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The Cochrane Database of Systematic... Jul 2015At December 2014, this review has been withdrawn from the Cochrane Library. This review is out of date, although it is correct at the date of publication. The review may... (Meta-Analysis)
Meta-Analysis Review
At December 2014, this review has been withdrawn from the Cochrane Library. This review is out of date, although it is correct at the date of publication. The review may be misleading as new studies could alter the original conclusions. All previous versions of the review can be found in the ‘Other versions’ tab. We are seeking additional authors to support the updating of this review. For further information, please contact PaPaS Managing Editor, Anna Hobson [Contact Person]. The editorial group responsible for this previously published document have withdrawn it from publication.
Topics: Acute Disease; Adolescent; Anti-Inflammatory Agents, Non-Steroidal; Child; Diclofenac; Humans; Pain; Pain Measurement; Pain, Postoperative; Randomized Controlled Trials as Topic
PubMed: 26134060
DOI: 10.1002/14651858.CD005538.pub3 -
Plastic and Reconstructive Surgery.... Nov 2021Pain and discomfort are frequently experienced following mastectomy with concomitant breast implant- or tissue expander-based alloplastic breast reconstruction (AlBR)....
INTRODUCTION
Pain and discomfort are frequently experienced following mastectomy with concomitant breast implant- or tissue expander-based alloplastic breast reconstruction (AlBR). Unfortunately, postoperative opioids have decreased efficacy in AlBR, short-term complication profiles, and are fraught by long-term dependence. This systematic review aims to identify opioid-sparing pain management strategies in AlBR.
METHODS
A systematic literature search of MEDLINE, Embase, Web of Science, and Cochrane Central Register was performed in September 2018. PRISMA guidelines were followed, and the review was prospectively registered in PROSPERO (CRD42018107911). The search identified 1184 articles. Inclusion criteria were defined as patients 18 years or older undergoing AlBR.
RESULTS
Fourteen articles were identified assessing opioid-sparing strategies in AlBR. This literature included articles evaluating enhanced recovery protocols (two), intercostal blocks (two), paravertebral blocks (four), liposomal bupivacaine (three), diclofenac (one), and local anesthesia infusion pumps (two). The literature included five randomized trials and nine cohort studies. Study characteristics, bias (low to high risk), and reporting outcomes were extensively heterogeneous between articles. Qualitative analysis suggests reduced opioid utilization in enhanced recovery after surgery (ERAS) pathways, paravertebral blocks, and use of liposomal bupivacaine.
CONCLUSIONS
A variety of opioid-sparing strategies are described for pain management in AlBR. Multimodal analgesia should be provided via ERAS pathways as they appear to reduce pain and spare opioid use. Targeted paravertebral blocks and liposomal bupivacaine field blocks appear to be beneficial in sparing opioids and should be considered as essential components of ERAS protocols. Additional prospective, randomized trials are necessary to delineate the efficacy of other studied modalities.
PubMed: 34796086
DOI: 10.1097/GOX.0000000000003932 -
BMJ Open Sep 2020To assess the comparative efficacy of traditional non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclo-oxygenase-2 inhibitors in patients with acute gout. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To assess the comparative efficacy of traditional non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclo-oxygenase-2 inhibitors in patients with acute gout.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
Medline, Web of Science, China National Knowledge Infrastructure and Wanfang Data published as of 4 April 2020.
METHODS
We performed meta-analysis of randomised controlled trials (RCTs) of traditional non-selective NSAIDs versus cyclo-oxygenase-2 inhibitors and RCTs of various cyclo-oxygenase-2 inhibitors in patients with acute gout. The main outcome measures were mean change in pain Visual Analogue Scale (VAS) score and 5-point Likert scale score on days 2-8.
