• FINAL NUMBER STUDIES INCLUDED = 25 studies included in mixed treatment comparison (MTC) analysis
• TOTAL PATIENTS INCLUDED IN REVIEW = 7,062
• KEY SAMPLE CHARACTERISTICS: Patients an average of 41.9 years of age; 53.5% of them were male and 54.4% were undergoing HSCT or bone marrow transplant at baseline; the most common underlying malignant disease was AML

PHASE OF CARE: Transition phase after active treatment
 
APPLICATIONS: Elder care

IFI prophylaxis reduces IFI risk but may not affect all-cause mortality. Posaconazole is superior for prophylaxis against IFIs in neutropenic patients; its effectiveness against Aspergillus is more pronounced than against Candida. Fluconazole does not protect against Aspergillus species. Results are consistent with previous studies. The order of antifungal preference matches that recommended by the German Society for Hematology and Oncology. These results were strong, and no severe problems with inconsistency were observed. The original hypothesis that studies with a higher proportion of patients with acute myeloid leukemia (AML) would show a higher risk of acquiring an IFI compared with other types of leukemia was not supported.

• Studies were inconsistent in reports and reporting outcomes.
• Inconsistencies in reporting underlying disease
• Underlying severity of the studied population makes isolation of the treatment effect difficult.
• Variations in dosing complicates the estimation of an aggregate prophylactic effect.
• No distinction between patients with neutropenia or immunosuppression due to chemotherapy or due to HSCT and bone marrow transplant

Intensive head-to-head comparisons are needed using both chemotherapy populations and HSCT populations. Additionally, institutions should assess the effectiveness of prophylactic options as well as the cost effectiveness of these newer agents. 

To determine the efficacy of interventions used in the management of fatigue and/or unintentional weight loss in adults with advanced progressive illness by reviewing the evidence contained within Cochrane reviews. This overview does not attempt to rereview the literature or provide information on outcomes not reported within the included Cochrane reviews.

The database searched was Cochrane Database of Systematic Reviews.

No keyword or subject heading was searched because it would be unreliable due to the diverse range of interventions and illnesses under review. The authors hand searched the Cochrane Database of Systematic Reviews by title for all reviews that might assess the effect of an intervention on fatigue and/or unintentional weight loss in adults with advanced progressive illness.

Studies were included if they reported interventions with fatigue and/or unintentional weight loss as the primary treatment intent.

Studies were excluded if the treatment of fatigue and/or unintentional weight loss was not a primary indication for the intervention, they were systematic reviews published outside the Cochrane Library, or if they only included children.
 

Twenty-seven systematic reviews were retrieved. Assessment of Multiple SysTemAtic Reviews (AMSTAR) was used to assess the methodological quality of each systematic review.

• The final number of systematic reviews included was 27.
• The total sample size included 302 studies with 31,833 participants.
• Adults 18 years or older with an advanced progressive illness known to have clinically significant fatigue and/or weight loss in the latter stages of illness were included. These conditions included degenerative neurological conditions, such as multiple sclerosis, Parkinson’s disease, dementia, irreversible organ failure, cancer with distant metastasis, and acquired immune deficiency syndrome (AIDS).
• The pharmacological interventions were eicosapentaenoic acid (EPA) and any drug therapy for the management of cancer-related fatigue. The nonpharmacological interventions were exercise, interventions by breast care nurses, and psychosocial interventions.

• Patients were undergoing the end of life phase of care.
• The study has clinical applicability for palliative care.

The review looked for the following outcomes:

1. Clinically significant improvements in fatigue and/or unintentional weight loss
2. Improvements in quality of life of people who have fatigue and/or unintentional weight loss
3. Withdrawals due to adverse events.

Results relative to fatigue in patients with cancer included identification of five systematic reviews (116 studies with 17,342 participants). 

Nonpharmacologic Interventions

The evidence provided some insight into interventions that may prove beneficial, such as exercise. However, recommendations could not be made for specific exercise interventions that might best manage fatigue. In a systematic review, Cruickshank et al. (2008) reviewed the effect of breast care management strategies on fatigue in women with breast cancer at any stage of their illness. No included study assessed fatigue as an independent outcome, and no conclusions could be drawn. In 2009, Goedendorp reported that for patients undergoing cancer treatment at any disease stage, there was insufficient evidence that psychosocial interventions were beneficial for fatigue management. 

