Objective evaluation of plantar hyperhidrosis after sympathectomy

OBJECTIVE:

The aim of the present study was to prospectively, randomly, blindly, and objectively investigate how surgery affects plantar sudoresis in patients with palmar and plantar hyperhidrosis over a one-year period using a sudorometer (VapoMeter).

METHODS:

From February 2007 to May 2009, 40 consecutive patients with combined palmar hyperhidrosis and plantar hyperhidrosis underwent video-assisted thoracic sympathectomy at the T3 or T4 ganglion level (15 women and 25 men, with a mean age of 25 years).

RESULTS:

Immediately after the operation and during the one-year follow-up, all of the patients were free from palmar hyperhidrosis episodes. Compensatory hyperhidrosis of varying degrees was observed in 35 (87.5%) patients after one year. Only two (2.5%) patients suffered from severe compensatory hyperhidrosis. There was a large initial improvement in plantar hyperhidrosis in 46.25% of the cases, followed by a progressive regression of that improvement, such that only 30% continued to show this improvement after one year. The proportion of patients whose condition worsened increased progressively (from 21.25% to 47.50%), and the proportion of stable patients decreased (32.5% to 22.50%). This was not related to resection level; however, a lower intensity of plantar hyperhidrosis prior to sympathectomy correlated with worse evolution.

CONCLUSION:

Patients with palmar hyperhidrosis and plantar hyperhidrosis who underwent video-assisted thoracic sympathectomy to treat their palmar hyperhidrosis exhibited good initial improvement in plantar hyperhidrosis, which then decreased to lesser degrees of improvement over a one-year period following the surgery. For this reason, video-assisted thoracic sympathectomy should not be performed when only plantar hyperhidrosis is present.     

Treatment of uncommon sites of focal primary hyperhidrosis: experience with pharmacological therapy using oxybutynin

OBJECTIVES:

Primary hyperhidrosis usually affects the hands, armpits, feet and cranio-facial region. Sweating in other areas is common in secondary hyperhidrosis (after surgery or in specific clinical conditions). Oxybutynin has provided good results and is an alternative for treating hyperhidrosis at common sites. Our aim was to evaluate the efficacy of oxybutynin as a treatment for primary sweating at uncommon sites (e.g., the back and groin).

METHODS:

This retrospective study analyzed 20 patients (10 females) who received oxybutynin for primary focal hyperhidrosis at uncommon sites. The subjects were evaluated to determine quality of life before beginning oxybutynin and six weeks afterward and they were assigned grades (on a scale from 0 to 10) to measure their improvement at each site of excessive sweating after six weeks and at the last consult.

RESULTS:

The median follow-up time with oxybutynin was 385 days (133-1526 days). The most common sites were the back (n = 7) and groin (n = 5). After six weeks, the quality of life improved in 85% of the subjects. Dry mouth was very common and was reported by 16 patients, 12 of whom reported moderate/severe dry mouth. Five patients stopped treatment (two: unbearable dry mouth, two: excessive somnolence and one: palpitations). At the last visit, 80% of patients presented with moderate/great improvement at the main sites of sweating.

CONCLUSION:

After six weeks, more than 80% of the patients presented with improvements in their overall quality of life and at the most important site of sweating. Side effects were common (80% reported at least one side effect) and caused 25% of the patients to discontinue treatment. Oxybutynin is effective for treating bothersome hyperhidrosis, even at atypical locations and most patients cope well with the side effects.     

