scholarly journals High-Dose Intravenous Immunoglobulin Is Effective in Painful Diabetic Polyneuropathy Resistant to Conventional Treatments. Results of a Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial

Pain Medicine ◽  
2020 ◽  
Vol 21 (3) ◽  
pp. 576-585 ◽  
Author(s):  
Stefano Jann ◽  
Raffaella Fazio ◽  
Dario Cocito ◽  
Antonio Toscano ◽  
Angelo Schenone ◽  
...  
Keyword(s):  
Placebo Group ◽  
Intravenous Immunoglobulin ◽  
Short Form ◽  
Diabetic Polyneuropathy ◽  
Multicenter Trial ◽  
Diabetic Patients ◽  
High Dose ◽  
Double Blind ◽  
Clinical Patient ◽  
Global Impression Of Change

Abstract Objectives The efficacy and safety of high-dose intravenous immunoglobulin (IVIG) in treatment-resistant diabetic painful polyneuropathy (DPN) were assessed. Design This was a randomized, double-blind, placebo-controlled, multicenter trial (EudraCT 2010–023883–42). Setting This trial was conducted at eight sites in Italy with a neurology specialist level of care. Subjects Twenty-six diabetic patients with DPN who reported baseline severity of pain >60 units (mm) on a VAS scale at enrollment and were resistant to antidepressants and antiepileptic drugs were enrolled; 23 were randomized (11 in the IVIG arm and 12 in the placebo arm). All patients completed the study and were evaluated. All patients were Caucasian, 15 were male, and 21 had a diagnosis of type II diabetes. Methods IVIG (0.4 g/kg/d) or placebo was given for five consecutive days. Pain intensity (visual analog scale, Neuropathic Pain Symptom Inventory) and quality of life (36-Item Short-Form Health Survey, Clinical/Patient Global Impression of Change questionnaires) assessments were performed at visits: baseline, start of therapy (one week later), end of therapy (five days later), and follow-up (four and eight weeks later). Results The study achieved its prespecified primary end point of ≥50% pain reduction at four weeks after IVIG, achieved in seven of 11 patients (63.6%) in the IVIG group vs zero of 12 in the placebo group (P = 0.0013). Only two adverse events were reported during the study: one patient in the treatment arm reported a mild “dermatitis psoriasiform,” whereas one patient from the placebo group reported a mild “influenza.” Conclusions Treatment with IVIG at the dose given was efficacious and safe for patients with DPN resistant to standard therapies.

scholarly journals Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis and Acute Exacerbation of Chronic Bronchitis: A Phase Ⅱ, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

2022 ◽  
Vol 12 ◽  
Author(s):  
Su Won Lee ◽  
Yee Ran Lyu ◽  
Si Yeon Kim ◽  
Won Kyung Yang ◽  
Seung Hyung Kim ◽  
...  
Keyword(s):  
Placebo Group ◽  
Standard Dose ◽  
Acute Bronchitis ◽  
Multicenter Trial ◽  
High Dose ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Treatment Groups ◽  
The Mean ◽  
Mean Differences

Acute bronchitis and acute exacerbations of chronic bronchitis (AECB) have cough and sputum as the main symptoms with a high prevalence and substantial economic burden. Although the demand for bronchitis treatment increases due to causes, such as air pollution, the appropriateness of antibiotic prescriptions and the effects of current symptomatic treatments for bronchitis are unclear. GHX02, which is a combined formulation containing four herbs, and has been clinically used for bronchitis in South Korea. We conducted a phase II, randomized, double-blind, and placebo-controlled, multicenter trial to evaluate its efficacy and safety. Patients with acute bronchitis or AECB were recruited and randomized to receive high-dose GHX02 (1920 mg/day), standard-dose GHX02 (960 mg/day), or placebo for 7 days. The primary outcome measure was the change in Bronchitis Severity Score (BSS) from baseline to Day 7. The secondary outcomes were the frequency of coughing fits, Questionnaire of Clinical Symptoms of Cough and Sputum (QCSCS), Leicester Cough Questionnaire (LCQ), Integrative Medicine Outcome Scale (IMOS), and Integrative Medicine Patient Satisfaction Scale (IMPSS). A total of 117 patients were randomized to parallel groups (38 in the high-dose GHX02, 41 in the standard-dose GHX02 group, and 38 in the placebo group). The mean differences in BSS from baseline to Day 7 in the treatment groups (4.2 ± 2.0 and 4.5 ± 1.8 in the high-dose GHX02 and standard-dose GHX02 groups, respectively) were higher than the placebo group (3.8 ± 2.1), p = 0.028. The mean differences in the frequency of coughing fits from baseline to Day 7 and IMPSS were better in the GHX02 treatment group than in the placebo group (standard-dose GHX02 group vs placebo group, p = 0.036). The QCSCS, LCQ, IMOS, and GHX02 of the treatment groups also showed more improvement than the placebo group, but there were no statistically significant differences between the groups. There were no severe adverse effects during the trial. This study supports that GHX02 is effective and safe for patients with bronchitis and provides the basis for progression to a phase III study.Clinical Trial Registration: [https://cris.nih.go.kr] WHO International Clinical Trials Registry Platform, Clinical Research Information Service [KCT0003665].

