Evaluation of efficacy, safety and effects on symptoms of androgenization of a generic oral contraceptive containing chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg.

BACKGROUND: This prospective noninterventional study assessed the contraceptive efficacy, safety and the effects on signs of androgenization of the generic oral contraceptive containing 2 mg chlormadinone acetate/0.03 mg ethinylestradiol (CMA/EE) in a real-world setting. STUDY DESIGN: A total of 1440 women were investigated during a six-cycle period by 229 gynecological practices throughout Germany. RESULTS: The adjusted Pearl index was 0.136 (unadjusted: 0.271). Of 463 patients with cycle irregularities at baseline, 83.4% had regular cycles after six cycles. Likewise, 74.1% of 162 patients with spotting or breakthrough bleeding at baseline were free from these symptoms at the end of study. The percentage of patients with dysmenorrhea decreased significantly from baseline (36.5%) to visit 3 after six cycles (12.3%; p=.0001), with a significant reduction in the use of pain medication (p<.0001). Additionally, the number of patients with skin and hair problems was significantly reduced (skin: 56.3% at baseline, 19.6% after six cycles; hair: 45.7% at baseline, 13.4% after six cycles; p=.001). CMA/EE was well tolerated by the patients, and 89.44% of the gynecologists were satisfied with the treatment. CONCLUSION: Generic CMA/EE exhibits very good contraceptive efficacy, cycle control and dysmenorrhea reduction. Furthermore, treatment with generic CMA/EE led to a favorable reduction of skin and hair problems in our study.

Determinants of uptake of surgical treatment for trachomatous trichiasis in North Ethiopia.

BACKGROUND: Surgery for trachomatous trichiasis prevents blindness. However people still decline surgery despite the availability of services in nearby health facilities. OBJECTIVES: To assess what proportion of cases of trichiasis had surgical treatment and to investigate the determinants of uptake of surgery. METHODS: Eight villages in Enebse Sarmidir district of Amhara Region-Ethiopia were randomly selected and all self-reported cases of trichiasis were approached. Both operated and un-operated trichiasis cases were interviewed using structured questionnaires. RESULT: The study employed a case control study design with patients with untreated trichiasis being cases (135) and those operated, controls (141). The main reasons given for not having surgery were burden of household tasks, indirect cost of surgery, lack of companion and fear of surgery. Uptake of surgery was found to rise with duration of illness (Chi Square for trend = 26.62, P < 0.05). Longer walking distance (more than one hour) to the nearby health facility was a negative predictor of uptake of surgical treatment (adjusted odd ratio 0.31, 95% confidence interval 0.15-0.67). CONCLUSION: Behavior change communication interventions targeted on early uptake of surgery are very important. Village-based surgical service provision may be worthwhile in settings of high blinding trachoma burden.

Azithromycin prevents recurrence of severe trichiasis following trichiasis surgery: STAR trial.

PURPOSE: Trichiasis, the potentially visually disabling result of chronic trachoma, is a leading cause of blindness world wide. Surgery can repair trichiasis, but recurrence of severe trichiasis (lashes touching the cornea) following surgery is likely to have immediate vision threatening consequences. Azithromycin use post-surgery appeared to be beneficial against recurrences but there were a mix of severe, moderate, and mild trichiasis; the specific effect on prevention of severe, vision-threatening recurrence is unknown. This randomized, clinical trial determined if treating trichiasis surgical patients with oral azithromycin compared to usual care (topical tetracycline) resulted in a reduction in severe recurrence of trichiasis to one year. METHODS: In a rural, trachoma hyperendemic district in Ethiopia, 1452 trichiasis patients age 18 or older presenting for surgery were randomly allocated to azithromycin, single 1 gram dose, versus topical tetracycline twice per day for six weeks. The outcome was recurrent severe trichiasis, defined as lashes touching the cornea, or more than 5 lashes touching the globe, to one year. RESULTS: Patients randomized to receive azithromycin had significantly fewer severe recurrences, 4.2/100 person years overall, compared to those randomized to topical tetracycline, 7.9/100 person years (p < 0.01). CONCLUSIONS: A single dose of azithromycin has been shown to reduce severe post-surgical trichiasis recurrence rates to one year and should become standard post surgical treatment.

Prevention of dermatologic side effects of bimatoprost 0.03% topical therapy.