Randomized controlled trial of zinc supplementation for persistent diarrhea in adults with HIV-1 infection

BACKGROUND: In children, zinc supplementation reduces the incidence and severity of diarrhea. METHODS: HIV-infected adults with > or =7 days of diarrhea recruited at 3 tertiary hospitals in Lima, Peru, received a zinc sulfate capsule containing 50 mg of elemental zinc twice daily or an identical placebo for 14 days. Outcomes included persistence of diarrhea at day 14 and time until cessation of diarrhea. RESULTS: The 81 subjects randomized to zinc and 78 randomized to placebo were comparable at baseline, except for higher prevalences of certain enteric pathogens in the zinc group; complete follow-up rates were 62% and 69%, respectively. Zinc concentrations were consistent with zinc deficiency at follow-up in 94% of placebo recipients and 66% of zinc recipients (P = 0.01). Persistence of diarrhea at day 14 according to follow-up interview (60% for zinc-treated patients and 57.4% for placebo-treated patients) or to patient diary (42.2% vs. 31.9%) did not differ significantly. Adjusting for enteric pathogens and CD4 count, the hazard ratio (HR) for zinc supplementation and cessation of diarrhea (according to the diaries) was 0.91 (95% confidence interval [CI]: 0.50 to 1.64). CONCLUSION: Supplemental zinc had no significant effect on the duration or remission of diarrhea in HIV-infected adults.     

Randomized placebo controlled trial of lofexidine hydrochloride for chronic pelvic pain in women

BACKGROUND: We hypothesised that the orally-active alpha(2)-adrenoceptor agonist lofexidine hydrochloride would ameliorate chronic pelvic pain in women. METHODS: A randomized placebo-controlled parallel group trial was undertaken in the University Hospital Gynaecology Clinic. Women with pelvic pain of at least 6 months duration were eligible, and were randomized using a sealed envelope system to receive up to 600 mg lofexidine hydrochloride twice daily over 8 weeks or placebo. Outcome measures were summary and daily diary visual analog scales for pain (VAS) and a 5 point self rating scale. RESULTS: 9/19 women randomized to lofexidine completed the study compared to 14/20 of those randomized to placebo. Intention-to-treat analysis showed that 4/19 in the lofexidine group achieved 50% or greater reduction in VAS compared with 8/20 in the placebo group (OR 2.5, 95% CI 0.6--10.3). Summary and diary VAS were closely correlated. CONCLUSIONS: Within the limits of a small study with power to detect only a substantial effect, we conclude that lofexidine hydrochloride is not effective for the treatment of chronic pelvic pain.     

Randomized clinical effectiveness trial of nurse-administered small-group cognitive behavior therapy for persistent insomnia in general practice

STUDY OBJECTIVES: Persistent insomnia, although very common in general practice, often proves problematic to manage. This study investigates the clinical effectiveness and the feasibility of applying cognitive behavior therapy (CBT) methods for insomnia in primary care. DESIGN: Pragmatic randomized controlled trial of CBT versus treatment as usual. SETTING: General medical practice. PARTICIPANTS: Two hundred one adults (mean age, 54 years) randomly assigned to receive CBT (n = 107; 72 women) or treatment as usual (n = 94; 65 women). INTERVENTION: CBT comprised 5 sessions delivered in small groups by primary care nurses. Treatment as usual comprised usual care from general practitioners. MEASUREMENTS AND RESULTS: Assessments were completed at baseline, after treatment, and at 6-month follow-up visits. Sleep outcomes were appraised by sleep diary, actigraphy, and clinical endpoint. CBT was associated with improvements in self-reported sleep latency, wakefulness after sleep onset, and sleep efficiency. Improvements were partly sustained at follow-up. Effect sizes were moderate for the index variable of sleep efficiency. Participants receiving treatment as usual did not improve. Actigraphically estimated sleep improved modestly after CBT, relative to no change in treatment as usual. CBT was also associated with significant positive changes in mental health and energy/vitality. Comorbid physical and mental health difficulties did not impair sleep improvement following CBT. CONCLUSION: This study suggests that trained and supervised nurses can effectively deliver CBT for insomnia in routine general medical practice. Treatment response to small-group service delivery was encouraging, although effect sizes were smaller than those obtained in efficacy studies. Further research is required to consider the possibility that CBT could become the treatment of first choice for persistent insomnia in primary healthcare.     

