Factors associated with quality of life among women with fecal incontinence

Introduction and hypothesis

Fecal incontinence (FI) is a distressing, highly prevalent condition affecting quality of life (QOL). The aim of our study was to identify predictors of moderate/severe health-related QOL among women with FI.

Methods

Data were collected from women presenting to a multispecialty clinic from January 2005 to July 2009 with FI. All completed questionnaires on demographics and validated instruments including the Fecal Incontinence Quality of Life Instrument (FIQL), Patient Health Questionnaire (PHQ) for depression, and Fecal Incontinence Severity Index (FISI). Logistic regression was used to identify factors associated with moderate/severe FI.

Results

The study included 226 women with an average age of 59.2 years (SD?=?14.1); 92 % were Caucasian, 67 % were married, and the average body mass index was 30.0 (SD?=?8.6). Their QOL was moderately/severely affected by FI in 35.6 %. Mean overall FIQL score was 2.5 (SD?=?0.8). Median QOL subscale measures were: lifestyle?=?2.7 (SD?=?1.0), coping?=?2.09 (SD?=?0.9), depression?=?2.8 (SD?=?1.0), and embarrassment?=?2.2 (SD?=?0.9). Average FISI score was 31.6 (SD?=?15.7) and average depression score on the PHQ was 8.93 (SD?=?8.1). In univariate analyses, diabetes, irritable bowel symptoms, prior hysterectomy, history of previous medical care for FI, higher FISI and PHQ scores were associated with moderate/severe FIQL scores (p?<?0.05). Higher PHQ scores and prior hysterectomy significantly predicted moderate/severe QOL in logistic regression analysis (p?<?0.05).

Conclusions

We confirm that women with higher depression scores and prior hysterectomy have moderate/severe QOL impairment. When evaluating FI, screening for depression should be undertaken.     

Are topical oestrogens useful in faecal incontinence? Double‐blind randomized trial

Background  Histopathological studies have shown the presence of oestrogenic receptors in the anal sphincter, which presumes a role in muscular trophism for circulating oestrogens. This could explain the increase in faecal incontinence (FI) in postmenopausal women.
Objective  To evaluate the effect of topical oestrogens (TE) in controlling symptoms of FI in postmenopausal women.
Hypothesis  The application of TE in postmenopausal women with FI improves continence.
Method  We performed a prospective double-blind randomized trial applying TE to the anal mucosa in postmenopausal women with FI. Study period: 2005–2006. The patients were randomized into two groups: I – topical estriol, II – placebo. In both groups, the ointment was applied three times daily for a period of 6 weeks. We compared Wexner's FI score and the FI quality of life scale, before commencing and after 6 weeks of application.
Results  In this period we evaluated 36 patients. Average age: 67 years (48–84). Group I: 18 patients and group II: 18 patients, one patient was excluded. Wexner's FI score in group I was 11 (5–18) and 7 (0–19) with pre- and postapplication respectively ( P  = 0.002). Wexner's FI score in group II was 12 and 9 with pre- and postapplication respectively ( P  = 0.013). When we compared the results between both groups, this was not statistically significant ( P  = 0.521).
Conclusion  There is improvement of continence in both groups that had the ointment applied; nonetheless this study could not show that TE improves FI more than a placebo does.     

Validation study of the Japanese version of the faecal incontinence quality of life scale

Aim The aim of the present study was to conduct a psychometric validation of the Japanese version of the FIQL (JFIQL). Method A retrospective analysis of data from the JFIQL was conducted. Wexner scores and Faecal Incontinence Severity Index (FISI) scores were collected prospectively in patients with faecal incontinence who visited our centre between 2008 and 2009. For convergent validity, the JFIQL scores were compared with stages on the Wexner scale for lifestyle alteration. To evaluate reliability, Cronbach’s alpha was calculated for internal consistency, whereas a test–retest study was performed to evaluate reproducibility. In assessing responsiveness, JFIQL scores before and after treatments were compared in patients whose FISI scores decreased by ≥ 50%. Results Convergent validity and internal consistency were determined in 70 patients (49 women; median age 68.5 years). The JFIQL scores were significantly associated with lifestyle alteration stages on the Wexner scale, demonstrating convergent validity in all four domains and the generic score. Cronbach’s alpha was > 0.7 for generic scores and all domains except Embarrassment. The intraclass correlations for the 27 patients available for the test–retest study were > 0.7 for generic scores and all domains except Embarrassment. The median JFIQL score improved significantly after treatment in the 23 patients whose FISI scores decreased ≥ 50%, indicating good responsiveness in all four domains and the generic score. Conclusion The JFIQL has been validated and is now ready for use in evaluating the symptom‐specific quality of life in Japanese patients with faecal incontinence.     