RESULTS
Twenty-four trials involving five drugs were evaluated. For pain Likert scale, etoricoxib was comparable to indomethacin (standardised mean difference (SMD): -0.09, 95% CI: -0.27 to 0.08) but better than diclofenac 50 mg three times a day (SMD: -0.53, 95% CI: -0.98 to 0.09). Regarding pain VAS score, etoricoxib was comparable to diclofenac 75 mg two times per day (SMD: -1.63, 95% CI: -4.60 to 1.34) and diclofenac 75 mg four times a day (SMD: -1.82, 95% CI: -5.18 to 1.53), while celecoxib was comparable to diclofenac 100 mg four times a day (SMD: -2.41, 95% CI: -5.91 to 1.09). Etoricoxib showed similar patients' global assessment of response (SMD: -0.10, 95% CI: -0.27 to 0.07) and swollen joint count (SMD: -0.25, 95% CI: -0.74 to 0.24), but better investigator's global assessment of response (SMD: -0.29, 95% CI: -0.46 to 0.11) compared with indomethacin. Etoricoxib showed more favourable pain VAS score than celecoxib (SMD: -2.36, 95% CI: -3.36 to 1.37), but was comparable to meloxicam (SMD: -4.02, 95% CI: -10.28 to 2.24). Etoricoxib showed more favourable pain Likert scale than meloxicam (SMD: -0.56, 95% CI: -1.10 to 0.02). Etoricoxib 120 mg four times a day was more likely to achieve clinical improvement than celecoxib 200 mg two times per day (OR: 4.84, 95% CI: 2.19 to 10.72).
CONCLUSION
Although cyclo-oxygenase-2 inhibitors and traditional non-selective NSAIDs may be equally beneficial in terms of pain relief, cyclo-oxygenase-2 inhibitors (especially etoricoxib) may confer a greater benefit.
Topics: Anti-Inflammatory Agents, Non-Steroidal; China; Diclofenac; Etoricoxib; Gout; Humans
PubMed: 32912981
DOI: 10.1136/bmjopen-2019-036748 -
Cureus Jan 2024The objective of this systematic review was to assess the effectiveness, acceptability, and safety of systemic enzyme therapy, consisting of trypsin, bromelain, and... (Review)
Review
The objective of this systematic review was to assess the effectiveness, acceptability, and safety of systemic enzyme therapy, consisting of trypsin, bromelain, and rutoside trihydrate, as an anti-inflammatory agent, either when utilized independently or in conjunction with non-steroidal anti-inflammatory drugs (NSAIDs). This systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Two studies met the inclusion criteria and were assessed in the review. The bias risk was evaluated using the risk-of-bias tool for randomized trials (RoB 2). Both studies revealed highly significant results for the study population. Individuals receiving oral enzymes and diclofenac sodium combination therapy showed a significant improvement in pain reduction, better eating, and mouth opening, as well as a decrease in joint noise and jerky mandibular motions. Patients receiving systemic enzyme therapy with diclofenac combinations performed better than those receiving NSAIDs alone, and the differences were quite substantial. For the treatment of internal derangement of the temporomandibular joint (TMJ), we recommend combining enzymes and diclofenac. Systemic enzyme therapy can be used in the treatment of TMJ osteoarthritis, as it shows a highly significant result in the study population.
PubMed: 38322061
DOI: 10.7759/cureus.51749 -
Biomedicine & Pharmacotherapy =... Aug 2021Tibetan traditional medicine CheeZheng Pain-Relieving Plaster (CZPRP) is frequently used as an over-the-counter external analgesic for musculoskeletal pain; however, its... (Meta-Analysis)
Meta-Analysis
ETHNOPHARMACOLOGICAL RELEVANCE
Tibetan traditional medicine CheeZheng Pain-Relieving Plaster (CZPRP) is frequently used as an over-the-counter external analgesic for musculoskeletal pain; however, its evidence for low back pain (LBP) has not been evaluated.
AIM OF THE STUDY
This study aims to assess the efficacy and safety of CZPRP for both acute, subacute and chronic LBP through a systematic review and meta-analysis of clinical trials.