Pharmacologic Interventions

Sufficient evidence was not provided for the use of EPA over placebo in patients with advanced cancer. A small but significant improvement with fatigue was found with the use of methylphenidate in 51 studies with 10,296 participants. Use of erythropoietin and darbepoetin showed evidence of an effect over standard of care or placebo for the treatment of cancer-related fatigue. However, increased safety concerns mean they are no longer recommended in practice for this use, especially if the person’s hemoglobin concentration is greater than 12 g/dL. No benefits over placebo were seen for fatigue with the use of antidepressant drug paroxetine, nor with progestational steroids.

There was a lack of robust evidence for interventions for fatigue management in the advanced stage of progressive illness related to cancer.

Extraction of data was limited to Cochrane reviews. Fatigue as an outcome indicator was not always sufficiently reported.

Exercise interventions can lead to an improvement in fatigue in patients with cancer; however, this beneficial effect requires further research for those in the advanced stage.

To determine if a home-based walking program is more effective than usual care in reducing fatigue, sleep disturbances, and symptoms of depression in older women receiving hormone treatment for breast cancer.

Patients were recruited from breast cancer clinics and randomized to usual care or a prescribed exercise program that focused on walking. Researchers followed patients' progress over a 14-week period. Patients completed study instruments at baseline, two weeks later via mail, 12 weeks after baseline at a clinic visit, and 14 weeks after baseline via mail. Cortisol, serotonin, interleukin-6 (IL-6), and bilirubin were collected at the initial clinic visit and again at three months. At visit 1 and at 12 weeks, patients were asked to wear a sleep-watch actigraph for 72 continuous hours. The walking exercise intervention was a moderate walking activity for 20 minutes, four times a week. Patients were to log the duration and frequency of walking activity.

• The sample was comprised of 18 women.
• Mean age was 65 years (range 56–78).
• All patients had breast cancer and were being treated, by means of hormone therapy, with tamoxifen, anastrozole, or letrozole.
• Of the patients, 65% were married, 55% were retired, 90% were Caucasian, and 40% had education at the college level or higher.
• Inclusion criteria were postmenopausal status and fatigue.

• Single site
• Outpatient
• Comprehensive cancer center in the southeastern United States

The study was a longitudinal, repeated-measures, randomized, clinical trial.

• Revised Piper Fatigue Scale (PFS-R)
• Pittsburgh Sleep Quality Index (PSQI)
• Center for Epidemiologic Studies Depression Scale (CESD)
• Sleep measurements collected by means of actigraphy

Levels of fatigue over time and between groups were not significantly different. PSQI scores decreased significantly over time in the exercise group (p = 0.007) and did not change in the usual care control. Actigraphy analysis after 12 weeks showed a shorter wake time (p = 0.02), sleep time (p = 0.05), and less movement during sleep (p = 0.002) in the exercise group. There was no difference between groups in regard to sleep efficiency, which is the ratio of total sleep time to time in bed. There were no differences in cortisol levels over time or between groups. ANOVA showed a significant difference between groups and across time in serotonin levels, with an intervention effect of exercise (p = 0.009). There were no differences between groups or over time in regard to symptoms of depression.

A home-based walking intervention appears to be acceptable to older women receiving hormone therapy for breast cancer and an intervention that is feasible for use in that population. Decline in PSQI scores in the exercise group suggest that this type of intervention may help improve sleep quality in this population. Effects of the exercise intervention on biomarkers are unclear.

• The study had a small sample size, with less than 30 patients.
• There was no intention-to-treat analysis.
• The study had a risk of bias due to no appropriate attentional control group.
• Although significance values were reported, the authors provided no other statistical results regarding significant findings. Such results would enable evaluation of the strength of the relationships.
• The authors did not report actual adherence to the exercise program, so the use of exercise as prescribed cannot be determined. It is also unknown whether members of the control group exercised on their own.
• The use of patient self-reporting—in this case, of exercise—is a limitation in itself. Furthermore, the authors did not provide or discuss the patient self-reports or their analysis.

An exercise program involving walking may be helpful to patients receiving hormone treatment for breast cancer, but the actual effects of such a program on fatigue, sleep, and symptoms of depression are unclear.

The primary aim was to determine if a home-based walking exercise program is more effective than usual care in reducing fatigue, sleep disturbances, and depressive symptoms in older women receiving hormonal treatment for breast cancer as a feasibility study.  The secondary aim was to examine the extent to which symptoms and biomarkers of cortisol, serotonin, interleukin-6 (IL-6), and bilirubin are related and change over time.

