Steroid Injection In Patients Research Articles

Comparison of local versus intramuscular steroid injection in patients with carpal tunnel syndrome: A prospective open label randomized clinical trial

AimThis study compared the efficacy and safety of local corticosteroid injection (LCI) vs intramuscular (IM) corticosteroid injection in mild to moderate carpal tunnel syndrome (CTS). MethodsThis is an open labeled, randomized controlled trial conducted during December 2021 to August 2023. Eighty-six patients with CTS were randomized in 1:1 ratio to receive either single 40 mg methylprednisolone (MP) injection at the wrist (LCI arm), or single 40 mg MP intramuscular injection (IM arm) in the deltoid. Primary outcome was absolute Symptom Severity Scale (SSS) at 3 months. Secondary outcomes were SSS score at 1-month, Functional Status Scale (FSS) score at 1 and 3 months, and recurrence at 3 months and injection site pain assessed on visual analog (VAS) scale. ResultsMedian age was 45 (range 22 – 80) years, and 86 % were females. Baseline characteristics were comparable between groups. Mean SSS score at 3 months was similar in two arms (1.72 ± 0.71 vs 2.0 ± 0.93) with mean difference (MD) −0.03 (-0.31 to 0.25, p = 0.83) after adjusting for baseline SSS scores. LCI, however, resulted in significantly better SSS (1.48 ± 0.51 vs 1.88 ± 0.69, adjusted p = 0.04), and FSS scores (1.57 ± 0.44 vs 1.80 ± 0.66, adjusted p = 0.03) at 1 month compared to IM arm. Response rate (67.4 % vs 55.8 %; p = 0.30) and recurrence rate (17.1 % vs 22.6 %, p = 0.74) at 3 months were similar. Injection site pain was severe in LCI arm[median 5 (range 3 – 8) vs median 3 (range 2 – 6)]. ConclusionsIn patients with mild to moderate CTS, LCI resulted in better improvement in the BCTQ scores at 1 month compared to IM steroid. However, 3-month’s outcome was similar. Intramuscular steroid injection was better tolerated.

Predictors of successful treatment after transforaminal epidural steroid injections in patients with lumbar disc herniation.

Epidural steroid injections are common procedures used to treat lumbosacral radicular pain due to lumbar disc herniation (LDH). It is crucial for the clinician to anticipate which patients can benefit from interventional treatment options. This study aimed to examine the effect of radiological and clinical parameters on lumbar transforaminal epidural steroid injections (TFESI)/local anesthetic injection outcomes in patients with LDH. This study included 286 patients with LDH (146 males and 140 females). All patients received a fluoroscopically guided TFESI (triamcinolone acetonide 40 mg, lidocaine 2%, and 2.5 ml of physiological saline). Patients were evaluated according to radicular pain, the Oswestry Disability Index (ODI) and the Hospital Anxiety and Depression Scale at baseline and 3 months after the injections. Demographic, clinical and magnetic resonance imaging (MRI) findings were recorded to assess the predictive factors for TFESI outcomes. Pfirrmann Grades 1 and 2 were classified as low-grade nerve root compression and Grade 3 was classified as highgrade nerve root compression. Compared to baseline measurements there were significant improvements in radicular pain, ODI score, Laseque angle, and Schober test scores 3 months after injection. Improvements of at least 50% in radicular pain relief and the ODI functionality index were (n= 214) 82%, (n= 182) 70% respectively at 3 months. Correlation analyses revealed that a shorter duration of symptoms, lowgrade nerve root compression and foraminal/extraforaminal location on MRI findings were associated with a favorable response. Lowgrade nerve root compression was a predictor of a favorable response to TFESI.

The Short-Term Outcome of Transforaminal Epidural Steroid Injection in Patients with Radicular Pain Due to Foraminal Stenosis from Lumbar Isthmic Spondylolisthesis.

