Summary of findings for the main comparison. Acupuncture compared to sham for premenstrual syndrome.
| Acupuncture compared to sham acupuncture for premenstrual syndrome | ||||||
| Patient or population: women with PMS Setting: outpatient clinic or community Intervention: acupuncture Comparison: sham acupuncture | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with sham acupuncture | Risk with Acupuncture | |||||
| Overall premenstrual symptoms ‐ Mood at two month follow‐up. Assessed with: Daily Record of Severity of Problems (DRSP) scale. Scale range for DRSP (mood) 0‐60. Lower scores indicate less severe premenstrual symptoms |
The mean overall premenstrual symptoms‐ Mood was 51.91 | MD 9.03 lower (10.71 lower to 7.35 lower) | ‐ | 67 (1 RCT) | ⊕⊕⊝⊝ LOW 1 | Acupuncture may reduce the number of mood PMS related symptoms women have, compared to sham acupuncture. |
| Overall premenstrual symptoms ‐ Physical at two month follow‐up.Assessed with: DRSP. Scale range for DRSP (physical) 0‐66. Lower scores indicate less severe premenstrual symptoms | The mean overall premenstrual symptoms ‐ Physical was 46.11 | MD 9.11 lower (10.82 lower to 7.40 lower) | ‐ | 67 (1 RCT) | ⊕⊕⊝⊝ LOW 1 | Acupuncture may reduce the number of physical PMS related symptoms women have, compared to sham acupuncture. |
| Adverse events at up to 2 months' follow‐up | 24 per 1000 | 42 per 1000 (10 to 189) | RR 1.74 (0.39 to 7.76) | 167 (3 RCTs) | ⊕⊝⊝⊝ VERY LOW 2 3 | There was insufficient evidence to determine whether there was any difference between the groups in the rate of adverse events. |
| Specific PMS symptoms ‐ not measured | ‐ | ‐ | ‐ | ‐ | ‐ | No studies reported on this outcome |
| Response rate at end of treatment | 327 per 1000 | 1000 per 1000 (147 to 1000) | RR 4.22 (0.45 to 39.88) | 100 (2 RCTs) | ⊕⊝⊝⊝ VERY LOW 4 5 6 | There was insufficient evidence to determine whether there was any difference in response rate between the groups. |
| Quality of Life
assessed with: WHOQOL‐BREF. Scale range 0‐100. Higher scores indicate greater quality of life. |
The mean quality of life score was 73.8 | MD 2.85 higher (1.47 higher to 4.23 higher) | ‐ | 67 (1 RCT) | ⊕⊕⊝⊝ LOW 1 | Acupuncture may improve quality of life, compared to sham acupuncture. |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; MD: mean difference; RCT: randomised controlled trial; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Downgraded two levels due to very serious imprecision: small sample size (67 participants)
2 Downgraded one level due to serious risk of bias: unclear risk of blinding of both participants and assessors in one of the three trials. This may have affected adverse event reporting.
3 Downgraded two levels due to very serious imprecision: small sample size (167 participants) and rare events. 95% confidence interval covers both benefit and harm
4 Downgraded two levels due to very serious imprecision: small sample size (100 participants)
5 Downgraded one level due to serious risk of bias: unclear risk of blinding of both participants and assessors in one of the two included trials. This may be affected response rate.
6 Downgraded one level due to serious inconsistency: significant heterogeneity (I2 = 82%) due to different definitions of response rate.