Review the efficacy, tolerability and safety of indomethacin and specialized Boswellia serrata extract (SBSE) in a cohort of hemicrania continua (HC) subjects who have used both effectively for treatment.

An absolute response to therapeutic doses of indomethacin is the sine qua non of HC.  Unfortunately,  indomethacin use is often associated with significant side effects and serious adverse events preventing effective long-term treatment. The discovery of reliable, better-tolerated and safer therapeutic alternatives are crucial for successful long-term management of HC.

Subjects with confirmed (demonstrated an absolute response to therapeutic doses of indomethacin) HC (n=37) completed an extensive medical history detailing treatment efficacy, tolerability and safety that occurred while using indomethacin and SBSE independently.  

Average duration of indomethacin use was 22 months and 24 months for SBSE.  Once at therapeutic doses, indomethacin took on average 3.0 days to become effective, whereas SBSE took 13 days.  Migraine Disability Assessment Scores were 52 (pre-treatment), 20 (while on indomethacin) and 16 while on SBSE.  Average pain scores and headache days per month were 7.5/30, 3.3/13 and 3.6/16 respectively. The overall perceived benefit score (0-10) of indomethacin was 7.7 and 7.8 for SBSE.  Subjects reported side effects with indomethacin 72% of the time and 15% of the time with SBSE.  Side effects with indomethacin versus SBSE were nausea (38%/8%), dyspepsia (29%/4%), fatigue (25%/15%), insomnia (25%/23%), poor concentration (21%/8%), “spacey” feeling (21%/4%), poor memory (17%/8%), bloating (17%/15%) and dizziness (8%/0%).  SBSE was void of adverse events whereas indomethacin was associated with easy bleeding/bruising (5%), anemia (5%), anaphylaxis (5%), gastric ulceration (5%), intestinal ulceration (5%), lower gastrointestinal bleeding (5%), hemorrhoidal bleeding (8%) and impaired renal function (8%). 

In this cohort, SBSE proved to be not only a highly efficacious treatment alternative, but also one which was extremely well tolerated and void of significant adverse events or major risks.