Intradermal mesotherapy versus intravenous dexketoprofen for the treatment of migraine headache without aura: a randomized controlled trial
BACKGROUND: Migraine is a prevalent disabling primary headache disorder that is classified into two major types: migraine without aura and migraine with aura. New therapeutic methods to reduce migraine headaches in the emergency department (ED) include intradermal mesotherapy. OBJECTIVE: Compare the...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
King Faisal Specialist Hospital and Research Centre
2021-06-01
|
| Series: | Annals of Saudi Medicine |
| Online Access: | https://www.annsaudimed.net/doi/full/10.5144/0256-4947.2021.127 |
| _version_ | 1818897727001460736 |
|---|---|
| author | Ilker Akbas Meryem Betos Kocak Abdullah Osman Kocak Sultan Tuna Akgol Gur Sinem Dogruyol Mehmet Demir Zeynep Cakir |
| author_facet | Ilker Akbas Meryem Betos Kocak Abdullah Osman Kocak Sultan Tuna Akgol Gur Sinem Dogruyol Mehmet Demir Zeynep Cakir |
| author_sort | Ilker Akbas |
| collection | DOAJ |
| description | BACKGROUND: Migraine is a prevalent disabling primary headache disorder that is classified into two major types: migraine without aura and migraine with aura. New therapeutic methods to reduce migraine headaches in the emergency department (ED) include intradermal mesotherapy. OBJECTIVE: Compare the efficacy of intradermal mesotherapy versus a systemic therapy in pain control in patients with headache related to migraine without aura. DESIGN: Prospective parallel-group randomized controlled trial. SETTING: University hospital in Turkey. PATIENTS AND METHODS: Patients 18 years of age and older who were admitted to the ED over a 15-month period with headache related to migraine without aura were eligible for inclusion if they had a VAS score of 4 or above. Patients were randomly allocated to one session of mesotherapy or intravenous dexketoprofen. Changes in pain intensity were measured by the score on a visual analog scale (VAS) at 30, 60, and 120 minutes and 24 hours after treatment. Efficacy was also assessed by the need for use of an analgesic drug within 24 hours, by readmission with the same complaint to the ED within 72 hours, and by adverse effect rates. MAIN OUTCOME MEASURE: Pain intensity on the VAS scale. SAMPLE SIZE: 148 patients (154 enrolled and treated; 1 patient in the mesotherapy and 5 patients in the systemic therapy group lost to follow up). RESULTS: Pain intensity on the VAS scale decreased from a median score of 8 to 4 in the mesotherapy group and from 8 to 5 in the systemic therapy group. These differences were statistically significant from baseline for all time intervals (P=.001 to 30 minutes, P=.004 to 60 minutes, P=.005 to 120 minutes, and P=.002 to 24 hours). The need to use analgesics and the rate of readmission to the ED were higher in the systemic therapy group (P=.013 and P=.030, respectively). Adverse effect rates were minimal and similar in the study groups during the one-week follow-up period. CONCLUSIONS: Mesotherapy is more efficacious than intravenous dexketoprofen in the management of acute attack of migraine without aura in the ED. LIMITATIONS: Unblinded. Valid for assessing short-term pain relief, but not sufficient to predict long-term efficacy. Not generalizable because single center and small sample size. CONFLICT OF INTEREST: None. REGISTRATION: ClinicalTrials.gov (NCT04519346) |
| first_indexed | 2024-12-19T19:20:46Z |
| format | Article |
| id | doaj.art-3db390f44f944815853a7905bcc73e53 |
| institution | Directory Open Access Journal |
| issn | 0256-4947 0975-4466 |
| language | English |
| last_indexed | 2024-12-19T19:20:46Z |
| publishDate | 2021-06-01 |
| publisher | King Faisal Specialist Hospital and Research Centre |
| record_format | Article |
| series | Annals of Saudi Medicine |
| spelling | doaj.art-3db390f44f944815853a7905bcc73e532022-12-21T20:09:00ZengKing Faisal Specialist Hospital and Research CentreAnnals of Saudi Medicine0256-49470975-44662021-06-0141312713410.5144/0256-4947.2021.1270256-4947.2021.127Intradermal mesotherapy versus intravenous dexketoprofen for the treatment of migraine headache without aura: a randomized controlled trialIlker Akbas0Meryem Betos Kocak1Abdullah Osman Kocak2Sultan Tuna Akgol Gur3Sinem Dogruyol4Mehmet Demir5Zeynep Cakir6From the Department of Emergency Medicine, Bingol State Hospital, Bingol, TurkeyFrom the Department of Family Medicine, Sukru Pasa Family Health Center, Erzurum, TurkeyFrom the Department of Emergency Medicine, Ataturk University Faculty of Medicine, Erzurum, TurkeyFrom the Department of Emergency Medicine, Ataturk University Faculty of Medicine, Erzurum, TurkeyFrom the Department of Emergency Medicine, Manisa Merkez Efendi State Hospital, Manisa, TurkeyFrom the Department of Emergency Medicine, Health Sciences University Bursa Higher Specialization Training