The Effect of Intranasal Cocaine and Lidocaine on Nitroglycerin‐Induced Attacks in Cluster Headache

Cephalalgia ◽  
2000 ◽  
Vol 20 (2) ◽  
pp. 85-91 ◽  
Author(s):  
A Costa ◽  
E Pucci ◽  
F Antonaci ◽  
G Sances ◽  
F Granella ◽  
...  
Keyword(s):  
Cluster Headache ◽  
Symptomatic Treatment ◽  
Local Administration ◽  
Cotton Swab ◽  
Double Blind ◽  
Anaesthetic Agents ◽  
Intranasal Cocaine ◽  
Cocaine Hydrochloride ◽  
Local Use ◽  
Symptomatic Side

The administration of nitroderivatives in cluster headache (CH) sufferers is the most reproducible experimental paradigm to induce spontaneous‐like pain attacks. Previous uncontrolled studies have reported that the local use of anaesthetic agents in the area of the sphenopalatine fossa is able to extinguish nitroglycerin (NTG)‐induced pain in CH. The present study, carried out according to a double‐blind placebo‐controlled design, included 15 CH patients, six with episodic CH (mean ± sd age of 36.8 ± 5.6 years), and nine with chronic CH (37.8 ± 10.4 years). Patients had undergone a standard NTG test (0.9 mg sublingually), during which the intensity of pain was scored using a visuo‐analogic scale (VAS, range 0–10). Nine patients (two with the episodic form, seven with the chronic form) experienced a typical, spontaneous‐like attack on the usual side, occurring in all cases within 45 min. In these patients, the test was repeated with an interval of 2 days, and once pain intensity reached 5 on the VAS, a 10% solution of cocaine hydrochloride (1 ml, mean amount per application 40–50 mg), or 10% lidocaine (1 ml), or saline was applied using a cotton swab in the area corresponding to the sphenopalatine fossa, under anterior rhinoscopy. This was done in both the symptomatic and the non‐symptomatic side, for 5 min. Treatments were always performed randomly, in separate sessions. All patients responded promptly to both anaesthetic agents, with complete cessation of induced pain occurring after 31.3 ± 13.1 min for cocaine and 37.0 ± 7.8 min for lidocaine (M ± sd). In the case of saline application, pain severity increased thereafter, and extinction of the provoked attacks occurred with a latency of 59.3 ± 12.3 min ( P < 0.01 and P < 0.01 vs. cocaine and lidocaine, respectively, Mann–Whitney U‐test). While further suggesting that the sphenopalatine ganglion participates in the mechanisms of pain, these findings indicate that the local administration of the anaesthetic agents cocaine and lidocaine is effective on NTG‐induced CH attacks, and may be used in the symptomatic treatment of this disorder.

Efficacy of galcanezumab in patients with episodic cluster headaches and a history of preventive treatment failure

2021 ◽  
Vol 4 ◽  
pp. 251581632110156
Author(s):  
Brian Plato ◽  
J Scott Andrews ◽  
Mallikarjuna Rettiganti ◽  
Antje Tockhorn-Heidenreich ◽  
Jennifer Bardos ◽  
...  
Keyword(s):  
Cluster Headache ◽  
Treatment Failure ◽  
Preventive Treatment ◽  
Mean Difference ◽  
Least Square ◽  
Double Blind Study ◽  
Double Blind ◽  
Cluster Headache Attack ◽  
Episodic Cluster Headache ◽  
History Of

Objective: The efficacy of galcanezumab was evaluated in patients with episodic cluster headache and history of preventive treatment failure. Methods: In the randomized, 8-week, double-blind study (CGAL), patients with episodic cluster headache received once-monthly subcutaneous injections of galcanezumab 300 mg or placebo. Patients who completed CGAL and enrolled in an open-label study were queried for preventive treatment history. In a subset of patients with a known history of failure of verapamil or any other prior preventive treatment, a post hoc analysis of least square mean change from baseline in weekly cluster headache attack frequency across Weeks 1 to 3 was assessed. Results: Fifteen patients provided data for known history of prior preventive treatment failure (6 placebo, 9 galcanezumab), of whom 11 failed verapamil. The mean reduction in the weekly frequency of cluster headache attacks was greater with galcanezumab compared to placebo among patients with prior preventive treatment failure (8.2 versus 2.4); mean difference 5.8 (95% confidence interval [CI] 2.0, 13.6) and among patients with verapamil failure (10.1 versus 1.6); mean difference 8.5 (95% CI 0.4, 16.7). Conclusion: In this exploratory analysis of patients with a known history of prior preventive treatment failures, treatment with galcanezumab resulted in greater mean reductions in weekly cluster headache attacks compared with placebo. ClinicalTrials.gov: NCT02397473 (I5Q-MC-CGAL) NCT02797951 (I5Q-MC-CGAR)

Symptomatic Treatment With Lanreotide Microparticles in Inoperable Bowel Obstruction Resulting From Peritoneal Carcinomatosis: A Randomized, Double-Blind, Placebo-Controlled Phase III Study

2012 ◽  
Vol 30 (35) ◽  
pp. 4337-4343 ◽  
Author(s):  
Pascale Mariani ◽  
Joëlle Blumberg ◽  
Alain Landau ◽  
Daniela Lebrun-Jezekova ◽  
Estelle Botton ◽  
...  
Keyword(s):  
Peritoneal Carcinomatosis ◽  
Bowel Obstruction ◽  
Well Being ◽  
Symptomatic Treatment ◽  
Phase Iii ◽  
Primary Analysis ◽  
Open Label ◽  
Double Blind ◽  
Parallel Group ◽  
Intent To Treat

