Francesca Galiano
|
08/08/2022 - Last update 30/12/2022

Lindsay Dixon, Kathryn Fotinos, Emilia Sherifi, Sachinthya Lokuge, Alexa Fine, Melissa Furtado, Leena Anand, Katharine Liberatore, Martin A Katzman | Year 2020

Effect of Osteopathic Manipulative Therapy on Generalized Anxiety Disorder

Pathology:

Generalized anxiety disorder

Type of study:

Non randomized trial

Date of publication of the study’:

2020/Mar/01

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Purpose of the study

  • Objective: to evaluate the efficacy of OMTh as an adjunctive treatment in the management of generalized anxiety disorder
  • Measured outcomes:
    • Primary: change in severity of anxiety measured by Hamilton Anxiety Scale (HAM-A), administered only by an expert
    • Secondary: change in anxiety symptoms through Beck Anxiety Inventory (BAI) and change in the capacity to tolerate uncertain events using the Intolerance for Uncertainty Scale (IUS), symptoms self-assessment questionnaires

Participants

  • Numbers: 26 people (20 female and 6 male, mean age 41.4 years)
  • Criteria of inclusion: age 18-65 years, primary diagnosis of moderate-severe generalized anxiety disorder, had not achieved remittance following a standard treatment of at least 8 weeks, score of 20 on HAM-A scale at the screening and at beginning of the study.
  • Criteria of exclusion: other Axis I primary diagnosis on DSM-IV in the previous 6 months; HAM-A scale score of ≥ 15; receiving other forms of manual therapy; alcohol or drugs abuse or dependence either current or in the previous 6 months; previous history of mania or hypomania according to the DSM-IV; a history of a bipolar mood disorder, personality disorder or psychotic disorder; cognitive disorder or dementia in the preceding 6 months; possible risk of suicide; currently pregnant or breastfeeding; intention to become pregnant before, during or 30 days after the beginning of the study; changes in the therapies received (medications or psychotherapy) during the study period; presence of other organic diseases, either significant or severe (eg, cardiac, endocrine, gastrointestinal, infective illnesses, liver or renal insufficiency, metabolic disturbance, neoplastic, neurologic, pulmonary or vascular illnesses).
  • Group of study: only one treatment group
    • OMTh, 26 people
      • 3 people left the study (1 for medical conditions before beginning and 2 drop-outs for difficulties in attending the visits)
      • muscle tension problems (24 people), insomnia or sleep problems (24 people), low back pain (18 people), irritable bowel syndrome (17 people)
      • present psychiatric comorbidities: major depressive disorder (24 people), panic disorder with limited symptoms (15 people), social anxiety disorder (15 people), agoraphobia (3 people), specific phobias (3 people), attention deficit disorder and adult hyperactivity disorder (3 people), post-traumatic stress disorder (2 people), obsessive-compulsive disorder (2 people)

Interventions and evaluations

  • Screening evaluation to confirm the primary diagnosis of generalized anxiety disorder via Mini International Neuropsychiatric Interview version 6.0.0)
  • Evaluation at the screening and 1 week after the last session using HAM-A and Hamilton Depression Rating Scale (HAM-D)
    Evaluation using HAM-A, BAI and IUS before each OMTh visit
  • 5 sessions of OMTh in a time of 8-9 weeks according to the following schedule: 1 week after screening; 3 weekly visits; 2 fortnightly visits
  • Prima visita di 1 ora e mezza, mentre visite successive di 60 minuti, di cui 15 dedicati alla valutazione generale dello stato della persona;
  • OMTh: black-box treatment, that is, tailored to the patient’s needs. Overall assessment of posture, mobility and palpation of the spine, joints, cranial bones, meninges, fascia and viscera to determine the main tissue restrictions to be treated with soft tissues, visceral, cranial, osteoarticular, direct or indirect myofascial release, muscle energy techniques
  • OMTh performed by only one osteopath
  • Medical and psychiatric evaluations carried out by a psychiatrist

Results

  • Primary outcomes: In the 23 patients who completed the study, the OMTh promoted a statistically significant reduction in anxiety measured by HAM-A between the first and the last visit (from 26.19 ± 3.88 to 11.29 ± 6.11, based on a range of 0 to 56). The same result was obtained considering the 2 patients who dropped out.
    In essence, 16 out of 26 patients reduced their anxiety, while 7 patients achieved remittance (HAM≤A 7).
  • Secondary outcomes: In the 23 patients who completed the study and in the 2 who did not complete it, the OMTh reduced the intolerance to uncertain events measured by the IUS in a statistically significant manner.

On the contrary, there were no differences in anxiety symptoms assessed via BAI.

Discussion

OMTh has shown that it can positively affect, up to the state of remittance, generalized anxiety disorder in people refractory to standard treatments.
In particular, OMTh seems able to easily act on those neurobiological networks, which research is showing us to be linked to the state of health of the rest of the organism, that allow people to better cognitively frame the situation in which they find themselves, how to interpret it and how to behave accordingly.
The two scales HAM-A and IUS tend in fact to evaluate more the cognitive aspects of anxiety, while the BAI scale is more shifted towards the physiological sensations felt during an anxiety attack, or at least towards the fear and discomfort associated with anxiety.

However, the characterization of the scales for anxiety disorders is quite complex and, therefore, other reasons can explain the difference in the results obtained, not to mention that the BAI scores at the beginning of the study were quite low.

In order to confirm the results obtained, studies with control groups will be needed, which will also assess the influence of factors like the influence of factors such as therapist-patient interaction (placebo effect), physical activity and diet, all able to act significantly on anxiety states.

The review of Osteopedia

By Marco Chiera

Strengths: very interesting results for an increasingly widespread problem that is often treated by acting only “on the head”; the black-box approach, although it reduces the experimental replicability, is close to the daily clinic and therefore represents the actual osteopathic practice; very detailed methodological description; well-articulated statistical analysis; the choice of a specific clinical endpoint to evaluate the outcome allows to build in the future more extensive and structured studies.

Limits: the small sample and the absence of a control group (understandable fact for an exploratory study) prevent the generalization of the results and the exclusion that the effects were due to a placebo effect (although we must remember that the recruited people had not had results with standard treatments); it would have been interesting to see the physiological and psychiatric picture of the patients also at the end of the study; description of the evaluation schedule with slightly “chaotic” questionnaires.

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