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The Cochrane Database of Systematic... Nov 2021Neurocysticercosis is the most common parasitic infection of the brain. Epilepsy is the most common clinical presentation, though people may also present with headache,... (Review)
Review
BACKGROUND
Neurocysticercosis is the most common parasitic infection of the brain. Epilepsy is the most common clinical presentation, though people may also present with headache, symptoms of raised intracranial pressure, hydrocephalus, and ocular symptoms depending upon the localisation of the parasitic cysts. Anthelmintic drugs, antiepileptic drugs (AEDs), and anti-oedema drugs, such as steroids, form the mainstay of treatment. This is an updated version of the Cochrane Review previously published in 2019.
OBJECTIVES
To assess the effects (benefits and harms) of AEDs for the primary and secondary prevention of seizures in people with neurocysticercosis. For the question of primary prevention, we examined whether AEDs reduce the likelihood of seizures in people who had neurocysticercosis but had not had a seizure. For the question of secondary prevention, we examined whether AEDs reduce the likelihood of further seizures in people who had had at least one seizure due to neurocysticercosis. As part of primary prevention studies, we also aimed to examine which AED was beneficial in people with neurocysticercosis in terms of duration, dose, and side-effect profile.
SEARCH METHODS
For the 2021 update of this review, we searched the Cochrane Register of Studies (CRS Web), MEDLINE, and LILACS to January 2021. CRS Web includes randomised or quasi-randomised, controlled trials from CENTRAL, the Specialised Registers of Cochrane Review Groups, including Epilepsy, PubMed, Embase, ClinicalTrials.gov, and the World Health Organisation International Clinical Trials Registry Platform. We also checked the reference lists of identified studies, and contacted experts and colleagues in the field to search for additional and ongoing studies.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials. Single-blind, double-blind, or unblinded studies were eligible for inclusion.
DATA COLLECTION AND ANALYSIS
We followed standard methodological procedures expected by Cochrane. Two review authors independently selected trials for inclusion and extracted the relevant data. The primary outcomes of interest were: proportion of individuals experiencing seizures, and time to first seizure post randomisation. Secondary outcomes included: seizure freedom, number of withdrawals, side effects, number of people seizure free with short or long durations of treatment, quality of life, therapy costs, hospitalisations, and mortality. We used an intention-to-treat analysis for the primary analysis. We calculated odds ratio (OR) for dichotomous data (proportion of individuals who experienced seizures, were seizure free for a specific time period (12 or 24 months), withdrew from treatment, developed drug-related side effects or complications, were seizure-free with each treatment policy, mortality), and planned to use mean difference (MD) for continuous data, if any continuous data were identified (quality of life, cost of treatment). We intended to evaluate time to first seizure after randomisation by calculating hazard ratios (HRs). We assessed precision using 95% confidence intervals (CIs). We stratified the analysis by treatment comparison. We also considered the duration of drug usage, co-medications, and the length of follow-up.
MAIN RESULTS
We did not find any trials that investigated the role of AEDs in preventing seizures among people with neurocysticercosis, presenting with symptoms other than seizures. We did not find any trials that directly compared individual AEDs for primary prevention in people with neurocysticercosis. We included four trials that evaluated the efficacy of short-term versus longer-term AED treatment for people with solitary neurocysticercosis (identified on computed tomography (CT) scan) who presented with seizures. In total, 466 people were enrolled. These studies compared AED treatment durations of 6, 12, and 24 months. The risk of seizure recurrence with six months of treatment compared with 12 to 24 months of treatment was inconclusive (odds ratio (OR) 1.34, 95% confidence interval (CI) 0.73 to 2.47; three studies, 360 participants; low-certainty evidence). The risk of seizure recurrence with six to 12 months of treatment compared with 24 months of treatment was inconclusive (OR 1.36, 95% CI 0.72 to 2.57; three studies, 385 participants; very low-certainty evidence). Two studies compared seizure recurrence with CT findings, and suggested that persistent and calcified lesions had a higher recurrence risk, and suggest longer duration of treatment with AEDs. One study reported no side effects, while the rest did not comment on side effects of the drugs. None of the studies addressed the quality of life of the participants. These studies had methodological deficiencies, such as small sample sizes, and a possibility of bias due to lack of blinding, which affect the results of the review.
