Patient Global Impression Of Change Scale Research Articles

Shoden promotes Relief from stress and anxiety: A randomized, double-blind, placebo-controlled study on healthy subjects with high stress levels

BackgroundThis randomized placebo-controlled study examined the effect of ashwagandha root and leaf extract 60 mg (AE60) and 120 mg (AE120) (35 % withanolide glycosides, Shoden) in physically healthy subjects with higher stress and anxiety. It is hypothesized that a low dose extract with higher withanolide glycosides would decrease cortisol and increase testosterone thereby reducing stress and anxiety. MethodsThis parallel arm study recruited 60 subjects with an allocation ratio of 1:1:1 (AE60:AE120: placebo) for 60 days. Subjects who fulfilled the DSM –IV Criteria for generalized anxiety disorder (GAD) with a Hamilton Anxiety Rating Scale, HAMA score >20, and morning serum cortisol >25 mcg/dl were included in the study. The participants did not have depression symptoms and were screened using Montgomery-Asberg Depression Rating Scale. The primary outcome measure was HAMA and the secondary measures were morning serum cortisol, testosterone, perceived stress scale (PSS), clinical global impressions scale (CGI), and patient's global impression of change scale (PGIC). ResultsAfter 60 days, significant differences were observed between the treatment groups and placebo. HAMA scores decreased by 59 % in both AE60 and AE120 groups compared to a negligible increase of 0.83 % in the placebo group (p < 0.0001). Morning serum cortisol levels decreased by 66 % in AE60 and 67 % in AE120, compared to a 2.22 % change in the placebo group (p < 0.0001). Testosterone levels increased by 22 % in AE60 and 33 % in AE120, compared to a 4 % increase in males in the placebo group (p < 0.0001). PSS scores decreased by 53 % in AE60 and 62 % in AE120, CGI-severity scores decreased by 72 % in AE60 and 68 % in AE120, and PGIC scores improved by 60 % in both AE60 and AE120 groups, all showing significant differences compared to the placebo group. ConclusionAshwagandha extract with 35 % withanolide glycosides (Shoden) at 60 mg and 120 mg was significantly effective in reduced morning serum cortisol and increasing total testosterone. Therefore, it can be recommended for reducing high stress and anxiety. Clinical trial registrationThe study was prospectively registered in Clinical Trial Registry, India with registration number CTRI/2022/04/042133 [Registered on: April 25, 2022].

Remote ischemic conditioning prevents ischemic cerebrovascular events in children with moyamoya disease: a randomized controlled trial.

Moyamoya disease (MMD) is a significant cause of childhood stroke and transient ischemic attacks (TIAs). This study aimed to assess the safety and efficacy of remote ischemic conditioning (RIC) in children with MMD. In a single-center pilot study, 46 MMD patients aged 4 to 14years, with no history of reconstructive surgery, were randomly assigned to receive either RIC or sham RIC treatment twice daily for a year. The primary outcome measured was the cumulative incidence of major adverse cerebrovascular events (MACEs). Secondary outcomes included ischemic stroke, recurrent TIA, hemorrhagic stroke, revascularization rates, and clinical improvement assessed using the patient global impression of change (PGIC) scale during follow-up. RIC-related adverse events were also recorded, and cerebral hemodynamics were evaluated using transcranial Doppler. All 46 patients completed the final follow-up (23 each in the RIC and sham RIC groups). No severe adverse events associated with RIC were observed. Kaplan-Meier analysis indicated a significant reduction in MACEs frequency after RIC treatment [log-rank test (Mantel-Cox), P = 0.021]. At 3-year follow-up, two (4.35%) patients had an ischemic stroke, four (8.70%) experienced TIAs, and two (4.35%) underwent revascularization as the qualifying MACEs. The clinical improvement rate in the RIC group was higher than the sham RIC group on the PGIC scale (65.2% vs. 26.1%, P < 0.01). No statistical difference in cerebral hemodynamics post-treatment was observed. RIC is a safe and effective adjunct therapy for asymptomatic children with MMD. This was largely due to the reduced incidence of ischemic cerebrovascular events.

The efficacy of repetitive transcranial magnetic stimulation in postherpetic neuralgia: a meta-analysis of randomized controlled trials.

