Elevated nitric oxide and carbon monoxide concentration in nasal-paranasal sinus air as a diagnostic tool of migraine: a case - control study.

BACKGROUND: A recent study showed that 60-s paranasal air suction results in an immediate pain relief in acute migraine. This is the study to assess the Nitric Oxide (NO) and Carbon Monoxide (CO) concentration in nasal-paranasal sinus air of migraine patients and to compare it with healthy controls. METHODOLOGY: The NO and CO levels of air sucked out from nasal-paranasal sinuses of 20 migraine adolescent and young adults among school students, aged 16 -19 years, and 22 healthy similar aged school students as controls were measured as key responses using a portable NO and a portable CO analyzer. RESULTS: Patients had comparatively high values compared to the controls for paranasal NO (both left and right sides), paranasal CO (both left and right sides), Fraction Exhaled NO (FeNO) and Fraction Exhaled CO (FeCO). Patients had median paranasal NO contents of 132.5 ppb and 154 ppb on left and right sides respectively compared to 36 ppb and 34.5 ppb corresponding values in controls (P <  0.0001). Similar pattern was observed with paranasal CO (P <  0.0001). FeNO and FeCO content were also higher in patients (P <  0.0001). Receiver characteristic operating curves of all gas measurements showed that they all could classify patients and controls effectively and NO was the most effective followed by paranasal CO. After air suction, the mean pain scores of general headache and tenderness dropped by a very large margin in migraine patients (P <  0.0001). CONCLUSIONS: Suctioned out high nasal-paranasal sinus NO and CO levels can be used to distinguish migraine patients from healthy subjects. In fact, suctioned out paranasal NO measurements of both sides with a cutoff point of 50 ppb provided a perfect classification of patients and controls. Increased sinus NO and CO during acute episode of migraine is an observation we had and we agree that further studies are needed to conclude that NO and CO can be a causative molecule for migraine headache. TRAIL REGISTRATION: Clinical Trial Government Identification Number - 1548/2016. Ethical Clearance Granted Institute - Medical Research Institute, Colombo, Sri Lanka (No 38/2016). Sri Lanka Clinical Trial Registration number: SLCTR/ 2017/018 (29/06/2017). Approval Granting Organization to use the device in the clinical trial- National Medicines Regulatory Authority Sri Lanka (16/06/2018), The device won award at Geneva international inventers exhibition in 2016 and President award in 2018 in Sri Lanka. It is a patented device in Sri Lanka and patent number was SLKP/1/18295. All methods were carried out in accordance with CONSORT 2010 guidelines.

Effectiveness of paranasal air suction on acute migraine using portable air sucker - a randomized, double blind study.

BACKGROUND: Migraine is a primary headache disorder and is the most common disabling primary headache disorder that occurs in children and adolescents. A recent study showed that paranasal air suction can provide relief to migraine headache. However, in order to get the maximum benefit out of it, an easy to use effective air sucker should be available. Aiming to fulfil the above requirement, a randomized, double blind control clinical trial was conducted to investigate the efficacy of a recently developed low-pressure portable air sucker. METHODS: Eighty-six Sri Lankan school children of age 16-19 years with migraine were enrolled for the study. They were randomly allocated into two groups, and one group was subjected to six intermittent ten-second paranasal air suctions using the portable air sucker for 120 s. The other group was subjected to placebo air suction (no paranasal air suction). The effect of suction using portable air sucker was the primary objective but side of headache, type of headache, and gender were also studied as source variables. The primary response studied was severity of headache. In addition, left and right supraorbital tenderness, photophobia, phonophobia, numbness over the face and scalp, nausea and generalized tiredness/weakness of the body were studied. The measurements on all those variables were made before and after suction, and the statistical analysis was performed based on before and after differences. As a follow-up, patients were monitored for 24-h period. RESULTS: There was a significant reduction in the severity of headache pain (OR = 25.98, P < 0.0001), which was the primary outcome variable, and other migraine symptoms studied, tenderness (left) (OR = 289.69, P < 0.0001), tenderness (right) (OR > 267.17, P < 0.0001), photophobia (OR = 2115.6, P < 0.0001), phonophobia (OR > 12.62, P < 0.0001) nausea (OR > 515.59, P < 0.0001) and weakness (OR = 549.06, P < 0.0001) except for numbness (OR = 0.747, P = 0.67) in the treatment group compared to the control group 2 min after the suction. These symptoms did not recur within 24-h period and there were no significant side effects recorded during the 24-h observation period. CONCLUSION: This pilot study showed that low-pressure portable air sucker is effective in paranasal air suction, and suction for 120 s using the sucker can provide an immediate relief which can last for more than 24-h period without any side effects. TRAIL REGISTRATION: Clinical Trial Government Identification Number - 1548/2016. Ethical Clearance Granted Institute - Medical Research Institute, Colombo, Sri Lanka (No 38/2016). Sri Lanka Clinical Trial Registration No: SLCTR/2017/018 . Date of registration = 29/ 06/2017. Approval Granting Organization to use the device in the clinical trial- National Medicines Regulatory Authority Sri Lanka (16 Jan 2018), The device won award at Geneva international inventers exhibition in 2016 and President award in 2018 in Sri Lanka. It is a patented device in Sri Lanka and patent number was SLKP/1/18295. All methods were carried out in accordance with CONSORT 2010 guidelines.

Paranasal sinus air suction for immediate pain relief of acute migraine - a randomized, double blind pilot study.

BACKGROUND: Migraine is a primary headache disorder, which cause significant disability in adolescence. This double blind, randomized clinical trial assessed the immediate effects of suction of paranasal sinus air during an acute migraine episode. METHODS: A randomized, double blind study was conducted with 56 selected Sri Lankan school children of 16-19 years of age. Participants who met International Headache Society criteria for migraine (with or without aura) were included in the study. Subjects were randomly allocated into 2 groups where one group was subjected to three intermittent 10 sec paranasal air suctions with a ten sec suction free interval between two suctions for each nostril and the other group was subjected to placebo air suction (no paranasal air suction) in similar arrangement. Severity of headache and sub-orbital tenderness before and after suction were recorded using standard pain rating scale. RESULTS: After dropouts, treated and placebo groups consisted of 27 and 23 subjects respectively. The mean headache pain score drop in the treated group was significantly higher compared to that of the control group. Moreover, there was a difference in the treatment response between the types of headache (with or without aura). With respect to tenderness there was a statistically significant drop in the treated group compared to the control. In general, airflow rates in left and right nostrils were different in these subjects. However such difference was not seen in the tenderness on two sides. Nevertheless it was revealed that airflow rate has a slight negative correlation with the tenderness irrespective of the side. CONCLUSION: Sixty-second paranasal air suction can provide an immediate pain relief for acute migraine in adolescents. We did not assess pain outcomes beyond 60 s, but the initial responses suggests the need to further study the efficacy of paranasal suction in migraine. A further study is suggested to evaluate the acute effects, efficacy and side effects of paranasal air suction using follow up over a prolong period. TRIAL REGISTRATION: Sri Lanka Clinical Trials Registry SLCTR/2017/018 , 29 Jun 2017. Retrospectively registered.