The effects of platelet-rich plasma injection in knee and hip osteoarthritis: a meta-analysis of randomized controlled trials

Clinical Rheumatology - We conducted this updated meta-analysis to evaluate the effects of PRP in patients with knee or hip OA. PubMed, Embase, and Web of Science were searched to identify...     

Efficacy and safety of corticosteroid in the treatment of hand osteoarthritis: a systematic review and meta-analysis of randomized controlled trials

Clinical Rheumatology - To assess the efficacy and safety of corticosteroid therapy including oral corticosteroid and intra-articular corticosteroid in patients with hand osteoarthritis (OA), to...     

Efficacy and safety of drug-eluting stents in patients with acute ST-segment-elevation myocardial infarction: a meta-analysis of randomized controlled trials

We compared the efficacy and safety of drug-eluting stents with that of bare-metal stents in patients who experienced acute ST-segment-elevation myocardial infarction (STEMI) and underwent primary percutaneous coronary intervention. To do this, we performed a meta-analysis of 13 randomized controlled trials in which drug-eluting stents were compared with bare-metal stents in STEMI patients. The trials involved 6,769 patients (4,246 received drug-eluting stents and 2,523 received bare-metal stents) and follow-up periods of 6 to 48 months. In comparison with bare-metal stents, drug-eluting stents significantly reduced the incidence of major adverse cardiac events, with a risk ratio (RR) of 0.59 (95% confidence interval [CI], 0.47-0.73; P < 0.00001). Drug-eluting stents were not associated with a significant reduction in overall death (RR = 0.94; 95% CI, 0.74-1.20; P = 0.64), but were associated with significant reductions in recurrent myocardial infarction (RR = 0.76; 95% CI, 0.58-0.98; P = 0.03), target-vessel revascularization (RR = 0.47; 95% CI, 0.39-0.56; P <0.00001), and in-stent restenosis (RR = 0.32; 95% CI, 0.25-0.39; P < 0.00001). Moreover, no significant difference was found in the comparative risk of stent thrombosis (RR = 0.85; 95% CI, 0.63-1.14; P = 0.27).On the basis of risk ratio, we conclude that using drug-eluting stents in STEMI patients who undergo primary percutaneous coronary intervention is safe with regard to stent thrombosis within 48 months, and that drug-eluting stents improve clinical outcomes by reducing the risks of major adverse cardiac events, recurrent myocardial infarction, reintervention, and in-stent restenosis, compared with bare-metal stents. However, in order to investigate possible very late stent thrombosis, follow-up of these trials beyond 48 months is warranted.     

Efficacy and safety of ceftriaxone for uncomplicated gonorrhoea: a meta-analysis of randomized controlled trials

We conducted a systematic review and meta-analysis of ceftriaxone for treatment of uncomplicated gonorrhoea compared with four other antibiotics. Thirteen randomized controlled trials (RCTs) totalling treatment of 2557 patients with uncomplicated gonorrhoea were included. Statistically significant differences were observed in side-effects, which were increased after ceftriaxone 250 mg versus cefotaxime 500 mg (odds ratio [OR] 1.87; 95% confidence interval [CI] 1.14-3.08). Cure rates of ceftriaxone 250 mg were significantly better than cefixime 400 mg (OR 1.77; 95% CI 1.11-2.80) as was ceftriaxone 125 mg versus spectinomycin 2 g (OR 3.44; 95% CI 1.08-10.90). There was no statistically significant difference between ceftriaxone 250 mg and cefixime 800 mg in cure rates (OR 1.39; 95% CI 0.92-2.10) or adverse effects (OR 1.29, 95% CI 0.58-2.84) for treating uncomplicated gonorrhoea. The cure rate after ceftriaxone 250 mg was not significantly different from that after spectinomycin 2 g (OR 1.96; 95% CI 1.00-3.87). In conclusion, this meta-analysis revealed that 250 mg ceftriaxone had a higher efficacy than 400 mg cefixime for uncomplicated gonorrhoea. Also, ceftriaxone 125 mg is a better choice than spectinomycin 2 g for patients with uncomplicated gonorrhoea, but ceftriaxone had higher side-effect rates than cefotaxime. In the current era further randomized controlled clinical trials of ceftriaxone for uncomplicated gonorrhoea are warranted.     

