A Computer Based Randomization Procedure - Essay Example

?I. Introduction In view of the fact that there is an acknowledged lack of conventional method in the treatment of drug dependence particularly cocaine addiction, auricular acupuncture has been employed by various drug treatment facilities in the United States for the rehabilitation of both primary cocaine-dependence and opiate-dependence. The objective of the research conducted is a thorough evaluation of the effectiveness of the auricular acupuncture method, as categorized by the National Acupuncture Detoxification Association (NADA) for the treatment of cocaine dependence. There has been significant amount of studies that attempted to measure the effectiveness of auricular acupuncture for the treatment of cocaine dependence; however, there have been various results and reports. Some studies showed the positive effects of acupuncture towards these disorders, a considerable number of reports also showed that there is no difference between those subjected to auricular acupuncture and those in controlled studies. Since acupuncture is a procedure, putting it into a clinical test would entail that meticulous guidelines be followed. These procedural guidelines stem from the methodical understanding of the nature of acupuncture and of the character of drugs used. Hence this study, aside from dealing with the specific controlling factors of acupuncture also takes into consideration factors that are non-specific such as the use of questionnaires, monitoring of drug use and other aspects that would result to confuse the findings. This study was conducted using a randomized clinical trial aiming to determine if auricular acupuncture has significant and positive results towards the treatment of drug dependence in methadone-maintained addicts. This specific patient population was opted for the use of addition to cocaine is a grave problem in methadone maintenance programs or MMPs. II. The Methods and Methodology Used in the Study A Randomized Controlled Trial of Auricular Acupuncture for Cocaine Dependence (Avants, et. al., 2000) Participant Selection: Entrance and Discontinuation Criteria The inclusion criteria for the research participants are the following: 1. They should be at least 18 years of age 2. They should be enrolled in methadone maintenance programs (MMPs) with a stable dose of methadone. 3. They should be able to meet the criteria for cocaine used as established by the Structured Clinical Interview for DSM-IV25 4. They should be able to show recent cocaine use: a. able to provide a cocaine-positive urine sample (at the time of screening) b. able to provide a detailed report of cocaine use (week before the screening) c. able to provide a cocaine positive urine sample (within two weeks before screening) The exclusion criteria for the research participants are the following: 1. They should not be dependent to other substance other than cocaine, nicotine or opiates 2. They should not undergo any current treatment for cocaine dependence They should not have any current use of psychotropic medication (except when they are maintained in a regimen for this specific medication for 90 days) 3. They should not have previous acupuncture treatment for a period of 30 days They should not manifest suicidal nor psychotic status The discontinuation* criteria for the research participants are the following 1. Failure to attend 3 of first 8 sessions 2. Failure to attend less than session per week * Those who discontinued the research were termed as noncompleters Figure 1. The flow and progress of patients and their corresponding treatments throughout the trial (Avants, et. al., 2000). Randomization A computer-based randomization procedure was conducted by a staff member after the completion of the patient’s screening as well as intake interviews. The randomization procedure was used in order to set of scales for the participants on conditions such as a) sex; b) race; and c) HIV status. During the orientation, patients were kept abreast of their treatment assignments through a prescribed standardized script. Patients were also regularly encouraged to treat the study procedures and treatment as a stress-reduction exercise; this serves as a means to increase credibility of the control conditions. Additionally, patients were provided with relaxation protocols. Implementation of the NADA Auricular Acupuncture Protocol The NADA Protocol detailed that needles should be inserted into 5 auricular zones. This is, on the other hand, different to what was practiced clinically that specified 3-5 needles should be inserted bilaterally. For this specific study, 4 needles were inserted bilaterally at NADA-specified sites namely: a) sympathetic, in the deltoid fossa in the junction of infra-antihelix crus and the medial order of the helix; b) lung, at the center of the cavun concha; c) liver, at the posterior to upper portion of the helix crus; and d) shen men, at the inferior corner of the branching point of the antihelix. The needles were placed into the cartilage at each specified points in such a way that they become perpendicular to the surface of the ear. It was ascertain that they entered the cartilage to a depth of 1-3 mm. The needles used were 0.20 mm in diameter and 15 mm long, sterilized with ethylene oxide gas, disposable and individually packaged in disinfected containers. Control Condition for Auricular Needle-Insertion Four needles specified to be of the same size and type were bilaterally inserted into the helix of the auricles and at 3 other zones not commonly used for the general treatment of any other disorder. The following enumerates the number of needles inserted into the different identified zones: a. Zone 1 – two needles were inserted, on the helix from the high point of the helix to just above the superior border of Darwin’s tubercle and another one on the antero-posterior dividing line border of the auricule b. Zone 2 – one needle, on the helix at the level of Darwin’s tubercle, from just below the superior order of the tubercle to just above the inferior order of the tubercle, on the antero-posterior dividing line border of the auricle c. Zone 3 – one needle, just below the inferior order of Darwin’s tubercle to approximately level with the end of the helix crus, on the antero-posterior dividing line border of the auricle Additional needles were inserted in order to minimize, as much as possible, the simulation