Clinical Trials evaluate the effects of Cannabis, Herbal Medicine, and Keto Diet on Anxiety

Anxiety is a natural phenomenon that occurs in anticipation of danger and is characterized by a state of fear and unease. It becomes pathological when it affects your day to day life due to frequent occurrence. Anxiety disorders are one of the commonest mental health disorders globally.

Risk Factors for Anxiety

The exact cause of anxiety disorder is not known yet concretely. These disorders appear to be caused by an interaction between various biopsychosocial factors. Vulnerable genes interact with stressful or traumatic situations produce clinically significant syndromes affecting day to day life.

Potential factors include:

• Positive family history for the presence of anxiety disorders.
• Substance abuse and withdrawal
• Unpleasant experiences and abuse sustained during childhood strained relationship and difficulties at work 
• Altered levels of brain chemicals (hormones) and electric signals (neurotransmitters) in your brain
• Presence of various chronic diseases.
• People who are timid and lack self-esteem are prone to developing anxiety

Clinical features of anxiety disorder:

• Nervousness and restlessness 
• Having a feeling of impending doom
• An increase in heart rate
• Fast breathing
• Excessive sweating and chills
• Difficulty in concentration and making decisions.
• The feeling of weakness and lethargy
• Insomnia- difficulty sleeping or hypersomnia- excessive sleeping
• High irritability
• A feeling of fear, worry, and apprehension in absence of serious threat that is uncontrollable
• Marked tendency to avoid factors triggering anxiety

 

Diagnosis

The diagnosis of anxiety is based mainly upon clinical history. The history aims at ruling out the presence of any comorbid condition causing anxiety and the presence of environmental stressors and alcohol and drug abuse. Physical examinations and various investigations may be required to rule out other conditions mimicking anxiety. There are various scales to assess the severity of anxiety once confirmed which include the Zung Self-Rating Anxiety Scale and Hamilton Anxiety scale.

Management of Anxiety

Benzodiazepine group of drugs are used to treat acute incidences of anxiety. Combined drug therapy with psychotherapy is required for treating chronic anxiety disorders.

Drug therapy: Different groups of drugs have shown to be effective in treating anxiety disorders

Antidepressants: Various groups of antidepressant drugs are shown to be effective in the treatment of anxiety. Selective serotonin reuptake inhibitors (SSRIs): This group of antidepressant drugs is considered first-line treatment options. These drugs increase the levels of serotonin in the brain which has a good influence on your mood, emotion, and sleep. Serotonin and norepinephrine reuptake inhibitors (SNRIs- Venlafaxine) and tricyclic antidepressants (Amitriptyline, imipramine) have shown to be effective in treating different anxiety disorders but the latter is associated with significant side effects.

Benzodiazepines: Drugs like Lorazepam and clonazepam are used to treat acute cases of anxiety as these drugs are fast-acting and highly effective. Its use in long-term therapy is however not recommended as it has shown to increase dependence and tolerance to the drug.

Buspirone: This anti-anxiety drug has been shown to reduce symptoms of anxiety and is less sedative and addictive as compared to benzodiazepines.

Beta-blockers: Beta-blockers like propranolol and atenolol have shown to be effective in treating physical symptoms of anxiety including excess sweating, dizziness, rapid breathing, and rapid heart rate among others.

Psychotherapy: It involves multiple counseling sessions with your therapist to reduce anxiety symptoms. Cognitive Behavioral Therapy (CBT) a form of psychotherapy is effective in teaching new skills to improve symptoms. By gradually exposing you to your anxiety triggers CBT helps you build confidence and tackle situations of anxiety better.

Treatment Modalities Currently Undergoing Clinical Trials

• Optimizing Psychotherapy:  Though CBT is effective in improving cognition and behavior of trigger avoidance in anxiety, 50% of patients undergoing CBT do not sufficiently benefit from it. A clinical trial to identify the predictors of psychotherapy success in patients is being carried out, the results of the study will help optimize anxiety therapy in individuals 

 

• Prazosin: Prazosin is an effective drug in the treatment of Post-traumatic stress disorder( PTSD).The fact that most clinical features of PTSD and anxiety disorder match researchers are evaluating its potential in treating symptoms of anxiety. The study assessing its efficacy and tolerability in anxiety disorder is currently in Phase 1 of its clinical trial.

 

• Ketogenic diet: Animal models have shown that a ketogenic diet could improve symptoms in patients living with anxiety disorders. A clinical trial to assess its efficacy in improving anxiety symptoms in humans is being conducted.

 

• Trans-diagnostic CBT: A clinical trial to assess the effectiveness of tCBT in improving multiple anxiety-related disorders in the elderly is being done in comparison to standard CBT. Transdiagnostic CBT is an intensive cognitive behavior therapy delivered over one weekend whereas standard therapy is delivered over 3 months. This study is currently in Phase-3 of its clinical trial.

 

• Herbal medicine: Plants of species Galphimia glauca has been used as a part of traditional Mexican medicine in the treatment of various mental disorders. A study aims at assessing the safety and efficacy of drugs prepared from extracts of this plant in treating symptoms of anxiety disorder by comparing them with Alprazolam, a common drug used in the treatment of anxiety disorder. The study is currently in Phase 2 of its clinical trial.

 

• Electroencephalography Neurofeedback: A study to assess the efficacy and safety of 12 weeks of EEG-NF therapy as an add-on treatment for anxiety disorder is also carried out. It is believed that EEG-NF alleviates anxiety symptoms and improves cognitive function in patients with an Anxiety disorder.

 

• Child Anxiety Learning Modules (CALM): Elementary students are shown to be prone to developing excessive anxiety, which results in impaired academic performance along with social and behavioral function impairment in them. A clinical trial assessing the efficacy and cost-effectiveness of CALM relative to relaxation-only programs in alleviating anxiety symptoms and improving academic levels is being carried out.

 

• Cannabinoids: The efficacy of sublingual (under the tongue) cannabis and cannabinoids in treating symptoms of anxiety especially impaired cognitive functions in adults is being studied and is currently in phase 2 of its clinical trial. It has been shown to have anti-anxiety effects.

 

• Psychological guided self-help: A clinical trial to assess the efficiency and feasibility of self-help under the guidance of trained lay providers instead of health professionals in treating symptoms related to anxiety disorders in the elderly is being done. Older people usually prefer psychotherapy over drug therapy.

   

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1. Suma P. Chand, Raman Marwaha et al. Anxiety. StatPearls Publishing; 2020 Jan-.
2. Andreas Ströhle et al. The Diagnosis and Treatment of Anxiety Disorders. Dtsch Arztebl Int. 2018 Sep; 115(37): 611–620.
3. Alexander Bystritsky et al. Current Diagnosis and Treatment of Anxiety Disorders. P T. 2013 Jan; 38(1): 30-38, 41-44, 57.

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