quality of life

Conservative interventions for treating urinary incontinence in women: an Overview of Cochrane systematic reviews

Author/s: 
Todhunter-Brown, A., Hazelton, ,C., Campbell, P., Elders, A., Hagen, S., McClurg, D.

Background: Urinary incontinence (UI) is the involuntary loss of urine and can be caused by several different conditions. The common types of UI are stress (SUI), urgency (UUI) and mixed (MUI). A wide range of interventions can be delivered to reduce the symptoms of UI in women. Conservative interventions are generally recommended as the first line of treatment.

Objectives: To summarise Cochrane Reviews that assessed the effects of conservative interventions for treating UI in women.

Methods: We searched the Cochrane Library to January 2021 (CDSR; 2021, Issue 1) and included any Cochrane Review that included studies with women aged 18 years or older with a clinical diagnosis of SUI, UUI or MUI, and investigating a conservative intervention aimed at improving or curing UI. We included reviews that compared a conservative intervention with 'control' (which included placebo, no treatment or usual care), another conservative intervention or another active, but non-conservative, intervention. A stakeholder group informed the selection and synthesis of evidence. Two overview authors independently applied the inclusion criteria, extracted data and judged review quality, resolving disagreements through discussion. Primary outcomes of interest were patient-reported cure or improvement and condition-specific quality of life. We judged the risk of bias in included reviews using the ROBIS tool. We judged the certainty of evidence within the reviews based on the GRADE approach. Evidence relating to SUI, UUI or all types of UI combined (AUI) were synthesised separately. The AUI group included evidence relating to participants with MUI, as well as from studies that combined women with different diagnoses (i.e. SUI, UUI and MUI) and studies in which the type of UI was unclear.

Main results: We included 29 relevant Cochrane Reviews. Seven focused on physical therapies; five on education, behavioural and lifestyle advice; one on mechanical devices; one on acupuncture and one on yoga. Fourteen focused on non-conservative interventions but had a comparison with a conservative intervention. No reviews synthesised evidence relating to psychological therapies. There were 112 unique trials (including 8975 women) that had primary outcome data included in at least one analysis. Stress urinary incontinence (14 reviews) Conservative intervention versus control: there was moderate or high certainty evidence that pelvic floor muscle training (PFMT), PFMT plus biofeedback and cones were more beneficial than control for curing or improving UI. PFMT and intravaginal devices improved quality of life compared to control. One conservative intervention versus another conservative intervention: for cure and improvement of UI, there was moderate or high certainty evidence that: continence pessary plus PFMT was more beneficial than continence pessary alone; PFMT plus educational intervention was more beneficial than cones; more-intensive PFMT was more beneficial than less-intensive PFMT; and PFMT plus an adherence strategy was more beneficial than PFMT alone. There was no moderate or high certainty evidence for quality of life. Urgency urinary incontinence (five reviews) Conservative intervention versus control: there was moderate to high-certainty evidence demonstrating that PFMT plus feedback, PFMT plus biofeedback, electrical stimulation and bladder training were more beneficial than control for curing or improving UI. Women using electrical stimulation plus PFMT had higher quality of life than women in the control group. One conservative intervention versus another conservative intervention: for cure or improvement, there was moderate certainty evidence that electrical stimulation was more effective than laseropuncture. There was high or moderate certainty evidence that PFMT resulted in higher quality of life than electrical stimulation and electrical stimulation plus PFMT resulted in better cure or improvement and higher quality of life than PFMT alone. All types of urinary incontinence (13 reviews) Conservative intervention versus control: there was moderate to high certainty evidence of better cure or improvement with PFMT, electrical stimulation, weight loss and cones compared to control. There was moderate certainty evidence of improved quality of life with PFMT compared to control. One conservative intervention versus another conservative intervention: there was moderate or high certainty evidence of better cure or improvement for PFMT with bladder training than bladder training alone. Likewise, PFMT with more individual health professional supervision was more effective than less contact/supervision and more-intensive PFMT was more beneficial than less-intensive PFMT. There was moderate certainty evidence that PFMT plus bladder training resulted in higher quality of life than bladder training alone.

Authors' conclusions: There is high certainty that PFMT is more beneficial than control for all types of UI for outcomes of cure or improvement and quality of life. We are moderately certain that, if PFMT is more intense, more frequent, with individual supervision, with/without combined with behavioural interventions with/without an adherence strategy, effectiveness is improved. We are highly certain that, for cure or improvement, cones are more beneficial than control (but not PFMT) for women with SUI, electrical stimulation is beneficial for women with UUI, and weight loss results in more cure and improvement than control for women with AUI. Most evidence within the included Cochrane Reviews is of low certainty. It is important that future new and updated Cochrane Reviews develop questions that are more clinically useful, avoid multiple overlapping reviews and consult women with UI to further identify outcomes of importance.

