Efficacy and safety of Sahastara remedy for pain relief: A systematic review and meta-analysis of randomized controlled trials

The Sahastara (SHT) remedy is an herbal medicine that can be used as an alternative treatment for improving pain symptoms. The aim of this study was to evaluate the efficacy and safety of the SHT remedy for pain relief. PubMed, Scopus, ScienceDirect, TCI, and ThaiLis were systematically searched for relevant articles from inception to April 2021. We only included randomized clinical trials (RCTs) in which the efficacy and safety of the SHT remedy were compared with those of non-steroidal anti-inflammatory drugs (NSAIDs). Study selection, data extraction, and quality assessment were independently performed by two reviewers. The clinical therapeutic outcomes were the pain score, WOMAC score, Oswestry Disability Index score, 100 meters walk result, global assessment, and adverse events of the SHT remedy. The outcomes were assessed and pooled using a random-effects model. Heterogeneity was assessed using the I2 test. Four studies with 213 participants were included in the analysis. The efficacy of the SHT remedy was not different from that of NSAIDs in terms of the pain score (standardized mean difference [SMD] = -0.31; 95% CI = -1.26, 0.65; I2 = 91%), WOMAC score (SMD = 0.05; 95% CI = -0.30, 0.41; I2 = 0.0%), Oswestry Disability Index score (SMD = -0.41, 95% CI = -1.18, 0.35), 100 meters walk result (SMD = 0.31; 95% CI = -0.25, 0.87; I2 = 0.0%), and global assessment (relative risk = 0.85; 95% CI = 0.62, 1.16; I2 = 0.0%). Moreover, there were no statistically significant differences between the SHT remedy and NSAID treatment groups in terms of adverse events or liver function. This meta-analysis demonstrated that the SHT remedy is not different from NSAIDs in terms of clinical therapeutic efficacy and adverse events. However, larger and well-designed studies are needed to confirm this conclusion.

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The Clinical Efficacy and Safety of Gumiganghwal-Tang in Knee Osteoarthritis: A Phase II Randomized Double Blind Placebo Controlled Study

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2018/3165125 ◽

2018 ◽

Vol 2018 ◽

pp. 1-8 ◽

Cited By ~ 2

Author(s):

Sung Hae Chang ◽

Yun-Kyung Song ◽

Seong-Su Nah

Keyword(s):

Adverse Events ◽

Knee Osteoarthritis ◽

Knee Pain ◽

Clinical Efficacy ◽

Global Assessment ◽

Womac Score ◽

Controlled Study ◽

Dependent Manner ◽

Efficacy And Safety ◽

Total Womac Score

Background. Gumiganghwal-tang (GMGHT) is a traditional herbal medicine consisting of nine different herbs. GMGHT inhibits the mRNA expression and production of inflammatory cytokines tumor necrosis factor-α (TNF- α), interleukin-6 (IL-6), and TNF- β on lipopolysaccharide- (LPS-) stimulated peritoneal macrophages in a dose-dependent manner. It is empirically used for the treatment of inflammatory disease, but there are few reports of clinical trials that investigate its efficacy and safety. The current study aimed to investigate the clinical efficacy and safety of GMGHT in patients with knee osteoarthritis (OA). Methods. This was a multicenter, two-armed, double-blinded, randomized, placebo controlled study of GMGHT over 6 weeks. Eligible patients who fulfilled the American College of Rheumatology criteria for OA were randomized to receive either GMGHT or the placebo. Clinical assessments included measurement of knee pain and function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), patient global assessment (PGA), and knee pain scores every 2 weeks. Results. A total of 128 patients were enrolled (91.4% female; mean age, 58.7 ± 8.1 years). At baseline, pain visual analogue score (VAS) was 67.2 ± 1.4, resp. 71.3 ± 1.6 (treatment, resp. placebo group, p=0.84), and total WOMAC score was 55.2 ± 1.6, resp. 55.6 ± 1.5 (p = 0.84). After 6 weeks, the pain VAS was 43.0 ± 2.5, resp. 61.6 ± 2.5 (p < 0.01) and the total WOMAC score was 34.1 ± 2.4, resp. 46.9 ± 1.8 (p < 0.01). No patients withdrew because of treatment emergent adverse events. Expected adverse events including dyspepsia, liver function abnormality, and lower extremity edema were comparable between both groups. Conclusions. Treatment with GMGHT resulted in significant improvement in pain, function, and global assessment, and it was generally safe and well tolerated in patients with OA.

