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The Cochrane Database of Systematic... 2000Neuroleptic drugs are controversial treatments in dementia, with evidence accumulating that they may hasten clinical decline. Despite these concerns, they are commonly... (Review)
Review
BACKGROUND
Neuroleptic drugs are controversial treatments in dementia, with evidence accumulating that they may hasten clinical decline. Despite these concerns, they are commonly prescribed for elderly and demented patients. Thioridazine, a phenothiazine neuroleptic, is one of the most commonly prescribed. It has often been a preferred agent because it is thought to produce relatively less frequent motor side effects. The drug has significant sedative effects, and it is thought that these are the main mechanism of action in calming and controlling the patient. However, pharmacologically, it also has marked anticholinergic properties that could potentially have a detrimental effect on cognitive function.
OBJECTIVES
To determine the evidence on which the use of thioridazine in dementia is based in terms of: 1) efficacy in controlling symptoms 2) cognitive outcome for the patient 3) safety
SEARCH STRATEGY
The Cochrane Controlled Trials Register and other electronic databases were searched using the terms 'thioridazine', 'melleril', 'dementia' and 'old age'. In addition, Novartis, the pharmaceutical company that developed and markets thioridazine, was approached and asked to release any published or unpublished data they had on file.
SELECTION CRITERIA
Unconfounded, single-blind or double-blind, randomised trials were identified in which treatment with thioridazine was administered for more than one dose and compared to an alternative intervention in patients with dementia of any aetiology. Trials in which allocation to treatment or comparator were not truly random, or in which treatment allocation was not concealed were reviewed but are not included in the data analysis.
DATA COLLECTION AND ANALYSIS
Data were extracted independently by the reviewers (VC, CAK and RJH). For continuous and ordinal variables, the main outcome measures of interest were the final assessment score and the change in score from baseline to the final assessment. The assessment scores were provided by behavioural rating scales, clinical global impression scales, functional assessment scales, psychometric test scores, and frequency and severity of adverse events. Data were pooled where appropriate or possible, and the Peto odds ratio (95%CI) or the weighted mean difference (95%CI) estimated. Where possible, intention to treat data were used.
MAIN RESULTS
The meta-analysis showed that, compared with placebo, thioridazine reduced anxiety symptoms as evidenced by changes on the Hamilton Anxiety Scale. However, there was no significant effect on clinical global change, and a non-significant trend for higher adverse effects with thioridazine. Compared to diazepam, thioridazine was superior in terms of some anxiety symptoms, with similar adverse effects. Global clinical evaluation scales mostly did not favour either treatment. Compared to chlormethiazole, thioridazine was significantly inferior when assessed on some items of the CAPE and the Crichton Geriatric Behavioural Rating Scales. Thioridazine was also associated with significantly more dizziness. No superiority for thioridazine was shown in comparisons with etoperidone, loxapine or zuclopenthixol.
REVIEWER'S CONCLUSIONS
Very limited data are available to support the use of thioridazine in the treatment of dementia. If thioridazine were not currently in widespread clinical use, there would be inadequate evidence to support its introduction. The only positive effect of thioridazine when compared to placebo is the reduction of anxiety. When compared to placebo, other neuroleptics, and other sedatives it has equal or higher rates of adverse effects. Clinicians should be aware that there is no evidence to support the use of thioridazine in dementia, and its use may expose patients to excess side effects.
Topics: Antipsychotic Agents; Dementia; Humans; Thioridazine
PubMed: 10796547
DOI: 10.1002/14651858.CD000464 -
Indian Journal of Psychiatry 2017Published studies have not demonstrated the benefits of the practice of psychotropic PRN administration.
BACKGROUND
Published studies have not demonstrated the benefits of the practice of psychotropic PRN administration.
AIM
The goal of this study is to perform a systematic review on pro re nata (PRN) psychotropic medications administration in children and adolescents and examine the safety and effectiveness of this practice in child and adolescent psychiatric care units.
SETTINGS AND DESIGN
This is a systematic review.