Participants were recruited from breast cancer clinics and randomized to usual care or a prescribed walking exercise program. Participants were followed over a 14-week period. At an initial clinic visit, demographic data were collected and participants completed study instruments. Study instruments were again completed two weeks later via mail, 12 weeks after baseline at a clinic visit, and at 14 weeks via mail. Cortisol, serotonin, IL-6, and bilirubin were collected at the initial clinic visit and at 3 months. Blood samples were carefully handled to ensure appropriate handling for radioimmunoassay and other laboratory testing. At visit 1 and at 12 weeks, patients were asked to wear a sleep watch actigraph for 72 continuous hours. A study coordinator or investigator explained the walking exercise intervention, which was a moderate walking activity for 20 minutes, four times a week. Participants in the exercise group were shown how to use a pedometer that was provided to them but were not required to use it. Participants were given a log to record the duration and frequency of walking activity.

• Twenty participants (100% female) were included; data analysis was completed on 18 participants.
• Mean age was 65 years (range 56–78). 
• All participants had breast cancer and were being treated with hormonal therapy with tamoxifen, anastrozole, or letrozole.
• Of the participants, 65% were married, 55% were retired, 90% were Caucasian, and 40% had education at the college level or higher.

Participants were included if they

• Were postmenopausal status
• Reported fatigue
• Had a Karnofsky score of 80 or greater.

Individuals were excluded if they had a history of neurologic deficits or mental illness in the past year or had neuromuscular deficits that would contraindicate use of a walking program.

• Setting Type1:  Single site
• Setting Type 2:  Home
• Comprehensive cancer center in southeastern United States

This was a longitudinal, repeated measures, randomized, clinical trial.

• Revised Piper Fatigue Scale (PFS)
• Pittsburgh Sleep Quality Index (PSQI)
• Center for Epidemiological Studies – Depression Scale (CES-D)
• Sleep actigraphy measurements

Levels of fatigue over time and between groups were not significantly different. PSQI scores decreased significantly over time in the exercise group (p = 0.007) and did not change in the usual care controls. Actigraphy analysis after 12 weeks showed a shorter wake time (p = 0.02), sleep time (p = 0.05), and less movement during sleep (p = 0.002) in the exercise group. There was no difference between groups in sleep efficiency, the ratio of total sleep time while in bed. There were no differences in cortisol levels over time or between groups. ANOVA showed a significant difference between groups and across time in serotonin levels, with an intervention effect of exercise (p = 0.009). Serotonin levels were correlated with actual wake time, but correlations were not statistically significant. There were no significant differences in IL-6 or bilirubin between groups or over time. Bilirubin levels in both groups were at or above the upper limit of normal range. Correlation analysis for cortisol, IL-6, and bilirubin were not reported. There were no differences between groups or over time in depressive symptoms. Actual patient adherence to prescribed exercise was not reported. Authors reported that the walking exercise intervention was accepted in this population.

Home-based walking intervention appears to be feasible and acceptable to older women receiving hormonal therapy for breast cancer. The decline in PSQI scores in the exercise group suggests that this type of intervention may be helpful in improving sleep quality in this population. Effects of the exercise intervention on biomarkers are unclear. There was no observed effect of the exercise intervention on fatigue.

• The study had a small sample size, with less than 30 participants.
• There was no intention-to-treat analysis.
• Although significance values were reported, there were no other statistical results provided for significant findings that enabled evaluation of the strength of relationships.
• Actual adherence to the exercise program was not reported, so the actual use of exercise as prescribed cannot be determined.
• It is also unknown whether the control group performed any exercise on their own.
• Although patient self-report of exercise is a limitation itself, results of patient self-reports were not provided or discussed.
• The study design lacked an appropriate attentional control group.

A walking exercise program may be helpful to patients receiving hormonal treatment for breast cancer, but actual effects on fatigue, sleep, and depressive symptoms are unclear.

Investigate the safety and efficacy of SAMITAL in the treatment of oral mucoitis with chemo-radiation therapy.

Patients received either Samital or a matching placebo mouth rinse. Patients were blinded to which treatment they had. Random assignment was not described.  Samital is a combination of three botanical drug extracts: vaccinium myrtillus, macleaya cordad, and Echinacea angustifolial root. The formulation is standardized, and forms a gel-like substance when re-constituted. Patients were to use the rinse 4 times daily for a total of 7 weeks. Each rinse was done using 4 aliquots over 30 minutes.

