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BMJ Clinical Evidence Aug 2007Up to 18% of people in industrialised societies have mild tinnitus, which severely affects daily life in 0.5% of people. Tinnitus can be associated with hearing loss,... (Review)
Review
INTRODUCTION
Up to 18% of people in industrialised societies have mild tinnitus, which severely affects daily life in 0.5% of people. Tinnitus can be associated with hearing loss, acoustic neuromas, drug toxicity, ear diseases, and depression. Tinnitus can last for many years, and can interfere with sleep and concentration.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for chronic tinnitus? We searched: Medline, Embase, The Cochrane Library and other important databases up to December 2006. (BMJ Clinical evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 37 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: acamprosate, acupuncture, antidepressant drugs, baclofen, benzodiazepines, carbamazepine, cinnarizine, ear-canal magnets, electromagnetic stimulation, ginkgo biloba, hearing aids, hyperbaric oxygen, hypnosis, lamotrigine, nicotinamide, psychotherapy, tinnitus-masking devices, tinnitus retraining therapy, zinc.
Topics: Tinnitus; United States
PubMed: 19454115
DOI: No ID Found -
The Cochrane Database of Systematic... Jan 2005Opioid antagonists can decrease alcohol consumption in animals. Their harms and benefits have been examined in many clinical trials. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Opioid antagonists can decrease alcohol consumption in animals. Their harms and benefits have been examined in many clinical trials.
OBJECTIVES
To determine the effectiveness of opioid antagonists in attenuating or preventing the recommencement of alcohol consumption in patients with alcohol dependence in comparison to placebo, other medications and psychosocial treatments. In addition, discontinuation rate, death, patient satisfaction, functioning, health-related quality of life and economic outcomes were also evaluated.
SEARCH STRATEGY
The specialised register of the Cochrane Group on Drugs and Alcohol was searched until September 2003. The search was integrated with previous searches of Cochrane Controlled Trials Register (Cochrane Library 2001, issue 4), MEDLINE (1966 - October 2001), EMBASE (1980 - December 2001) and CINHAL (1982 - December 2001). Du Pont Pharmaceutical and Ivax Corporation were contacted for information regarding unpublished trials. The reference lists of the obtained papers were also examined.
SELECTION CRITERIA
All relevant randomised controlled trials (RCTs) were included. Participants were people with alcohol dependence. Naltrexone (NTX), nalmefene (NMF) and other opioid antagonists with/without other biological or psychosocial treatments were examined. Two primary outcomes were number of participants with relapses (including those who return to heavy drinking) and number of participants who return to drinking. Other outcomes of interest were time to first drink, percentage or number of drinking days, number of standard drinks, craving, percentage or number of days or episodes of heavy drinking, amount of alcohol consumed, discontinuation rate, patient satisfaction, impaired function, health-related quality of life, economic and death.
DATA COLLECTION AND ANALYSIS
Two reviewers evaluated and extracted the data independently. The dichotomous data were extracted on an intention-to-treat basis. The Relative Risk with the 95% confidence interval was used to assess the dichotomous data. A weighted (or standardised) mean difference (WMD or SMD) with 95% confidence interval was used to assess the continuous data.
MAIN RESULTS
The review included 29 RCTs presented in 36 articles. Except two RCTs of nalmefene, all others investigated NTX. In comparison to placebo, a short-term treatment of NTX significantly decreased the relapse [RR (95% CI) = 0.64 (0.51 to 0.82)] and was likely to decrease the return to drinking [RR (95% CI) = 0.87 (0.76 to 1.00). In the respect of acceptability, NTX treatment significantly diminished treatment withdrawal [RR (95% CI) = 0.82 (0.70 to 0.97). While a medium-term treatment of NTX gave no benefit in the respect of relapse prevention, it was found to be beneficial on two of four secondary outcomes by increasing time to first drink and diminishing craving. A medium-term treatment of NTX was superior to acamprosate in reducing relapses, standard drinks and craving. NTX plus an intensive psychosocial treatment (PST) was not superior to NTX plus a simple PST on any primary and secondary short-term outcomes. For a medium-term treatment, NTX plus an intensive PST was superior to NTX plus a simple PST in increasing time to first drink and decreasing craving.
