Anxiety Trial

Acupuncture for Anxiety – Trial

Traditional Chinese Medicine (TCM) and Acupuncture, a component of TCM, have a wide range of therapeutic applications, including the effective treatment of a variety of psychiatric disorders. With a focus on Anxiety and the application of the aforementioned modalities to treat this, this study poses the question, “can an underlying TCM pattern be identified and a combined needling and treatment protocol be used to treat anxiety effectively in a group?”

In the West, Anxiety by definition is “…an emotion characterized by feelings of tension, worried thoughts, and physical changes…” and is also “…considered a future-oriented, long-acting response broadly focused on a diffuse threat.” (American Psychological Association, 2022).  It is a natural behavioral, physiological and psychological response of the body to stress, developed through millennia of human evolution as a survival mechanism to keep the species alive and safe from danger. When a situation arises that is perceived as stressful, the sympathetic nervous system kicks in activating a cascade of hormones that speed up the heart rate, delivering more blood and oxygen to the extremities, and thus providing quicker reactions coupled with increased strength and speed. This allows for the situation to be escaped from or fought against. Once the danger is dealt with the parasympathetic nervous system is designed to activate, relaxing the body back to balance.

As can be seen, anxiety is a helpful emotion when acute but prolonged periods of stress triggering anxiety can cause the emotion to become chronic and over time develop into a debilitating disorder. The International Classification of Diseases, 11th Edition (ICD-11) lists 28 disorders that come under the umbrella term ‘Anxiety and/or Fear-related Disorders’, including Panic Disorder, Obsessive Compulsive Disorder (OCD), Generalized Anxiety Disorder (GAD), and Social Anxiety Disorder (SAD), all of which have the emotion of anxiety at their core. Incapacitating symptoms of all these disorders include: difficulty controlling worry, an inability to concentrate or focus on anything else, nervousness, panic, hyperventilation, gastrointestinal issues, and avoidance of things that trigger the anxiety (International Classification of Diseases, 2022).

Mental Health UK estimates over 8 million people, around 11.9% of the total UK population, experience some form of anxiety at any one time, and this number continues to rise (Mental Health UK, n.d). Of the population who suffer with anxiety related disorders in the UK, Panic disorder effects approximately 0.6%, OCD effects around 1.2%, GAD effects around 5%, and SAD effects around 10% (Anxiety UK, n.d).

Mainstream interventions in the West for the treatment of anxiety and related disorders are primarily talking therapies such as Cognitive Behavioural Therapy (CBT) or medications like Serotonin Reuptake Inhibitors (SSRIs). There are however a number of common pitfalls with both of these interventions which deter patients from undergoing treatment, including fear of adverse reactions to pharmaceutical drugs or the possibility of long-term side effects. Furthermore, possible lengthy referral waiting times for Improving Access to Psychological Therapies (IAPT) treatments provided by the NHS is often a patient concern. In a poll of 535 adults the Royal College of Psychiatrists (2022) found around 23% of IAPT referrals had a wait time of 12 weeks or more, 12% waited 6 months plus and 6% were left waiting for more than a year before beginning treatment (Royal College of Psychiatrists, 2022).

Due to the aforementioned issues some patients have with mainstream treatment, people are turning more and more to Complementary and Alternative Medicine (CAM) which is defined as any treatment that does not fall within the parameters of mainstream health care. Whereas conventional medicine is allopathic, using invasive drugs, procedures or surgery to address symptoms and disease, complementary medicine utilises a ‘natural’ more holistic approach. Many different therapies come under CAM including Traditional Chinese Medicine (TCM) and Acupuncture.

As previously mentioned, TCM and Acupuncture are effective treatments of Anxiety. A number of studies have been performed that show the positive effect of acupuncture on situational anxiety [ (Bae, Bae, Min, & Cho, 2014) (Klausenitz, et al., 2016)], for example, Karst et al., 2007, who performed a randomized controlled trial (RCT) into the efficacy of auricular acupuncture on dental anxiety, in which there were 3 treatment groups – auricular acupuncture, placebo-auricular acupuncture, and midazolam (drug intervention). They found that the patients who received the auricular acupuncture were significantly less anxious compared with the placebo group (Karst, et al., 2007). Similarly, numerous systematic reviews and meta-analyses have also demonstrated the efficacy of acupuncture treatment (Amorim, et al., 2018). Yang et al., 2021 looked at 20 RCTs designed to treat GAD, 18 of which were published in Chinese, and found that acupuncture was effective on anxiety symptoms (Yang, Yang, Huang, Ren, & Li, 2021)

He et al., 2014 designed a scalp acupuncture protocol, focusing on two new areas of stimulation, for the treatment of 2 patients with anxiety disorders. Patient 1 had GAD with nighttime panic attacks and received 4 sessions; Patient 2 had Posttraumatic Stress Disorder (PTSD) with irritability, insomnia, severe anxiety and flashbacks along with back, chest and joint pain from military injuries and received 6 sessions. They found their scalp acupuncture protocol to be significantly effective for the treatment of both patient’s anxiety disorders and symptoms (He, Chen, Pan, & Ying, 2014).