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The efficacy and safety of Curcuma longa Extract and curcumin supplements on osteoarthritis: a systematic review and meta-analysis

Bioscience Reports ◽

10.1042/bsr20210817 ◽

2021 ◽

Author(s):

Liuting Zeng ◽

Kailin Yang ◽

Wensa Hao ◽

Ganpeng Yu ◽

Hua Chen

Keyword(s):

Adverse Events ◽

Curcuma Longa ◽

Meta Analysis ◽

Score Function ◽

Womac Score ◽

Cochrane Library ◽

Efficacy And Safety ◽

Bias Assessment ◽

Randomized Controlled ◽

Evidence Quality

Objective: To assess the efficacy and safety of Curcuma longa Extract and curcumin supplements on osteoarthritis (OA). Methods: The databases such as Pubmed and Cochrane Library were searched to collect the article about Curcuma longa Extract and curcumin in the treatment of OA. Then, randomized controlled trials (RCTs) were selected and their data was extracted. Finally, the RevMan5.3 was utilized for risk of bias assessment and meta-analysis, the STATA15.0 were utilized for publication bias assessment, and GRADE tool were used for the evidence quality assessment of primary outcomes. Results: A total of 15 RCTs involving 1621 participants were included. (1) Compared with placebo, Curcuma longa Extract and curcumin (C.) can decrease the VAS and WOMAC score-pain, the WOMAC score-function and the WOMAC score-stiffness. In terms of adverse events, Curcuma longa Extract and curcumin are comparable to those of placebo. (2) Compared with NSAIDs, Curcuma longa Extract and curcumin have similar effects on joint pain, function and stiffness. The incidence of adverse events in Curcuma longa Extract and curcumin was lower. (3) Compared with the NSAIDs group, C.+NSAIDs can also decrease the VAS and WOMAC score-pain, the WOMAC score-function and the WOMAC score-stiffness. In terms of adverse events, the addition of Curcuma longa Extract and curcumin to NSAIDs did not increase adverse events. Conclusion: Curcuma longa Extract and curcumin may be a safer and effective supplement for OA patients. It is recommended to use Curcuma longa Extract and curcumin supplement for OA patients for more than 12 weeks.

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Efficacy and Safety of Antigen-specific Immunotherapy in the Treatment of Patients with Non-small-cell Lung Cancer: A Systematic Review and Meta-analysis

Current Cancer Drug Targets ◽

10.2174/1568009618666180430124738 ◽

2019 ◽

Vol 19 (3) ◽

pp. 199-209 ◽

Cited By ~ 1

Author(s):

Bing-Di Yan ◽

Xiao-Feng Cong ◽

Sha-Sha Zhao ◽

Meng Ren ◽

Zi-Ling Liu ◽

...

Keyword(s):

Lung Cancer ◽

Systematic Review ◽

Adverse Events ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Specific Immunotherapy ◽

Meta Analysis ◽

Small Cell ◽

Efficacy And Safety ◽

Small Cell Lung

Background and Objective: We performed this systematic review and meta-analysis to assess the efficacy and safety of antigen-specific immunotherapy (Belagenpumatucel-L, MAGE-A3, L-BLP25, and TG4010) in the treatment of patients with non-small-cell lung cancer (NSCLC). Methods: A comprehensive literature search on PubMed, Embase, and Web of Science was conducted. Eligible studies were clinical trials of patients with NSCLC who received the antigenspecific immunotherapy. Pooled hazard ratios (HRs) with 95% confidence intervals (95%CIs) were calculated for overall survival (OS), progression-free survival (PFS). Pooled risk ratios (RRs) were calculated for overall response rate (ORR) and the incidence of adverse events. Results: In total, six randomized controlled trials (RCTs) with 4,806 patients were included. Pooled results showed that, antigen-specific immunotherapy did not significantly prolong OS (HR=0.92, 95%CI: 0.83, 1.01; P=0.087) and PFS (HR=0.93, 95%CI: 0.85, 1.01; P=0.088), but improved ORR (RR=1.72, 95%CI: 1.11, 2.68; P=0.016). Subgroup analysis based on treatment agents showed that, tecemotide was associated with a significant improvement in OS (HR=0.85, 95%CI: 0.74, 0.99; P=0.03) and PFS (HR=0.70, 95%CI: 0.49, 0.99, P=0.044); TG4010 was associated with an improvement in PFS (HR=0.87, 95%CI: 0.75, 1.00, P=0.058). In addition, NSCLC patients who were treated with antigen-specific immunotherapy exhibited a significantly higher incidence of adverse events than those treated with other treatments (RR=1.11, 95%CI: 1.00, 1.24; P=0.046). Conclusion: Our study demonstrated the clinical survival benefits of tecemotide and TG4010 in the treatment of NSCLC. However, these evidence might be limited by potential biases. Therefore, further well-conducted, large-scale RCTs are needed to verify our findings.