MATERIALS AND METHODS
Several databases were searched till date. One hundred and sixty-five titles and abstracts were found and a total of 14 studies, for which most were retrospective, met the absolute criteria. The patients studied were children, adolescents and patients that presented to the emergency room or admitted as inpatient.
RESULTS
Indications for admission included aggression and agitation for all the studies. Most the medications used include haloperidol, olanzapine, diazepam, and risperidone. Commonly reported adverse effects following the administration of the PRN medications were sleepiness, acute dystonia, and drowsiness. The effectiveness of PRN medications, which was reported in four of reviewed studies, ranged from 30% to 50%.
CONCLUSION
Different effectiveness/outcome measures were used for all the studies; therefore, we could not generalize effectiveness across all the studies. Findings of the reviewed articles show the imperativeness of more research to evaluate the safety and effectiveness of PRN medications among child and adolescent populations.
PubMed: 29085084
DOI: 10.4103/psychiatry.IndianJPsychiatry_34_17 -
The Cochrane Database of Systematic... Oct 2018Gamma aminobutyric acid (GABA) receptor agonists have been shown to have a neuroprotectant effect in reducing infarct size and improving functional outcome in animal... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Gamma aminobutyric acid (GABA) receptor agonists have been shown to have a neuroprotectant effect in reducing infarct size and improving functional outcome in animal models of cerebrovascular disease. However, the sedative effects of GABA receptor agonists have limited their wider application in people with acute stroke, due to the potential risk of stupor. This is an update of a Cochrane Review first published in 2013, and previously updated in 2014 and 2016.
OBJECTIVES
To determine the efficacy and safety of GABA receptor agonists in the treatment of acute stroke.
SEARCH METHODS
We searched the Cochrane Stroke Group Trials Register (accessed May 2018), the Cochrane Central Register of Controlled Trials (CENTRAL) 2018, Issue 4 (accessed May 2018), MEDLINE (from 1949 to May 2018), Embase (from 1980 to May 2018), CINAHL (from 1982 to May 2018), AMED (from 1985 to May 2018), and 11 Chinese databases (accessed May 2018). In an effort to identify further published, unpublished, and ongoing trials we searched ongoing trial registers, reference lists, and relevant conference proceedings, and contacted authors and pharmaceutical companies.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) investigating GABA receptor agonists versus placebo for people with acute stroke (within 12 hours after stroke onset), with the primary outcomes of efficacy and safety.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened the titles and abstracts of identified records, selected studies for inclusion, extracted eligible data, cross-checked the data for accuracy, and assessed the risk of bias. We used the GRADE approach to assess the quality of the evidence.
MAIN RESULTS
We included five trials with 3838 participants (acute ischemic or hemorrhagic stroke patients, 3758 analyzed). Most of the participants recruited had acute ischaemic stroke, with limited data available from participants with other stroke subtypes, including total anterior circulation syndrome (TACS). The methodological quality of the included trials was generally good, with an unclear risk for selection bias only. For death and dependency at three months, pooled results did not find a significant difference for chlormethiazole versus placebo (risk ratio (RR) 1.03, 95% confidence interval (CI) 0.96 to 1.11; four trials; 2909 participants; moderate-quality evidence) and for diazepam versus placebo (RR 0.94, 95% CI 0.82 to 1.07; one trial; 849 participants; moderate-quality evidence). The most frequent adverse events related to chlormethiazole were somnolence (RR 4.56, 95% CI 3.50 to 5.95; two trials; 2527 participants; moderate-quality evidence) and rhinitis (RR 4.75, 95% CI 2.67 to 8.46; two trials; 2527 participants; moderate-quality evidence).
AUTHORS' CONCLUSIONS
This review provides moderate-quality evidence that fails to support the use of GABA receptor agonists (chlormethiazole or diazepam) for the treatment of people with acute stroke. More well-designed RCTs with large samples of participants with total anterior circulation syndrome are required to determine if there are benefits for this subgroup. Somnolence and rhinitis are frequent adverse events related to chlormethiazole.
