Patricia J. Sulak

Headaches and oral contraceptives: impact of eliminating the standard 7-day placebo interval.

Objective.—The aim was to assess the timing and severity of self‐reported headaches in patients utilizing a standard 28‐day oral contraceptive (OC) cycle consisting of 21 hormone (estrogen + progestin)‐containing pills and 7 placebo pills (ie, 21/7‐day cycle) converted to a placebo‐free extended OC regimen.

Frequency and management of breakthrough bleeding with continuous use of the transvaginal contraceptive ring: a randomized controlled trial.

OBJECTIVE: To assess bleeding patterns with continuous use of the transvaginal contraceptive ring. METHODS: We did a prospective analysis of daily menstrual flow during a 21/7 cycle followed by 6 months of continuous use and institution of a randomized protocol to manage breakthrough bleeding/spotting. Seventy-four women completed the baseline 21/7 phase and were randomized equally into two groups during the continuous phase. Group 1 was instructed to replace the ring monthly on the same calendar day with no ring-free days. Group 2 was instructed to use the same process, but if breakthrough bleeding/spotting occurred for 5 days or more, they were to remove the ring for 4 days, store it, and then reinsert that ring. RESULTS: Sixty-five women completed the continuous phase with reduced average flow scores in the continuous phase compared with the 21/7 phase (P<.02). Most patients had no to minimal bleeding during continuous use, with group 2 experiencing a statistically greater percentage of days without breakthrough bleeding or spotting (95%) compared with group 1 (89%) (P=.016). Instituting a 4-day hormone-free interval was more (P<.001) effective in resolving breakthrough bleeding/spotting than continuing ring use. CONCLUSION: A reduction in bleeding occurred during continuous use with replacement of the transvaginal ring compared with baseline 21/7 use. Continuous vaginal ring use resulted in an acceptable bleeding profile in most patients, reduction in flow, reduction in pelvic pain, and a high continuation rate. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00475553 LEVEL OF EVIDENCE: I

Clinical comparison of triphasic norgestimate/35 μg ethinyl estradiol and monophasic norethindrone acetate/20 μg ethinyl estradiol: Cycle control, lipid effects, and user satisfaction

This six-cycle, multicenter, open-label, randomized study compared the clinical experience of two low-dose oral contraceptives (OC): a triphasic OC containing norgestimate (NGM) and 35 micrograms ethinyl estradiol (EE) (Ortho Tri-Cyclen) and a monophasic OC containing norethindrone acetate (NETA) and 20 micrograms EE (Loestrin Fe 1/20). Cycle control, lipid and androgen profiles, and user satisfaction were studied in new-start OC users (i.e., no prior use within 60 days). Breakthrough bleeding or breakthrough spotting (BTB/BTS) occurred in a significantly smaller percentage of NGM/EE users than NETA/EE users during each of six cycles (p < or = 0.002). The incidence of BTB/BTS ranged from 3.7% to 13.5% for NGM/EE users and from 23.5% to 49.7% for NETA/EE users. Significantly fewer NGM/EE users than NETA/EE users experienced absence of menses at cycles 2 through 6 (p < or = 0.003). The percentages of women having no menses at each cycle ranged from 0.9% to 4.7% for NGM/EE users and from 10.3% to 21.3% for NETA/EE users. NGM/EE users reported a significantly (p < 0.001) higher level of satisfaction with their OC at the end of six cycles than did NETA/EE users, but there was no significant difference in compliance, discontinuation rates, or adverse events between the two groups. NGM/EE produced a significantly (p < or = 0.001) greater beneficial effect on HDL-C, HDL2, and apo A-I than did NETA/EE. No statistically significant treatment differences were found for total cholesterol, LDL-C, triglycerides, or apo-B. Both OC increased sex hormone binding globulin and decreased free testosterone, but NGM/EE had a significantly greater effect (p < 0.009).

Extended Cycle Combined Oral Contraceptives and Prophylactic Frovatriptan During the Hormone-Free Interval in Women with Menstrual-Related Migraines