scholarly journals Psychometric assessment of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Robin Pokrzywinski ◽  
Ahmed M. Soliman ◽  
Eric Surrey ◽  
Michael C. Snabes ◽  
Karin S. Coyne
Keyword(s):  
Internal Consistency ◽  
Short Form ◽  
Intraclass Correlation ◽  
Change Score ◽  
Reproductive Age ◽  
Phase Iii ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Good Reliability ◽  
Global Impression Of Change

Abstract Background Endometriosis is a common problem in women of reproductive age and has impacts on health-related quality of life and productivity. Fatigue is an important part of the burden of endometriosis, it is not often included as an endpoint in clinical trials. Objectives The study assessed the psychometric properties of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain. Methods In a phase III double-blind, placebo-controlled clinical trial (NCT01620528), women aged 18–49 years with moderate-to-severe endometriosis-related pain were randomized to elagolix 150 mg once daily, elagolix 200 mg twice daily, or placebo for 6 months. PROMIS Fatigue and dysmenorrhea and non-menstrual pelvic pain (NMPP) scores were assessed at baseline and months 1, 3, and 6, and Patient Global Impression of Change (PGIC) was assessed at months 1, 3, and 6. Reliability (internal consistency and test-retest reliability), construct validity (convergent and known groups validity), and responsiveness were evaluated. Results The analysis included 871 women, mean age 31.5 years. Internal consistency supported a single concept (Cronbach’s alpha 0.93). For the 238 patients with no change in PGIC at month 1, the intraclass correlation coefficient for the PROMIS Fatigue T-score was 0.7 and paired t-test statistically significant (2.84, p = 0.0049). Correlations with other measures were expected to be fairly low as concepts were not redundant. The PROMIS Fatigue discriminated among known groups with mean scores of 55.3, 62.3, and 65.8 at month 3 (PGIC improvement, no change, worsening, respectively). Statically significant discrimination, and change score responsiveness, were seen using clinically relevant anchors (dysmenorrhea and NMPP) at months 3 and 6 between responders and non-responders. Anchor-based (PGIC) responsiveness showed significant improvement from baseline to months 3 and 6 (p < 0.0001). Conclusions PROMIS Fatigue has good reliability, validity, and responsiveness in women with moderate-to-severe endometriosis-associated pain.

scholarly journals Intravenous immunoglobulin to prevent myasthenic crisis after thymectomy and other procedures can be omitted in patients with well-controlled myasthenia gravis

2019 ◽  
Vol 12 ◽  
pp. 175628641986449 ◽  
Author(s):  
Josep Gamez ◽  
María Salvadó ◽  
Francesc Carmona ◽  
Miriam de Nadal ◽  
Laura Romero ◽  
...  
Keyword(s):  
Placebo Group ◽  
Myasthenia Gravis ◽  
General Anaesthesia ◽  
Intravenous Immunoglobulin ◽  
Univariate Analysis ◽  
Myasthenic Crisis ◽  
Double Blind ◽  
Single Centre Study ◽  
Life Threatening ◽  
The Mean

Background: Myasthenic crisis (MC) is a potentially life-threatening complication of myasthenia gravis. Its precipitating factors include surgical procedures, particularly thymectomy. The role of preoperative intravenous immunoglobulin (IVIg) in preventing MC in patients scheduled for thymectomy and other surgery with general anaesthesia is unknown. Our objective was to test the hypothesis that preoperative IVIg is effective in preventing myasthenic crisis in patients with myasthenia gravis scheduled for surgery under general anaesthesia, including thymectomy. Methods: A prospective, randomized, double-blind, single-centre study was conducted over a 4-year period. The treatment group received IVIg, 0.4 g/kg/day preoperatively for 5 consecutive days, and the placebo group received saline solution under the same conditions. The two groups were age-matched, with similar functional status, and Myasthenia Gravis Foundation of America class. All patients had well-controlled myasthenia gravis with minimal manifestations before surgery. The primary outcome measured was MC. Intubation times, time in the recovery room, number of postoperative complications, and days of hospitalization were the secondary outcomes measured. Results: A total of 47 patients were randomized, 25 to the IVIg group and 22 to placebo. There were 19 men and 28 women, with a mean age of 58.6 years, mean body mass index of 27.8 kg/m2, and mean acetylcholine receptor antibodies of 12.9 nmol/l. The mean forced vital capacity was 84.4%. The mean quantitative myasthenia gravis sum score was 6.3. Ten patients (five in each arm) had a history of MC. Thymectomy was performed in 16 patients. Only one patient in the placebo group presented with MC requiring non-invasive ventilation (but no reintubation) for 6 days. Neither differences between groups in the univariate analysis nor risk factors for MC in the multivariate analysis were found. Conclusions: Preoperative IVIg to prevent MC does not appear to be justified in well-controlled myasthenia gravis patients. This study provides class I evidence that preparation with IVIg to prevent MC is not necessary in well-controlled myasthenia gravis patients scheduled for surgery with general anaesthesia.

