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Indian Journal of Otolaryngology and... Apr 2023Aim: The aim of the study is to compare the effects of vestibular rehabilitation and pharmacological treatment in benign paroxysmal positional vertigo (BPPV). Materials...
UNLABELLED
Aim: The aim of the study is to compare the effects of vestibular rehabilitation and pharmacological treatment in benign paroxysmal positional vertigo (BPPV). Materials and methods: Thirty patients (40.93 ± 8.66 years old) diagnosed with BPPV were recruited. Patients were equally divided into pharmacological control group and vestibular rehabilitation group. The pharmacological control group was further divided into Group A (n = 8, 2 doses/day, 24 mg betahistine) and Group B (n = 7, 1 dose/day, 50 mg dimenhydrinate in addition to betahistine). Patients in the rehabilitation group underwent repeated head and eye movements, and Epley or Barbecue Roll Maneuvers were applied for 4 weeks. Subjective assessment of vertigo was measured with the visual analog scale. Static balance parameters were measured with the tandem, one-legged stance, and Romberg tests. Dynamic visual acuity was measured with a Snellen chart, and vestibular dysfunction was measured with the Unterberger (Fukuda stepping) test. All parameters were evaluated before and after treatment. Results: Vestibular rehabilitation resulted in greater improvement in severity of vertigo, balance parameters except Romberg test, and vestibular dysfunction than pharmacological therapy (p < 0,001). There was no significant difference in dynamic visual acuity between groups (p = 0,24). The effects of medication with the active ingredients betahistine and dimenhydrinate were similar (p > 0,05). Conclusion: The vestibular rehabilitation method can positively change the severity of vertigo, balance ability, and vestibular dysfunction compared to pharmacological therapy. Dimenhydrinate administered in combination with betahistine was not superior to betahistine alone but can be recommended for its antiemetic effect.
SUPPLEMENTARY INFORMATION
The online version contains supplementary material available at 10.1007/s12070-023-03598-4.
PubMed: 37206852
DOI: 10.1007/s12070-023-03598-4 -
Clinical Drug Investigation Sep 2022The source data of four individual randomised, double-blind, reference- and/or placebo-controlled clinical trials with virtually identical study design were pooled for... (Meta-Analysis)
Meta-Analysis
Efficacy and Safety of a Fixed-Dose Combination of Cinnarizine 20 mg and Dimenhydrinate 40 mg in the Treatment of Patients with Vestibular Vertigo: An Individual Patient Data Meta-Analysis of Randomised, Double-Blind, Controlled Clinical Trials.
BACKGROUND AND OBJECTIVE
The source data of four individual randomised, double-blind, reference- and/or placebo-controlled clinical trials with virtually identical study design were pooled for the present meta-analysis. The main objective was to further evaluate the efficacy and safety of the fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg in comparison to various other antivertigo treatments in patients suffering from central and/or peripheral vestibular vertigo.
METHODS
Adult male and female outpatients were subjected to a 4-week treatment with the fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg, cinnarizine (20 mg, 50 mg), dimenhydrinate (40 mg, 100 mg), betahistine dimesylate (12 mg), betahistine dihydrochloride (16 mg) and placebo, respectively. The primary efficacy endpoint was the reduction of a validated mean vertigo score (MVS), a composite score of 12 individual vertigo symptoms, the intensities of which were each evaluated by the patients on a 5-point visual analogue scale. For analysis of primary and further secondary efficacy endpoints, baseline-adjusted analysis of covariance (ANCOVA) was used to calculate adjusted least squares means (LSM) with associated two-sided 95% confidence intervals (CIs) for the difference in MVS reductions between treatment groups. Moreover, various sensitivity analyses, responder and subgroup analyses as well as descriptive analyses with respect to safety/tolerability of the treatments were conducted.