Acupuncture Treatment for Symptom Management in Atopic Dermatitis: A Study Protocol for a Randomized, Participant- and Assessor-Blind, Sham-Controlled Trial

Author/s: 
Park. J. G., Park, H.J., Chae, Y., Kim, Y., Lee, H., Kim, K.

Atopic dermatitis (AD) is a chronic inflammatory skin disease with persistent itching, which impairs quality of life (QoL). Although various conventional treatments for AD exist, patients with AD often seek complementary and alternative therapies when conventional therapy has failed to relieve their AD symptoms or has had adverse effects. Acupuncture treatment may relieve AD symptoms, but controlled trials are needed to confirm this. Following our pilot study, which found that acupuncture treatment improves AD symptoms in mild-to-moderate AD patients, we will assess the effect of acupuncture treatment for symptom relief of AD using a trial with a complemented protocol. This is a two-arm, randomized, participant- and assessor-blinded, sham-controlled trial. A total of 36 mild-to-moderate AD patients will be randomly assigned in a 1:1 ratio to receive eight sessions twice weekly of either verum acupuncture (VA) or nonpenetrating sham acupuncture (SA) over four weeks. The primary outcome measured will be the change in the total Scoring Atopic Dermatitis (SCORAD) score. Secondary outcomes will be (1) changes in AD symptoms, QoL, dyspepsia symptoms, and electroencephalography (EEG) between baseline and week 4 and (2) changes in AD symptoms and QoL at baseline and at weeks 2, 4, and 8. This study will assess acupuncture treatment for the alleviation of AD symptoms in patients with mild-to-moderate AD. This clinical trial gas been registered in Korean Clinical Trial Registry (registration number: KCT0002796; date of registration: April 13, 2018).

Association of Therapies With Reduced Pain and Improved Quality of Life in Patients With Fibromyalgia: A Systematic Review and Meta-analysis

Author/s: 
Mascarenhas, Rodrigo O., Souza, Mateus B., Oliveira, Murilo X., Lacerda, Ana C., Mendonca, Vanessa A., Henschke, Nicholas, Oliveira, Vinicius C.

Importance: Fibromyalgia is a chronic condition that results in a significant burden to individuals and society.

Objective: To investigate the effectiveness of therapies for reducing pain and improving quality of life (QOL) in people with fibromyalgia.

Data sources: Searches were performed in the MEDLINE, Cochrane, Embase, AMED, PsycInfo, and PEDro databases without language or date restrictions on December 11, 2018, and updated on July 15, 2020.

Study selection: All published randomized or quasi-randomized clinical trials that investigated therapies for individuals with fibromyalgia were screened for inclusion.

Data extraction and synthesis: Two reviewers independently extracted data and assessed risk of bias using the 0 to 10 PEDro scale. Effect sizes for specific therapies were pooled using random-effects models. The quality of evidence was assessed using the Grading of Recommendations Assessment (GRADE) approach.

Main outcomes and measures: Pain intensity measured by the visual analog scale, numerical rating scales, and other valid instruments and QOL measured by the Fibromyalgia Impact Questionnaire.

Results: A total of 224 trials including 29 962 participants were included. High-quality evidence was found in favor of cognitive behavioral therapy (weighted mean difference [WMD], -0.9; 95% CI, -1.4 to -0.3) for pain in the short term and was found in favor of central nervous system depressants (WMD, -1.2 [95% CI, -1.6 to -0.8]) and antidepressants (WMD, -0.5 [95% CI, -0.7 to -0.4]) for pain in the medium term. There was also high-quality evidence in favor of antidepressants (WMD, -6.8 [95% CI, -8.5 to -5.2]) for QOL in the short term and in favor of central nervous system depressants (WMD, -8.7 [95% CI, -11.3 to -6.0]) and antidepressants (WMD, -3.5 [95% CI, -4.5 to -2.5]) in the medium term. However, these associations were small and did not exceed the minimum clinically important change (2 points on an 11-point scale for pain and 14 points on a 101-point scale for QOL). Evidence for long-term outcomes of interventions was lacking.

Conclusions and relevance: This systematic review and meta-analysis suggests that most of the currently available therapies for the management of fibromyalgia are not supported by high-quality evidence. Some therapies may reduce pain and improve QOL in the short to medium term, although the effect size of the associations might not be clinically important to patients.

Screening for Anxiety in Adolescent and Adult Women: A Recommendation From the Women's Preventive Services Initiative

Author/s: 
Gregory, K.D., Chelmow, C., Nelson, H.D., Sayres Van Niel, M., Conry, J.A., Garcia, F., Kendig, S.M., O'Reilly, N., Qaseem, A., Ramos, D., Salganicoff , A., Son, S., Wood, J.K, Zahn, C.