MATERIALS AND METHODS
PubMed, CENTRAL, CNKI, CQVIP, and Wanfang databases were searched through April 20, 2020 for randomized controlled trials of CZPRP for LBP. Eligible comparators were placebo, active treatment, or usual care. Clinical outcomes included pain severity, lower back function score, pain-free rate, and adverse events (AEs). Qualitative evaluations were conducted using the Cochrane risk of bias assessment tools. Quantitative analyses were conducted using a random-effects model.
RESULTS
This study includes 1674 LBP patients from nine clinical studies. Pooled analyses among subjects with acute LBP show 1) significant pain reductions (mean difference -0.84, 95% confidence interval[CI] -1.31, -0.37) in CZPRP plus diclofenac versus diclofenac, 2) significant improvements in lower back function (standard mean difference -1.50, 95% CI -2.16, -0.85) in CZPRP versus diclofenac, and 3) a higher pain-free rate in CZPRP alone (risk ratio 1.48, 95% CI 1.16, 1.89; I = 61%) or CZPRP plus nonsteroidal anti-inflammatory drugs (NSAIDs) (risk ratio 1.66, 95% CI 1.14, 2.40; I = 0%) versus NSAIDs. However, in a heterogeneous population with mixed LBP subtypes, there was no significant difference in pain outcomes between CZPRP and diclofenac. Additionally, CZPRP use did not increase AEs compared with no CZPRP (p = 0.40). All nine studies are associated with moderate to high risk of bias.
CONCLUSIONS
The use of CZPRP is associated with improved acute LBP outcomes compared to diclofenac. However, due to the moderate to high risk of bias of the studies, future rigorous randomized controlled trials are needed to evaluate the effects of CZPRP for acute and chronic LBP.
Topics: Analgesics; Animals; Diclofenac; Humans; Low Back Pain; Medicine, Traditional; Plant Preparations; Randomized Controlled Trials as Topic; Tibet
PubMed: 34015584
DOI: 10.1016/j.biopha.2021.111727 -
Journal of Clinical Medicine Jul 2020Multiple interventions are available for the treatment of actinic keratosis (AK) showing high efficacy in pivotal trials. However, data from post-marketing surveillance...
Multiple interventions are available for the treatment of actinic keratosis (AK) showing high efficacy in pivotal trials. However, data from post-marketing surveillance studies have received little attention until now. Here, we systematically investigate interventions for AK from post-marketing surveillance trials as a proxy for real-world efficacy and tolerability. A systematic literature search was conducted in Medline, Embase, and CENTRAL. Pertinent trial registers were hand-searched until 25 March 2020. Results were pooled using a random-effects model to calculate pooled proportions and relative risks (RR) or were described qualitatively. Eleven records with a total sample size of = 4109 were included. Three of the studies had an active-controlled design, while seven were single-armed. Participant complete clearance ranged from 23.1% for diclofenac sodium 3% gel to 88.9% for ingenol mebutate 0.05% gel. The lesion-specific clearance rate for photodynamic therapy (PDT) was 74% (95% confidence interval (CI) 56-87%). The recurrence rate was significantly higher for diclofenac sodium 3% in comparison to imiquimod 5% cream (RR 1.10, 95% CI 1.02-1.1.8) and ranged from 10.6% for ingenol mebutate 0.015% gel to 23.5% for PDT. Few patients discontinued the trials due to adverse events. The results from the majority of the post-marketing surveillance studies deviated from those of pivotal trials.
PubMed: 32679902
DOI: 10.3390/jcm9072253 -
The Cochrane Database of Systematic... Jul 2015Fear of pain during insertion of intrauterine contraception (IUC) is a barrier to use of this method. IUC includes copper-containing intrauterine devices and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Fear of pain during insertion of intrauterine contraception (IUC) is a barrier to use of this method. IUC includes copper-containing intrauterine devices and levonorgestrel-releasing intrauterine systems. Interventions for pain control during IUC insertion include non-steroidal anti-inflammatory drugs (NSAIDs), local cervical anesthetics, and cervical ripening agents such as misoprostol.