The study was comprised of 17 patients, with a mean age of 52.4 years.

MALES 89%, FEMALES 11%

KEY DISEASE CHARACTERISTICS: All had head and neck cancer and were receiving chemo-radiation. All had oral mucositis ≥ grade 3 on study entry, and 30% had cancer of the tongue.
 

SITE: Single site

SETTING TYPE: Outpatient

LOCATION: India

PHASE OF CARE: Active antitumor treatment

Single, blind, placebo controlled phase II

• Investigator modified WHO mucositis scale
• Daily oral mucositis questionnaire
• VAS for oral pain
   

None of the control group patients completed the study; most only completed seven days. Patients on SAMITAL showed significant improvement from baseline in mucositis grade from 2.94 ± 0.43 to 2.0 ± 0.35, drinking, eating, sleeping, and speaking (p < 0.05) after day 31. Those in the placebo group did not show significant changes from baseline.

Findings suggest that SAMITAL might have some benefit in management of oral mucositis; however, this study has substantial limitations and does not provide strong evidence.

• Small sample (<30)
• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results*
• Measurement/methods were not well described.  
• Measurement validity/reliability questionable*
• Subject withdrawals ≥10%
• Other limitations/*explanation: There was no discussion of analgesics used in the analysis. Very high number of dropouts, and patients lost to followup. The lack of most control patients beyond week 2 makes any differences seen between the controls and experimental group highly suspect. Revised WHO scale has unknown reliability etc. It is not stated that group assignment was actually random, and though patients were blinded to the treatment, evaluators were not.

This study examined use of SAMITAL, a botantical preparation, for its efficacy in management of oral mucositis. Some positive effects are described; however, this study does not provide strong evidence. Further well-designed research in this area may be warranted.

STUDY PURPOSE: To assess the evidence for use of corticosteroids as adjuvant analgesics in patients with cancer pain

TYPE OF STUDY: Systematic review

DATABASES USED: PubMed, EMBASE, Cochrane Collaboration, Cochrane Central Register of Controlled Trials

KEYWORDS: Specific search terms for PubMed are provided.

INCLUSION CRITERIA: RCT; adult patients with cancer; compared corticosteroids when added to standard pain treatment; assessed outcomes in pain, analgesic use, and adverse events

EXCLUSION CRITERIA: Non-English language

TOTAL REFERENCES RETRIEVED = 514

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Grading of Recommendations Assessment, Development and Evaluation; overall study quality in terms of risk of bias was low.

• FINAL NUMBER STUDIES INCLUDED = Four included, but only one study met all inclusion criteria
• SAMPLE RANGE ACROSS STUDIES = 40–403
• TOTAL PATIENTS INCLUDED IN REVIEW = 667
• KEY SAMPLE CHARACTERISTICS: Primary cancers were gastrointestinal, breast, lung, and genitourinary. All patients were receiving palliative intervention.

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care

Of the four studies included, one showed lower pain severity and analgesic consumption with steroid, two had unclear results because of lack of findings reported, and one showed no benefit.

The evidence regarding efficacy of adjuvant corticosteroids for pain management in patients with cancer is insufficient to draw firm conclusions. No current evidence is strong enough to show efficacy, and information is limited about adverse events with any long-term use.

• Very few studies
• Most studies had low quality.
• 50% of studies did not provide reporting of any adverse events.
• Studies were short-term.
• Despite limitations, authors suggest at least a weak recommendation for the use of corticosteroids.

Evidence is insufficient to demonstrate benefit from the addition of corticosteroids to usual pain management in patients with cancer, and evidence is very limited regarding adverse effects in this setting. Studies only have been reported with short-term use, so long-term adverse effects are not clearly known.

To compare the analgesic efficacy of corticosteroid therapy versus a placebo

The intervention was methylprednisolone 32 mg daily for seven days. The research team used a computerized randomization program to assign participants to intervention or placebo groups. Randomization stratification was based on study center and verified pain related to bone metastases. Both the research team and study participants were blinded to study assignment. Pain intensity, fatigue, and appetite loss were measured at baseline and day 7. Analgesic use was recorded daily. Satisfaction with the intervention was measured at day 7. Semistructured interviews were conducted at day 7 to determine any adverse effects experienced by study participants.