scholarly journals Does High-Dose Metformin Cause Lactic Acidosis in Type 2 Diabetic Patients after CABG Surgery? A Double Blind Randomized Clinical Trial

2011 ◽  
Vol 6 (1) ◽  
pp. hi.2011.e8 ◽  
Author(s):  
Afshin Gholipour Baradari ◽  
Mohammad Reza Habibi ◽  
Hadi Darvishi Khezri ◽  
Mohsen Aarabi ◽  
Mohammad Khademloo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lactic Acidosis ◽  
Randomized Clinical Trial ◽  
Diabetic Patients ◽  
High Dose ◽  
Type 2 Diabetic Patients ◽  
Double Blind ◽  
Cabg Surgery ◽  
Type 2 Diabetic

scholarly journals Moriche Palm (Aguaje) Extract improves indefinite complaints in Japanese females: a randomized, placebo-controlled, double-blind trial

2020 ◽  
Vol 10 (9) ◽  
Author(s):  
Hiroshi Shimoda ◽  
Tsuyoshi Takara ◽  
Kazuo Yamamoto ◽  
Naoko Suzuki ◽  
Shinichiro Yamashita ◽  
...  
Keyword(s):  
Placebo Group ◽  
Short Form ◽  
Random Number Generator ◽  
Japanese Version ◽  
Summary Score ◽  
Controlled Study ◽  
Clinical Effects ◽  
Double Blind ◽  
Sf 36 ◽  
Menstrual Distress

Background and objective: The fruit of Mauritia flexuosa (moriche palm), which is known as “Aguaje,” has been used for beverages and processed foods. Recently, we found that several methoxyflavans are contained in the fruit and they exhibit estrogenic activities. Therefore, moriche palm extract (MPE) may function as a phytoestrogen and improve the symptoms induced by estrogen deficiency. However, the clinical effects of MPE on females has not yet been reported. We conducted a clinical trial of MPE on undefined complaints related to premenstrual syndrome (PMS) in healthy Japanese females.Methods: This randomized, double-blind, placebo-controlled study examined the effects of MPE (100 mg daily) containing 12.6  g of 5,4'-dihydroxy-7-methoxy-6-methylflavan. Forty-four Japanese women with indefinite complaints in premenstrual and menstrual periods were enrolled in the study. All subjects were randomly allocated into either the MPE (100 mg) group (n=22) or the placebo group (n=22) using a computerized random-number generator. Capsules containing either MPE (100 mg) or placebo were administered for 8 weeks between October and December in 2018. The severity of uncertain complaints and emotional status were evaluated using the Japanese version of the menstrual distress questionnaire (MDQ) as a primary outcome, and Medical Outcomes Study Short-Form 36-Item Health (SF-36) questionnaire at 4 and 8 weeks of ingestion. Blood, urine, and body parameters were also evaluated.Results: Forty-three subjects completed the trial, and the per protocol set comprised 21 subjects in the MPE (100 mg) group and 22 subjects in the placebo group. After ingesting MPE for 4 weeks, arousal in the premenstrual period significantly improved in the MPE (100 mg) group. After 8 weeks, the summary score, water retention, impaired concentration and control during menstrual period significantly improved in the MPE (100 mg) group. Contrarily, among SF-36 domain scores, significant ameliorating effects of MPE were not observed compared with those of the placebo group. Laboratory tests revealed no abnormalities suggesting adverse effects of MPE.Conclusions: MPE (100 mg/day for 8 weeks) improved several indefinite complaint parameters related to mensuration. MPE was suggested to be useful for improving anxiety related to PMS.Keywords: Menstrual distress questionnaire; SF-36 questionnaire; moriche palm; methoxyflavan; indefinite complaint

scholarly journals Ranirestat Improved Nerve Conduction Velocities, Sensory Perception, and Intraepidermal Nerve Fiber Density in Rats with Overt Diabetic Polyneuropathy