AUTHORS' CONCLUSIONS
Despite neurocysticercosis being the most common cause of epilepsy worldwide, there is currently no evidence available regarding the use of AEDs as seizure prophylaxis among people presenting with symptoms other than seizures. For those presenting with seizures, there is no reliable evidence regarding the duration of treatment required. Therefore, there is a need for large scale randomised controlled trials to address these questions.
Topics: Anticonvulsants; Humans; Neurocysticercosis; Quality of Life; Randomized Controlled Trials as Topic; Seizures
PubMed: 34723391
DOI: 10.1002/14651858.CD009027.pub4 -
Plastic and Reconstructive Surgery.... Oct 2021A variety of complications after injection of nonpermanent fillers for facial rejuvenation have been reported so far. However, to date, the overall complication rate is...
BACKGROUND
A variety of complications after injection of nonpermanent fillers for facial rejuvenation have been reported so far. However, to date, the overall complication rate is still a matter of debate. The aim of this study was to perform a systematic review of literature to assess the type and severity of associated complications following injections in different anatomical regions of the face.
METHODS
The entire PubMed/Medline database was screened to identify case reports and clinical studies describing complications that have occurred after injection of nonpermanent fillers in the face. These complications have been reviewed and analyzed according to their occurrence in different anatomical regions of the face.
RESULTS
Forty-six articles including a total of 164 patients reported on a total of 436 complications during the time period between January 2003 and February 2020. The majority of the complications were reported after injections to the nose and the nasolabial fold (n = 230), the forehead and the eyebrows (n = 53), and the glabellar region (n = 36). Out of 436 complications, 163 have been classified as severe or permanent including skin necrosis (n = 46), loss of vision (n = 35), or encephalitis (n = 1), whereas 273 complications were classified as mild or transient, such as local edema (n = 74), skin erythema (n = 69), and filler migration (n = 2). The most severe complications were observed in treatments of nose, glabella, and forehead.
CONCLUSIONS
Nonpermanent facial fillers are associated with rare but potentially severe complications. Severity and impact of complications depend on the anatomical region of the face and eventually require profound knowledge of facial anatomy.
PubMed: 34703713
DOI: 10.1097/GOX.0000000000003851 -
Cells Oct 2021The incidence of spinal cord injury (SCI) is ever-growing, resulting in life-changing neurological deficits which can have devastating long-term impacts on a person's... (Meta-Analysis)
Meta-Analysis
The incidence of spinal cord injury (SCI) is ever-growing, resulting in life-changing neurological deficits which can have devastating long-term impacts on a person's quality of life. There is an unmet clinical need for a treatment which will prevent progression of the injury, allowing improved axonal regeneration and functional recovery to occur. The initial mechanical insult, followed by a cascade of secondary mechanisms, leads to the exacerbation and remodelling of the lesion site, thus inhibiting neurological recovery. Oedema rapidly accumulates following SCI and contributes to the detrimental pathophysiology and worsens functional outcomes. This study systematically reviewed the current experimental treatments being explored in the field of SCI, which specifically target oedema. Abiding by PRISMA guidelines and strict inclusion criteria, 14 studies were identified and analysed from three online databases (PubMed, Web of Science and EMBASE). As a result, we identified three key modalities which attenuate oedema: selective inhibition of the main water channel protein, aquaporin 4 (AQP4), modulation of inflammation and surgical interventions. Collectively, however, they all result in the downregulation of AQP4, which crucially leads to a reduction in oedema and improved functional outcomes. We concluded that trifluoperazine (TFP), a calmodulin kinase inhibitor which prevents the cell-surface localisation of AQP4, was the most efficacious treatment, significantly eliminating oedema within 7 days of administration. To date, this study is the most concise analysis of current experimental treatments for oedema, exposing its molecular mechanisms and assessing potential therapeutic pathways for future research.
