The Effects of Short-Term Immunotherapy Using Molecular Standardized Grass and Rye Allergens Compared with Symptomatic Drug Treatment on Rhinoconjunctivitis Symptoms, Skin Sensitivity, and Specific Nasal Reactivity

2005 ◽  
Vol 133 (4) ◽  
pp. 538-543 ◽  
Author(s):  
L. Klimek ◽  
T. Mewes ◽  
H. Wolf ◽  
I. Hansen ◽  
J. Schnitker ◽  
...  
Keyword(s):  
Drug Treatment ◽  
Grass Pollen ◽  
Randomized Study ◽  
Provocation Test ◽  
Treated Group ◽  
Short Term ◽  
Skin Sensitivity ◽  
Double Blind ◽  
Nasal Provocation ◽  
Significant Difference

BACKGROUND: The efficacy and safety of short-term immunotherapy with molecular standardized allergens (STI) has been demonstrated by double-blind placebo-controlled clinical trials. The aim of this study was to compare STI with symptomatic drug treatment. METHODS: Forty-eight patients with rhinoconjunctivitis to grass and/or rye pollen were treated either with STI (ALK7, n = 24) plus anti-allergic drugs or anti-allergic drugs, alone (n = 24) in a prospective, randomized study. Symptoms and use of drugs were reported in patient diaries and titrated nasal provocation and skin prick tests were performed at baseline, before, and after season. RESULTS: Median overall symptom ( P = 0.022, U test) and medication scores ( P = 0.003) were significantly lower in the STI group, as was the result for a simultaneous analysis of conjunctival, nasal, and bronchial symptom scores and medication ( P = 0.005). Sensitivity in the nasal provocation test decreased in the STI group but not in the drug-treated group. These differences became significant directly after STI ( P = 0.027) as well as after the grass pollen season ( P < 0.001). Skin sensitivity did not change in the STI group but increased in the drug-treated group after season, with a significant difference between the two groups for the erythema ( P < 0.001). CONCLUSIONS: STI reduces grass pollen-induced rhinoconjunctivitis symptoms and drug use, and specific nasal reactivity and skin sensitivity, more efficiently than a standard symptomatic treatment.

scholarly journals Spontaneous improvement of carbohydrate-deficient transferrin in PMM2-CDG without mannose observed in CDG natural history study

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Peter Witters ◽  
Andrew C. Edmondson ◽  
Christina Lam ◽  
Christin Johnsen ◽  
Marc C. Patterson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Natural History ◽  
Randomized Study ◽  
Short Term ◽  
Double Blind ◽  
Natural History Study ◽  
Natural History Studies ◽  
Carbohydrate Deficient Transferrin ◽  
Spontaneous Improvement

AbstractA recent report on long-term dietary mannose supplementation in phosphomannomutase 2 deficiency (PMM2-CDG) claimed improved glycosylation and called for double-blind randomized study of the dietary supplement in PMM2-CDG patients. A lack of efficacy of short-term mannose supplementation in multiple prior reports challenge this study’s conclusions. Additionally, some CDG types have previously been reported to demonstrate spontaneous improvement in glycosylated biomarkers, including transferrin. We have likewise observed improvements in transferrin glycosylation without mannose supplementation. This observation questions the reliability of transferrin as a therapeutic outcome measure in clinical trials for PMM2-CDG. We are concerned that renewed focus on mannose therapy in PMM2-CDG will detract from clinical trials of more promising therapies. Approaches to increase efficiency of clinical trials and ultimately improve patients’ lives requires prospective natural history studies and identification of reliable biomarkers linked to clinical outcomes in CDG. Collaborations with patients and families are essential to identifying meaningful study outcomes.

Efficacy of Phenazone in the Treatment of Acute Migraine Attacks: A Double-Blind, Placebo-Controlled, Randomized Study

Cephalalgia ◽  
2004 ◽  
Vol 24 (10) ◽  
pp. 888-893 ◽  
Author(s):  
H Göbel ◽  
A Heinze ◽  
U Niederberger ◽  
T Witt ◽  
V Zumbroich
Keyword(s):  
Adverse Events ◽  
Randomized Study ◽  
Controlled Study ◽  
Acute Migraine ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Number Of Patients ◽  
Significant Difference ◽  
Main Target

