Hangover Headache and Prostaglandins: Prophylactic Treatment with Tolfenamic Acid

Cephalalgia ◽  
1983 ◽  
Vol 3 (1) ◽  
pp. 31-36 ◽  
Author(s):  
S. Kaivola ◽  
J. Parantainen ◽  
T. Österman ◽  
H. Timonen
Keyword(s):  
Prophylactic Treatment ◽  
Subjective Evaluation ◽  
Plasma Concentrations ◽  
Drug Efficacy ◽  
Tolfenamic Acid ◽  
Double Blind ◽  
Symptom Scores ◽  
Blood Alcohol Levels ◽  
Hangover Headache ◽  
Better Than

Tolfenamic acid (TA), a potent inhibitor of prostaglandin (PG) biosynthesis and action, was tested prophylactically against hangover symptoms in 30 healthy volunteers in a double–blind cross-over study. One capsule of TA (200 mg) or placebo was taken before starting to drink alcohol and another before going to bed. The hangover symptoms were evaluated in the morning. TA was found significantly better than placebo in the subjective evaluation of drug efficacy ( p<0.001) and in reducing the reported hangover symptoms in general (p < 0.01). In the TA group, significantly lower symptom scores were obtained for headache (p<0.01), and for nausea, vomiting, irritation, tremor, thirst and dryness of mouth (all p < 0.05). In a separate study with eight participants, plasma levels of PGs were followed during ingestion of alcohol with or without TA. The plasma concentrations of PGE2 and TXB2 (a metabolite of thromboxane A2) were lower in the TA group during alcohol ingestion, while PGF2a and 6-keto-PGF1a (a metabolite of prostacyclin) were unaffected. TXB2 correlated with blood alcohol levels in a U-shaped manner.

Tolfenamic Acid, Metoclopramide, Caffeine and Their Combinations in The Treatment of Migraine Attacks

Cephalalgia ◽  
1984 ◽  
Vol 4 (4) ◽  
pp. 253-263 ◽  
Author(s):  
Riitta A Tokola ◽  
Pentti Kangasniemi ◽  
Pertti J Neuvonen ◽  
Olavi Tokola
Keyword(s):  
Side Effects ◽  
Clinical Studies ◽  
Tolfenamic Acid ◽  
Acute Migraine ◽  
Double Blind ◽  
Better Than

Tolfenamic acid is a fenamate which inhibits prostaglandin (PG) biosynthesis and may act as a PG antagonist as well. Caffeine and metoclopramide are used in combination with analgesics and ergotamine in the treatment of migraine attacks, but controlled clinical studies on fixed combinations with analgesics are rare. The effects of orally given tolfenamic acid (200 mg), caffeine (100 mg), metoclopramide (10 mg), tolfenamic acid + caffeine (200 mg + 100 mg), tolfenamic acid + metoclopramide (200 mg + 10 mg) and placebo were studied in 49 migraine patients (3 men, 46 women) in a double-blind randomized cross-over study comprising 482 migraine attacks. The patients were allowed to take either one or two capsules of each preparation for an attack. Additional drugs were allowed after 3 h. Parameters characterizing the effects and side-effects of the drugs were registered. Tolfenamic acid and its combinations were found to be effective in the treatment of acute migraine, but caffeine and metoclopramide alone did not differ from placebo. Combination with metoclopramide was better than tolfenamic acid alone as judged by the smaller dose needed and the intensity of attack. Between tolfenamic acid alone and its caffeine combination there were no statistically significant differences.

Prophylactic treatment of irinotecan-induced diarrhea with neomycin (a randomized, placebo-controlled, double-blind study)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3626-3626
Author(s):  
R. H. Mathijssen ◽  
F. A. De Jong ◽  
D. F. Kehrer ◽  
R. H. Van Schaik ◽  
J. Verweij ◽  
...  
Keyword(s):  
Prophylactic Treatment ◽  
Plasma Concentrations ◽  
Aminoglycoside Antibiotic ◽  
Concomitant Administration ◽  
Patient Characteristics ◽  
Common Side Effect ◽  
Double Blind Study ◽  
Double Blind ◽  
Severe Diarrhea ◽  
Grade 3