Topics: Acute Disease; Chlormethiazole; Diazepam; Disorders of Excessive Somnolence; GABA Agonists; Humans; Neuroprotective Agents; Randomized Controlled Trials as Topic; Rhinitis; Stroke; gamma-Aminobutyric Acid
PubMed: 30376593
DOI: 10.1002/14651858.CD009622.pub5 -
Frontiers in Pharmacology 2020Midazolam is recommended by health guidelines for sedation and hypnosis in children. Oral solution is a suitable dosage form for children. But there is no conclusive...
Midazolam is recommended by health guidelines for sedation and hypnosis in children. Oral solution is a suitable dosage form for children. But there is no conclusive evidence for sedative-hypnosis and antianxiety effects by midazolam oral solution in children. Relevant studies were identified through searching PubMed, Embase, Cochrane Library, CINAHL, International Pharmaceuticals, four Chinese electronic databases, and relevant lists. Two reviewers independently selected trials, assessed trial quality, and extracted the data. Eighty-nine randomized controlled trials (RCTs) comparing midazolam oral solution with placebo or blank ( = 33), dexmedetomidine ( = 15), ketamine ( = 11), different midazolam doses ( = 10), midazolam injection ( = 8), chloral hydrate ( = 7), diazepam ( = 5), NO ( = 5), triclofos ( = 4), butorphanol ( = 2), fentanyl ( = 2), hydroxyzine ( = 1), and thiopental ( = 1) were identified. Meta-analysis showed no significant difference in the success rate and duration of sedation and hypnosis between midazolam oral and injectable solution ( > 0.05). The success rate of sedation and hypnosis of midazolam was higher than that of ketamine [risk ratio (RR) = 1.32, 95% CI (1.07, 1.62), = 0%, < 0.01]. No significant difference was found in the success rate of sedation and hypnosis, mask acceptance, and parental separation between midazolam oral solution and dexmedetomidine ( > 0.05), and the result of one cohort study was consistent. The results of RCTs and a prospective cohort study showed that the incidence of adverse drug reactions (ADR) was 19.57% (189/966). Incidence of adverse reactions between dose groups of (0.25, 0.5] and (0.5, 1.0] mg/kg was similar [Pf (95% CI) = 0.10 (0.04, 0.24) and Pf (95% CI) = 0.09 (0.02, 0.39), respectively], higher than that of the dose group of (0, 0.25] mg/kg [Pf (95% CI) = 0.01 (0.00, 0.19)]. Available evidence suggests that midazolam oral solution is as good as midazolam injection and dexmedetomidine and is better than ketamine. Based on efficacy and safety results, an oral midazolam solution dose of 0.5-1 mg/kg is recommended for children.
PubMed: 32256348
DOI: 10.3389/fphar.2020.00225 -
Frontiers in Psychiatry 2023Postictal agitation (PIA) after electroconvulsive therapy (ECT) is a serious clinical problem estimated to occur in 7-36% of patients and recur in 19-54% of patients....
BACKGROUND
Postictal agitation (PIA) after electroconvulsive therapy (ECT) is a serious clinical problem estimated to occur in 7-36% of patients and recur in 19-54% of patients. PIA has the potential to cause dangerous situations for the patient and staff members aside from the financial impact. To date, it is unclear which pharmacological interventions should be used in the management of PIA. This study aimed to systematically review the (preventative) pharmacological treatment options for PIA after ECT.
METHOD
A systematic search was done in PubMed, EMBASE, PsycINFO, and Web of Science from inception until 10 November 2022. We included randomized trials with any pharmacological intervention or comparison and a predefined outcome measure on PIA. Studies that solely included patients with neurodegenerative disorders or stroke were excluded. Data quality was assessed with the RoB2 and GRADE. Meta-analysis was performed if possible. This study was registered on PROSPERO under CRD42021262323.
RESULTS
We screened 2,204 articles and included 14 studies. Dexmedetomidine was investigated in 10 studies. Alfentanil, lignocaine, esmolol, midazolam, propofol, ketamine, haloperidol, and diazepam were each studied in only one study. Meta-analysis revealed an OR of 0.45 (0.32-0.63), a moderate effect size, in favor of dexmedetomidine than placebo to prevent PIA with very low heterogeneity (I = 0%). The certainty of the evidence was moderate. The other interventions studied were all found to have low certainty of evidence.