This systematic review and meta-analysis aimed to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS) in postherpetic neuralgia (PHN). Through an extensive search in four databases until October 2023, we selected five randomized controlled trials adhering to our specific criteria, involving 257 patients in total. For continuous outcomes, the standardized mean difference (SMD) was calculated. Heterogeneity among the studies was assessed using Cochran's I 2 and Q statistics, adopting a random-effects model for I 2 values over 50%. For assessing potential publication bias, we utilized both funnel plot and Egger's test. Our analysis found that rTMS reduced the overall visual analogue scale (VAS) (SMD: -1.52, 95% CI: -2.81 to -0.23, p = 0.02), VAS at 1 month post-treatment (SMD: -2.21, 95% CI: -4.31 to -0.10, p = 0.04), VAS at 3 months post-treatment (SMD: -1.51, 95% CI: -2.81 to -0.22, p = 0.02), as well as patients' global impression of change scale (PGIC) (SMD: -1.48, 95% CI: -2.87 to -0.09, p = 0.04) and short-form McGill pain questionnaire (SF-MPQ) (SMD: -1.25, 95% CI: -2.41 to -0.09, p = 0.03) compared to the sham-rTMS group. Our study suggests that rTMS might have a potential alleviating effect on PHN symptoms. However, due to the limited number of studies and variations in rTMS parameters, larger sample studies involving more diverse populations, as well as further clarification of the most appropriate stimulation protocol, are still needed. https://www.crd.york.ac.uk/prospero/, Identifier ID: CRD42023488420.

A clinical audit in a UK-based acupuncture private practice: assessing patient demographics, outcomes and experience.

The aim of this clinical audit was to assess patient demographics, outcomes and experience with care in patients who received acupuncture in a private practice setting in the United Kingdom. Demographic and clinical data were extracted from patients' records over a 7-year period. The Measure Yourself Medical Outcomes Profile (MYMOP) questionnaire and an adapted Patient Global Impression of Change (PGIC) scale were used routinely to monitor patient outcomes over an 18-month period. Finally, a retrospective questionnaire was used to assess patient beliefs regarding treatment effectiveness, adverse events and overall experience with care. Patients not providing consent or known to be deceased were excluded. Data were collected for 306 patients presenting with 376 separate health complaints, 58% of which were musculoskeletal. Follow-up outcomes (MYMOP scores (n = 51) and PGIC scale responses (n = 50)) showed a clinically significant improvement compared to baseline for the majority of health complaints (93% of PGIC scores were 'improved' and 79% MYMOP demonstrated > 1 point change). Total mean MYMOP severity scores were reduced by almost 50% (p < 0.001) after 1-4 weeks, and this was sustained in the medium-to-long term. There was a strong negative correlation (r = -0.767, p < 0.001) between the MYMOP and PGIC scores. A total of 118 health complaints were reported by 85/255 patients who responded to a retrospective questionnaire. Over 84% of patients believed that the treatments they received were 'effective' at addressing their health complaints. Seven minor adverse events were reported and four patients experienced negative treatment outcomes. Although musculoskeletal conditions were the most common, this audit found that patients sought treatment for a wide range of predominantly chronic health complaints, for many of which there is a currently a lack of quality evidence to support the use of acupuncture. Overall, the small sample of patients who responded to outcome questionnaires reported clinically meaningful and sustained improvements.

Early Use of Erenumab vs Nonspecific Oral Migraine Preventives

Patients with migraine often cycle through multiple nonspecific preventive medications due to poor tolerability and/or inadequate efficacy leading to low adherence and increased disease burden. To compare the efficacy, tolerability, patient adherence, and patient satisfaction between erenumab and nonspecific oral migraine preventive medications (OMPMs) in patients with episodic migraine (EM) who had previously failed 1 or 2 preventive treatments. The 12-month prospective, interventional, global, multicenter, active-controlled, randomized clinical trial comparing sustained benefit of 2 treatment paradigms (erenumab qm vs oral prophylactics) in adult episodic migraine patients (APPRAISE) trial was a 12-month open-label, multicenter, active-controlled, phase 4 randomized clinical trial conducted from May 15, 2019, to October 1, 2021. This pragmatic trial was conducted at 84 centers across 17 countries. Overall, participants 18 years or older with a 12-month or longer history of migraine, and 4 or more but fewer than 15 monthly migraine days (MMDs) were included. Patients were randomized (2:1) to receive erenumab or OMPMs. Dose adjustment was permitted (label dependent). The primary end point was the proportion of patients completing 1 year of the initially assigned treatment and achieving a reduction of 50% or greater from baseline in MMDs at month 12. Secondary end points included the cumulative mean change from baseline in MMDs during the treatment period and the proportion of responders according to the Patients' Global Impression of Change (PGIC) scale at month 12 for patients taking the initially assigned treatment. A total of 866 patients were screened, of whom 245 failed the screening and 621 completed the screening and baseline period. Of the 621 randomized patients (mean [SD] age, 41.3 [11.2] years; 545 female [87.8%]; 413 [66.5%] in the erenumab group; 208 [33.5%] in the OMPM group), 523 (84.2%) completed the treatment phase, and 98 (15.8%) discontinued the study. At month 12, significantly more patients assigned to erenumab vs OMPM achieved the primary end point (232 of 413 [56.2%] vs 35 of 208 [16.8%]; odds ratio [OR], 6.48; 95% CI, 4.28-9.82; P <.001). Compared with OMPMs, treatment with erenumab showed higher responder rate (314 of 413 [76.0%] vs 39 of 208 [18.8%]; OR, 13.75; 95% CI, 9.08-20.83; P <.001) on the PGIC scale (≥5 at month 12). Significant reduction in cumulative average MMDs was reported with erenumab treatment vs OMPM treatment (-4.32 vs -2.65; treatment difference [SE]: -1.67 [0.35] days; P < .001). Substantially fewer patients in the erenumab arm compared with the OMPM arm switched medication (9 of 413 [2.2%] vs 72 of 208 [34.6%]) and discontinued treatment due to adverse events (12 of 408 [2.9%] vs 48 of 206 [23.3%]). No new safety signals were identified. Results of this randomized clinical trial demonstrated that earlier use of erenumab in patients with EM who failed 1 or 2 previous preventive treatments provided greater and sustained efficacy, safety, and adherence than continuous OMPM. ClinicalTrials.gov Identifier: NCT03927144.