Efficacy and safety of high-density lipoprotein cholesterol-increasing compounds: a meta-analysis of randomized controlled trials

OBJECTIVES: The aim of this research was to estimate the efficacy and safety of current high-density lipoprotein cholesterol (HDL-C)-increasing drugs. BACKGROUND: Epidemiologic evidence has shown that HDL-C is inversely related to coronary heart disease (CHD) risk. However, the evidence for reducing CHD risk by raising HDL-C is thin, predominantly due to the paucity of effective and safe HDL-increasing drugs. METHODS: Randomized controlled trials with fibrates and niacin, published between 1966 through February 2004 (MEDLINE), were retrieved. Information on treatment, baseline characteristics, serum lipids, end points, and side-effects were independently abstracted by two authors using a standardized protocol. RESULTS: Data from 53 trials (16,802 subjects) using fibrates and 30 trials (4,749 subjects) using niacin were included. Random-effects model showed 11% versus 10% reduction in total cholesterol, 36% versus 20% reduction in triglycerides, 8% versus 14% reduction in low-density lipoprotein cholesterol, and 10% versus 16% increase in HDL-C for fibrates and niacin, respectively. Apart from flushes in the niacin group, both fibrates and niacin were shown to be well-tolerated and safe. Fibrates reduced the risk for major coronary events by 25% (95% confidence interval 10% to 38%), whereas current available data for niacin indicate a 27% reduction. CONCLUSIONS: Fibrates reduce major coronary events and increase HDL-C levels without significant toxicity. Niacin has a more potent effect on HDL-C levels, whereas data on cardiovascular event rate reduction are limited. Future studies need to evaluate whether additional HDL increase by fibrates or particularly newer niacin formulations on top of statin therapy translates into further event reduction in high-risk subjects, without significant toxicity.     

Efficacy and safety of intraarticular hylan or hyaluronic acids for osteoarthritis of the knee: a randomized controlled trial

OBJECTIVE: To compare the efficacy and safety of intraarticular hylan and 2 hyaluronic acids (HAs) in osteoarthritis (OA) of the knee. METHODS: This was a multicenter, patient-blind, randomized controlled trial in 660 patients with symptomatic knee OA. Patients were randomly assigned to receive 1 cycle of 3 intraarticular injections per knee of 1 of 3 preparations: a high molecular weight cross-linked hylan, a non-cross-linked medium molecular weight HA of avian origin, or a non-cross-linked low molecular weight HA of bacterial origin. The primary outcome measure was the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 6 months. Secondary outcome measures included local adverse events (effusions or flares) in injected knees. During months 7-12, patients were offered a second cycle of viscosupplementation. RESULTS: Pain relief was similar in all 3 groups. The difference in changes between baseline and 6 months between hylan and the combined HAs was 0.1 on the WOMAC pain score (95% confidence interval [95% CI] -0.2, 0.3). No relevant differences were observed in any of the secondary efficacy outcomes, and stratified analyses provided no evidence for differences in effects across different patient groups. There was a trend toward more local adverse events in the hylan group than in the HA groups during the first cycle (difference 2.2% [95% CI -2.4, 6.7]), and this trend became more pronounced during the second cycle (difference 6.4% [95% CI 0.6, 12.2]). CONCLUSION: We found no evidence for a difference in efficacy between hylan and HAs. In view of its higher costs and potential for more local adverse events, we see no rationale for the continued use of hylan in patients with knee OA.     

Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with knee osteoarthritis: a randomized controlled non-inferiority trial

This study is aimed at comparing the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) with loxoprofen sodium tablet (LX-T) in patients with knee osteoarthritis (OA). One hundred sixty-nine patients were enrolled in a randomized, controlled, double-blind, double-dummy, multicenter, non-inferiority trial of LX-P. Patients were randomly assigned to either LX-P or LX-T groups for a 4-week treatment. The primary efficacy endpoint was the proportion of patients with an overall improvement of ≥50 %, and the secondary efficacy endpoint was the proportion of patients with an improvement of ≥25 % from baseline in each of the seven main symptoms. The non-inferiority trial was based on a power of 80 % and significance level of 2.5 % with a non-inferiority margin of ?10 %. In both intention-to-treat (ITT) and per-protocol (PP) analyses, LX-P was as effective as LX-T in regard to the primary endpoint. In the ITT analysis, the difference between the two groups was 12.6 % [95 % confidence interval, ?1.7 to 26.9 %]. No significant differences were found between the two groups in any of the secondary efficacy outcomes. A lower incidence of adverse events was observed in LX-P group; however, the difference was not statistically significant. No serious adverse events were reported in the LX-P group, whereas one case was reported in LX-T group. Based on the present study, topical loxoprofen patch was non-inferior to oral loxoprofen in patients with knee osteoarthritis.     

Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials

Clinical Rheumatology - To address the efficacy and safety of secukinumab in comparison with placebo in active rheumatoid arthritis (RA) patients who had an inadequate response to tumor necrosis...     

Acupuncture in patients with osteoarthritis of the knee or hip: a randomized, controlled trial with an additional nonrandomized arm

OBJECTIVE: To investigate the effectiveness of acupuncture in addition to routine care, compared with routine care alone, in the treatment of patients with chronic pain due to osteoarthritis (OA) of the knee or hip. METHODS: In a randomized, controlled trial, patients with chronic pain due to OA of the knee or hip were randomly allocated to undergo up to 15 sessions of acupuncture in a 3-month period or to a control group receiving no acupuncture. Another group of patients who did not consent to randomization underwent acupuncture treatment. All patients were allowed to receive usual medical care in addition to the study treatment. Clinical OA severity (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) and health-related quality of life (Short Form 36) were assessed at baseline and after 3 months and 6 months. RESULTS: Of 3,633 patients (mean +/- SD age 61.8 +/- 10.8 years; 61% female), 357 were randomized to the acupuncture group and 355 to the control group, and 2,921 were included in the nonrandomized acupuncture group. At 3 months, the WOMAC had improved by a mean +/- SEM of 17.6 +/- 1.0 in the acupuncture group and 0.9 +/- 1.0 in the control group (3-month scores 30.5 +/- 1.0 and 47.3 +/- 1.0, respectively [difference in improvement 16.7 +/- 1.4; P < 0.001]). Similarly, quality of life improvements were more pronounced in the acupuncture group versus the control group (P < 0.001). Treatment success was maintained through 6 months. The changes in outcome in nonrandomized patients were comparable with those in randomized patients who received acupuncture. CONCLUSION: These results indicate that acupuncture plus routine care is associated with marked clinical improvement in patients with chronic OA-associated pain of the knee or hip.     

Topical diclofenac therapy for osteoarthritis: a meta-analysis of randomized controlled trials

The objective of this study was to evaluate the efficacy and safety of topical diclofenac therapy for osteoarthritis (OA). A meta-analysis of randomized controlled trials was conducted. A comprehensive literature search, covering the databases of Medline, the Cochrane Central Register of Controlled Trials, and EMBASE, was conducted in September 2014 to identify the randomized controlled trials which adopted the topical diclofenac therapy for OA. A total of nine papers were included in this meta-analysis. Topical diclofenac appears to be effective in both pain relief (standard mean differences (SMD)?=?0.40; 95 % confidence interval (CI) 0.19 to 0.62; P?=?0.0003) and function improvement (SMD?=?0.23; 95 % CI 0.03 to 0.43; P?=?0.03) when compared with the control group. The sensitivity analysis and subgroup analysis showed that the result of pain intensity was stable and reliable, while the result of physical function improvement was vague. With respect to safety, topical diclofenac demonstrated a higher incidence of adverse events such as dry skin, rash, dermatitis, neck pain, and withdrawal. Topical diclofenac is effective in pain relief as a treatment of OA. It may also have a potential effect in function improvement, which needs further studies to be explored. Although, some adverse effects were observed in the application of topical diclofenac, none of them was serious.     

