Gonadotrophin-releasing hormone agonist therapy for hirsutism is as effective as high dose cyproterone acetate but results in a longer remission

Both cyproterone acetate (CPA) and the gonadotrophin-releasing hormone agonist (GnRHa) have been shown to be effective for the treatment of hirsutism. We wished to compare the effectiveness of CPA in two standard doses with GnRHa and add-back therapy and to compare the length of remission after these treatments. A total of 60 hirsute hyperandrogenic women was assigned to the following treatment groups: CPA 2 mg with 35 microg of ethinylestradiol for 21 days each month (Diane group), CPA 50 mg, days 5-15, and ethinylestradiol 50 microg, days 5-25, each month (CPA group) or Decapeptyl 3.75 mg i.m. every 28 days with the addition of conjugated oestrogen 0.625 mg, days 1-21, and medroxyprogesterone acetate 10 mg, days 12-21 (GnRHa group). Hirsutism was graded by the Ferriman-Gallwey-Lorenzo (FGL) index and anagen hair shaft diameters and serum luteinizing hormone (LH) and testosterone were assessed before and every 3 months during and after treatment. All women were treated for 1 year with 1 year follow-up. At baseline hirsutism and endocrine patterns were similar in all groups. After one year of treatment, hirsutism decreased in all groups but the changes were greater (P <0.05) in the CPA and GnRHa groups than in the Diane group. Serum LH and testosterone were lowest in the GnRHa group. After withdrawal, hirsutism increased rapidly in the Diane and CPA groups and after 6 months, FGL scores and hair shaft diameters were similar to pretreatment values. In the GnRHa group, hirsutism increased more gradually and after 1 year of withdrawal, FGL scores and hair diameters were significantly (P <0.05) less than pretreatment values. Serum LH and testosterone increased rapidly in all three groups reaching pretreatment values by 6 months. These data suggest equal efficacy of the GnRHa and the high dose CPA regimen for the treatment of hirsutism in hyperandrogenic women. GnRHa with add-back treatment appears to result in a longer remission of hirsutism in comparison with CPA.      

Maxillary sinusitis in adults: an evaluation of placebo-controlled double-blind trials

BACKGROUND: In general practice, acute sinusitis is frequently diagnosed and treated with antibiotics. OBJECTIVE: This study aimed to determine the evidence for the effectiveness of antibiotic treatment in acute maxillary sinusitis in adults by assessing the methodological quality of placebo-controlled double-blind randomized trials. METHOD: An evaluation by four raters through a 35-item scoring-scale for internal and external validity of all placebo-controlled double-blind randomized trials on acute sinusitis found between January 1966 and July 1996. RESULTS: Eighty-five trials were excluded because they were not placebo-controlled, double-blind, randomized, or were carried out in patients with chronic sinusitis or in children. The three remaining trials were performed in different populations (one in general practice) between 1973 and 1978. Only one study claimed superiority of antibiotic treatment. Different inclusion criteria and major outcome measures were used by the authors. The reliability of major outcome events was reported poorly or not at all and in two studies outcome measures were clinically inappropriate. The studies scored 30-62% of the maximum attainable score for internal validity and 10-20% for external validity. CONCLUSION: The effectiveness of antibiotic treatment in acute maxillary sinusitis in a general practice population is not based sufficiently on evidence.      

Upper and midureteral calculi: percutaneous extraction with an occlusion balloon catheter

In 44 patients with one or more calculi in the upper two-thirds of the ureter, single-stage percutaneous nephrolithotomy was performed through a middle or upper calyceal nephrostomy after cystoscopic placement of an occlusion balloon catheter distal to the calculus; in 42, the procedure was successful. The occlusion balloon catheter permitted retrograde opacification of all systems for enhanced renal puncture. In the last 30 patients an attempt was made either to push the calculus upward mechanically or to flush it upward into the renal pelvis with carbon dioxide or dilute contrast material. This was successful in 24 of these patients. Prior overnight occlusion of the ureter by means of ureteral dilatation further facilitates dislodgment of the calculus, which was successful in 12 of 13 patients.     

