The prevalence of mechanical neck disorders (MND) is known to be both a hindrance to individuals ... more The prevalence of mechanical neck disorders (MND) is known to be both a hindrance to individuals and costly to society. As such, massage is widely used as a form of treatment for MND. To assess the effects of massage on pain, function, patient satisfaction, global perceived effect, adverse effects and cost of care in adults with neck pain versus any comparison at immediate post-treatment to long-term follow-up. We searched The Cochrane Library (CENTRAL), MEDLINE, EMBASE, MANTIS, CINAHL, and ICL databases from date of inception to 4 Feburary 2012. Studies using random assignment were included. Two review authors independently conducted citation identification, study selection, data abstraction and methodological quality assessment. Using a random-effects model, we calculated the risk ratio and standardised mean difference. Fifteen trials met the inclusion criteria. The overall methodology of all the trials assessed was either low or very low GRADE level. None of the trials were of strong to moderate GRADE level. The results showed very low level evidence that certain massage techniques (traditional Chinese massage, classical and modified strain/counter strain technique) may have been more effective than control or placebo treatment in improving function and tenderness. There was very low level evidence that massage may have been more beneficial than education in the short term for pain bothersomeness. Along with that, there was low level evidence that ischaemic compression and passive stretch may have been more effective in combination rather than individually for pain reduction. The clinical applicability assessment showed that only 4/15 trials adequately described the massage technique. The majority of the trials assessed outcomes at immediate post-treatment, which is not an adequate time to assess clinical change. Due to the limitations in the quality of existing studies, we were unable to make any firm statement to guide clinical practice. We noted that only four of the 15 studies reported side effects. All four studies reported post-treatment pain as a side effect and one study (Irnich 2001) showed that 22% of the participants experienced low blood pressure following treatment. No recommendations for practice can be made at this time because the effectiveness of massage for neck pain remains uncertain.As a stand-alone treatment, massage for MND was found to provide an immediate or short-term effectiveness or both in pain and tenderness. Additionally, future research is needed in order to assess the long-term effects of treatment and treatments provided on more than one occasion.
BackgroundPublications suggest immunomodulation co-therapy improves responder rates in uncontroll... more BackgroundPublications suggest immunomodulation co-therapy improves responder rates in uncontrolled/refractory gout patients undergoing pegloticase treatment. The MIRROR open-label trial showed a 6-month pegloticase + methotrexate co-therapy responder rate of 79%, compared to an established 42% pegloticase monotherapy responder rate. Longer-term efficacy/safety data are presented here.MethodsUncontrolled gout patients (serum urate [SU] ≥ 6 mg/dL and SU ≥ 6 mg/dL despite urate-lowering therapy [ULT], ULT intolerance, or functionally-limiting tophi) were included. Patients with immunocompromised status, G6PD deficiency, severe kidney disease, or methotrexate contraindication were excluded. Oral methotrexate (15 mg/week) and folic acid (1 mg/day) were administered 4 weeks before and during pegloticase therapy. Twelve-month responder rate (SU < 6 mg/dL for ≥ 80% during month 12), 52-week change from baseline in SU, and extended safety were examined. Efficacy analyses were performed f...
Background:The prevalence of gout is high in kidney transplant (KT) recipients (up to 13%), large... more Background:The prevalence of gout is high in kidney transplant (KT) recipients (up to 13%), largely because of decreased kidney function and calcineurin inhibitor use.1 Residual chronic kidney disease (CKD) leading to decreased urate lowering therapy clearance and drug interactions make managing gout in KT recipients challenging. Studies show that successful treatment with pegloticase, a pegylated uricase, leads to marked reductions in serum uric acid (sUA)2 and a subsequent decrease in overall urate load and tophi burden.3 However, pegloticase use in solid organ transplant recipients has not been systematically studied or well-characterized in the literature.4,5Objectives:To examine the safety and efficacy of pegloticase in KT recipients with uncontrolled gout.Methods:This ongoing multicenter, open-label, efficacy and safety study of pegloticase in KT recipients (NCT04087720) included patients with uncontrolled gout sUA ≥7 mg/dL, urate lowering therapy [ULT] contraindication/ineffi...
