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Botox, group problem-solving therapies produce mixed results in patients with fibromyalgia
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Some patients with fibromyalgia had reduced pain, anxiety, or suicidal thoughts with Botox infusions, group problem-solving therapies or a combination of both, but the results were mixed, according to recently published research.
Seventy-two patients with fibromyalgia with predominantly cervical pain and without lumbar pathology in Southern Catalonia were recruited between July 2012 and December 2013. Exclusion criteria included any obstruction to infiltration, such as narrow cervical canal or cervical disk hernia, cognitive impairment or life expectancy under 1 year.
All patients were Hispanic, 96.9% were women, with a mean age of 58 years, with 50.8% of patients aged older than 60 years (range 18-82 years).
Patients were randomized to one of three intervention groups. Group A received trigger point infiltration with Botox (BTXA, Hugh, marketed as onabotulinumtoxinA, Allergan in the United States) by an anesthesiologist. Group B received group problem-solving therapy conducted by two nurses trained in the method. Patients in group B attended four sessions, including three sessions each week at 1-week intervals and a fourth session 1 month later. Participants identified the primary physical, psychological or social problems perceived and potential solutions, emotional responses and other aspects were explored in the group sessions that followed. Group C received both interventions with onabotulinumtoxinA administered at baseline.
Patients engaged in questionnaires to assess quality of life, anxiety, mobility, pain, participation in usual activities, sleep quality and daytime sleepiness. Suicide risk was assessed with the Spanish, validated version of the Plutchik suicide risk scale and severity of pain was measured on a VAS. Patients who received infiltration received a satisfaction questionnaire.
At 2 months, the perceived general state of health improved following intervention met statistical significance in group A and group B. The overall suicide risk fell from 7.3 to 6.8 and was significantly reduced in Group C. Nocturnal sleep disruption changed from 8.9 at baseline to 8.3 postintervention.
Pain was reduced in 31.8% of patients in group A, in 13.6% of patients in group B and in 22.7% of patients in group C. Pain remained unchanged in 50%, 77.3% and 59.1% of patients, respectively. Pain worsened in 18.2%, 9.1% and 18.2% of patients, respectively.
Of patients in group A, 36.4% of patients improved, 36.4% remained unchanged and 27.2% worsened. Forty-five percent of patients in group B had improvements in anxiety and depression, 45% remained unchanged and 9.1% worsened, compared to 36.4%, 54.5% and 9.1% of patients in group C.
“As with studies by other authors, this study showed the complexity of reducing chronic pain while increasing the quality of life of people with fibromyalgia,” the researchers wrote. – by Shirley Pulawski
Disclosure: The researchers report the study was supported by a grant awarded by the URV-Banco de Santander 2012LINE-01, with start date July 7, 2012 and end date Dec. 31, 2013; code: 004098.
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