Comparison of finasteride versus spironolactone in the treatment of idiopathic hirsutism

OBJECTIVE: To compare the efficacy of finasteride and spironolactone in the treatment of idiopathic hirsutism. DESIGN: Prospective, randomized, single-blind study. SETTING: A tertiary hirsutism clinic. PATIENT(S): Forty women with idiopathic hirsutism were selected. INTERVENTION(S): Patients were assigned randomly to receive either 5 mg of finasteride or 100 mg of spironolactone for 9 months. MAIN OUTCOME MEASURE(S): Hirsutism scores were measured according to the Ferriman-Gallwey scoring system, and side effects were monitored for 9 months of treatment. Blood samples were taken at each visit for assessment of endocrine, biochemical, and hematologic parameters. RESULT(S): Hirsutism scores were decreased significantly in both groups at the end of 9 months. The mean percent change (+/- SD) in hirsutism scores in the finasteride and spironolactone groups was as follows: 5.91% +/- 7.18% and 20.60% +/- 12.59% at 3 months, 10.61% +/- 12.18% and 32.57% +/- 15.68% at 6 months, and 15.15% +/- 15.38% and 42.36% +/- 12.31% at 9 months, respectively. There was a significantly better response with spironolactone treatment at the end of 9 months. Eleven (55%) of 20 patients in the spironolactone group experienced side effects. However, none of them stopped treatment because of side effects. CONCLUSION(S): The present data suggest that both finasteride and spironolactone are effective in the treatment of idiopathic hirsutism. However, it appears that the spironolactone group responded significantly better.     

Finasteride and flutamide in the treatment of hirsutism

BACKGROUND: The aim of this work was to evaluate the efficacy of two new antiandrogen drugs, finasteride and flutamide, in 80 hirsute patients: 44 with Polycystic Ovary Syndrome (PCOS) and 36 with Idiopathic Hirsutism (IH). METHODS: The study was conducted in a randomized way and randomization was carried out according to hospitalization. Before and after the treatment, all of the patients underwent hematochemical tests, hormone assays and assessment of hirsutism with the Ferriman Gallway score (F.G. score) and with measurement of the hair diameter in four different body areas. Finasteride was administered per os to 40 women at the dose of 5 mg/die; flutamide per os to 40 women at the dose of 250 mg twice daily. Both drugs were employed for 6 consecutive months. RESULTS: Both finasteride and flutamide significantly reduced the F.G. score and hair diameter. CONCLUSIONS: Abdominal hairs were more sensitive to the therapy.     

Successful treatment of hirsutism in HAIR-AN syndrome using flutamide, spironolactone, and birth control therapy

Myofibroblastoma of the breast is an uncommon stromal tumor most often found in older men. It usually presents as a solitary well-circumscribed breast lesion consisting of slender bipolar spindle cells and broad bands of hyalinised collagen. This is the first documented case of myofibroblastoma of the breast in Australia. Found in a 71-year-old man, this case demonstrates many of the typical features of this entity. A history of previous trauma to the chest wall was present in this case, a finding only rarely associated with this lesion.     

Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial

CONTEXT: Postherpetic neuralgia (PHN) is a syndrome of often intractable neuropathic pain following herpes zoster (shingles) that eludes effective treatment in many patients. OBJECTIVE: To determine the efficacy and safety of the anticonvulsant drug gabapentin in reducing PHN pain. DESIGN: Multicenter, randomized, double-blind, placebo-controlled, parallel design, 8-week trial conducted from August 1996 through July 1997. SETTING: Sixteen US outpatient clinical centers. PARTICIPANTS: A total of 229 subjects were randomized. INTERVENTION: A 4-week titration period to a maximum dosage of 3600 mg/d of gabapentin or matching placebo. Treatment was maintained for another 4 weeks at the maximum tolerated dose. Concomitant tricyclic antidepressants and/or narcotics were continued if therapy was stabilized prior to study entry and remained constant throughout the study. MAIN OUTCOME MEASURES: The primary efficacy measure was change in the average daily pain score based on an 11-point Likert scale (0, no pain; 10, worst possible pain) from baseline week to the final week of therapy. Secondary measures included average daily sleep scores, Short-Form McGill Pain Questionnaire (SF-MPQ), Subject Global Impression of Change and investigator-rated Clinical Global Impression of Change, Short Form-36 (SF-36) Quality of Life Questionnaire, and Profile of Mood States (POMS). Safety measures included the frequency and severity of adverse events. RESULTS: One hundred thirteen patients received gabapentin, and 89 (78.8%) completed the study; 116 received placebo, and 95 (81.9%) completed the study. By intent-to-treat analysis, subjects receiving gabapentin had a statistically significant reduction in average daily pain score from 6.3 to 4.2 points compared with a change from 6.5 to 6.0 points in subjects randomized to receive placebo (P<.001). Secondary measures of pain as well as changes in pain and sleep interference showed improvement with gabapentin (P<.001). Many measures within the SF-36 and POMS also significantly favored gabapentin (P< or =.01). Somnolence, dizziness, ataxia, peripheral edema, and infection were all more frequent in the gabapentin group, but withdrawals were comparable in the 2 groups (15 [13.3%] in the gabapentin group vs 11 [9.5%] in the placebo group). CONCLUSIONS: Gabapentin is effective in the treatment of pain and sleep interference associated with PHN. Mood and quality of life also improve with gabapentin therapy.     

Interferon-gamma in the treatment of systemic sclerosis: a randomized controlled multicentre trial

We report the results of a randomized controlled multicentre study on interferon-gamma (IFN-gamma) treatment of systemic sclerosis as determined by skin sclerosis, renal and other organ involvement, global assessment, subjective symptoms and quality of life. Forty-four patients were enrolled into the trial, 27 in the treatment group and 17 in the control group. All patients presented with type I or type II scleroderma. Twenty-nine patients (64%) finished the study. The mean duration of Raynaud's phenomenon and skin sclerosis was 15.3 and 10.8 years, respectively. The skin scores tended to improve in the treatment group (P > 0.05). Mouth aperture increased significantly from 38.5 to 47.7 mm in the treatment group (P < 0.001). Subanalysis of IFN-gamma treated patients with normalized skin sclerosis scores >/=1 showed significant improvement in both skin involvement and subjective symptoms (P < 0.05). Organ involvement improved in eight of 18 treatment patients and in three of 11 control patients. It worsened in three of 18 treatment patients and in four of 11 control patients. One control patient died due to cardiorespiratory failure during the study. No deterioration of renal function occurred during IFN-gamma treatment. There was a significant improvement in quality of life parameters in the control group but not in the treatment group. Plasma levels of neopterin increased significantly during IFN-gamma treatment but not in the control group, whereas N-terminal procollagen III peptide levels did not change in either group. There was a high frequency of mild to moderate influenza-like adverse events during IFN-gamma treatment. Only four of nine drop-out patients, however, experienced symptoms most probably associated with IFN-gamma treatment. We conclude that IFN-gamma therapy has mild beneficial effects on skin sclerosis and disease-associated symptoms in type I and II scleroderma. IFN-gamma treatment was associated with acceptable tolerability and did not induce major renal dysfunction in our patients.     