CONCLUSION
For clinical practice, we believe that our results indicate that dexmedetomidine should be considered for the prevention of PIA in patients that have previously experienced PIA.
PubMed: 37151968
DOI: 10.3389/fpsyt.2023.1170931 -
Journal of Neurology Jul 2022Convulsive status epilepticus is the most severe form of epilepsy and requires urgent treatment. We synthesised the current evidence on first-line treatments for... (Review)
Review
BACKGROUND
Convulsive status epilepticus is the most severe form of epilepsy and requires urgent treatment. We synthesised the current evidence on first-line treatments for controlling seizures in adults with convulsive status epilepticus before, or at, arrival at hospital.
METHODS
We conducted a systematic review of randomised controlled trials (RCTs) assessing antiepileptic drugs offered to adults as first-line treatments. Major electronic databases were searched.
RESULTS
Four RCTs (1234 adults) were included. None were conducted in the UK and none assessed the use of buccal or intranasal midazolam. Both intravenous lorazepam and intravenous diazepam administered by paramedics were more effective than placebo and, notably, intramuscular midazolam was non-inferior to intravenous lorazepam. Overall, median time to seizure cessation from drug administration varied from 2 to 15 min. Rates of respiratory depression among participants receiving active treatments ranged from 6.4 to 10.6%. Mortality ranged from 2 to 7.6% in active treatment groups and 6.2 to 15.5% in control groups.
CONCLUSIONS
Intravenous and intramuscular benzodiazepines are safe and effective in this clinical context. Further research is needed to establish the most clinically and cost-effective first-line treatment and preferable mode of administration. Head-to-head trials comparing buccal versus intranasal midazolam versus rectal diazepam would provide useful information to inform the management of the first stage of convulsive status epilepticus in adults, especially when intravenous or intramuscular access is not feasible. Approaches to improve adherence to clinical guidelines on the use of currently available benzodiazepines for the first-line treatment of convulsive status epilepticus should also be considered.
Topics: Adult; Anticonvulsants; Diazepam; Humans; Lorazepam; Midazolam; Seizures; Status Epilepticus
PubMed: 35094154
DOI: 10.1007/s00415-022-10979-2 -
PloS One 2015To assess the efficacy of midazolam for anxiety control in third molar extraction surgery. (Review)
Review
PURPOSE
To assess the efficacy of midazolam for anxiety control in third molar extraction surgery.
METHODS
Electronic retrievals were conducted in Medline (via PubMed, 1950-2013.12), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 3), Embase (via OVID 1974-2013.12), and the System for Information on Grey Literature in Europe (SIGLE). The bibliographies of relevant clinical trials were also checked. Randomized controlled trials satisfying the inclusion criteria were evaluated, with data extraction done independently by two well-trained investigators. Disagreements were resolved by discussion or by consultation with a third member of the review team.
RESULTS
Ten studies were included, but meta-analysis could not be conducted because of the significant differences among articles. All but one article demonstrated that midazolam could relieve anxiety. One article demonstrated that propofol offered superior anxiolysis, with more rapid recovery than with midazolam. Compared with lorazepam and diazepam, midazolam did not distinctly dominate in its sedative effect, but was safer. Two articles used midazolam in multidrug intravenous sedation and proved it to be more effective than midazolam alone.
CONCLUSION
It was found, by comparison and analysis, that midazolam might be effective for use for anxiety control during third molar extraction and can be safely administered by a dedicated staff member. It can also be used with other drugs to obtain better sedative effects, but the patient's respiratory function must be monitored closely, because multidrug sedation is also more risky.
