Hypericum Perforatum in the Treatment of ADHD - Essay Example

Hypericum Perforatum in the Treatment of ADHD Introduction In the US 3% to 5% of children suffer a condition Attention-deficit/Hyperactivity Disorder. The disease affects adolescent and young children and their bodies do not respond to pharmaceutical medications. At times, the medications have adverse effects on the children making them insomnia, nausea and loss weight. Due to this reasons parents are forced to find alternative ways that will be helpful to their kids thus parents try to find alternative medicines for their children with ADHD disorder. Objective This made researchers to carry out a randomized control trial to determine the safety and effectiveness of Hypericum perforatum in the treatment of ADHD. This study was to understand why parents seek alternative therapies and medication when stimulant medications are found to be effective in treatment of ADHD Most of the herbal medicines in the US that may help in the ADHD treatment are from St John’s wort. Hypericum perforatum is a botanical name of an extract from St John’s Wort. It has been analysed widely and alleged to treat depression in adults but the results brought out some mixed feeling. The same analysis were carried out on children with depression and the results showed that Hypericum perforatum plays a role of inhibiting reuptake of substances like norepinephrine, serotonin, and dopamine. Design and setting This led to conduction of a test, which was a placebo-controlled test that was aimed at determining if the Hypericum perforatum was an effective alternative stimulant in reducing the severity of ADHD symptoms in children and adolescent by measuring it on an ADHD rating Scale. Method of the trial The Office of Scientific and Ethical Review Board of Bastyr University approved the study placebo controlled that was to be carried out on Hypericum perforatum for the treatment of ADHD. All equipment’s and facilities required for the trial was set in the Clinical research of the university. Participants and expectation Patients were referred to the Bastyr University, Kenmore where the trial was to be done. The trial was schedule between March 2005 and August 2006 and the participants that were eligible to be examined the trial was to be carried on children and adolescents of the age between 6-17 years old. They were to undergo a diagnostic and statistical test of mental disorders. The consents and assessment forms were served to the participants and their parents. Both the parents and participants were supposed to attend all the study visits and the participants were supposed to swallow pills. Exclusion was on participants who had severe depression. Those who were those who scored less than 1.5 SDs above the age and sex norms and RS-IV on the ADHD Scale were excluded. The participants were not allowed use any other kind of medication for the ADHD treatment. Fifty-nine participants were obtained after Diagnostic and Statistical Manual of Mental Disorders. These participants were assigned to the two groups and were monitored for all the 8 weeks but only 54 were enrolled for the trial after random selection was done. During the trial 6 participants had a large response but they were not excluded. Two of them were randomized to join the study medication while four they joined placebo. The principal investigator interviewed the participants. The principal investigator and the pediatric psychopharmacology discussed any risk and uncertainties that could arise in the trial After the participants were excluded, the eligible participants were now to undergo screening visits, which was scheduled for two visits. During the first visit, consents and assessments of the participants were obtained and were written down. During the visit, the parents were supposed to provide the child’s medical information as well as the family’s medical history. The principal investigator examined the participants by giving them a physical examination. The parents were to complete a structural interview. Participants were interviewed differently depending on their age. Subjective experience of symptoms An 18 standardized ADHD RS-IV instrument is reliable and valid in diagnosis and assessment of children with ADHD that is carried out on weekly basis. The instrument describes each symptom in a ratio of 0-to-3 points Likert Scale. In the study, participants had 1.5 SDs. participant improvement in global impairment was also measured using the CGI improvement scale. This scale is used in week 4 to week 8. From the scales, it was seen that there was improvement in the ADHD RS ADHD RS-IV total score in H perforatum while there was little difference in the participants who were rated improved or very much improved Method of randomization. The method of random allocation of participants is not specified although it is stated. The participants were only selected at random Exclusion criteria .participants who were found using over the counter medications that had isoenzymes were to be excluded. This is because Hypericum perforatum interacts with many of the medicines. Intervention After analyzing the adherence of pill count, those participants who were less than 80% were excluded. Participants who had a dramatic response to placebo trial during the time of run-in phase were also excluded from the trial before randomization. Those participants who made through to all of these factors were considered eligible and were randomized to receive the Hypericum perforatum. This treatment was to be for a period of eight weeks the hypericum perforatum is standardized and has hypericinh element of about 0.3% and free from pesticides and heavy metals. The placebo pill contains a mixture of small activated charcoal and rice protein powder. Hypericum perforatum and placebo pill were combined in specific proportion and provide with some nutrients that are vital. Outcome After the 8th week of visits, study, and trial the principal investigator evaluated the participants. From the evaluation, there was reduction in the symptoms of the ADHD as measured by the ADHD RS-IV. There were also changes in the scale of CGI improvement in the eighth week as well as there was little adverse effect on using the medication. This ADHD scale is reliable and valid instrument used in diagnosing and weekly assessment of responses in children with ADHD .on the scale every item describes the symptom of an ADHD disease. The scale was used to determine the eligibility of participants. The participants had at least 1.5 SDs above the age and child’s norms. The CGI scale was used to check whether there is improvement or worsening of maintenance and global impairments of the participants who were enrolled. Quality of life and side effects There was no side effect reported from the trial although one patient was discontinued from attending because of being far from the university. Assessing of the safety of the participants was the outcome that was primarily assessed by monitoring of the side effects that may arise during the trial. This can be observed by checking whether the participants encountered any side effect. Sample size Sample size is used to determine the number of participants that are needed to detect the effects that are similar to those that are similar to those of the reported in similar ADHD cases. In the ADHD RS-IV, scale there was a reduction of five points while thirteen points in the placebo group. The study was to enable researchers detect differences in between the groups. A26 sample size per group were required to attain 80 percent with a level of significance 0f 0.5 while assuming an equivalent SD of 10.1 in both groups. In the estimation, there was a 10% dropout of in the study with a minimum number of 58 participants required to achieve the target of 26 participants per group. Randomization and Binding This will help in medical allocation in appropriate sequence that will ensure there is equal number of participants receiving Hypericum perforatum and placebo.. In order to assess the success of the procedure at the end of the trial the participants and their parents were asked if the think they consumed placebo or Hypericm perforatum. The evaluation of the adherence of the pills, the pills were counted both before and after the pills were distributed and returned (Sandberg, 2002). Statistical analysis The X2 test was carried out to compare the number of individual’s withCGI improvement score of two or less compared to the higher score in the Hypericum perforatum In the secondary evaluation, there is examination of analysis, which was conducted by using strata method. In other analysis, the parent measures the children’s behavior by using a guide about the child’s behavior. From the trial, it was found that the test is valid and reliable because it has been used in pediatric research. Result and conclusion In the randomization, study participants had a mean of 82% of the medication that was studied with 77.5%-86.4% confidence level. This showed that there was little difference between the placebo and Hypericum perforatum groups. No participant in the two groups had side effects from the results it is vividly seen that there is little additional benefit in administration of Hypericum perofatum to that of placebo. In conclusion, this study has brought several limitations e.g. the patients should be highly monitored during the medication. The participants were evaluated for 8 weeks with specialized personnel’s. Further follow up is needed to confirm whether improvements are sustainable of a long period of. Reference Sandberg, S. (2002). Hyperactivity and attention disorders of childhood. Cambridge, UK: Cambridge University Press Read More