BACKGROUND Migraine headaches are a significant problem for American women with many of them suffering from headaches around the time of their menstrual cycle. Women taking oral contraceptives in the standard 21/7 cycle regimen often suffer from headaches around the time of the hormone free intervals (HFIs) as well. Extended oral contraceptive regimens have been shown to decrease the frequency, but not eliminate these headaches. This study is a double-blind, randomized, placebo-controlled pilot study of participants with menstrual-related migraines (MRMs) who were initiated on extended combined oral contraceptives and given frovatriptan prophylactically during HFIs. METHODS Participants having spontaneous menstrual cycles or taking daily combined oral contraceptives in a 21/7 regimen with MRMs were placed on a contraceptive containing levonorgestrel and ethinyl estradiol. Analyses compared headache scores during pre-study baseline cycles to those in a 168-day extended regimen with placebo versus frovatriptan treatments during HFIs. RESULTS Daily headache scores decreased (p=0.034) from 1.29 ± 0.10 during pre-study cycles to 1.10 ± 0.14 during extended combined oral contraceptive use. Frovatriptan blocked the increase in headache score over the placebo during HFIs. However, following the withdrawal of frovatriptan, headache scores increased (p>0.01) despite resuming combined oral contraceptive use. CONCLUSIONS Extended combined oral contraceptive regimen reduces MRM severity. Frovatriptan prevents headaches during HFIs, but is associated with new headache symptoms when withdrawn.

Intrauterine device practice guidelines : Patient types

Currently available IUDs--the Copper T 380A and the progesterone-releasing device--may offer a viable contraceptive choice to millions of US women who have not yet found a satisfactory method. Although most IUD users in the US are 35 years of age and above, the method is appropriate for many young adults and even teenagers, provided they are in stable, monogamous relationships. Recent studies have determined that nulliparity is not a risk factor for pelvic inflammatory disease; however, both expulsion and increased menstrual bleeding and pain are more common among nulliparous women. Copper-bearing IUDs can be inserted in women who are only 4 weeks postpartum without an increased risk of perforation, expulsion, or excessive bleeding. Other candidates for IUD use include women who have undergone abortion, lactating women, perimenopausal women, those with a prior history of ectopic pregnancy, and women who cannot use oral contraception. Finally, IUDs are appropriate for women who are considering sterilization but are not yet ready to take this irreversible step. In all cases, screening for sexually transmitted disease risk factors is essential in user selection.

Evaluation of 3‐day course of doxycycline for the treatment of uncomplicated Chlamydia trachomatis cervicitis

Objective: The purpose of this study was to compare the efficacy of a 3-day course of doxycycline to a standard 7-day course for treating uncomplicated chlamydia cervicitis. Methods: During an 18-month period, 77 women with uncomplicated chlamydia cervicitis were randomized to receive either a 3-day or a 7-day course of doxycycline (100 mg twice daily). Tests of cure were performed 3 weeks after completion of therapy with the Amplicor polymerase chain reaction (PCR) assay (Roche Molecular Systems, Branchburg, NJ). Demographics, therapeutic results, and side effects for the two groups were compared. Results: Seventy-three patients completed the study: 35 in the 3-day group and 38 in the 7-day group. There were no significant differences in age, gravidity, or parity between the groups. There was a 94% (33/35) cure rate in the 3-day group and a 95% (36/38) cure rate in the 7-day group (P = 1.0). Thirty-four percent and 32% of the patients in the 3- and 7-day groups reported side effects, respectively; there was no significant differences between the 3- and 7-day groups in regard to population demographics, patient compliance, therapeutic outcome, or side effects. Conclusions: A 3-day course of doxycycline appears to be as effective as a 7-day course of doxycycline for the treatment of uncomplicated chlamydia cervicitis.

Performance of the Syva Direct Fluorescent AntibodyAssay for Chlamydia in a Low-Prevalence Population

Chlamydia trachomatis is the most common reportable sexually transmitted disease (STD) in the United States. In the 1980s, rapid diagnostic tests for chlamydia began to replace more cumbersome tissue culture methods. Current data on rapid antigen detection assays demonstrate acceptable sensitivity, specificity, and predictive values in populations with a high prevalence of chlamydia. Few studies report the performance of these assays in a low-prevalence obstetric and gynecologic (Ob/Gyn) population, This study compares the most commonly used direct fluorescent antibody (DFA) assay (Syva Microtrak) with tissue culture (TC) in a low-prevalence population. Endocervical specimens (775) were tested from women at risk for chlamydia infection, and the prevalence was found to be 7.7%. The DFA assay demonstrated a sensitivity of 80% and a specificity of 97% compared with TC. The positive and negative predictive values were 72% and 98%, respectively. The results of this study indicate that the Syva DFA assay lacks the sensitivity and positive predictive value for routine use in Ob/Gyn populations with a lowprevalence of C. trachomatis.

