Meta-analysis using individual patient data from randomised trials to assess the effectiveness of laparoscopic uterosacral nerve ablation in the treatment of chronic pelvic pain: a proposed protocol.

BACKGROUND: Currently, there are a number of clinical trials, but no international collaboration for collating research on effectiveness of laparoscopic uterosacral nerve ablation (LUNA) for alleviating chronic pelvic pain. OBJECTIVE: Meta-analysis was used by collecting individual patient data (IPD) from the existing trials, to provide a comprehensive assessment of the effectiveness of LUNA that will be generalisable in various clinical contexts. METHODS: IPD will be sought and collected from all relevant (both already finished and continuing) randomised trials identified through previous systematic reviews. After obtaining raw data and cleaning the database, analysis will be of all patients ever randomised based on the intention-to-treat principle using endpoints measured at 12 months following randomisation. PROPOSAL: We will update searches, contact all authors, obtain data in whatever form it can be provided, build a single database, produce results for individual studies, have them verified by original authors, explore of any heterogeneity and reasons behind it and finally pool all raw data in to a meta-analysis using appropriate statistical methods. The project will test the effectiveness of LUNA for women with chronic pelvic pain. It will also motivate collaborating primary investigators to undertake new primary studies to corroborate or improve upon the conclusions derived from the retrospective analysis.

Dehydroepiandrosterone and exercise in golden hamsters.

Dehydroepiandrosterone (DHEA) and dehydroepiandrosterone sulfate (DHEAS) are adrenal androgens that have been associated with a sense of well-being in humans. We describe two experiments done to test the hypothesis that an increase in DHEA or DHEAS secretion is associated with the inclination to exercise using a hamster model. In the first experiment, morning blood samples were obtained from adult male golden hamsters at various intervals after being placed in cages with (EX group) or without (SED group) access to running wheels. The EX group had lower DHEA (6, 12, and 14 weeks; p < 0.05) and DHEAS (13 and 16 weeks; p < 0.01) levels than the SED hamsters. In the second experiment, the number of wheel revolutions was monitored in castrated adult male hamsters implanted with Silastic capsules containing no hormone (blank control group), testosterone, or DHEA. The number of wheel revolutions in the group receiving DHEA was not significantly different than the blank control group, whereas testosterone increased wheel running at 4, 5, and 7 weeks (p < 0.05). These results indicate that DHEA and DHEAS levels decrease with exercise in male golden hamsters and that exogenous DHEA does not enhance the tendency to run on wheels.

Surgical treatment of primary dysmenorrhea with laparoscopic uterine nerve ablation.

With approximately 25% of dysmenorrheic patients reporting no improvement with nonsteroidal anti-inflammatory drugs, a study was devised to evaluate the effectiveness of a laparoscopic technique for the interruption of the uterosacral nerves. In a double-blind study of 21 patients with primary dysmenorrhea, 81% (9 of 11) reported significant relief from menstrual pain after the surgery. Performed as an outpatient procedure, laparoscopic uterine nerve ablation may alleviate dysmenorrheic complaints when other modalities have failed. Half the treated women reported continued relief of menstrual pain at 12 months. These results suggest that uterosacral nerve interruption may prove an effective alternative treatment for this menstrual disorder.

Efficacy of danazol in the control of hormonal migraine.

Of 131 women with hormonally related migraines unresponsive to standard medication, 67 (51.1%) noted profound relief after a 12-month, phased study using danazol for migraine prevention. The first three phases consisted of two-month cycles: dietary control and acetazolamide, the addition of danazol and danazol discontinuation. Eighty-three women (63.36%) reported control of their hormonal migraines while using danazol. In phase IV, 81 women whose headaches were controlled by danazol restarted danazol for an additional six months. Sixty-seven (82.7%) reported continued success with this medication. Danazol proved highly successful in the control of women's cyclic migraine. Its effectiveness remained consistent throughout the treatment course. In the prophylactic treatment of women's hormonal migraine, 400 mg of danazol administered daily for 25 days each month can prove effective when standard medical therapy fails. Furthermore, the response to danazol supported the concept that hormonal migraine should be treated as a distinct clinical entity.

Estrogen and alternative therapy of the menopausal patient.