Traditional Chinese Medicine, acupuncture and their principles grew out of Daoism (Taoism), an ancient Chinese thought and belief system still practiced today. The fundamental principle of the above disciplines is that the Cosmos and all its form is animated by Qi, the original energy of the universe and the singular building block of creation and existence. All things come from Qi and are Qi.

Qi and all its manifestations are composed of opposing components, Yin and Yang, and each manifestation has its own unique and varied yin-yang orientation defining the physical and non-physical make up all things, including the human body, emotions, the spirit and so on. This fundamental concept is best represented in the Taijitu, the Daoist and TCM Yin-Yang Symbol, shown in Figure 1. Furthermore, whilst everything in existence is “separate” it is also inherently interconnected and therefore, changes in one thing will bring about changes in another. For example, humans exist separately to their environment but are connected to it at the same time – we are all intrinsically aware that atmospheric cold in winter can bring about a decrease in core body temperature causing internal cold.

Figure 1. The Taijitu – Daoist principle of Taiji. The symbol, as a whole, represents Qi and all its manifestations. Made up of yang, the white section; and yin, the black section. Each yin and yang component contains varied proportions of its opposing component: the black circle within the white section – yin within yang; and the white circle in the black section – yang within yin.

The above concept of the reciprocal interdependence of all things is denoted in the Wu Xing – the Five Elements or Five Phases – shown in Figure 2 below. In this theory, each manifestation of qi and its yin-yang orientation in nature is believed to come from the main five elements of the universe, namely wood, fire, earth, metal and water. Each element in this concept acts as a category that exemplifies the yin-yang aspect of a substance, characteristic, state and dynamic process. For example, the Zang-fu in TCM is a Wu Xing cycle representing the yin-yang paired organs and their associated characteristics and functions in relation to the main five elements. The Liver-Gallbladder is wood, the Heart-Small Intestine is fire, the Spleen-Stomach is earth, the Lungs-Large Intestine is metal, and the Kidneys-Bladder is water.

There are four interweaving cycles or relationships expressed in the Five Phases that demonstrate how each element interacts with another, and creates balance or imbalance within the system (nature). The Sheng and Ke cycles, represent harmony and the Cheng and Wu, disharmony.

The Sheng Cycle, also known as the generating cycle or ‘parent-child’ relationship, is the clockwise sequence on the circle in Figure 2. This cycle demonstrates how the gathering qi of one element/phase generates another, in a nourishing and supporting role as in the ‘mother-child’ relationship, for example Wood (Liver) generates Fire (Heart), Fire (Heart) creates Earth (Spleen), and so on.

The Ke Cycle – the clockwise sequence of the pentagram in Figure 2 – shows how the gathering qi of an element controls another so as to keep it in check and keep the system balanced as a whole; for instance, Wood (Liver) controls Earth (Spleen). This cycle is also known as the Control or Destruction Cycle, and the ‘Grandparent-Grandchild’ relationship.

Both the Cheng and Wu cycles represent imbalance and disharmony within the Ke Cycle. The Cheng Cycle (AKA Overacting) follows the grandparent-grandchild relationship but occurs when the element in the grandparent role is excessive, leading to deficiency of the grandchild element. For example, too much Wood (trees) depletes Earth (soil). The Wu cycle also involves the grandparent-grandchild relationship but is the reverse sequence (anticlockwise) shown on the pentagram in Figure 2. Also known as the Insulting Cycle, the grandchild element in this relationship is imbalanced and excessive and therefore begins to control (‘insult’) the grandparent element, making this deficient. For instance, too much Earth (Spleen energy) buries Wood (Liver energy) (Carahealth, n.d.).

Figure 2. TCM concept of the Wu Xing (Five Elements/Phases) and the cycles, interactions and relationships of balance and imbalance between the Elements.

As can be seen from Figure 2 and its description above, all elements in the Wu Xing are equally important and form a balance whilst constantly moving and interacting in cyclical change. When each thing is in its completely natural state everything is in harmony and balance. The Neijing, an ancient Chinese medical text attributed to Emperor Huang Di in the 3rd millennium BCE, stresses that any disharmony to this balance results in changes that, in living beings show up as symptoms of disease (Maoshing, 1995). These individual symptoms, when pulled together, form patterns of disharmony in the body of the three major functional entities – the five fundamental substances, the Zang-fu organs and functions, and the meridians. TCM and acupuncture work on utilising Qi and all its varied manifestations to restore the balance of physical and non-physical yin-yang permutations within the body, thus restoring health.