OBJECTIVES
To review randomized controlled trials (RCTs) of interventions for reducing IUC insertion-related pain
SEARCH METHODS
We searched for trials in CENTRAL, MEDLINE, EMBASE, POPLINE, ClinicalTrials.gov, and ICTRP. The most recent search was 22 June 2015. We examined reference lists of pertinent articles. For the initial review, we wrote to investigators to find other published or unpublished trials.
SELECTION CRITERIA
We included RCTs that evaluated an intervention for preventing IUC insertion-related pain. The comparison could have been a placebo, no intervention, or another active intervention. The primary outcomes were self-reported pain at tenaculum placement, during IUC insertion, and after IUC insertion (up to six hours).
DATA COLLECTION AND ANALYSIS
Two authors extracted data from eligible trials. For dichotomous variables, we calculated the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). For continuous variables, we computed the mean difference (MD) with 95% CI. In meta-analysis of trials with different measurement scales, we used the standardized mean difference (SMD).
MAIN RESULTS
We included 33 trials with 5710 participants total; 29 were published from 2010 to 2015. Studies examined lidocaine, misoprostol, NSAIDs, and other interventions. Here we synthesize results from trials with sufficient outcome data and moderate- or high-quality evidence.For lidocaine, meta-analysis showed topical 2% gel had no effect on pain at tenaculum placement (two trials) or on pain during IUC insertion (three trials). Other formulations were effective compared with placebo in individual trials. Mean score for IUC-insertion pain was lower with lidocaine and prilocaine cream (MD -1.96, 95% CI -3.00 to -0.92). Among nulliparous women, topical 4% formulation showed lower scores for IUC-insertion pain assessed within 10 minutes (MD -15.90, 95% CI -22.77 to -9.03) and at 30 minutes later (MD -11.10, 95% CI -19.05 to -3.15). Among parous women, IUC-insertion pain was lower with 10% spray (median 1.00 versus 3.00). Compared with no intervention, pain at tenaculum placement was lower with 1% paracervical block (median 12 versus 28).For misoprostol, meta-analysis showed a higher mean score for IUC insertion compared with placebo (SMD 0.27, 95% CI 0.07 to 0.46; four studies). In meta-analysis, cramping was more likely with misoprostol (OR 2.64, 95% CI 1.46 to 4.76; four studies). A trial with nulliparous women found a higher score for IUC-insertion pain with misoprostol (median 46 versus 34). Pain before leaving the clinic was higher for misoprostol in two trials with nulliparous women (MD 7.60, 95% CI 6.48 to 8.72; medians 35.5 versus 20.5). In one trial with nulliparous women, moderate or severe pain at IUC insertion was less likely with misoprostol (OR 0.30, 95% CI 0.16 to 0.55). In the same trial, the misoprostol group was more likely to rate the experience favorably. Within two trials of misoprostol plus diclofenac, shivering, headache, or abdominal pain were more likely with misoprostol. Participants had no vaginal delivery. One trial showed the misoprostol group less likely to choose or recommend the treatment.Among multiparous women, mean score for IUC-insertion pain was lower for tramadol 50 mg versus naproxen 550 mg (MD -0.63, 95% CI -0.94 to -0.32) and for naproxen versus placebo (MD -1.94, 95% CI -2.35 to -1.53). The naproxen group was less likely than the placebo group to report the insertion experience as unpleasant and not want the medication in the future. An older trial showed repeated doses of naproxen 300 mg led to lower pain scores at one hour (MD -1.04, 95% CI -1.67 to -0.41) and two hours (MD -0.98, 95% CI -1.64 to -0.32) after insertion. Most women were nulliparous and also had lidocaine paracervical block.