In this study we compared the efficacy of 1000 mg phenazone with that of placebo in the treatment of acute migraine attacks in a randomized double-blind, placebo-controlled study of 208 patients. The main target criterion was the number of patients with a pain reduction from severe or moderate to slight or no pain 2 h after taking the pain medication. The percentage of patients satisfying the main target criterion was 48.6% for phenazone and 27.2% ( P < 0.05) for placebo. Freedom from pain after 2 h was reported by 27.6% with phenazone treatment and 13.6% ( P < 0.05) with placebo. Compared with placebo, the phenazone treatment also resulted in a significant improvement in the associated migraine symptoms of nausea, phonophobia and photophobia. Of patients treated with phenazone 11.4%, and 5.8% of those treated with placebo reported adverse events. There was no significant difference between the groups with regard to numbers of patients with adverse events. No serious adverse events occurred. The results show that phenazone at a dosage of 1000 mg is effective and well tolerated in the treatment of acute migraine attacks.

Double-Blind Comparison of Maternal Analgesia and Neonatal Neurobehaviour following Intravenous Butorphanol and Meperidine

1979 ◽  
Vol 7 (3) ◽  
pp. 224-230 ◽  
Author(s):  
Robert Hodgkinson ◽  
Robert W Huff ◽  
Robert H Hayashi ◽  
Farkhanda J Husain
Keyword(s):  
Side Effects ◽  
Severe Pain ◽  
Randomized Study ◽  
Analgesic Efficacy ◽  
Foetal Heart Rate ◽  
Efficacy And Safety ◽  
Cervical Dilation ◽  
Double Blind ◽  
Significant Difference ◽  
Blind Comparison

Butorphanol (1 mg and 2 mg) and meperidine (40 mg and 80 mg), given intravenously, were evaluated for analgesic efficacy and safety in a double-blind randomized study employing 200 consenting pre-partum patients in moderate to severe pain during the late first stage of labour. Both drugs provided adequate relief of pain to the mothers. There was no significant difference in the rate of cervical dilation, the foetal heart rate, the Apgar score, pain relief or neonatal neurobehavioural scores between those receiving butorphanol and those receiving meperidine. Twenty-two mothers who received butorphanol and eleven who received meperidine nursed their infants with no adverse effects observed. Side-effects were generally infrequent in this study; however, more side-effects were reported by the patients and observed by the investigator in the meperidine-treated cases (13%) than in the cases treated with butorphanol (2%).

A Double-Blind Out-Patient Trial of Indalpine vs Mianserin

1985 ◽  
Vol 147 (3) ◽  
pp. 306-309 ◽  
Author(s):  
G. J. Naylor ◽  
B. Martin
Keyword(s):  
Side Effects ◽  
Treated Group ◽  
Blind Study ◽  
Antidepressant Effect ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference

SummaryIndalpine 150 mg per day and mianserin 60 mg per day were compared in a double-blind study of 65 depressed out-patients: 52 patients completed the 4-week trial. At the end of four weeks there was no significant difference in antidepressant effect between the two drugs; but in the first two weeks, improvement in the mianserin-treated group was significantly greater than that in the indalpine group. The mianserin-treated group reported more side-effects of sedation (eg. drowsiness, clumsiness, heaviness of limbs etc.) and one patient on indalpine developed a mild leucopenia.

The lack of sustained effect of bright light in non-seasonal major depression

2006 ◽  
Vol 36 (9) ◽  
pp. 1247-1252 ◽  
Author(s):  
KLAUS MARTINY ◽  
MARIANNE LUNDE ◽  
MOGENS UNDÉN ◽  
HENRIK DAM ◽  
PER BECH
Keyword(s):  
Major Depression ◽  
Randomized Study ◽  
Bright Light ◽  
Light Therapy ◽  
Treated Group ◽  
Bright Light Therapy ◽  
Double Blind ◽  
Sustained Effect ◽  
The Difference

Background. Recently accumulated evidence has demonstrated that bright-light therapy in combination with antidepressants is effective in patients with non-seasonal major depression. Whether bright light has a sustained effect after discontinuation is, however, poorly investigated.Method. In this double-blind randomized study we report the results from a 4-week follow-up period in patients with major non-seasonal depression who had been treated for 5 weeks with sertraline combined with bright-light therapy or sertraline combined with dim-light therapy. At the beginning of the follow-up period the light therapy was stopped while sertraline treatment continued for 4 weeks.Results. Depression scores decreased substantially in both groups, resulting in high response and remission rates in both groups after 9 weeks of treatment. The difference in depression scores at week 5, favouring the bright-light-treated group, disappeared gradually in the 4-week follow-up period, resulting in similar end-point scores.Conclusions. Bright light did not have a sustained effect after discontinuation. The offset of effect was complete after 4 weeks.