In this study, we evaluated the therapeutic outcomes of transforaminal epidural steroid injection (TFESI) in managing chronic radicular pain due to foraminal stenosis. Furthermore, we evaluated its effectiveness according to isthmic spondylolisthesis (IS) severity. We included 40 patients with radicular pain due to IS-derived foraminal stenosis in our study and treated them with TFESI. Two patients were lost during follow-up. Based on the lateral lumbar radiograph findings, we allocated the recruited patients with < 25% slippage by IS to Group 1 (n = 23) and those having 25-50% slippage to Group 2 (n = 15). The degree of pain was measured using a numeric rating scale (NRS) at pre-treatment and 1 and 2 months after TFESI. In 38 patients who completed the study, the NRS at pre-treatment was significantly reduced at the 1- and 2-month follow-ups. In the Group analysis, the NRS scores were significantly reduced after TFESI in both Groups 1 and 2, regardless of IS severity. However, the reduction in NRS scores 1 month after TFESI was significantly greater in Group 1 than in Group 2. Moreover, the rate of successful treatment outcomes was significantly higher (65.2%) in Group 1 than in Group 2 (26.7%). After TFESI, chronic radicular pain was significantly reduced regardless of IS severity, and its effect persisted for at least 2 months. However, its effect was superior when the vertebra slippage by IS was less than 25% compared to patients with 25%-50%.

Functional outcome of transforaminal steroid injection in patients suffering from prolapsed intervertebral disc

Functional outcome of transforaminal steroid injection in patients suffering from prolapsed intervertebral disc

Prognostic Factors Affecting Therapeutic Efficacy of Intradiscal Steroid Injection in Patients with Chronic Discogenic Low Back Pain

Prognostic Factors Affecting Therapeutic Efficacy of Intradiscal Steroid Injection in Patients with Chronic Discogenic Low Back Pain

Glenohumeral versus subacromial steroid injections for impingement syndrome with mild stiffness: a randomized controlled trial.

The subacromial (SA) space is a commonly used injection site for treatment of impingement syndrome. For shoulder stiffness, glenohumeral (GH) injections are commonly performed. However, in cases of impingement syndrome with mild shoulder stiffness, the optimal site of steroid injection has yet to be identified. This prospective, randomized study compared the short-term outcomes of ultrasound-guided GH and SA steroid injections in patients who were diagnosed with impingement syndrome and mild stiffness. Each group comprised 24 patients who received either a GH or SA injection of 40 mg of triamcinolone. Range of motion and clinical scores were assessed before and 3, 7, and 13 weeks after the injection. GH and SA injections significantly improved the range of motion and clinical scores after 13 weeks of follow-up. Notably, targeting the GH joint resulted in an earlier gain of forward elevation, external rotation, and internal rotation in 3 weeks (P<0.001, P=0.012, and P=0.002, respectively) and of internal rotation and a Constant-Murley score in 7 weeks (P<0.001 and P=0.046). Subsequent measurements were similar between the groups and showed a steady improvement in all ranges of motion and clinical scores. GH injections may be more favorable than SA injections for treatment of impingement syndrome with mild stiffness, especially in improving the range of motion in the early period. However, the procedures showed similar outcomes after 3 months. Level of evidence: I.

Predictive factors for treatment success of epidural steroid injections in patients with lumbar spinal surgery.

The efficacy of epidural steroid injections (ESIs) in the treatment of radicular pain in patients undergoing lumbar spinal surgery is still unclear. The aim of this study was to investigate the factors affecting the success of ESIs in the treatment of ongoing radicular pain in patients undergoing lumbar spinal surgery. This study was designed as a single-center, retrospective study, and was conducted at a Pain Management Center of a tertiary care center. A total of 260 patients with failed back surgery syndrome who received fluoroscopy-guided lumbar ESI were included. Treatment success was defined as ≥50% reduction in the numeric rating scale score at the one-month follow-up. The patients were divided into the treatment success and the treatment failure groups. The presence of spinal instrumentation was significantly lower in the treatment success group (p=0.045). Symptom duration and the numeric rating scale score at 1 hour were significantly lower in the treatment success group (p<0.05). The use of triamcinolone acetonide in the treatment success group was found to be significantly higher than in the treatment failure group (p=0.027). The short duration of symptoms and the absence of instrumentation seem to be prognostic factors that positively affect the success of ESI treatment in operated patients. A ≥50% pain reduction in the first hour after the procedure is a valuable indicator that treatment success can be achieved in the short term. Finally, the steroid type can also affect the treatment results.