Background:Gout is a painful inflammatory arthritis caused by persistently elevated serum uric ac... more Background:Gout is a painful inflammatory arthritis caused by persistently elevated serum uric acid (sUA) levels. Pegloticase, an infused recombinant PEGylated uricase, rapidly lowers sUA levels by converting uric acid to allantoin, a water-soluble molecule that is readily excreted by the kidneys. In the phase 3 clinical trials, 42% of patients1dosed with pegloticase every two weeks maintained sUA levels below 6.0 mg/dL during months 3 and 6 of pegloticase treatment. The loss of pegloticase efficacy has been attributed to the development of anti-drug antibodies (ADAs)1-3and these ADAs have been associated with infusion reactions (IRs).1,2Case reports4and prospective case series5, 6indicate that methotrexate (MTX) may allow patients to attain more complete therapeutic benefits, presumably through attenuation of pegloticase immunogenicity. The current study prospectively examines the efficacy and safety of MTX-pegloticase co-therapy in patients with uncontrolled gout.Objectives:To ass...
Background:Gout development follows persistent serum uric acid (sUA) elevation. Patients who are ... more Background:Gout development follows persistent serum uric acid (sUA) elevation. Patients who are refractory to or cannot tolerate oral urate lowering therapies (ULTs) have limited treatment options. Pegloticase is effective in treating refractory gout, but many patients develop anti-drug antibodies (ADAs), which are associated with loss of urate-lowering efficacy1-3 and infusion reactions (IRs).1,2 In phase 3 trials, the pooled pegloticase responder rate during Months 3 and 6 combined was 42% (8 mg infusion every 2 weeks), with high-titer ADA positive patients losing efficacy prior to 6 months.1 The 6-month results from the MIRROR open-label trial (79% response rate [11/14], 95%CI 49-95%)4 suggest that methotrexate (MTX) administered in conjunction with pegloticase increases treatment responder rate.Objectives:To examine longer-term (12-month) exploratory endpoints from the MIRROR open-label trial, including joint, overall health, and gout global assessments. Serial dual-energy comp...
Background: Publications suggest immunomodulation co-therapy improves responder rates in uncontro... more Background: Publications suggest immunomodulation co-therapy improves responder rates in uncontrolled/refractory gout patients undergoing pegloticase treatment. The MIRROR open-label trial showed a 6-month pegloticase+methotrexate co-therapy responder rate of 79%, compared to an established 42% pegloticase monotherapy responder rate. Longer-term efficacy/safety data are presented here.Methods: Uncontrolled gout patients (serum urate [SU]≥6 mg/dL and SU≥6 mg/dL despite urate-lowering therapy [ULT], ULT intolerance, or functionally-limiting tophi) were included. Patients with immunocompromised status, G6PD deficiency, severe kidney disease, or methotrexate contraindication were excluded. Oral methotrexate (15 mg/week) and folic acid (1 mg/day) were administered 4-weeks before and during pegloticase therapy. Twelve-month responder rate (SU<6 mg/dL for ≥80% during Month 12), 52-week change from baseline in SU, and extended safety were examined. Efficacy analyses were performed for pa...