Real-world experience of patients with sickle cell disease treated with crizanlizumab.

In 2019, crizanlizumab was approved by the Food and Drug Administration (FDA) to reduce the rate of vaso-occlusive crisis in patients with sickle cell disease (SCD). We aimed to study the real-world effectiveness of crizanlizumab in our comprehensive sickle cell center. This was a retrospective cohort analysis of patients with SCD who received at least two consecutive doses of crizanlizumab. Clinically significant improvement was captured using the patient global impression of change scale (PGI-C). As of December 2022, there were 18 patients eligible for analysis with a median age of 30.5 years. Eight patients had the HbSS genotype, 7 HbSC, and 3 HbSB null genotype. Median duration of exposure to crizanlizumab was 53.6 weeks, and 16 (88.9%) patients received crizanlizumab for ≥26 weeks. Crizanlizumab was very well tolerated with no serious adverse events (grade ≥3) related to treatment. There was no significant difference in laboratory parameters. There was a remarkable improvement in patients' subjective response to crizanlizumab infusion. The median PGI-C score of our patients was 5, signifying moderately better with slight but noticeable changes. The morphine equivalent daily doses (MEDD) were lower after crizanlizumab infusion. MEDD prior to crizanlizumab was 90; after ≥2 consecutive crizanlizumab doses, it was 60. There was also a reduction in the hospital admissions, emergency, and urgent care visit for acute pain crisis in 6 (28%) patients. This study shows that crizanlizumab was associated with improvement in patients' response, both directly and indirectly related to the reduction of opioids used, which is consistent with results from the SUSTAIN trial.

Treatment of chronic cluster headache with burst and tonic occipital nerve stimulation: A case series.

Chronic cluster headache (CCH) is a rare but severely debilitating primary headache condition. A growing amount of evidence suggests that occipital nerve stimulation (ONS) can offer effective treatment in patients with severe CCH for whom conventional medical therapy does not have a sufficient effect. The paresthesia evoked by conventional (tonic) stimulation can be bothersome and may thus limit therapy. Burst ONS produces paresthesia-free stimulation, but the amount of evidence on the efficacy of burst ONS as a treatment for intractable CCH is scarce. In this case series, we report 15 patients with CCH treated with ONS at Aarhus University Hospital, Denmark, from 2013 to 2020. Nine of these received burst stimulation either as primary treatment or as a supplement to tonic stimulation. The results were assessed in terms of the frequency of headache attacks per week and their intensity on the Numeric Rating Scale, as well as the Patient Global Impression of Change (PGIC) with ONS treatment. At a median (range) follow-up of 38 (16-96) months, 12 of the 15 patients (80%) reported a reduction in attack frequency of ≥50% (a reduction from a median of 35 to 1 attack/week, p < 0.001). Seven of these patients were treated with burst ONS. A significant reduction was also seen in maximum pain intensity. Overall, 10 patients stated a clinically important improvement in their headache condition following ONS treatment, rated on the PGIC scale. A total of 16 adverse events (nine of which were in the same patient) were registered. Occipital nerve stimulation significantly reduced the number of weekly headache attacks and their intensity. Burst ONS seems to function well alone or as a supplement to conventional tonic ONS as a preventive treatment for CCH; however, larger prospective studies are needed to determine whether the effect can be confirmed and whether the efficacy of the two stimulation paradigms is even.