Abstract

Description: The Women's Preventive Services Initiative (WPSI), a national coalition of women's health professional organizations and patient representatives, developed a recommendation on screening for anxiety in adolescent and adult women to improve detection; achieve earlier diagnosis and treatment; and improve health, function, and well-being. The WPSI's recommendations are intended to guide clinical practice and coverage of services for the Health Resources and Services Administration and other stakeholders. The target audience for this recommendation includes all clinicians providing preventive health care to women, particularly in primary care settings. This recommendation applies to women and adolescent girls aged 13 years or older who are not currently diagnosed with anxiety disorders, including pregnant and postpartum women.

Methods: The WPSI developed this recommendation after evaluating results of a systematic review of the effectiveness of screening, accuracy of screening instruments, and benefits and harms of treatments in adolescent girls and adult women. No studies directly evaluated the overall effectiveness or harms of screening for anxiety. Twenty-seven screening instruments and their variations were moderately to highly accurate in identifying anxiety (33 individual studies and 2 systematic reviews; 171 studies total). Symptoms improved and relapse rates decreased with psychological therapies (246 randomized controlled trials [RCTs] in 5 systematic reviews) and with selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors (126 RCTs in 3 systematic reviews). The WPSI also considered the effect of screening on symptom progression and identification of associated and underlying conditions, as well as implementation factors.

Recommendation: The WPSI recommends screening for anxiety in women and adolescent girls aged 13 years or older who are not currently diagnosed with anxiety disorders, including pregnant and postpartum women. Optimal screening intervals are unknown, and clinical judgment should be used to determine frequency. When screening suggests the presence of anxiety, further evaluation is necessary to establish the diagnosis and determine appropriate treatment and follow-up.

Keywords: Adolescents; Anxiety; Anxiety disorders; Forecasting; Health services administration and management; Quality of life; Questionnaires; Reuptake inhibitors; Serotonin; Systematic reviews.

Ginger Extract Versus Loratadine in the Treatment of Allergic Rhinitis: A Randomized Controlled Trial

Author/s: 
Yamprasert, R., Chanvimalueng, W., Mukkasombut, N., Itharat, A.

Background: Allergic rhinitis (AR) is a non-infectious immune disease and incidents of the disease has continuously increased in Thailand. Ginger, a Thai herb, is used in food and Thai traditional medicine. This study was designed to assess efficacy and safety of ginger extract in comparison with loratadine for AR treatment.

Methods: AR patients were treated with ginger extract 500 mg (n = 40) against those treated with loratadine 10 mg (n = 40) in a randomized, double-blind, controlled trial for 3 and 6 weeks. The efficacy was evaluated from clinical examinations i.e. total nasal symptom scores (TNSS), cross-sectional area of the nasal cavity with acoustic rhinometry (ARM) and rhinoconjunctivitis quality of life questionnaire (RQLQ). The safety of treatment was measured by blood pressure, blood analysis and history-taking for side effects.

Results: The results showed both ginger extract and loratadine treated groups significantly decreased TNSS scores but there was no significant difference between the two groups. In acoustic rhinometry measurement, the ginger treated group significantly gradually increased the estimated volume of the nasal cavity and decreased distances from the nostril, but the loratadine treated group did not cause a change. Both groups gave significantly improvement in every aspect of the RQLQ at third weeks. The treatment with ginger extract was as safe as loratadine as shown by renal and liver function results obtained from blood analysis. Both treatments had no effect on blood pressure of the patients.

Conclusions: The ginger extract is as good as loratadine in improving nasal symptoms and quality of life in AR patients. However, ginger extract caused less side effects especially, drowsiness, fatigue, dizziness and constipation. Therefore, the ginger extract could be used as alternative treatment for patients with AR.

Trial registration: Registered with ClinicalTrials.gov (Registration number: NCT02576808) on 15 October 2015.

Keywords: Allergic rhinitis; Clinical trials; Ginger extract; Loratadine; Quality of life.

How Will Treating My Early-Stage Prostate Cancer Affect My Quality of Life?

Author/s: 
Patient-Centered Outcomes Research Institute

Early-stage prostate cancer can be treated in different ways. The three main ways are active surveillance, surgery, and radiotherapy. Active surveillance means having your prostate checked every few months to make sure the cancer is not spreading. Surgery would take out the prostate, and radiotherapy uses high-energy rays to kill cancer cells in the prostate.

Two recent PCORI-funded studies compare the effects of these choices on the quality of life for men with early-stage prostate cancer. These studies looked at three effects treatment might have on a man’s quality of life. These are problems having sex, urinary problems, and bowel problems.