Cochrane Database of Systematic Reviews, Apr 19, 2004
Controversy persists regarding medicinal therapies and injections. To determine the effects of me... more Controversy persists regarding medicinal therapies and injections. To determine the effects of medication and injections on primary outcomes (e.g. pain) for adults with mechanical neck disorders and whiplash. We searched CENTRAL, MANTIS, CINAHL from their start to May 2006; MEDLINE and EMBASE to December 2006. We scrutinised reference lists for other trials. We included randomised controlled trials with adults with neck disorders, with or without associated headache or radicular findings. We considered medicinal and injection therapies, regardless of route of administration. Two authors independently selected articles, abstracted data and assessed methodological quality. When clinical heterogeneity was absent, we combined studies using random-effects models. We found 36 trials that examined the effects of oral NSAIDs, psychotropic agents, steroid injections, and anaesthetic agents. Trials had a mean of 3.1 on the Jadad Scale for methodological quality; 70% were high quality. For acute whiplash, administering intravenous methylprednisolone within eight hours of injury reduced pain at one week (SMD -0.90, 95% CI -1.57 to -0.24), and sick leave but not pain at six months compared to placebo in one trial. For chronic neck disorders at short-term follow-up, intramuscular injection of lidocaine was superior to placebo (SMD -1.36, 95% CI -1.93 to -0.80); NNT 3, treatment advantage 45% and dry needling, but similar to ultrasound in one trial each. In chronic neck disorders with radicular findings, epidural methylprednisolone and lidocaine reduced neck pain and improved function more than when given by intramuscular route at one-year follow-up, in one trial. In subacute and chronic neck disorders, muscle relaxants, analgesics and NSAIDs had limited evidence and unclear benefits. In participants with chronic neck disorders with or without radicular findings or headache, there was moderate evidence from five high quality trials that Botulinum toxin A intramuscular injections had similar effects to saline in improving pain (pooled SMD: -0.39, 95%CI -1.25 to 0.47), disability or global perceived effect. The major limitations are the lack of replication of the findings and sufficiently large trials. There is moderate evidence for the benefit of intravenous methylprednisolone given within eight hours of acute whiplash, from a single trial. Lidocaine injection into myofascial trigger points appears effective in two trials. There is moderate evidence that Botulinum toxin A is not superior to saline injection for chronic MND. Muscle relaxants, analgesics and NSAIDs had limited evidence and unclear benefits.
INTRODUCTION: Rescue analgesic use was evaluated in two phase 3 studies, wherein 6-months (M) of ... more INTRODUCTION: Rescue analgesic use was evaluated in two phase 3 studies, wherein 6-months (M) of elagolix (an oral, non-peptide GnRH antagonist) treatment was associated with improved dysmenorrhea and nonmenstrual pelvic pain compared to placebo in women with endometriosis-associated pain. METHODS: Elaris EM-I (N=871) and Elaris EM-II (N=815) were randomized, double-blind, 6M, placebo-controlled phase 3 studies evaluating two elagolix doses (150mg once daily [QD] or 200mg twice daily [BID]) in women with moderate/severe endometriosis-associated pain. Women could use either naproxen and/or a single opioid as rescue analgesic (opioid varied by country). Daily pill counts were recorded in an electronic-diary. RESULTS: At baseline, the mean daily rescue analgesic pill count ranged 0.7-0.9 across studies/doses. The mean percent decrease from baseline in average daily rescue analgesic pill count (any analgesic) was significantly greater compared to placebo for elagolix 200mg BID at M3 in ...
randomized, double blind, placebo controlled trial. (Ultracet) in treatment of chronic low back p... more randomized, double blind, placebo controlled trial. (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, Analgesic efficacy and safety of tramadol / acetaminophen combination tablets
Neck pain is a frequently reported complaint of the musculoskeletal system which can be disabling... more Neck pain is a frequently reported complaint of the musculoskeletal system which can be disabling and costly to society. Mechanical traction is often used as an adjunct therapy in outpatient rehabilitation. To assess the effects of mechanical traction for neck disorders. A research librarian searched computerized bibliographic databases without language restrictions up to March 2008 for randomized controlled trials (RCTs) from the medical, chiropractic, and allied health literature. The RCTs we selected examined adults with neck disorders who received mechanical traction alone or in combination with other treatments compared to a placebo or another treatment. Our outcomes of interest were pain, function, disability, global perceived effect, patient satisfaction, and quality of life measures. Two review authors with different backgrounds in medicine, physiotherapy, massage therapy and chiropractics independently conducted study selection, risk of bias assessment and data abstraction using pre-piloted forms. We resolved disagreement through consensus. Of the seven selected RCTs (total participants = 958), only one (N = 100) had a low risk of bias. It found no statistically significant difference (SMD -0.16: 95%CI: -0.59 to 0.27) between continuous traction and placebo traction in reducing pain or improving function for chronic neck disorders with radicular symptoms. Our review found no evidence from RCTs with a low potential for bias that clearly supports or refutes the use of either continuous or intermittent traction for neck disorders. The current literature does not support or refute the efficacy or effectiveness of continuous or intermittent traction for pain reduction, improved function or global perceived effect when compared to placebo traction, tablet or heat or other conservative treatments in patients with chronic neck disorders. Large, well conducted RCTs are needed to first determine the efficacy of traction, then the effectiveness, for individuals with neck disorders with radicular symptoms.
