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Efficacy of valdecoxib versus naproxen sodium in primary dysmenorrhea
OBJECTIVE: To determine the number of general hospitals in Pennsylvania that provide emergency contraception for victims of sexual assault. METHODS: Of the 248 hospitals in Pennsylvania, 165 were eligible to participate. A 15-item telephone survey was administered to the eligible hospitals over the 3-month period of January to March 2000. RESULTS: One hundred twenty-five (76%) hospitals responded to the survey. Only 32% of hospitals routinely offer counseling about emergency contraception to victims of sexual assault. CONCLUSION: Improved protocols should be implemented to ensure that victims of sexual assault are routinely counseled about emergency contraception.
The Perinatal Hospice: FamilyFocused Care When the Fetus Has a Lethal Congenital Condition Byron C. Calhoun, MD Madigan Army Medical Center, Lakewood, WA
Melissa V. Terry, MD, Carie Bussey, RN, and Nathan J. Hoeldtke, MD OBJECTIVE: To describe the authors’ experience in providing a program of structured interdisciplinary care for the
GYNECOLOGIC OUTCOMES
Efficacy of Valdecoxib versus Naproxen Sodium in Primary Dysmenorrhea Stephen E. Daniels, DO Scirex Corporation, Austin, TX
Sarah Torris, MPH, RD, and Michael C. Snabes, MD, PhD OBJECTIVE: To evaluate whether valdecoxib, a novel Cox2–specific inhibitor, provides effective treatment of menstrual pain due to primary dysmenorrhea.
30S
MONDAY POSTERS
families of fetuses prenatally diagnosed with a lethal congenital anomaly. METHODS: The authors developed a comprehensive ‘perinatal hospice’ program for the supportive care of families with fetuses known to have a lethal condition and evaluated the response of patients to this service. Upon prenatal diagnosis of a lethal fetal condition, parents were presented with the option of elective pregnancy termination versus a multidisciplinary program of ongoing supportive care until the time of spontaneous labor or until delivery was required for obstetric indications to include 1 year of follow-up after delivery. RESULTS: The population consisted of 27 patients with lethal anomalies. Twenty-three (85%) chose to participate in the perinatal hospice program. Of these, 8/23 (35%) had intrauterine fetal demise and 15/23 (65%) delivered a liveborn infant at Madigan Army Medical Center. Among the liveborn infants there were 12 vaginal deliveries, five preterm and seven at term. Obstetric indications or maternal request resulted in cesarean delivery for 3/23 (13%), two preterm and one term, all liveborn. All liveborn infants died within 20 minutes to 2 months of life. There were no maternal complications. CONCLUSION: The availability of a structured program providing comprehensive multidisciplinary supportive perinatal care offers a tangible and safe alternative to early elective termination for patients carrying a fetus with a lethal congenital condition.
METHODS: In two single-center, double-blind crossover studies, patients with moderate to severe menstrual pain received valdecoxib 20 or 40 mg, naproxen sodium 550 mg, or placebo in a single-dose phase, then twice a day as required for up to 3 days. Time-weighted sums of pain relief (TOTPAR) and of pain intensity differences (SPID) were assessed at 8 hours and 12 hours following a single dose. RESULTS: Two hundred thirty-eight women were randomized, and 180 who completed all four cycles were included in pooled efficacy analyses. TOTPAR and SPID scores for valdecoxib 20 or 40 mg at 8 and 12 hours were significantly better than placebo and similar to those for naproxen sodium 550 mg. Valdecoxib 40 mg provided significantly better TOTPAR and SPID scores at 12 hours compared with valdecoxib 20 mg. The incidence of adverse events was similar between active and placebo groups. TOTPAR and SPID at 8 hours and 12 hours (least mean squares) are shown in the table.