Topics: Animals; Blood-Brain Barrier; Edema; Humans; Motor Activity; Publication Bias; Rats; Recovery of Function; Risk; Spinal Cord Injuries; Treatment Outcome
PubMed: 34685662
DOI: 10.3390/cells10102682 -
The Cochrane Database of Systematic... Sep 2021Chronic deep venous insufficiency is caused by incompetent vein valves, blockage of large-calibre leg veins, or both; and causes a range of symptoms including recurrent... (Review)
Review
BACKGROUND
Chronic deep venous insufficiency is caused by incompetent vein valves, blockage of large-calibre leg veins, or both; and causes a range of symptoms including recurrent ulcers, pain and swelling. Most surgeons accept that well-fitted graduated compression stockings (GCS) and local care of wounds serve as adequate treatment for most people, but sometimes symptoms are not controlled and ulcers recur frequently, or they do not heal despite compliance with conservative measures. In these situations, in the presence of severe venous dysfunction, surgery has been advocated by some vascular surgeons. This is an update of the review first published in 2000.
OBJECTIVES
To assess the effects of surgical management of deep venous insufficiency on ulcer healing and recurrence, complications of surgery, clinical outcomes, quality of life (QoL) and pain.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases, and the WHO ICTRP and ClinicalTrials.gov trials registries to 23 June 2020.
SELECTION CRITERIA
We considered randomised controlled trials (RCTs) of surgical treatment versus another surgical procedure, usual care or no treatment, for people with deep venous insufficiency.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion, extracted data and assessed the risk of bias with the Cochrane risk of bias tool. We evaluated the certainty of the evidence using GRADE. We were unable to pool data due to differences in outcomes reported and how these were measured. Outcomes of interest were ulcer healing and recurrence, complications of surgery, clinical changes, QoL and pain.
MAIN RESULTS
We included four RCTs (273 participants) comparing valvuloplasty plus surgery of the superficial venous system with surgery of the superficial venous system for primary valvular incompetence. Follow-up was two to 10 years. All included studies investigated primary valve incompetence. No studies investigated other surgical procedures for the treatment of people with deep venous insufficiency or surgery for secondary valvular incompetence or venous obstruction. The certainty of the evidence was downgraded for risk of bias concerns and imprecision due to small numbers of included trials, participants and events. None of the studies reported ulcer healing or ulcer recurrence. One study included 27 participants with active venous ulceration at the time of surgery; the other three studies did not include people with ulcers. There were no major complications of surgery, no incidence of deep vein thrombosis and no deaths reported (very low-certainty evidence). All four studies reported clinical changes but the data could not be pooled due to different outcome measures and reporting of the data. Two studies assessed clinical changes using subjective and objective measurements, as specified in the clinical, aetiological, anatomical and pathophysiological (CEAP) classification score (low-certainty evidence). One study reported mean CEAP severity scores and one study reported change in clinical class using CEAP. At baseline, the mean CEAP severity score was 18.1 (standard deviation (SD) 4.4) for limbs undergoing external valvuloplasty with surgery to the superficial venous system and 17.8 (SD 3.4) for limbs undergoing surgery to the superficial venous system only. At three years post-surgery, the mean CEAP severity score was 5.2 (SD 1.6) for limbs that had undergone external valvuloplasty with surgery to the superficial venous system and 9.2 (SD 2.6) for limbs that had undergone surgery to the superficial venous system only (low-certainty evidence). In another study, participants with progressive clinical dynamics over the five years preceding surgery had higher rates of improvement in clinical condition in the treatment group (valvuloplasty plus ligation) compared with the control group (ligation only) (80% versus 51%) after seven years of follow-up. Participants with stable preoperative clinical dynamics demonstrated similar rates of improvement in both groups (95% with valvuloplasty plus ligation versus 90% with ligation only) (low-certainty evidence). One study reported disease-specific QoL using cumulative scores from a 10-item visual analogue scale (VAS) and reported that in the limited anterior plication (LAP) plus superficial venous surgery group the score decreased from 49 to 11 at 10 years, compared to a decrease from 48 to 36 in participants treated with superficial venous surgery only (very low-certainty evidence). Two studies reported pain. Within the QoL VAS scale, one item was 'pain/discomfort' and scores decreased from 4 to 1 at 10 years for participants in the LAP plus superficial venous surgery group and increased from 2 to 3 at 10 years in participants treated with superficial venous surgery only. A second study reported that 'leg heaviness and pain' was resolved completely in 36/40 limbs treated with femoral vein external valvuloplasty plus high ligation and stripping of the great saphenous vein (GSV) and percutaneous continuous circumsuture and 22/40 limbs treated with high ligation and stripping of GSV and percutaneous continuous circumsuture alone, at three years' follow-up (very low-certainty evidence).
