Author: Sheikh, Amer Ikram
Date published: March 1, 2010
Recent adequately powered, randomised controlled trials have shown the effi cacy of corticosteroids in Bells palsy. These contradict the recent study by Tong et al published in Acupuncture in Medicine and the 2004 Cochrane review on the subject. The authors believe that the study by Tong et al has serious methodological fl aws that make its results invalid in determining the effi cacy of corticosteroids or acupuncture for idiopathic facial palsy.
We would like to express our concerns regarding the randomised controlled trial from Tong et al, which aimed to show the effi cacy of steroids or acupuncture for idiopathic peripheral facial paralysis.1
1. The authors mention in the Introduction that there is no good evidence that medication is effective for Bells palsy and refer to the Cochrane database of systematic reviews. Since there is no citation, we assume that they are referring to the 2004 Cochrane review, which included four trials with a total of 179 patients, and concluded that there was no evidence for the effi cacy of corticosteroids. 2 Since that review, there have been two recently published, adequately powered, randomised controlled trials that contradict the fi ndings of the 2004 Cochrane review and the results of the trial by Tong et al. Both of these trials had signifi cantly greater numbers than the Cochrane review and showed that prednisolone signifi cantly improves the chances of complete recovery and shortens the time to recovery in patients with Bells palsy.3 4
2. We believe that this study has major fl aws in its methodology that seriously compromise its internal validity. It is apparent that the sample size of this trial was not calculated before the start of the study. This resulted in a small sample size that did not have the power to detect the effect of steroids or acupuncture in the treatment of Bells palsy. The authors have not explained why there were disparate numbers of patients recruited in the three groups with almost twice the number in the steroid group as there were randomised to receive acupuncture. Block randomisation could have been used to avoid the signifi cant imbalance in sample size among the three groups.
3. Although the authors have mentioned that poor prognostic factors include poor initial grade of severity, diabetes mellitus and hypertension, they have only made mention of initial grade of severity in the three groups. Since there were signifi - cantly milder cases in the control group, this was likely to affect the fi nal results when a comparison was made with acupuncture or corticosteroids. This is a major fl aw in the study and could have been avoided if randomisation of patients was stratifi ed by the initial grade of facial palsy. Also, no mention was made of the numbers of diabetic or hypertensive patients in the three groups, so it is not possible to say if these groups were comparative.
4. The Copenhagen Facial Nerve Study showed that 85% of people with idiopathic peripheral facial nerve palsy regained normal function within 3 weeks.5 As this has been previously established in the literature, most interventional study designs involve early recruitment of affected patients, and the two recent studies quoted above started intervention within 72 h of onset of symptoms. In our view, it is unfair to assess the effect of any attempted intervention by broadening the recruitment period to 2 weeks as Tong et al have done in this study.
Although the acupuncture points used were according to Traditional Chinese Medicine, they would also be acceptable to Western Medical acupuncturists, since they were over the muscles supplied by the facial nerve. However, it is debatable whether an adequate acupuncture dose was given.6 The use of 20 min of manual acupuncture eliciting de qi given three times each week may be adequate for chronic conditions such as knee pain. However, we would like to have seen the use of electroacupuncture in an acute condition such as idiopathic facial palsy when time is of the essence in affecting a change, especially when starting as late as 2 weeks after onset as the authors have done in this study.
Amer Ikram Sheikh, Abdullah Al Khenizan
Department of Family Medicine & Polyclinics, King Faisal Specialist Hospital & Research Centre, Riyadh, Kingdom of Saudi Arabia
Correspondence to Dr Amer Ikram Sheikh, Department of Family Medicine & Polyclinics, King Faisal Specialist Hospital & Research Centre, MBC-62, PO Box 3354, Riyadh 11211, Kingdom of Saudi Arabia; email@example.com
Competing interests None.
Provenance and peer review Not commissioned; not externally peer reviewed.
Accupunct Med 2010;28:56. doi:10.1136/aim.2010.002337
Our study was designed and written before the publication of some recent randomised controlled trials on treatment of facial palsy, including those mentioned by Dr Amer and also some others using acupuncture; our design and results will have been different if those results were known.
The number of patients in the steroid group was larger, due to randomisation, which was unexpected and uncontrollable. We tried to focus our study on comparison of steroid and acupuncture. The initial grade of facial palsy did affect the outcome, as mentioned in our Discussion column, but stratifi cation would split them into even smaller groups and would further decrease the statistical signifi cance. The effects of diabetes and hypertension were not the focus of our study.
We tried to recruit more patients into the study by including those with onset within 2 weeks. Most patients were treated early with an average onset of just 2.6 days.
There were various reported acupuncture regime in treating facial palsy, including electroacupuncture, acupuncture plus moxibustion, acupuncture using different acupoints, strength and duration, and we based our protocol on standard offi cial acupuncture textbooks for senior colleges in mainland China. Electroacupuncture is not recommended for acute facial paralysis, according to the textbooks.
Our study was certainly not perfect, as we mentioned in the Discussion. We hope we can prompt a large-scale study on the comparison of effi cacies of steroid and acupuncture with suffi cient statistical signifi cance in future.
F M Tong
Correspondence to Dr F M Tong, Department of ENT, Pamela Youde Nethersole Eastern Hospital, ENT Unit, PYNEH, Lok Man Road, Chai Wan, Hong Kong 852, PR China; firstname.lastname@example.org
Provenance and peer review Not commissioned; not externally peer reviewed.
Accupunct Med 2010;28:56. doi:10.1136/aim.2010.002451
1. Tong FM, Chow SK, Chan PY, et al. A prospective randomised controlled study on effi cacies of acupuncture and steroid in treatment of idiopathic peripheral facial paralysis. Acupunct Med 2009;27:16973
2. Salinas RA, Alvarez G, Alvarez MI, et al. Corticosteroids for Bells palsy (idiopathic facial paralysis). Cochrane Database Syst Rev 2002;1:CD001942.
3. Sullivan FM, Swan IR, Donnan PT, et al. Early treatment with prednisolone or acyclovir in Bells palsy. N Engl J Med 2007;357:1598607.
4. Engstrm M, Berg T, Stjernquist-Desatnik A, et al. Prednisolone and valaciclovir in Bells palsy: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet Neurol 2008;7:9931000.
5. Peitersen E. Bells palsy: the spontaneous course of 2,500 peripheral facial nerve palsies of different etiologies. Acta Otolaryngol Suppl 2002;549:430.
6. White A, Cummings M, Barlas P, et al. Defi ning an adequate dose of acupuncture using a neurophysiological approacha narrative review of the literature. Acupunct Med 2008;26:11120.