Topics: Anti-Anxiety Agents; Anxiety; Clinical Trials as Topic; Female; Humans; MEDLINE; Male; Midazolam; Molar; Tooth Extraction
PubMed: 25849859
DOI: 10.1371/journal.pone.0121410 -
The Cochrane Database of Systematic... May 2022Developments in ultrasound assessment of pregnancy has resulted in the increasing diagnosis of antenatal fetal issues. Many structural fetal conditions as well as... (Review)
Review
BACKGROUND
Developments in ultrasound assessment of pregnancy has resulted in the increasing diagnosis of antenatal fetal issues. Many structural fetal conditions as well as complications associated with multiple pregnancies have the potential for in-utero treatment to improve both pregnancy and neonatal outcomes. Procedures such as laser ablation for twin-twin syndrome or cord occlusion for selective fetal termination require fetal immobilisation. Immobilisation of the fetus can occur through administration of medication to the mother or directly to the fetus. This improves procedural success and reduces the ongoing risk to the pregnancy. Evidence regarding the best medication and mode of delivery helps to ensure the optimal decision is made for both the mother and the fetus.
OBJECTIVES
To assess the effects of perioperative pharmacological interventions for fetal immobilisation during fetal surgery and invasive procedures on fetal, neonatal, and maternal outcomes. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (10 May 2021), and reference lists of retrieved studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and quasi-RCTs (including published abstracts) which compared different classes of medication administered to the mother or fetus to allow in-utero procedures to be performed. We also included cluster-randomised trials but excluded cross-over trials.
DATA COLLECTION AND ANALYSIS
We used the standard Cochrane Pregnancy and Childbirth methods for data collection and analysis. Two review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked them for accuracy.
MAIN RESULTS
One study with three trial reports met the inclusion criteria. This involved 54 women with a multiple pregnancy. The study was conducted in a tertiary European hospital maternal-fetal medicine unit and compared remifentanil to diazepam for fetal immobilisation and maternal sedation during fetoscopic surgery. Low-certainty evidence suggested that remifentanil may reduce fetal movement more than diazepam for two outcomes of fetal movement, one of fetal immobilisation at 40 minutes using a visual analogue score (VAS) (where 0 = immobile and 100 = baseline mobility), and one of gross body and limb movements (score was absolute number of movements), both assessed by a sonographer evaluating a taped ultrasound sequence (mean difference (MD) -65.00, 95% confidence interval (CI) -69.38 to -60.62 and MD -10.00, 95% CI -11.62 to -8.38; 1 study, 50 women). Surgeons may also report being more satisfied with the procedure when using remifentanil rather than diazepam (risk ratio (RR) 2.88, 95% CI 1.60 to 5.15; 1 study, 50 women; low-certainty evidence). However, maternal respiratory rate may decrease more during the surgical procedure with remifentanil compared with diazepam (MD -6.00, 95% CI -8.29 to -3.71; 1 study, 50 women; low-certainty evidence). Maternal sedation may also be worse with remifentanil compared with diazepam (RR 0.09, 95% CI 0.01 to 0.65; 1 study, 50 women; low-certainty evidence) measured using an observer assessment of alertness/sedation (where a score of < 4 equates to profound sedation and > 4 equates to insufficient sedation). Perinatal mortality and time taken to perform the procedure were not reported in the trial. We prespecified 20 outcomes and planned to use GRADE for 6 of them, all other outcomes were not able to be reported against for the purpose of meta-analysis due to data not being provided or unable to be interpreted. We assessed the included study at low risk of selection bias (appropriate random sequence generation and allocation concealment), performance bias (blinding of participants and personnel), detection bias (outcome assessors were blinded), attrition bias (incomplete outcome data minimal), and reporting bias. Our GRADE assessment for certainty of the evidence indicates that there is low certainty of the evidence.
AUTHORS' CONCLUSIONS
We were only able to include one study with a small number of women, from a single centre, a European tertiary hospital. This study was published in 2005 with an abstract of this trial published in 2004. This study evaluated two intravenous medications administered to the mother - remifentanil and diazepam. This study reported our prespecified primary outcome but only evaluated several of our secondary outcomes, which limited further assessment. Low-certainty evidence suggested that remifentanil may be better at reducing fetal movements and surgeons were more satisfied with the procedure. However, maternal sedation and depression of breathing may be worse with remifentanil. Further high-quality RCTs assessing both fetal and maternal medications are required to evaluate their efficacy for fetal immobilisation as well as safety for both mother and fetus.