Duloxetine for mild to moderate postprostatectomy incontinence: preliminary results of a randomised, placebo-controlled trial

Background

Duloxetine is effective in the management of stress urinary incontinence (SUI) in women but has been poorly evaluated in the treatment of SUI following radical prostatectomy (RP).

Objective

To establish the superiority of duloxetine over placebo in SUI after RP.

Design, setting, and participants

We conducted a prospective, randomised, placebo-controlled, double-blind, monocentric superiority trial. After a placebo run-in period of 2 wk, patients with SUI after RP were randomised to receive either 80 mg of duloxetine daily or matching placebo for 3 mo.

Measurements

The primary outcome measure was the relative variation in incontinence episodes frequency (IEF) at the end of study compared to baseline. Secondary outcomes included quality of life (QoL) measures (Incontinence Impact Questionnaire Short Form [IIQ-SF], Urogenital Distress Inventory Short Form [UDI-SF], Incontinence Quality of Life [I-QoL]), symptom scores (Urinary Symptom Profile [USP] questionnaire, International Consultation on Incontinence/World Health Organisation Short Form questionnaire [ICIQ-SF], the Beck Depression Inventory [BDI-II] questionnaire), 1-h pad test, and assessment of adverse events.

Results and limitations

Thirty-one patients were randomised to either the treatment (n = 16) or control group (n = 15). Reduction in IEF was significant with duloxetine compared to placebo (mean ± standard deviation [SD] variation: −52.2% ± 38.6 [range: −100 to +46] vs +19.0% ± 43.5 [range: −53 to +104]; mean difference: 71.2%; 95% confidence interval [CI] for the difference: 41.0–101.4; p < 0.0001). IIQ-SF total score, UDI-SF total score, SUI subscore of the USP questionnaire, and question 3 of the ICIQ-SF questionnaire showed improvement in the duloxetine group (p = 0.006, p = 0.02, p = 0.0004, and p = 0.003, respectively). Both treatments were well tolerated throughout the study period.

Conclusions

Duloxetine is effective in the treatment of incontinence symptoms and improves QoL in patients with SUI after RP.     

A randomized controlled trial of duloxetine alone, pelvic floor muscle training alone, combined treatment and no active treatment in women with stress urinary incontinence

PURPOSE: We primarily compared the effectiveness of combined pelvic floor muscle training (PFMT) and duloxetine with imitation PFMT and placebo for 12 weeks in women with stress urinary incontinence (SUI). In addition, we compared the effectiveness of combined treatment with single treatments, single treatments with each other and single treatments with no treatment. MATERIALS AND METHODS: This blinded, doubly controlled, randomized trial enrolled 201 women 18 to 75 years old with SUI at 17 incontinence centers in the Netherlands, United Kingdom and United States. Women averaged 2 or more incontinence episodes daily and were randomized to 1 of 4 combinations of 80 mg duloxetine daily, placebo, PFMT and imitation PFMT, including combined treatment (in 52), no active treatment (in 47), PFMT only (in 50) and duloxetine only (in 52). The primary efficacy measure was incontinence episode frequency. Other efficacy variables included the number of continence pads used and the Incontinence Quality of Life questionnaire score. RESULTS: The intent to treat population incontinence episode frequency analysis demonstrated the superiority of duloxetine with or without PFMT compared with no treatment or with PFMT alone. However, pad and Incontinence Quality of Life analyses suggested greater improvement with combined treatment than single treatment. A completer population analysis demonstrated the efficacy of duloxetine with or without PFMT and suggested combined treatment was more effective than either treatment alone. CONCLUSIONS: The data support significant efficacy of combined PFMT and duloxetine in the treatment of women with SUI. We hypothesize that complementary modes of action of duloxetine and PFMT may result in an additive effect of combined treatment.     