Journal of Pain & Palliative Care Pharmacotherapy, 2011
Neck disorders are common, disabling and costly. Botulinum toxin (BoNT) intramuscular injections ... more Neck disorders are common, disabling and costly. Botulinum toxin (BoNT) intramuscular injections are often used with the intention of treating neck pain. To systematically evaluate the literature on the treatment effectiveness of BoNT for neck pain, disability, global perceived effect and quality of life in adults with neck pain with or without associated cervicogenic headache, but excluding cervical radiculopathy and whiplash associated disorder. We searched CENTRAL, MEDLINE, AMED, Index to Chiropractic Literature, CINAHL, LILACS, and EMBASE from their origin to 20 September 2010. We included randomised and quasi-randomised controlled trials in which BoNT injections were used to treat subacute or chronic neck pain. A minimum of two review authors independently selected articles, abstracted data, and assessed risk of bias, using the Cochrane Back Review Group criteria. In the absence of clinical heterogeneity, we calculated standardized mean differences (SMD) and relative risks, and performed meta-analyses using a random-effects model. The quality of the evidence and the strength of recommendations were assigned an overall grade for each outcome. We included nine trials (503 participants). Only BoNT type A (BoNT-A) was used in these studies.High quality evidence suggests there was little or no difference in pain between BoNT-A and saline injections at four weeks (five trials; 252 participants; SMD pooled -0.07 (95% confidence intervals (CI) -0.36 to 0.21)) and six months for chronic neck pain. Very low quality evidence indicated little or no difference in pain between BoNT-A combined with physiotherapeutic exercise and analgesics and saline injection with physiotherapeutic exercise and analgesics for patients with chronic neck pain at four weeks (two trials; 95 participants; SMD pooled 0.09 (95% CI -0.55 to 0.73)) and six months (one trial; 24 participants; SMD -0.56 (95% CI -1.39 to 0.27)). Very low quality evidence from one trial (32 participants) showed little or no difference between BoNT-A and placebo at four weeks (SMD 0.16 (95% CI -0.53 to 0.86)) and six months (SMD 0.00 (95% CI -0.69 to 0.69)) for chronic cervicogenic headache. Very low quality evidence from one trial (31 participants), showed a difference in global perceived effect favouring BoNT-A in chronic neck pain at four weeks (SMD -1.12 (95% CI: -1.89 to -0.36)). Current evidence fails to confirm either a clinically important or a statistically significant benefit of BoNT-A injection for chronic neck pain associated with or without associated cervicogenic headache. Likewise, there was no benefit seen for disability and quality of life at four week and six months.
ObjectiveTo examine the efficacy and safety of pegloticase in combination with methotrexate (MTX)... more ObjectiveTo examine the efficacy and safety of pegloticase in combination with methotrexate (MTX) in patients with uncontrolled gout in an exploratory, open-label clinical trial (ClinicalTrials.gov: NCT03635957) prior to a randomized, controlled trial.MethodsA multicenter, open-label efficacy and safety study of pegloticase with MTX co-treatment was conducted in patients with uncontrolled gout. Patients were administered oral MTX (15 mg/week) and folic acid (1 mg/day) 4 weeks prior to and throughout pegloticase treatment. The primary study outcome was the proportion of responders, defined as serum uric acid (sUA) < 6 mg/dL for ≥ 80% of the time during Month 6 (Weeks 20, 22, and 24). All analyses were performed on a modified intent-to-treat population, defined as patients who received ≥ 1 pegloticase infusion.ResultsSeventeen patients were screened and 14 patients (all men, average age 49.3 ± 8.7 years) were enrolled. On Day 1, mean sUA was 9.2 ± 2.5 mg/dL, and 12 of the 14 patien...
