled trial of prompt endoscopy versus a test-and-eradicate strategy. Randomization using random number tables was accomplished using sealed numbered envelopes. Groups were similar at the beginning of the study, although patients in the prompt endoscopy group had a longer history of dyspepsia. Patients were interviewed at follow-up intervals of 1 month and 1 year and completed a diary for 1 week out of each month during the study year. Patients randomized to the test-and-eradicate strategy had C-urea breath testing for H pylori. Those with a positive test were treated with a 2-week course of lansoprazole 30 mg twice daily (a proton pump inhibitor [PPI]), metronidazole 500 mg 3 times daily, and amoxicillin 1000 mg twice daily. H pylori negative patients with primarily reflux symptoms were treated with a PPI for 1 month and continued on demand. Patients who did not improve or relapsed during follow-up were offered endoscopy. Patients randomized to prompt endoscopy were treated according to endoscopic findings. Those with duodenal ulcers received eradication therapy followed by 2 weeks of PPI. Patients with gastric ulcerations were treated according to H pylori status. Gastric ulcers were biopsied every 6 weeks until healed. Patients with reflux esophagitis were given PPI therapy, for 8 weeks of PPI. Those diagnosed with functional dyspepsia were reassured, given lifestyle modification advice, and prescribed PPIs if they had previously used them successfully. The strengths of this study include its randomized design, high follow-up rate, recruitment from primary care practices, and focus on patient-oriented outcomes. The authors do not mention if attempts were made to blind interviewers or assessors to patient group status. The results are likely applicable to primary care populations, but referral to a teaching hospital may have created expectation biases on the part of patients. Although analysis was not by intention to treat, the number of dropouts was the same between groups and was only 10% overall. The sample size was adequate to detect a difference of 10% in the number of days of symptoms.

OUTCOMES MEASURED: The main outcome was the percentage of days without dyspeptic symptoms. Secondary outcomes included the number of sick leave days, quality of life measured with a visual analog scale, and the gastrointestinal symptoms rating scale, visits to general practitioners, hospital admissions, satisfaction, use of endoscopy, and use of PPIs.

RESULTS: No differences were found in the proportion of days without dyspeptic symptoms, scores on quality of life measures, outpatient visits, hospital admissions, or sick leave days. Significantly more patients in the prompt endoscopy group (20% vs 28%) reported improved symptoms at 1 month, but there were no differences at 1 year. The patients assigned to the test-and-eradicate strategy were more likely to be dissatisfied at 1 year (12% vs 4%). As expected, the use of encoscopy (0.5 vs 1.25 per person, P <.001) was significantly lower in the test-and-eradicate group.

RECOMMENDATIONS FOR CLINICAL PRACTICE

A test-and-eradicate strategy cured or identified 91% of all peptic ulcer patients and was as effective as immediate endoscopy at reducing the number of days of symptoms. In areas where access to endoscopy is institutionally limited, expensive, or there is a prolonged waiting time, a test-and-eradicate strategy is preferable. However, patient satisfaction monitoring should accompany adoption of this strategy. This is a rapidly evolving field, and several studies of endoscopy versus various treatments are due to be published soon.

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University of North Carolina Chapel Hill E-mail: vking@med.unc.edu

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University of North Carolina Chapel Hill E-mail: vking@med.unc.edu

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Valerie J. King, MD, MPH
University of North Carolina Chapel Hill E-mail: vking@med.unc.edu

BACKGROUND: A recent Cochrane review found that early endoscopy was not more effective than initial acid suppressive therapy, but the 3 available studies lacked statistical power to confirm a clear difference. No eligible trials of treatment guided by the results of H pylori testing versus treatment guided by initial endoscopy were found.1

POPULATION STUDIED: A total of 576 dyspeptic patients with a median age of approximately 45 years were recruited from Danish general practitioners. After exclusion for significant comorbidities or complicating factors, such as such as upper gastrointestinal bleeding, 500 patients were randomized, and 447 completed 1 year follow-up.

STUDY DESIGN AND VALIDITY: This was a randomized controlled trial of prompt endoscopy versus a test-and-eradicate strategy. Randomization using random number tables was accomplished using sealed numbered envelopes. Groups were similar at the beginning of the study, although patients in the prompt endoscopy group had a longer history of dyspepsia. Patients were interviewed at follow-up intervals of 1 month and 1 year and completed a diary for 1 week out of each month during the study year. Patients randomized to the test-and-eradicate strategy had C-urea breath testing for H pylori. Those with a positive test were treated with a 2-week course of lansoprazole 30 mg twice daily (a proton pump inhibitor [PPI]), metronidazole 500 mg 3 times daily, and amoxicillin 1000 mg twice daily. H pylori negative patients with primarily reflux symptoms were treated with a PPI for 1 month and continued on demand. Patients who did not improve or relapsed during follow-up were offered endoscopy. Patients randomized to prompt endoscopy were treated according to endoscopic findings. Those with duodenal ulcers received eradication therapy followed by 2 weeks of PPI. Patients with gastric ulcerations were treated according to H pylori status. Gastric ulcers were biopsied every 6 weeks until healed. Patients with reflux esophagitis were given PPI therapy, for 8 weeks of PPI. Those diagnosed with functional dyspepsia were reassured, given lifestyle modification advice, and prescribed PPIs if they had previously used them successfully. The strengths of this study include its randomized design, high follow-up rate, recruitment from primary care practices, and focus on patient-oriented outcomes. The authors do not mention if attempts were made to blind interviewers or assessors to patient group status. The results are likely applicable to primary care populations, but referral to a teaching hospital may have created expectation biases on the part of patients. Although analysis was not by intention to treat, the number of dropouts was the same between groups and was only 10% overall. The sample size was adequate to detect a difference of 10% in the number of days of symptoms.