• N = 49  
• MEAN AGE: 64 years
• MALES: 51%, FEMALES: 49% 
• KEY DISEASE CHARACTERISTICS: Cancer diagnoses were breast, prostate, gastrointestinal, lung, gynecologic, and “other.” All patients but one in each arm of the study had metastatic disease. Seven participants were receiving chemotherapy and six were receiving hormonal therapy; pain score > 4.
• OTHER KEY SAMPLE CHARACTERISTICS: Mean Karnofsky score was 62.5 (intervention group) and 66.0 (placebo group)

• SITE: Multi-site    
• SETTING TYPE: Multiple settings    
• LOCATION: Norway

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Palliative care

Placebo-controlled, double-blind, randomized controlled trial

• Brief Pain Inventory (BPI)
• Edmonton Symptom Assessment System (ESAS)
• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ–C30)
• Satisfaction measured with intervention Numeric Rating Scale (NRS)
• Patient diary for recording daily analgesics
• Semistructured interviews

No significant difference was found between groups for average pain intensity at day 7, change in pain intensity from baseline, opioid intake, or adverse events. However, the intervention group did have a significant improvement in fatigue (p = .003) and appetite (p = .003) at day 7 compared to the placebo group. In addition, their overall satisfaction with treatment was also significantly greater (p = .001).

Pain relief was not improved for patients with advanced cancer who were taking on average a 222 mg oral morphine equivalent dose (MED). It is unknown whether this may be effective for different patient populations such as those taking a lower MED. Improvement in fatigue and appetite and a low number of adverse events were important clinical outcomes. Further study is needed to determine the long-term effects of this intervention.

• Small sample (< 100)
• Baseline sample/group differences of import
• Other limitations/explanation: Intervention group had a significantly higher dosage of MEDs compared to the control group

Nurses should be aware that methylprednisolone 32 mg daily may not be effective for improving pain relief in patients with advanced cancer who are taking an average opioid dose of ≥ 220 MED; however, it may improve fatigue and appetite with minimal adverse effects. Long-term effects have not yet been established. Long-term steroid use can contribute to other adverse side effects and should be weighed carefully with benefit of treatment.

STUDY PURPOSE: To determine the risk of hepatitis B virus (HBV) reactivation with or without antiviral prophylaxis, and the effectiveness of prophylaxis

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 26
• TOTAL PATIENTS INCLUDED IN REVIEW: 2,079
• SAMPLE RANGE ACROSS STUDIES: 6–258 patients
• KEY SAMPLE CHARACTERISTICS: Included patients with chronic HBV and resolved HBV

PHASE OF CARE: Active antitumor treatment

Risk for HBV reactivation without prophylaxis ranged from 4%–68% (median = 25%) and with prophylaxis ranged from 0.9%–31.4% (median = 4.1%). Among 13 studies comparing reactivation risk between patients who did and did not receive HBV prophylaxis, the pooled odds ratio [OR] was 0.12 (95% confidence interval [CI] [0.06, 0.22]).

HBV prophylaxis can help reduce the odds of HBV reactivation in patients with solid tumors undergoing chemotherapy.

• High heterogeneity among studies prevented an analysis of risk of reactivation in individuals without prophylaxis.
• Only one RCT
• Small effect size, although statistically significant

HBV prophylaxis may reduce the chance of patients with a history of HBV experiencing reactivation when undergoing chemotherapy for solid tumors. The authors of this article noted that guidelines regarding HBV screening vary. While the American Society of Clinical Oncology (ASCO) recommends screening for individuals at high risk, the Centers for Disease Control and Prevention (CDC) and others recommend screening all patients receiving immunosuppressive therapy. The findings here provide some support for broad HBV screening and the appropriate use of HBV prophylaxis; however, this analysis had multiple limitations. Further study is warranted to determine the screening, prophylaxis, and cost-effectiveness benefits of these actions.

To examine the effectiveness of intravenous (IV) versus subcutaneous (SC) granulocyte colony-stimulating factor (G-CSF) as related to time to neutropenia resolution and secondarily to assess comparative rates of infection, adverse effects, and patient satisfaction

Randomized, controlled, open-label trial with a 1:1 randomization to SC versus IV filgrastim. Patients were given either IV or SC filgrastim on a prescribed day (day 7 of chemotherapy for patients with acute myeloid leukemia [AML], day 2 after completion of chemotherapy for lymphoma and myeloma, and the day after infusion for patients undergoing hematopoietic stem cell transplantation [HSCT]). On the subsequent chemotherapy course (at least 30 days later), patients were crossed over to the alternative study arm.