3626 Background: Delayed-type diarrhea is a common side-effect of irinotecan, and is associated with a bacterial-mediated formation of the active irinotecan metabolite SN-38 from its glucuronide conjugate in the intestines. We hypothesized that concomitant administration of the aminoglycoside antibiotic neomycin would diminish exposure of the gut to SN-38, ameliorating the incidence of diarrhea. Methods: Patients were treated with irinotecan in a randomized, placebo-controlled, double-blind trial. In arm A, patients received irinotecan (350 mg/m2 i.v. for 90 minutes once every 3 weeks) combined with neomycin (660 mg orally 3 times daily for 3 consecutive days, starting 2 days before chemotherapy). In arm B, patients received the same irinotecan regimen with placebo. To detect a 50% reduction to less than grade 2 diarrhea (power=.80; P=.05), 60 patients had to be studied. Blood samples for additional pharmacokinetic and pharmacogenetic analyses were obtained after separate informed consent. Results: Sixty-two patients were evaluable for toxicity analysis. Relevant baseline patient characteristics (P>.06), SN-38 plasma concentrations (P=.80; N=43), and UGT1A1*28 genotype status (P=.58; N=52) were similar in both arms. Distribution, severity, and duration of diarrhea did not differ significantly between both arms (P>.32), although grade 3 diarrhea tended to be less frequent in the neomycin arm (45% reduction; P=.19). Grade 2 nausea was more common in this arm (39% vs. 9%; P<.01). The presence of at least one UGT1A1*28 allele was strongly related to the incidence of grade 2–3 diarrhea (69% vs. 34%; P=.01). Conclusions: Our results do not suggest a role for neomycin in the prophylactic treatment of irinotecan-induced diarrhea. In addition, neomycin does not influence systemic SN-38 pharmacokinetics. Also, it is suggested that each patient’s UGT1A1*28 genotype status could be used as a prospective screening tool to prevent severe diarrhea. No significant financial relationships to disclose.

Metoprolol and Propranolol in The Prophylactic Treatment of Classical and Common Migraine. A Double-Blind Study

Cephalalgia ◽  
1984 ◽  
Vol 4 (2) ◽  
pp. 91-96 ◽  
Author(s):  
P Kangasniemi ◽  
C Hedman
Keyword(s):  
Controlled Release ◽  
Beta Blocker ◽  
Prophylactic Treatment ◽  
Subjective Evaluation ◽  
Double Blind Study ◽  
Attack Frequency ◽  
Double Blind ◽  
Release Formulation ◽  
Once Daily ◽  
Acute Medication

In a double-blind, cross-over study the effect and tolerance of the non-selective beta-blocker propranolol in a dosage of 80 mg twice daily was compared to that of the beta1-selective beta-blocker metoprolol 200 mg once daily in Durules(r) (a controlled-release formulation). The attack frequency, migraine days, severity score, consumption of acute medication and subjective evaluation were the main parameters used for evaluation. Thirty-six patients with classical or common migraine were included. Thirty-three completed the investigation. It is concluded from the results that there are no differences in efficacy between metoprolol and propranolol regarding the studied parameters. Both drugs reduced the migraine symptoms compared to the run-in period and were generally well tolerated.

No beneficial effect of isopathic prophylactic treatment for birch pollen allergy during a low-pollen season: a double-blind, placebo-controlled clinical trial of homeopathic Betula 30c

2000 ◽  
Vol 89 (04) ◽  
pp. 169-173 ◽  
Author(s):  
S Aabel
Keyword(s):  
Pollen Season ◽  
Prophylactic Treatment ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Birch Pollen ◽  
Pollen Allergy ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Birch Pollen Allergy ◽  
Symptom Scores

AbstractThe objective of this research was to determine if the homeopathic medicine Betula 30c is more effective than placebo at reducing symptoms of pollen allergy in patients sensitive to birch pollen. It was a double-blind, randomized, placebo-controlled trial. Tablets were given both as a prophylactic agent, once a week four weeks before the pollen season and as an acute remedy during the pollen season. The study was done in Oslo, Norway, in May 1996 and involved 73 children, adolescents and young adults from 7 to 25 y of age. Allergy-symptoms were assessed on a visual analogue scale (VAS) by patients or parents. Main outcome measure was the median (with its 95% confidence interval) of the symptom scores for all the treated patients, each day during a 10-day period. The pollen count was very low in 1996, only three days were high enough to provoke allergic symptoms. Surprisingly, the verum treated patients fared worse than the placebo group; they used more rescue medication and had higher symptom scores during these three days. Homeopaths might attribute the findings to a putative aggravation response, but the results certainly do not lend support to the usefulness of the tested prophylactic approach, under conditions of low allergen exposure.