Current Treatments for Localized Prostate Cancer and Symptom-Related Quality of Life

Author/s: 
Patient-Centered Outcomes Research Institute

Given the evidence of high 5- and 10-year survivorship rates for localized prostate cancer, the effect of treatment on symptom-related quality of life is an important consideration for men choosing among available treatment options. Two PCORI-funded studies published in the March 21, 2017 issue of JAMA compare the impact of current treatments on symptom-related quality of life for men with localized prostate cancer. Quality of life scores refer to symptoms, how much men were bothered by symptoms, or a combination of the two. The studies looked at observed outcomes from a combined total of 3,600 men for periods of two and three years following treatment. This evidence offers information that can help patients make treatment decisions.

Abnormal Uterine Bleeding in Reproductive-Age Women

Author/s: 
Kaunitz, Andrew M.

Abnormal uterine bleeding (AUB) in reproductive-age women (defined as abnormal in duration, quantity, or timing) is experienced by approximtely one-third of all women throughout their lifetime, impairs quality of life, and can be effectively managed medically in most cases.1

To minimize confusion associated with previously used terms including menorrhagia and meno-metrorrhagia, the International Federation of Gynecology and Obstetrics introduced updated terminology for AUB in nonpregnant women in 2011. Heavy menstrual bleeding (HMB) refers to ovulatory (cyclic) bleeding exceeding 8 days’ duration or heavy enough to interfere with a woman’s quality of life, a pattern of AUB distinct from the irregular bleeding associated with ovulatory dysfunction (AUB-O).1

How Will Treating My Early-Stage Prostate Cancer Affect My Quality of Life?

Early-stage prostate cancer can be treated in different ways. The three main ways are active surveillance, surgery, and radiotherapy. Active surveillance means having your prostate checked every few months to make sure the cancer is not spreading. Surgery would take out the prostate, and radiotherapy uses high-energy rays to kill cancer cells in the prostate.

Two recent PCORI-funded studies compare the effects of these choices on the quality of life for men with early stage prostate cancer. These studies looked at three effects treatment might have on a man’s quality of life. These are problems having sex, urinary problems, and bowel problems.

Glucose Self-monitoring in Non–Insulin-Treated Patients With Type 2 Diabetes in Primary Care Settings

Author/s: 
Young, Laura A., Buse, John B., Weaver, Mark A., Vu, Maihan B., Mitchell, C. Madeline, Blakeney, Tamara, Grimm, Kimberlea, Rees, Jennifer, Niblock, Franklin, Donahue, Katrina E.

IMPORTANCE:

The value of self-monitoring of blood glucose (SMBG) levels in patients with non-insulin-treated type 2 diabetes has been debated.

OBJECTIVE:

To compare 3 approaches of SMBG for effects on hemoglobin A1c levels and health-related quality of life (HRQOL) among people with non-insulin-treated type 2 diabetes in primary care practice.

DESIGN, SETTING, AND PARTICIPANTS:

The Monitor Trial study was a pragmatic, open-label randomized trial conducted in 15 primary care practices in central North Carolina. Participants were randomized between January 2014 and July 2015. Eligible patients with type 2 non-insulin-treated diabetes were: older than 30 years, established with a primary care physician at a participating practice, had glycemic control (hemoglobin A1c) levels higher than 6.5% but lower than 9.5% within the 6 months preceding screening, as obtained from the electronic medical record, and willing to comply with the results of random assignment into a study group. Of the 1032 assessed for eligibility, 450 were randomized.

INTERVENTIONS:

No SMBG, once-daily SMBG, and once-daily SMBG with enhanced patient feedback including automatic tailored messages delivered via the meter.

MAIN OUTCOMES AND MEASURES:

Coprimary outcomes included hemoglobin A1c levels and HRQOL at 52 weeks.

RESULTS:

A total of 450 patients were randomized and 418 (92.9%) completed the final visit. There were no significant differences in hemoglobin A1c levels across all 3 groups (P = .74; estimated adjusted mean hemoglobin A1c difference, SMBG with messaging vs no SMBG, -0.09%; 95% CI, -0.31% to 0.14%; SMBG vs no SMBG, -0.05%; 95% CI, -0.27% to 0.17%). There were also no significant differences found in HRQOL. There were no notable differences in key adverse events including hypoglycemia frequency, health care utilization, or insulin initiation.

CONCLUSIONS AND RELEVANCE:

In patients with non-insulin-treated type 2 diabetes, we observed no clinically or statistically significant differences at 1 year in glycemic control or HRQOL between patients who performed SMBG compared with those who did not perform SMBG. The addition of this type of tailored feedback provided through messaging via a meter did not provide any advantage in glycemic control.

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