Manipulation Under Anesthesia with Intra-Articular Steroid Injection versus Manipulation under Anesthesia in Idiopathic Adhesive Capsulitis of the Shoulder in terms of Functional Outcome

Objective: To compare the outcome between manipulation under anaesthesia with intra-articular steroid injection in patients with shoulder adhesive capsulitis.&#x0D; Study Design: Retrospective longitudinal study&#x0D; Place and Duration of Study: Ziauddin Hospital, Karachi Pakistan, from Sep 2019 to Feb 2020.&#x0D; Methodology: A total of 70 patients diagnosed with primary ACS were distributed into two groups, i.e., Group-M (35 in manipulation under anaesthesia only) and Group-MI (35 in manipulation under anaesthesia with an intra-articular steroid injection). All patients were assessed for shoulder pain and disability index along with the pain severity on the visual analogue scale at each subsequent visit on the first week, 1st, third and sixth months after the intervention.&#x0D; Results: The results indicated a significant time effect (p=0.001) in both groups. The mean shoulder pain, disability index and pain on the visual analogue scale were lesser in the MI-Group than in the M-Group. Further, we found a statistically significant difference in mean shoulder pain (p=0.001) and disability index (p=0.016) between groups at six months.&#x0D; Conclusion: In the initial post-procedure period and over six months of follow-up, MI showed improved outcomes than M. These patients require additional counselling and motivation for long-term physical therapy programs even after intervention for optimal results.Keywords: Adhesive capsulitis of the shoulder, Intra-articular steroid injection, Manipulation under anaesthesia

Clinical Effectiveness of Single Lumbar Periradicular Infiltration in Patients with Sciatica.

Periradicular therapy (PRT) is a minimally invasive radiological procedurein patients with chronic lumbar pain.The aim of the study is to identify clinical and radiological predictive factors for treatment success after a single PRT treatment in patients with sciatica.The study includes a prospective follow-up of 166 patients treated with PRT. The pain intensity is determined according to the VAS scale and the degree of improvement is presented as excellent (over 75%), good (50-70%), moderate (25-49%), and weak (less than 25%). The follow up of the treated patients was done at 2 weeks, 3 and 6 months. In patients with pain duration up to 3 months, the improvement was excellent in n=32 (58.18%) after 2 weeks, after 3 months n=41 (74.55%) and after 6 months n=41 (74.55%). This stands in contrast to patients with pain over 1 year. The percentage of improvement after 6 months, post-intervention, was highest in patients without nerve root compression (86.25±19.2),and the highest improvement after 6 months was in patients with localization of pain at the L4-L5 level (69.69±29.7), the greatest improvement after six months was in patients with extraforaminal hernia (62.82±34.3), and the lowest in patients with central stenosis (40.21±30.7).Our study results suggest that the shorter a pain duration, low-grade root compression, injection level and type of herniation area predictor the more favourable response patients have to transforaminal epidural steroid injection in patients with sciatica.

Changes in pain scores and walking distance after transforaminal epidural steroid injection in patients with lumbar foraminal spinal stenosis.

Transforaminal epidural steroid injections (TFESI) are widely used in patients with lumbar foraminal spinal stenosis. Previous studies have evaluated the effects of TFESI on lumbar foraminal spinal stenosis using only pain scores. However, no study has evaluated the effect of TFESI on pain scores and walking distance in patients with lumbar foraminal spinal stenosis. This study aimed to assess the effect of TFESI on pain scores and walking distance in patients with lumbar foraminal spinal stenosis stratified according to disease severity. This retrospective study reviewed the medical records of patients who received TFESI for lumbar foraminal spinal stenosis. A total of 128 patients were divided into the moderate and severe groups based on the extent of fat obliteration and the presence of nerve root compression. A significant decrease in the numeric rating scale (NRS) scores was observed in the moderate and severe groups compared with the corresponding baseline values 4 weeks after TFESI; however, the NRS pain scores were lower in the moderate group than those in the severe group. In addition, the proportion of patients who experienced pain reduction (≥50%) was higher in the moderate group than that in the severe group. The moderate and severe groups showed a significant increase in walking distance compared with the baseline values 4 weeks after the treatment. However, the walking distance values did not differ significantly between the moderate and severe groups. Furthermore, the degree of satisfaction was higher in the moderate group than that in the severe group. Lumbar TFESI may reduce pain scores and increase walking distance in patients with moderate or severe lumbar foraminal spinal stenosis. Patients with moderate foraminal stenosis had better pain relief outcomes than those with severe foraminal stenosis.