AUTHORS' CONCLUSIONS
Nearly all trials used modern IUC. Most effectiveness evidence was of moderate quality, having come from single trials. Lidocaine 2% gel, misoprostol, and most NSAIDs did not help reduce pain. Some lidocaine formulations, tramadol, and naproxen had some effect on reducing IUC insertion-related pain in specific groups. The ineffective interventions do not need further research.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Female; Humans; Ibuprofen; Intrauterine Devices; Lidocaine; Misoprostol; Naproxen; Oxytocics; Pain; Prilocaine; Randomized Controlled Trials as Topic
PubMed: 26222246
DOI: 10.1002/14651858.CD007373.pub3 -
Evidence-based Complementary and... 2020Lumbar disc herniation (LDH) is based on the degenerative changes of the intervertebral disc. Many drugs are used to treat and prevent LDH, including Western medicine...
OBJECTIVE
Lumbar disc herniation (LDH) is based on the degenerative changes of the intervertebral disc. Many drugs are used to treat and prevent LDH, including Western medicine and Chinese medicine. Duhuo Jisheng Decoction (DHJSD) is one of the most classic Chinese medicine prescriptions. The purpose of our meta-analysis is to evaluate the efficacy and safety of modified DHJSD in the treatment of LDH.
METHODS
We searched multiple databases including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI) databases, Wanfang Database, and Chinese Scientific Journal Database (VIP) to identify studies that met the inclusion criteria. This meta-analysis was registered at INPLASY with reference number ID: INPLASY202060053.
RESULTS
Fourteen randomized controlled trials (RCTs) were identified, including 1560 patients. This meta-analysis showed that the total effective rate and cure rate of modified DHJSD are higher than those of diclofenac sodium enteric-coated tablets (total effective rate: RR = 1.18, 95% CI: 1.12 to 1.25, < 0.0001, = 0%; cure rate: RR = 1.60, 95% CI: 1.30 to 1.97, < 0.00001, = 2%), diclofenac sodium enteric-coated tablets plus ibuprofen and indomethacin (total effective rate: RR = 1.23, 95% CI: 1.11 to 1.37, =0.0001, = 0%; cure rate: RR = 1.58, 95% CI: 1.22 to 2.04, =0.0005, = 0%), and diclofenac sodium sustained-release capsule (total effective rate: RR = 1.49, 95% CI: 1.27 to 1.74, < 0.00001, = 0%; cure rate: RR = 10.07, 95% CI: 3.29 to 30.88, < 0.00001, = 5%). Modified DHJSD was also better than Western medicine (MD = -1.56, 95% CI: -2.42 to -0.70, =0.0004, = 74%) in terms of visual analogue scale (VAS) scores. Three RCTs showed no adverse events in the modified DHJSD group, but adverse events existed in the Western medicine group.
CONCLUSION
This meta-analysis showed that modified DHJSD had a more favorable effect on the treatment of LDH than Western medicine, and there were no obvious adverse events. More high-quality RCTs are needed to complement existing conclusions.
PubMed: 32714400
DOI: 10.1155/2020/2381462 -
The Cochrane Database of Systematic... Apr 2021Trigger finger is a common hand condition that occurs when movement of a finger flexor tendon through the first annular (A1) pulley is impaired by degeneration,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Trigger finger is a common hand condition that occurs when movement of a finger flexor tendon through the first annular (A1) pulley is impaired by degeneration, inflammation, and swelling. This causes pain and restricted movement of the affected finger. Non-surgical treatment options include activity modification, oral and topical non-steroidal anti-inflammatory drugs (NSAIDs), splinting, and local injections with anti-inflammatory drugs.
OBJECTIVES
To review the benefits and harms of non-steroidal anti-inflammatory drugs (NSAIDs) versus placebo, glucocorticoids, or different NSAIDs administered by the same route for trigger finger.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, CINAHL, CNKI (China National Knowledge Infrastructure), ProQuest Dissertations and Theses, www.ClinicalTrials.gov, and the WHO trials portal until 30 September 2020. We applied no language or publication status restrictions.
SELECTION CRITERIA
We searched for randomised controlled trials (RCTs) and quasi-randomised trials of adult participants with trigger finger that compared NSAIDs administered topically, orally, or by injection versus placebo, glucocorticoid, or different NSAIDs administered by the same route.