Anxiety as a disease and disorder is a relatively new term, believed to have been coined by George Miller Beard, an American Doctor, in 1869 (Stossel, 2014). There is no exact equivalent in TCM although 4 disease entities closely resemble it – Jing Ji (Fear and Palpitations), Zheng Chong (Panic Throbbing), Fan Zao (Mental Restlessness), and Zang Zao (Agitation) (Maciocia, Fear and Anxiety – The Traditional Chinese Medicine Perspective/Anxiety, n.d.). However, anxiety as an emotion does exist in TCM. Moreover, emotions are recognised as playing a major role in both health and disease because Chinese Medicine views the body and mind as a unified web of relationships and interactions. There are 7 main emotions in TCM: joy, anger, fear, fright, worry/pensiveness, grief and anxiety, all of which are seen as mental activities connected to their corresponding organ system’s functions. Imagine them as part of the energetic blueprint of Qi and its yin-yang manifestations within the body. When each emotion and its energy are in balance we achieve harmony but when they are in excess the energetic balance of the system is disrupted and correlating symptoms of disease (patterns of disharmony) appear. It is important to note here that in TCM there is a cause-consequence relationship between the organs and the emotions meaning that excessive or prolonged experiences of an emotion can bring about disharmony in the linked organ system, or an imbalance within the organ system itself can produce heightened and more frequent experiences of the linked emotion.

In the Zang-fu, the emotion of joy is linked to the Heart, anger to the Liver, fear and fright to the Kidneys, worry/pensiveness to the Spleen and grief to the Lungs. Anxiety, in TCM is classified as a secondary emotion resulting from excessive or prolonged exposure to one or more of the other primary emotions, particularly excess joy, fear and worry or an imbalance within the associated organ(s). Too much joy creates an energetic imbalance within the heart. One of the heart’s many functions is to house the Shen, the part of our spirit that embodies consciousness. When the heart is balanced the Shen has a peaceful place to stay, but when in disharmony the Shen is scattered. Excessive or prolonged exposure to joy means the Shen is disturbed leading to chronic anxiety because it cannot settle. Symptomatology of anxiety of the heart and disturbed Shen includes restlessness, insomnia and palpitations.

Fear depletes the Kidneys or vice versa – Kidney depletion due to over-taxation leads to increased experiences of fear. A chronic state of fear, unease and kidney depletion then leads to anxiety about life situations, with correlating symptoms including feeling threatened, dizziness and light-headedness because according to Giovanni Maciocia “…anxiety of the kidney makes Qi rise to the head.” (Maciocia, The Psyche in Chinese Medicine: Treatment of Emotional and Mental Disharmonies with Acupuncture and Chinese Herbs, 2009, p. 426).

Anxiety arising from worry or pensiveness is characterised by over-thinking and pertains to the Spleen. The Spleen-stomach system is responsible for digestion and transformation of both Gu Qi – the energy derived from food; and our thoughts and ideas. Overwhelm of this organ system due to excessive consumption of food (or inadequate/incorrect food), or chronic ruminating depletes the energy of this organ system meaning it no longer has the capacity to effectively digest or transform, further adding to the anxiety.  Several studies into Spleen functionality and anxiety have been performed, some approaching it from the TCM viewpoint and others from a Western medical stance. Chung, Chen and Ko (2016) reviewed and analysed TCM research into “…anxiety and spleen function, …finding that there is a cause/consequence relationship between the two and that it may be bi-lateral.” (Chung, Chen, & Ko, 2016).

A series of experiments by Wohleb et al., 2013, 2014, 2015, 2016 looked at repeated social stress, immunity and anxiety-related disorder characteristics in mice. They found that immune cells in the spleen contribute to chronic anxiety after a period of psychological stress due to monocyte trafficking from the spleen to the brain. Moreover, these monocytes expand over time creating a reservoir of inflammatory cells that act like a “stress memory”. [ (Wohleb, Powell, Godbout, & Sheridan, 2013); (Wohleb, et al., 2014); (Wohleb, McKim, Sheridan, & Godbout, 2015); (McKim, et al., 2016)]. What is clear from this aforementioned research is that, regardless of the approach to investigation – Western or Eastern – there is a two-way causal relationship between the spleen and anxiety.

The liver zang-fu, although not directly related to anxiety, is responsible for over 500 functions in TCM, one of which is the processing of all emotions. According to the Lingshu Jing, “the liver stores the blood (blood stores the Hun – the ethereal soul) and controls deliberations, indicative of emotions. Thus, it stands to reason that as anxiety is a secondary emotion, it will be processed by the liver, therefore chronic anxiety will cause taxation, overwork and imbalance to the liver (Liu, Shu, Tu, Zhang, & Hong, 2017).