2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Saeko Asano ◽  
Tatsuhito Himeno ◽  
Tomohide Hayami ◽  
Mikio Motegi ◽  
Rieko Inoue ◽  
...  
Keyword(s):  
Placebo Group ◽  
Neurite Outgrowth ◽  
Conduction Velocity ◽  
Nerve Conduction ◽  
Nerve Conduction Velocity ◽  
Diabetic Polyneuropathy ◽  
Diabetic Rats ◽  
Diabetic Patients ◽  
Fiber Density ◽  
Conduction Velocities

Distal sensory-motor polyneuropathy is one of the most frequent diabetic complications. However, few therapies address the etiology of neurodegeneration in the peripheral nervous systems of diabetic patients. Several metabolic mechanisms have been proposed as etiologies of this polyneuropathy. In this study, we revisited one of those mechanisms, the polyol pathway, and investigated the curative effects of a novel strong aldose reductase inhibitor, ranirestat, in streptozotocin-induced diabetic rats with preexisting polyneuropathy. Twelve weeks after the onset of diabetes, rats which had an established polyneuropathy were treated once daily with a placebo, ranirestat, or epalrestat, over 6 weeks. Before and after the treatment, nerve conduction velocities and thermal perception threshold of hindlimbs were examined. After the treatment, intraepidermal fiber density was evaluated. As an ex vivo assay, murine dorsal root ganglion cells were dispersed and cultured with or without 1 μmol/l ranirestat for 48 hours. After the culture, neurite outgrowth was quantified using immunological staining. Sensory nerve conduction velocity increased in diabetic rats treated with ranirestat (43.3±3.6 m/s) compared with rats treated with placebo (39.8±2.3). Motor nerve conduction velocity also increased in the ranirestat group (45.6±3.9) compared with the placebo group (38.9±3.5). The foot withdrawal latency to noxious heating was improved in the ranirestat group (17.7±0.6 seconds) compared with the placebo group (20.6±0.6). The decrease in the intraepidermal fiber density was significant in the diabetic placebo group (21.6±1.7/mm) but not significant in the diabetic ranirestat group (26.2±1.2) compared with the nondiabetic placebo group (30.3±1.5). Neurite outgrowth was promoted in the neurons supplemented with ranirestat (control 1446±147 μm/neuron, ranirestat 2175±149). Ranirestat improved the peripheral nervous dysfunctions in rats with advanced diabetic polyneuropathy. Ranirestat could have potential for regeneration in the peripheral nervous system of diabetic rats.

scholarly journals Double-Blind, Randomized, Three-Armed, Placebo-Controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects

2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Ralf Uebelhack ◽  
Udo Bongartz ◽  
Stephanie Seibt ◽  
Gordana Bothe ◽  
Pee Win Chong ◽  
...  
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Placebo Group ◽  
Body Fat ◽  
Dose Group ◽  
Low Dose ◽  
Clinical Investigation ◽  
Controlled Trial ◽  
High Dose ◽  
Double Blind

Objective. This study was performed to determine the efficacy and tolerability/safety of IQP-AE-103 on body weight reduction in overweight to moderately obese adults. Methods. A double-blind, randomized, placebo-controlled trial involved one hundred and eight subjects (BMI between 25 and 35 kg/m2) that were randomly assigned to either the low-dose or the high-dose IQP-AE-103 group, or the placebo group. Following a 2-week run-in period, subjects received two capsules of investigational product after three daily main meals for 12 weeks. Subjects were instructed to maintain a nutritionally balanced hypocaloric diet according to the individual’s energy requirement. Body weight, body fat, and waist and hip circumference were measured at baseline, and after 2, 4, 8, and 12 weeks. Subjects also rated their feelings of hunger and fullness using visual analogue scales, and food craving on a 5-point scale at the same time intervals. Blood samplings for safety laboratory parameters were taken before and at the end of the study. Results. After 12 weeks of intake, the high-dose IQP-AE-103 group had a significantly greater weight loss compared with the placebo (5.03 ± 2.50 kg vs. 0.98 ± 2.06 kg, respectively; p<0.001) and the low-dose group (3.01 ± 2.19 kg; p=0.001). The high-dose group experienced a decrease in body fat of 3.15 ± 2.41 kg compared with a decrease of 0.23 ± 2.74 kg for the placebo group (p<0.001). High-dose IQP-AE-103 also decreased the feeling of hunger in 66% subjects. A beneficial effect of IQP-AE-103 on the lipid metabolism was also demonstrated in the subgroup of subjects with baseline total cholesterol levels above 6.2 mmol/L. No side effects related to the intake of IQP-AE-103 were reported. Conclusions. These findings indicate that IQP-AE-103 could be an effective and safe weight loss intervention. This trial is registered with NCT03058367.

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