Spinal manipulation in the treatment of episodic tension-type headache: a randomized controlled trial

CONTEXT: Episodic tension-type headache is common and is often treated using manual therapies. Few data exist for the efficacy of these interventions. OBJECTIVE: To determine the effects of spinal manipulation therapy on adults with episodic tension-type headache. DESIGN: Randomized controlled trial lasting 19 weeks. SETTING: Outpatient facility of a National Health Service-funded chiropractic research institution in Denmark. PARTICIPANTS: Volunteer sample of 26 men and 49 women aged 20 to 59 years who met the diagnostic criteria for episodic tension-type headache as defined by the International Headache Society. INTERVENTION: Participants were randomized into 2 groups, 1 receiving soft tissue therapy and spinal manipulation (the manipulation group), and the other receiving soft tissue therapy and a placebo laser treatment (the control group). All participants received 8 treatments over 4 weeks; all treatments were performed by the same chiropractor. MAIN OUTCOME MEASURES: Daily hours of headache, pain intensity per episode, and daily analgesic use, as recorded in diaries. RESULTS: Based on intent-to-treat analysis, no significant differences between the manipulation and control groups were observed in any of the 3 outcome measures. However, by week 7, each group experienced significant reductions in mean daily headache hours (manipulation group, reduction from 2.8 to 1.5 hours; control group, reduction from 3.4 to 1.9 hours) and mean number of analgesics per day (manipulation group, reduction from 0.66 to 0.38; control group, reduction from 0.82 to 0.59). These changes were maintained through the observation period. Headache pain intensity was unchanged for the duration of the trial. CONCLUSION: As an isolated intervention, spinal manipulation does not seem to have a positive effect on episodic tension-type headache.     

Parents and procedures: a randomized controlled trial

INTRODUCTION: Previous work has shown that parents prefer to be present when their children undergo common invasive procedures, although physicians are ambivalent about parental presence. PURPOSE: To determine the effect of a parent-focused intervention on the pain and performance of the procedure, anxiety of parents and clinicians, and parental satisfaction with care. POPULATION: Children younger than 3 years old undergoing venipuncture, intravenous cannulation, or uretheral catheterization. SETTING: Pediatric emergency department of Boston City Hospital. DESIGN: Randomized controlled trial with three groups; parents present and given instructions on how to help their children; parents present, but no instructions given; and parents not present. INTERVENTION: The parents were instructed to touch, talk to, and maintain eye contact during the procedure. RESULTS: A total of 431 parents was randomized to the intervention (N = 153), present (N = 147), and not present (N = 131) groups. The groups were equivalent with respect to measured sociodemographic variables and parents' previous experience in the pediatric emergency department. No differences emerged with respect to pain (3-point scale measured by parent and clinician, and analysis of cry); performance of the procedure (number of attempts, completion of procedure by first clinician, time); clinician anxiety; or parental satisfaction with care. Parents who were present were more likely to rate the pain of the children as extreme/severe (52%) in comparison to clinicians (15%, kappa .07, poor agreement) and were significantly less anxious than parents who were not present. CONCLUSION: Overall, the intervention was not effective in reducing the pain of routine procedures. Parental presence did not negatively affect performance of the procedure or increase clinician anxiety. Parents who were present were less anxious than those who were not present. CLINICAL IMPLICATION: In general, parents have indicated that they want to be present when their children undergo procedures. The results of this study challenge the traditional belief that parental presence negatively affects our ability to successfully complete procedures. We should encourage parents who want to be present to stay during procedures.     

Nebulized budesonide and oral dexamethasone for treatment of croup: a randomized controlled trial

CONTEXT: The effectiveness of glucocorticoids for patients with croup is well established but it remains uncertain which glucocorticoid regimen is most effective. OBJECTIVE: To determine the effectiveness of 3 glucocorticoid regimens in patients with croup. DESIGN: Randomized controlled trial with parallel design. SETTING: Emergency departments of 2 Canadian pediatric tertiary care hospitals. PARTICIPANTS: Children with a clinical syndrome consistent with croup, aged 3 months to 5 years, with a croup score of 2 or greater following at least 15 minutes of mist therapy. INTERVENTIONS: Oral dexamethasone, 0.6 mg/kg, and nebulized placebo; oral placebo and nebulized budesonide, 2 mg; or oral dexamethasone, 0.6 mg/kg, and nebulized budesonide, 2 mg. MAIN OUTCOME MEASURES: Westley croup score (primary outcome), hospital admission rates, time spent in the emergency department, return visits to the emergency department, or ongoing symptoms at 1 week. RESULTS: The mean change in the croup score from baseline to the final study assessment was -2.3 (95% confidence interval [CI], -2.6 to -2.0) in the budesonide group (n = 65), -2.4 (95% CI, -2.6 to -2.2) in the dexamethasone group (n = 69), and -2.4 (95% CI, -2.7 to -2.1) in the budesonide and dexamethasone group (n = 64, P = .70). CONCLUSIONS: Based on the similar outcomes in the 3 groups, oral dexamethasone is the preferred intervention because of its ease of administration, lower cost, and more widespread availability.     

