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Biomedical subjects

David S Guzick

Publications and source records attributed to David S Guzick.

At least 19 recordsLinked to original sources
PubMed2006

Clomiphene citrate monitoring for intrauterine insemination timing: a randomized trial.

OBJECTIVE: To compare pregnancy rates with two different methods of intrauterine insemination (IUI) timing in patients treated with clomiphene citrate (CC). DESIGN: Prospective, randomized trial. SETTING: Academic medical center. PATIENT(S): One hundred fifty ovulatory, infertile women. INTERVENTION(S): Patients were randomized into a luteinizing hormone (LH) surge group or a follicle monitoring/human chorionic gonadotropin (hCG) group. All patients underwent baseline ultrasound, and took clomiphene citrate, during days 5-9. Patients in the LH surge group underwent IUI on the day after a home test for the LH surge was positive, whereas those in the hCG group received hCG according to ultrasound parameters and underwent insemination 33-40 hours later. Patients remained in the same study group for up to three cycles. MAIN OUTCOME MEASURE(S): Pregnancy rates per cycle and per patient. RESULT(S): No significant differences were found between groups in pregnancy rates per patient or per cycle. The LH surge group underwent IUI significantly later than the hCG group. Cancellation rates were significantly higher for the LH surge group (31% vs. 11%) and attributable mainly to failure to detect an LH surge. The majority of pregnancies in both treatment groups occurred in the first cycle. CONCLUSION(S): The decision to use hCG for IUI timing should be influenced by factors other than pregnancy rates.

Adult↗
PubMed2006

The decline of infertility: apparent or real?

Data on trends in fertility and infertility are of significant interest, because they may reflect social, behavioral, biological, or environmental changes. The conclusion that infertility has declined in the United States, based on data from the National Survey of Family Growth, must be interpreted with great caution because of definitional and methodologic concerns.

Adolescent↗
PubMed2006

Gabapentin, estrogen, and placebo for treating hot flushes: a randomized controlled trial.

OBJECTIVE: To compare the efficacy of gabapentin, estrogen, and placebo in the treatment of hot flushes. METHODS: We performed a randomized, double-blind, placebo-controlled trial of 60 postmenopausal women to assess the efficacy of estrogen and gabapentin in the treatment of moderate-to-severe hot flushes. Participants were randomly assigned to receive either 0.625 mg/d of conjugated estrogens (n = 20), placebo (n = 20), or gabapentin titrated to 2,400 mg/d (n = 20) for 12 weeks. Participants recorded frequency and severity of baseline hot flushes on a hot flush diary for 2 weeks before randomization and for 12 weeks after randomization. The primary outcome measure was the weekly hot flush composite score, which takes into account both severity and frequency of hot flushes. Secondary outcome measures were differences in pre- and posttreatment scores pertaining to depression (Zung Depression Scale) and other climacteric symptoms (Greene Climacteric Scale). RESULTS: Intention-to-treat analysis showed that the reduction in the hot flush composite score for both estrogen (72%, P = .016) and gabapentin (71%, P = .004) was greater than the reduction associated with placebo (54%) at the conclusion of the 12th week. The extent of reduction in hot flush composite score, however, was not significantly different between estrogen and gabapentin (P = .63). No differences were seen between groups in the Zung Depression Scale, or in any of the Greene Climacteric subscales except for the Somatic Symptom cluster, which was significantly greater in the gabapentin arm than in the placebo arm. Despite a lack of group differences in adverse events, the Headache, Dizziness, and Disorientation cluster appeared with greater frequency in the gabapentin group. Estimation of the number needed to harm in this cluster suggests that these symptoms may occur with every fourth patient treated with gabapentin. CONCLUSION: Despite the small scale of this study, gabapentin appears to be as effective as estrogen in the treatment of postmenopausal hot flushes. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT 00276081. LEVEL OF EVIDENCE: I.

Amines↗
PubMed2006

Effect of mifepristone for symptomatic leiomyomata on quality of life and uterine size: a randomized controlled trial.