OBSTETRICS & GYNECOLOGY
Naproxen Valdecoxib Valdecoxib sodium Placebo 20 mg 40 mg 550 mg (n ⫽ 180) (n ⫽ 180) (n ⫽ 180) (n ⫽ 180) TOTPAR, 8h TOTPAR, 12 h SPID, 8 h SPID, 12 h
14.58
19.25*
20.87*
20.63*
22.94
29.97*
32.92*‡
32.10*
6.89 11.07
10.03* 15.62*
10.63* 16.95*‡
10.69* 16.67*
* P ⱕ 0.05 versus placebo. ‡ P ⱕ 0.05 versus valdecoxib 20 mg.
CONCLUSION: Valdecoxib 20 or 40 mg provides similar efficacy to naproxen sodium and superior efficacy to placebo in the relief of menstrual pain due to primary dysmenorrhea. Valdecoxib 40 mg demonstrates superior efficacy to the 20-mg dose.
DISCUSSION: The preliminary results suggest a slightly distorted expectation of outcome from minimally invasive treatments of uterine fibroids. The longer the patient recovered, the better her response scores were. The author concluded that surgical procedures require appropriate postoperative recovery prior to assessment of quality-of-life issues and that quality-of-life issues are important to the development of new technologies.
Medroxyprogesterone Acetate for Treatment of Abnormal Uterine Bleeding: Factors Predicting Success Holly E. Richter, PhD, MD University of Alabama at Birmingham, Birmingham, AL
Interventional Magnetic Resonance Imaging Cryoablation of Uterine Leiomyomata: Patient Satisfaction Bryan D. Cowan, MD University of Mississippi Medical Center, Jackson, MS
OBJECTIVE: To assess patient quality-of-life issues after minimally invasive cryoablation of uterine myomata was performed, the author developed a survey instrument to measure patient satisfaction with this therapy. STUDY DESIGN: A seven-question telephone survey was given to eight postoperative patients who had undergone cryoablation. METHODS: Patients were contacted between 214 and 557 days after their procedure and asked to rate the medical facilities and personnel and their overall surgical experience. A four-point rating scale was constructed for three questions in the questionnaire, ranging from excellent (4) to poor (1). In addition, patients were asked if their expectations had been fulfilled regarding recovery time, symptom relief, and choice of this treatment option (yes/no responses, three questions). Finally, patients were allowed to express their general opinion about the procedure and to relate any new symptoms (free form). The data were compared with t test, chi-square test, and linear regression when appropriate. RESULTS: The hospital and staff/faculty evaluation rated best, with an average score of 3.3. The surgical experience was rated at 2.5. Concerning recovery, 55% of patients indicated that they had returned to work at the expected time after the procedure, and 50% were glad that they had chosen it.
VOL. 99, NO. 4 (SUPPLEMENT), APRIL 2002
Lee A. Learman, MD, PhD, R. Edward Varner, MD, Susan L. Hendrix, DO, Robert L. Summitt, MD, and A. Eugene Washington, MD OBJECTIVE: To predict satisfaction with a cyclic regimen of medroxyprogesterone acetate (MPA) in premenopausal patients with abnormal uterine bleeding. METHODS: A prospective cohort study of 413 women who were considering subsequent participation in a randomized trial of medical versus surgical treatments for abnormal uterine bleeding was performed. A baseline assessment of demographics, gynecologic history, bleeding history, prior treatments for control of bleeding, and attitudes about uterine bleeding and treatment alternatives was conducted. Patients were treated for 3–5 months with oral MPA 10 –20 mg per day for 10 –14 days per month; patient satisfaction and willingness to continue MPA was then assessed. Baseline characteristics showing univariate associations with treatment satisfaction were entered into multiple logistic regression analysis. RESULTS: Sixty-five percent of subjects (271) completed at least 3 months of MPA, and 79% (215) of those individuals filled out a satisfaction survey. Satisfaction with MPA was not predicted by bleeding history but instead by age 35 years or older (OR 2.67; CI, 1.07– 6.7), desire for uterine conservation (OR 1.36; CI, 1.11– 1.66), perceived importance of stopping bleeding (OR 0.69; CI, 0.54 – 0.87), and tubal sterilization history (OR 0.52; CI, 0.28 – 0.96). Parity did not predict MPA satisfaction either independently or through an interaction with age. CONCLUSION: Short-term success of cyclic MPA is likely in women ages 35 or older who have not had a tubal sterilization and who value retaining the uterus. Younger women who prioritize resolution of abnormal bleeding and who do not value uterine conservation are unlikely to be satisfied with cyclic MPA.