Sacral nerve stimulation for the treatment of faecal incontinence following low anterior resection for rectal cancer

Aim The aim of this study was to assess the effectiveness of sacral nerve stimulation (SNS) in the management of faecal incontinence following neoadjuvant therapy and low anterior resection (LAR) for rectal cancer. Method In a prospective single‐centre study, 15 patients (12 men, median age 72 years) were enrolled between 2005 and 2008. All had severe incontinence after total mesorectal excision, and 14 had received preoperative full‐course chemoradiotherapy. The patients were followed up for a median of 50 (range: 24–144) months. There was no recurrence (local or distal). Incontinence was evaluated using the Cleveland Clinic Florida Fecal Incontinence (CCF‐FI) scoring system. Quality of life (QoL) was evaluated using the Fecal Incontinence Quality of Life (FIQL) questionnaire. SNS was performed in three stages. Results During percutaneous nerve evaluation (PNE), a good response was observed in seven patients, all of whom received a permanent implant. The median follow up was 12 (range: 1–44) months. The mean CCF‐FI score was reduced from 19.2 [standard deviation (SD) 1.2] to 6.2 (SD 1.7) (P < 0.01). The mean number of days per week with an incontinent episode decreased from 7 (SD 0) to 0.2 (SD 0.3) (P < 0.01), and the mean number of defaecations per week decreased from 42.5 (SD 13.7) to 13.2 (SD 7.4) (P < 0.01). In the five patients with a permanent implant who were followed up for longer than 6 months, all FIQL scores improved. An increase in the mean resting and squeeze pressures was seen in four patients with a permanent implant. Conclusions SNS is a treatment option for faecal incontinence after LAR for rectal cancer.     

Short-term outcome following percutaneous tibial nerve stimulation for faecal incontinence: a single-centre prospective study

Aim Percutaneous tibial nerve stimulation (PTNS) is increasingly being used as a treatment for faecal incontinence (FI). The evidence for its efficacy is limited to a few studies involving small numbers of patients. The aim of the study was to assess the efficacy of PTNS in patients with urge, passive and mixed FI. Method A prospective cohort of 100 patients with FI was studied. Continence scores were determined before treatment and following 12 sessions of PTNS using a validated questionnaire [Cleveland Clinic Florida (CCF)‐FI score]. The deferment time and average number of weekly incontinence episodes before and after 12 sessions of treatment were estimated from a bowel dairy kept by the patient. Quality of life was assessed prior to and on completion of 12 sessions of PTNS using a validated questionnaire [Rockwood Faecal Incontinence Quality of Life (QoL)]. Results One hundred patients (88 women) of median age of 57 years were included. Patients with urge FI (n = 25) and mixed FI (n = 60) demonstrated a statistically significant improvement in the mean CCF‐FI score (11.0 ± 4.1 to 8.3 ± 4.8 and 12.8 ± 3.7 to 9.1 ± 4.4) with an associated improvement in the QoL score. This effect was not observed in patients with purely passive FI (n = 15). Conclusion The study demonstrates that PTNS benefits patients with urge and mixed FI, at least in the short term.     

Does incontinence severity correlate with quality of life? Prospective analysis of 502 consecutive patients

Objective The Fecal Incontinence Severity Index (FISI) is widely used in the assessment of patients with faecal incontinence, but the relationship between FISI and the measurements of quality of life, such as the Fecal Incontinence Quality of Life Scale (FIQL) and the Medical Outcomes Survey (SF‐36) has not been evaluated previously. The aim of the present study was to evaluate the relationship between disease severity and quality of life in a large cohort of patients. Method Five hundred and two consecutive patients (84.4% female, mean age 56 years) were evaluated for faecal incontinence between May 2004 and October 2005. Patients completed FISI, FIQL and SF‐36 questionnaires. Pearson's coefficients were determined for the relationships between FISI and subscales of FIQL and SF‐36. Quality of life scores were compared between groups of patients with different levels of incontinence severity (mild, moderate, severe) using Student's t‐test. Results Sixty‐eight per cent of patients were incontinent of solid stool, 62% of liquid stool, and 90% of gas or mucus. The average FISI score was 36 (0–61). Moderate correlations were found between FISI and all subscales in FIQL (negative 0.29 to 0.41; P < 0.0001). Weak correlations were found between FISI and the social functioning (?0.21) and mental health (?0.17) scales in SF‐36 (P < 0.05). Scores on the FIQL differed significantly between mild, moderate and severe incontinence. Conclusion FISI was only moderately correlated with a disease‐specific quality of life measurement (FIQL). Even though this supports the common assumption that the quality of life in the patients with faecal incontinence worsens with an increase in disease severity, it also stresses the need of measuring both variables to determine the true impact of any treatment.     