Resistance training for hot flushes in postmenopausal women: Randomized controlled trial protocol

ObjectivesHot flushes and night sweats affect 75% of all women after menopause and is a common reason for decreased quality of life in mid-aged women. Hormone therapy is effective in ameliorating symptoms but cannot be used by all women due to contraindications and side effects. Engagement in regular exercise is associated with fewer hot flushes in observational studies, but aerobic exercise has not proven effective in randomized controlled trials. It remains to be determined whether resistance training is effective in reducing hot flushes and improves quality of life in symptomatic postmenopausal women. The aim of this study is to investigate the effect of standardized resistance training on hot flushes and other health parameters in postmenopausal women.Study designThis is an open, parallel-group, randomized controlled intervention study conducted in Linköping, Sweden. Sixty symptomatic and sedentary postmenopausal women with a mean of at least four moderate to severe hot flushes per day or 28 per week will be randomized to an exercise intervention or unchanged physical activity (control group). The intervention consists of 15 weeks of standardized resistance training performed three times a week under supervision of a physiotherapist.Main outcome measuresThe primary outcome is hot flush frequency assessed by self-reported hot flush diaries, and the difference in change from baseline to week 15 will be compared between the intervention group and the control group.ConclusionThe intention is that this trial will contribute to the evidence base regarding effective treatment for hot flushes.     

Influence of thoracic sympathectomy on cardiac induced oscillations in tissue blood volume

The photoplethysmographic (PPG) signal, which measures cardiac-induced changes in tissue blood volume by light transmission measurements, shows spontaneous fluctuations. In this study, PPG was simultaneously measured in the right and left index fingers of 16 patients undergoing thoracic sympathectomy, and, from each PPG pulse, the amplitude of the pulse (AM) and its maximum (BL) were determined. The parameter AM/BL is proportional to the cardiac-induced blood volume increase, which depends on the arterial wall compliance. AM/BL increased after the thoracic sympathectomy treatment (for male patients, from 2.60±1.49% to 4.81±1.21%), as sympathetic denervation decreases arterial tonus in skin. The very low-frequency (VLF) fluctuations of BL or AM showed high correlation (0.90±0.11 and 0.92±0.07, respectively) between the right and left hands before the thoracic sympathectomy, and a significant decrease in the right-left correlation coefficient (to 0.54±0.22 and 0.76±0.20, respectively) after the operation. The standard deviation of the BL or AM VLF fluctuations also reduced after the treatment, indicating sympathetic mediation of the VLF PPG fluctuations. The study also shows that the analysis of the PPG signal and the VLF fluctuations of the PPG parameters enable the assessment of the change in sympathetic nervous system activity after thoracic sympathectomy.     

Randomized trial of treatment for children with sexual behavior problems: ten-year follow-up

This study prospectively follows 135 children 5-12 years of age with sexual behavior problems from a randomized trial comparing a 12-session group cognitive-behavioral therapy (CBT) with group play therapy and follows 156 general clinic children with nonsexual behavior problems. Ten-year follow-up data on future juvenile and adult arrests and child welfare perpetration reports were collected. The CBT group had significantly fewer future sex offenses than the play therapy group (2% vs. 10%) and did not differ from the general clinic comparison (3%), supporting the use of short-term CBT. There were no group differences in nonsexual offenses (21%). The findings do not support assumptions about persistent or difficult to modify risk and raise questions about policies and practices founded on this assumption.     