Effects of Oral Steroids Combined with Postauricular Steroid Injection on Patients with Sudden Sensorineural Hearing Loss with Delaying Intervention: A Retrospective Analysis.

In the otology clinic, we often receive some sudden sensorineural hearing loss (SSNHL) patients accompanied by annoying tinnitus, who usually visited over three weeks after the onset. Nevertheless, due to the high treatment cost and relatively low cure rate, there are still great disputes about hospitalization or not for these patients. Aim: This study aimed to perform a retrospective analysis for analyzing the efficacy of treatment with oral steroids combined with postauricular steroid injection in patients with delaying effective treatment. A total of 157 eligible SSNHL patients with delaying effective treatment over three weeks were enrolled in this study. According to different treatment methods of oral steroids with or without postauricular steroid injection, these patients were divided into three groups: PO (prednisone oral) group, PSI (prednisone oral and postauricular steroid injection) group, and PII (prednisone oral and postauricular lidocaine injection) group. The changes in level of hearing, mean subjective tinnitus loudness, and side effects were analyzed in the three groups. Hearing improvement and tinnitus remission were all observed in three groups after treatment. Compared with PO and PII groups, those patients in PSI groups had more improvement in level of hearing and mean subjective tinnitus. The level of tinnitus loudness was statistically significantly correlated with the level of PTA both before treatment and after treatment. Oral steroids combined with postauricular steroid injection should be employed for treatment of SSNHL patients with delaying effective treatment over three weeks.

Prolotherapy Versus Phonophoresis and Corticosteroid Injections for the Treatment of Plantar Fasciitis: A Randomized, Double-Blind Clinical Trial

The aim of this study was to compare the effectiveness of prolotherapy with phonophoresis and steroid injection in patients with plantar fasciitis (PF). One hundred forty-six patients with PF were randomly divided into prolotherapy, phonophoresis, and injection groups. The treatment method to be applied to them was determined by drawing lots of equal numbers of papers with "Prolotherapy", "Corticosteroid" and "Phonophoress" written on it among those who accepted to be treated. Patients were evaluated using Heel Sensitivity Index (HSI), VAS (Visual Analogue Scale), Foot function index (FFI), and Short Form (SF)-36 at baseline, first and third months after the therapy. Plantar fascia thickness (PFT) was measured by ultrasonography (USG) at baseline, first and third months after the therapy. Statistically significant improvements were found in all parameters at 1 and 3 months after treatment in all groups (p <0.05). There was no significant difference between VAS and FFI scores between the three groups (p>0.05). Improvement in the HSI (p=0.021) and SF-36 general health (GH) subscales at the third month after treatment in the prolotherapy group was significantly better at the first and third months compared to the other groups (p= 0.033 and p<0.01).No complications were observed in any of the patients. Our study results suggest that prolotherapy, phonophoresis, and steroid injection are beneficial as safe treatment modalities in the early period of PF treatment. The improvement of HSI and SF-36 GH subscale lasts longer with prolotherapy, but ultrasonographic findings do not change in the third month of these treatment applications. LEVEL OF CLINICAL EVIDENCE: 1.

EVALUATION OF THERAPEUTIC EFFICACY OF TRANSFORAMINAL EPIDURAL STEROID INJECTION AND SUBPEDICULAR STEROID INJECTION IN PATIENTS WITH PROLAPSED INTERVERTEBRAL DISC (PIVD) WITH CORRESPONDING LEVEL RADICULOPATHY.

Background: Lumber prolapsed intervertebral disc induce radiating pain in lower limbs, for which epidural steroid injection is one of the safe and effective therapeutic option. This prospective study compares the results of 2 different techniques of transforaminal epidural steroid injection (TFESI) and subpedicular steroid injection in patients with prolapsed intervertebral disc (PIVD) in relieving lumbar radicular pain. Methods: Records of 80 patients who had undergone transforaminal and subpedicular epidural steroid injection for lumbar radicular pain were analyzed. Visual analogue scale (VAS) score were measured at before procedure and at 4th day post procedure and 2, 4, 6 and 24 weeks thereafter and straight leg raise test (SLRT) were measured before procedure, 4th day and 4 week post procedure. Results:At 24 weeks, the VAS was signicantly lower than the baseline in both groups; VAS in the TFESI group was signicantly lower than VAS in the subpedicular group at 6 and 24 weeks. SLRT score was signicantly higher in the TFESI group and subpedicular ESI group through the 4-week time point (P= 0.0021 at 4th day; P= 0.0001 at 4 weeks). At the end of 24 weeks, a signicantly greater number of patients in the TFESI group and subpedicular ESI showed difference In VAS (P = 0.0003). Conclusions: At the end of 24 weeks, TFESI appears to be a superior technique in relieving lumbar radicular pain in PIVD patients and could be an alternative to the subpedicular approach in severe spinal canal stenosis when it is hard to place the needle in the anterior epidural space through the safe triangle.