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Comparative efficacy and safety of different regimens of ranibizumab for neovascular age-related macular degeneration: a network meta-analysis of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2020-040906 ◽

2021 ◽

Vol 11 (2) ◽

pp. e040906

Author(s):

Xinyu Zhao ◽

Lihui Meng ◽

Youxin Chen

Keyword(s):

Adverse Events ◽

Macular Degeneration ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Age Related Macular Degeneration ◽

Controlled Trials ◽

Cochrane Central Register ◽

Efficacy And Safety ◽

Age Related ◽

Randomised Controlled

ObjectiveTo give a comprehensive efficacy and safety ranking of different therapeutic regimens of ranibizumab for neovascular age-related macular degeneration (nAMD).DesignA systematic review and network meta-analysis.MethodsThe PubMed, Embase, Cochrane Central Register of Controlled Trials, and other clinical trial registries were searched up to 1 October 2019 to identify related randomised controlled trials (RCT) of different regimens of ranibizumab for nAMD. The primary efficacy outcome was the changes of best-corrected visual acuity (BCVA) at 1 year, the primary safety outcome was the incidence of severe ocular adverse events. Secondary outcomes such as changes of central retinal thickness (CRT) were evaluated. We estimated the standardised mean difference (SMD), ORs, 95% CIs, the surface under the cumulative ranking curves and the mean ranks for each outcome using network meta-analyses with random effects by Stata 14.0.ResultsWe identified 26 RCTs involving 10 821 patients with nAMD randomly assigned to 21 different therapeutic regimens of ranibizumab or sham treatment. Ranibizumab 0.5 mg (treat and extend, T&E) is most effective in terms of changes of BCVA (letters, SMD=21.41, 95% CI 19.86 to 22.95) and three or more lines of BCVA improvement (OR=2.83, 95% CI 1.27 to 4.38). However, it could not significantly reduce retreatment times compared with monthly injection (SMD=−0.94, 95% CI −2.26 to 0.39). Ranibizumab 0.5 mg (3+pro re nata)+non-steroidal anti-inflammatory drugs (NSAIDs) is most effective in reducing CRT and port delivery system of ranibizumab (100 mg/mL) could reduce the number of retreatment most significantly. All regimes have no more risk of severe ocular complications (including vitreous haemorrhage, rhegmatogenous retinal detachment, endophthalmitis, retinal tear and retinal pigment epithelium tear) or cardiocerebral vascular complications.ConclusionsRanibizumab 0.5 mg (T&E) is most effective in improving the visual outcome. The administration of topical NSAIDs could achieve additional efficacy in CRT reduction and visual improvement. Both interventions had acceptable risks of adverse events.

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Inhaled Levodopa (CVT-301) for the Treatment of Parkinson Disease: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Neurology Clinical Practice ◽

10.1212/cpj.0000000000001143 ◽

2021 ◽

pp. 10.1212/CPJ.0000000000001143

Author(s):

Glenardi Glenardi ◽

Tutwuri Handayani ◽

Jimmy Barus ◽

Ghea Mangkuliguna

Keyword(s):

Systematic Review ◽

Placebo Group ◽

Adverse Events ◽

Respiratory Symptoms ◽

Meta Analysis ◽

Motor Fluctuation ◽

Controlled Trials ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Improve Motor Function

ABSTRACTPurposeof Review: To investigate the efficacy and safety of CVT-301 for motor fluctuation in Parkinson’s disease (PD).Recent Findings:This study demonstrated that the CVT-301 group had a higher proportion of patients achieving an ON state than the placebo group (OR=2.68; 95% CI: 1.86-3.86; p<0.00001). Moreover, CVT-301 had also shown to improve motor function by UPDRS-III score (SMD=3.83; 95% CI: 2.44-5.23; p<0.00001) and promote an overall improvement of PD by PGIC self-rating (OR=2.95; 95% CI: 1.78-4.9; p<0.00001). The most common adverse events encountered were respiratory symptoms (OR=12.18; 95% CI: 5.01-29.62; p<0.00001) and nausea (OR=3.95; 95% CI: 1.01-15.41; p=0.05).Summary:CVT-301 had the potential to be an alternative or even a preferred treatment for motor fluctuation in PD patients.