#5821 CLINICALLY MEANINGFUL IMPROVEMENT IN QUALITY OF LIFE ACCOMPANIES ITCH RELIEF IN PATIENTS WITH CHRONIC KIDNEY DISEASE ASSOCIATED PRURITUS

Abstract Background and Aims The impairing effect of chronic kidney disease-associated pruritus (CKD-aP) on the quality of life (QoL) of patients undergoing haemodialysis (HD) is well-established. The aim of this post-hoc analysis was to assess the impact of itch relief on QoL, as measured by the 5-D itch scale, in patients with CKD-aP enrolled in the Phase 3 KALM-1 and -2 clinical trials. This study also aimed to confirm the use of ≥5-point reduction in 5-D itch scale total score as a threshold for clinically meaningful improvement in itch-related QoL, by comparing to notable improvement on the Patients’ Global Impression of Change (PGI-C) scale. Method Data were pooled from 851 patients with moderate-to-severe CKD-aP undergoing HD in the KALM-1 and -2 trials testing difelikefalin vs placebo. Sustained responders were defined as patients who achieved a ≥3-point improvement in the weekly mean 24-hour Worst Itching Intensity Numerical Rating Scale [WI-NRS] score at Week 12 of the study, whereas non-sustained responders were defined as patients that reported a ≥3-point improvement in any week of the study but not at Week 12. Improvements in QoL, as measured by the mean change in 5-D itch scale total score from baseline to Week 12, were compared in sustained responders vs non-sustained responders. Data were analysed by ANCOVA multiple imputation, with a missing-at-random assumption. The mean change in 5-D itch scale total score was analysed in relation to patients’ reporting on the five categories of the PGI-C scale. Results In pooled analysis, 305 patients undergoing HD with CKD-aP qualified as sustained responders, whereas 128 patients were non-responders. Reduction in 5-D itch scale total score over 12 weeks was significantly higher in sustained responders compared with non-sustained responders (least squares [LS] mean ±standard error; –7.1±0.2 vs –4.0±0.3, LS mean difference –3.0±0.3, p&amp;lt;0.001) (Figure 1). Greater reductions in 5-D itch scale total score were observed in patients reporting more substantial improvements in PGI-C. Specifically, patients reporting much, or very much, improvement in PGI-C scored ≥5-point reduction on the 5-D itch scale (mean ±standard error; –5.3±0.2 and –8.2±0.3, respectively) (Figure 2). Conclusion This study observed a greater improvement in QoL, as measured by the 5-D itch scale total score, in patients with CKD-aP who reported a clinically meaningful reduction in itch, as measured by WI-NRS, at Week 12. These results also support the use of ≥5-point reduction in the 5-D itch scale total score as a threshold for clinically meaningful improvement in the QoL of patients with CKD-aP. As only sustained responders exceeded this threshold, these data suggest that continued treatment of itch may be necessary to maximally improve QoL in these patients.

Short-Term Effects of Manual Therapy on Balance: A Multicenter, Randomized, Double-Blind Controlled Trial

ObjectiveThe purpose of this study was to analyze short-term changes in dynamic and static balance after a manual therapy protocol in healthy participants and analyze any repercussions on mood and perception of change after applying articulatory techniques. MethodsA single-blind, randomized, multicenter clinical trial was conducted. Participants were allocated to either a manual therapy group (MTG) (n = 101) or a control group (CG) without intervention (n = 99), and measures were taken before treatment, after the intervention, and 1 week after treatment. Assessments included the Star Excursion Balance Test, Unipedal Stance Test (UPST), Profile of Mood States (POMS), and Patient Global Impression of Change (PGIC) scale. ResultsTwo hundred healthy participants completed the study (mean age, 22 [SD = 2.67]). There was a statistically significant interaction between groups and time measurements in the right leg for anterior (P = .003), posteromedial (P < .001), and posterolateral (P = .001) directions in favor of the MTG, as well as in the left leg for anterior (P < .001), posteromedial (P < .001), and posterolateral (P = .012) directions. The analysis failed to show statistically significant interactions between any of the factors for the UPST and POMS (P > .05). The MTG showed a significant improvement compared to the CG after treatment (P = .003) and at 1-week follow-up (P < .001) on the PGIC scale. ConclusionThe results suggest the MT intervention was effective on dynamic balance in post-intervention in healthy participants, and some of the directions maintained the results at 1-week follow-up. Perception of change in post-treatment and 1-week follow-up also significantly improved. The protocol did not seem to produce changes in static balance and mood states. Positive changes after manual therapy were maintained in the short term.

Surgical treatment of post-traumatic vertebral osteonecrosis including intravertebral expansive implants-clinical, functional and imaging outcomes and a center experience over 7 years.

