Nifedipino para la dismenorrea primaria
Referencias
Referencias de los estudios incluidos en esta revisión
Referencias de los estudios excluidos de esta revisión
Referencias adicionales
Characteristics of studies
Characteristics of included studies [ordered by study ID]
Ir a:
| Study characteristics | ||
| Methods | Randomised controlled trial | |
| Participants | Women aged 16 to 30 years with primary dysmenorrhoea (n = 40) | |
| Interventions | Nifedipine 10 mg sublingual 8 hourly as needed versus placebo | |
| Outcomes | Improvement in pain, duration of menstruation, amount of bleeding, menstrual symptoms/side‐effects | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Used random number table with double‐blind technique |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | Low risk | Stated used double‐blind technique |
| Blinding of outcome assessment (detection bias) | Low risk | Stated used double‐blind technique |
| Incomplete outcome data (attrition bias) | Unclear risk | Unclear if all participants accounted for |
| Selective reporting (reporting bias) | Low risk | Questionnaire used for all participants to collect data |
| Other bias | Low risk | Nil identified |
| Study characteristics | ||
| Methods | Double blind randomised placebo controlled parallel trial | |
| Participants | 14‐25 year old females with primary dysmenorrhoea | |
| Interventions | Nifedipine 5mg 8 hourly as needed for up to 3 days (n = 22) versus placebo (n = 20) | |
| Outcomes | Relief score (ability to relieve symptoms), severity score (degree to which dysmenorrhoea interfered with activities), need for additional analgesics, side effects | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not stated in methods |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | Low risk | Stated used double‐blind technique |
| Blinding of outcome assessment (detection bias) | Unclear risk | Stated used double‐blind but not clearly described |
| Incomplete outcome data (attrition bias) | High risk | 8 out of total 50 patients dropped out of trial without stating reasons |
| Selective reporting (reporting bias) | Low risk | All remaining 42 participants' data included |
| Other bias | Low risk | Nil identified |
| Study characteristics | ||
| Methods | Randomised controlled trial | |
| Participants | Women aged 15 to 35 years with primary dysmenorrhoea (n = 24) | |
| Interventions | Nifedipine 10 mg capsules (n = 19) versus placebo (n = 5) | |
| Outcomes | Relief of pain, if substance was better than previous analgesic, if would use substance monthly, amount of relief, dosage schedule needed if more than one pill used, side effects | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Probably done but uncertain; "randomised through hospital pharmacy". Very uneven numbers in each group: nifedipine = 19; placebo = 5. |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | Unclear risk | Placebo capsules were identical‐looking. Not clearly stated |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not clearly stated |
| Incomplete outcome data (attrition bias) | Low risk | All participants accounted for |
| Selective reporting (reporting bias) | Unclear risk | Participants recorded reaction to the medications as they occurred but these and side effects were discussed with investigator at follow‐up visit |
| Other bias | Low risk | Nil identified |
Characteristics of excluded studies [ordered by study ID]
Ir a:
| Study | Reason for exclusion |
| Review article | |
| The intervention in this study was a different calcium channel blocker, ineligible for this review | |
| In vitro study of myometrial extracts | |
| Not a randomised controlled trial (nifedipine given as intervention but no control) | |
| Not a randomised controlled trial (nifedipine given as intervention but no control) |
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Pain relief (any) Show forest plot | 2 | 66 | Odds Ratio (M‐H, Fixed, 95% CI) | 9.04 [2.61, 31.31] |
| Analysis 1.1  Comparison 1: Nifedipine vs placebo, Outcome 1: Pain relief (any) | ||||
| 1.2 Good or excellent pain relief Show forest plot | 2 | 66 | Odds Ratio (M‐H, Fixed, 95% CI) | 43.78 [5.34, 359.01] |
| Analysis 1.2  Comparison 1: Nifedipine vs placebo, Outcome 2: Good or excellent pain relief | ||||
| 1.3 Total side effects Show forest plot | 1 | 24 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.94 [0.08, 10.90] |
| Analysis 1.3  Comparison 1: Nifedipine vs placebo, Outcome 3: Total side effects | ||||
| 1.4 Bothersome side effects Show forest plot | 1 | 24 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.54 [0.07, 4.20] |
| Analysis 1.4  Comparison 1: Nifedipine vs placebo, Outcome 4: Bothersome side effects | ||||
| 1.5 Requirement for additional medication Show forest plot | 1 | 42 | Odds Ratio (M‐H, Fixed, 95% CI) | 13.60 [3.09, 59.83] |
| Analysis 1.5  Comparison 1: Nifedipine vs placebo, Outcome 5: Requirement for additional medication | ||||
Study flow diagram.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Comparison 1: Nifedipine vs placebo, Outcome 1: Pain relief (any)
Comparison 1: Nifedipine vs placebo, Outcome 2: Good or excellent pain relief
Comparison 1: Nifedipine vs placebo, Outcome 3: Total side effects
Comparison 1: Nifedipine vs placebo, Outcome 4: Bothersome side effects
Comparison 1: Nifedipine vs placebo, Outcome 5: Requirement for additional medication
| Nifedipine compared to placebo for primary dysmenorrhoea | ||||||
| Patient or population: primary dysmenorrhoea | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with placebo | Risk with nifedipine | |||||
| Pain relief (any) | 400 per 1,000 | 858 per 1,000 | OR 9.04 | 66 | ⊕⊝⊝⊝ |
|
| Good or excellent pain relief | 0 per 1,000 | 0 per 1,000 | OR 43.78 | 66 | ⊕⊝⊝⊝ |
|
| Health‐related quality of life | Not reported in any study |
|
| |||
| Total adverse effects | 800 per 1,000 | 790 per 1,000 | OR 0.94 | 24 | ⊕⊝⊝⊝ |
|
| Bothersome adverse effects | 400 per 1,000 | 265 per 1,000 | OR 0.54 | 24 | ⊕⊝⊝⊝ |
|
| Requirement for additional medication | 800 per 1,000 | 219 per 1,000 | OR 0.07 | 42 | ⊕⊝⊝⊝ |
|
| *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). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1Downgraded 2 levels for imprecision; data from two small trials and thus likely underpowered to make reliable conclusions about outcomes | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Pain relief (any) Show forest plot | 2 | 66 | Odds Ratio (M‐H, Fixed, 95% CI) | 9.04 [2.61, 31.31] |
| 1.2 Good or excellent pain relief Show forest plot | 2 | 66 | Odds Ratio (M‐H, Fixed, 95% CI) | 43.78 [5.34, 359.01] |
| 1.3 Total side effects Show forest plot | 1 | 24 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.94 [0.08, 10.90] |
| 1.4 Bothersome side effects Show forest plot | 1 | 24 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.54 [0.07, 4.20] |
| 1.5 Requirement for additional medication Show forest plot | 1 | 42 | Odds Ratio (M‐H, Fixed, 95% CI) | 13.60 [3.09, 59.83] |
