Acupuncture for Post-traumatic Olfactory Dysfunction: A Randomized Controlled Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Acupuncture: Acupoint selection: Fengchi (GB20, bilateral, quick needling), Jingbailao (bilateral, quick needling), Dazhuipang (bilateral, quick needling); Shenting (DU24), Baihui (DU20), Yingxiang penetrating Bitong (bilateral), Quanliao penetrating Bitong (bilateral), Hegu (LI4, bilateral), Wailaogong (bilateral), Zusanli (ST36, bilateral), Taichong (LR3, bilateral). Procedure: The patient is first seated upright. Quick needling (without needle retention) is performed at Fengchi, Jingbailao, and Dazhuipang. Then the patient assumes a supine position. Needles are inserted at Shenting, Baihui, Wailaogong, and Taichong, while deep needling is applied at Yingxiang penetrating Bitong, Quanliao penetrating Bitong, Hegu, and Zusanli. After achieving deqi (needle sensation), the needles are retained for 20 minutes. Course of treatment: Acupuncture is given 3 times per week for 4 weeks (total 12 sessions)

Corticosteroid therapy: Oral prednisone given as a short-term course (4 weeks). Dosage and tapering schedule: Week 1: 30 mg/d; Week 2: 15 mg/d; Week 3: 10 mg/d; Week 4: 5 mg/d, then discontinued after 4 weeks.

sham acupuncture: Sham acupuncture: Park sham acupuncture device (placebo needle) is used. The acupoint selection and operation sites are the same as those in the treatment group. After routine disinfection, the needle holder is applied to the acupoint, and the needle is inserted into the holder without penetrating the skin, and retained for 20 minutes. The treatment course is the same as the treatment group (3 times per week for 4 weeks).

Oral Prednisone placebo: The placebo tablets were manufactured to be identical in appearance (color, size, shape) and taste to the active prednisone tablets, ensuring effective blinding. Participants received the placebo orally according to the same tapering regimen as the control group: 30 mg/day (as equivalent tablet count) for week 1, 15 mg/day for week 2, 10 mg/day for week 3, and 5 mg/day for week 4, after which the medication was discontinued. The total course lasted 4 weeks, matching the duration of both the active prednisone therapy and the acupuncture sessions.

Study summary

The goal of this clinical trial is to learn if acupuncture based on the "Form-Qi-Spirit" theory works to treat post-traumatic olfactory dysfunction in adults. It will also learn about the safety of this acupuncture treatment.

The main questions it aims to answer are:

Is the efficacy of 4-week acupuncture treatment superior to 4-week steroid treatment for post-traumatic olfactory dysfunction?

What medical problems or side effects do participants have when receiving acupuncture?

Researchers will compare real acupuncture plus a placebo (a look-alike pill with no active drug) to sham acupuncture (non-penetrating placebo needles) plus low-dose oral steroids (prednisone) - to see if the real acupuncture strategy works better than the steroid strategy for post-traumatic olfactory dysfunction.

Participants will:

Receive real acupuncture + placebo pills, OR sham acupuncture + low-dose prednisone, for 4 weeks

Undergo acupuncture/sham sessions 3 times per week (12 sessions in total)

Take the assigned pills daily (with tapering doses over 4 weeks)

Visit the clinic for smell tests, psychological assessments, and safety checks at baseline, at 4 weeks (end of treatment), and at 12 weeks (8 weeks after treatment ends)

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Eligibility

Primary outcome measure(s)

• Improvement rate of the CSIT score at 4 weeks — From enrollment to the end of treatment at 4 weeks
  Improvement rate of the CSIT score at 4 weeks.The olfactory identification test is the Chinese Smell Identification Test (CSIT), developed by the Human Olfaction Laboratory, Institute of Psychology, Chinese Academy of Sciences, based on the Chinese population. It contains 40 odor items familiar to the Chinese population and has a 6-month test-retest reliability of 0.92.If the CSIT score improves by 4 points or more, this indicates an improvement in olfactory function.

Trial sites (2)

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