Biofeedback-based behavioral treatment for chronic tinnitus: Results of a randomized controlled trial.

Many tinnitus sufferers believe that their tinnitus has an organic basis and thus seek medical rather than psychological treatments. Tinnitus has been found to be associated with negative appraisal, dysfunctional attention shift, and heightened psychophysiological arousal, so cognitive-behavioral interventions and biofeedback are commonly suggested as treatments. This study developed and investigated the efficacy of a biofeedback-based cognitive-behavioral treatment for tinnitus. In total, 130 tinnitus patients were randomly assigned to an intervention or a wait-list control group. Treatment consisted of 12 sessions of a biofeedback-based behavioral intervention over a 3-month period. Patients in the wait-list group participated in the treatment after the intervention group had completed the treatment. Results showed clear improvements regarding tinnitus annoyance, diary ratings of loudness, and feelings of controllability. Furthermore, changes in coping cognitions as well as changes in depressive symptoms were found. Improvements were maintained over a 6-month follow-up period in which medium-to-large effect sizes were observed. The treatment developed and investigated in this study is well accepted and leads to clear and stable improvements. Through demonstration of psychophysiological interrelationships, the treatment enables patients to change their somatic illness perceptions to a more psychosomatic point of view. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Preventing sleep problems in infants: a randomized controlled trial

In the pre-school years sleep problems are one of the most common subjects on which parents seek advice from health professionals. In the majority of cases a sleepless child causes significant stress within the family, and if parents do not obtain sufficient sleep this can have a detrimental effect on their physical and emotional well-being. In a small number of cases a child who wakes frequently and will not settle back to sleep may be at risk of physical abuse. In recent years it has been suggested that it may be possible to prevent sleep problems developing by providing parents with advice in the post-natal period. Parents have stated that they find this type of intervention helpful, however, there has been no attempt to establish whether a preventive approach is effective. The aim of this research was to evaluate the efficacy of health education in reducing the incidence of sleep problems. Adopting an experimental approach, participants were randomly allocated to a control group or an intervention group. Parental knowledge of sleep and settling behaviour was manipulated when the children in the intervention group were 3 months old. The sleeping behaviour of the infants in both groups was compared 6 months later, when the children were 9 months old. Data was collected from 86 families in the intervention group and 83 families in the control group. A comprehensive analysis of the sleeping behaviour demonstrated that a significantly smaller percentage of babies in the intervention group had settling and night-waking difficulties than in the control group.     

Outcome of subacute stroke rehabilitation: a randomized controlled trial

We compared the biological activity of a new group of keto-C-glycosides to that of a narrow spectrum of unsaturated ketonucleosides in a panel of non-small-cell lung cancer (NSCLC) cells with various levels of intrinsic resistance to standard chemotherapy drugs. Unlike cisplatin, etoposide, adriamycin, or taxol, for which a significant difference in the cytotoxic effect was observed between sensitive cell lines (H460, H125, and MGH4) and drug-resistant cell lines (H661, MGH7, and FADU), nucleoside analogs were equally cytotoxic in NSCLC cell lines, with compound 92 being 10-fold more active than compound 43, 44, 81, or 161, while compound 3 was the least active. Apoptotic measurements with flow cytometric analysis of terminal uridine deoxynucleotide nick end-labeled cells revealed that the cytotoxic activity of these nucleosides correlated with their potency to induce apoptosis. Compound 92 triggered death in cells with wild-type p53, mutated p53, or p53 gene deletion. Our findings suggest that keto-C-glycosides may be promising alternative anticancer agents which merit further studies in in vivo cancer models refractory to standard chemotherapy drugs.     

Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus: a randomized controlled trial

CONTEXT: Pain is the most disturbing symptom of diabetic peripheral neuropathy. As many as 45% of patients with diabetes mellitus develop peripheral neuropathies. OBJECTIVE: To evaluate the effect of gabapentin monotherapy on pain associated with diabetic peripheral neuropathy. DESIGN: Randomized, double-blind, placebo-controlled, 8-week trial conducted between July 1996 and March 1997. SETTING: Outpatient clinics at 20 sites. PATIENTS: The 165 patients enrolled had a 1- to 5-year history of pain attributed to diabetic neuropathy and a minimum 40-mm pain score on the Short-Form McGill Pain Questionnaire visual analogue scale. INTERVENTION: Gabapentin (titrated from 900 to 3600 mg/d or maximum tolerated dosage) or placebo. MAIN OUTCOME MEASURES: The primary efficacy measure was daily pain severity as measured on an 11-point Likert scale (0, no pain; 10, worst possible pain). Secondary measures included sleep interference scores, the Short-Form McGill Pain Questionnaire scores, Patient Global Impression of Change and Clinical Global Impression of Change, the Short Form-36 Quality of Life Questionnaire scores, and the Profile of Mood States results. RESULTS: Eighty-four patients received gabapentin and 70 (83%) completed the study; 81 received placebo and 65 (80%) completed the study. By intent-to-treat analysis, gabapentin-treated patients' mean daily pain score at the study end point (baseline, 6.4; end point, 3.9; n = 82) was significantly lower (P<.001) compared with the placebo-treated patients' end-point score (baseline, 6.5; end point, 5.1; n = 80). All secondary outcome measures of pain were significantly better in the gabapentin group than in the placebo group. Additional statistically significant differences favoring gabapentin treatment were observed in measures of quality of life (Short Form-36 Quality of Life Questionnaire and Profile of Mood States). Adverse events experienced significantly more frequently in the gabapentin group were dizziness (20 [24%] in the gabapentin group vs 4 [4.9%] in the control group; P<.001) and somnolence (19 [23%] in the gabapentin group vs 5 [6%] in the control group; P = .003). Confusion was also more frequent in the gabapentin group (7 [8%] vs 1 [1.2%]; P = .06). CONCLUSION: Gabapentin monotherapy appears to be efficacious for the treatment of pain and sleep interference associated with diabetic peripheral neuropathy and exhibits positive effects on mood and quality of life.     

Mifepristone in combination with methotrexate for the medical treatment of tubal pregnancy: a randomized, controlled trial

In the search for a more potent alternative to a single i.m. injection of methotrexate for ectopic pregnancy, a randomized trial was organized. The efficacy of a combination of methotrexate and mifepristone was compared with methotrexate alone in the treatment of unruptured tubal pregnancies. The diagnosis of an unruptured tubal pregnancy was confirmed laparoscopically in 50 patients during a 2 year period. Women were randomized to receive a single i.m. injection of 50 mg/m2 methotrexate alone or a single dose of 600 mg oral mifepristone in combination with the same dose of methotrexate. Both treatment protocols were successful in achieving the resolution of unruptured ectopic pregnancy (18/25 in the methotrexate group and 22/25 in the combination group) following the initial intervention. A second injection was needed in four (16%) cases in the methotrexate group and in one (4%) case in the combination group. Overall, a complete resolution was achieved in 22/25 and 23/25 cases respectively. Unruptured ectopic pregnancy resolved faster in women given the combination of methotrexate and mifepristone compared to women given methotrexate only (P = 0.01). The effect of the methotrexate and mifepristone combination was more pronounced in women with higher human chorionic gonadotrophin concentrations.     

