Center for Health and Healing

<html><head> <title>The Center for Health & Healing</title> <link rel=stylesheet href="../chhstyle.css" type="text/css"> <meta name="keywords" content="research,complementary,alternative,integrative,evidence-based,clincial trials,randomized,placebo,double blind, gold standard,"> <script language="JavaScript">  </script> </head> <body bgcolor="#ffffff" leftmargin="0" topmargin="0" marginwidth="0" marginheight="0"> <base target="_top"> <a name="head"></a> <table border="0" cellpadding="0" cellspacing="0" width="98%"> <tr> <td width="149" bgcolor="#ffffff"><img src="../images/spacer.gif" width="149" height="1" border="0" alt=""></td> <td width="95%" bgcolor="#95a920"><img src="../images/spacer.gif" width="500" height="1" border="0" alt=""></td> <td width="5%" bgcolor="#95a920"><img src="../images/spacer.gif" width="60" height="1" border="0" alt=""></td> </tr> <tr> <td width="149" bgcolor="#ffffff" align="left" valign="top"><a name="top"></a><img src="../images/spacer.gif" width="149" height="24" border="0" alt=""></td> <td> <table width="100%" border="0" cellpadding="0" cellspacing="0" style="padding:0px 0px 0px 5px"> <tr> <td bgcolor="#95a920" align="left" valign="top"><img src="../images/spacer.gif" width="274" height="1" border="0" alt=""></td> <td align="right"><img src="../images/spacer.gif" width="123" height="1" border="0" alt=""></td> </tr>  <tr> <td bgcolor="#95a920" width="274" align="left" valign="top" class="title">Research & Guidelines</td> <td align="right">  <form name="form1" method="post" action=""> <select name="menu1" onChange="MM_jumpMenu('top',this,0)"> <option value="#" selected="selected">Select One</option> <option value='gen_clinical.asp'>General</option> <option value='accu_clinical.asp'>Acupuncture</option> <option value='acupress_clinical.asp'>Acupressure/Shiatsu</option> <option value='alexander_clinical.asp'>Alexander Technique</option> <option value='aroma_clinical.asp'>Aromatherapy</option> <option value='art_clinical.asp'>Art 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class="leftNavOff" href="recguide.asp">Recommendations & Guidelines</a></p> <p><a class="leftNavOff" href="rescentr.asp">Research at the Center</a></p> </td> </tr> </table> </td> <td valign="top" bgcolor="#ffffff">  <table width="100%" cellpadding="0" cellspacing="0" border="0"> <tr> <td nowrap="nowrap" style="padding: 0px 0px 5px 0px;"> <p class="headline"><br> General Research Issues</p> </td> <td width="100%"><img src="../images/spacer.gif" width="1" height="1" border="0" alt=""></td> </tr> <tr> <td bgcolor="95a920"><img src="../images/spacer.gif" width="1" height="1" border="0" alt=""></td> <td width="100%" bgcolor="ffffff" height="1"><img src="../images/spacer.gif" width="1" height="1" border="0" alt=""></td> </tr> <tr> <td bgcolor="ffffff" colspan="2"><img src="../images/spacer.gif" width="1" height="10" border="0" alt=""></td> </tr> </table>  <table width="100%" cellpadding="0" cellspacing="0" border="0"> <tr> <td class='content'> <p>On the whole, the Western biomedical community has only recently taken an interest in researching complementary/alternative medicine practices and traditional healing systems. In large part, increased consumer interest and widespread use resulted in the call for more rigorous, scientific, evidence-based research in those fields to evaluate their safety and effectiveness.</p> <p>The aim of this section is to present high quality research results as well as to reflect the general status of research activity for all of the therapeutic approaches in the drop down menu. The research results are presented in a format that ranges from individual clinical trials to reviews of many clinical trials to practice guidelines and recommendations, which represent the widespread acceptance of the treatment by the medical community based on strong accumulative evidence.</p> <p><span class='head3'>Understanding Scientific Research and Study Design</span><br /> In order to interpret research findings and evaluate their application to the treatment and prevention of disease, it is helpful to first understand the basic components of research design, general issues involved in all types of clinical research, and specific issues encountered in the study of alternative and complementary medicine. This may assist in gaining a perspective on the often contradictory and inconclusive results from different trials studying the same issue.</p> <p>The first principle upheld at the Continuum Center for Health and Healing is that alternative medicine does not mean alternative science. By this we mean that the same rules of evidence must apply to both conventional and alternative medicine research, requiring the same study design characteristics to rule out other explanations of findings such as placebo effect and suggestion. The gold standard for research design is the randomized, placebo controlled, double blind study.