Topics: Diazepam; Female; Fetus; Humans; Infant, Newborn; Perinatal Mortality; Pregnancy; Prenatal Care; Remifentanil
PubMed: 35553414
DOI: 10.1002/14651858.CD011068.pub2 -
BMJ Open Jan 2021It can be challenging to manage patients who are anxious during dental procedures. There is a lack of evidence regarding the effectiveness and safety of oral sedation in...
OBJECTIVES
It can be challenging to manage patients who are anxious during dental procedures. There is a lack of evidence regarding the effectiveness and safety of oral sedation in adults. This study evaluated the effectiveness and safety of oral sedation in patients undergoing dental procedures.
DESIGN
Systematic review.
METHODS
Randomised clinical trials (RCTs) compared the oral use of benzodiazepines and other medications with a placebo or other oral agents in adult patients. A search of the Cochrane (CENTRAL), MEDLINE (via Ovid), EMBASE (via Ovid) and Cumulative Index to Nursing and Allied Health Literature (via Ovid) databases was conducted, without any restrictions on language or date of publication. The primary outcomes included the adverse effects and anxiety level. The secondary outcomes included sedation, satisfaction with the treatment, heart rate, respiratory rate, blood pressure and oxygen saturation. Reviewers, independently and in pairs, assessed each citation for eligibility, performed the data extraction and assessed the risk of bias. A narrative synthesis of the data was provided.
RESULTS
A number of RCTs (n=327 patients) assessed the use of benzodiazepines (n=9) and herbal medicines (n=3). We found good satisfaction with treatment after the use of midazolam 7.5 mg or clonidine 150 µg and reduced anxiety with alprazolam (0.5 and 0.75 mg). Midazolam 15 mg promoted greater anxiety reduction than L. 260 mg, while 100 mg and 500 mg were more effective than a placebo. More patients reported adverse effects with midazolam 15 mg. Diazepam 15 mg and 100 mg promoted less change in the heart rate and blood pressure than a placebo.
CONCLUSIONS
Given the limitations of the findings due to the quality of the included studies and the different comparisons made between interventions, further RCTs are required to confirm the effectiveness and safety of oral sedation in dentistry.
PROSPERO REGISTRATION NUMBER
CRD42017057142.
Topics: Adult; Alprazolam; Anesthesia; Benzodiazepines; Diazepam; Humans; Midazolam
PubMed: 33495257
DOI: 10.1136/bmjopen-2020-043363 -
The Cochrane Database of Systematic... Mar 2014Biofeedback therapy has been used to treat the symptoms of people with chronic constipation referred to specialist services within secondary and tertiary care settings.... (Review)
Review
BACKGROUND
Biofeedback therapy has been used to treat the symptoms of people with chronic constipation referred to specialist services within secondary and tertiary care settings. However, different methods of biofeedback are used within different centres and the magnitude of suggested benefits and comparable effectiveness of different methods of biofeedback has yet to be established.
OBJECTIVES
To determine the efficacy and safety of biofeedback for the treatment of chronic idiopathic (functional) constipation in adults.
SEARCH METHODS
We searched the following databases from inception to 16 December 2013: CENTRAL, the Cochrane Complementary Medicine Field, the Cochrane IBD/FBD Review Group Specialized Register, MEDLINE, EMBASE, CINAHL, British Nursing Index, and PsychINFO. Hand searching of conference proceedings and the reference lists of relevant articles was also undertaken.
SELECTION CRITERIA
All randomised trials evaluating biofeedback in adults with chronic idiopathic constipation were considered for inclusion.
DATA COLLECTION AND ANALYSIS
The primary outcome was global or clinical improvement as defined by the included studies. Secondary outcomes included quality of life, and adverse events as defined by the included studies. Where possible, we calculated the risk ratio (RR) and corresponding 95% confidence interval (CI) for dichotomous outcomes and the mean difference (MD) and 95% CI for continuous outcomes. We assessed the methodological quality of included studies using the Cochrane risk of bias tool. The overall quality of the evidence supporting each outcome was assessed using the GRADE criteria.