The effective treatment of post-traumatic vertebral osteonecrosis continues to be an under discussion and controversial subject. Armed kyphoplasty with expansive intravertebral implants is an emerging procedure, which, in theory, allow for a more effective preservation of the restored vertebral height. The development of the indications for these recent devices has given rise to auspicious outcomes in vertebral non-union situations. The aim of this study is to evaluate the clinical, functional and imaging outcomes of the surgical treatment of situations of post-traumatic vertebral necrosis, following a therapeutic algorithm that includes armed kyphoplasty with intravertebral expansive implants and bridge pedicular stabilization, according to a predefined necrosis stage. We present a retrospective observational study, in which 35 patients took part, including a total of 35 cases of post-traumatic vertebral osteonecrosis submitted to surgical treatment over 7 years (between 2016 and 2023) at the same center according to a defined therapeutic algorithm. The cases were staged according to vertebral morphology (non-plana or plana) and mobility (mobile or immobile)-stages 1m (mobile necrotic vertebra non-plana), 1i (immobile necrotic vertebra non-plana), 2m (mobile necrotic vertebra plana), and 2i (immobile necrotic vertebra plana)-and the following surgeries were performed: armed kyphoplasty with intravertebral expansive implants filled with bone cement, associated or not to adjacent pedicle instrumentation; or bridge pedicle fixation of the adjacent levels. Clinical results [Patient Global Impression of Change (PGIC), Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI)] as well as imaging outcomes (restoration and preservation of the heights of the vertebral body) were studied. The mean follow-up time corresponded to 3.17 years (range, 1-7.5 years). Most of the clinical-functional and imaging parameters showed important improvements after surgical treatment, with few complications. A statistically significant greater degree of functional improvement was found in plana vertebrae when compared to non-plana, which reflects that the first are quite symptomatic and disabling at the beginning and improve a lot with surgical treatment. Significant indirect correlations were found between the time from the initial fracture to surgical intervention after diagnosis of vertebral necrosis and the anterior sagittal height in the immediate postoperative time and at the ending of the follow-up. Also, a significant direct correlation was identified between this time and the VAS for pain at the end of the follow-up and the PGIC scale in the same period. It was also found that patients with surgical complications had a statistically significantly longer time between the initial fracture and surgery for post-traumatic necrosis. We present the results of a surgical therapeutic algorithm that includes the use of recent expansive intravertebral implants at post-traumatic vertebral osteonecrosis, resulting in satisfactory clinical, functional and imaging results. This work shows a pioneering statistical demonstration of the clinical, functional and imaging importance of early detection of this condition (ideally in vertebrae non-plana morphology stages), so that there is still sufficient bone tissue in the vertebral body to permit the stabilization and restoration of its anatomy through a minimally invasive interior reconstruction, with percutaneous access and quicker convalescence, that is to say, armed kyphoplasty, avoiding the unwanted disease progression that will require more aggressive surgical solutions that doesn't allow anatomical restauration.

Role of Protopine and Nuciferine in the Management of Nocturia, Urgency, and Dysuria in Pre- and Postmenopausal Women: A Prospective Pilot Study

Objectives: Nocturia was commonly treated with drugs burdened with high costs and numerous side effects; in fact, more than 70% of patients drop out of long-term treatment. Protopine and nuciferine are two alkaloids that have different effects on the neurotransmitter receptors involved in the regulation mechanism of the onset of urinary stimuli. The aim of the study was to evaluate the efficacy in controlling primarily nocturia and secondarily urgency and dysuria after 3 months of treatment with combination therapy of protopine and nuciferine syrup. Design: This is a prospective cohort study in which all patients were diagnosed with overactive bladder syndrome (OAB) and the presence of the following symptoms: nocturia, urgency, and dysuria. Thirty patients were administered 10 mL/die (16.6 mg of nuciferine, 0.09 mg of protopine) of syrup for 3 months. Patients were evaluated at baseline (T₀) with the International Consultation on Incontinence Questionnaire (ICIQ), Visual Analogue Scale (VAS) for the evaluation of dysuria, Patient Perception of Intensity of Urgency Scale (PPIUS) and at 3 months (T₁) with the Patients’ Global Impression of Change (PGI-C) scale, PPIUS, VAS, and ICIQ. Participants: Women with diagnosis of OAB; the presence of nocturia, urgency, and dysuria symptoms agreeing to undergo treatment and compiling informed consent; and the absence of contraindications to the use of active ingredients were included in the study. Setting: Patients were recruited at T0 during the visit to the Uro-Gynecology clinic of the University of “Campus Bio-Medico” and visited again 3 months (T1) after the initiation of therapy. Methods: We explored survey data by descriptive statistics: in particular, continuous values (i.e., ICIQ) have been summarized by mean and standard deviation of discrete ordinal values (i.e., VAS, PPIUS, and bladder diary parameters at T₀ and T₁) by median, minimum, and maximum reported scores. Where we could assume normality in distribution, assessed by the Shapiro-Wilk test and the evaluation of the QQ plot, we compared the observation of T₀ and T1 with the paired Student’s t test; otherwise, we tested differences in distribution with the paired Mann-Whitney U test. Results: Thirty patients completed a 3-month therapy. The ICIQ and VAS questionnaires for the assessment of dysuria, both, reported an improvement in dysuria at T₁ (p < 0.001). The PPIUS questionnaire reported an improvement in urinary urgency at T₁ (p < 0.001). The PGI-C scale in T1 indicated an improvement in symptoms: 93% for nocturia, 70% for urinary urgency, and 63% for dysuria. Limitations: The weaknesses of this study are the small number of patients; as a pilot study, the study design was not randomized with a placebo and without blinding; and the short follow-up. Conclusions: Protopine and nuciferine can be an interesting alternative to primarily treat and reduce nocturia episodes, in addition to improving OAB-related urgency and dysuria.