Efficacy and safety of Lianhuaqingwen for mild or moderate coronavirus disease 2019: A meta-analysis of randomized controlled trials

Background: Coronavirus disease 2019 (COVID-19) is an emerging and rapidly evolving disease, with no recommended effective anti-coronavirus treatments. Traditional Chinese Medicine (TCM) has been widely used to treat COVID-19 in China, and the most used one is Lianhuaqingwen (LH). This study aimed to assess the efficacy and safety of LH combined with usual treatment vs usual treatment alone in treating mild or moderate COVID-19 by a meta-analysis of randomized controlled trials (RCTs).Methods and analysis: We systematically searched the Medline (OVID), Embase, the Cochrane Library, and 4 Chinese databases from inception to July 2020 to include the RCTs that evaluated the efficacy and safety of LH in combination with usual treatment vs usual treatment for mild or moderate COVID-19. A meta-analysis was performed to calculate the risk ratio (RR) and 95% confidence interval (CI) for binary outcomes and mean difference (MD) for continuous outcomes.Results: A total of 5 RCTs with 824 individuals with mild or moderate COVID 19 were included. Compared with the usual treatment alone, LH in combination with usual treatment significantly improved the overall clinical efficacy (RR = 2.39, 95% CI 1.61–3.55), increased the rate of recovery of chest computed tomographic manifestations (RR = 1.80, 95% CI 1.08–3.01), reduced the rate of conversion to severe cases (RR = 0.47, 95% CI 0.29–0.74), shorten the duration of fever (MD = −1.00, 95% CI −1.17 to −0.84). Moreover, LH in combination with usual treatment did not increase the occurrence of the adverse event compared to usual treatment alone.Conclusion: Our meta-analysis of RCTs indicated that LH in combination with usual treatment may improve the clinical efficacy in patients with mild or moderate COVID-19 without increasing adverse events. However, given the limitations and poor quality of included trials in this study, further large-sample RCTs or high-quality real-world studies are needed to confirm our conclusions.     

Efficacy and safety of interleukin-17A inhibitors in patients with ankylosing spondylitis: a systematic review and meta-analysis of randomized controlled trials

Clinical Rheumatology - To assess the efficacy and safety of interleukin (IL)-17A inhibitors in patients with ankylosing spondylitis (AS). PubMed, EMBASE, and Web of Science were searched up to 5...     

Efficacy and safety of rofecoxib 12.5 mg versus nabumetone 1,000 mg in patients with osteoarthritis of the knee: a randomized controlled trial

OBJECTIVES: To evaluate the use of starting doses of rofecoxib and nabumetone in patients with osteoarthritis (OA) of the knee. DESIGN: A 6-week, randomized, parallel-group, double-blind, placebo-controlled study. SETTING: One hundred thirteen outpatient sites in the United States. PARTICIPANTS: A total of 1,042 male and female patients aged 40 and older with OA of the knee (>6 months). INTERVENTIONS: Rofecoxib 12.5 mg once a day (n=424), nabumetone 1,000 mg once a day (n=410), or placebo (n=208) for 6 weeks. MEASUREMENTS: The primary efficacy endpoint was patient global assessment of response to therapy (PGART) over 6 weeks, which was also specifically evaluated over the first 6 days. The main safety measure was adverse events during the 6 weeks of treatment. RESULTS: The percentage of patients with a good or excellent response to therapy as assessed using PGART at Week 6 was significantly higher with rofecoxib (55.4%) than nabumetone (47.5%; P=.018) or placebo (26.7%; P<.001 vs rofecoxib or nabumetone). Median time to first report of a good or excellent PGART response was significantly shorter in patients treated with rofecoxib (2 days) than with nabumetone (4 days, P=.002) and placebo (>5 days, P<.001) (nabumetone vs placebo; P=.007). The safety profiles of rofecoxib and nabumetone were generally similar, including gastrointestinal, hypertensive, and renal adverse events. CONCLUSION: Rofecoxib 12.5 mg daily demonstrated better efficacy over 6 weeks of treatment and quicker onset of OA efficacy over the first 6 days than nabumetone 1,000 mg daily. Both therapies were generally well tolerated.     