MAIN RESULTS
Seventeen eligible studies were identified with a total of 931 participants. Most participants had chronic constipation and dyssynergic defecation. Sixteen of the trials were at high risk of bias for blinding. Attrition bias (4 trials) and other potential bias (5 trials) was also noted. Due to differences between study populations, the heterogeneity of the different samples and large range of different outcome measures, meta-analysis was not possible. Different effect sizes were reported ranging from 40 to 100% of patients who received biofeedback improving following the intervention. While electromyograph (EMG) biofeedback was the most commonly used, there is a lack of evidence as to whether any one method of biofeedback is more effective than any other method of biofeedback. We found low or very low quality evidence that biofeedback is superior to oral diazepam, sham biofeedback and laxatives. One study (n = 60) found EMG biofeedback to be superior to oral diazepam. Seventy per cent (21/30) of biofeedback patients had improved constipation at three month follow-up compared to 23% (7/30) of diazepam patients (RR 3.00, 95% CI 1.51 to 5.98). One study compared manometry biofeedback to sham biofeedback or standard therapy consisting of diet, exercise and laxatives. The mean number of complete spontaneous bowel movements (CSBM) per week at three months was 4.6 in the biofeedback group compared to 2.8 in the sham biofeedback group (MD 1.80, 95% CI 1.25 to 2.35; 52 patients). The mean number of CSBM per week at three months was 4.6 in the biofeedback group compared to 1.9 in the standard care group (MD 2.70, 95% CI 1.99 to 3.41; 49 patients). Another study (n = 109) compared EMG biofeedback to conventional treatment with laxatives and dietary and lifestyle advice. This study found that at both 6 and 12 months 80% (43/54) of biofeedback patients reported clinical improvement compared to 22% (12/55) laxative-treated patients (RR 3.65, 95% CI 2.17 to 6.13). Some surgical procedures (partial division of puborectalis and stapled transanal rectal resection (STARR)) were reported to be superior to biofeedback, although with a high risk of adverse events in the surgical groups (wound infection, faecal incontinence, pain, and bleeding that required further surgical intervention). Successful treatment, defined as a decrease in the obstructed defecation score of > 50% at one year was reported in 33% (3/39) of EMG biofeedback patients compared to 82% (44/54) of STARR patients (RR 0.41, 95% CI 0.26 to 0.65). For the other study the mean constipation score at one year was 16.1 in the balloon sensory biofeedback group compared to 10.5 in the partial division of puborectalis surgery group (MD 5.60, 95% CI 4.67 to 6.53; 40 patients). Another study (n = 60) found no significant difference in efficacy did not demonstrate the superiority of a surgical intervention (posterior myomectomy of internal anal sphincter and puborectalis) over biofeedback. Conflicting results were found regarding the comparative effectiveness of biofeedback and botulinum toxin-A. One small study (48 participants) suggested that botulinum toxin-A injection may have short term benefits over biofeedback, but the relative effects of treatments were uncertain at one year follow-up. No adverse events were reported for biofeedback, although this was not specifically reported in the majority of studies. The results of all of these studies need to be interpreted with caution as GRADE analyses rated the overall quality of the evidence for the primary outcomes (i.e. clinical or global improvement as defined by the studies) as low or very low due to high risk of bias (i.e. open label studies, self-selection bias, incomplete outcome data, and baseline imbalance) and imprecision (i.e. sparse data).
AUTHORS' CONCLUSIONS
Currently there is insufficient evidence to allow any firm conclusions regarding the efficacy and safety of biofeedback for the management of people with chronic constipation. We found low or very low quality evidence from single studies to support the effectiveness of biofeedback for the management of people with chronic constipation and dyssynergic defecation. However, the majority of trials are of poor methodological quality and subject to bias. Further well-designed randomised controlled trials with adequate sample sizes, validated outcome measures (especially patient reported outcome measures) and long-term follow-up are required to allow definitive conclusions to be drawn.
Topics: Adult; Botulinum Toxins, Type A; Chronic Disease; Constipation; Diazepam; Feedback, Physiological; Humans; Laxatives; Muscle Relaxants, Central; Neurofeedback; Neuromuscular Agents; Randomized Controlled Trials as Topic
PubMed: 24668156
DOI: 10.1002/14651858.CD008486.pub2