OBJECTIVE: To assess the effect of low-dose mifepristone on quality of life, pain, bleeding, and uterine size among women with symptomatic leiomyomata. METHODS: Forty-two women with symptomatic uterine leiomyomata and uterine volume of 160 mL or more were randomized to mifepristone, 5 mg daily, or placebo for 26 weeks. Quality of life (Uterine Fibroid Symptoms Quality of Life Questionnaire and Medical Outcomes Study 36-Item Short Form survey) and uterine and leiomyoma size (ultrasonography) were assessed at baseline, and at 1 month, 3 months, and 6 months of treatment. Bleeding (daily logs and pictorial charts) and pain (McGill Pain Questionnaire) were assessed monthly. Endometrial pathology was assessed at baseline and 6 months. RESULTS: Forty-two women were randomized; 37 women completed all 6 months. Women randomized to mifepristone showed an improvement in leiomyoma-specific quality of life. Forty-one percent became amenorrheic, rates of anemia improved, and adjusted uterine size was reduced by 47%. Compared with the placebo group, improvements in these outcomes in the treatment group were significantly greater (P<.05 to .001). There were no significant differences in adverse effects between the groups. No endometrial hyperplasia was noted in any participant. CONCLUSION: Low-dose mifepristone improves leiomyoma-specific quality of life and reduces leiomyoma size among women with symptomatic leiomyomata. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov www.clinicaltrials.gov NCT00133705 LEVEL OF EVIDENCE: I.

Adult↗
PubMed2006

Pelvic organ prolapse in nulliparous women and their parous sisters.

OBJECTIVE: To investigate the role of vaginal delivery and familial factors in the development of pelvic organ prolapse by comparing the prevalence of this condition in nulliparous women and their parous sisters. METHODS: Pairs of nulliparous and parous postmenopausal sisters were recruited for assessment of pelvic organ prolapse. One hundred one sister pairs underwent clinical evaluation. Pelvic organ prolapse was recorded using the Pelvic Organ Prolapse Quantification System. RESULTS: The majority of women had no pelvic organ prolapse. By compartment there was a 74.3% to 91.1% concordance in prolapse stage within sister pairs. In discordant sister pairs, the parous sister was found to have the more advanced prolapse 88% of the time. CONCLUSION: High concordance of pelvic organ prolapse in nulliparous and parous sister pairs suggests a familial predisposition toward developing this condition. However, vaginal delivery does appear to confer a risk for more advanced pelvic organ prolapse. LEVEL OF EVIDENCE: II-2.

Delivery, Obstetric↗
PubMed2005

Occupational exposures and male infertility.

The purpose of this study was to determine the association between male occupational exposures and infertility. A retrospective case-control study was performed using data collected between 1991 and 1997 at nine US clinical sites as part of a previously conducted large multicenter trial. Cases were defined as infertile males whose partner had an infertility evaluation with normal results, and controls were defined as fertile males whose partner became pregnant within 2 years. Exposures were assessed by means of self-report questionnaires. Bivariate, stratified, and multivariable analyses were performed. A total of 650 infertile cases and 698 fertile controls were compared. In the final model, a protective association with infertility was observed for occupational exposures to radiation (odds ratio=0.21, 95% confidence interval: 0.06, 0.77) and video display terminals (odds ratio=0.30, 95% confidence interval: 0.13, 0.68). No significant associations were noted between infertility and exposure to shift work, metal fumes, electromagnetic fields, solvents, lead, paint, pesticides, work-related stress, or vibration. Overall, no clear, clinically important associations between occupational exposures and male infertility could be identified in this study.

Adult↗
PubMed2005

Urinary incontinence in nulliparous women and their parous sisters.