RESULTS
Of 795 randomised patients, 779 belonged to the intent-to treat (ITT) and 723 to the per-protocol (PP) population. The main efficacy analysis was based on the ITT population (mean age 52.1 years, 61% female). The mean decrease of the MVS from baseline to Week 4 in the cinnarizine/dimenhydrinate group (-1.10) proved to be significantly larger than in any of the comparator groups. LSM differences for comparators versus the fixed combination ranged between 0.16 (95% confidence interval (CI) 0.03; 0.30, p = 0.017) for cinnarizine 20 mg and 0.60 (95% CI 0.42; 0.78; p < 0.001) for betahistine dimesylate 12 mg in favour of the fixed combination. Furthermore, after 4 weeks of treatment, 74 patients (24.7%) in the cinnarizine/dimenhydrinate group were completely symptom free (MVS = 0), a significantly greater proportion than in any of the comparator groups. Sensitivity analyses showed that baseline characteristics such as age, sex, duration of vertigo and antivertigo pretreatment had only a very minor and clinically non-relevant impact on the efficacy results regarding the primary efficacy outcome. Subgroup analyses with respect to age groups (< 65 years/≥ 65 years) and sex showed no significant differences in efficacy within any of the treatment groups. All treatments were well tolerated. A total of 55 patients (6.9%) reported 75 non-serious adverse events (AEs), and 19 patients (2.4%) discontinued the study prematurely because of AEs. Nearly 95% of the patients (cinnarizine/dimenhydrinate group: 97.9%) rated the tolerability of the study medications as either "good" or "very good".
CONCLUSION
The findings of the present meta-analysis indicate that the fixed combination of cinnarizine and dimenhydrinate is a safe and potentially superior treatment option for patients suffering from central and/or peripheral vestibular vertigo, as compared to current standard treatments such as cinnarizine, dimenhydrinate or betahistine given alone in monotherapy.
Topics: Adult; Aged; Betahistine; Cinnarizine; Dimenhydrinate; Double-Blind Method; Female; Humans; Male; Middle Aged; Randomized Controlled Trials as Topic; Vertigo
PubMed: 35864302
DOI: 10.1007/s40261-022-01184-0 -
Wiener Klinische Wochenschrift May 2016The efficacy and safety of the fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg in the treatment of vertigo of various origins have been investigated in... (Observational Study)
Observational Study
The efficacy and safety of the fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg in the treatment of vertigo of various origins have been investigated in a prospective, noninterventional study involving private practices throughout Germany. A total of 1275 patients with an average age of 61.2 years participated in the study. The vertigo symptoms, measured by a validated mean vertigo score (primary efficacy endpoint) improved by 61 % in the course of the observational period (median: 6 weeks). Concomitant symptoms frequently associated with vertigo such as nausea, vomiting and tinnitus were also markedly reduced by 84, 85 and 51 %, respectively. Overall efficacy has been rated by the physicians as 'very much improved' or 'much improved' in 95 % of the patients. A total of 47 patients (3.7 %) reported 51 adverse drug reactions (all nonserious). The results indicate a good tolerability and efficacy of the fixed combination of cinnarizine and dimenhydrinate in the treatment of vertigo in daily medical practice, which is in line with previous findings of numerous interventional, randomised, double-blind, controlled clinical trials.
Topics: Adolescent; Adult; Age Distribution; Aged; Aged, 80 and over; Antiemetics; Cinnarizine; Dimenhydrinate; Drug-Related Side Effects and Adverse Reactions; Female; Germany; Histamine H1 Antagonists; Humans; Male; Middle Aged; Prevalence; Risk Factors; Sex Distribution; Treatment Outcome; Vertigo; Young Adult
PubMed: 26659910
DOI: 10.1007/s00508-015-0905-5 -
Iranian Journal of Nursing and... Mar 2014Nausea and vomiting are the common symptoms of early pregnancy. Without treatment, vomiting can complicate the pregnancy, so it must be reduced. Wide varieties of...
BACKGROUND
Nausea and vomiting are the common symptoms of early pregnancy. Without treatment, vomiting can complicate the pregnancy, so it must be reduced. Wide varieties of treatment have been used for nausea and vomiting in pregnancy. This study compared the effectiveness of vitamin B6 and dimenhydrinate for gestational nausea and vomiting.
MATERIALS AND METHODS
One hundred and forty pregnant women with a gestational age of <16 weeks who had symptoms of nausea and vomiting were selected. They were randomly allocated into group A (n = 70) and group B (n = 70). The patients in group A received a vitamin B6 tablet, while the patients in group B received a dimenhydrinate tablet daily; the tablets were identical in appearance. The degree of nausea and vomiting was assessed by physical symptoms of Rhodes score.