• N = 120 
• MEAN AGE = 49.2 years
• MALES: 43.9% (first-course IV); 59% (first-course SC), FEMALES: 56.1% (first-course IV); 41% (first-course SC)
• KEY DISEASE CHARACTERISTICS: All hematologic malignancies. AML: IV (26.3%) and SC (37.7%). Acute lymphoblastic leukemia (ALL): IV (8.8%) and SC (13.1%). Non-Hodgkin's lymphoma (NHL): IV (36.8%) and SC (19.7%). Myeloma: IV (19.3%) and SC (19.7%). Other: IV (8.8%) and SC (9.8%).
• OTHER KEY SAMPLE CHARACTERISTICS: Almost 30% of patients in each cohort had a fever episode before randomization. 20%–25% had infection documented before randomization. The total median neutrophil count in the IV group was 0.1; the median neutrophil count in the SC group was 0; the median total leukocyte count in the IV group was 0.29; and the median leukocyte count in the SC group was 0.41.

• SITE: Single-site    
• SETTING TYPE: Inpatient    
• LOCATION: Hematology/oncology and bone marrow transplantation wards at the Davidoff Cancer Center, Beilinson Hospital, Petah Tikva, Israel

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled, open-label trial

• Primary outcomes: Time from start of filgrastim to stable neutrophil recovery (> 500 cells/µL for three consecutive days) and a composite clinical outcome of 30-day mortality or infection (clinically or morphologically documented infections, bacteremia or probable/proven invasive fungal infections)
• Secondary outcomes: Time to stable neutrophil recovery (> 100 cells/µL), any invasive fungal infections (IFIs) including possible IFIs, fever days, thrombocytopenia duration, duration of hospital stay for patients discharged within 30 days, and adverse events
• Patients’ pain and satisfaction were also assessed by interview.

Time to neutrophil resolution was longer with an IV bolus G-CSF compared to SC G-CSF with an overall mean difference of 2.5 days. There were no differences in clinical outcomes, including infection rates or adverse events observed.

The trial was not powered to examine possible serious complications of SC G-CSF administration and was stopped prematurely due to the observed results.

Findings support the continued use of SC G-CSF for limiting the duration of neutropenia. Education about the use of G-CSF in the prevention of neutropenia and managing related side effects is important.

To compare the time of first bowel movement (BM) following pelvic reconstructive surgery in patients randomized to placebo or senna with docusate.

Patients were enrolled prior to surgery. After surgery, patients were randomized to either senna with docusate or placebo. Dosing was as follows.

• Take two tablets on the first night postoperation.
• If no BM, take two tablets the following morning.
• If no BM, take three tablets in the evening.
• If no BM the following morning, take three additional tablets twice daily until BM, or take magnesium citrate.

• The study reported on a sample of 93 women.
• Mean patient age was 59.5 years (SD = 12.6) in the senna with docusate group and 56.2 years (SD = 10) in the placebo group.
• The sample comprised patients with nonmalignant gynecologic and genitourinary cancer undergoing pelvic reconstructive surgery. Vaginal parity was 2 in the senna with docusate group (range 0–4) and 3 in the placebo group (range 0–7).

• Single site
• Inpatient
• Hartford Hospital in Connecticut

Patients were undergoing the active treatment phase of care.

This was a randomized, double-blinded, placebo-controlled trial.

• Seven-day bowel diary (baseline)
• Bristol Stool Scale
• Degree of strain and pain (11-point visual analog scale from 0 to 10)
• Medications taken
• Daily diary

• A significant difference existed in time of first BM in the senna with docusate group compared with the placebo group (3 days, SD = 1.5 versus 4 days, SD = 1.5; p < 0.002).
• More patients in the placebo group needed to use magnesium citrate to initiate a BM than in the senna with docusate group (43.6% versus 7%, p < 0.001).

The use of a stool softener with a laxative such as senna with docusate decreases the time to first BM following pelvic reconstructive surgery compared with placebo and lessens the need for use of magnesium citrate.

• The sample size was small (fewer than 100 patients).
• The study lacked an intention-to-treat analysis.

Nurses should be proactive in the management of patients' bowels following reconstructive surgery. Management with medications such as senna with docusate may be an option for patients following this form of surgery.