OBJECTIVE: To investigate the role of vaginal delivery and familial factors in the development of urinary incontinence by comparing the prevalence of this condition in nulliparous women and their parous sisters. METHODS: A sample of 143 pairs of nulliparous/parous postmenopausal sisters completed a comprehensive questionnaire regarding symptoms of pelvic floor disorders. Of these, 101 pairs underwent clinical evaluation of urinary incontinence and genital prolapse. RESULTS: Among this sample of biological sisters, urinary incontinence was reported by 47.6% of nulliparous women and by 49.7% of parous women (P = .782). We found no difference in the severity or type of urinary incontinence between these 2 groups. There was a high concordance in continence status, however, within biological sisters. CONCLUSION: Vaginal birth does not seem to be associated with urinary incontinence in postmenopausal women. Considering the high concordance in continence status between sister pairs, and considering that the majority of parous women are continent, an underlying familial predisposition toward the development of urinary incontinence may be present.

Age Distribution↗
PubMed2004

Utility of urine reagent strip in screening women with incontinence for urinary tract infection.

The aim of this study was to determine the utility of urine reagent strips in screening women with urinary incontinence for urinary tract infections. Subjects were all women presenting with urinary incontinence. A urine specimen was screened for urinary tract infection with a urine reagent strip and urine culture. Using the urine culture result as the gold standard, the sensitivity, specificity, and positive and negative predictive values of the urine reagent strips were calculated. A total of 265 pairs of reagent strips and urine cultures were evaluated. Thirty-one cultures grew out of a single organism; nine of these had a positive urine reagent strip, yielding a sensitivity of 29%. The specificity of the urine reagent strip was 99%, the positive predictive value was 82% and the negative predictive value was 92%. For women presenting with urinary incontinence, the sensitivity of a urine reagent test for diagnosing urinary tract infection was low.

Bacteriological Techniques↗
PubMed2004

For now, one well-timed intrauterine insemination is the way to go.

Two articles on pregnancy rates from superovulation and IUI in relation to the IUI protocol were reviewed. Results from a meta-analysis of IUI number (one vs. two) and from a randomized trial of IUI timing (33 hours vs. 39 hours after hCG administration) suggest that one well-timed insemination within several hours of ovulation represents a reasonable balance between efficacy and cost.

Female↗
PubMed2004

A randomized, 48-week, placebo-controlled trial of intensive lifestyle modification and/or metformin therapy in overweight women with polycystic ovary syndrome: a pilot study.

OBJECTIVE: To obtain data from a pilot randomized trial on the effect of metformin therapy and lifestyle modification on ovulation and androgen concentrations in women with polycystic ovary syndrome (PCOS). DESIGN: Prospective, randomized, placebo-controlled pilot trial. SETTING: Academic medical center. PATIENT(S): Thirty-eight overweight or obese women with PCOS. INTERVENTION(S): All subjects were randomized to one of four 48-week interventions: metformin 850 mg two times per day, lifestyle modification plus metformin 850 mg two times per day, lifestyle modification plus placebo, or placebo alone. MAIN OUTCOME MEASURE(S): Recruitment, dropout, and compliance with a long-term lifestyle intervention in PCOS; preliminary estimates of treatment effect on ovulation, as measured by weekly urinary pregnanediol glucuronide, and on total T and free androgen index. RESULT(S): It was necessary to screen seven women to have one subject randomized. The dropout rate was 39%, with the majority of dropouts occurring within the first 24 weeks. Mean body mass index was >39 mg/kg(2). Modest weight reduction was found in all treatment groups, with the most significant reduction occurring with the combination of metformin and lifestyle intervention. Significant androgen reduction occurred in the combination group only. Ovulation rates did not differ significantly between groups. However, when data were analyzed by presence or absence of weight reduction in subjects, independent of treatment group, the estimated odds ratio for weight loss was 9.0 (95% confidence interval 1.2-64.7) with respect to regular ovulation. If weight loss occurred during metformin therapy, the odds ratio for regular ovulation was 16.2 (95% confidence interval 4.4-60.2). CONCLUSION(S): Key methodologic issues for a large-scale, randomized trial of lifestyle intervention in PCOS include minimizing early dropout from the lifestyle intervention and including a range of body mass index that is not skewed toward severe obesity. Weight reduction might play the most significant role in restoration of ovulation in obese women with PCOS.

