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Is strengthened stimulation during manual acupuncture effective for the treatment of Bell palsy?
Date of publication of the randomized controlled trial: April 2013
Design
Randomized controlled trial (RCT).
Participants
338 Bell palsy patients aged 18 to 65 years with unilateral facial-nerve weakness without an identifiable cause within 168 hours after the onset of symptoms, and had not received any treatment (mean age for de qi group: 38.12 years, mean age for no de qi group: 38.15 years, male%: 57.1%).
Intervention
Manual acupuncture was provided in 20 sessions over 4 weeks. Each session lasted for 30 minutes and the frequency of each session was 5 times per week. Needles were manipulated manually after insertion, using techniques such as lifting, thrusting and twirling until de qi was achieved. The needles were left in place for 30 minutes.
Comparator
Comparison: Manual acupuncture with strong stimulation that elicited de qi versus manual acupuncture with no de qi. Manual acupuncture with no de qi referred to needles inserting and leaving in place for 30 minutes without manipulation.
Major Outcomes
Outcome 1: Facial-nerve functions as measured by the rates of grade 1 scores on the House-Brackmann Scale at 6 months (Grade 1 indicates normal facial-nerve function and grade 6 indicates complete paralysis);
Outcome 2: Disability as measured by Facial Disability Index at 6 months;
Outcome 3: Health-related quality of life as measured by the WHO’s Quality of Life (brief version) score at 6 months.
Outcome 2: Disability as measured by Facial Disability Index at 6 months;
Outcome 3: Health-related quality of life as measured by the WHO’s Quality of Life (brief version) score at 6 months.
Settings
This trial was conducted at 11 tertiary care hospitals in China.
Comparison Manual acupuncture with strong stimulation that elicited de qi versus manual acupuncture with no de qi
Main Results
Compared to manual acupuncture with no de qi, patients in de qi group demonstrated better facial function (adjusted differences of least squares means: 4.2, 95% CI: 2.2 to 7.8), better disability assessment (adjusted differences of least squares means: 9.80, 95% CI: 6.29 to 13.30) and better quality of life (adjusted differences of least squares means: 29.9, 95% CI: 22.3 to 37.4).
| Outcomes (units) | No. of studies (Total no. of participants) | No. of normal facial-nerve function/ No. of participants | Heterogeneity test (I2) | Adjusted differences of least squares means (95% CI) | Overall quality of evidence* | |
| Intervention | Comparator | |||||
| 1 (NA) | 1 (338) | 150/ 167 | 121/ 171 | Not applicable as there is only 1 study | 4.2 (2.2 to 7. 8) | Moderate |
| Outcomes (units) | No. of studies (Total no. of participants) | Mean score / No. of participants | Heterogeneity test (I2) | Adjusted differences of least squares means (95% CI) | Overall quality of evidence* | |
| Intervention | Comparator | |||||
| 2 (NA) | 1 (338) | 191.8 / 167 | 182.0 / 171 | Not applicable as there is only 1 study | 9.80 (6.29 to 13.30) | Moderate |
| 3 (NA) | 1 (338) | 340.1/ 167 | 310.3/ 171 | Not applicable as there is only 1 study | 29.9 (22.3 to 37.4) | Moderate |
Comparison Manual acupuncture with strong stimulation that elicited de qi versus manual acupuncture with no de qi
Main Results
Compared to manual acupuncture with no de qi, patients in de qi group demonstrated better facial function (adjusted differences of least squares means: 4.2, 95% CI: 2.2 to 7.8), better disability assessment (adjusted differences of least squares means: 9.80, 95% CI: 6.29 to 13.30) and better quality of life (adjusted differences of least squares means: 29.9, 95% CI: 22.3 to 37.4).
Comparison: Manual acupuncture with strong stimulation that elicited de qi versus manual acupuncture with no de qi among patients with Bell palsy at 6 months
| Outcomes (units) | 1 (NA) | |
|---|---|---|
| No. of studies (Total no. of participants) | 1 (338) | |
| No. of normal facial-nerve function/ No. of participants | Intervention | 150/ 167 |
| Comparator | 121/ 171 | |
| Adjusted differences of least squares means (95% CI) | 4.2 (2.2 to 7. 8) | |
| Overall quality of evidence* | Moderate | |
| Outcomes (units) | 2 (NA) | 3 (NA) | |
|---|---|---|---|
| No. of studies (Total no. of participants) | 1 (338) | 1 (338) | |
| Mean score / No. of participants | Intervention | 191.8 / 167 | 340.1/ 167 |
| Comparator | 182.0 / 171 | 310.3/ 171 | |
| Adjusted differences of least squares means (95% CI) | 9.80 (6.29 to 13.30) | 29.9 (22.3 to 37.4) | |
| Overall quality of evidence* | Moderate | Moderate | |
Keys: CI = confidence interval.
Conclusion
Benefits
Compared to no de qi group, manual acupuncture with strong stimulation that elicited de qi significantly improved the therapeutic effect for patients with Bell palsy. After 6 months, patients in the de qi group had better facial function, better disability assessment and better quality of life.
For all outcomes, the overall quality of evidence is moderate. Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
Harms
No serious adverse events were reported. In total, 212 adverse events were reported in de qi group and 203 adverse events were reported in the no de qi group. Most of the adverse events include minor bleeding, needling pain, bruising and faintness during treatment.
Link to Original Article
https://www.ncbi.nlm.nih.gov/pubmed/23439629The synopsis is based on the following article:
Xu SB, Huang B, Zhang CY, Du P, Yuan Q, Bi GJ, et al. Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial. Canadian Medical Association Journal. 2013 Apr 2;185(6):473-8.
Xu SB, Huang B, Zhang CY, Du P, Yuan Q, Bi GJ, et al. Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial. Canadian Medical Association Journal. 2013 Apr 2;185(6):473-8.
* Interpretation of quality assessment results:
• Very low: Further research is most likely to have an important impact on our confidence in this estimate of effect.
• Low: Further research is likely to have an important impact on our confidence in this estimate of effect.
• Moderate: Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
• High: Further research is unlikely to have an important impact on our confidence in this estimate of effect.
• Very high: Further research is most unlikely to have an important impact on our confidence in this estimate of effect.
Details of assessment method can be found at Chung VC, Wu XY, Ziea ET, Ng BF, Wong SY, Wu JC. Assessing internal validity of clinical evidence on effectiveness of CHinese and integrative medicine: Proposed framework for a CHinese and Integrative Medicine Evidence RAting System (CHIMERAS). European Journal of Integrative Medicine. 2015 Aug 31;7(4):332-41.
• Very low: Further research is most likely to have an important impact on our confidence in this estimate of effect.
• Low: Further research is likely to have an important impact on our confidence in this estimate of effect.
• Moderate: Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
• High: Further research is unlikely to have an important impact on our confidence in this estimate of effect.
• Very high: Further research is most unlikely to have an important impact on our confidence in this estimate of effect.
Details of assessment method can be found at Chung VC, Wu XY, Ziea ET, Ng BF, Wong SY, Wu JC. Assessing internal validity of clinical evidence on effectiveness of CHinese and integrative medicine: Proposed framework for a CHinese and Integrative Medicine Evidence RAting System (CHIMERAS). European Journal of Integrative Medicine. 2015 Aug 31;7(4):332-41.