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Efficacy and safety of omalizumab in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2020-047344 ◽

2021 ◽

Vol 11 (9) ◽

pp. e047344

Author(s):

Qingwu Wu ◽

Lianxiong Yuan ◽

Huijun Qiu ◽

Xinyue Wang ◽

Xuekun Huang ◽

...

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Chronic Rhinosinusitis ◽

Randomised Controlled Trials ◽

Nasal Polyps ◽

Meta Analysis ◽

Cochrane Library ◽

Controlled Trials ◽

Efficacy And Safety ◽

Randomised Controlled

ObjectivesTo assess the efficacy and safety of omalizumab for chronic rhinosinusitis with nasal polyps (CRSwNP) and to identify evidence gaps that will guide future research on omalizumab for CRSwNP.DesignSystematic review and meta-analysis.Data sourcesA comprehensive search was performed in PubMed, Embase, Web of Science and the Cochrane Library on 13 October 2020.Eligibility criteriaRandomised controlled trials (RCTs) comparing omalizumab with placebo, given for at least 16 weeks in adult patients with CRSwNP.Data extraction and synthesisTwo independent authors screened search results, extracted data and assessed studies using the Cochrane risk of bias tool. Data were pooled using the inverse-variance method and expressed as mean differences (MDs) with 95% CIs. Heterogeneity was assessed by the χ2 test and the I2 statistic.ResultsA total of four RCTs involving 303 participants were identified. When comparing omalizumab to placebo, there was a significant difference in Nasal Polyps Score (MD=−1.20; 95% CI −1.48 to −0.92), Nasal Congestion Score (MD=−0.67; 95% CI −0.86 to −0.48), Sino-Nasal Outcome Test-22 (MD=−15.62; 95% CI −19.79 to −11.45), Total Nasal Symptom Score (MD=−1.84; 95% CI −2.43 to −1.25) and reduced need for surgery (risk ratio (RR)=5.61; 95% CI 1.99 to 15.81). Furthermore, there was no difference in the risk of serious adverse events ((RR=1.40; 95% CI 0.29 to 6.80), adverse events (RR=0.83; 95% CI 0.60 to 1.15) and rescue systemic corticosteroid (RR=0.52; 95% CI 0.17 to 1.61).ConclusionsThis was the first meta-analysis that identified omalizumab significantly improved endoscopic, clinical and patient-reported outcomes in adults with moderate to severe CRSwNP and it was safe and well tolerated.PROSPERO registration numberCRD42020207639.

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Efficacy and safety of pirfenidone in the treatment of idiopathic pulmonary fibrosis patients: a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2021-050004 ◽

2021 ◽

Vol 11 (12) ◽

pp. e050004

Author(s):

Wenjuan Wu ◽

Lingxiao Qiu ◽

Jizhen Wu ◽

Xueya Liu ◽

Guojun Zhang

Keyword(s):

Systematic Review ◽

Idiopathic Pulmonary Fibrosis ◽

Pulmonary Fibrosis ◽

Adverse Events ◽

Acute Exacerbation ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Controlled Trials ◽

Efficacy And Safety ◽

Randomised Controlled

ObjectivesIdiopathic pulmonary fibrosis (IPF) has been defined as a distinctive type of chronic fibrotic disease, characterised by a progressive decline in lung function and a common histological pattern of interstitial pneumonia. To analyse the efficacy and safety of pirfenidone in the treatment of IPF, a systematic review and meta-analysis was performed.DesignThis is a meta-analysis study.ParticipantsPatients were diagnosed as IPF.InterventionsUse of pirfenidone.Primary and secondary outcomeProgression-free survival (PFS), acute exacerbation and worsening of IPF and Impact on adverse events.MeasuresThe inverse variance method for the random-effects model was used to summarise the dichotomous outcomes, risk ratios and 95% CIs.ResultsA total of 9 randomised controlled trials with 1011 participants receiving pirfenidone and 912 controls receiving placebo were summarised. The pooled result suggested a statistically significant difference inall-cause mortality after pirfenidone use, with a summarised relative ratio of 0.51 (p<0.01). Longer PFS was observed in patients receiving pirfenidone compared with those who were given placebo (p<0.01). The IPF groups presented a high incidence of adverse events with a pooled relative ratio of 3.89 (p<0.01).ConclusionsPirfenidone can provide survival benefit for patients with IPF. Pirfenidone treatment was also associated with a longer PFS, a lower incidence of acute exacerbation and worsening of IPF.