Adipose Tissue↗
PubMed2004

Histological dating of timed endometrial biopsy tissue is not related to fertility status.

OBJECTIVE: To assess the ability of histological dating to discriminate between women of fertile and infertile couples. The utility of histological dating of endometrium in the evaluation of infertile couples is uncertain. DESIGN: Prospective multicenter study, with subjects randomly assigned to biopsy timing. Criterion standard for infertility was 12 months of unprotected, regular intercourse without conception and for fertility at least one live birth within 2 years. SETTING: University-based infertility practices. PATIENT(S): Volunteer subjects (847) recruited at 12 clinical sites participating in the National Institutes of Health-funded Reproductive Medicine Network. Inclusion criteria included ages 20-39 years, regular menstrual cycles, and no hormonal treatment or contraceptive use for 1 month before the study. Fertile controls were excluded if they had a history of infertility, recurrent pregnancy loss, or recent breastfeeding. INTERVENTION(S): Subjects underwent daily urinary LH testing. After detection of the LH surge, subjects were randomized to biopsy in the mid (days 21-22) or the late (days 26-27) luteal phase. Pathologists at each site estimated the cycle day based on standard criteria. For the primary analysis, an out-of-phase biopsy was defined as a greater than 2-day delay in the histological maturation of the endometrium. MAIN OUTCOME MEASURE(S): The proportion of out-of-phase biopsies in fertile and infertile women was compared using logistic regression models with age at randomization as a covariate. Comparisons were also made between fertile vs. infertile at the midluteal or late luteal phase time points. RESULT(S): Biopsies were evaluated (301 mid and 318 late; N = 619). Out-of-phase biopsy results poorly discriminated between women from fertile and infertile couples in either the midluteal (fertile: 49.4%, infertile: 43.2%) or late luteal phase (fertile: 35.3%, infertile 23.0%). Results did not substantially differ using alternative definitions of "out-of-phase" or standardized cycle day. CONCLUSION(S): Histological dating of the endometrium does not discriminate between women of fertile and infertile couples and should not be used in the routine evaluation of infertility.

Adult↗
PubMed2004

Polycystic ovary syndrome.

Women with polycystic ovarian syndrome have chronic anovulation and androgen excess not attributable to another cause. This condition occurs in approximately 4% of women. The fundamental pathophysiologic defect is unknown, but important characteristics include insulin resistance, hyperandrogenism, and altered gonadotropin dynamics. Inadequate follicle-stimulating hormone is hypothesized to be a proximate cause of anovulation. Obesity frequently complicates polycystic ovarian syndrome but is not a defining characteristic. The diagnostic approach should be based largely on history and physical examination, thus avoiding numerous laboratory tests that don't contribute to clinical management. Women with polycystic ovarian syndrome typically present because of irregular bleeding, hirsutism, and/or infertility. These conditions can be treated directly with oral contraceptives, oral contraceptives plus spironolactone, and ovulation induction, respectively. However, women with polycystic ovarian syndrome also have a substantially higher prevalence of diabetes and increased risk factors for cardiovascular disease. They should also be screened, therefore, for these conditions and followed closely if any risk factors are uncovered. For obese women with polycystic ovarian syndrome, behavioral weight management is a central component of the overall treatment strategy.

Decision Trees↗
PubMed2004

Can differences in labor induction rates be explained by case mix?