DATA COLLECTION AND ANALYSIS
Two or more review authors independently screened the reports, extracted data, and assessed risk of bias and GRADE certainty of evidence. The seven major outcomes were resolution of trigger finger symptoms, persistent moderate or severe symptoms, recurrence of symptoms, total active range of finger motion, residual pain, patient satisfaction, and adverse events. Treatment effects were reported as risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs).
MAIN RESULTS
Two RCTs conducted in an outpatient hospital setting were included (231 adult participants, mean age 58.6 years, 60% female, 95% to 100% moderate to severe disease). Both studies compared a single injection of a non-selective NSAID (12.5 mg diclofenac or 15.0 mg ketorolac) given at lower than normal doses with a single injection of a glucocorticoid (triamcinolone 20 mg or 5 mg), with maximum follow-up duration of 12 weeks or 24 weeks. In both studies, we detected risk of attrition and performance bias. One study also had risk of selection bias. The effects of treatment were sensitive to assumptions about missing outcomes. All seven outcomes were reported in one study, and five in the other. NSAID injection may offer little to no benefit over glucocorticoid injection, based on low- to very low-certainty evidence from two trials. Evidence was downgraded for bias and imprecision. There may be little to no difference between groups in resolution of symptoms at 12 to 24 weeks (34% with NSAIDs, 41% with glucocorticoids; absolute effect 7% lower, 95% confidence interval (CI) 16% lower to 5% higher; 2 studies, 231 participants; RR 0.83, 95% CI 0.62 to 1.11; low-certainty evidence). The rate of persistent moderate to severe symptoms may be higher at 12 to 24 weeks in the NSAIDs group (28%) compared to the glucocorticoid group (14%) (absolute effect 14% higher, 95% CI 2% to 33% higher; 2 studies, 231 participants; RR 2.03, 95% CI 1.19 to 3.46; low-certainty evidence). We are uncertain whether NSAIDs result in fewer recurrences at 12 to 24 weeks (1%) compared to glucocorticoid (21%) (absolute effect 20% lower, 95% CI 21% to 13% lower; 2 studies, 231 participants; RR 0.07, 95% CI 0.01 to 0.38; very low-certainty evidence). There may be little to no difference between groups in mean total active motion at 24 weeks (235 degrees with NSAIDs, 240 degrees with glucocorticoid) (absolute effect 5% lower, 95% CI 34.54% lower to 24.54% higher; 1 study, 99 participants; MD -5.00, 95% CI -34.54 to 24.54; low-certainty evidence). There may be little to no difference between groups in residual pain at 12 to 24 weeks (20% with NSAIDs, 24% with glucocorticoid) (absolute effect 4% lower, 95% CI 11% lower to 7% higher; 2 studies, 231 participants; RR 0.84, 95% CI 0.54 to 1.31; low-certainty evidence). There may be little to no difference between groups in participant-reported treatment success at 24 weeks (64% with NSAIDs, 68% with glucocorticoid) (absolute effect 4% lower, 95% CI 18% lower to 15% higher; 1 study, 121 participants; RR 0.95, 95% CI 0.74 to 1.23; low-certainty evidence). We are uncertain whether NSAID injection has an effect on adverse events at 12 to 24 weeks (1% with NSAIDs, 1% with glucocorticoid) (absolute effect 0% difference, 95% CI 2% lower to 3% higher; 2 studies, 231 participants; RR 2.00, 95% CI 0.19 to 21.42; very low-certainty evidence).