Summary of Additional Endpoints during Part I (6 weeks of treatment). Table S2. Summary of Additi... more Summary of Additional Endpoints during Part I (6 weeks of treatment). Table S2. Summary of Additional Endpoints during Part II Among Inadequate Responders from Part I. (DOCX 21 kb)
The prevalence of mechanical neck disorders (MND) is known to be both a hindrance to individuals ... more The prevalence of mechanical neck disorders (MND) is known to be both a hindrance to individuals and costly to society. As such, massage is widely used as a form of treatment for MND. To assess the effects of massage on pain, function, patient satisfaction, global perceived effect, adverse effects and cost of care in adults with neck pain versus any comparison at immediate post-treatment to long-term follow-up. We searched The Cochrane Library (CENTRAL), MEDLINE, EMBASE, MANTIS, CINAHL, and ICL databases from date of inception to 4 Feburary 2012. Studies using random assignment were included. Two review authors independently conducted citation identification, study selection, data abstraction and methodological quality assessment. Using a random-effects model, we calculated the risk ratio and standardised mean difference. Fifteen trials met the inclusion criteria. The overall methodology of all the trials assessed was either low or very low GRADE level. None of the trials were of strong to moderate GRADE level. The results showed very low level evidence that certain massage techniques (traditional Chinese massage, classical and modified strain/counter strain technique) may have been more effective than control or placebo treatment in improving function and tenderness. There was very low level evidence that massage may have been more beneficial than education in the short term for pain bothersomeness. Along with that, there was low level evidence that ischaemic compression and passive stretch may have been more effective in combination rather than individually for pain reduction. The clinical applicability assessment showed that only 4/15 trials adequately described the massage technique. The majority of the trials assessed outcomes at immediate post-treatment, which is not an adequate time to assess clinical change. Due to the limitations in the quality of existing studies, we were unable to make any firm statement to guide clinical practice. We noted that only four of the 15 studies reported side effects. All four studies reported post-treatment pain as a side effect and one study (Irnich 2001) showed that 22% of the participants experienced low blood pressure following treatment. No recommendations for practice can be made at this time because the effectiveness of massage for neck pain remains uncertain.As a stand-alone treatment, massage for MND was found to provide an immediate or short-term effectiveness or both in pain and tenderness. Additionally, future research is needed in order to assess the long-term effects of treatment and treatments provided on more than one occasion.
BackgroundPublications suggest immunomodulation co-therapy improves responder rates in uncontroll... more BackgroundPublications suggest immunomodulation co-therapy improves responder rates in uncontrolled/refractory gout patients undergoing pegloticase treatment. The MIRROR open-label trial showed a 6-month pegloticase + methotrexate co-therapy responder rate of 79%, compared to an established 42% pegloticase monotherapy responder rate. Longer-term efficacy/safety data are presented here.MethodsUncontrolled gout patients (serum urate [SU] ≥ 6 mg/dL and SU ≥ 6 mg/dL despite urate-lowering therapy [ULT], ULT intolerance, or functionally-limiting tophi) were included. Patients with immunocompromised status, G6PD deficiency, severe kidney disease, or methotrexate contraindication were excluded. Oral methotrexate (15 mg/week) and folic acid (1 mg/day) were administered 4 weeks before and during pegloticase therapy. Twelve-month responder rate (SU < 6 mg/dL for ≥ 80% during month 12), 52-week change from baseline in SU, and extended safety were examined. Efficacy analyses were performed f...
Background:The prevalence of gout is high in kidney transplant (KT) recipients (up to 13%), large... more Background:The prevalence of gout is high in kidney transplant (KT) recipients (up to 13%), largely because of decreased kidney function and calcineurin inhibitor use.1 Residual chronic kidney disease (CKD) leading to decreased urate lowering therapy clearance and drug interactions make managing gout in KT recipients challenging. Studies show that successful treatment with pegloticase, a pegylated uricase, leads to marked reductions in serum uric acid (sUA)2 and a subsequent decrease in overall urate load and tophi burden.3 However, pegloticase use in solid organ transplant recipients has not been systematically studied or well-characterized in the literature.4,5Objectives:To examine the safety and efficacy of pegloticase in KT recipients with uncontrolled gout.Methods:This ongoing multicenter, open-label, efficacy and safety study of pegloticase in KT recipients (NCT04087720) included patients with uncontrolled gout sUA ≥7 mg/dL, urate lowering therapy [ULT] contraindication/ineffi...