According to Giovanni Maciocia in his book ‘The Psyche in Chinese Medicine’, emotions are the main cause of anxiety. There are however, other etiological contributors such as overworking, blood loss, constitution and diet (Maciocia, The Psyche in Chinese Medicine: Treatment of Emotional and Mental Disharmonies with Acupuncture and Chinese Herbs, 2009). In TCM, diet and nutrition play an important role in both causing and healing disease. There are many aspects of dietary theory in Chinese Medicine that effect the equilibrium of the body including the energetic properties of food at digestion (hot, warm, neutral, cool, and cold), the Five Flavours and their effects on their corresponding Zang-fu, how damp or drying a food is on the body fluids, and so on. For example, dairy is considered an excessively dampening food because it is highly nutrition and supplements the yin substances and fluids of the body efficiently in small amounts. Over-consumption will generate too much body fluids leading to turbidity and pathological dampness that impedes the system (Flaws, 1998).  Furthermore, excessive consumption of dampening foods obstruct the spleen’s function of transforming and transporting because damp is the corresponding element of the spleen-stomach (Earth) in the Wu Xing. This obstruction disrupts the spleen’s digestive function and if not dealt with leads to a cascading imbalance of the other Zang-fu. Looking at a patient’s diet and eating habits is thus, an integral part of any effective TCM and acupuncture treatment, and if deemed necessary suggesting recommended alternatives coupled with lifestyle changes to assist in bringing the patient’s body and systems back into balance as a whole.

As previously mentioned, imbalance within the body shows up as symptoms of disease, which point to patterns of disharmony. Pattern identification is an essential aspect of the diagnosis procedure in any TCM and acupuncture treatment because Chinese medicine and its principles place great importance on individuality. In real life settings a patient would undergo a thorough diagnosis to determine patterns of disharmony via the Eight Principles and Four Pillars. Pattern identification then shows the practitioner which treatment principle to use, allowing for effective selection of relevant acupoints, dietary and lifestyle advice, herbs and so on. However, studies, systematic reviews and meta-analyses that perform individual pattern identification are either rare or do not state its use. Due to this fact, none could be found in relation to pattern identification, anxiety and the efficacy of acupuncture for use as background research. Nevertheless, there are studies and reviews regarding acupuncture using pattern identification and the treatment of other diseases and illnesses, including psychiatric disorders. MacPherson et al., 2013 performed a large randomised controlled trial over an 18 month period, with 755 patients recruited from mainstream care who were continuing to experience depression, in order to identify underlying TCM patterns of disharmony, and document the treatment principles used to treat these patterns.  Primary and secondary organ syndromes were identified for 99% of the patients, showing 66% had Liver Qi Stagnation cluster patterns and 34% had Spleen Xu cluster patterns and concluded that pattern diagnosis provided useful insight into on-going depression after receiving mainstream interventions (MacPherson, Elliot, Hopton, Lansdown, & Richmond, 2013).

Kim et al., 2016 performed a comprehensive review and meta-analysis of 19 randomised controlled trials – 11 acupuncture and 8 electro-acupuncture – into the efficacy of using pattern identification and insomnia treatment. They found that pattern identification had a more significant effectiveness rate than medication but they did not utilise a design that included an ‘acupuncture without pattern identification’ group for direct comparison (Kim, Jeong, Lim, & Kim, 2019).

Having discussed anxiety as a secondary emotion and its two-way relationship with the Zang-fu, one would expect to find TCM patterns of Liver, Spleen, Heart and/or Kidney disharmony pertaining to participants’ anxiety at the diagnosis stage of the study that follows. Furthermore, having talked about the Wu Xing cycles and the way each element (organ) interacts when imbalanced and the sequence(s) of this, one would expect the pattern differentiations of the organs for each participant to follow the Cheng or Wu sequences of imbalance, if the participants have more that one pattern of disharmony. Thus, due to both the aforementioned concepts and theories, primary, secondary and tertiary (if applicable) patterns will be diagnosed.

Moreover, having briefly discussed the effects that certain foods’ nature and energetic properties can have on the body and corresponding organs, if a singular TCM pattern of disharmony can be identified across all 7 participants (as was the question posed at the beginning), a dietary and lifestyle advice sheet will be created based on Chinese Medicine’s dietary theory to stay true to in clinic TCM treatment principles. Furthermore, emotional guidance and techniques such as journaling or use of the ‘Future Me’ perspective will be given to assist in rebalancing the excess energy of the anxiety and the mind-body, again to stay true to real life treatment.

Method

Participants.

Seven participants, all female, took part in this mini study. They were recruited by means of voluntary response sampling for ease of use, as the timeframe was limited. The occupations of the participants were varied and included: one Civil Servant, one Student, two Business Owners, one Sales Assistant, one Therapy Assistant, and one Administrator. Participant ages ranged between 17 years to 47 years. As this was a one-group design, all seven participants received the experimental treatment and none of them received payment for taking part in the trial.

Design.

A one-group, pre-test – mid-test – post-test design was used to investigate the effectiveness of a combined group acupuncture and TCM treatment protocol on anxiety levels. As this was a one-group design, all participants undertook the experimental condition, i.e. the TCM and acupuncture treatment protocol. Participants were selected via voluntary response sampling, by means of answering an advert on Facebook (see Appendix S) and were given a brief overview of what the study would entail before agreeing to take part (see Appendices T1 and T2) after which, all participants gave their informed consent.

The dependant variables in this study i.e. the variables being tested, were the total number of symptoms selected on the Advanced TCM Diagnosis document (Appendix B), the total scores on the GAD7, HADS and BAFSQ emotional measures assessments (Appendices O, P1, P2, and Q), and the ratings given by participants on the PGIC scale (Appendix R).