MONDAY POSTERS
31S
The Perinatal Hospice: FamilyFocused Care When the Fetus Has a Lethal Congenital Condition Byron C. Calhoun, MD Madigan Army Medical Center, Lakewood, WA
Melissa V. Terry, MD, Carie Bussey, RN, and Nathan J. Hoeldtke, MD OBJECTIVE: To describe the authors’ experience in providing a program of structured interdisciplinary care for the
GYNECOLOGIC OUTCOMES
Efficacy of Valdecoxib versus Naproxen Sodium in Primary Dysmenorrhea Stephen E. Daniels, DO Scirex Corporation, Austin, TX
Sarah Torris, MPH, RD, and Michael C. Snabes, MD, PhD OBJECTIVE: To evaluate whether valdecoxib, a novel Cox2–specific inhibitor, provides effective treatment of menstrual pain due to primary dysmenorrhea.
30S
MONDAY POSTERS
families of fetuses prenatally diagnosed with a lethal congenital anomaly. METHODS: The authors developed a comprehensive ‘perinatal hospice’ program for the supportive care of families with fetuses known to have a lethal condition and evaluated the response of patients to this service. Upon prenatal diagnosis of a lethal fetal condition, parents were presented with the option of elective pregnancy termination versus a multidisciplinary program of ongoing supportive care until the time of spontaneous labor or until delivery was required for obstetric indications to include 1 year of follow-up after delivery. RESULTS: The population consisted of 27 patients with lethal anomalies. Twenty-three (85%) chose to participate in the perinatal hospice program. Of these, 8/23 (35%) had intrauterine fetal demise and 15/23 (65%) delivered a liveborn infant at Madigan Army Medical Center. Among the liveborn infants there were 12 vaginal deliveries, five preterm and seven at term. Obstetric indications or maternal request resulted in cesarean delivery for 3/23 (13%), two preterm and one term, all liveborn. All liveborn infants died within 20 minutes to 2 months of life. There were no maternal complications. CONCLUSION: The availability of a structured program providing comprehensive multidisciplinary supportive perinatal care offers a tangible and safe alternative to early elective termination for patients carrying a fetus with a lethal congenital condition.
METHODS: In two single-center, double-blind crossover studies, patients with moderate to severe menstrual pain received valdecoxib 20 or 40 mg, naproxen sodium 550 mg, or placebo in a single-dose phase, then twice a day as required for up to 3 days. Time-weighted sums of pain relief (TOTPAR) and of pain intensity differences (SPID) were assessed at 8 hours and 12 hours following a single dose. RESULTS: Two hundred thirty-eight women were randomized, and 180 who completed all four cycles were included in pooled efficacy analyses. TOTPAR and SPID scores for valdecoxib 20 or 40 mg at 8 and 12 hours were significantly better than placebo and similar to those for naproxen sodium 550 mg. Valdecoxib 40 mg provided significantly better TOTPAR and SPID scores at 12 hours compared with valdecoxib 20 mg. The incidence of adverse events was similar between active and placebo groups. TOTPAR and SPID at 8 hours and 12 hours (least mean squares) are shown in the table.
OBSTETRICS & GYNECOLOGY
Naproxen Valdecoxib Valdecoxib sodium Placebo 20 mg 40 mg 550 mg (n ⫽ 180) (n ⫽ 180) (n ⫽ 180) (n ⫽ 180) TOTPAR, 8h TOTPAR, 12 h SPID, 8 h SPID, 12 h
14.58
19.25*
20.87*
20.63*
22.94
29.97*
32.92*‡
32.10*
6.89 11.07
10.03* 15.62*
10.63* 16.95*‡
10.69* 16.67*
* P ⱕ 0.05 versus placebo. ‡ P ⱕ 0.05 versus valdecoxib 20 mg.
