Table.
GRADE Evaluation of interventions for Dysmenorrhoea.
| Important outcomes | Daily activities and work, Pain, Quality of life | ||||||||
| Studies (Participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of treatments for primary dysmenorrhoea? | |||||||||
| 19 (1175) | Pain | NSAIDs versus placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for unclear randomisation methodology and reporting of results post-crossover |
| at least 4 (at least 229) | Daily activities and work | NSAIDs versus placebo | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for unclear randomisation methodology. Directness point deducted for inclusion of data on aspirin v placebo |
| 6 (972) | Pain | Different NSAIDs versus each other | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for unclear randomisation methodology and reporting of results post-crossover. Directness point deducted for large number of comparators |
| 2 (205) | Pain | Acupressure versus sham acupressure or no treatment | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for incomplete reporting of results. Directness point deducted for narrow inclusion criteria |
| 1 (144) | Pain | Acupressure versus NSAIDs | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for narrow inclusion criteria |
| 9 (522) | Pain | Aspirin versus placebo | 4 | –2 | –1 | 0 | 0 | Very low | Quality points deducted for short follow-up and reporting of results post-crossover. Consistency point deducted for different results for different outcomes |
| at least 3 (at least 203) | Daily activities and work | Aspirin versus placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for short follow-up and reporting of results post-crossover |
| 1 (30) | Pain | Paracetamol versus placebo | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting, and reporting of results post-crossover |
| 1 (30) | Pain | Paracetamol versus aspirin | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting, and reporting of results post-crossover |
| 1 (32) | Pain | Aspirin versus NSAIDs | 4 | –3 | 0 | 0 | 0 | Very low | Quality point deducted for sparse data, incomplete reporting, and methodological weaknesses including short follow-up, and reporting of results post-crossover |
| 2 (128) | Pain | Paracetamol versus NSAIDs | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting, and methodological weaknesses including short follow-up, and reporting of results post-crossover |
| 1 (556) | Pain | Thiamine versus placebo | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for restricted population (Indian adolescent women) |
| 1 (50) | Pain | Toki-shakuyaku-san versus placebo | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, unclear allocation methodology, and incomplete reporting of results |
| 1 (40) | Pain | Topical heat versus placebo | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for inclusion of volunteer women as well as those presenting for medical care |
| 1 (41) | Pain | Topical heat versus NSAIDs | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for inclusion of volunteer women as well as those presenting for medical care |
| 1 (301) | Pain | Topical heat versus paracetamol | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for incomplete reporting of results and short follow-up |
| at least 3 (at least 75) | Pain | High-frequency TENS versus placebo TENS | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, reporting of results post-crossover, and uncertainty about randomisation and blinding |
| 1 (24) | Daily activities and work | High-frequency TENS versus placebo TENS | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data and uncertainty about randomisation and blinding |
| 1 (26) | Quality of life | High-frequency TENS versus placebo TENS | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and reporting of results post-crossover |
| 4 (86) | Pain | Low-frequency TENS versus placebo TENS or placebo tablet | 4 | –3 | –1 | 0 | 0 | Very low | Quality points deducted for sparse data, reporting of results post-crossover, and uncertainty about randomisation and blinding. Consistency point deducted for different results for different outcomes |
| 1 (24) | Daily activities and work | Low-frequency TENS versus placebo TENS or placebo tablet | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data and uncertainty about randomisation and blinding |
| 3 (at least 39) | Pain | High-frequency TENS versus low-frequency TENS | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, reporting of results post-crossover, and uncertainty about randomisation and blinding |
| 1 (24) | Daily activities and work | High-frequency TENS versus low-frequency TENS | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data and uncertainty about randomisation and blinding |
| 1 (32) | Pain | High-frequency TENS versus NSAIDs | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and reporting of results after crossover |
| 3 (478) | Pain | Vitamin E versus placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for uncertainty about method of randomisation and no significance assessment performed in 1 RCT |
| 3 (292) | Pain | Acupuncture versus placebo acupuncture or no treatment | 4 | 0 | 0 | –2 | 0 | Low | Directness points deducted for uncertainty about method for assessing outcomes (use of non-validated pain scales in 1 RCT), inclusion of women with secondary dysmenorrhoea in 1 RCT, and large number of comparators |
| 1 (201) | Quality of life | Acupuncture versus placebo acupuncture or no treatment | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for significant baseline differences. Directness point deducted for inclusion of women with secondary dysmenorrhoea |
| 1 (120) | Pain | Acupuncture versus NSAIDs | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 1 (69) | Pain | Relaxation treatment versus no treatment/waiting list control | 4 | –1 | –1 | –1 | 0 | Very low | Quality point deducted for sparse data. Consistency point deducted for different results for subgroups. Directness point deducted for older classification of disease no longer used |
| 6 (497) | Pain | Combined oral contraceptives versus placebo/no treatment | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for methodological flaws in included RCTs. Consistency point deducted for statistical heterogeneity |
| 2 (<120) | Pain | Fish oil versus placebo | 4 | –2 | –1 | –1 | 0 | Very low | Quality points deducted for sparse data and reporting of results post-crossover. Consistency point deducted for conflicting results. Directness point deducted for uncertainty about diagnosis |
| 3 (204) | Pain | Chinese herbal medicine versus placebo/no treatment | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for incomplete reporting of results. Directness point deducted for inclusion of different regimens |
| 14 (1441) | Pain | Chinese herbal medicine versus NSAIDs | 4 | 0 | –1 | –2 | 0 | Very low | Consistency point deducted for statistical heterogeneity. Directness points deducted for large number of comparators and inclusion of additional treatments |
| 2 (156) | Pain | Chinese herbal medicine versus acupuncture | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data and methodological weakness in RCTs (uncertainty about follow-up, randomisation method, and blinding) |
| 1 (55) | Pain | Chinese herbal medicine versus topical heat | 4 | –3 | 0 | –1 | +2 | Low | Quality points deducted for sparse data and methodological weaknesses (uncertainty about follow-up and randomisation method). Directness point deducted for uncertainty about method of assessment of outcome. Effect-size points added for large effect size |
| 1 (108) | Pain | Iranian herbal medicine versus placebo/no treatment | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 1 (106) | Pain | Iranian herbal medicine versus mefenamic acid | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for no direct statistical comparison between groups |
| 2 (68) | Pain | Laparoscopic uterine nerve ablation versus diagnostic laparoscopy | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for sparse data. Consistency point deducted for different results at different time points |
| 1 (68) | Pain | Laparoscopic uterine nerve ablation versus laparoscopic presacral neurectomy | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for sparse data. Consistency point deducted for different results at different time points |
| 3 (207) | Pain | Spinal manipulation versus sham manipulation or no treatment | 4 | –2 | –1 | 0 | 0 | Very low | Quality points deducted for sparse data and methodological weaknesses (poor allocation concealment and poor blinding). Consistency point deducted for different results at different time points and between studies |
We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.