PubMed · 11678812
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M D Ferrari. 2001. Sumatriptan by injection.. https://doi.org/10.1046/0333102401021s0103
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'Flashbacks' following use of hallucinogenic drugs have been reported for decades; they are recognized in DSM-IV as 'Hallucinogen Persisting Perception Disorder (Flashbacks)', or HPPD. We located and analyzed 20 quantitative studies between 1955 and 2001 examining this phenomenon. However, many of these studies were performed before operational criteria for HPPD were published in DSM-III-R, so they are difficult to interpret in the light of current diagnostic criteria. Overall, current knowledge of HPPD remains very limited. In particular (1) the term 'flashbacks' is defined in so many ways that it is essentially valueless; (2) most studies provide too little information to judge how many cases could meet DSM-IV criteria for HPPD; and consequently (3) information about risk factors for HPPD, possible etiologic mechanisms, and potential treatment modalities must be interpreted with great caution. At present, HPPD appears to be a genuine but uncommon disorder, sometimes persisting for months or years after hallucinogen use and causing substantial morbidity. It is reported most commonly after illicit LSD use, but less commonly with LSD administered in research or treatment settings, or with use of other types of hallucinogens. There are case reports, but no randomized controlled trials, of successful treatment with neuroleptics, anticonvulsants, benzodiazepines, and clonidine. Although it may be difficult to collect large samples of HPPD cases, further studies are critically needed to augment the meager data presently available regarding the prevalence, etiology, and treatment of HPPD.
BACKGROUND AND OBJECTIVE: There is evidence if the low rate of participation or even exclusion of women in clinical trials (CT), and that sex-differences are not considered in the design and analysis of the CT. The objectives of the study were to determine whether women are properly represented in the CT with rofecoxib and to analyze the information of CT with rofecoxib from a gender perspective. MATERIAL AND METHOD: Twenty eight rofecoxib CT in adults have been reviewed, all indexed in Medline and published between 1999-2001. The FDA Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation Drugs was used to analyze the information. RESULTS: An 80% of the trials do not describe efficacy results by sex, and only one reports side effects by sex. A 78.3% does not report stratified analysis by sex. In the discussion the possible difference by sex of the results is mentioned in 3 occasions. Only 8% of the CT considers the influence of hormonal variation in the results. The pharmacokinetics issues related specifically to women are poorly followed: in 60% of the CT it is not specified the influence of oral contraceptives in the results of the trial, and in 88.9% of CT it is not specified the influence of estrogen treatment in the results of the trial. Pregnancy as exclusion criteria is only considered in 50% of the trials. CONCLUSIONS: CT with rofecoxib has included more women than men. Important information on specific situation related to gender, recommends by FDA Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation Drugs, have not been followed.
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