Outcome of subsequent pregnancy after treatment for persistent gestational trophoblastic tumour

BACKGROUND: This study analysed subsequent pregnancy outcome in patients treated for persistent gestational trophoblastic tumour (GTT). METHODS: Between 1974 and 1999, a total of 378 patients with GTT (83 patients with high-risk and 295 patients with low-risk GTT) were treated at Chiba University Hospital, Japan. Of these 378 patients, 363 (96.0%) achieved primary remission and 315 survivors have been followed at our hospital. RESULTS: To date, 129 patients have had 243 subsequent conceptions. While pregnancy outcome was comparable with that of the general Japanese population, the incidence of repeat molar pregnancy (2.1%) was approximately seven times higher than that of the general population. During the mandatory HCG follow-up period of 1 year, 15 patients conceived within 6 months of completion of chemotherapy. The incidence of spontaneous abortion in these 15 patients was significantly higher than that in patients who conceived after a waiting period of >6 months (P = 0.0053). CONCLUSIONS: Patients treated for GTT may anticipate a normal future reproductive outcome, although it would be better to avoid pregnancy for at least 6 months after completion of chemotherapy.     

Randomized clinical trial of a levonorgestrel-releasing intrauterine system and a depot GnRH analogue for the treatment of chronic pelvic pain in women with endometriosis

BACKGROUND: The objective of this multicentre randomized, controlled clinical trial was to compare the efficacy of a levonorgestrel-releasing intrauterine system (LNG-IUS) and a depot-GnRH-analogue in the control of endometriosis-related pain over a period of six months. METHODS: Eighty-two women, 18 to 40 years of age (mean 30 years), with endometriosis, dysmenorrhoea and/or CPP, were randomized using a computer-generated system of sealed envelopes into either LNG-IUS (n = 39) or GnRH analogue (n = 43) treatment groups at three university centres. Daily scores of endometriosis-associated CPP were evaluated using the Visual Analogue Scale (VAS), daily bleeding score was calculated from bleeding calendars, and improvement in quality of life was evaluated using the Psychological General Well-Being Index Questionnaire (PGWBI). The pain score diary was based on the VAS in which women recorded the occurrence and intensity of pain on a daily basis. A monthly score was calculated from the result of the sum of the daily scores divided by the number of days in each observation period. RESULTS: CPP decreased significantly from the first month throughout the six months of therapy with both forms of treatment and there was no difference between the groups (P > 0.999). In both treatment groups, women with stage III and IV endometriosis showed a more rapid improvement in the VAS pain score than women with stage I and II of the disease (P < 0.002). LNG-IUS users had a higher bleeding score than GnRH-analogue users at all time points of observation with 34% and 71% of patients in the LNG-IUS and GnRH-analogue groups, respectively, reporting no bleeding during the first treatment month, and 70% and 98% reporting no bleeding during the sixth month. No difference was observed between groups with reference to improvement in quality of life. CONCLUSIONS: Both, the LNG-IUS and the GnRH-analogue were effective in the treatment of CPP-associated endometriosis, although no differences were observed between the two treatments. Among the additional advantages of the LNG-IUS is the fact that it does not provoke hypoestrogenism and that it requires only one medical intervention for its introduction every 5 years. This device could therefore become the treatment of choice for CPP-associated endometriosis in women who do not wish to conceive.     

Randomized, double-blind pilot trial comparing lamotrigine versus citalopram for the treatment of bipolar depression

BACKGROUND: Uncertainty exists regarding the best approach for treating bipolar depression among patients already receiving a first-line mood stabilizer. The aim of this pilot study was to compare adding a second mood stabilizer or an antidepressant at this treatment decision point. METHODS: Twelve-week, randomized, double-blind pilot trial comparing the addition of lamotrigine or citalopram for bipolar depressed patients on mood stabilizer medication. Change in depressive symptoms and risk of switch were examined. RESULTS: Twenty subjects were randomized. Each treatment group experienced a significant mean reduction in total MADRS scores (citalopram Delta - 14.2, p=0.002; lamotrigine Delta - 13.3, p= 0.001), and there was no significant difference between treatment groups (p=0.78). Total response rates increased from 31.6% at week 6 to 52.6% at week 12. One out of ten patients in each group experienced a switch to hypomania. LIMITATIONS: Small sample size. Lack of a placebo arm. CONCLUSIONS: Results of this small trial suggest that both lamotrigine and citalopram appear to be reasonable choices as add-on acute treatment for bipolar depression, with response rates continuing to rise considerably past 6 weeks of treatment.     