and Research Hospital, Bursa, TurkeyFrom the Department of Emergency Medicine, Ataturk University Faculty of Medicine, Erzurum, TurkeyBACKGROUND: Migraine is a prevalent disabling primary headache disorder that is classified into two major types: migraine without aura and migraine with aura. New therapeutic methods to reduce migraine headaches in the emergency department (ED) include intradermal mesotherapy. OBJECTIVE: Compare the efficacy of intradermal mesotherapy versus a systemic therapy in pain control in patients with headache related to migraine without aura. DESIGN: Prospective parallel-group randomized controlled trial. SETTING: University hospital in Turkey. PATIENTS AND METHODS: Patients 18 years of age and older who were admitted to the ED over a 15-month period with headache related to migraine without aura were eligible for inclusion if they had a VAS score of 4 or above. Patients were randomly allocated to one session of mesotherapy or intravenous dexketoprofen. Changes in pain intensity were measured by the score on a visual analog scale (VAS) at 30, 60, and 120 minutes and 24 hours after treatment. Efficacy was also assessed by the need for use of an analgesic drug within 24 hours, by readmission with the same complaint to the ED within 72 hours, and by adverse effect rates. MAIN OUTCOME MEASURE: Pain intensity on the VAS scale. SAMPLE SIZE: 148 patients (154 enrolled and treated; 1 patient in the mesotherapy and 5 patients in the systemic therapy group lost to follow up). RESULTS: Pain intensity on the VAS scale decreased from a median score of 8 to 4 in the mesotherapy group and from 8 to 5 in the systemic therapy group. These differences were statistically significant from baseline for all time intervals (P=.001 to 30 minutes, P=.004 to 60 minutes, P=.005 to 120 minutes, and P=.002 to 24 hours). The need to use analgesics and the rate of readmission to the ED were higher in the systemic therapy group (P=.013 and P=.030, respectively). Adverse effect rates were minimal and similar in the study groups during the one-week follow-up period. CONCLUSIONS: Mesotherapy is more efficacious than intravenous dexketoprofen in the management of acute attack of migraine without aura in the ED. LIMITATIONS: Unblinded. Valid for assessing short-term pain relief, but not sufficient to predict long-term efficacy. Not generalizable because single center and small sample size. CONFLICT OF INTEREST: None. REGISTRATION: ClinicalTrials.gov (NCT04519346)https://www.annsaudimed.net/doi/full/10.5144/0256-4947.2021.127 |
| spellingShingle | Ilker Akbas Meryem Betos Kocak Abdullah Osman Kocak Sultan Tuna Akgol Gur Sinem Dogruyol Mehmet Demir Zeynep Cakir Intradermal mesotherapy versus intravenous dexketoprofen for the treatment of migraine headache without aura: a randomized controlled trial Annals of Saudi Medicine |
| title | Intradermal mesotherapy versus intravenous dexketoprofen for the treatment of migraine headache without aura: a randomized controlled trial |
| title_full | Intradermal mesotherapy versus intravenous dexketoprofen for the treatment of migraine headache without aura: a randomized controlled trial |
| title_fullStr | Intradermal mesotherapy versus intravenous dexketoprofen for the treatment of migraine headache without aura: a randomized controlled trial |
| title_full_unstemmed | Intradermal mesotherapy versus intravenous dexketoprofen for the treatment of migraine headache without aura: a randomized controlled trial |
| title_short | Intradermal mesotherapy versus intravenous dexketoprofen for the treatment of migraine headache without aura: a randomized controlled trial |
| title_sort | intradermal mesotherapy versus intravenous dexketoprofen for the treatment of migraine headache without aura a randomized controlled trial |
| url | https://www.annsaudimed.net/doi/full/10.5144/0256-4947.2021.127 |
| work_keys_str_mv | AT ilkerakbas intradermalmesotherapyversusintravenousdexketoprofenforthetreatmentofmigraineheadachewithoutauraarandomizedcontrolledtrial AT meryembetoskocak intradermalmesotherapyversusintravenousdexketoprofenforthetreatmentofmigraineheadachewithoutauraarandomizedcontrolledtrial AT abdullahosmankocak intradermalmesotherapyversusintravenousdexketoprofenforthetreatmentofmigraineheadachewithoutauraarandomizedcontrolledtrial AT sultantunaakgolgur intradermalmesotherapyversusintravenousdexketoprofenforthetreatmentofmigraineheadachewithoutauraarandomizedcontrolledtrial AT sinemdogruyol intradermalmesotherapyversusintravenousdexketoprofenforthetreatmentofmigraineheadachewithoutauraarandomizedcontrolledtrial AT mehmetdemir intradermalmesotherapyversusintravenousdexketoprofenforthetreatmentofmigraineheadachewithoutauraarandomizedcontrolledtrial AT zeynepcakir intradermalmesotherapyversusintravenousdexketoprofenforthetreatmentofmigraineheadachewithoutauraarandomizedcontrolledtrial |