AUTHORS' CONCLUSIONS
We only identified evidence from four RCTs for valvuloplasty plus surgery of the superficial venous system for primary valvular incompetence. We found no studies investigating other surgical procedures for the treatment of people with deep venous insufficiency, or that included participants with secondary valvular incompetence or venous obstruction. None of the studies reported ulcer healing or recurrence, and few studies reported complications of surgery, clinical outcomes, QoL and pain (very low- to low-certainty evidence). Conclusions on the effectiveness of valvuloplasty for deep venous insufficiency cannot be made.
Topics: Edema; Humans; Saphenous Vein; Stockings, Compression; Varicose Ulcer; Venous Insufficiency
PubMed: 34591328
DOI: 10.1002/14651858.CD001097.pub4 -
The role of matrix metalloproteinase-9 and its inhibitor TIMP-1 in burn injury: a systematic review.International Journal of Burns and... 2021Matrix metalloproteinase-9 (MMP-9) and its endogenous inhibitor, tissue inhibitor of metalloproteinase-1 (TIMP-1), are key mediators of acute inflammation and regulators... (Review)
Review
Matrix metalloproteinase-9 (MMP-9) and its endogenous inhibitor, tissue inhibitor of metalloproteinase-1 (TIMP-1), are key mediators of acute inflammation and regulators of the wound healing process. The aim of this systematic review was to determine the local and systemic involvement of the MMP-9/TIMP-1 system following burn injury. Two databases (Scopus and MEDLINE) were searched for all studies reporting MMP-9 and/or TIMP-1 after burn injury. Based on our eligibility criteria, we reviewed 24 studies involving 508 burns patients in 11 clinical studies and 367 animals in 13 preclinical studies. Local, systemic, and peripheral gene expression, protein levels and activity of MMP-9 and TIMP-1 were assessed. Increased MMP-9 was reported at the site of injury early after burn trauma in all studies, and remained elevated in non-healing wounds. Increased TIMP-1 expression in burn wounds occurred later than MMP-9, and was persistent in hypertrophic burn scars. Similar to local expression, systemic MMP-9 and TIMP-1 concentrations were significantly elevated after burn injury in response to upregulation of proinflammatory cytokines. While no association was found between systemic MMP-9 concentration and extent of injury or outcome, serum or plasma TIMP-1 showed good correlation with survival and burn severity. This review also found evidence of the MMP-9/TIMP-1 system contributing to secondary tissue damage distant from the burn site, including burn-associated musculoskeletal damage and acute lung injury. In addition, increased MMP-9 synthesis and activity in the brain after peripheral burn may lead to blood-brain barrier dysfunction and cerebral edema, a significant contributor to mortality. This systematic review provides an overview of the available evidence of the role of MMP-9 and TIMP-1 in burn injury pathophysiology and finds that TIMP-1 may be a promising biomarker in outcome prognostication of burns patients. Large-scale studies of both pediatric and adult burns patients with increased female representation and repeated sampling are recommended to validate the reliability of TIMP-1 as a prognostic marker following burn injury.
PubMed: 34557330
DOI: No ID Found -
Journal of Hand and Microsurgery Jul 2021The purpose of this study was to review and compare clinical outcomes between percutaneous needle fasciotomy (PNF) and collagenase (CCH) injection for the treatment...
The purpose of this study was to review and compare clinical outcomes between percutaneous needle fasciotomy (PNF) and collagenase (CCH) injection for the treatment of Dupuytren's contracture. A systematic review was performed including all level I-III evidence studies investigating the clinical outcomes of PNF and CCH injection in the treatment of Dupuytren's contracture. Five studies (278 CCH patients, 225 PNF patients; 285 CCH fingers, 246 PNF fingers, 405 males, and 98 females) were analyzed. Two randomized studies were level I evidence, one randomized study was level II, and two nonrandomized studies were level III. Two studies analyzed a total of 205 patients, each demonstrating statistically superior outcomes in one outcome measure (contracture improvement and Michigan Hand Questionnaire (MHQ) satisfaction subscore) with PNF, while the remaining three studies demonstrated no significant differences in outcomes between the two techniques. Three studies reported a statistically higher rate of minor complications (local pain, edema, ecchymosis, lymphadenopathy, pruritis) with CCH, while the remaining two studies demonstrated no significant difference in complication rates. For the treatment of Dupuytren's contracture, there is some evidence that suggests superior clinical outcomes of PNF compared with CCH and a higher minor complication rate with CCH.
