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Study Title and Description

Acupuncture for tension-type headache in pregnancy: A prospective, randomized, controlled study



Key Questions Addressed
2 Direct Evidence (Primary Studies): KQ 2 - What are the (comparative) benefits and harms of interventions to treat acute attacks of primary headache in women who are pregnant (or attempting to become pregnant), postpartum, or breastfeeding?
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Primary Publication Information
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TitleData
Title Acupuncture for tension-type headache in pregnancy: A prospective, randomized, controlled study
Author J.B. Guerreiro da Silva a, M.U. Nakamurab, J.A. Cordeiro a, L. Kulay b
Country
Year 2012
Numbers

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Extraction form for Direct Evidence (Primary Studies)
Arms
Number Title Description Comments
1 Complementary therapies: Acupuncture
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2 Conventional treatment
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Design Details
Question... Follow Up Answer Follow-up Answer
Which KEY QUESTION (KQ) does this study address? KQ2: Treatment of primary headache
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KQ2: Treatment of primary headache
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KQ2: Treatment of primary headache
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What is the STUDY DESIGN? Randomized controlled trial (RCT).....Skip to Question 5
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In what COUNTRY was the study done? ... Other, specify ... Brazil
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What was the FUNDING SOURCE of the study? ... Can't tell/Not reported ...
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Does the study have a NAME or ACRONYM? No/not reported
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Does the study have a CLINICALTRIALS.GOV IDENTIFICATION NUMBER? ... Yes, specify the NCT number ("include NCT")... ...
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What were the START and END YEARS of the study? 2001
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2006
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What were the study INCLUSION criteria? ages from 15 to 39 years, 15 to 30 weeks of pregnancy and tension-type headache (minimum of 4 in a Numerical Rated Scale of zero to ten, where zero meant no pain and ten the greatest pain imaginable), diagnosed as that by JBGS, according to the IHS (International Headache Society)
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What were the study EXCLUSION criteria? The exclusion criteria were high-risk pregnancy (defined by the obstetricians), underlying diseases which were a potential cause of the symptoms, similar symptoms prior to pregnancy and acupuncture treatment in the preceding year.
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Do you have any NOTES regarding the design or any overall aspects of this study?
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Baseline Characteristics
Question Complementary therapies: Acupuncture Conventional treatment Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
What was the SAMPLE SIZE at baseline? 20 23 43
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What were the RACE/ETHNICITY of the women in the study? Not reported Not reported Not reported
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What was the AGE DISTRIBUTION of the women in the study? (CONTINUOUS data) Mean 27.3 Mean 25.3
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Standard deviation (SD) 4.3 Standard deviation (SD) 6.1
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What was the AGE DISTRIBUTION of the women in the study? (CATEGORICAL data) No data entered.
In what PHASE were the women in the study? 2nd trimester...% 100 2nd trimester...% 100 2nd trimester...% 100
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What was the GESTATIONAL AGE DISTRIBUTION of the women in the study? (CONTINUOUS data) Mean 19.8 Mean 19.4
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Standard deviation (SD) 4.0 Standard deviation (SD) 4.1
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What was the UNIT for the gestational age you answered in the previous question? Weeks Weeks
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What was the GRAVIDITY DISTRIBUTION of the women in the study? (CONTINUOUS data) Mean 2.0 Mean 2.0 Not reported
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Standard deviation (SD) 2.7 Standard deviation (SD) 2.0
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What was the PARITY DISTRIBUTION of the women in the study? (CONTINUOUS data) Mean 1.0 Mean 1.0 Not reported
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Standard deviation (SD) 2.0 Standard deviation (SD) 2.0
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What were the TYPES of PRIMARY HEADACHE in the women in the study? Tension headache...% 100 Tension headache...% 100 Not reported...%
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What percentage of the women in the study had a HISTORY OF PRIMARY HEADACHE? Not reported Not reported Not reported
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Do you have any NOTES regarding the baseline characteristics in this study? No data entered.



Results & Comparisons


Results Data
P-Value
Outcome: Medication use      Population: All Participants Between-Arm Comparisons
Time Point Measure Complementary therapies: Acupuncture Conventional treatment Comparison Measure Complementary therapies: Acupuncture vs. Conventional treatment


8 weeks

N Analyzed 20 23 0.001
Counts 14 6
Percentage 70 26.1
P-Value
Outcome: Acute headache attacks - Severity      Population: All Participants Between-Arm Comparisons
Time Point Measure Complementary therapies: Acupuncture Conventional treatment Comparison Measure Complementary therapies: Acupuncture vs. Conventional treatment


8 weeks

N Analyzed 20 23 0.028
Counts 16 11
Percentage 80 47.8
P-Value
Outcome: Adverse events - Fetal/Infant - Low birth weight      Population: All Participants Between-Arm Comparisons
Time Point Measure Complementary therapies: Acupuncture Conventional treatment Comparison Measure Complementary therapies: Acupuncture vs. Conventional treatment


Delivery N/A

N Analyzed 20 23 0.4
Mean 3244 3146
SD 336 424
P-Value
Outcome: Medication use      Population: All Participants Between-Arm Comparisons
Time Point Measure Complementary therapies: Acupuncture Conventional treatment Comparison Measure Complementary therapies: Acupuncture vs. Conventional treatment


8 weeks

N Analyzed 20 23 0.009
Mean 6.0 0.6
SD 9.0 3.3
P-Value
Outcome: Acute headache attacks - Severity      Population: All Participants Between-Arm Comparisons
Time Point Measure Complementary therapies: Acupuncture Conventional treatment Comparison Measure Complementary therapies: Acupuncture vs. Conventional treatment


8 weeks

N Analyzed 20 23 0.035
Mean 3.9 1.7
SD 3.4 4.4
P-Value P-Value
Outcome: Adverse events - Fetal/Infant - Perinatal complications      Population: All Participants Between-Arm Comparisons
Time Point Measure Complementary therapies: Acupuncture Conventional treatment Comparison Measure Complementary therapies: Acupuncture vs. Conventional treatment


1 minutes

N Analyzed 20 23 NR
Mean 9 9
SD 0 1


5 minutes

N Analyzed 20 23 0.76
Mean 10 10
SD 0 0


Quality Dimensions
Dimension Value Notes Comments
Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study?
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Q2: Did the study divide the follow up time of each individual participant into the different interventions?
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Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains?
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Q4: ROBINS-I 1.5. If Y/PY to 1.4: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study?
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Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention?
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Q6: Risk of bias judgement for BIAS DUE TO CONFOUNDING
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Q7: ROBINS-I 2.1. Was selection of participants into the study (or into the analysis) based on participant characteristics observed after the start of intervention?
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Q8: ROBINS-I 2.2. If Y/PY to 2.1: Were the post-intervention variables that influenced selection likely to be associated with intervention?
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Q9: ROBINS-I 2.3 If Y/PY to 2.2: Were the post-intervention variables that influenced selection likely to be influenced by the outcome or a cause of the outcome?
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Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants?
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Q11: Did the start and follow up calendar years coincide for most participants in the study?
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Q12: ROBINS-I 2.5. If Y/PY to 2.2 and 2.3, or N/PN to 2.4: Were adjustment techniques used that are likely to correct for the presence of selection biases?
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Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY
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Q14: Cochrane - Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence Unclear
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Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment Low
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Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study High
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Q17: Cochrane - Blinding of personnel/ care providers (performance bias): Performance bias due to knowledge of the allocated interventions by personnel/care providers during the study. High
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Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. High
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Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. High
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Low
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low
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Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. Low
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Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? Yes
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Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? Yes
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? Yes
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Quality Rating
No quality rating data was found.