A base score on the Advanced TCM Diagnosis document for symptomatic health issues, i.e. total number of symptoms, for each participant was established prior to session 1. These symptoms were then reviewed at session 3 and session 6 (see Appendix U). Similarly, a base score for each participant on each of the 3 emotional measures tests was established at session 1 and reviewed at sessions 3 and 6.

Participants also completed the PGIC scale assessment document at session 3 and 6 to establish how effective they perceived the treatment to be on their anxiety levels.

  The independent variables in this study i.e. the variables being manipulated, were the combined group acupuncture needling protocol (see separate Materials document), the Yanagi Ryu NADA protocol (Appendix H), and the dietary & lifestyle advice sheet (Appendix I).

The combined group acupuncture needling protocol was developed as follows:

     

      1. Identify each individual participant’s primary, secondary and tertiary pattern of disharmony via the Advanced TCM Diagnosis document

      1. Identify the most effective acupoints to treat each participant’s primary, secondary and tertiary pattern of disharmony via Total Therapy’s Organ Differentiations documents (Appendices D, E, F and G), and Deadman’s A Manual of Acupuncture App’s ‘General Index’

      1. Compile the acupoints selected in 2) and rate them in terms of frequency of occurrence from highest (i.e. most selected) to lowest (i.e. least selected), and across the number of participants. For example, SP-6 occurred 18 times across all 7 participants and DU-9 occurred only once for 1 participant.

      1. Discard acupoints on compiled list in 3) that occurred for only 3 participants or lower.

      1. Separate the acupoints kept in 4) via body position to create both a front and back needling treatment

    It is important to note here that many acupoints could have been selected based on different systems to address the anxiety and physical symptoms individually and that it was originally intended to use a selection of suggested acupoints specified for anxiety by Giovanni Maciocia in his book “The Psyche in Chinese Medicine”. However, to keep the number of needles down for a stronger treatment, any and all acupoints that did not treat both the emotion and physical symptom(s) together were discarded.

    Once the combined group needling protocol consisting of a front and back treatment was created, the tonifying, sedating or balancing method for each acupoint along with either single or both side needling was established by determining the actions of each point coupled with its influence needed on the organ differentiation, for example BL20 (PiShu) tonifies Spleen qi and yang, and raises qi, therefore the tonification method for this acupoint was chosen to assist treatment of Spleen Qi Xu.

    The administration of the combined group needling protocol across the study (sessions 1 to 6) was as follows:

       

        1. Sessions 1 to 3 – a front needling treatment inserted from feet to head, of the following acupoints:

        1. ST-45 (LiDui) – right side – sedating method

        1. ST-44 (NeiTing) – right side – sedating method

        1. LIV-2 (XingJian) – right side – sedating method

        1. LIV-3 (TaiChong) – both sides – balancing method

        1. ST-36 (ZuSanLi) – left side – balancing method

        1. LIV-13 (ZhangMen) – left side – tonifying method

        1. REN-12 (ZhongWan) – sedating method

        1. REN-13 (ShangWan)– sedating method

        1. ST-21 (LiangMen) – both sides – sedating method

        1. LIV-14 (QiMen) – right side – tonifying method

        1. Sessions 4 to 6 – a back needling treatment inserted from feet to head of the following acupoints:

        1. SP-4 (GongSun) – both sides – balancing method

        1. SP-6 (SanYinJiao) – both sides – balancing method

        1. P-6 (NeiGuan) – both sides – sedating method

        1. BL-21 (WeiShu) – both sides – sedating method

        1. BL-20 (PiShu) – both sides – tonifying method

        1. BL-18 (GanShu) – both sides – balancing method

      The Yanagi Ryu NADA protocol was administered for homework for each participant at the end of each treatment session, 1 to 6.

      Participants completed 5 weekly food diaries for homework. Diaries 1 and 2 were completed to determine their base dietary pattern prior to dietary intervention. At session 3, each participant received a TCM Dietary & Lifestyle Therapy advice sheet for self-implementation and continued completing food diaries to show if diet and lifestyle changes had been made.

      Procedure.

      Participants received six individual treatment sessions overall. 5 participants received one treatment session once a week for a period of 6 weeks and 2 participants (Client 2 and 4) received their 6 treatment sessions over a period of 7 weeks due to affecting life factors (see case study notes for Client 2 sessions 2 and 5; and Client 4 sessions 4 and 5, for more details).

      The treatment and session procedure was as follows:

         

          • Sessions 1 to 6:

          • Complete each section of the treatment or additional treatment form i.e. Medical History or changes in medical circumstances, prior to commencing needling

          • Perform Tongue and Pulse diagnosis, note both yin and yang pulses and take a picture of the tongue for reference

          • Inform the participant of the session procedure – i.e. needle placement, duration and so on

          • Mark up acupoint locations for that session

          • Sanitise hands (practitioner) and clean acupoints location with alcohol wipes

          • Insert sterilised needles (see Materials document for needle information) at marked points (from feet to head)

          • Manipulate needles according to design to achieve deqi response (again from feet to head)

          • Leave needles in situ for 30 minutes – practitioner to note participants’ sensations, conversation etc.