of an active treatment to the patients. With this precaution, extraordinary care was taken into consideration not to insert needles into the liver “Yang points” which are located in these regions also. The needles were also inserted subcutaneously at an oblique angle so that the needles do not interleave into the cartilage. Assessment and Statistical Treatments Urine analysis – urine samples from the patients were collected 3 times a week during Mondays, Wednesday and Fridays; at the same time as the patient remained in treatment and tested for the presence of benzoylecognine (a metabolite) using fluorescence polarization immunoassay. Such method has been shown to have reliable and precise assay results. Urine sample results with 300ng/mL levels of benzoylecognine were considered as cocaine positive. It is furthermore considered that doses between 13 and 130mg of topically used cocaine, the test should remain positive (this in congruence with the standard sensitivity for the use of cocaine such as nasal, freebase or the popular intravenous routes). Before treatments and at the end of an 8-week trial period, detailed and well-accepted standards were administered to the patients, as follows: a. Addiction Severity Index (ASI) – a structured interview used in various addiction research (not only to cocaine dependence) that supplies amalgamated scores in the assessment of the severity of the seven areas of addiction-related areas. b. Treatment Credibility Scale and the Stages of Change Readiness – a 5-item questionnaire that measures the confidence of a specific treatment to a target disorder; then these scales are averaged in order to come up with consolidated and single treatment credibility score. c. Treatment Eagerness Scale (SOCRATES) – a questionnaire with 9 items that aims to assess the level of readiness for a particular substance abuse treatment. To compare the survival time and to the dropout rate, the Kaplan-Meier along with the log-rank test were used. Variables were used for the differential retention by treatment condition on pretreatment sociodemographic and drug. A series of 3 (treatment condition) x 2 (retention status) analyses of variance or ANOVA of continuous variables were used on perceived treatment credibility, therapeutic alliance and to the acute effects of treatments. Also, X2 analyses were employed for treatment and retention status for categorical variables. III. A Critique on the Methods and Methodologies Employed 1. On the exclusion participants that undergo cocaine treatment but not for those with nicotine and other opiates dependent. What the methodology required is the exclusion of participants that undergo cocaine treatments. Acupuncture is often used in substance abuse because of its capabilities to stimulate endorphin production. Endorphin, a neurotransmitter, is a natural painkiller. It was shown in several contemporary acupuncture studies to be accountable, to some extent, to withdrawal symptoms. Many investigators came to a conclusion that acupuncture eases up withdrawal symptom pains by producing more endorphins and therefore bringing the body back to balance and equilibrium. This effect caused by endorphin could perhaps be the reason for the effectiveness of alleviating withdrawal symptoms for other opiates addiction such as morphine and heroin. However, since non-opiate substances operate in a different pathway of withdrawal, in the context of endorphin mechanism, it cannot be explained how acupuncture is just as valuable in treating these non-opiate addiction such as cocaine and alcohol (Scott & Scott, 1997). In this milieu, this grey area should not have been taken for granted. Since science and clinical evaluations still cannot verify why acupuncture can in the same way effective in both cocaine and nicotine addiction, it could have been a better decision if participants did not go through both nicotine and cocaine treatments. Addiction to these two substances could create a different pathway for addition and thus produce a different effect in its withdrawal. 2. On the exclusion criterion that participants should not have undergone any acupuncture treatment for a period of 30 days. The period is advised to be for a span of more than 30-days. Since participants who do not go through cocaine treatment are included, current treatments for nicotine and other opiates may be included, in this regards, it could take thirty days or more before full metabolism of these substances are reached. Presence and trances of these unaccounted drugs and addictive substances in the system may capitulate placebo effects that will not institute customary behavior of these substances and the effects of acupuncture to them. Complete metabolism and digestion of these substances must be made sure in order to re-create a pure withdrawal syndrome. 3. On the limited criteria for randomization procedure. The science of acupuncture is still an active area that requires substantial clinical and randomized controlled data. Clinical data on acupuncture aims to conclude whether certain acupuncture methods work; illustrate how it works and on the level of its effectiveness. This objective of every study must therefore the bases for the selected methodologies which includes randomization procedure (World Health Organization, 1996). What we have here is testing the efficacy of acupuncture to cocaine addiction and whether or not such method is helpful on the effects of withdrawal syndrome, therefore evaluation factors must be kept in mind. These factors would be how fast the metabolism of cocaine, nicotine and other opiates occurs in relation to a person’s age and other variables such as how long has that person been dependent to the substance. The length of dependence may deploy consequence to the competence of acupuncture methods employed. Other factors that should have been included in the criteria are history of ailments and diseases of the participants such as digestive organs disorders specifically the liver, gallbladder or the large intestines that are responsible for the digestion, metabolism and absorption of these substances. At a different perspective, genetic defects and other similar abnormalities would also mean that there are possible aberrations in the metabolism of these substances in terms of the production of the correct amount of hormones necessary in their proper metabolism. The criteria for the randomization procedure are very limited; the