Efficacy and safety of thread embedding acupuncture for knee osteoarthritis: A randomized controlled pilot trial

Background:Thread embedding acupuncture (TEA) is a widely used clinical procedure for the treatment of musculoskeletal pain. However, few clinical studies have been conducted on the efficacy and safety of TEA for knee osteoarthritis (KOA), and data from randomized controlled trials are lacking. This randomized controlled pilot study aimed to assess the feasibility of conducting large-scale studies on the efficacy and safety of TEA for KOA.Methods:Forty participants were included in the study and randomly divided into 2 groups (TEA and acupuncture) of 20 each. The intervention period was 6 weeks. The experimental group received TEA once a week (total of 6 sessions) on 14 defined knee areas, and the control group received acupuncture twice a week (total of 12 sessions) on 9 defined acupuncture points. The primary outcome measure was the visual analogue scale score, and the secondary outcome measures were the short-form McGill pain questionnaire, and Western Ontario and McMaster Universities Osteoarthritis Index scores. Participants were assessed prior to the intervention (baseline) and at 3, 6, and 10 weeks (4 weeks after the end of intervention). The adverse effects of TEA and acupuncture were documented. Hematological examination and biochemical tests were performed at the screening and at 6 weeks.Results:Of the 40 participants, 37 completed the study and 3 participants dropped out. Both the TEA and acupuncture groups showed a significant improvement in the visual analogue scale, short-form McGill Pain Questionnaire, and Western Ontario and McMaster Universities Osteoarthritis Index scores in a time-dependent manner. However, there was no significant interaction between group and time. No serious adverse events were reported in the groups, and no clinically significant changes were observed in the hematological and biochemical parameters.Conclusion:This pilot study suggests that TEA is a safe and effective procedure for relieving pain in patients with KOA. The results of this study provide basic data and indicate the feasibility of large-scale clinical studies to evaluate the efficacy and safety of TEA for KOA.     

Total shoulder arthroplasty versus hemiarthroplasty in patients with shoulder osteoarthritis: A meta-analysis of randomized controlled trials

Objectives

Total shoulder arthroplasty (TSA) and hemiarthroplasty (HA) are treatment choices for end-stage shoulder osteoarthritis. The decision of whether to use TSA or HA is controversial. The objective of this study was to compare the effects of TSA and HA for shoulder osteoarthritis.

Methods

We conducted a search for clinical studies that had been published in any language in December 2012 or before. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and several other databases. Randomized and quasi-randomized controlled clinical studies that evaluated different methods were included. At least two review authors independently performed the study selection, data collection, and data extraction. The software Revman 5.1 was used for the statistical analysis.

Results

This study included 4 clinical trials. Two of the trials were published clinical trials, and the other 2 clinical trials were presented as unpublished abstracts. A total of 146 patients with 153 shoulders were included in the trials. Compared with HA, TSA presents with a higher UCLA shoulder scale (MD 3.10, 95% CI 1.13–5.08) and a higher ASES (MD 10.17, 95% CI 1.40–18.87). There was no significant difference between TSA and HA for revision (RR 0.35, 95% CI 0.10–1.19), WOOS (MD 9.10, 95% CI −2.72 to 20.92), and incidence of instability (RR 0.88, 95% CI 0.19–3.98). HA had a lower operation time (MD 39.00, 95% CI 17.05–60.95).

Conclusion

The available evidence suggests that TSA is more effective than HA for patients with shoulder arthritis.     

Efficacy and safety of diacerein in early knee osteoarthritis: a randomized placebo-controlled trial

The objective of this study was to evaluate the efficacy and safety of diacerein in early, symptomatic knee osteoarthritis in Indian population. Sixty-four patients of knee osteoarthritis fulfilling American College of Rheumatology Criteria were randomized to receive either diacerein or placebo for 8 weeks, followed by 4 weeks “treatment-free” follow-up in this single-blind, parallel group, post-marketing trial. Primary efficacy variable was visual analogue scale (VAS) assessment of pain on movement; secondary efficacy variables included Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC) subscores for stiffness and physical function, rescue medication use and physician's clinical global impression (CGI). Compared to placebo, diacerein showed highly significant (p < 0.01) reductions in VAS pain scores, significant (p < 0.05) reductions in WOMAC physical function scores, significantly lower requirement for rescue medication, and significantly better CGI grades. Incidence of adverse events were significantly (p < 0.01) higher in diacerein arm with urine discoloration and soft stool being the most common ones. However, most events were of mild to moderate intensity. In Indian patients with knee osteoarthritis, diacerein effectively reduces pain and improves physical function, and despite frequent adverse events, overall tolerability seemed to be good.