Background:Gout is a painful inflammatory arthritis caused by persistently elevated serum uric ac... more Background:Gout is a painful inflammatory arthritis caused by persistently elevated serum uric acid (sUA) levels. Pegloticase, an infused recombinant PEGylated uricase, rapidly lowers sUA levels by converting uric acid to allantoin, a water-soluble molecule that is readily excreted by the kidneys. In the phase 3 clinical trials, 42% of patients1dosed with pegloticase every two weeks maintained sUA levels below 6.0 mg/dL during months 3 and 6 of pegloticase treatment. The loss of pegloticase efficacy has been attributed to the development of anti-drug antibodies (ADAs)1-3and these ADAs have been associated with infusion reactions (IRs).1,2Case reports4and prospective case series5, 6indicate that methotrexate (MTX) may allow patients to attain more complete therapeutic benefits, presumably through attenuation of pegloticase immunogenicity. The current study prospectively examines the efficacy and safety of MTX-pegloticase co-therapy in patients with uncontrolled gout.Objectives:To ass...
Background:Gout development follows persistent serum uric acid (sUA) elevation. Patients who are ... more Background:Gout development follows persistent serum uric acid (sUA) elevation. Patients who are refractory to or cannot tolerate oral urate lowering therapies (ULTs) have limited treatment options. Pegloticase is effective in treating refractory gout, but many patients develop anti-drug antibodies (ADAs), which are associated with loss of urate-lowering efficacy1-3 and infusion reactions (IRs).1,2 In phase 3 trials, the pooled pegloticase responder rate during Months 3 and 6 combined was 42% (8 mg infusion every 2 weeks), with high-titer ADA positive patients losing efficacy prior to 6 months.1 The 6-month results from the MIRROR open-label trial (79% response rate [11/14], 95%CI 49-95%)4 suggest that methotrexate (MTX) administered in conjunction with pegloticase increases treatment responder rate.Objectives:To examine longer-term (12-month) exploratory endpoints from the MIRROR open-label trial, including joint, overall health, and gout global assessments. Serial dual-energy comp...
Background: Publications suggest immunomodulation co-therapy improves responder rates in uncontro... more Background: Publications suggest immunomodulation co-therapy improves responder rates in uncontrolled/refractory gout patients undergoing pegloticase treatment. The MIRROR open-label trial showed a 6-month pegloticase+methotrexate co-therapy responder rate of 79%, compared to an established 42% pegloticase monotherapy responder rate. Longer-term efficacy/safety data are presented here.Methods: Uncontrolled gout patients (serum urate [SU]≥6 mg/dL and SU≥6 mg/dL despite urate-lowering therapy [ULT], ULT intolerance, or functionally-limiting tophi) were included. Patients with immunocompromised status, G6PD deficiency, severe kidney disease, or methotrexate contraindication were excluded. Oral methotrexate (15 mg/week) and folic acid (1 mg/day) were administered 4-weeks before and during pegloticase therapy. Twelve-month responder rate (SU<6 mg/dL for ≥80% during Month 12), 52-week change from baseline in SU, and extended safety were examined. Efficacy analyses were performed for pa...