Nutrient Intake as a Predictor of Health Improvement on the Low Glutamate Diet in Veterans With Gulf War Illness (GWI)

ObjectivesGulf War Illness (GWI) is a chronic multi-symptom condition characterized by widespread chronic pain, fatigue, cognitive dysfunction, and mood dysregulation. Previous research found that the low glutamate diet can reduce overall symptoms of GWI, including systemic inflammation. Micronutrients thought to be protective against excitotoxicity include riboflavin, vitamins B6, C, D, and E, and magnesium. This research examined whether changes in these micronutrients after one month on the low glutamate diet could predict overall improvement in GWI symptoms, after accounting for changes in free glutamate intake.MethodsForty veterans with GWI were recruited, and three-day food diaries, among other health measurements, were collected at baseline and after one month on the low glutamate diet. Nutrition Data Systems for Research was used to analyze dietary intake data. Dietary adherence was measured with a glutamate food frequency questionnaire (FFQ), and improvement on the diet was defined as being “much/very much” improved on the patient global impression of change scale (PGIC) or as having ≥30% of their symptoms remit. Logistic regression was used to model improvement on the diet, after adjusting for age, sex, change in FFQ, and change in BMI.ResultsIncreased vitamin C intake significantly predicted improvement based on ≥30% symptom remission (p = 0.02). Similarly, increased intake of vitamin E and magnesium each marginally predicted improvement based on the PGIC (both p = 0.06).ConclusionsThese findings suggest that in addition to reduction in free glutamate consumption, improved intake of vitamin C, vitamin E, and magnesium, may be driving improvement in neurological symptoms on the low glutamate diet. Further research is warranted.Funding SourcesThis work was supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Gulf War Illness Research Program under Award No. W81XWH-17-1-0457.

Topical clonidine for neuropathic pain in adults.

Topical clonidine for neuropathic pain in adults.

Intra-articular pulsed radiofrequency with methyl prednisolone injection in chronic sacroiliac joint arthritis: A randomized clinical trial

ABSTRACT Background Sacroiliac joint pain (SIJP) is an important cause of low back pain and seriously affects the patients’ quality of life. Therefore, it is urgent to find effective treatment methods. The goal of our research was to assess the effectiveness of radiofrequency ablation combined with steroid injection versus steroid injection alone in the treatment of chronic sacroiliac joint arthritis (SIJ) pain. Methods Sixty patients with chronic SIJ pain were divided into two groups randomly: Group RF (n = 30) received intraarticular RF + methylprednisolone, while Group C (n = 30) received intraarticular methylprednisolone alone. The Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), and Patient Global Impression of Change Scale (PGIC) were followed up at each observation time (before the intervention, 1 month, 3 months, 6 months, 9 months, and 12 months). Results The NRS and ODI reduced following treatment compared to pretreatment values; however, the PGIC increased in both groups. The NRS in the RF group reduced significantly than in the control group after treatment at nearly all time intervals after the third month with p = 0.015*, 0.004*, 0.049*, and 0.025*, respectively. After the first month, the difference in PGIC score between the two groups becomes statistically significant at nearly all time intervals with p < 0.05. At nearly all time intervals, the RF group had higher PGIC scores. Conclusion PRF ablation with methylprednisolone injection is a safe and efficient treatment for sacroiliac pain. It has the potential to considerably reduce sacroiliac pain, lower ODI, raise PGIG, and improve physical and mental quality of life.