A clinical trial of adjunctive oestrogen treatment in women with schizophrenia

Summary A double-blind, 28-day, placebo-controlled study was conducted with three groups of women of child-bearing age (N = 12 in each group) who received standardised antipsychotic medication plus a) 50 μg transdermal estradiol or b) 100 μg transdermal estradiol or c) transdermal placebo. Preliminary analyses show that women receiving 100 μg of estradiol made greater improvements in the symptoms of schizophrenia than either the 50 μg estradiol or placebo groups. The addition of 100 μg adjunctive transdermal oestrogen significantly enhanced treatment responsivity of acute, severe psychotic symptoms in women with schizophrenia. The positive impact of oestrogen treatment on psychotic symptoms via a multiplicity of possible actions (see accompanying articles in this issue) may prove clinically useful in the overall treatment of women with schizophrenia. Accepted June 2002, Published online September 16, 2002 Correspondence: Prof. Jayashri Kulkarni, Alfred Psychiatry Research Centre, Alfred Hospital, Commercial Road, Prahran. Vic. 3181, Australia; e-mail: jayashri.kulkarni@med.monash.edu.au     

Prevention of pleural adhesions using a membrane containing polyethylene glycol in rats

Background: Recurrent thoracotomies regardless of the cause are not a rare occurrence. However, each thoracotomy results in adhesion to some extent. This adhesions increase morbidity and mortality presents a significant inconvenience for surgeons and prolongs the length of operations.Objective: We investigated the efficacy of Prevadh®, an anti-adhesion agent to prevent intrapleural adesions following thoracotomy in a rat model.Methods: Twenty male adult Wistar Albino rats were divided into a sham group (Group A, n = 4), a control group (Group B, n = 8), and a study group (Group C, n = 8). Only left thoracotomy was performed in Group A. Group B underwent left thoracotomy, induction of adhesion, and 1 ml saline solution was administered to the thoracic cavity. However, in Group C underwent left thoracotomy, induction of adhesion, and Prevadh® was placed between the pleura and the lung. The rats were sacrificed on day 21, and adhesions were analyzed using both macroscopic and histopathological methods. The results were statistically analyzed. A value of P<0.05 was considered statistically significant.Results: Mean lengths of adhesion differed statistically significantly among all three groups, while mean intensity of adhesion differed between Group A and Group B, and between Group B and Group C (P>0.05). There was also a statistically significant difference between Group A and Group C in mesothelium proliferation score (P>0.05). No statistically significant differences were found among the groups in terms of pleural thickness, macrophage and mononuclear cell infiltration (P>0.05).Conclusions: Prevadh® was shown in a rat model to effectively prevent post-thoracotomy adhesions.     

Randomized, placebo-controlled trial of Lactobacillus rhamnosus GG as treatment of atopic dermatitis in infancy