Estrogen therapy is indicated for the vasomotor, genitourinary, and menstrual changes of the climacteric woman. Estrogens should be prescribed to relieve these symptoms specifically, and in the lowest dosage for the shortest time. Vaginal estrogens are appropriate in the treatment of genitourinary symptoms and may be given until sexual activity ceases. Vaginal ointments may be given even to patients in whom oral therapy may be contraindicated. Alternative therapy is helpful in the treatment of vasomotor symptoms, vulvitis, and breast tenderness. Appropriate therapy for all women includes a complete history and physical examination, and a thorough discussion of the physiologic and psychological changes of menopause. Appropriate studies include tests for estrogen effect to monitor therapy. They assist in treatment of the complexity of the menopause.

Individual patient data meta-analysis of randomized evidence to assess the effectiveness of laparoscopic uterosacral nerve ablation in chronic pelvic pain.

BACKGROUND: There have been conflicting results in randomized trials of the effects of laparoscopic uterosacral nerve ablation (LUNA) in chronic pelvic pain. Our objective was to perform a meta-analysis using individual patient data (IPD) to provide the most comprehensive and reliable assessment of the effectiveness of LUNA. METHODS: Electronic searches were conducted in the Medline, Embase, PsycInfo and Cochrane Library databases from database inception to August 2009. The reference lists of known relevant papers were searched for any further articles. Randomized trials comparing LUNA with no additional intervention were selected and authors contacted for IPD. Raw data were available from 862 women randomized into five trials. Pain scores were calibrated to a 10-point scale and were analysed using a multilevel model allowing for repeated measures. RESULTS: There was no significant difference between LUNA and No LUNA for the worst pain recorded over a 12 month time period (mean difference 0.25 points in favour of No LUNA on a 0-10 point scale, 95% confidence interval: -0.08 to 0.58; P = 0.1). CONCLUSIONS: LUNA does not result in improved chronic pelvic pain.

A microcomputer nursing workstation.

This paper describes the early development and implementation of a microcomputer-based nursing work station at Sinai Hospital of Detroit. The system was designed by a multidisciplinary team of nurses, doctors, programmers and other hospital personnel. The software is designed to: (1) facilitate effective communication between health professionals; (2) encourage data-based nursing decision-making; (3) standardize nursing care documentation; and, (4) decrease the time nurses spend on clerical functions. Future plans for evaluation and expansion of the system are described.

Clinically significant danazol-carbamazepine interaction.

In six patients with epilepsy and fibrocystic breast disease the concentration in serum of antiepileptic drugs was obtained before, during, and after danazol therapy. Carbamazepine serum levels increased almost twofold in the presence of danazol. Thus, interaction between carbamazepine and danazol producing acute carbamazepine toxicity is clinically significant. If these drugs are administered concurrently, an awareness of the potential for this drug-drug interaction along with monitoring of carbamazepine levels is required for optimal patient care.

The confirmation of a biochemical marker for women's hormonal migraine: the depo-estradiol challenge test.

PRECIS: Will estrogen withdrawal cause migraines in post-menopausal women? OBJECTIVE: To record the changes in serum estradiol and total estrogen levels after an intramuscular estradiol injection in menopausal subjects and then record any subsequent migraine occurrence. DESIGN: Open selection process, comparative trial. PATIENTS: Twenty-eight postmenopausal women volunteers were given 5 mg depo-estradiol cyprionate as an intramuscular injection. Sixteen (migraine group) had a history of severe, cyclic, menstrually related migraine attacks before becoming menopausal. Twelve (control group) had no history of migraine or headache. All volunteers were on continuous estrogen replacement therapy at the beginning of the study. Progestins were not used in the study. MAIN OUTCOME MEASURES: Serum estradiol and total estrogen levels were measured prior to the depo-estradiol injection and on subsequent days 4, 7, 14, 21, and 28. RESULTS: Total estrogen and estradiol levels varied greatly at every measured interval. Menopausal complaints of vasomotor symptoms were relieved for at least the first 2 weeks of the study. No member of the control group reported a migraine during the month. However, a severe migraine was reported by all 16 women with a history of migraine. The average day of the migraine occurrence was 18.5 +/- 2.8. The serum level of estradiol on the day of the worst migraine was 46.4 +/- 5.6 pg/mL. The significance of these findings was at the 95% confidence level. CONCLUSIONS: This study confirms two factors about menopausal hormonal migraine: (1) it can be precipitated by a drop in serum estrogen levels, and (2) a period of estrogen priming is a necessary prerequisite. This study also identifies that there are two biologically different populations of postmenopausal women: (1) those who developed migraine after a single depo-estradiol injection, and (2) those who did not. By understanding that in addition to the biological predisposition to migraine there exists the biochemical cofactor of falling estrogen levels, we may better understand this phenomenon and develop means to prevent its occurrence.