Pharmacokinetics and Safety Assessment of Anti-HIV Dapivirine Vaginal Microbicide Rings with Multiple Dosing

2020 ◽  
Author(s):  
Lungwani Muungo
Keyword(s):  
Ex Vivo ◽  
Oral Treatment ◽  
Plasma Concentrations ◽  
Vaginal Ring ◽  
Vaginal Fluid ◽  
Cervical Tissue ◽  
Double Blind ◽  
Group A ◽  
Group B ◽  
Anti Hiv

Objectives: Self-administered vaginal rings are a promising method for delivery of topical anti-HIV microbicidesand might offer an adherence advantage over daily or coitally-dependent dosage forms such as gels. This trialassessed the safety and pharmacokinetic aspects of the Dapivirine Vaginal Ring-004 when worn as multiple rings oversequential periods of ring use by healthy, sexually-active, HIV-negative women.Methods: This double-blind trial was conducted among 48 women (18-40 years). Participants were randomlyassigned to two groups (A or B) and received (3:1) either the dapivirine or a placebo vaginal ring. Group A used tworings over a 56-day period and Group B used three rings over a 57-day period. Safety evaluations were conductedthroughout the trial. Dapivirine concentrations were measured in plasma, vaginal fluid and cervical tissue samplescollected during and after the 56 days (Group A) or 57 days (Group B) of vaginal ring use.Results: Ring-004 was safe and well tolerated in all participants. The pharmacokinetic profile demonstrated arapid increase in plasma and vaginal fluid concentrations and achieved concentrations in vaginal fluids and cervicaltissue well above the in vitro IC99 in cervical tissue (3.3 ng/mL) that were sustained for a 28 to 35-day ring use period(approximately 3000 times higher in vaginal fluids and 14 -1000 times higher in cervical tissue). Drug levels wereassociated with significant inhibitory activity of genital secretions against HIV ex vivo, a biomarker of pharmacodynamics.Individual plasma dapivirine concentrations did not exceed 553 pg/mL and were well below plasma concentrations atthe maximum tolerated dose for oral treatment (mean Cmax 2286 ng/mL).Conclusions: The consecutive use of several rings over a period of up to 57 days was safe and well tolerated, andPK data indicate that a single Ring-004 is likely to be protective for at least 35 days.

Tonabersat, a Gap-Junction Modulator: Efficacy and Safety in Two Randomized, Placebo-Controlled, Dose-Ranging Studies of Acute Migraineceph

Cephalalgia ◽  
2009 ◽  
Vol 29 (2_suppl) ◽  
pp. 17-27 ◽  
Author(s):  
SD Silberstein ◽  
J Schoenen ◽  
H Göbel ◽  
HC Diener ◽  
AH Elkind ◽  
...  
Keyword(s):  
Adverse Events ◽  
North American ◽  
Cortical Spreading Depression ◽  
Spreading Depression ◽  
Plasma Concentrations ◽  
International Study ◽  
Maximum Plasma ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Dose Ranging

Tonabersat is a novel benzopyran derivative that blocks the cortical spreading depression proposed to be associated with migraine attacks. The ability of single oral doses of 15, 25, 40 and 80 mg of tonabersat to relieve the symptoms of moderate to severe migraine was evaluated in 859 migraineurs enrolled in two dose-ranging, double-blind, randomized, placebo-controlled, parallel-group trials, one international and the other North American. In the international study, significantly more patients given tonabersat than given placebo experienced relief of headache pain at 2 h (15 mg, 36.8%; 40 mg, 40.7%), the principal efficacy variable, and at 4 h (40 mg, 63.0%) and complete abolition of headache at 4 h (40 mg, 34.3%). None of the primary or secondary efficacy variables indicated significant differences between tonabersat and placebo in the North American study. Tonabersat was generally well tolerated, with dizziness and nausea the most common side-effects. Serious adverse events were uncommon, and no patient withdrew from either study because of adverse events. These results suggest a possible interplay between tonabersat pharmacokinetics (the relatively long time required to reach maximum plasma concentrations) and patient characteristics (previous triptan exposure) in the management of acute migraine attacks. Based on the pharmacokinetics and actions on cortical spreading depression, tonabersat may have potential value in migraine prophylaxis.

A Multicentric Clinical Trial Comparing Otocerol® with Cerumol® as Cerumenolytics

1978 ◽  
Vol 6 (3) ◽  
pp. 241-244 ◽  
Author(s):  
Gabriel Jaffé ◽  
Jack Grimshaw
Keyword(s):  
Clinical Trial ◽  
General Practitioners ◽  
Comparative Trial ◽  
Double Blind ◽  
Better Than

Fifteen general practitioners conducted a randomized, double-blind comparative trial of two cerumenolytics, namely, Otocerol® and Cerumol®. A total of 106 patients were entered into the study (fifty-three in each group). Otocerol was shown to be marginally better than Cerumol in all parameters evaluated.