RESULTS
One hundred and thirty-five women returned to follow-up. Dimenhydrinate and vitamin B6 significantly reduced nausea and vomiting scores from 8.3 (7.4) to 2.8 (2.0) and from 8.6 (2.9) to 3.8 (2.3), respectively. The mean score change after treatment with dimenhydrinate was greater than with vitamin B6.
CONCLUSION
Both dimenhydrinate and vitamin B6 were effective in the treatment of nausea and vomiting in early pregnancy. Dimenhydrinate was more effective than vitamin B6.
PubMed: 24834091
DOI: No ID Found -
Clinical Drug Investigation Nov 2019Vertigo derived from peripheral vestibular disorders is quite frequently encountered in daily clinical practice and can be a severely disabling symptom associated with... (Comparative Study)
Comparative Study Randomized Controlled Trial
Efficacy and Safety of a Fixed Combination of Cinnarizine 20 mg and Dimenhydrinate 40 mg vs Betahistine Dihydrochloride 16 mg in Patients with Peripheral Vestibular Vertigo: A Prospective, Multinational, Multicenter, Double-Blind, Randomized, Non-inferiority Clinical Trial.
BACKGROUND AND OBJECTIVE
Vertigo derived from peripheral vestibular disorders is quite frequently encountered in daily clinical practice and can be a severely disabling symptom associated with substantial impairment of health-related quality of life for the affected patients. Betahistine, a structural analogue of histamine and presumably the most widely prescribed anti-vertigo drug worldwide, has previously been shown to be an effective and safe treatment for these patients. The objective of the present study was to evaluate whether the fixed combination of cinnarizine and dimenhydrinate (Arlevert) is non-inferior and thus a potentially useful alternative to betahistine dihydrochloride in the treatment of patients suffering from peripheral vestibular vertigo.
METHODS
In this prospective, multicenter, double-blind, randomized, non-inferiority clinical trial, outpatients from 8 ENT clinics in Austria, Bulgaria, the Czech Republic and Russia were randomly assigned to receive three times daily one tablet of either the fixed combination cinnarizine 20 mg/dimenhydrinate 40 mg or betahistine dihydrochloride 16 mg for 4 weeks. Primary endpoint was the reduction of the mean vertigo score (MVS), a validated 12-item composite score defined as the mean of 6 vertigo symptoms (dystasia and walking unsteadiness, staggering, rotary sensation, tendency to fall, lift sensation, blackout) and 6 trigger factors for vertigo (change of position, bowing, getting up, driving by car/train, head movements, eye movement), after 4 weeks of therapy, as judged by the patient on a 5-point visual analogue scale (VAS). The non-inferiority margin was set to 0.3. Secondary outcomes included the patient's and investigator's judgment of global efficacy, the patient's rating of impairment of daily activities, and safety/tolerability of the treatments.
RESULTS
Three hundred and six patients (mean age 53.5 years, approximately 60% female) were enrolled and randomized to the fixed combination cinnarizine/dimenhydrinate (n = 152) or betahistine (n = 154) groups; 297 patients completed the study and 294 (146 and 148, respectively) were valid for the per-protocol analysis, which was used for the non-inferiority analysis. Treatment with cinnarizine/dimenhydrinate led to a stronger reduction of the MVS [least squares mean (LSM)] after 4-week therapy (primary endpoint) in comparison to betahistine (0.395 vs 0.488; difference: - 0.093, 95% CI - 0.180; - 0.007, p = 0.035); since the upper limit of the two-sided 95% confidence interval was not only below the non-inferiority margin of 0.3, but also entirely below 0, superiority of the fixed combination could be demonstrated. The combination preparation was also more effective after 1 week of therapy and received more favorable patient's ratings on overall efficacy and impairment of daily activities. Both treatments were very well tolerated. Only 12 patients (3.92%) reported 13 non-serious adverse events; 2 cinnarizine/dimenhydrinate-treated patients discontinued the study prematurely due to adverse events as compared to 5 betahistine-treated patients.