Cochrane Database of Systematic Reviews, Apr 19, 2004
Controversy persists regarding medicinal therapies and injections. To determine the effects of me... more Controversy persists regarding medicinal therapies and injections. To determine the effects of medication and injections on primary outcomes (e.g. pain) for adults with mechanical neck disorders and whiplash. We searched CENTRAL, MANTIS, CINAHL from their start to May 2006; MEDLINE and EMBASE to December 2006. We scrutinised reference lists for other trials. We included randomised controlled trials with adults with neck disorders, with or without associated headache or radicular findings. We considered medicinal and injection therapies, regardless of route of administration. Two authors independently selected articles, abstracted data and assessed methodological quality. When clinical heterogeneity was absent, we combined studies using random-effects models. We found 36 trials that examined the effects of oral NSAIDs, psychotropic agents, steroid injections, and anaesthetic agents. Trials had a mean of 3.1 on the Jadad Scale for methodological quality; 70% were high quality. For acute whiplash, administering intravenous methylprednisolone within eight hours of injury reduced pain at one week (SMD -0.90, 95% CI -1.57 to -0.24), and sick leave but not pain at six months compared to placebo in one trial. For chronic neck disorders at short-term follow-up, intramuscular injection of lidocaine was superior to placebo (SMD -1.36, 95% CI -1.93 to -0.80); NNT 3, treatment advantage 45% and dry needling, but similar to ultrasound in one trial each. In chronic neck disorders with radicular findings, epidural methylprednisolone and lidocaine reduced neck pain and improved function more than when given by intramuscular route at one-year follow-up, in one trial. In subacute and chronic neck disorders, muscle relaxants, analgesics and NSAIDs had limited evidence and unclear benefits. In participants with chronic neck disorders with or without radicular findings or headache, there was moderate evidence from five high quality trials that Botulinum toxin A intramuscular injections had similar effects to saline in improving pain (pooled SMD: -0.39, 95%CI -1.25 to 0.47), disability or global perceived effect. The major limitations are the lack of replication of the findings and sufficiently large trials. There is moderate evidence for the benefit of intravenous methylprednisolone given within eight hours of acute whiplash, from a single trial. Lidocaine injection into myofascial trigger points appears effective in two trials. There is moderate evidence that Botulinum toxin A is not superior to saline injection for chronic MND. Muscle relaxants, analgesics and NSAIDs had limited evidence and unclear benefits.
INTRODUCTION: Rescue analgesic use was evaluated in two phase 3 studies, wherein 6-months (M) of ... more INTRODUCTION: Rescue analgesic use was evaluated in two phase 3 studies, wherein 6-months (M) of elagolix (an oral, non-peptide GnRH antagonist) treatment was associated with improved dysmenorrhea and nonmenstrual pelvic pain compared to placebo in women with endometriosis-associated pain. METHODS: Elaris EM-I (N=871) and Elaris EM-II (N=815) were randomized, double-blind, 6M, placebo-controlled phase 3 studies evaluating two elagolix doses (150mg once daily [QD] or 200mg twice daily [BID]) in women with moderate/severe endometriosis-associated pain. Women could use either naproxen and/or a single opioid as rescue analgesic (opioid varied by country). Daily pill counts were recorded in an electronic-diary. RESULTS: At baseline, the mean daily rescue analgesic pill count ranged 0.7-0.9 across studies/doses. The mean percent decrease from baseline in average daily rescue analgesic pill count (any analgesic) was significantly greater compared to placebo for elagolix 200mg BID at M3 in ...
randomized, double blind, placebo controlled trial. (Ultracet) in treatment of chronic low back p... more randomized, double blind, placebo controlled trial. (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, Analgesic efficacy and safety of tramadol / acetaminophen combination tablets
Neck pain is a frequently reported complaint of the musculoskeletal system which can be disabling... more Neck pain is a frequently reported complaint of the musculoskeletal system which can be disabling and costly to society. Mechanical traction is often used as an adjunct therapy in outpatient rehabilitation. To assess the effects of mechanical traction for neck disorders. A research librarian searched computerized bibliographic databases without language restrictions up to March 2008 for randomized controlled trials (RCTs) from the medical, chiropractic, and allied health literature. The RCTs we selected examined adults with neck disorders who received mechanical traction alone or in combination with other treatments compared to a placebo or another treatment. Our outcomes of interest were pain, function, disability, global perceived effect, patient satisfaction, and quality of life measures. Two review authors with different backgrounds in medicine, physiotherapy, massage therapy and chiropractics independently conducted study selection, risk of bias assessment and data abstraction using pre-piloted forms. We resolved disagreement through consensus. Of the seven selected RCTs (total participants = 958), only one (N = 100) had a low risk of bias. It found no statistically significant difference (SMD -0.16: 95%CI: -0.59 to 0.27) between continuous traction and placebo traction in reducing pain or improving function for chronic neck disorders with radicular symptoms. Our review found no evidence from RCTs with a low potential for bias that clearly supports or refutes the use of either continuous or intermittent traction for neck disorders. The current literature does not support or refute the efficacy or effectiveness of continuous or intermittent traction for pain reduction, improved function or global perceived effect when compared to placebo traction, tablet or heat or other conservative treatments in patients with chronic neck disorders. Large, well conducted RCTs are needed to first determine the efficacy of traction, then the effectiveness, for individuals with neck disorders with radicular symptoms.