OBJECTIVE: To determine whether differences in case mix account for variations in labor induction rates between hospitals and whether case mix adjustment is helpful in evaluating hospital induction rates. STUDY DESIGN: Using a New York State birth certificate database, factors associated with induction of labor were entered into a logistic regression to calculate labor induction probabilities. The probabilities were used to calculate expected induction rates at each of 16 regional hospitals. Each hospital's observed and expected induction rates were compared to determine the degree of residual variation. RESULTS: Excluding women who delivered by cesarean section without labor, the regional labor induction rate was 20.8%, with a 3.9-fold difference between the highest and lowest hospital rates (P < .0001). Adjusting for risk factors explained only 12.6% of the variation in induction rates. Risk adjustment to compare labor induction rates had a minimal effect on rank ordering of rates but made clearer some hospitals' rates. CONCLUSION: Differences in case mix do not explain labor induction rate variation, but adjustment for case mix may aid in interpreting rates at individual hospitals.

Adult↗
PubMed2003

Low-dose mifepristone for uterine leiomyomata.

OBJECTIVE: To compare the effect of 5 and 10 mg of mifepristone on uterine leiomyoma size and symptoms, and to measure side effects. METHODS: Forty premenopausal women with large, symptomatic leiomyomata were randomized to receive either 5 or 10 mg of mifepristone daily for 6 months in an open-label study. Uterine volume was measured at bimonthly intervals by sonography. Serum concentrations of hemoglobin levels, follicle-stimulating hormone, and liver enzymes were obtained, and endometrial samples, symptoms, and menstrual bleeding were also assessed. RESULTS: Nineteen of 20 subjects taking 5 mg and all 20 subjects taking 10 mg completed all 6 months of the study. Mean uterine volume shrank by 48% (P <.001) in the 5-mg group and 49% (P <.001) in the 10-mg group, a nonsignificant difference. Leiomyoma-related symptoms were comparably reduced in both groups. Amenorrhea occurred in 60-65% of both groups. Hemoglobin levels increased by 2.5 g/dL in anemic subjects. The incidence of hot flashes increased significantly over baseline in the 10-mg group but not in the 5-mg group. Simple endometrial hyperplasia occurred in 28% of all subjects, with no difference between groups. No atypical hyperplasia was noted. CONCLUSION: Mifepristone in doses of 5 mg or 10 mg results in comparable leiomyoma regression, improvement in symptoms, and few side effects. Further study is needed to assess the long-term safety and efficacy of low-dose mifepristone.

Adult↗
PubMed2003

Evaluating the efficacy of intervention.

The standard for reaching a verdict in civil trials is "the preponderance of the evidence." This is a valid standard to apply to evaluating the medical literature as well. Every published report should be given weight based on physicians' judgment of its reliability. Larger-scale studies should be weighted more heavily than smaller-scale studies, randomized trials more heavily than observation studies, rigorously designed trials more heavily than studies that may be biased. If there seems to be a relationship between a factor and an outcome, this does not necessarily imply that the factor caused the outcome. The association could be a result of chance variation between individuals. Statistical testing allows researchers to exclude chance as a likely cause of the relationship, but this is the only explanation ruled out by a significance test. The relationship could be a result of bias: bias in the selection of individuals for the study, bias in measurement of the factor or the outcome, or bias in differential loss to follow-up. A thorough analysis of the data is necessary to identify and exclude other possible explanations of the association. A government agency dealing with environmental regulations experimented with replacing administrative law judges with scientists. It was believed that scientists were better qualified to make the necessary technical evaluations. The experiment was not considered successful because, as one observer remarked, "Judges are used to having to reach a verdict within a short period of time based on whatever evidence is presented--scientists just can't seem to make decisions." This illustrates a similar difference between the role of the researcher and the role of the physician. The physician must decide the best treatment for each patient based only on whatever evidence is available. There is little question, however, what the patient would decide if allowed to choose between receiving the standard therapy today or waiting 5 years until conclusive scientific evidence has been obtained about whether an alternative treatment is better. Few patients would choose to wait. Yet the decisions a physician makes today will be criticized in 5 years, especially by those who never have had to make similar decisions themselves. Some decisions will turn out to be wrong when additional data are available, but physicians must make choices based on the best data currently available. The choice of medicine as a profession implies the acceptance of a life sentence to jury duty: the evidence will never stop accumulating, and the verdict must be continually reevaluated.

Data Interpretation, Statistical↗