Therapeutics

Strong stimulation acupuncture with needle manipulation improved recovery in Bell palsy

Xu SB, Huang B, Zhang CY, et al. Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial. CMAJ. 2013;185:473-9.

Clinical impact ratings: F ★★★★★✩✩ N ★★★★★★✩ Question In patients with Bell palsy, what is the efficacy of strong stimulation acupuncture with needle manipulation compared with acupuncture without needle manipulation?

Patient follow-up: 93% (intention-to-treat analysis).

Methods Design: Randomized controlled trial. Clinicaltrials.gov NCT00685789.

Main results The main results are in the Table.

Allocation: Concealed.* Blinding: Blinded* (patients, recruiters, and outcome assessors). Follow-up period: 6 months. Setting: 11 tertiary care hospitals in China. Patients: 338 patients 18 to 65 years of age (mean age 38 y, 57% men) within 168 hours of onset of untreated unilateral facial nerve weakness with no identifiable cause. Exclusion criteria included facial paralysis due to herpes zoster; recurrent facial paralysis; prior noticeable asymmetry of the face; or history of peptic ulcer, severe hypertension, uncontrolled diabetes, liver or kidney dysfunction, mental illness, or serious systemic diseases. Intervention: Strong stimulation acupuncture with needle manipulation (n = 167) or acupuncture without needle manipulation (needles inserted and left in place) (n = 171) for five 30-minute sessions each week for 4 weeks. Strengthened acupuncture comprised manual manipulation of the needles every 10 minutes after insertion (e.g., lifting, thrusting, or twirling) until patients reported a compound sensation of soreness, tingling, fullness, aching, coolness, warmth, heaviness, and a radiating sensation at and around acupoints. All patients received prednisone for 14 days. The study was stopped early due to expiration of funding. Strong stimulation acupuncture with needle manipulation vs acupuncture with no needle manipulation in patients with Bell palsy† Outcomes‡ Recovery§

Event rates Manipulation No manipulation 90%

71%

Mean score QOL¶

340

310

Disability**

192

182

At 6 mo RBI (95% CI) NNT (CI) 29% (19 to 34)

5 (5 to 8)

Difference of least square means (CI)|| 30 (22 to 37) 9.8 (6.3 to 13.3)

†RBI = relative benefit increase; QOL = quality of life; other abbreviations defined in Glossary. RBI, NNT, and CI calculated from control event rate and adjusted odds ratio in article. ‡Last observation carried forward to impute missing data for 22 patients. §Complete recovery (House–Brackmann score = 1, assessed by 3 neurologists using digitally recorded standard facial expressions). ||Adjusted for age, sex, center, time from onset to treatment, day-1 House–Brackmann score, and baseline Facial Disability Index and quality-of-life scores. ¶World Health Organization’s quality of life, brief version; higher score = better quality of health. **Facial Disability Index; higher score = less disability.

JC8

Outcomes: Primary outcome was recovery of facial nerve function (House–Brackmann score = 1, assessed by 3 neurologists using digitally recorded standard facial expressions). Secondary outcomes were quality of life and disability.

© 2013 American College of Physicians

Downloaded From: http://annals.org/ by a University of Otago User on 12/08/2016

Conclusion In patients with Bell palsy, strong stimulation acupuncture with needle manipulation improved recovery more than acupuncture without needle manipulation. *See Glossary.

Sources of funding: National Science Fund for Distinguished Young Scholars; Natural Science Foundation of China; National Basic Research Program. For correspondence: Dr. W. Wang, Huazhong University of Science and Technology, Wuhan, Hubei, China. E-mail wwang_tjh@ yahoo.com.cn. ■

Commentary Although acupuncture has a long history, the evidence base of modern clinical trials is sparse. A search of the Cochrane Database of Systematic Reviews for “acupuncture” (accessed 1 Sep 2013) returned 127 reviews, most of which conclude that there is insufficient evidence to support the use of acupuncture or that the methodologic quality of the included studies was low. In contrast, Xu and colleagues conducted a high-quality RCT in patients with Bell palsy. The study measured validated objective outcomes using blinded ratings of central image assessment of facial movements. Rather than using a sham procedure as a control, the study compared acupuncture with needle manipulation with intent to achieve de qi, a sensation felt by the patient, or acupuncture in the same location and of the same duration but without the goal of de qi. Patient questionnaires validated the differential achievement of de qi, but questionnaire responses may reflect patient awareness of de qi and unblinding of study group assignment. Despite its potential limitations, the study was able to detect a clinically relevant effect of strengthened stimulation during acupuncture. The study is also novel because it focused on peripheral nerve injury rather than on pain or other neurologic diseases. Although the study was carefully performed, it should be replicated. Based on the results of this trial, acupuncture can be added to evidence-based therapies for Bell palsy. Of note, study participants received acupuncture added to standard corticosteroid therapy. If the study results are to be applied, the acupuncture methods described in the study should be followed. Ken Uchino, MD, FAHA Cleveland Clinic Cleveland, Ohio, USA 19 November 2013 | ACP Journal Club | Volume 159 • Number 10

ACP Journal Club. Strong stimulation acupuncture with needle manipulation improved recovery in Bell palsy.

ACP Journal Club. Strong stimulation acupuncture with needle manipulation improved recovery in Bell palsy. - PDF Download Free
236KB Sizes 0 Downloads 0 Views