Journal of Pain & Palliative Care Pharmacotherapy, 2011
Neck disorders are common, disabling and costly. Botulinum toxin (BoNT) intramuscular injections ... more Neck disorders are common, disabling and costly. Botulinum toxin (BoNT) intramuscular injections are often used with the intention of treating neck pain. To systematically evaluate the literature on the treatment effectiveness of BoNT for neck pain, disability, global perceived effect and quality of life in adults with neck pain with or without associated cervicogenic headache, but excluding cervical radiculopathy and whiplash associated disorder. We searched CENTRAL, MEDLINE, AMED, Index to Chiropractic Literature, CINAHL, LILACS, and EMBASE from their origin to 20 September 2010. We included randomised and quasi-randomised controlled trials in which BoNT injections were used to treat subacute or chronic neck pain. A minimum of two review authors independently selected articles, abstracted data, and assessed risk of bias, using the Cochrane Back Review Group criteria. In the absence of clinical heterogeneity, we calculated standardized mean differences (SMD) and relative risks, and performed meta-analyses using a random-effects model. The quality of the evidence and the strength of recommendations were assigned an overall grade for each outcome. We included nine trials (503 participants). Only BoNT type A (BoNT-A) was used in these studies.High quality evidence suggests there was little or no difference in pain between BoNT-A and saline injections at four weeks (five trials; 252 participants; SMD pooled -0.07 (95% confidence intervals (CI) -0.36 to 0.21)) and six months for chronic neck pain. Very low quality evidence indicated little or no difference in pain between BoNT-A combined with physiotherapeutic exercise and analgesics and saline injection with physiotherapeutic exercise and analgesics for patients with chronic neck pain at four weeks (two trials; 95 participants; SMD pooled 0.09 (95% CI -0.55 to 0.73)) and six months (one trial; 24 participants; SMD -0.56 (95% CI -1.39 to 0.27)). Very low quality evidence from one trial (32 participants) showed little or no difference between BoNT-A and placebo at four weeks (SMD 0.16 (95% CI -0.53 to 0.86)) and six months (SMD 0.00 (95% CI -0.69 to 0.69)) for chronic cervicogenic headache. Very low quality evidence from one trial (31 participants), showed a difference in global perceived effect favouring BoNT-A in chronic neck pain at four weeks (SMD -1.12 (95% CI: -1.89 to -0.36)). Current evidence fails to confirm either a clinically important or a statistically significant benefit of BoNT-A injection for chronic neck pain associated with or without associated cervicogenic headache. Likewise, there was no benefit seen for disability and quality of life at four week and six months.
ObjectiveTo examine the efficacy and safety of pegloticase in combination with methotrexate (MTX)... more ObjectiveTo examine the efficacy and safety of pegloticase in combination with methotrexate (MTX) in patients with uncontrolled gout in an exploratory, open-label clinical trial (ClinicalTrials.gov: NCT03635957) prior to a randomized, controlled trial.MethodsA multicenter, open-label efficacy and safety study of pegloticase with MTX co-treatment was conducted in patients with uncontrolled gout. Patients were administered oral MTX (15 mg/week) and folic acid (1 mg/day) 4 weeks prior to and throughout pegloticase treatment. The primary study outcome was the proportion of responders, defined as serum uric acid (sUA) < 6 mg/dL for ≥ 80% of the time during Month 6 (Weeks 20, 22, and 24). All analyses were performed on a modified intent-to-treat population, defined as patients who received ≥ 1 pegloticase infusion.ResultsSeventeen patients were screened and 14 patients (all men, average age 49.3 ± 8.7 years) were enrolled. On Day 1, mean sUA was 9.2 ± 2.5 mg/dL, and 12 of the 14 patien...
Summary of Additional Endpoints during Part I (6 weeks of treatment). Table S2. Summary of Additi... more Summary of Additional Endpoints during Part I (6 weeks of treatment). Table S2. Summary of Additional Endpoints during Part II Among Inadequate Responders from Part I. (DOCX 21 kb)
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