</p> <p>Randomization comprises two concepts: randomized selection and random assignment. Randomized selection means that the people presenting with a medical condition for a study are a random representation of all the people in a particular group, such as a country, who have that condition. This is difficult to achieve without encountering selection bias due to a variety of factors: in recruiting patients some people are easier to locate and contact than others, some are more willing to participate in research, some are more able to get to the study site, and so on. This is a problem found in all research, conventional or alternative. Random assignment means that there is an equal probability that study participants will be assigned to any of the research conditions, the real intervention as well as the control condition where no intervention is given or a sham intervention (placebo) is given. Random assignment is important in order to equalize the probability of outside factors influencing the results and is an important characteristic of all good research.</p> <p>Studies include placebo conditions in order to control for the very powerful ability of the mind to affect the body through suggestion. Ideally, research should have a condition in which it appears that the participant is getting the intervention but in fact is not, but this may not always be possible. New drugs are routinely compared to sugar pills or placebos, pills that look just like the real thing but which contain no active ingredients. Similarly, alternative therapies, such as herbs, need to have the same placebo condition to compare the real thing to, and most research testing their effectiveness and safety use placebo controls. Some interventions are harder to create a placebo for than others. A placebo for a standard surgical technique would involve cutting open the skin without actually performing any meaningful operation. Not only is this difficult to carry out in a credible fashion, it may be unethical as well. As a result, many surgical techniques have never been subjected to rigorous clinical trial research. Another example is the physical manipulation of the body, such as physical therapy or massage. This is also difficult to simulate without the recipient becoming suspicious that nothing is really happening. With something like acupuncture, where the needle can be seen to penetrate the skin, it is very difficult to create a condition where the needle appears to go in, yet really doesnt. So this type of challenge exists in both conventional and complementary medicine.</p> <p>Finally it is important for a clinical trial to be double blind. To be blinded means that you do not know which experimental condition you are in, the real one or the placebo control. Double-blinded means that neither the researcher nor the patient knows which condition the patient is in. When doing research on drugs or herbals, this is relatively easy to accomplish. The placebo pill looks just like the active pill, so the patient does not know which pill he or she is receiving. The researcher does not know, because another person, an administrator otherwise not involved with the study, keeps track of this information, and all the drug containers are identified by a code that only the administrator knows. With interventions like surgery, physical therapy or acupuncture, it is often quite difficult to create any blinding. Surgery leaves a scar, so even if the patient is anesthetized he or she will still guess which condition they were in unless a sham surgery is performed to create a scar without doing anything. And the surgeon will obviously know whether it is the real thing or not. With acupuncture, you may be able to conceal the condition from the patient by putting needles into non-acupuncture points, but this is still a difficult task to accomplish successfully, since the body may react in a generalized manner whenever a needle penetrates the skin. And it is almost impossible to blind the acupuncturist as to whether it is real or sham acupuncture.</p> <p>Within the context of the general considerations for good research design, each alternative therapy has its own set of characteristics that require special attention in conducting research. These include the individualized nature of many diagnostic systems and treatments, varying guidelines for the number of treatments depending on the condition, different treatment approaches within a modality with differing treatment protocols, a long time frame to determine effects, combinations of treatments in traditional medicine systems such as Traditional Chinese Medicine and Ayurveda, and difficulty in objectively studying the spiritual side of this approach. Specific design issues are discussed in the research issues section under each modality.</p> <p>Please select a modality from the drop down menu for research information on each therapeutic approach. </p> <a href='#head' target='_self' class='disclaimer'>Top</a> <br /><a class='disclaimer' href='../disclaimer.asp'>Disclaimer</a> <p class="timestamp">Content last modified on Apr 29, 2005</p> </td> </tr> </table> </td> <td valign="top" bgcolor="#ffffff"><img src="../images/bg_curve.gif" width="60" height="300" align="right" border="0" vspace="0" hspace="0"></td> </tr> <tr> <td bgcolor="#ffffff"><img src="../images/spacer.gif" width="1" height="1" border="0" alt=""></td> <td bgcolor="#ffffff"><img src="../images/spacer.gif" width="1" height="1" border="0" alt=""></td> <td bgcolor="#ffffff"><img src="../images/spacer.gif" width="1" height="200" border="0" alt=""></td> </tr>  <tr> <td width="149" bgcolor="ffffff"> </td> <td colspan="2" bgcolor="ffffff"> <p> </p> <p class="copyright">©2002 Center for Health and Healing</p> </td> </tr> </table> </body> </html>