Milk ribonuclease-enriched lactoferrin induces positive effects on bone turnover markers in postmenopausal women

Summary  Current treatments for postmenopausal osteoporosis suffer from side effects. Safe and natural milk proteins, ribonuclease, and lactoferrin promote formation of new capillaries and bone formation. A ribonuclease-enriched lactoferrin supplement studied here, demonstrates significant reduction in resorption and increase in formation, towards restoring the balance of bone turnover within 6 months. Introduction  Osteoporosis, a major health issue among postmenopausal women, causes increased bone resorption and reduced bone formation. A reduction in angiogenesis could also contribute to this imbalance. Current treatments such as hormone replacement therapy and bisphosphonates have drawbacks of severe side effects. Milk ribonuclease (RNase) is known to promote angiogenesis and lactoferrin (LF) to stimulate bone formation by osteoblasts. We examine the effect of ribonuclease-enriched lactoferrin supplement on the bone health of postmenopausal women. Methods  A total of 38 healthy, postmenopausal women, aged 45 to 60 years were randomized into placebo or RNAse-enriched-LF (R-ELF) supplement groups. The bone health status was monitored by assessing bone resorption markers, serum N-telopeptides (NTx), and urine deoxypyridinoline (Dpd) crosslinks and serum bone formation markers, bone-specific alkaline phosphatase (BAP), and osteocalcin (OC). Results  R-ELF supplementation demonstrated a decrease in urine Dpd levels by 14% (19% increase for placebo) and serum NTx maintained at 24% of the baseline (41% for placebo), while serum BAP and OC levels showed a 45% and 16% elevation (25% and 5% for placebo). Conclusions  R-ELF supplementation demonstrated a statistically significant reduction in bone resorption and increase in osteoblastic bone formation, to restore the balance of bone turnover within a short period.     

The effect of obesity on fecal incontinence symptom distress, quality of life, and diagnostic testing measures in women

Introduction and hypothesis

Weight-loss has been demonstrated to result in an improvement in fecal incontinence (FI) severity; however, there is a paucity of data addressing the differential impact of FI on the quality of life (QOL) and results of diagnostic testing across BMI categories. We wished to evaluate symptom distress, QOL, and diagnostic testing parameters among normal, overweight, and obese women with fecal incontinence.

Methods

Women undergoing evaluation for FI between 2003 and 2012 were identified. Participants completed validated, symptom-specific distress, impact, and general QOL measures including the Modified Manchester Questionnaire (MMHQ), which includes the Fecal Incontinence Severity Index (FISI), and the mental and physical component summary scores, MCS and PCS, respectively, of the Short Form-12. Anorectal manometry measures were also included. Multivariate regression analyses were performed.

Results

Participants included 407 women with a mean age ± SD of 56?±?13. Multivariate analyses revealed no differences in symptom-specific distress and impact as measured by MMHQ, MCS, and PCS across BMI groups; however, obese women had increased resting and squeeze pressures compared with normal and overweight BMI women (p?<?0.0001 and p?<?0.0001; p?=?0.007 and p?=?0.004 respectively).

Conclusions

Obese women with FI did not have more general impact and symptom-specific distress and impact on quality of life compared with normal and overweight women. Obese women with FI had higher baseline anal resting and squeeze pressures suggesting a lower threshold to leakage with pressure increases.     

Faecal incontinence in men

Aim A few studies have specifically addressed faecal incontinence (FI) in men. We sought to describe patterns of male FI, assess treatment outcome and compare some aspects of FI between men and women, including quality of life. Method Prospectively recorded data on 85 consecutive male patients evaluated for FI at our pelvic floor centre in 2004 and 2005 were reviewed and compared with a cohort of 408 female patients. Treatment outcome in men was assessed by questionnaire. Results The aetiology of FI could be determined in 61 (72%) men and was most commonly related to anal surgery (n = 23), prostate cancer therapy (n = 9) and spinal injury (n = 9). Eight patients had idiopathic soiling only. Mean age, Fecal Incontinence Severity Index (FISI) and quality of life scores were similar between men and women. Maximal mean resting pressure (MRP) and squeeze pressure (MSP) were on average higher in men than in women [MRP 56.9 (26.2) vs 40 (20.4) mmHg; P < 0.0001]; [MSP 98.1 (67.3) vs 39.4 (28.5) mmHg; P < 0.0001]. Sphincter defects involved the external sphincter less often in men (35 vs 70%, P = 0.004). Differences in faecal incontinence quality of life (FIQL) and SF‐36 scores between men and women were minimal. After a median follow up of 2 years, complete resolution of symptoms was reported in 17% and improvement of symptoms in another 48% of men. Conclusion Although physiological and anatomical features of FI differ between men and women, its severity and impact on quality of life are similar. External sphincter defects are less common in men; hence, direct sphincter repair is less frequently an option. Evaluation and treatment improves symptoms in more than half of male patients.     