Evaluation of BCNU and/or radiotherapy in the treatment of anaplastic gliomas

1978 ◽  
Vol 49 (3) ◽  
pp. 333-343 ◽  
Author(s):  
Michael D. Walker ◽  
Eben Alexander ◽  
William E. Hunt ◽  
Collin S. MacCarty ◽  
M. Stephen Mahaley ◽  
...  
Keyword(s):  
Performance Status ◽  
Randomized Study ◽  
Cranial Nerves ◽  
Age Distribution ◽  
Treated Group ◽  
Conventional Care ◽  
Surgical Biopsy ◽  
Content Type ◽  
Anaplastic Gliomas ◽  
Significant Difference

✓ A controlled, prospective, randomized study evaluated the use of 1,3-bis(2-chloroethyl)-l-nitrosourea (BCNU) and/or radiotherapy in the treatment of patients who were operated on and had histological confirmation of anaplastic glioma. A total of 303 patients were randomized into this study, of whom 222 (73%) were within the Valid Study Group (VSG), having met the protocol criteria of neuropathology, corticosteroid control, and therapeutic approach. Patients were divided into four random groups, and received BCNU (80 mg/sq m/day on 3 successive days every 6 to 8 weeks), and/or radiotherapy (5000 to 6000 rads to the whole brain through bilateral opposing ports), or best conventional care but no chemotherapy or radiotherapy. Analysis was performed on all patients who received any amount of therapy (VSG) and on the Adequately Treated Group (ATG), who had received 5000 or more rads radiotherapy, two or more courses of chemotherapy, and had a minimum survival of 8 or more weeks (the interval that would have been required to have received either the radiotherapy or chemotherapy). Median survival of patients in the VSG was, best conventional care: 14 weeks (ATG: 17.0 weeks); BCNU: 18.5 weeks (ATG: 25.0 weeks); radiotherapy: 35 weeks (ATG: 37.5 weeks); and BCNU plus radiotherapy: 34.5 weeks (ATG: 40.5 weeks). All therapeutic modalities showed some statistical superiority compared to best conventional care. There was no significant difference between the four groups in relation to age distribution, sex, location of tumor, diagnosis, tumor characteristics, signs or symptoms, or the amount of corticosteroid used. An analysis of prognostic factors indicates that the initial performance status (Karnofsky rating), age, the use of only a surgical biopsy, parietal location, the presence of seizures, or the involvement of cranial nerves II, III, IV, and VI are all of significance. Toxicity included acceptable, reversible thrombocytopenia and leukopenia.

Evaluation of mithramycin in the treatment of anaplastic gliomas

1976 ◽  
Vol 44 (6) ◽  
pp. 655-667 ◽  
Author(s):  
Michael D. Walker ◽  
Eben Alexander ◽  
William E. Hunt ◽  
Carl M. Leventhal ◽  
M. Stephen Mahaley ◽  
...  
Keyword(s):  
Randomized Study ◽  
Age Distribution ◽  
Gastrointestinal Symptoms ◽  
Treated Group ◽  
Anaplastic Glioma ◽  
Control Group ◽  
Duration Of Symptoms ◽  
Content Type ◽  
Anaplastic Gliomas ◽  
Significant Difference

✓ A controlled, prospective, randomized study evaluated the use of mithramycin in the treatment of anaplastic glioma compared to a similar group of patients receiving best conventional care. From a total of 116 patients in the study, 96 were within the valid study group. All patients were operated on, had histological confirmation of anaplastic glioma, and received radiotherapy at the discretion of the principal investigator. Fifty-two patients received mithramycin at a dose of 25 µg/kg/day for 21 days, while 44 patients were in the control group. There was no significant difference in the median survival from time of randomization in those receiving mithramycin (21 weeks) as compared to those not receiving mithramycin (26 weeks). There was no significant difference between the two groups in relation to age distribution, sex, location, diagnosis, tumor characteristics, signs or symptoms, or radiotherapy received. Duration of symptoms correlates positively with survival and was also significantly longer in the control group than in the treated group. This, however, did not account for the failure of mithramycin to be found an effective agent. Although the study was not designed to evaluate the efficacy of radiotherapy, patients who were so treated had a significant improvement in survival. The toxic complications of mithramycin included gastrointestinal symptoms, dermatological involvement, anemia, and liver dysfunction, indicating the need for close supervision.