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Efficacy and safety of repetitive transcranial magnetic stimulation for generalised anxiety disorder: A meta-analysis

General Psychiatry ◽

10.1136/gpsych-2019-100051 ◽

2019 ◽

Vol 32 (5) ◽

pp. e100051

Author(s):

Huiru Cui ◽

Lijuan Jiang ◽

Yanyan Wei ◽

Wei Li ◽

Hui Li ◽

...

Keyword(s):

Transcranial Magnetic Stimulation ◽

Anxiety Disorder ◽

Adverse Events ◽

Magnetic Stimulation ◽

Repetitive Transcranial Magnetic Stimulation ◽

Meta Analysis ◽

Risk Of Bias ◽

Efficacy And Safety ◽

Generalised Anxiety Disorder ◽

Grade Approach

BackgroundPharmacological and conventional non-pharmacological treatments are only moderately effective in treating generalised anxiety disorder (GAD). Recently, repetitive transcranial magnetic stimulation (rTMS) has attracted interest because of its potential therapeutic value.AimTo investigate the efficacy and safety of rTMS treatment for GAD.MethodsLiterature studies published in English or Chinese were screened in 10 electronic databases up to 5 December 2018. The included studies’ bias risk was assessed using Cochrane risk of bias assessment tool. Meta-analysis was performed to compute the standardised mean difference (SMD) and risk ratio (RR) along with its 95% CIs through using RevMan V.5.3. Heterogeneity was inspected by I2 and the χ2 test. We performed subgroup analysis and meta-regression to investigate heterogeneity. We used funnel plot to assess publication bias. We used the GRADE approach to assess the whole quality of evidence.ResultsTwenty-one studies, with a total sample size of 1481, were analysed. The risk of bias in most studies included is moderate, the majority of which are lacking of blinding methods of treatment allocation. The treatment had beneficial effects in the rTMS group compared with the control group in mean anxiety score (SMD=−0.68; 95% CI −0.89 to −0.46). None of the 21 studies included here reported severe adverse events. As for dropout rates, there are no statistically significant differences between the two groups (RR 1.14, 95% CI 0.72 to 1.82) or adverse events (RR 0.95, 95% CI 0.77 to 1.18). No particular influence on the heterogeneity of any variable was observed. The risk of publication bias was low. According to the GRADE approach, the evidence levels of primary outcome (treatment effects) and secondary outcomes (acceptability and safety) were rated as ‘medium’.ConclusionThe use of rTMS combined with medication treatment may have a significant positive anti-anxiety effect on patients with GAD. However, we should interpret the results cautiously due to the relatively high heterogeneity of the meta-analysis. Future high-quality clinical trials are needed to confirm our results.

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Lamotrigine augmentation in treatment-resistant unipolar depression: A comprehensive meta-analysis of efficacy and safety

Journal of Psychopharmacology ◽

10.1177/0269881119844199 ◽

2019 ◽

Vol 33 (6) ◽

pp. 700-713 ◽

Cited By ~ 2

Author(s):

Kah Kheng Goh ◽

Chun-Hsin Chen ◽

Yi-Hang Chiu ◽

Mong-Liang Lu

Keyword(s):