Purpose To investigate the somatostatin analog lanreotide as symptomatic treatment for inoperable bowel obstruction due to peritoneal carcinomatosis. Patients and Methods In all, 80 patients with peritoneal carcinomatosis, inoperable malignant digestive obstruction, and two or more vomiting episodes per day or nasogastric tube (NGT) who were previously treated with intravenous corticosteroids and proton pump inhibitors were randomly assigned to one 30-mg injection of lanreotide microparticles (n = 43) or placebo (n = 37) in a 10-day, double-blind, parallel-group phase. The primary end point was the proportion of patients responding on day 7 (one or fewer episodes of vomiting per day or no vomiting recurrence after NGT removal [for ≥ 3 consecutive days in both cases]). Vomiting frequency/NGT secretion volumes, nausea, abdominal pain, well-being, and safety were also assessed. Patients could then enter an open-label lanreotide-only phase. The study was conducted at 22 European hospitals. Results More patients receiving lanreotide than placebo were responders; this difference was not statistically significant for the intent-to-treat (ITT) population on the basis of diary cards (primary analysis; 41.9% [18 of 43] v 29.7% [11 of 37], respectively; odds ratio, 1.75; 95% CI, 0.68 to 4.49; P = .24) but was statistically significant for the corresponding supportive per protocol analysis (57.7% [15 of 26] v 30.4% [seven of 23]; P < .05) and ITT analysis, on the basis of investigators' assessments (50.0% [19 of 38] v 28.6% [10 of 35]; P < .05). Improvements in well-being were significantly greater with lanreotide on days 3, 6, and 7. No significant differences were observed for other secondary end points. Only two (mild/moderate) treatment-emergent adverse events were considered related to lanreotide. Conclusion These results show that lanreotide has some efficacy and is safe in the symptomatic treatment of patients with inoperable bowel obstruction due to peritoneal carcinomatosis.

Autonomic Disorders in Cluster Headache, With Special Reference to Salivation, Nasal Secretion and Tearing

Cephalalgia ◽  
1984 ◽  
Vol 4 (1) ◽  
pp. 57-64 ◽  
Author(s):  
C Saunte
Keyword(s):  
Cluster Headache ◽  
Special Reference ◽  
Nasal Secretion ◽  
Test Battery ◽  
Innervation Pattern ◽  
Autonomic Disorders ◽  
Symptomatic Side

Attacks of cluster headache are often associated with symptoms of an autonomic nature. A test battery allowing quantitation of salivation, nasal secretion and tearing has been employed. Fourteen patients examined under basal conditions hardly differed from a group of controls (N = 20). After stimulation with pilocarpine the patients responded like the controls. During attacks we found minimal bilateral salivation, but an increase of tearing and nasal secretion, mostly on the symptomatic side. These results correspond with those found in CPH. The finding of the minimal salivation is consistent with the notion that the headache attacks are associated with increased sympathico-tonus. The results may suggest that the complexity of the innervation pattern of the different secretory organs examined is more marked than hitherto known.

scholarly journals A randomised placebo-controlled double-blind multicentre trial comparing antibiotic therapy with placebo in the treatment of uncomplicated acute appendicitis: APPAC III trial study protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. e023623 ◽  
Author(s):  
Suvi Sippola ◽  
Juha Grönroos ◽  
Ville Sallinen ◽  
Tero Rautio ◽  
Pia Nordström ◽  
...  
Keyword(s):  
Acute Appendicitis ◽  
Antibiotic Therapy ◽  
Ct Scan ◽  
Symptomatic Treatment ◽  
Spontaneous Resolution ◽  
University Hospital ◽  
Controlled Study ◽  
Double Blind ◽  
Uncomplicated Acute Appendicitis

IntroductionRecent studies show that antibiotic therapy is safe and feasible for CT-confirmed uncomplicated acute appendicitis. Spontaneous resolution of acute appendicitis has already been observed over a hundred years ago. In CT-confirmed uncomplicated acute diverticulitis (left-sided appendicitis), studies have shown no benefit from antibiotics compared with symptomatic treatment, but this shift from antibiotics to symptomatic treatment has not yet been widely implemented in clinical practice. Recently, symptomatic treatment of uncomplicated acute appendicitis has been demonstrated in a Korean open-label study. However, a double-blinded placebo-controlled study to illustrate the role of antibiotics and spontaneous resolution of uncomplicated acute appendicitis is still lacking.Methods and analysisThe APPAC III (APPendicitis ACuta III) trial is a multicentre, double-blind, placebo-controlled, superiority randomised study comparing antibiotic therapy with placebo in the treatment CT scan-confirmed uncomplicated acute appendicitis aiming to evaluate the role of antibiotics in the resolution of uncomplicated acute appendicitis. Adult patients (18–60 years) with CT scan-confirmed uncomplicated acute appendicitis (the absence of appendicolith, abscess, perforation and tumour) will be enrolled in five Finnish university hospitals.Primary endpoint is success of the randomised treatment, defined as resolution of acute appendicitis resulting in discharge from the hospital without surgical intervention within 10 days after initiating randomised treatment (treatment efficacy). Secondary endpoints include postintervention complications, recurrent symptoms after treatment up to 1 year, late recurrence of acute appendicitis after 1 year, duration of hospital stay, sick leave, treatment costs and quality of life. A decrease of 15 percentage points in success rate is considered clinically important difference. The superiority of antibiotic treatment compared with placebo will be analysed using Fisher’s one-sided test and CI will be calculated for proportion difference.Ethics and disseminationThis protocol has been approved by the Ethics Committee of Turku University Hospital and the Finnish Medicines Agency (FIMEA). The findings will be disseminated in peer-reviewed academic journals.Trial registration numberNCT03234296; Pre-results.

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