The Mystery of Figure 2—A Case for Ovulatory Migraine? A Response

Headache medicine is an integral part of neurology. Given the fact that there are no ̈ surgical, invasive, or complex diagnostic procedures involved in headache medicine, and since headache medicine is mainstream neurology, the neurological community should seriously question (1) the requirement for a separate headache certification in the field of neurology and (2) the reason why ALL neurologists are not mandated to be experts in headache medicine by the American Board of Psychiatry and Neurology. Dr. Finkel points out that the 105 neurologists who have been certified by the United Council for Neurologic Subspecialties–Headache Medicine (this author included), were certified under the practice track.1 The brightest headache researchers and clinicians in the world are part of this group. None of us completed a headache fellowship. We read, attend conferences, teach, and apply the basic science of headache medicine to manage our patients. If a neurological subspecialty requires in-depth training of invasive, surgical, or diagnostic procedures, or contains a body of knowledge that is outside the scope of mainstream neurology, then a 1-year fellowship with special certification should be required. For example, in pain management it is important to master all the invasive procedures and be competent in the medical and invasive aspects of this field so as to competently practice pain medicine without causing harm to patients. However, for neurologists not to be able to comprehensively master headache medicine during residency with continuity of expertise into clinical practice is very disturbing and sends the wrong message to the public. The public expects that a neurologist is most competent with the authoritative final word on headache disorders. Now we are telling the public that we have 2 neurologists, a neurologist that is board certified in neurology who is expected to be proficient in managing headache patients, and another type of neurologist who is more competent in managing headaches. Imagine the ludicrous analogy of certification in chest pain medicine in cardiology, and certification in abdominal pain medicine in gastroenterology. The medical community should be indebted and very respectful of the important headache medicine contributions made by neurologists who limit their work to headache in academic settings as teachers, researchers, and clinicians. All neurologists have the duty to stay abreast and be experts in all neurological disorders. Regardless of the scope of practice, a good neurologist has strong foundations in general medicine and especially in all neurological disorders as headache patients almost always have co-existing/co-morbid issues. Headache medicine can be easily assimilated into 3-year residency programs and into patient practice. Headache pathophysiology, treatment, differential diagnoses, does not require specialty training or specialty certification. Subspecialty training and certification is certainly essential in many areas of medicine and surgery. However, fellowship training and certification for neurologists for headache is absurd and resonates elitism. One wonders what it will mean to be a neurologist when other groups such as movement disorders and multiple sclerosis start forming their own certification/fellowship clubs.

Review and update on oral contraceptives for the psychiatric practitioner

Abstract Oral contraceptive therapy is used by many women of contraceptive age. Although an effective contraceptive, other uses include menstrual problems such as menorrhagia and dysmenorrhea and premenstrual syndrome. Because of the prevalence of use, psychiatric practitioners should be familiar with their components and educational tools that improve product selection and patient compliance. Oral contraceptives containing ethinyl estradiol 35 mcg or less are used by most women today. Much of the documentation of adverse effects are from the higher dose products used in the past. Many women are not aware of the many noncontraceptive benefits such as decreased incidences of breast and ovarian cancer and improvements in menstrual problems. Oral contraceptives are associated with increased thromboembolic disease, but the risk is less than the risk in pregnancy. Other health risks have not been conclusively proven or the increased risk is so small that the benefits often outweigh the risks. Drug interactions with commonly encountered concomitant drugs are also discussed.

Extensión de la duración de las píldoras anticonceptivas orales para manejar los síntomas de supresión hormonal

Objetivo: Probar la hipotesis que extendiendo el numero de contraceptivos orales activos (CO) administrados, podria disminuirse la frecuencia de problemas relacionados con la menstruacion incluyendo dismenorrea, menorragia, sintomas de tipo premenstrual y migranas menstruales.Metodos: Se diseno un analisis prospectivo para seguir las experiencias de 50 mujeres que tomaban CO y presentaban problemas relacionados con la menstruacion. Se siguieron 50 mujeres consecutivas, quienes estaban tomando CO y tenian sintomas durante el intervalo libre de pildoras en una clinica de multiespecialidades por un equipo de medico y enfermera. Se les permitio a las pacientes extender el numero de CO activos consecutivos para retardar los sintomas relacionados con la menstruacion.Resultados: El resultado inmediato de las 50 pacientes revelo que el 74% (37 pacientes) se estabilizaron en un regimen extendido de 6 a 12 semanas de dias consecutivos con. CO activos. Veintiseis por ciento (13 pacientes) descontinuaron los CO o regresaron al regimen estandar con 3 semanas de pildoras activas. De las 37 pacientes que se estabilizaron en un regimen extendido, 27 han completado entre 5 y 13 ciclos extendidos con 6-23 meses de seguimiento (promedio 16 meses).Conclusion: La experiencia con una serie de 50 usuarias de CO con sintomas relacionados con la menstruacion demostro que retardar la menstruacion extendiendo el numero de dias consecutivos de pildoras activas es bien tolerado y eficaz. Se amerita un gran estudio prospectivo para aumentar el conocimiento en esta area.