Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial

Background:

The traditional Chinese theory of acupuncture emphasizes that the intensity of acupuncture must reach a threshold to generate de qi, which is necessary to achieve the best therapeutic effect. De qi is an internal compound sensation of soreness, tingling, fullness, aching, cool, warmth and heaviness, and a radiating sensation at and around the acupoints. However, the notion that de qi must be achieved for maximum benefit has not been confirmed by modern scientific evidence.

Methods:

We performed a prospective multicentre randomized controlled trial involving patients with Bell palsy. Patients were randomly assigned to the de qi (n = 167) or control (n = 171) group. Both groups received acupuncture: in the de qi group, the needles were manipulated manually until de qi was reached, whereas in the control group, the needles were inserted without any manipulation. All patients received prednisone as a basic treatment. The primary outcome was facial nerve function at month 6. We also assessed disability and quality of life 6 months after randomization.

Results:

After 6 months, patients in the de qi group had better facial function (adjusted odds ratio [OR] 4.16, 95% confidence interval [CI] 2.23–7.78), better disability assessment (differences of least squares means 9.80, 95% CI 6.29–13.30) and better quality of life (differences of least squares means 29.86, 95% CI 22.33–37.38). Logistic regression analysis showed a positive effect of the de qi score on facial-nerve function (adjusted OR 1.07, 95% CI 1.04–1.09).

Interpretation:

Among patients with Bell palsy, acupuncture with strong stimulation that elicited de qi had a greater therapeutic effect, and stronger intensity of de qi was associated with the better therapeutic effects. Trial registration: Clinicaltrials.gov no. NCT00685789.The use of acupuncture has gained increasing attention worldwide.^1,2 There is a long-held belief in the traditional theory and clinical practice of acupuncture that the intensity of the stimulus must reach a threshold to elicit de qi, which plays a pivotal role in achieving the best therapeutic effects.^3,4De qi — an internal compound sensation of soreness, tingling, fullness, aching, cool, warmth, heaviness and a radiating sensation at and around acupoints — is elicited by manipulation of the needles (rotated as well as being moved upward and downward).⁵ The concept of de qi, originating from the long-term accumulation of clinical experiences, has been explained to some degree by several scientific studies.^6–11 However, this long-held belief has not been confirmed by sufficient evidence from randomized controlled trials.⁵ Consequently, de qi and its related techniques have been neglected in acupuncture practice and research. As such, the therapeutic effects of acupuncture may be seriously compromised.^12–14In this study, we compared the efficacy of acupuncture with either strong (intended to elicit de qi) or weak stimulation among patients with Bell palsy.