Ergoloids and Ischaemic Strokes; Efficacy and Mechanism of Action

1995 ◽  
Vol 23 (3) ◽  
pp. 154-166 ◽  
Author(s):  
O Elwan ◽  
AA Helmy ◽  
ME Tamawy ◽  
MA Naseer ◽  
IE Banhawy ◽  
...  
Keyword(s):  
Short Term Memory ◽  
Randomized Study ◽  
Quantitative Difference ◽  
Short Term ◽  
Limb Function ◽  
Double Blind ◽  
The Difference ◽  
Ischaemic Insult ◽  
Assessment Geriatric ◽  
Computerized Electroencephalography

In this double-blind, randomized study the efficacy of the ergoloid compounds, co-dergocrine mesylate and nicergoline, in the rehabilitation of patients with ischaemic stroke was investigated. A group of 30 patients was treated daily with 60 mg nicergoline, orally, and a second group of 27 patients was given 1.8 – 6 mg co-dergocrine mesylate, orally or intramuscularly, daily (depending on the time since the initial ischaemic insult) for 6 months. Outcome measures included: motoricity index (limb function); Sandoz Clinical Assessment Geriatric (SCAG) scale; psychometric tests to assess functions such as attention, psychomotor performance, perception and sensory and short-term memory; conventional and computerized electroencephalography; and P300 and reaction time measures. The results showed improvements in some aspects such as limb function ( P < 0.05), SCAG score ( P < 0.01) and some electrophysiological parameters ( P < 0.01) after treatment with both drugs. Though statistically significant most of the changes were not large. The efficacy of both drugs was qualitatively similar. The quantitative difference in some aspects in favour of nicergoline could be attributed to differences in the mechanisms of action of the two drugs, although it is also possible that the difference may reflect the dosages used. Nootropic drugs may induce a condition that facilitates the effects of cognitive training.

scholarly journals Effect of Photopheresis on Lymphocyte Population in Children with Newly Diagnosed Type 1 Diabetes

2004 ◽  
Vol 11 (5) ◽  
pp. 856-861 ◽  
Author(s):  
J. Ernerudh ◽  
J. Ludvigsson ◽  
G. Berlin ◽  
U. Samuelsson
Keyword(s):  
Type 1 Diabetes ◽  
Placebo Group ◽  
Lymphocyte Subsets ◽  
Randomized Study ◽  
Disease Process ◽  
Treated Group ◽  
Newly Diagnosed ◽  
Recent Infection ◽  
Double Blind

ABSTRACT In recent years photopheresis has been claimed to be an effective form of immunomodulation. It has also been shown to have an effect on the disease process at the onset of type 1 diabetes. In a double-blind, placebo-controlled randomized study, we analyzed if the effect of photopheresis in children with newly diagnosed diabetes is related to changes in the balance of lymhocyte populations. We also analyzed if lymphocyte subsets were related to recent infection, mild or aggressive disease manifestations, heredity, or gender. Nineteen children received active treatment with photopheresis, while 21 children received sham pheresis (placebo group). No influence of a history of previous infection, heredity, or certain clinical parameters on lymphocyte subsets was found. At the onset of type 1 diabetes, girls showed a higher proportion and a larger number of T cells (CD3+) and T-helper cells (CD4+) and a higher proportion of naïve CD4+CD45RA+ cells. In the placebo group, an increase in the number of subsets with the activated phenotype in both the CD4 (CD29+) and the CD8 (CD11a+) compartments was noted during the course of the study. These changes did not occur in the photopheresis group. No relation between lymphocyte subsets and clinical outcome was found 1 year after the treatment with photopheresis. In conclusion, we found no major effect of photopheresis on lymphocyte populations in a group of children with newly diagnosed type 1 diabetes. However, in the placebo group the proportions of activated CD4 and CD8 cells increased over time. Since these changes did not occur in the actively treated group, our findings suggest that photopheresis may have some suppressive effects.

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