PURPOSE: To investigate the efficacy of reducing the drop-skin contact to prevent dermatologic side effects of bimatoprost 0.03% topical therapy. DESIGN: Prospective, randomized, single-blinded, internally controlled study. METHODS: Enrolled subjects started bimatoprost 0.03% therapy once at night in both eyes and were instructed to wipe selectively only one eye (eye 1) with an adsorbent pad during and after drops administration for four months. The fellow eye acted as the internal control. Eyelash growth, regional skin hypertrichosis, and pigmentation on the periocular skin were assessed at baseline and during the four months of follow-up. RESULTS: A lower incidence of eyelash growth and skin pigmentation in the inferonasal pericanthal region were observed in eye 1. The incidence of pigmentation in the inferotemporal skin region and skin hypertrichosis were similar in the two eyes. CONCLUSION: The reduction of the drop-skin contact affects the regional incidence and the extent of dermatologic skin changes that are related to bimatoprost 0.03% topical therapy.

Impact of oral azithromycin on recurrence of trachomatous trichiasis in Nepal over 1 year.

BACKGROUND: Recently, a significant association between Chlamydia trachomatis infection and postoperative trachomatous trichiasis (TT) recurrence was shown. The current study evaluated whether azithromycin treatment at the time of surgery could reduce recurrence. METHODS: As part of Nepal's national trachoma control programme, patients received azithromycin (53 patients) or placebo (56 patients) at surgery. Conjunctivae were graded for trachoma and swabbed to detect chlamydiae preoperatively and postoperatively up to 12 months. Logistic regression was performed for associations of treatment option with recurrence, infection, and active trachoma (by eye and by patient). RESULTS: TT recurrence was 28.9% at 12 months. Recurrence was significantly lower for those with major TT at baseline in the azithromycin group at 12 months (p = 0.03); incident recurrence was also significantly lower at 6 months (OR, 0.056; 95% CI, 0 to 0.423; p = 0.004). There was a trend for increased recurrence among those with minor TT at baseline and for reduction of active trachoma and infection in the azithromycin group but not the placebo group. CONCLUSION: These data suggest that azithromycin treatment at the time of surgery may be warranted for patients with major TT. However, treatment should be investigated further for minor TT, for efficacy at subsequent time intervals and in other trachoma endemic settings.

Single-dose azithromycin prevents trichiasis recurrence following surgery: randomized trial in Ethiopia.

BACKGROUND: Trichiasis recurrence following surgery is a serious problem for trachoma programs. OBJECTIVE: To determine if postoperative treatment with azithromycin compared with topical tetracycline reduces recurrence up to 1 year, and if azithromycin treatment of household members provides additional benefit compared with treating only the surgical patient. DESIGN: A randomized, single-masked, clinical trial was conducted in Ethiopia. A total of 1452 patients with trichiasis were randomized 1:1:1 to the following 3 arms: single-dose (1 g) oral azithromycin alone, single-dose azithromycin for household members (20 mg/kg up to 1 g) plus the patient, or topical tetracycline (twice per day for 6 weeks). MAIN OUTCOME MEASURES: Trichiasis recurrence within 1 year following surgery. RESULTS: The combined azithromycin groups had significantly fewer recurrences, 6.9 of 100 person-years overall, compared with topical tetracycline, 10.3 of 100 person-years (P = .047). There was no additional reduction in the arm that also treated household members, 8.1 of 100 person-years, compared with treating the surgical patients alone, 5.8 of 100 person-years (P = .19). CONCLUSIONS: In trachoma-endemic areas, a single dose of azithromycin reduced postoperative trichiasis recurrence rates by one third compared with topical tetracycline. Application to Clinical Practice In countries where azithromycin is part of the Trachoma Control Program, patients with trachomatous trichiasis should be treated postoperatively to prevent recurrence.

A randomised controlled trial of azithromycin following surgery for trachomatous trichiasis in the Gambia.

BACKGROUND/AIM: Trachomatous trichiasis frequently returns following surgery. Several factors may promote recurrence: preoperative disease severity, surgeon ability, surgical procedure, healing responses, and infection. This study investigates whether enhanced control of infection, both of Chlamydia trachomatis and other bacteria, with azithromycin can improve surgical outcome in a trachoma control programme. METHODS: Individuals with trachomatous trichiasis were examined and operated. After surgery patients were randomised to the azithromycin or control group. The azithromycin group and children in their household were given a dose of azithromycin. Antibiotic treatment was repeated at 6 months. All patients were reassessed at 6 months and 12 months. Samples were collected for C trachomatis polymerase chain reaction and general microbiology at each examination. RESULTS: 451 patients were enrolled. 426 (94%) were reassessed at 1 year, of whom 176 (41.3%) had one or more lashes touching the eye and 84 (19.7%) had five or more lashes. There was no difference in trichiasis recurrence between the azithromycin and control group. Recurrent trichiasis was significantly associated with more severe preoperative trichiasis, bacterial infection, and severe conjunctival inflammation at 12 months. Significant variability in outcome was found between surgeons. Visual acuity and symptoms significantly improved following surgery. CONCLUSION: In this setting, with a low prevalence of active trachoma, azithromycin did not improve the outcome of trichiasis surgery conducted by a trachoma control programme. Audit of trichiasis surgery should be routine.