Wrist &amp; Hand

The February 2023 Wrist &amp; Hand Roundup360 looks at: ‘Self-care’ protocol for minimally displaced distal radius fractures; Treatment strategies for acute Seymour fractures in children and adolescents: including crushed open fractures; Routinely collected outcomes of proximal row carpectomy; Moving minor hand surgeries in the office-based procedure room: a population-based trend analysis; A comparison between robotic-assisted scaphoid screw fixation and a freehand technique for acute scaphoid fracture: a randomized, controlled trial; Factors associated with conversion to surgical release after a steroid injection in patients with a trigger finger; Two modern total wrist arthroplasties: a randomized comparison; Triangular fibrocartilage complex suture repair reliable even in ulnar styloid nonunion.

Outcome of Corticosteroid Injection in Reducing the Intensity of Pain in Patients with Plantar Fasciitis

Introduction: Plantar fasciitis is one of the most common causes of heel pain, accounting for about one million patient visits per year in the United States. Objectives: The main objective of the study is to find the outcome of corticosteroid injection in reducing the intensity of pain in patients with plantar fasciitis. Material and methods: This descriptive study was conducted in CMH Kharian during March 2022 to September 2022. Data was collected with the permission of ethical committee of hospital. All the data related to physical examination, BMI, age, history of diseases and socioeconomic status were collected. The injections were applied to all patients who included unilateral foot symptoms and didn't respond to conservative treatment for at least six months. Results: Data was collected from 100 patients. Most of the cases were males 63 (63.3%) and rest 36 (36.7%) were females. Age with mean standard deviation was 38.15±10.26 years and had body mass index 23.11±13.51 kg/m2. Practical implication: This study will help us to treat the plantar fasciitis treated with single injection of corticosteroid injection resulted in significant pain reduction. Conclusion: It is concluded that plantar fasciitis treated with single injection of corticosteroid injection resulted in significant pain reduction in our patients. We recommend steroid injection in patients who are refractory to 6 weeks anti-inflammatory drugs and physiotherapy treatment. Keywords: Pain, Reduction, Injection, Corticosteroid, Significant, Treated

Outcome of C-arm Guided Epidural Steroid Injections in Patients with Prolapsed Lumbar Intervertebral Disc with Radiculopathy

Background: Prolapsed Lumbar Intervertebral Disc (PLID) is one of the most common health problems worldwide, as well as in our country, and is one of the potential causes of temporary disability, morbidity, and reasoning of absence at workplaces.

Efficacy of Physical Therapy after Intra-Articular Steroid Injection in Patients with Adhesive Capsulitis of the Hip Joint

Efficacy of Physical Therapy after Intra-Articular Steroid Injection in Patients with Adhesive Capsulitis of the Hip Joint

Comparison of Platelet-Rich Plasma Treatment and Partial Plantar Fasciotomy Surgery in Patients with Chronic Plantar Fasciitis: A Randomized, Prospective Study