In search of a gold standard patient-reported outcome measure to use in the evaluation and treatment-decision making in migraine prevention. A real-world evidence study

BackgroundPatient-Reported Outcomes (PROs) have been developed to numerically quantify disability, impact and quality of life. They have been widely used in migraine clinical trials. However, we still do not know which PRO more accurately reflects preventive treatment response from a patient’s perspective or which one may help us with treatment decisions in clinical practice. They have been used to enforce the efficacy results in clinical trials and real-world evidence so far. The aim of this study was to analyze which PROM is (1) better correlated with all primary efficacy endpoints and (2) which one is better associated with treatment continuation with CGRP-mAbs at week-12, which is usually the moment when this decision is made.MethodsPatients with migraine who had received 3 administrations of CGRP-mAbs were evaluated in this prospective cohort study. Primary efficacy outcomes considered: a change in migraine days (MMD), headache days (MHD), pain intensity (INT), acute medication days (AMD) and 50% responder rate. The Spearman coefficient (rs) was the measure used for quantify the strength of the correlation between PROMs and treatment efficacy outcomes changes. A stepwise logistic regression identified which PROM was independently associated with treatment continuation at week-12.Results263 patients completed 12 weeks of treatment. The efficacy outcomes and PROMs scores were statistically significantly reduced at week-12 for all patients. The role function-restrictive (RFR) domain of the Migraine-Specific Quality of Life (MSQ) questionnaire was statistically significantly correlated with all primary efficacy outcomes. Relative changes in MSQ total score (OR[95%]: 0.840[0.619-0.973]; p=0.037) and Patient Global Impression of Change (PGIC) scale (OR[95%]: 15.569[6.254-31.533]; p<0.001) were the PROMs associated with treatment continuation as independent factors at week-12.ConclusionsChanges in MSQ questionnaire and PGIC scale at week-12 were the PROMs with higher association with CGRP-mAbs response from a patient’s perspective and medical decision-taking.

Transnasal Sphenopalatine Ganglion Block for Management of Postdural Puncture Headache in Non-Obstetric Patients.

This study investigated the efficacy and safety of transnasal sphenopalatine ganglion block (SPGB) for treatment of postural puncture headache (PDPH) in non-obstetric patients. This retrospective study was conducted at the Ankara Research and Educational Hospital, in Turkey, and included 26 non-obstetric patients (age, ≥18 years) who were diagnosed with PDPH and unresponsive to conservative therapy or unable to continue it because of side effects. Transnasal SPGB was performed in each nostril. Pain severity was assessed with the Visual Analogue Scale (VAS) at 15 min, 30 min, 24 h, and 48 h after the procedure, while patients were seated. The patients were monitored for 48 h for adverse effects (AEs). Patient treatment satisfaction was assessed at 48 h after the procedure by using the Patient Global Impression of Change (PGIC) scale. Headache at 15 min post-procedure was relieved rapidly. At 24 h post-procedure, nearly half of patients (42.3%) had no pain, and all patients (100%) had a VAS score of <3. Nasal discomfort, throat numbness, and nausea were AEs reported after SPGB; however, these AEs were completely relieved at 24 h after the procedure. According to the PGIC scale scores at 48 h post-procedure, 73.1% of patients evaluated themselves as "much improved" and 26.9% evaluated themselves as "very much improved". When PDPH does not respond to conservative treatment, it may be treated effectively with transnasal SPGB, which is a noninvasive, safe, well-tolerated, and straightforward method with a low complication rate.

Spinal cord stimulation in severe cases of complex regional pain syndrome: A retrospective cohort study with long-term follow-up.

Complex regional pain syndrome (CRPS) is a debilitating pain condition often resistant to standard treatment modalities. In these cases, spinal cord stimulation (SCS) can be an option, but the effect on CRPS remains disputed. We aimed to assess the long-term effect of SCS on CRPS. We retrospectively analysed 51 CRPS patients implanted with an SCS system at the University Hospitals in Aarhus or Odense, Denmark, with a median follow-up time of 4.4years. Primary outcomes were pain intensity on a numeric rating scale (NRS) and the Patients' Global Impression of Change (PGIC). Secondary outcomes were patient satisfaction, work status, consumption of pain medication, the Major Depression Inventory (MDI), Pain Catastrophizing Scale (PCS) and quality of life (QoL) measured using the Short-Form Health Survey (SF-36). For each outcome measure, baseline data were compared to the latest collected data point. A significant pain relief was found with a mean reduction in NRS score of 2.4 (95% CI: 1.7-3.0, p<0.0001). 68.8% reported 'much improved' or 'very much improved' on the PGIC scale. 87.5% would choose SCS again for the same outcome. A significant beneficial impact was found on MDI score, PCS, SF-36 summary scores and consumption of tricyclic antidepressants, antiepileptic drugs and opioids. No statistical effect was found on work status. Pain intensity, depression, pain catastrophizing, pain medication use and QoL were significantly improved after SCS implantation, with high patient satisfaction rates in CRPS patients. This study supports the continued use of SCS in the treatment of severe CRPS. This study presents detailed data from a large, well-characterized cohort of Danish CRPS patients treated with SCS, analyzing several outcome measures. The results serve to document SCS as an effective treatment for severe CRPS and expands the cumulative level of evidence in favor of its use. Additionally, analysis of preoperative patient characteristics suggests that SCS treatment should not be withheld in patients with a high degree of psychological distress or high consumption of analgesics.