          • Give emotional guidance and techniques if necessary

          • Re-sanitise hands. Remove needles in order of insertion (feet to head)

          • Administer NADA protocol via ASP or press needles (see Materials document) for homework

          • Exchange food diaries

           

            • Sessions 1, 3, and 6 – as above, plus:

            • Participant completion of the 3 emotional measures assessments

            • Review pattern identification symptoms on TCM Advanced Diagnosis form

             

              • Sessions 3 and 6 – as above, plus:

              • Complete PGIC form

               

                • Session 3 only – as above, plus:

                • Give each participant an identical copy of the TCM Dietary and Lifestyle Advice sheet

                • Explain how to implement the above

              Results.

              As a reminder, the aims and objectives of this study were to identify (if possible) an underlying TCM pattern of disharmony across all participants pertaining to their anxiety, and to test the effectiveness of a combined group needling and treatment protocol on the anxiety levels of the participants both individually and as a group.

              Primary, secondary and tertiary (if applicable) TCM patterns of disharmony by organ syndrome, for each participant, as identified by the Advanced TCM Diagnosis forms and analysis are shown in Table 1 below. As can be seen in this table, a TCM pattern of Spleen-Stomach Disharmony was identified across all 7 participants, whether primary, secondary or tertiary.

              Primary, secondary and tertiary Five Element disharmonies by organ cluster are shown below in Table 2. It shows 3 participants’ disharmony patterns follow the Wu Cycle sequence of imbalance (Client 1, 3, and 4) and 2 participants’ follow the Cheng Cycle sequence of imbalance (Client 2 and 6). It also shows 1 participant with only 1 organ cluster of imbalance (Client 7) and therefore no sequence to demonstrate. The Table further highlights that 1 participant has a disharmony pattern that follows neither the Cheng nor Wu cycles of disharmony sequences (Client 5).

              Table 3 shows the total scores and percentage decrease in symptoms on the Advanced TCM Diagnosis forms for each participant across the study at sessions 1, 3 and 6. It illustrates that all 7 participants experienced a reduction in total symptom scores from session 1 to 6 and shows an overall percentage decrease range in symptoms of 57.2% (Client 3) to 99.8% (Client 7).

              Table 4 shows the GAD7 and HADS-A anxiety level severity ratings for each participant across the study at sessions 1, 3 and 6. This table illustrates all 7 participants HADS-A anxiety severity ratings decreased from ‘Abnormal or Borderline abnormal’ at session 1 to ‘Normal’ at session 6. Furthermore, 6 participants GAD7 severity ratings were the lowest – ‘Minimal’ – at session 6 (Client 1, 2, 4, 5, 6, 7), and 1 participant’s GAD7 severity rating decreased from ‘Moderate’ at session 1 to ‘Mild’ at session 6 (Client 3).

              Table 5 illustrates the combined total scores and percentage increase or decrease for the Emotional Measures Tests for each participant across the study at sessions 1, 3 and 6. This table shows 6 of the 7 participants experienced a consistent reduction in total scores across the study, from sessions 1 to 3, and 3 to 6 (Client 1, 2, 3, 5, 6, 7). It also shows 1 participant had a 1 point increase in total scores from session 1 to 3 but went on to experience a reduction in total scores from session 3 to 6, with this reduction being significantly lower at session 6 than the score at session 1 (Client 4).

              An overall percentage decrease in combined emotional measures assessment scores can also be seen in the table below for all 7 participants from sessions 1 to 6, with a decrease range of 40.8% (Client 4) to 99.9% (Client 7).

              Table 6 shows the mean total scores and mean percentage decrease in symptoms on the Advanced TCM Diagnosis forms for the group across the study at sessions 1, 3 and 6. As highlighted by this table, the combined group TCM diagnosis symptom scores at session 3 were inconclusive as 2 participants (shown in Table 2) were unable to report changes to symptoms relating to menstruation, as they had not entered that phase in their menstrual cycle since prior to the study commencing. However, as can also be seen in Table 5, the group experienced a 68.4% overall reduction in symptoms on the Advanced TCM Diagnosis form following the 6 sessions of acupuncture.

              Mean total score and mean percentage decrease for the combined results of the 3 Emotional Measures Tests for the group across the study at sessions 1, 3 and 6 can be seen in Table 7 below. It shows the group experienced a combined reduction of 40.6% in Anxiety levels on the 3 emotional measures tests at session 3 and an overall combined reduction of 68.4% after the full 6 sessions of acupuncture.

               

              Follow ups with all 7 participants were done 5+ weeks after study completion, either in person or digitally, to which all bar 1 participant responded (Client 4). All 6 participants reported a significant reduction or total disappearance of debilitating anxiety related symptoms such as panic attacks, knots in the stomach, avoiding social contact and so on. 2 participants reported having stopped taking antidepressant medication completely and 2 reported decreasing their antidepressants by at least half (Client 5 and 3 – see case studies session 6 trial notes for these two participants for details).