AUTHORS' CONCLUSIONS
For adults with trigger finger, by 24 weeks' follow-up, results from two trials show that compared to glucocorticoid injection, NSAID injection offered little to no benefit in the treatment of trigger finger. Specifically, there was no difference in resolution, symptoms, recurrence, total active motion, residual pain, participant-reported treatment success, or adverse events.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Bias; Diclofenac; Female; Glucocorticoids; Humans; Ketorolac; Male; Middle Aged; Placebos; Randomized Controlled Trials as Topic; Treatment Outcome; Triamcinolone; Trigger Finger Disorder
PubMed: 33849080
DOI: 10.1002/14651858.CD012789.pub2 -
The Cochrane Database of Systematic... Jul 2015Tension-type headache (TTH) affects about one person in five worldwide. It is divided into infrequent episodic TTH (fewer than one headache per month), frequent episodic... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Tension-type headache (TTH) affects about one person in five worldwide. It is divided into infrequent episodic TTH (fewer than one headache per month), frequent episodic TTH (1 to 14 headaches per month), and chronic TTH (15 headaches a month or more). Ibuprofen is one of a number of analgesics suggested for acute treatment of headaches in frequent episodic TTH.
OBJECTIVES
To assess the efficacy and safety of oral ibuprofen for treatment of acute episodic TTH in adults.
SEARCH METHODS
We searched CENTRAL (The Cochrane Library), MEDLINE, EMBASE, and our own in-house database to January 2015. We sought unpublished studies by asking personal contacts and searching on-line clinical trial registers and manufacturers' websites.
SELECTION CRITERIA
We included randomised, placebo-controlled studies (parallel-group or cross-over) using oral ibuprofen for symptomatic relief of an acute episode of TTH. Studies had to be prospective and include at least 10 participants per treatment arm.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed studies for inclusion, and extracted data. Numbers of participants achieving each outcome were used to calculate risk ratio (RR) and number needed to treat for an additional beneficial outcome (NNT) or number needed to treat for an additional harmful outcome (NNH) of oral ibuprofen compared to placebo for a range of outcomes, predominantly those recommended by the International Headache Society (IHS).
MAIN RESULTS
We included 12 studies, all of which enrolled adult participants with frequent episodic TTH. Nine used the IHS diagnostic criteria, but two used the older classification of the Ad Hoc Committee, and one did not describe diagnostic criteria but excluded participants with migraines. While 3094 people with TTH participated in these studies, the numbers available for any form of analysis were lower than this; placebo was taken by 733, standard ibuprofen 200 mg by 127, standard ibuprofen 400 mg by 892, and fast-acting ibuprofen 400 mg by 230. Participants had moderate or severe pain at the start of treatment. Other participants were either in studies not reporting outcomes we could analyse, or were given one of several active comparators in single studies.For the IHS-preferred outcome of being pain free at 2 hours the NNT for ibuprofen 400 mg (all formulations) compared with placebo was 14 (95% confidence interval (CI), 8.4 to 47) in four studies, with no significant difference from placebo at 1 hour (moderate quality evidence). The NNT was 5.9 (4.2 to 9.5) for the global evaluation of 'very good' or 'excellent' in three studies (moderate quality evidence). No study reported the number of participants experiencing no worse than mild pain at 1 or 2 hours. The use of rescue medication was lower with ibuprofen 400 mg than with placebo, with the number needed to treat to prevent one event (NNTp) of 8.9 (5.6 to 21) in two studies (low quality evidence).Adverse events were not different between ibuprofen 400 mg and placebo; RR 1.1 (0.64 to 1.7) (high-quality evidence). No serious adverse events were reported.
AUTHORS' CONCLUSIONS
Ibuprofen 400 mg provides an important benefit in terms of being pain free at 2 hours for a small number of people with frequent episodic tension-type headache who have an acute headache with moderate or severe initial pain. There is no information about the lesser benefit of no worse than mild pain at 2 hours.
Topics: Acetaminophen; Administration, Oral; Adult; Analgesics, Non-Narcotic; Cyclooxygenase Inhibitors; Diclofenac; Humans; Ibuprofen; Ketoprofen; Naproxen; Numbers Needed To Treat; Pain Measurement; Piroxicam; Randomized Controlled Trials as Topic; Tension-Type Headache; Time Factors
PubMed: 26230487
DOI: 10.1002/14651858.CD011474.pub2