Behavioral vs drug treatment for urge urinary incontinence in older women: a randomized controlled trial

CONTEXT: Urinary incontinence is a common condition caused by many factors with several treatment options. OBJECTIVE: To compare the effectiveness of biofeedback-assisted behavioral treatment with drug treatment and a placebo control condition for the treatment of urge and mixed urinary incontinence in older community-dwelling women. DESIGN: Randomized placebo-controlled trial conducted from 1989 to 1995. SETTING: University-based outpatient geriatric medicine clinic. PATIENTS: A volunteer sample of 197 women aged 55 to 92 years with urge urinary incontinence or mixed incontinence with urge as the predominant pattern. Subjects had to have urodynamic evidence of bladder dysfunction, be ambulatory, and not have dementia. INTERVENTION: Subjects were randomized to 4 sessions (8 weeks) of biofeedback-assisted behavioral treatment, drug treatment (with oxybutynin chloride, possible range of doses, 2.5 mg daily to 5.0 mg 3 times daily), or a placebo control condition. MAIN OUTCOME MEASURES: Reduction in the frequency of incontinent episodes as determined by bladder diaries, and patients' perceptions of improvement and their comfort and satisfaction with treatment. RESULTS: For all 3 treatment groups, reduction of incontinence was most pronounced early in treatment and progressed more gradually thereafter. Behavioral treatment, which yielded a mean 80.7% reduction of incontinence episodes, was significantly more effective than drug treatment (mean 68.5% reduction; P=.04) and both were more effective than the placebo control condition (mean 39.4% reduction; P<.001 and P=.009, respectively). Patient-perceived improvement was greatest for behavioral treatment (74.1% "much better" vs 50.9% and 26.9% for drug treatment and placebo, respectively). Only 14.0% of patients receiving behavioral treatment wanted to change to another treatment vs 75.5% in each of the other groups. CONCLUSION: Behavioral treatment is a safe and effective conservative intervention that should be made more readily available to patients as a first-line treatment for urge and mixed incontinence.     

Folic acid in the treatment of acute watery diarrhoea in children: a double-blind, randomized, controlled trial

One-hundred and six male children aged 6-23 months with a history of acute watery diarrhoea of less than 72 h duration were randomized to receive either folic acid in a dose of 5 mg at 8-h intervals or placebo for 5 d. There were 54 children in the folic acid group and 52 in the placebo group. The admission characteristics were comparable between the two groups. No significant differences were observed in the intake of oral rehydration solution or stool output between the groups. The mean+/-SD of total stool output (g kg(-1)) was 532+/-476 vs 479+/-354 and the duration (h) of diarrhoea was 108+/-68 vs 103+/-53 in the folic acid vs placebo group, respectively. The findings, therefore, should have a positive influence on preventing the inappropriate use of folic acid in acute diarrhoea.     

Prophylactic endoscopic sclerosing treatment of the esophageal wall in varices -- a prospective controlled randomized trial

From January 1, 1978 to January 1, 1980 a controlled randomized trial comparing conservative treatment with prophylactic sclerotherapy of esophageal varices prior to hemorrhage was carried out. In all 71 patients liver cirrhosis was histologically confirmed. The two randomly assigned groups were comparable. Indications of endoscopic treatment were the existence of varices III-IV bearing erosions, varices II-IV without erosions but coagulation factors below 30%, or both. Six patients left the trial. In group Ia -- treatment by conservative means -- a high rate of variceal bleeding and death was observed. Comparing these results with those of group Ib treated by sclerotherapy, bleeding and death rates were found to be highly significantly lower. -- Thus the investigated criteria for predicting a recent variceal hemorrhage are confirmed. Prophylactic sclerotherapy in esophageal varices with erosions and/or poor coagulation reserve of the liver can largely prevent an esophageal hemorrhage from varices, and prolongs the life of these chronically ill patients.