               

              Discussion.

              The findings of this study demonstrate that acupuncture and TCM treatment is an effective intervention for anxiety (individual participant reduction range in anxiety levels = 40.8-99.9% decrease (Table 5, Results section), mean reduction = 68.4% decrease (Table 7)). Furthermore, these findings support the results of Karst et al., 2007; Bae et al., 2014; He et al., 2014; Klausenitz et al., 2016; Amorim et al., 2018; and Yang et al., 2021 for the efficacy of acupuncture in the treatment of anxiety.

              In relation to Zangfu Wu Xing cycles, the results show 5 of the 7 participants organ cluster imbalance followed the sequences of disharmony of the Five Elements (Table 2, Results section). 3 participants’ disharmony patterns, primary-to-tertiary, followed the Wu cycle of imbalance (Client 1, 3, and 4, Table 2), and 2 participants’ patterns, again primary-to-tertiary, followed the Cheng cycle of imbalance (Client 2 and 6, Table 2), therefore adding supportive evidence to this theory. Of the remaining 2 participants, 1 had a singular primary pattern of disharmony (Client 7, Table 2) and thus neither supports nor refutes the theory so her results cannot be discussed concerning Wu Xing cycles.

               

              The final participant’s organ cluster patterns of disharmony were: primary organ of imbalance = Liver, secondary = Kidney, tertiary = Spleen which refutes 5 Element Theory, as it neither follows the Cheng nor Wu cycle sequences (Client 5 – Table 2). However, there may be several explanations for this participant’s resulting sequence pattern. The participant was, and has been, on a lot of medications at the time of, and prior to, taking part in the study. It is well documented (both in Western medicine and TCM) that drugs are processed by the liver causing overwork, overwhelm and taxation, thus increasing the imbalance in this organ and it is therefore not surprising that the Liver came out as the primary organ of imbalance, but perhaps 5 Element Theory does not take drug implications on the organs into account.

              Furthermore, maybe this participant’s causative factor (CF) due to childhood or constitutional weakness is the kidney. This means the ‘mother’ element (kidney) cannot nourish the ‘son’ (liver) due to dysfunction, causing a heightened imbalance in the son via transmutation of engendering. This participant spoke about her there being a lot of fear in the household when she was very young. Heightened and prolonged experiences of fear have a cause/consequence relationship with the kidney (as discussed in the introduction) thus causing taxation and imbalance in that organ system. Experiencing a lot of fear in the childhood corresponds to Kidney as this participant’s CF, demonstrated by the disharmony via organ syndromes (Client 5) in Table 1, and supporting the CF explanation, as the primary pattern here was Kidney Yin Xu (as opposed to Liver). However, further examination of all the syndrome disharmonies of the Liver would be required to identify a corresponding Liver Yin Xu pattern in support of the transmutation of engendering sequence. 

              What is evident from the findings of all 7 participants’ patterns of disharmony, both by organ syndrome and organ cluster (Tables 1 and 2), is that perhaps the 5 element theory of Wu Xing cycles is too simplistic, i.e. it only demonstrates basic patterns of disharmony via organ cluster, does not explain deeper specific organ syndrome issues or how these cascade, nor provide an explanation for more complex patterns of disharmony, such as the case of participant Client 5’s primary-to-tertiary diagnosis. However, a thorough discussion of this and the aforementioned postulations would require a deeper dive into Five Element Theory that neither the timeframe permits nor focus of this study (anxiety) necessitates.

              The findings of this study support the idea that anxiety points to an imbalance of the Zang-fu, as can be seen by the TCM patterns of disharmony identified for all 7 participants (Table 1 and Table 2, Results section). Yet, they do not show a heart disharmony pattern – as expected at the research stage – be it primary, secondary nor tertiary, pertaining to anxiety, with 0 participants receiving a heart disharmony diagnosis. Furthermore, just 2 participants (Client 5, 6) received a diagnosis of a kidney disharmony (Tables 1 and 2), with only 1 one of which being the primary diagnosis of imbalance and merely by organ cluster not organ syndrome (Client 5, Table 2). It is important to note here that this study focused on primary-to-tertiary patterns of disharmony only and that perhaps, if diagnosis was opened up to accommodate further patterns, heart and kidney disharmonies and a full systemic imbalance i.e. disharmonies of all Zangfu, may have been identified in accordance with Wu Xing disharmony cycles.

              Identification of liver patterns of disharmony for 6 out of the 7 participants (Client 1, 2, 3, 4, 5, and 6) provide supportive evidence for the theory that one of the livers functions is to process emotions and that chronic anxiety, as a secondary emotion has a two-way relationship with liver imbalance (Tables 1, 2, 5, and 7 in Results section).