PubMed: 34511831
DOI: 10.1055/s-0040-1721876 -
Integrative Cancer Therapies 2021Branched-chain amino acids (BCAAs; leucine, isoleucine, and valine) are essential amino acids involved in immune responses, and may have roles in protein malnutrition... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Branched-chain amino acids (BCAAs; leucine, isoleucine, and valine) are essential amino acids involved in immune responses, and may have roles in protein malnutrition and sarcopenia. Furthermore, certain liver diseases have been associated with a decreased Fischer's ratio (BCAAs to aromatic amino acids; phenylalanine, tyrosine, and tryptophan). We aimed to evaluate the safety and efficacy of BCAAs use in patients with cancer undergoing surgery.
METHODS
MEDLINE, Embase, and CENTRAL were searched (inception to July 24, 2020) for randomized controlled trials (RCTs) and comparative observational studies in English evaluating BCAAs (alone or in combinations) during the oncological peri-operative period. Study selection, data extraction, and quality appraisal were done in duplicate. RCT risk-of-bias was appraised using Cochrane Risk-of-Bias tool, and observational studies' quality assessment was conducted with Newcastle-Ottawa Scale. Meta-analyses were conducted when appropriate.
RESULTS
20 articles were included comprising 13 RCTs and 6 observational cohort studies in 7 reports and 2019 total participants overall. Among 13 RCTs, 77% involved liver cancer. Methodological study quality scored substantial risk-of-bias across most RCTs. Meta-analysis of RCTs found a 38% decreased risk of post-operative infections in BCAAs group compared to controls (RR = 0.62; 95% CI = 0.44 to 0.87; = .006; number of RCTs, = 6; total sample size, N = 389; = 0%). BCAAs were also found to be beneficial for ascites (RR = 0.55; 95% CI = 0.35 to 0.86; = .008; = 4; N = 296; = 0%), body weight (MD = 3.24 kg; 95% CI = 0.44 to 6.04; = .02; = 3; N = 196; = 24%), and hospitalization length (MD = -2.07 days; 95% CI = -3.97 to -0.17; = .03; = 5; N = 362; = 59%). No differences were found between BCAAs and controls for mortality, recurrence, other post-operative complications (liver failure, edema, pleural effusion), blood loss, quality of life, ammonia level, and prothrombin time. No serious adverse events were related to BCAAs; however, serious adverse events were reported due to intravenous catheters. No safety concerns from observational studies were identified.
CONCLUSIONS
Branched-chain amino acids during the oncological surgical period demonstrated promise in reducing important post-operative morbidity from infections and ascites compared to controls. Blinded, placebo-controlled confirmatory trials of higher methodological quality are warranted, especially using oral, short-term BCAAs-enriched supplements within the context of recent ERAS programs.
PROSPERO REGISTRATION
CRD42018086168.
Topics: Amino Acids, Branched-Chain; Dietary Supplements; Humans; Neoplasm Recurrence, Local; Postoperative Complications; Quality of Life
PubMed: 33648360
DOI: 10.1177/1534735421997551 -
Frontiers in Neurology 2020As not all ischemic stroke patients benefit from currently available treatments, there is considerable need for neuroprotective co-therapies. Therapeutic hypothermia is...