CONCLUSION: Valdecoxib 20 or 40 mg provides similar efficacy to naproxen sodium and superior efficacy to placebo in the relief of menstrual pain due to primary dysmenorrhea. Valdecoxib 40 mg demonstrates superior efficacy to the 20-mg dose.
DISCUSSION: The preliminary results suggest a slightly distorted expectation of outcome from minimally invasive treatments of uterine fibroids. The longer the patient recovered, the better her response scores were. The author concluded that surgical procedures require appropriate postoperative recovery prior to assessment of quality-of-life issues and that quality-of-life issues are important to the development of new technologies.
Medroxyprogesterone Acetate for Treatment of Abnormal Uterine Bleeding: Factors Predicting Success Holly E. Richter, PhD, MD University of Alabama at Birmingham, Birmingham, AL
Interventional Magnetic Resonance Imaging Cryoablation of Uterine Leiomyomata: Patient Satisfaction Bryan D. Cowan, MD University of Mississippi Medical Center, Jackson, MS
OBJECTIVE: To assess patient quality-of-life issues after minimally invasive cryoablation of uterine myomata was performed, the author developed a survey instrument to measure patient satisfaction with this therapy. STUDY DESIGN: A seven-question telephone survey was given to eight postoperative patients who had undergone cryoablation. METHODS: Patients were contacted between 214 and 557 days after their procedure and asked to rate the medical facilities and personnel and their overall surgical experience. A four-point rating scale was constructed for three questions in the questionnaire, ranging from excellent (4) to poor (1). In addition, patients were asked if their expectations had been fulfilled regarding recovery time, symptom relief, and choice of this treatment option (yes/no responses, three questions). Finally, patients were allowed to express their general opinion about the procedure and to relate any new symptoms (free form). The data were compared with t test, chi-square test, and linear regression when appropriate. RESULTS: The hospital and staff/faculty evaluation rated best, with an average score of 3.3. The surgical experience was rated at 2.5. Concerning recovery, 55% of patients indicated that they had returned to work at the expected time after the procedure, and 50% were glad that they had chosen it.
VOL. 99, NO. 4 (SUPPLEMENT), APRIL 2002
Lee A. Learman, MD, PhD, R. Edward Varner, MD, Susan L. Hendrix, DO, Robert L. Summitt, MD, and A. Eugene Washington, MD OBJECTIVE: To predict satisfaction with a cyclic regimen of medroxyprogesterone acetate (MPA) in premenopausal patients with abnormal uterine bleeding. METHODS: A prospective cohort study of 413 women who were considering subsequent participation in a randomized trial of medical versus surgical treatments for abnormal uterine bleeding was performed. A baseline assessment of demographics, gynecologic history, bleeding history, prior treatments for control of bleeding, and attitudes about uterine bleeding and treatment alternatives was conducted. Patients were treated for 3–5 months with oral MPA 10 –20 mg per day for 10 –14 days per month; patient satisfaction and willingness to continue MPA was then assessed. Baseline characteristics showing univariate associations with treatment satisfaction were entered into multiple logistic regression analysis. RESULTS: Sixty-five percent of subjects (271) completed at least 3 months of MPA, and 79% (215) of those individuals filled out a satisfaction survey. Satisfaction with MPA was not predicted by bleeding history but instead by age 35 years or older (OR 2.67; CI, 1.07– 6.7), desire for uterine conservation (OR 1.36; CI, 1.11– 1.66), perceived importance of stopping bleeding (OR 0.69; CI, 0.54 – 0.87), and tubal sterilization history (OR 0.52; CI, 0.28 – 0.96). Parity did not predict MPA satisfaction either independently or through an interaction with age. CONCLUSION: Short-term success of cyclic MPA is likely in women ages 35 or older who have not had a tubal sterilization and who value retaining the uterus. Younger women who prioritize resolution of abnormal bleeding and who do not value uterine conservation are unlikely to be satisfied with cyclic MPA.
MONDAY POSTERS
31S