AUTHORS' CONCLUSIONS
The review findings support that short-term treatment of NTX decreases the chance of alcohol relapses for 36% (number-needed-to-treat or NNT = 7) and likely to reduce the chance of returning to drinking for 13% (NNT = 12). In comparison to placebo group, NTX treatment can lower the risk of treatment withdrawal in alcohol-dependent patients for 28% (NNT = 13). Some major limitations of the available evidence include short study duration in many trials, small sample sizes in most trials and lack of data on psychosocial benefits. In conclusion, NTX should be accepted as a short-term treatment for alcoholism. Strategies to improve adherence to NTX treatment, eg, PSTs and management of adverse effects, should be concomitantly given. We have not yet known so far how long alcohol-dependent patients who respond to NTX treatment should continue their treatment. Due to too little evidence, NMF should have no role for the treatment of alcohol dependence.
Topics: Alcoholism; Controlled Clinical Trials as Topic; Humans; Naltrexone; Narcotic Antagonists; Randomized Controlled Trials as Topic
PubMed: 15674887
DOI: 10.1002/14651858.CD001867.pub2 -
Addiction (Abingdon, England) Jul 2004To ascertain the efficacy and safety of naltrexone and acamprosate in the treatment of alcohol dependence. (Meta-Analysis)
Meta-Analysis Review
AIMS
To ascertain the efficacy and safety of naltrexone and acamprosate in the treatment of alcohol dependence.
METHODS
Systematic review of the literature (1990-2002) and meta-analysis of full published randomized and controlled clinical trials assessing acamprosate or naltrexone therapy in alcohol dependence. Estimates of effect were calculated according to the fixed-effects model.
MEASUREMENTS
Relapse and abstinence rates, cumulative abstinence duration and treatment compliance were considered as primary outcomes. Findings Thirty-three studies met the inclusion criteria. Acamprosate was associated with a significant improvement in abstinence rate [odds ratio (OR): 1.88 (1.57, 2.25), P < 0.001] and days of cumulative abstinence [WMD: 26.55 (17.56, 36.54]. Short-term administration of naltrexone reduced the relapse rate significantly [OR: 0.62 (0.52, 0.75), P < 0.001], but was not associated with a significant modification in the abstinence rate [OR: 1.26 (0.97,1.64), P = 0.08]. There were insufficient data to ascertain naltrexone's efficacy over more prolonged periods. Acamprosate had a good safety pattern and was associated with a significant improvement in treatment compliance [OR: 1.29 (1.13,1.47), P < 0.001]. Naltrexone's side effects were more numerous, yet the drug was nevertheless tolerated acceptably without being associated with a lower adherence to treatment (OR: 0.94 (0.80, 1.1), P = 0.5). However, overall compliance was relatively low with both medications.
CONCLUSIONS
Both acamprosate and naltrexone are effective as adjuvant therapies for alcohol dependence in adults. Acamprosate appears to be especially useful in a therapeutic approach targeted at achieving abstinence, whereas naltrexone seems more indicated in programmes geared to controlled consumption. Both drugs are safe and acceptably tolerated but issues of compliance need to be addressed adequately to assure their usefulness in clinical practice.
Topics: Acamprosate; Alcohol Deterrents; Alcoholism; Humans; Naltrexone; Narcotic Antagonists; Randomized Controlled Trials as Topic; Taurine; Treatment Outcome
PubMed: 15200577
DOI: 10.1111/j.1360-0443.2004.00763.x -
The Cochrane Database of Systematic... 2002The results from animal studies suggest that opioid antagonists may prevent the reinforcing effects of alcohol consumption. Based on the results of those animal studies,... (Review)
Review
BACKGROUND
The results from animal studies suggest that opioid antagonists may prevent the reinforcing effects of alcohol consumption. Based on the results of those animal studies, some opioid antagonists, such as, naltrexone, nalmefene, have been studied for their benefits in treating alcohol dependence.