CONCLUSION
The fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg was found to be not only non-inferior, but superior to betahistine 16 mg in the improvement of peripheral vestibular vertigo. Furthermore, taking into account a good and slightly favorable safety profile, the present study provides evidence that the fixed-combination preparation is a potent and even superior alternative to betahistine in the treatment of vertigo related to peripheral vestibular disorders.
STUDY REGISTRATION
EudraCT No. 2011-004025-27.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Betahistine; Cinnarizine; Dimenhydrinate; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Prospective Studies; Vertigo; Young Adult
PubMed: 31571128
DOI: 10.1007/s40261-019-00858-6 -
Galen Medical Journal 2018Design, formulation and physicochemical evaluation of dimenhydrinate 25 mg oral tablets that disintegrate in oral cavity in a proper time. This product is easy to use...
BACKGROUND
Design, formulation and physicochemical evaluation of dimenhydrinate 25 mg oral tablets that disintegrate in oral cavity in a proper time. This product is easy to use for babies, geriatrics and people who have difficulty in swallowing.
MATERIALS AND METHODS
31 formulations were designed in 3 categories via Design-Expert software version 7. Group 1 consist of super-disintegrating bases, group 2 consist of effervescent bases and group 3 consist of super-disintegrating and effervescent bases together. Proposed by DesignExpert software, the optimum formulations were selected in each category and the tablets were produced by direct compression method. Tablets evaluated by friability, thickness, hardness, weight variation, drug content, content uniformity, disintegration time, wetting time, dissolution and moisture uptake tests.
RESULTS
The angle of repose and compressibility index of formulations were in the range of 24.65-29.08 and 5.02-9.01 % respectively. Thickness, hardness, wetting time, friability and content uniformity of formulations were in the range of 3.36-3.84 mm, 33.25-38.03 N, 19-37 seconds, 0.31-0.42 % and 96.44-99.02 % respectively. Disintegration time of the groups 1, 2 and 3 were in the range of 16-70, 47-72 and 12-35 seconds respectively.
CONCLUSION
Mixture of powders and orally dispersible tablets passed all tests. The results showed that formulations containing both of super-disintegrants and effervescent bases had better disintegration time compare to other formulations.
PubMed: 34466419
DOI: 10.22086/gmj.v0i0.936 -
The Cochrane Database of Systematic... Sep 2011Vomiting is a common manifestation of acute gastroenteritis in children and adolescents. When untreated it can be a hindrance to oral rehydration therapy, which is the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Vomiting is a common manifestation of acute gastroenteritis in children and adolescents. When untreated it can be a hindrance to oral rehydration therapy, which is the cornerstone in the management of acute gastroenteritis. Evidence is needed concerning the safety and efficacy of antiemetic use for vomiting in acute gastroenteritis in children.
OBJECTIVES
To assess the safety and effectiveness of antiemetics on gastroenteritis induced vomiting in children and adolescents.
SEARCH STRATEGY
We searched the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register comprising references identified from comprehensive electronic database searches and hand searches of relevant journals and abstract books of conferences.The search was re-run and is up to date as on 20 July 2010.
SELECTION CRITERIA
Randomized controlled trials comparing antiemetics with placebo or no treatment, in children and adolescents under the age of 18, for vomiting due to gastroenteritis.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and extracted data.
MAIN RESULTS
We included seven trials involving 1,020 participants. Mean time to cessation of vomiting in one study was 0.34 days less with dimenhydrinate suppository compared to placebo (P value = 0.036). Pooled data from three studies comparing oral ondansetron with placebo showed: a reduction in the immediate hospital admission rate (RR 0.40, NNT 17, 95% CI 10 to 100) but no difference between the hospitalization rates at 72 hours after discharge from the Emergency Department (ED); a reduction in IV rehydration rates both during the ED stay (RR 0.41, NNT 5, 95% CI 4 to 8), and in follow-up to 72 hours after discharge from the ED stay (worst-best scenario for ondansetron RR 0.57, NNT 6, 95% CI 4 to 13) and an increase in the proportion of patients with cessation of vomiting (RR 1.34, NNT 5, 95% CI 3 to 7)). No significant difference was noted in the revisit rates or adverse events, although diarrhea was reported as a side effect in four of the five ondansetron studies. In one study the proportion of patients with cessation of vomiting in 24 hours was (58%) with IV ondansetron, (17%) placebo and (33%) in the metoclopramide group (P value = 0.039).