BACKGROUND: Some studies have suggested that supplementation of food with lactobacilli may prevent or improve atopic dermatitis in children. This study was designed to investigate the therapeutic effect of Lactobacillus rhamnosus GG (LGG) as a food supplement in infants suffering from atopic dermatitis. METHODS: Infants aged 3-12 months suffering from mild-to-moderate atopic dermatitis (severity scoring of atopic dermatitis or SCORAD index of 15-40) without current antiinflammatory treatment were randomized to receive LGG (5 x 10(9) colony forming units b.i.d.) or placebo as a food supplement for 12 weeks. Severity scoring of atopic dermatitis index and use of hydrocortisone 1% ointment as rescue medication (2 points per application) were recorded at 4, 8, and 12 weeks of treatment and combined as symptom load (SL). RESULTS: Fifty-four infants (LGG group, mean +/- SD SCORAD index 24.6 +/- 8.8) and 48 infants (placebo group, SCORAD index 23.6 +/- 7.8) were randomized and completed the treatment period (intention-to-treat analysis). Symptom load generally improved over time at 4 weeks (LGG vs placebo, 23.8 +/- 12.4 vs 20.6 +/- 9.9), 8 weeks (22.5 +/- 14.6 vs 17.9 +/- 13.1), and 12 weeks (19.6 +/- 15.4 vs 15.1 +/- 12.1), without statistically significant group differences. When stratified for age, eczema severity or use of rescue medication, no statistically significant group differences, in improvement, were found. No significant group differences were found for the use of rescue medication (0.8 +/- 45.0 g vs 3.5 +/- 29.8 g), increase in mean logarithmic total serum IgE (0.17 +/- 0.30 kU/l vs 0.26 +/- 0.45 kU/l), and newly developed allergic sensitization against hen's egg or cow's milk (18.8%vs 10.0%). CONCLUSION: This placebo-controlled trial showed no therapeutic effect of LGG against mild-to-moderate atopic dermatitis in infancy.     

Low-dose fluticasone propionate compared with montelukast for first-line treatment of persistent asthma: a randomized clinical trial

BACKGROUND: Both inhaled corticosteroids and leukotriene modifiers are used in the maintenance treatment of persistent asthma. OBJECTIVE: The goal was to compare the efficacy and safety of low-dose fluticasone propionate (FP) and montelukast as first-line maintenance therapy in symptomatic patients by using short-acting beta2-agonists alone to treat persistent asthma. METHODS: In this multicenter, randomized, double-blind, double-dummy, parallel-group study, 533 patients (>15 years old) with persistent asthma who remained symptomatic while taking short-acting beta2-agonists alone were treated with FP (88 microg [2 puffs of 44 microg] twice daily) or montelukast (10 mg once daily) for 24 weeks. RESULTS: Compared with treatment with montelukast, treatment with FP resulted in significantly greater improvements at endpoint in morning predose FEV(1) (22.9% vs 14.5%, P <.001), forced midexpiratory flow (0.66 vs 0.41 L/sec, P <.001), forced vital capacity (0.42 vs 0.29 L, P =.002), morning peak expiratory flow (PEF) (68.5 vs 34.1 L/min, P <.001), and evening PEF (53.9 vs 28.7 L/min, P <.001). Similar improvements in PEF were observed in patients with milder asthma (>70%-80% predicted FEV(1)). At endpoint, FP was more effective than montelukast at decreasing rescue albuterol use (3.1 puffs/day vs 2.3 puffs/day, P <.001), asthma symptom scores (-0.85 [48.6% decrease] vs -0.60 [30.5%], P <.001), and nighttime awakenings due to asthma (-0.64 awakenings/night [62% decrease] vs -0.48 awakenings/night [47.5%], P =.023), and FP increased the percentage of symptom-free days (32.0% vs 18.4% of days, P <.001) compared with montelukast. The adverse event and asthma exacerbation profiles for FP and montelukast were similar. CONCLUSIONS: Low-dose FP is more effective than montelukast as first-line maintenance therapy for patients with persistent asthma who are undertreated and remain symptomatic while taking short-acting beta2-agonists alone.     

Randomized trial using piperacillin versus ampicillin and amikacin for treatment of premature neonates with risk factors for sepsis

Premature infants with risk factors for early onset sepsis who were less than seven days of age were blindly randomized to receive either piperacillin and placebo (200 infants) or ampicillin and amikacin (196 infants). One of 30 treated infants developed positive blood cultures. The overall mortality in the two groups was 8.5 % for piperacillin/placebo and 13.8 % for ampicillin/amikacin (p=0.11). Serum creatinine elevation above 100 µmol/l (1.131 mg/dl) during treatment was similar in the two groups. The effectiveness of piperacillin/placebo is similar to that of ampicillin/amikacin for empiric treatment of premature newborns with risk factors for early onset sepsis.