OBJECTIVES
To determine the effectiveness of opioid antagonists in attenuating or preventing the recommencement of alcohol consumption in patients with alcohol dependence in comparison to placebo, other medications and psychosocial treatments. In addition, discontinuation rate, death, patient satisfaction, functioning, health-related quality of life and economic outcomes were also evaluated.
SEARCH STRATEGY
Electronic searches of Cochrane Controlled Trials Register (Cochrane Library 2001, issue 4), MEDLINE (1966 - October 2001), EMBASE (1980 - December 2001), and CINHAL (1982 - December 2001) were undertaken. Du Pont Pharmaceutical and Ivax Corporation were contacted for information regarding unpublished trials. The reference lists of the obtained papers were also examined.
SELECTION CRITERIA
All relevant randomised controlled trials (RCTs) and controlled clinical trials (CCTs) were included. Participants were people with alcohol dependence. Naltrexone (NTX), nalmefene (NMF) and other opioid antagonists with/without other biological or psychosocial treatments were examined. Four primary outcomes of interest were number of patients who return to drinking, percentage or number of drinking days, number of standard drinks of alcohol and amount of alcohol consumed. A number of secondary outcomes were also considered.
DATA COLLECTION AND ANALYSIS
Two reviewers evaluated and extracted the data independently. The dichotomous data were extracted on an intention-to-treat basis. The Relative Risk with the 95% confidence interval was used to assess the dichotomous data. Weighted (or Standardised) Mean Difference with 95% confidence interval was used to assess the continuous data.
MAIN RESULTS
The review included 19 RCTs or CCTs presented in 26 articles. In comparison to placebo, two of four short-term primary outcomes were significantly in favour of NTX. Those were number of patients who return to drinking (61% in NTX group vs 69% in placebo group) [RR (95% CI) = 0.88 (0.80 to 0.98), NNT = 14] and percentage or number of drinking days [WMD (95% CI) = -4.52 (-5.29 to -3.75)]. However, the short-term discontinuation rates were high and not different between NTX and placebo groups [RR (95% CI) = 0.96 (0.81 to 1.13)]. No medium-term outcomes of NTX and placebo groups showed any significant difference after the completion of NTX treatment for three to six months. However, those who were regularly treated with NTX treatment in both short and medium terms consumed smaller amounts of alcohol than placebo-treated patients. Because of the small sample sizes, there were few significant differences for other comparisons.
REVIEWER'S CONCLUSIONS
NTX at the dose of 50 mg/day is effective for alcohol dependence in short-term treatment. The optimal duration of NTX treatment may be longer than 3 months. The evidence so far may be too little to support the superiority of NTX to acamprosate and the inferiority of NTX to disulfiram. NTX treatment should be concurrently given with a psychosocial intervention. Other patterns of NTX administration should not be used at present, e.g., a dose of three times a week, combined NTX with other biological treatments. NMF has no role for the treatment of alcohol dependence in clinical practice. Randomised, double-blind, placebo-controlled trials of NTX treatment in patients with alcohol dependence are still needed. Some issues should be concerned in further studies. Firstly, further trials should be conducted in larger sample sizes and over longer periods of time. Secondly, other than the outcomes relevant to alcohol use, some important outcomes should also be measured, e.g., functioning, health-related quality of life, economic cost. Thirdly, the comparisons between NTX and other treatments for alcohol dependence, both biological and psychosocial, should be investigated. Fourthly, combined treatments of NTX and other biological treatments for alcohol dependence may be in issue of interest. Lastly, high discontinuation rate in both treatment and control groups should be concerned.
Topics: Alcoholism; Controlled Clinical Trials as Topic; Humans; Naltrexone; Narcotic Antagonists; Randomized Controlled Trials as Topic
PubMed: 12076425
DOI: 10.1002/14651858.CD001867