Platelet-Rich Plasma (PRP) injection has become a desirable alternative to Partial Plantar Fasciotomy (PPF) surgery and steroid injection for patients with chronic plantar fasciitis (CPF) due to its potential for shorter recovery times, reduced complications, and similar activity scores. As such, we compared PRP treatment to PPF surgery in patients with CPF. Between January 2015 and January 2017, patients were randomly divided into two groups, a PRP treatment group, and a PPF group. All procedures were performed by a single foot and ankle fellowship-trained specialist surgeon. Visual Analog Score (VAS) and Roles-Maudsley Scale (RM) were collected during the preoperative visit and 3, 6, and 12 months postoperatively. The patients were also closely followed by a physiotherapist. There were 16 patients in each group after four patients refused to participate. Patients in the PPF had low Roles-Maudsley Scale (RM) scores compared to the PRP group one-year after treatment (3.77 vs. 2.72, p < 0.0001). Both procedures showed a reduction in RM scores during the follow-up year (9 to 1.62 for PPF and 8.7 to 2.4 for PRP). There was no significant change in VAS pain between the two groups (p = 0.366). Patients treated with PRP injection reported a significant increase in their activity scores, shorter recovery time, and lower complication rates compared to PPF treatment. Moreover, with respect to existing literature, PRP may be as efficient as steroid injection with lower complication rates, including response to physical therapy. Therefore, PRP treatment may be a viable option before surgery as an earlier line treatment for CPF. Level of Clinical Evidence: II.

Preoperative epidural steroid injections do not increase the risk of postoperative infection in patients undergoing lumbar decompression or fusion: a systematic review and meta-analysis.

Epidural corticosteroid injections (ESI) are a mainstay of nonoperative treatment for patients with lumbar spine pathology. Recent literature evaluating infection risk following ESI after elective orthopedic surgery has produced conflicting evidence. Our primary objective was to review the literature and provide a larger meta-analysis analyzing the temporal effects of steroid injections on the risk of infection following lumbar spine surgery. We conducted a query of the PubMed, Embase, and Scopus databases from inception until April 1, 2022 for studies evaluating the risk of infection in the setting of prior spinal steroid injections in patients undergoing lumbar spine decompression or fusion. Three meta-analyses were conducted, (1) comparing ESI within 30-days of surgery to control, (2) comparing ESI within 30-days to ESI between 1 and 3months preoperatively, and (3) comparing any history of ESI prior to surgery to control. Tests of proportions were utilized for all comparisons between groups. Study heterogeneity was assessed via forest plots, and publication bias was assessedquantiatively via funnel plots and qualitatively with the Newcastle-Ottawa Scale. Nine total studies were included, five of which demonstrated an association between ESI and postoperative infection, while four found no association. Comparison of weighted means demonstrated no significant difference in infection rates between the 30-days ESI group and control group (2.67% vs. 1.69%, p = 0.144), 30-days ESI group and the > 30-days ESI group (2.34% vs. 1.66%, p = 0.1655), or total ESI group and the control group (1.99% vs. 1.70%, p = 0.544). Heterogeneity was low for all comparisons following sensitivity analyses. Current evidence does not implicate preoperative ESI in postoperative infection rates following lumbar fusion or decompression. Operative treatment should not be delayed due to preoperative steroid injections based on current evidence. There remains a paucity of high-quality data in the literature evaluating the impact of preoperative ESI on postoperative infection rates. II.

Comparison of Distal and Proximal Local Steroid Injection for Carpal Tunnel Syndrome: a Systematic Review and Meta-analysis of Randomized Controlled Trials.

Local steroid injection (LSI) in the carpal tunnel is a mainstay of conservative treatment in patients with carpal tunnel syndrome (CTS). Currently, clinicians generally perform a conventional proximal approach (PA) or novel distal approach (DA) for LSI. Recent systematic reviews comparing the two injection methods are lacking. This systematic review and meta-analysis aimed to assess whether LSI using the DA was superior to PA in treating patients with CTS. Databases including Pubmed, Embase, and the Cochrane library were searched up to 30 May 2022 to identify relevant randomized controlled trials (RCTs) comparing the DA with the PA steroid injection in patients with CTS. The outcomes mainly included Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQs) and Functional Status Scale (BCTQf), visual analog scores (VAS), electrophysiological outcomes, pain of injection, duration of injection, or adverse events. Five RCTs involving 339 patients were identified. Pooled analysis showed that the DA group took less time [mean difference (MD) -19.91; 95% CI -34.48 to -5.35; P = 0.007] and acquired better sensory nerve action potential amplitude [standardized mean difference (SMD) -0.37; 95% CI -0.62 to -0.11; P = 0.005]. The two groups were not significantly different in terms of BCTQs and BCTQf, VAS, other electrophysiological outcomes, pain of injection, or adverse events (P > 0.05). Although providing similar improvement in pain relief or function improvement, the distal approach is superior to the proximal approach in terms of timing, without increasing other side effects. Further high-quality randomized studies are required to confirm these results.