| Outcomes | No of Participants (studies*) Follow up | Quality of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects | |
|---|---|---|---|---|---|
| Risk with Control | Risk difference with Staphylococcus vaccine (Staphypan Berna) versus placebo (95% CI) | ||||
|
Pain: pain on VAS Scale from: unclear |
98 (1 study) 32 weeks |
⊕⊕⊝⊝ LOW1 due to indirectness |
The mean pain: pain on vas at 32 weeks in the control groups was 6.2 |
The mean pain: pain on vas at 32 weeks in the intervention groups was 0.3 lower (1.12 lower to 0.52 higher) | |
| Adverse events |
100 (1 study) 32 weeks |
⊕⊝⊝⊝ due to indirectness, imprecision | RR 1.08 (0.75 to 1.55) | 520 per 1000 |
42 more per 1000 (from 130 fewer to 286 more) |
|
Symptom scales: clinical global impression of change Scale from; 1 to 7. |
98 (1 study) 32 weeks |
⊕⊝⊝⊝ due to indirectness, imprecision |
The mean symptom scales: clinical global impression of change at 32 weeks in the control group was 4.4 |
The mean symptom scales: clinical global impression of change at 32 weeks in the intervention groups was 0.7 lower (1.22 to 0.18 lower) | |
|
Symptom scales: clinical global impression of severity Scale from: 1 to 7. |
98 (1 study) 32 weeks |
⊕⊝⊝⊝ due to indirectness, imprecision |
The mean symptom scales: clinical global impression of severity at 32 weeks in the control group was 4.8 |
The mean symptom scales: clinical global impression of severity at 32 weeks in the intervention groups was 0.3 lower (0.53 to 0.07 lower) | |
The majority of the evidence included an indirect population (downgraded by one increment) or a very indirect population (downgraded by two increments):1) downgraded if the ME/CFS diagnostic criteria used did not include PEM as a compulsory feature [original analysis]; percentage of participants with PEM unclear [PEM reanalysis – see Appendix G for additional details]; 2) further downgraded as the population was also required to also meet diagnostic criteria for fibromyalgia.
Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs
Studies included: Zachrisson 2002
From: Pharmacological interventions
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