Implantation of ethylene vinyl alcohol copolymer for faecal incontinence management

Purpose: The primary objectives of this trial were to evaluate the safety and feasibility of treatment and to gain a preliminary indication of the effectiveness of ethylene vinyl alcohol injections into the anal sphincters of faecally incontinent patients. Methods: Between April 2004 and February 2006, we conducted a prospective, single‐arm, procedure optimization study of ethylene vinyl alcohol injections in 21 subjects with well‐characterized faecal incontinence and an intact external anal sphincter at two Australian hospitals. Results: There was a significant decrease in the Cleveland Clinic Florida Faecal Incontinence Score (CCFFIS) (P= 0.0005) and the Faecal Incontinence Severity Index score (P= 0.005) after treatment. At 12 months post‐treatment, the mean CCFFIS had decreased by 37% (P= 0.0021), and 47% of subjects had a ≥50% improvement in CCFFIS. There were significant improvements in embarrassment (P= 0.0455) and coping/behaviour (P= 0.0056) domains of the Faecal Incontinence Quality of Life. At 12 months, the mean anal canal length had increased by 29% (P= 0.066), with 40% of patients demonstrating increases of 50% or more. There were no further improvements following retreatment. Conclusions: Ethylene vinyl alcohol injection into the anal intersphincteric plane is feasible and well tolerated. Improvement in faecal incontinence compared with baseline was seen. Retreating initial non‐responders was not successful.     

Surgery for fistula-in-ano: an audit of practise of colorectal and general surgeons.

Objective Some conditions, previously managed by general surgeons, may be treated more successfully by colorectal specialists. This argument is well established for rectal cancer but does it also apply to benign conditions? This study compares the treatment strategies and outcomes for fistulae‐in‐ano by general and colorectal surgeons in a district general hospital. Method Patients who had surgery for fistula‐in‐ano from January 1992–October 2003 were identified from theatre records. Case notes were reviewed for data on type of fistula, aetiology, surgery performed and recurrence. All patients were sent a questionnaire requesting details of recurrence and incontinence. The severity of incontinence was assessed using the Faecal Incontinence Quality of Life Scale (FIQOLS) and the Faecal Incontinence Severity Index (FISI). Results Eighty four patients (male = 53) were identified. Colorectal surgeons performed surgery in 34 and general surgeons in 50 patients. These groups were comparable with terms of age, gender, aetiology (colorectal: IBD = 5, cryptoglandular = 21: general IBD = 14, cryptoglandular = 24; P = 0.28; Chi‐squared test), and type of fistulae (colorectal: inter‐sphincteric = 20, trans‐sphincteric = 13: general inter‐sphincteric = 30, trans‐sphincteric = 18: P = 1.0; Fisher's exact test). Colorectal surgeons carried out fewer fistulotomies (47.1%vs 84.0%; P < 0.001; Fisher's exact test), more staged fistulotomies with Setons (44.1%vs 10.0%: P < 0.001; Fisher's exact test), and had fewer recurrences (9.7%vs 30.0%: P < 0.05; Fisher's exact test) when compared with general surgeons. Five patients with recurrence from the general surgery group were subsequently referred to the colorectal surgeons; four patients had further surgery (fistulotomy = 2; staged fistulotomy = 2) with no recurrence to date; one patient required proctectomy. Forty seven (64.4%) patients answered the questionnaire. There was no difference between patients operated on by colorectal or general surgeons with regards the frequency (43.5%vs 62.5%: P = 0.25; Fisher's exact test) or severity [FISI 26 (21–38); median (inter‐quartile range) vs 26 (17–38); median (inter‐quartile range: P = 0.85; Mann–Whitney test) of faecal incontinence. There was no difference between the groups with regards any of the four scales that comprised the FIQOLS. Conclusions The number of included patients is far too low to draw any conclusions but there were some interesting trends. For similar patient samples, colorectal surgeons seem to adopt a more conservative approach and have fewer recurrences than general surgeons. These differences are not reflected in the frequency or severity of postoperative incontinence.     

