Trial Outcomes & Findings for Acupuncture in the Treatment of Gulf War Illness (NCT NCT01305811)

NCT ID: NCT01305811

Last Updated: 2015-06-15

Results Overview

Ten items addressing physical functioning which are part of a short-form health survey with 36 questions. Scores range between 0 and 100 with higher scores indicating better function.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 104 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2015-06-15

Participant Flow

Participant milestones

Measure	Bi-weekly Acupuncture Treatment Veterans with diagnosed symptoms of Gulf War Illness were randomized to six months of biweekly acupuncture treatments.	Wait List Veterans with diagnosed symptoms of Gulf War Illness were randomized to 2 months of waitlist followed by weekly acupuncture treatments for 4 months.
Overall Study STARTED	52	52
Overall Study COMPLETED	44	41
Overall Study NOT COMPLETED	8	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acupuncture in the Treatment of Gulf War Illness

Baseline characteristics by cohort

Measure	Bi-weekly Acupuncture Treatment n=52 Participants Bi-weekly acupuncture treatment for 6 months	Wait List n=52 Participants Wait list for 2 months then weekly acupuncture for four months	Total n=104 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	52 Participants n=7 Participants	104 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	48.2 years STANDARD_DEVIATION 9.9 • n=5 Participants	48.2 years STANDARD_DEVIATION 3.5 • n=7 Participants	48.2 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	45 Participants n=7 Participants	90 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants	52 participants n=7 Participants	104 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Ten items addressing physical functioning which are part of a short-form health survey with 36 questions. Scores range between 0 and 100 with higher scores indicating better function.

Outcome measures

Measure	Bi-Weekly Acupuncture n=44 Participants group mean SF-36 P score at 6 months	Wait List Then Weekly Acupuncture n=41 Participants group mean SF-36 P score at 6 months
SF-36P	73.7 units on a scale Interval 67.7 to 79.8	64.3 units on a scale Interval 57.1 to 71.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 months

Ten items addressing physical functioning which are part of a short-form health survey with 36 questions. Scores range between 0 and 100 with higher scores indicating better function.

Outcome measures

Measure	Bi-Weekly Acupuncture n=50 Participants group mean SF-36 P score at 6 months	Wait List Then Weekly Acupuncture n=50 Participants group mean SF-36 P score at 6 months
SF-36P	0.32 units on a scale Standard Deviation 16.8	4.53 units on a scale Standard Deviation 14.8

Adverse Events

Bi-Weekly Acupuncture

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Wait List

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bi-Weekly Acupuncture n=52 participants at risk Bi-Weekly Acupuncture for 6 months 1 serious unexpected adverse event in the biweekly group: Subject's practitioner was told by subject of a suicide attempt. Case was reviewed and the medical monitor and identified as needing follow up. Subject was hospitalized for observation, released to his daughter's custody. Both the VA and the Crisis Center were in touch with him on Feb 27th and are making arrangements to take him, (patient reported), either in patient or into a program. He had a follow-up appointment Feb 28th at the VA and he was hospitalized at this time and is currently hospitalized. The practitioner will also follow up with subject's PCP.	Wait List n=52 participants at risk Wait list for 2 months followed by 4 months of weekly acupuncture No Adverse events were reported in the Wait list group
Social circumstances Serious unexpected	1.9% 1/52 • 2 years 5 months All potential adverse events which occurred in either study arm were reviewed by the study's medical monitor. Serious and/or unexpected events were reported to the Main IRB and the funder's review office (Army Human Research Protection Office (HRPO)).	0.00% 0/52 • 2 years 5 months All potential adverse events which occurred in either study arm were reviewed by the study's medical monitor. Serious and/or unexpected events were reported to the Main IRB and the funder's review office (Army Human Research Protection Office (HRPO)).

Other adverse events

Measure	Bi-Weekly Acupuncture n=52 participants at risk Bi-Weekly Acupuncture for 6 months 1 serious unexpected adverse event in the biweekly group: Subject's practitioner was told by subject of a suicide attempt. Case was reviewed and the medical monitor and identified as needing follow up. Subject was hospitalized for observation, released to his daughter's custody. Both the VA and the Crisis Center were in touch with him on Feb 27th and are making arrangements to take him, (patient reported), either in patient or into a program. He had a follow-up appointment Feb 28th at the VA and he was hospitalized at this time and is currently hospitalized. The practitioner will also follow up with subject's PCP.	Wait List n=52 participants at risk Wait list for 2 months followed by 4 months of weekly acupuncture No Adverse events were reported in the Wait list group
Social circumstances Pain on needling	1.9% 1/52 • Number of events 52 • 2 years 5 months All potential adverse events which occurred in either study arm were reviewed by the study's medical monitor. Serious and/or unexpected events were reported to the Main IRB and the funder's review office (Army Human Research Protection Office (HRPO)).	0.00% 0/52 • 2 years 5 months All potential adverse events which occurred in either study arm were reviewed by the study's medical monitor. Serious and/or unexpected events were reported to the Main IRB and the funder's review office (Army Human Research Protection Office (HRPO)).

Additional Information

Lisa Conboy

New England School of Acupuncture

Phone: 6175581788

Email: lconboy@nesa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place