options available are only a) race; b) sex and c) HIV status. As discussed, additional criteria would have been more favorable to produce a randomized set of participants. The need for a randomization procedure can be generalized to three reasons a) that bias should be eliminated in the treatments; b) that the blinding or the masking of the identity of the treatments are made possible, c) so that probability functions that fullest knowing that experiments are run by statistics. In order to realize these goals, it is vital that randomization procedures would result to an unpredictable progression of allocations to different treatments; that is patients should be allocated to groups of equal probabilities. In researches using clinical methodologies and procedures to check the validity of a hypothesis, a potential problem could arise with the use of a small trial size, similar to this case. The predicament in small size clinical randomization is the possibility of imbalanced results – imbalanced covariates against one variables therefore resulting to a false outcomes (Smoak and Lin). The scenario here is the presence of a limited number of people categorized simply race, sex and HIV status; the tendency of this is randomization procedure, as discussed, would be inconsistent or even arbitrary results. However, this randomization process is quite impractical especially of the presence of exclusion and inclusion criteria and because of the statistically limited number of patients available. Another method usually employed in randomization is called allocation concealment which simply makes sure that the allocation assignments are not made known. The same is employed in the study methodology employed above. On the other hand, standards for randomization has been established, and they are characterized as such; first, the group size must be equal and sufficient for a statistical power; second should be the assurance that there is a low selection partiality where the investigators must not be able to predict the subject assignment and lastly, a balance among the covariates across groups. Even if it is entirely impossible to get all these standards met, the best randomization procedures are those that are closest to this principle. Even if the method in this study was not able to meet the criteria for the simple randomization procedure, the researchers were able to assure that randomization was still applied in the context of allocation concealment where the randomization was protected so that the treatments that are to made to the patients continued to remain unknown to them until they join the program. The control trial participants were made to believe that that they undergo this certain treatments like others coupled with a relaxation procedure and therefore, the researchers were successful in “distorting” study results. 4. On the control condition employed The Standards for Reporting Interventions in Controlled Trials of Acupuncture also known as the STRICTA recommendations has provided how the control condition should be chosen and what are the effects expected from them. They also specified that they must well-presented and rationalized based in the research question involved and its application to the preference of methodologies used (MacPherson, et. al., 2002). In this particular scenario, it cannot be determined how and why such relaxation control procedure was utilized (Avants, et. al., 2000). It was not provided in the research as to the effects of such procedure and its substantial effects to the overall procedure. 5. On the divergence with the NADA-specified protocol and use of subcutaneous insertion Despite the numerous clinical results and data gathered that tested the efficacy of acupuncture, it is still very complicated to compare and contrast the results of these studies and to come up to a conclusion which methods and methodologies would yield best result. Many scientists point this complexity because these methods use dissimilar techniques such as electrical or manual and the employment of different controls as well as outcome measures give different results (Ernst, 2006). Therefore, given the premise that the NADA has provided protocols, this study lacks examination and explanation of such diversion. However, I would contend that such diversion from the original may point to a specific expectation of results, which could be the production of placebo or sham effects or a simulation (Ernst, 2006). 6. Overall evaluation. Acupuncture, an ancient healing procedure or practice, is among the oldest in the world. The modern societies have embraced this ancient knowledge and have successfully injected science to the same. However, the clinical results and trial results for many scientific studies of acupuncture have gathered worldwide dissatisfaction. Some of these studies and clinical trials failed to improve the reporting design of their research design resulting to discrepancies in many replicate studies and thus yielding different outcomes – such is a major concern to date despite the provision of protocols and standards in acupuncture researches. In this standpoint, the cited criticisms in the paper A Randomized Controlled Trial of Auricular Acupuncture for Cocaine Dependence is built in this premise. There were diversions from established and universally accepted protocols however, no detailed and inclusive explanation was provided for them. word count: 2, 882 References Avants, K., Margolin,A., Holford,T.,& Kosten,T. (2000) A Randomized Controlled Trial of Auricular Acupuncture for Cocaine Dependence. Arch Intern Med. VOL 160. Ernst E. (2006). Acupuncture—a critical analysis. Journal of Internal Medicine. 259(2):125-137. MacPherson, H., White, P., Cummings, M., Jobst, K., Rose, K., and Niemtzow, R. (2002) Standards for Reporting Interventions in Controlled Trials of Acupuncture: The STRICTA Recommendations. Journal of Alternative and Complementary Medicine. Vol. 8. Num. 1. Scott, S. & Scott, W. (1997). A Biochemical Hypothesis for the Effectiveness of Acupuncture in the Treatment of Substance Abuse: Acupuncture and the Reward Cascade. American Journal of Acupuncture. Vol. 25, No. 1. Smoak, C &N Lin, J. A SAS® Program to perform adaptive randomization. Accessed from http://www2.sas.com/proceedings/sugi26/p242-26.pdf on April 9, 2011. World Health Organization. (1996). Acupuncture: Review and Analysis of Reposrts on Controled Clinical Trials. Read More