Early postoperative feeding after elective colorectal surgery is not a benefit unique to laparoscopy-assisted procedures

Previous analyses of non-prospectively randomized trials have suggested that early oral postoperative feeding might be a benefit unique to laparoscopic surgery. However, some authors have indicated that early feeding can be tolerated by the majority of patients after elective open surgery. Aim: This prospective randomized study was undertaken to assess whether the time prior to oral intake of food after laparoscopy-assisted surgery is shorter than that after standard laparotomy. Methods: This trial included 40 patients who were divided randomly into two groups before operation. Group I included 20 patients (mean age, 52 years; range , 15 – 77 years) who underwent a laparoscopy-assisted colon or rectal procedure (LAP). Group II consisted of 20 patients (mean age, 56 years, range, 41 – 74 years) who underwent surgery with a standard midline incision (SMI). On the evening after surgery, patients were allowed clear liquids ab libitum. This regimen was continued until the first postoperative day at which time they could elect to start eating a regular diet. If a patient had two episodes of vomiting, a nasogastric tube was inserted. Results: Five laparoscopic procedures were converted to SMI because of adhesions (25%) and an equal number of patients was excluded from the group that was treated in the traditional manner. Therefore, only 30 patients were included in the analysis. There were no deaths in this trial. Complications appeared in four of the patients in the LAP group and in two of the patients in the SMI group (no significant difference). There were no statistically significant differences between the two groups in terms of the ability to tolerate the early oral intake of food, in the frequency of vomiting or in the incidence of insertion of a nasogastric tube. The time to the first bowel movement was 5.4 days in LAP and 5.5 days in SMI, and the difference was not significant. Conclusion: This study invalidates the claim by laparoscopic surgeons that earlier oral intake of food is tolerated by their patients than by patients who undergo standard procedures.

---

Résumé. Des études randomisées non prospectives ont suggéré que la reprise précoce de l'alimentation orale peut être un bénéfice particulier à la chirurgie laparoscopique. Certains auteurs ont indiqué que la reprise précoce de l'alimentation orale peut être bien tolérée par la plupart des patients après chirurgie élective ouverte. Cette étude prospective randomisée a été entreprise pour déterminer si la reprise orale de l'alimentation après chirurgie laparoscopique peut être plus précoce qu'après une laparotomie standard. Quarante patients ont été inclus dans cette étude et ont été divisés de manière randomisée en deux groupes avant chirurgie. Le groupe 1 comporte 20 patients (15 à 77 ans, moyenne d'age 52 ans) qui ont subi une résection colique ou rectale laparoscopique (LAP). Le groupe II comporte 20 patients (41 à 74 ans, moyenne d'age 56 ans) qui ont subi une chirurgie par une incision médiane standard (SMI). Le soir de l'intervention chirurgicale, les patients ont été autorisés à boire librement. Ce régime a été continué le premier jour postopératoire à partir duquel les patients pouvaient débuter une alimentation normale. Si un patient présente deux épisodes de vomissements, une sonde naso-gastrique a été mise en place. Cinq interventions laparaoscopiques ont d?être converties en chirurgie ouverte en raison d'adhérences (25%) et un nombre égal de patients ont été exclus du groupe qui a été traité de manière traditionelle. En conséquence, 30 patients ont été inclus dans l'analyse. Aucun décès n'est à déplorer. Quatre complications sont survenues chez des patients du groupe laparoscopique et deux dans le collectif des patients ayant subi un chirurgie ouverte (pas de différence statistique significative). Il n'y a pas de différence statistique significative entre les deux groupes en ce qui concerne la tolérance à la reprise orale de l'alimentation, à la fréquence des vomissements ou à la nécessité de réinsérer un tube naso-gastrique. La première exonération est survenue au 5.4 jour dans le groupe laparoscopique et au 5,5 jour dans le groupe de chirurgie ouverte sans que la différence ne soit significative. En conclusion: Cette étude infirme l'idée que la chirurgie laparoscopique permet une reprise précoce et bien tolérée de l'alimentation en comparaison à la chirrugie ouverte.

---

---

Accepted: 20 June 1996     

Determination of sertaconazole nitrate, a new imidazole antifungal, by high-performance liquid chromatography.