Cost-effectiveness of trachoma control in seven world regions.

BACKGROUND/AIMS: The fight against blinding trachoma is being addressed with an integrated strategy of surgery, antibiotics, hygiene promotion, and environmental improvement-the SAFE strategy, but its cost-effectiveness is largely unknown. This paper estimates the cost effectiveness of surgery and antibiotics in trachoma-endemic areas in seven world regions. METHODS: A population model was applied to follow the lifelong impact on individuals receiving trachoma control. Intervention costs and effectiveness estimates were based on a combination of primary data collection and literature review. RESULTS: Providing trichiasis surgery to 80% of those who need it would avert over 11 million DALYs per year globally, with cost effectiveness ranging from I$13 to I$78 per DALY averted across regions. Mass antibiotic treatment of all children using azythromycin at prevailing market prices would avert more than 4 million DALYs per year globally with cost-effectiveness ranging between I$9,000 and I$65,000 per DALY averted. The intervention is only cost-effective if azythromycin is donated or becomes available at reduced prices. Mass treatment of all children with tetracycline and targeted treatment with azythromycin are not cost-effective. CONCLUSIONS: As individual components of the SAFE strategy, trichiasis surgery for trachoma is a cost-effective way of restoring sight in all epidemiological sub-regions considered, as is the use of azythromycin, if donated or at reduced prices. Large study uncertainties do not change study conclusions. The results should be interpreted in the context of the overall SAFE strategy to address issues of sustainability.

Advice on hair and scalp care during cranial radiotherapy: a prospective randomized trial.

BACKGROUND: The advice on hair washing during brain irradiation is aimed at minimizing radiation induced skin toxicity. We performed a prospective randomized trial to assess the effect of advice on scalp care on the local skin reaction in patients undergoing cranial radiotherapy. METHODS: One hundred and nine patients undergoing cranial radiotherapy were randomized into two groups. Patients in group 1 were advised not to wash hair during treatment and patients in group 2 to maintain normal pattern of hair washing. They were assessed weekly over a period of 10 weeks from the start of treatment. Symptoms of pain and itching were recorded using a modified RTOG/EORTC acute skin reaction scoring system and skin reaction was assessed clinically using erythema/desquamation score. The frequency of hair washing and the distress of changing the practice of normal hygiene were recorded on a diary card. Skin reaction scores were compared as a summary measure using area under the curve per week (AUC/week) and median scores, and the differences between groups were assessed by means of the t-test. RESULTS: One hundred and nine patients commencing cranial radiotherapy according to standard protocol were randomized into the trial (group 1, 55 patients; group 2, 54 patients). Patients asked to restrict hair washing, washed at a lower average frequency. There were no significant differences between scores of skin reaction in the two groups for each of the variables measured. CONCLUSIONS: The practice of normal hair washing is not associated with increased severity of adverse skin reaction. As a request to change the pattern of normal hygiene may cause distress, the current advice should be to maintain normal hair washing during cranial radiotherapy.

Consecutive wide and long single hair-bearing transposition flaps in combination with hair transplantation for the management of slot formation after alopecia reducing surgery.

BACKGROUND: Because the Frechet-style triple hair-bearing transposition flaps use up a great deal of scalp laxity from both occipitoparietal areas, it is virtually impossible to perform simultaneous donor harvesting for hair transplantation. The flaps in this technique are also prone to tip necroses due to their narrow width and pointed tips. This article presents a sequential protocol that dramatically and easily treats the slot, while simultaneously allowing hair transplantation to be performed to the frontal area. OBJECTIVE: To present a simple method that combines hair transplantation with consecutive wide and long single hair-bearing transposition flaps for the management of slot formation after alopecia reducing surgery. METHOD: A wide and long single hair-bearing transposition flap is first performed. The area directly inferior and contralateral to the side from where the superior flap is transposed is then used for donor harvesting. This method is repeated with each progressive hair grafting session until the desired result is accomplished. RESULTS: In the over 100 cases performed by the author to date, the results have been consistently excellent with complications nonexistent thus far. CONCLUSION: Using consecutive wide and long single hair-bearing transposition flaps is a safer, more aesthetically pleasing, and easier way to manage slot formation when compared with the triple flap technique. Besides these advantages, it affords the surgeon the opportunity to work on the frontal hairline immediately after the flap procedure is performed.