As not all ischemic stroke patients benefit from currently available treatments, there is considerable need for neuroprotective co-therapies. Therapeutic hypothermia is one such co-therapy, but numerous issues have hampered its clinical use (e.g., pneumonia risk with whole-body cooling). Some problems may be avoided with brain-specific methods, such as intra-arterial selective cooling infusion (IA-SCI) into the arteries supplying the ischemic tissue. Our research question was about the efficacy of IA-SCI in animal middle cerebral artery occlusion models. We hypothesized that IA-SCI would be beneficial, but translationally-relevant study elements may be missing (e.g., aged animals). We completed a systematic review of the PubMed database following the PRISMA guidelines on May 21, 2020 for animal studies that administered IA-SCI in the peri-reperfusion period and assessed infarct volume, behavior (primary meta-analytic endpoints), edema, or blood-brain barrier injury (secondary endpoints). Our search terms included: "focal ischemia" and related terms, "IA-SCI" and related terms, and "animal" and related terms. Nineteen studies met inclusion criteria. We adapted a methodological quality scale from 0 to 12 for experimental design assessment (e.g., use of blinding/randomization, sample size calculations). Studies were relatively homogenous (e.g., all studies used young, healthy animals). Some experimental design elements, such as blinding, were common whereas others, such as sample size calculations, were infrequent (median methodological quality score: 5; range: 2-7). Our analyses revealed that IA-SCI provides benefit on all endpoints (mean normalized infarct volume reduction = 23.67%; 95% CI: 19.21-28.12; mean normalized behavioral improvement = 35.56%; 95% CI: 25.91-45.20; mean standardized edema reduction = 0.95; 95% CI: 0.56-1.34). Unfortunately, blood-brain barrier assessments were uncommon and could not be analyzed. However, there was substantial statistical heterogeneity and relatively few studies. Therefore, exploration of heterogeneity meta-regression using saline infusion parameters, study quality, and ischemic duration was inconclusive. Despite convincing evidence of benefit in ischemic stroke models, additional studies are required to determine the scope of benefit, especially when considering additional elements (e.g., dosing characteristics). As there is interest in using this treatment alongside current ischemic stroke therapies, more relevant animal studies will be critical to inform patient studies.
PubMed: 33488495
DOI: 10.3389/fneur.2020.588479 -
European Annals of Otorhinolaryngology,... May 2021There are emerging reports of the effectiveness of in-office awake vocal-fold corticosteroid injection in the treatment of exudative vocal-fold lesions. The aim of this...
OBJECTIVES
There are emerging reports of the effectiveness of in-office awake vocal-fold corticosteroid injection in the treatment of exudative vocal-fold lesions. The aim of this study was to review this therapy and specify indications, practical modalities and outcomes.
STUDY DESIGN
Systematic review of the literature without meta-analysis.
METHODS
A systematic review by PubMed search for the period January 2000 to December 2018 was carried out.
RESULTS
Nine articles were included, for a total of 502 lesions: nodules (46.4%), polyps (31.7%), and Reinke's edema (21.9%). Submucosal injection of low-dose triamcinolone acetonide (0.1 to 0.3mL) was transoral, transcutaneous or transnasal via flexible endoscope with operating channel. Lesion volume was significantly reduced in more than 90% of cases, with significant vocal improvement in all studies. Relapse rates ranged between 4% and 31%, with time to relapse of 1 to 40 months.
CONCLUSIONS
First-line treatment of exudative glottic lesions by submucosal corticosteroid injection provides at least transient significant reduction in lesion volume and vocal improvement. It is consensually reserved to moderate-sized mainly exudative lesions without fibrosis. In-office injection provides an immediate therapeutic response in case of vocal impairment, enabling surgery under general anesthesia to be postponed.
Topics: Adrenal Cortex Hormones; Humans; Laryngeal Edema; Polyps; Vocal Cords
PubMed: 33191161
DOI: 10.1016/j.anorl.2020.09.001 -
The Cochrane Database of Systematic... Oct 2020Perineal trauma is common during childbirth and may be painful. Contemporary maternity practice includes offering women numerous forms of pain relief, including the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Perineal trauma is common during childbirth and may be painful. Contemporary maternity practice includes offering women numerous forms of pain relief, including the local application of cooling treatments. This Cochrane Review is an update of a review last updated in 2012.
OBJECTIVES
To evaluate the effectiveness of localised cooling treatments compared with no treatment, placebo, or other cooling treatments applied to the perineum for pain relief following perineal trauma sustained during childbirth.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (7 October 2019) and reference lists of retrieved studies.
SELECTION CRITERIA
Published and unpublished randomised and quasi-randomised trials (RCTs) that compared a localised cooling treatment applied to the perineum with no treatment, placebo, or another cooling treatment applied to relieve pain related to perineal trauma sustained during childbirth.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies. Data were double checked for accuracy. The certainty of the evidence was assessed using the GRADE approach.