AUTHORS' CONCLUSIONS
Oral ondansetron increased the proportion of patients who had ceased vomiting and reduced the number needing intravenous rehydration and immediate hospital admission. Intravenous ondansetron and metoclopramide reduced the number of episodes of vomiting and hospital admission, and dimenhydrinate as a suppository reduced the duration of vomiting.
Topics: Acute Disease; Adolescent; Antiemetics; Child; Child, Preschool; Fluid Therapy; Gastroenteritis; Hospitalization; Humans; Metoclopramide; Ondansetron; Randomized Controlled Trials as Topic; Vomiting
PubMed: 21901699
DOI: 10.1002/14651858.CD005506.pub5 -
RSC Advances Oct 2020The British Pharmacopeia (BP) reported that the carcinogenic and hepatotoxic, benzophenone (BZP) is a dimenhydrinate (DMH) impurity. On the other hand, cinnarizine (CIN)...
The British Pharmacopeia (BP) reported that the carcinogenic and hepatotoxic, benzophenone (BZP) is a dimenhydrinate (DMH) impurity. On the other hand, cinnarizine (CIN) is reported to have five impurities (A-E). The toxicity profile of CIN impurities was studied and the data revealed that impurity A [1-(diphenylmethyl)piperazine] (DPP) was the most toxic CIN impurity, and hence it was selected during this work. TLC-densitometric method was developed for separation and simultaneous quantitation of DMH, CIN and their toxic impurities. In the proposed method hexane : ethanol : acetone : glacial acetic acid (7 : 3 : 0.7 : 0.5, by volume) with UV scanning at 225 nm were used. Method validation was carried out according to ICH guidelines and linearity was achieved in the range 0.2-4, 0.5-5, 0.1-2.0, and 0.05-2.2 μg per band for DMH, CIN, BZP and DPP, respectively. On the application of the method to pharmaceutical formulation, no interference from additives was observed. The greenness of the method was evaluated using the analytical eco-scale and the results revealed the low negative environmental impact of the developed method.
PubMed: 35521250
DOI: 10.1039/d0ra06147f -
British Journal of Anaesthesia Jul 1999The past decade has witnessed the introduction of several significant innovations to combat POV, particularly the introduction of serotonin antagonists and the use of... (Review)
Review
The past decade has witnessed the introduction of several significant innovations to combat POV, particularly the introduction of serotonin antagonists and the use of combinations of drugs for analgesia and control of POV. Based on current knowledge, the anaesthetic plan for a patient with a previous history of severe PONV and undergoing a procedure known to be associated with a high incidence of this problem should include premedication with a benzodiazepine and/or clonidine and the preferential use of regional anaesthetic techniques. If general anaesthesia is essential, anaesthetists should consider the use of propofol for both induction and maintenance of anaesthesia, together with avoidance of nitrous oxide, opioids and neuromuscular antagonists. Pain control is extremely important, and a peripheral regional block should be used if possible. A combination of prophylactic antiemetics such as dexamethasone, a 5-HT3 antagonist and an antiemetic of a different class (e.g. perphenazine or dimenhydrinate) should be administered. Non-pharmacological measures such as acupressure and suggestion should also be considered, together with nursing measures to avoid sudden movement from one position to another during the postoperative period. A quiet environment, adequate i.v. fluids and not forcing the patient to drink before discharge all contribute to decreased emesis. It is possible that the advent of a new class of antiemetic agents, the NKI antagonists, may have major effects on the incidence of this complication. Drugs in this group differ from other currently available drugs in having the ability to effectively block the emetic response to many stimuli in experimental animals. Postoperative vomiting remains a significant problem, resulting in patient suffering and prolonged recovery from anaesthesia. Our aim should be to eliminate this complication in all children who require surgery. It should not be considered merely as the 'big, little problem'.
Topics: Antiemetics; Child; Humans; Postoperative Nausea and Vomiting; Research Design; Risk Factors
PubMed: 10616338
DOI: 10.1093/bja/83.1.104