621 PL02.05 LONG-TERM TREATMENT OF PATIENTS WITH EOSINOPHILIC GASTRITIS AND/OR EOSINOPHILIC DUODENITIS WITH LIRENTELIMAB, A MONOCLONAL ANTIBODY AGAINST SIGLEC-8

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Kathryn Peterson ◽  
Mirna Chehade ◽  
Joseph Murray ◽  
Gary Falk ◽  
Nirmala Gonsalves ◽  
...  
Keyword(s):  
Mast Cells ◽  
Common Adverse Event ◽  
Symptom Improvement ◽  
Duration Of Treatment ◽  
Open Label ◽  
Double Blind ◽  
Long Term Treatment ◽  
Patient Reported ◽  
Symptom Scores

Abstract   Eosinophilic esophagitis (EoE), gastritis (EG), and/or duodenitis (EoD) are associated with accumulation and activation of eosinophils and mast cells in the esophagus, stomach, and/or duodenum, respectively. Lirentelimab (AK002), an antibody against siglec-8, depletes eosinophils and inhibits mast cells. We performed an open-label extension (OLE) study of subjects who completed ENIGMA (a randomized, double-blind, placebo-controlled phase 2 study of lirentelimab in adults with symptomatic, biopsy-confirmed EG and/or EoD, with or without EoE) to evaluate long-term responses. Methods Subjects who received 4 monthly infusions of lirentelimab or placebo during ENIGMA (n = 59) were eligible for the OLE; they received monthly, escalating doses of lirentelimab (0.3 or 1 mg/kg escalating to 3 mg/kg). Symptoms were assessed weekly using an electronic daily patient-reported outcome questionnaire and total symptom scores (TSS) were calculated. Patients underwent upper endoscopy with biopsy at screening and at the end of ENIGMA (day 99, week 16, blinded); in the OLE, endoscopies were performed on day 323 (30 weeks after the first dose in the OLE). Histopathology was assessed by a single pathologist. Results Fifty-eight subjects entered the OLE; 45 completed ≥52 weeks lirentelimab (including exposure during ENIGMA) and 29 completed 70 weeks. Mean TSS improved through week 70 (Figure 1). Subjects receiving 70 weeks lirentelimab (ENIGMA+OLE) had further improvements in TSS from baseline (mean reductions: 68% at weeks 29–30, 70% at weeks 51–52, 75% at weeks 69–70). Symptom scores (abdominal pain, nausea, vomiting, early satiety, appetite loss, abdominal cramping, bloating, diarrhea) decreased significantly from baseline. Treatment response was not associated with concomitant EoE. The most common adverse event was mild to moderate infusion-related reactions, usually with the first infusion. Conclusion In the OLE of the ENIGMA study, patients with EG and or EoD (with or without concomitant EoE) who received lirentelimab had sustained tissue eosinophil depletion and significant long-term symptom improvement. Symptoms continued to improve with duration of treatment. Lirentelimab appears to be a promising targeted treatment for EG and/or EoD.

Double-Blind Placebo Controlled Oral Analgesic Comparison of Butorphanol and Pentazocine in Patients with Moderate to Severe Post-Operative Pain

1973 ◽  
Vol 1 (2) ◽  
pp. 422-428
Author(s):  
Robert E S Young
Keyword(s):  
The Other ◽  
Dose Effect ◽  
Surgical Patients ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Oral Analgesic ◽  
Post Operative Pain ◽  
Maximum Pain ◽  
Better Than ◽  
Observation Period

A double-blind, randomized trial was conducted in 120 post-surgical patients to evaluate the oral analgesic activity of butorphanol tartrate (4 mg and 8 mg) and pentazocine HCl (50 mg) as compared to placebo. Both doses of butorphanol as well as pentazocine proved to be significantly (p <0.05) more effective than placebo. Butorphanol 4 mg and pentazocine 50 mg were never significantly different from each other, while butorphanol 8 mg was significantly better than both butorphanol 4 mg as well as pentazocine 50 mg in several instances, demonstrating a significant dose effect relationship for butorphanol. All of the active treatments provided maximum pain relief within 1 to 2 hours and were effective over 4 hours. In contrast to the other treatments, none of the 8 mg butorphanol patients required remedication during the 4-hour observation period. Generally, the incidence of side-effects appeared low.

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