Effect of the low glutamate diet on inflammatory cytokines in veterans with Gulf War Illness (GWI): A pilot study

AimTo examine the effects of the low glutamate diet on inflammatory cytokines in veterans with Gulf War Illness (GWI). Main methodsForty veterans with GWI were recruited from across the country. Anthropometric measurements and blood samples were collected at baseline and after one month on the low glutamate diet. Dietary adherence was measured with a glutamate food frequency questionnaire (FFQ). Inflammatory cytokines (IL-1β, IL-6, IFN-γ, and TNF-α) were measured in pre- and post-diet serum (N = 34). Improvement was defined as being “much” or “very much” improved on the patient global impression of change scale (PGIC), or as having ≥30% of their symptoms remit. Correlations of the FFQ and the cytokines were calculated, followed by multivariable linear regression for significant findings. Mann Whitney U tests were used to compare cytokine levels according to improvement on the diet, and then logistic regression was used to estimate the association after adjustment for potential confounders. Classification trees were also produced to determine the ability of change in the inflammatory cytokines to predict improvement on the diet. Key findingsDietary adherence was significantly associated with reduction in TNF-α, and PGIC improvement was significantly associated with reduced IL-1β, after adjustment for potential confounders. Classification trees demonstrated that IL-1β, TNF-α, and IL-6 can predict improvement on the diet with 76.5% accuracy. SignificanceFindings suggest that the low glutamate diet may be able to reduce systemic inflammation in veterans with GWI.

Hemifacial spasm through the last three decades: From etiology to efficacy and safety of long-term botulinum toxin treatment

BackgroundHemifacial spasm (HFS) is an uncommon movement disorder characterized by involuntary contractions of muscles innervated by the facial nerve. The aim of this study is to analyze the etiology of HFS as well as the efficacy and safety of long-term botulinum toxin type A (BTX-A) treatment. MethodsRetrospective study including 125 patients with HFS treated with BTX-A from 1993 to 2019. Demographic and etiological variables as well as doses, number of sessions of BTX-A, infiltrated muscles, therapeutic response according to Patient Global Impression of Change Scale (PGIC-S), side effects and adjuvant treatments were analyzed. In addition, these variables were compared according to the etiology (idiopathic versus secondary). Results92 patients (73.6%) were women and the mean age at diagnosis was 58.63 years (SD 15.4). The etiology was idiopathic in 79 patients (63.2%), 17.6% were secondary to Bell’s palsy, 14.4% to vascular compression and 2.4% to tumors. A higher total dose per session was observed in the secondary group. PGIC-S showed a good response in 96% of cases. 16 patients (12.8%) required pharmacological concomitant treatment. 59 patients (47.2%) developed side effects. Transient eyelid ptosis and facial weakness were the most common. ConclusionsThe structural origin of a significant number of cases of HFS makes essential to complete an etiological diagnosis in all patients. In addition, the existence of a secondary cause could be associated with greater doses of BTX-A to achieve a good response. Regardless the etiology, long-term treatment with BTX-A in HFS is safe and effective.

Pain Catastrophizing Does Not Predict Spinal Cord Stimulation Outcomes: A Cohort Study of 259 Patients With Long-Term Follow-Up

ObjectiveSpinal cord stimulation (SCS) is an important treatment modality used to treat chronic neuropathic pain. However, reported success rates of 26%-70% entail an increased focus on patient selection. An area of core interest is psychological evaluation, often using scales such as the Pain Catastrophizing Scale (PCS). The aim of this study was to assess the relation between baseline PCS scores obtained before implantation and SCS outcomes defined as (1) Rating on Patients’ Global Impression of Change scale (PGIC), (2) Pain relief on the Numeric Rating Scale (NRS), (3) Cessation of pain medication, and (4) Risk of permanent explantation. Materials and MethodsUsing records from the Neurizon Neuromodulation Database, we performed a multicenter open cohort study of 259 permanently implanted SCS patients. Follow-up ranged from six months to nine years (median = three years). For each of the defined SCS outcomes, patients were grouped according to their latest follow-up registration. Subsequently, we used a one-way ANOVA and exact t-tests to compare mean baseline PCS scores between groups. ResultsNo difference in mean baseline PCS scores was found between PGIC groups. Baseline PCS scores was not associated with the probability of obtaining 30% or 50% pain relief on latest registration. Baseline PCS scores of patients able to cease all usage of tricyclic antidepressants, antiepileptics, or opioids during SCS treatment did not differ from baseline scores of continuous users. We found no association between baseline PCS scores and risk of permanent explantation. ConclusionThis study did not demonstrate any associations between baseline PCS scores and SCS outcomes.