A high-performance liquid chromatographic method is developed for the determination of bulk sertaconazole nitrate and related compounds (potential impurities and degradation products) as well as a sertaconazole nitrate cream formulation. A 10-microns Spherisorb CN column is used along with a mobile phase consisting of acetonitrile and aqueous 0.01 M sodium phosphate (37:63, v/v). The sertaconazole nitrate peak is monitored at a wavelength of 260 nm; the retention time being 19.3 min. The detector response for sertaconazole nitrate is linear over the concentration range from 64 to 96 micrograms ml-1. The method is found to be sufficiently selective for the reliable determination of related compounds, FI-7001, FI-7009 and FI-7011, as indicated by same-day and between-day relative standard deviations (RSD) for replicate assays of 1.72% (n = 9) and 2.17% (n = 24), respectively. The application of this method to a cream formulation of sertaconazole nitrate is found to give a mean percentage recovery of 99.4% with RSD of 1.14% (n = 9); none of the cream vehicle peaks are found to interfere with the determination of sertaconazole nitrate.     

Intraoperative radiotherapy in the multidisciplinary treatment of bone sarcomas in children and adolescents

From September 1984 to December 1989, 38 patients of pediatric age with localized bone sarcomas received intraoperative radiotherapy (IORT) as part of a multidisci plinary treatment program. The age ranged from 6 to 21 years. The tumor histologies were 22 osteosarcomas and 16 Ewing's sarcomas. Thirty-four had initial primary disease (90%) and 4 were treated for local recurrence (10%). IORT was used on 32 untreated patients and in 6 previously treated with external beam radiotherapy (EBR). The IORT field included the surgically exposed tumor bed area. Single radiation doses ranging from 10 to 20 Gy were delivered, using 6–20 MeV electron beams. The median follow-up time for the entire group is 25 months (2–65+ months). The projected 5-year disease-free and overall survival rates are 65% and 69%, respectively. One patient developed a local recurrence in each histological group: one chondroblastic osteosarcoma and one cervical Ewing's sarcoma. Six patients died from metastatic progression: 3 initially recurrent tumors and three primary disease cases. Severe neuropathy and soft tissue necrosis were seen in some patients as IORT related complications. IORT is a feasible technique to be integrated in multidisciplinary programs that may promote local control in pediatric and adolescent patients with bone sarcomas. Peripheral nerves are dose-limiting tissue structures for IORT.     

Retention of "safe" blood donors. The Retrovirus Epidemiology Donor Study

BACKGROUND: There are obvious advantages to increasing donor retention. However, for reasons of blood safety, certain donors may, in fact, be more desirable to retain than others. “Safe” donors are defined as those who provided a blood donation that was negative on all laboratory screening tests and who subsequently reported no behavioral risks in response to an anonymous survey. This study identifies the most important factors affecting the intention of “safe” donors to provide another donation. STUDY DESIGN AND METHODS: An anonymous survey asking about donation history, sexual history, injecting drug use, and recent donation experience was mailed to 50,162 randomly selected allogeneic donors (including directed donors) who gave blood from April through July or from October through December 1993 at one of the five United States blood centers participating in the Retrovirus Epidemiology Donor Study. Before mailing, questionnaires were coded to designate donors with nonreactive laboratory screening tests at their most recent donation. RESULTS: A total of 34,726 donors (69%) responded, with substantially higher response among repeat donors. According to reported intentions only, the vast majority of “safe” donors indicated a high likelihood of donating again within the next 12 months. Only 3.4 percent reported a low likelihood of donating again. A comparison of those likely to return and those unlikely to return reveals significant differences in demographics and in ratings of the donation experience. A higher proportion of those unlikely to return were first-time donors, minority-group donors, and donors with less education. The highest projected loss among “safe” donors was seen for those who gave a fair to poor assessment of their treatment by blood center staff or of their physical well-being during or after donating. CONCLUSION: These data suggest that efforts to improve donors' perceptions of their donation experience, as well as attention to the physical effects of blood donation, may aid in the retention of both repeat and first-time donors.