              The main finding of this study is the two-way cause/consequence relationship of chronic anxiety being linked to worry/pensiveness and spleen imbalance. All 7 participants’ results at pattern identification and diagnosis stage (prior to treatment) was that of a Spleen-Stomach Disharmony, be it primary, secondary or tertiary (Table 1 and 2 Results section). This corroborates Chung et al., 2016; and Wohleb et al., 2013, 2014, 2015, and 2016’s findings of spleen related anxiety and answers the first part of the research question – that an underlying Spleen-Stomach TCM pattern of disharmony pertains to anxiety.

              Moreover, the results demonstrate that use of pattern identification at diagnosis stage, creation of a combined group needling and treatment protocol based on compilation of individual participant highest frequency of occurrence acupoints; along with spleen-supporting dietary advice and lifestyle changes such as use of the ‘Future Me’ emotional technique; is an effective treatment for anxiety (range = 40.8-99.9% reduction in anxiety, mean = 68.4% reduction in anxiety). Thus answering the latter part of the research question.

              In terms of methodology, the use of a ‘pre-test – mid-test – post-test’ design demonstrates exactly how and where each participants’ symptoms and anxiety levels changed over time. If a simple ‘pre-test – post-test’ design had been employed, the results would have shown only a decrease in symptoms and anxiety levels across the study whereas, in actuality, one participant had an increase of 1 point in their anxiety levels on the emotional measures scores at session 3. Adding a ‘mid-test’ phase to the design therefore increased the validity and reliability of this study.

              Employment of the Advanced TCM Diagnosis document removes interpreter bias of the practitioner at the diagnosis stage and systematically accounts for all symptoms presented by participants and their corresponding syndromes. This allows for easy replication of the diagnosis procedure applied in this study in future research and increases the reliability of the findings.

              Use of three different emotional measures assessments for anxiety and stress allows for more detailed scores of anxiety levels plus removes any possible confounding variables or bias that only using one assessment could possibly have caused. Moreover, several of the emotional measures assessments employed here already have a Cronbach’s Alpha (a measure of internal consistency) that show each assessment as having a high reliability coefficient and therefore strengthened the validity of the results of this study.

              Several methodological issues need addressing to increase the degree of certainty and decrease possible confounding variables of future studies that may utilise this one’s design and methodology. The use of a one-group design meant that all participants underwent the experimental condition, and therefore there was no control group to demonstrate the difference in receiving acupuncture for the treatment of anxiety versus no treatment. In future, a control group utilising sham acupoints should be employed to increase the validity of the results on efficacy of acupuncture for anxiety. Furthermore, it is suggested that in future two experimental conditions be utilised – one for true body acupuncture only (i.e. the needling protocol created), and the other for true body acupuncture coupled with NADA, so as to further demonstrate the efficacy of the combined needling protocol.

              This study consisted of 6 treatment sessions, falling at the lower end of the typical average number of treatments needed to treat disease in TCM. 6 sessions were given as the study took part in the summer holidays and participants were unable to agree to more sessions due to other commitments. The findings therefore may demonstrate only a portion of the significance of the efficacy of acupuncture on anxiety had it involved a greater number of treatment sessions. Thus, in future it is suggested that a minimum of 8 sessions be used.

              It is possible that the sample size used was too small and therefore the results do not fully represent the true target population, meaning a decrease in reliability. It is suggested that, a sample size of 30 plus participants be employed in future as this number has been scientifically deemed the appropriate sample size for target population representation in research. Furthermore, males should be included in the sample of future research to increase representation of the target population. All female participants was not the intention of this study but occurred due to voluntary response sampling which may have affected reliability of the results for both pattern identification and treatment efficacy.

              Finally, in addition to using percentage reduction of symptoms and anxiety levels at the results stage, future research should also utilise statistical analysis testing such as an ANOVA. This would demonstrate the exact level of significance the methodology and combined acupuncture and TCM treatment had on treating anxiety, thus increasing the validity of the results.

              The findings of this study highlight a few possible practical applications of how it could be applied to real life settings and facilitate anxiety treatment. The methodology can be applied to any group of individuals suffering from anxiety and create an effective acupuncture and TCM treatment protocol that would work as a stand-alone group anxiety intervention program. Furthermore, the procedure could be replicated for the intervention and treatment of depression and/or other psychiatric disorders with positive effects. Finally, this study’s methodology could be utilised alongside other Western mainstream care interventions for anxiety, such as CBT or medications, providing a multifaceted approach to the treatment of anxiety. 

              Conclusion.

              The results of this study demonstrate that an underlying Spleen-Stomach disharmony pattern was present across all 7 participants and can therefore be said to pertain to their anxiety. Furthermore the findings show that it is possible to create an effective combined group needling and treatment protocol from individual pattern identification (primary, secondary and tertiary) that significantly reduces anxiety levels of both the participants individually and the group as a whole which could be utilised as either an effective group anxiety intervention program on its own or used alongside Western mainstream care interventions for anxiety, compounding the efficacy of all treatments, quicker and more efficiently.

              by Beth Thompson Lic.Ac.TCM MAA RBAF – Acupuncturist – Mind Body & Soul Holistic Health (Goole)

               

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