Adverse Events ◽

Rating Scale ◽

Meta Analysis ◽

Unipolar Depression ◽

Severe Illness ◽

Discontinuation Rate ◽

Efficacy And Safety ◽

Treatment Resistant ◽

Chinese Studies ◽

Hamilton Rating Scale

Objective: Augmentation strategies are commonly applied when an individual is unresponsive to antidepressant monotherapy. Lamotrigine is currently considered at best only as second line augmentation for treatment-resistant unipolar depression while its clinical efficacy and safety profiles remain inconclusive. We intended to assess the therapeutic effects and safety profiles of lamotrigine augmentation in patients with treatment-resistant unipolar depression by conducting a meta-analysis. Methods: MEDLINE, Embase, EBSCO, Cochrane, Web of Science, Scopus, Wanfang and Ariniti databases were searched. Coprimary outcomes, including changes in severity of depression and response rate, were measured in this study. Secondary outcomes were defined as the safety profile of the intervention, including reported discontinuation rate and adverse events. Results: Eight double-blinded randomized controlled trials with 677 patients overall were included. Significant improvements in Hamilton Rating Scale for Depression scores and response rates were shown in lamotrigine augmentation groups compared with control groups, of which the pooled result of six Chinese studies showed positive effects of Hamilton Rating Scale for Depression improvement while the pooled result of two non-Chinese studies was statistically non-significant. Patients with more severe illness and longer duration of illness were more effectively treated with lamotrigine augmentation. The magnitude of depression improvement after lamotrigine augmentation was higher in patients treated with selective serotonin reuptake inhibitors than those treated with serotonin-norepinephrine reuptake inhibitors. Lamotrigine augmentation is well-tolerated in terms of all-cause discontinuation rate and adverse events. Conclusions: Lamotrigine augmentation may serve as a possible choice for patients with treatment-resistant unipolar depression and further trials are warranted to clarify the optimal dosage of lamotrigine augmentation together with the treatment duration and safety over time.

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Efficacy and safety of iron therapy in patients with chronic heart failure and iron deficiency: a systematic review and meta-analysis based on 15 randomised controlled trials

Postgraduate Medical Journal ◽

10.1136/postgradmedj-2019-137342 ◽

2020 ◽

pp. postgradmedj-2019-137342

Author(s):

Junyi Zhang ◽

Shengda Hu ◽

Yufeng Jiang ◽

Yafeng Zhou

Keyword(s):

Heart Failure ◽

Chronic Heart Failure ◽

Adverse Events ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Iron Therapy ◽

Controlled Trials ◽

Efficacy And Safety ◽

6Mwt Distance ◽

Randomised Controlled

Trials studying iron administration in patients with chronic heart failure (CHF) and iron deficiency (ID) have sprung up these years but the results remain inconsistent. The aim of this meta-analysis was to comprehensively evaluate the efficacy and safety of iron therapy in patients with CHF and ID. A literature search was conducted across PubMed, Embase, Cochrane Library, OVID and Web of Science up to 31 July 2019 to search for randomised controlled trials (RCT) comparing iron therapy with placebo in CHF with ID, regardless of presence of anaemia. Published studies reporting data of any of the following outcomes were included: all-cause death, cardiovascular hospitalisation, adverse events, New York Heart Association (NYHA) functional class, left ventricular ejection fraction (LVEF), N-terminal pro b-type natriuretic peptide, peak oxygen consumption, 6 min walking test (6MWT) distance and quality of life (QoL) parameters. 15 RCTs with a total of 1627 patients (911 in iron therapy and 716 in control) were included. Iron therapy was demonstrated to reduce the risk of cardiovascular hospitalisation (OR 0.35, 95% CI 0.12 to 0.99, p=0.049), but was ineffective in reducing all-cause death (OR 0.59, 95% CI 0.33 to 1.06, p=0.078) or cardiovascular death (OR 0.80, 95% CI 0.39 to 1.63, p=0.540). Iron therapy resulted in a reduction in NYHA class (mean difference (MD) −0.73, 95% CI −0.99 to −0.47, p<0.001), an increase in LVEF (MD +4.35, 95% CI 0.69 to 8.00, p=0.020), 6MWT distance (MD +35.44, 95% CI 11.55 to 59.33, p=0.004) and an improvement in QoL: EQ-5D score (MD +4.07, 95% CI 0.84 to 7.31, p=0.014); Minnesota Living With Heart Failure Questionnaire score (MD −19.47, 95% CI −23.36 to −15.59, p<0.001) and Patients Global Assessment (PGA) scale (MD 0.71, 95% CI 0.32 to 1.10, p<0.001). There was no significant difference in adverse events or serious adverse events between iron treatment group and control group. Iron therapy reduces cardiovascular hospitalisation in patients with CHF with ID, and additionally improves cardiac function, exercise capacity and QoL in patients with CHF with ID and anaemia, without an increase of adverse events.

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