MAIN RESULTS
We included 10 RCTs that enrolled 1233 women randomised to the use of one cooling treatment (ice, cold gel pad, cooling plus compression, cooling plus compression plus (being) horizontal) compared with another cooling treatment, no treatment, or placebo (water pack, compression). The included trials were at low or uncertain risk of bias overall, with the exception that the inability to blind participants and personnel to group allocation meant that we rated all trials at unclear or high risk for this domain. We undertook a number of comparisons to evaluate the different treatments. Cooling treatment (ice pack or cold gel pad) versus no treatment There was limited very low-certainty evidence that cooling treatment may reduce women's self-reported perineal pain within four to six hours (mean difference (MD) -4.46, 95% confidence interval (CI) -5.07 to -3.85 on a 10-point scale; 1 study, 100 participants) or between 24 and 48 hours of giving birth (risk ratio (RR) 0.73, 95% CI 0.57 to 0.94; 1 study, 316 participants). The evidence is very uncertain about the various measures of wound healing, for example, wound edges gaping when inspected five days after giving birth (RR 2.56, 95% CI 0.58 to 11.33; 1 study, 315 participants). Women generally rated their satisfaction with perineal care similarly following cooling or no treatment. The potential exception was that there may be a trivially lower mean difference of -0.1 on a five-point scale of psychospiritual comfort with cooling treatment, that is unlikely to be of clinical importance. Cooling treatment (cold gel pad) + compression versus placebo (gel pad + compression) There was limited low-certainty evidence that there may be a trivial MD of -0.43 in pain on a 10-point scale at 24 to 48 hours after giving birth (95% CI -0.73 to -0.13; 1 study, 250 participants) when a cooling treatment plus compression from a well-secured perineal pad was compared with the placebo. Levels of perineal oedema may be similar for the two groups (low-certainty evidence) and perineal bruising was not observed. There was low-certainty evidence that women may rate their satisfaction as being slightly higher with perineal care in the cold gel pad and compression group (MD 0.88, 95% CI 0.38 to 1.38; 1 trial, 250 participants). Cooling treatment (ice pack) versus placebo (water pack) One study reported that no women reported pain after using an ice pack or a water pack when asked within 24 hours of giving birth. There was low-certainty evidence that oedema may be similar for the two groups when assessed at four to six hours (RR 0.96, 95% CI 0.50 to 1.86; 1 study, 63 participants) or within 24 hours of giving birth (RR 0.36, 95% CI 0.08 to 1.59). No women were observed to have perineal bruising at these times. The trialists reported that no women in either group experienced any adverse effects on wound healing. There was very low-certainty evidence that women may rate their views and experiences with the treatments similarly (for example, satisfied with treatment: RR 0.91, 95% CI 0.77 to 1.08; 63 participants). Cooling treatment (ice pack) versus cooling treatment (cold gel pad) The evidence is very uncertain about the effects of using ice packs or cold gel pads on women's self-rated perineal pain, on perineal bruising, or on perineal oedema at four to six hours or within 24 hours of giving birth. Perineal oedema may persist 24 to 48 hours after giving birth in women using the ice packs (RR 1.69, 95% CI 1.03 to 2.7; 2 trials, 264 participants; very low-certainty). The risk of gaping wound edges five days after giving birth may be decreased in women who had used ice packs (RR 0.22, 95% CI 0.05 to 1.01; 215 participants; very low-certainty). However, this did not appear to persist to day 10 (RR 3.06, 95% CI 0.63 to 14.81; 214 participants). Women may rate their opinion of treatment less favourably following the use of ice packs five days after giving birth (RR 0.33, 95% CI 0.17 to 0.68; 1 study, 49 participants) and when assessed on day 10 (RR 0.82, 95% CI 0.73 to 0.92; 1 study, 208 participants), both very low-certainty.
AUTHORS' CONCLUSIONS
There is limited very low-certainty evidence that may support the use of cooling treatments, in the form or ice packs or cold gel pads, for the relief of perineal pain in the first two days following childbirth. It is likely that concurrent use of several treatments is required to adequately address this issue, including prescription and non-prescription analgesia. Studies included in this review involved the use of cooling treatments for 10 to 20 minutes, and although no adverse effects were noted, these findings came from studies of relatively small numbers of women, or were not reported at all. The continued lack of high-certainty evidence of the benefits of cooling treatments should be viewed with caution, and further well-designed trials should be conducted.
Topics: Combined Modality Therapy; Episiotomy; Female; Humans; Hypothermia, Induced; Pain Management; Parturition; Perineum; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 33034900
DOI: 10.1002/14651858.CD006304.pub4