Growth hormone, glutamine, and an optimal diet reduces parenteral nutrition in patients with short bowel syndrome: a prospective, randomized, placebo-controlled, double-blind clinical trial

OBJECTIVE: To determine if growth hormone (GH) and glutamine (Gln) might allow for a reduction in parenteral nutrition (PN) in individuals with short bowel syndrome. BACKGROUND DATA: Following massive intestinal resection, patients frequently sustain severe nutrient malabsorption and are dependent on PN for life. GH treatment with or without Gln might allow for a reduction in PN. METHODS: A prospective, double-blind, randomized, placebo-controlled clinical trial performed in 41 adults dependent on PN. Following screening, patients were admitted to an in-house facility for 6 weeks. After 2 weeks of stabilization and dietary optimization, patients were randomized to one of 3 treatment arms (1:2:2 ratio): oral Gln (30 g/day) + GH placebo (control group, n = 9), Gln placebo + GH (0.1 mg/kg per day, n = 16), or Gln + GH (n = 16). Standard criteria based on clinical and laboratory measurements were followed to determine PN volume and content. After 4 weeks of treatment, patients were discharged and monitored; GH and GH placebo were discontinued, but the diet with Gln or Gln placebo was continued for 3 months. RESULTS: Patients receiving GH + Gln placebo + diet showed greater reductions in PN volume (5.9 +/- 3.8 L/wk, mean +/- SD), PN calories (4338 +/- 1858 calories/wk), and PN infusions (3 +/- 2 infusions/wk) than corresponding reductions in the Gln + diet group (3.8 +/- 2.4 L/wk; 2633 +/- 1341 calories/wk; 2 +/- 1 infusions/wk, P < 0.05). Patients who received GH + Gln + diet showed the greatest reductions (7.7 +/- 3.2 L/wk; 5751 +/- 2082 calories/wk; 4 +/- 1 infusions/wk, P < 0.001 versus Gln + diet). At the 3-month follow-up, only patients who had received GH + Gln + diet maintained significant reductions in PN (P < 0.005) compared with the Gln + diet. CONCLUSIONS: Treatment with GH + diet or GH + Gln + diet initially permitted significantly more weaning from PN than Gln + diet. Only subjects receiving GH + Gln + diet maintained this effect for at least 3 months.     

The effects of calcium supplementation and exercise on bone density in elderly Chinese women

A randomized controlled trial was carried out to determine whether calcium supplementation and load-bearing exercise can increase or maintain bone mass in the elderly. Fifty Chinese women, aged 62–92 years, living in a hostel for the elderly in Hong Kong were randomized to enter one of four treatment groups: (I) calcium supplementation of 800 mg (as calcium lactate gluconate) daily; (II) load-bearing exercise four times a week plus a daily placebo tablet; (III) calcium supplementation daily and load-bearing exercise four times a week; (IV) a placebo tablet daily. The interventions went on for 10 months. The bone mineral density (BMD) was measured at three sites in the hip (femoral neck, Ward's triangle and intertrochanteric area) and the L2–4 level of the spine. The percentage change in BMD in 10 months was used as the main outcome measurement. The parathyroid hormone level and indices of bone metabolism were also measured before and after 10 months of intervention.The BMD at Ward's triangle and the intertrochanteric area increased significantly in subjects on calcium supplement (p<0.05), but there was no significant change at the spine and femoral neck. Exercise had no effect on bone loss at any site. However, the results of two-way analysis of variance showed a significant joint effect of calcium supplements and exercise at the femoral neck (p<0.05), but not at the other sites. The parathyroid hormone levels fell significantly in subjects on calcium supplements (p<0.01).Calcium supplement in the form of calcium lactate gluconate was adequately absorbed in elderly Chinese women with a calcium intake of less than 300 mg per day. It was effective in reducing bone loss at the hip, and there may be interaction effects with exercise in maintaining bone density.     

Efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia

Objectives:   To assess the efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia (BPH).
Methods:   This was a randomized, double-blind, placebo-controlled, parallel-group study. A total of 378 subjects with clinical BPH having an International Prostate Symptom Score (IPSS) of 8 points or greater, a prostate volume of 30 mL or greater, and a maximal urinary flow rate (Qmax) of 15 mL/s or less were randomized to receive placebo or dutasteride once daily for 52 weeks. Subjects were stratified according to tamsulosin use at baseline. The numbers of subjects with and without tamsulosin use were 242 and 136, respectively. IPSS, Qmax, prostate volume and drug safety were evaluated.
Results:   Continued improvement in IPSS was noted in the dutasteride group, and dutasteride significantly decreased IPSS compared with placebo. At week 52, dutasteride significantly improved Qmax and prostate volume compared with placebo. Drug-related sexual function events in the dutasteride group were infrequent and generally were not treatment limiting.
Conclusions:   Dutasteride improves urinary symptoms and flow rate and reduces prostate volume. In Japanese men with BPH, it is effective and generally well tolerated during the one-year treatment period.     

Total colectomy and ileorectal anastomosis in the treatment of total colonic aganglionosis: a long-term follow-up study of six patients

Six patients with total colonic aganglionosis (TCA) with ileal involvement were treated with a total colectomy and ileorectal anastomosis according to Rehbein. Follow-up lasted from 1 to 7 years and showed no mortality. Postoperative management consisted of total parenteral nutrition initially, followed by gradual introduction of oral feeding beginning with a low-osmolarity low-residue diet, the use of loperamide, an adequate oral intake of salt, and regular bowel deflation. Major postoperative complications disappeared and all patients demonstrated weight gain by the end of the first postoperative year, with normal feeding and two to three soft stools per day.     

Intravenous dolasetron and ondansetron in prevention of postoperative nausea and vomiting: a multicenter, double-blind, placebo-controlled study

Background: Intravenous dolasetron mesilate has shown efficacy in the prevention of postoperative nausea and vomiting (PONV) when administered as a single dose prior to emergence from anesthesia. This trial compared intravenous dolasetron and ondansetron for the prevention of PONV when administered at induction of anesthesia.
Methods: This double-blind, placebo-controlled, multicenter trial randomized patients to one of four single IV treatments: placebo, 25 or 50 mg dolasetron, or 4 mg ondansetron. Efficacy was measured by complete response (0 emetic episodes and no rescue medication), nausea severity and patient satisfaction as measured on a visual analog scale (VAS), investigator's rating of nausea severity, and total response (complete response with no nausea [≤ mm VAS]).
Results: 514 patients at 24 sites were evaluated for efficacy. The 50 mg dolasetron and 4 mg ondansetron doses were statistically equivalent, and superior to placebo, for all efficacy measures. Complete response rates were 49%, 51%, 71% and 64% for placebo, 25 and 50 mg dolasetron, and ondansetron, respectively. Dolasetron 50 mg was statistically superior to 25 mg dolasetron for complete response, total response, VAS maximum nausea, time to first emetic episode, and patient satisfaction. The majority of adverse events were of mild-to-moderate intensity. Headache was the most frequently reported treatment-related adverse event with a 3%-5% incidence across treatments.
Conclusion: When given at induction of anesthesia, 50 mg intravenous dolasetron is equivalent to 4 mg ondansetron and superior to 25 mg dolasetron and placebo for the prevention of PONV. All treatments were safely administered and well tolerated.     

Increased natriuretic ability and hypotensive effect during short-term high calcium intake in essential hypertension

The present study has investigated whether an increased natriuresis could account for the hypotensive effect of a high calcium diet which has been reported by others. A calcium supplement (equivalent to 1 g of elemental calcium) was given for 5 days to 18 patients with essential hypertension in a randomized single-blind, placebo-controlled, cross-over trial. In 15 of the patients, 2 liters of isotonic saline were infused intravenously over 4 h during the last day of each test period and hourly urine collections were taken. Calcium supplementation produced a mild but significant hypercalcemia as well as increased urinary calcium excretion. Body weight and systolic blood pressure decreased significantly. The blood pressure decrease was indirectly related to the pretreatment plasma renin activity (r = -0.61, p less than 0.01). Urinary sodium excretion increased during calcium diet (80 mmol/day negative balance, p less than 0.01). During saline infusion under calcium supplementation the urine volume, osmolality and sodium excretion were significantly higher compared with placebo. The changes in urinary sodium excretion correlated positively with the changes in urinary calcium excretion (r = 0.68, p less than 0.01) in patients given the high calcium diet, when infused with saline. We conclude that calcium supplementation induces a considerable sodium loss in the urine which is very likely to result in the hypotensive effect.