OUTCOMES MEASURED: The main outcome was the percentage of days without dyspeptic symptoms. Secondary outcomes included the number of sick leave days, quality of life measured with a visual analog scale, and the gastrointestinal symptoms rating scale, visits to general practitioners, hospital admissions, satisfaction, use of endoscopy, and use of PPIs.

RESULTS: No differences were found in the proportion of days without dyspeptic symptoms, scores on quality of life measures, outpatient visits, hospital admissions, or sick leave days. Significantly more patients in the prompt endoscopy group (20% vs 28%) reported improved symptoms at 1 month, but there were no differences at 1 year. The patients assigned to the test-and-eradicate strategy were more likely to be dissatisfied at 1 year (12% vs 4%). As expected, the use of encoscopy (0.5 vs 1.25 per person, P <.001) was significantly lower in the test-and-eradicate group.

RECOMMENDATIONS FOR CLINICAL PRACTICE

A test-and-eradicate strategy cured or identified 91% of all peptic ulcer patients and was as effective as immediate endoscopy at reducing the number of days of symptoms. In areas where access to endoscopy is institutionally limited, expensive, or there is a prolonged waiting time, a test-and-eradicate strategy is preferable. However, patient satisfaction monitoring should accompany adoption of this strategy. This is a rapidly evolving field, and several studies of endoscopy versus various treatments are due to be published soon.

BACKGROUND: A recent Cochrane review found that early endoscopy was not more effective than initial acid suppressive therapy, but the 3 available studies lacked statistical power to confirm a clear difference. No eligible trials of treatment guided by the results of H pylori testing versus treatment guided by initial endoscopy were found.1

POPULATION STUDIED: A total of 576 dyspeptic patients with a median age of approximately 45 years were recruited from Danish general practitioners. After exclusion for significant comorbidities or complicating factors, such as such as upper gastrointestinal bleeding, 500 patients were randomized, and 447 completed 1 year follow-up.

STUDY DESIGN AND VALIDITY: This was a randomized controlled trial of prompt endoscopy versus a test-and-eradicate strategy. Randomization using random number tables was accomplished using sealed numbered envelopes. Groups were similar at the beginning of the study, although patients in the prompt endoscopy group had a longer history of dyspepsia. Patients were interviewed at follow-up intervals of 1 month and 1 year and completed a diary for 1 week out of each month during the study year. Patients randomized to the test-and-eradicate strategy had C-urea breath testing for H pylori. Those with a positive test were treated with a 2-week course of lansoprazole 30 mg twice daily (a proton pump inhibitor [PPI]), metronidazole 500 mg 3 times daily, and amoxicillin 1000 mg twice daily. H pylori negative patients with primarily reflux symptoms were treated with a PPI for 1 month and continued on demand. Patients who did not improve or relapsed during follow-up were offered endoscopy. Patients randomized to prompt endoscopy were treated according to endoscopic findings. Those with duodenal ulcers received eradication therapy followed by 2 weeks of PPI. Patients with gastric ulcerations were treated according to H pylori status. Gastric ulcers were biopsied every 6 weeks until healed. Patients with reflux esophagitis were given PPI therapy, for 8 weeks of PPI. Those diagnosed with functional dyspepsia were reassured, given lifestyle modification advice, and prescribed PPIs if they had previously used them successfully. The strengths of this study include its randomized design, high follow-up rate, recruitment from primary care practices, and focus on patient-oriented outcomes. The authors do not mention if attempts were made to blind interviewers or assessors to patient group status. The results are likely applicable to primary care populations, but referral to a teaching hospital may have created expectation biases on the part of patients. Although analysis was not by intention to treat, the number of dropouts was the same between groups and was only 10% overall. The sample size was adequate to detect a difference of 10% in the number of days of symptoms.

OUTCOMES MEASURED: The main outcome was the percentage of days without dyspeptic symptoms. Secondary outcomes included the number of sick leave days, quality of life measured with a visual analog scale, and the gastrointestinal symptoms rating scale, visits to general practitioners, hospital admissions, satisfaction, use of endoscopy, and use of PPIs.

RESULTS: No differences were found in the proportion of days without dyspeptic symptoms, scores on quality of life measures, outpatient visits, hospital admissions, or sick leave days. Significantly more patients in the prompt endoscopy group (20% vs 28%) reported improved symptoms at 1 month, but there were no differences at 1 year. The patients assigned to the test-and-eradicate strategy were more likely to be dissatisfied at 1 year (12% vs 4%). As expected, the use of encoscopy (0.5 vs 1.25 per person, P <.001) was significantly lower in the test-and-eradicate group.

RECOMMENDATIONS FOR CLINICAL PRACTICE

A test-and-eradicate strategy cured or identified 91% of all peptic ulcer patients and was as effective as immediate endoscopy at reducing the number of days of symptoms. In areas where access to endoscopy is institutionally limited, expensive, or there is a prolonged waiting time, a test-and-eradicate strategy is preferable. However, patient satisfaction monitoring should accompany adoption of this strategy. This is a rapidly evolving field, and several studies of endoscopy versus various treatments are due to be published soon.

Issue
The Journal of Family Practice - 49(11)
Issue
The Journal of Family Practice - 49(11)
Page Number
1048
Page Number
1048
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Is test-and-eradicate or prompt endoscopy more effective for treatment of dyspepsia in Helicobacter pylori–positive patients?
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Is test-and-eradicate or prompt endoscopy more effective for treatment of dyspepsia in Helicobacter pylori–positive patients?
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